
[Federal Register Volume 79, Number 230 (Monday, December 1, 2014)]
[Rules and Regulations]
[Pages 71155-71259]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27833]



[[Page 71155]]

Vol. 79

Monday,

No. 230

December 1, 2014

Part II





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Parts 11 and 101





Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants 
and Similar Retail Food Establishments; Calorie Labeling of Articles of 
Food in Vending Machines; Final Rule

  Federal Register / Vol. 79 , No. 230 / Monday, December 1, 2014 / 
Rules and Regulations  

[[Page 71156]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]
RIN 0910-AG57


Food Labeling; Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: To implement the nutrition labeling provisions of the Patient 
Protection and Affordable Care Act of 2010 (Affordable Care Act or 
ACA), the Food and Drug Administration (FDA or we) is requiring 
disclosure of certain nutrition information for standard menu items in 
certain restaurants and retail food establishments. The ACA, in part, 
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), among 
other things, to require restaurants and similar retail food 
establishments that are part of a chain with 20 or more locations doing 
business under the same name and offering for sale substantially the 
same menu items to provide calorie and other nutrition information for 
standard menu items, including food on display and self-service food. 
Under provisions of the ACA, restaurants and similar retail food 
establishments not otherwise covered by the law may elect to become 
subject to these Federal requirements by registering every other year 
with FDA. Providing accurate, clear, and consistent nutrition 
information, including the calorie content of foods, in restaurants and 
similar retail food establishments will make such nutrition information 
available to consumers in a direct and accessible manner to enable 
consumers to make informed and healthful dietary choices.

DATES: Effective date: December 1, 2015.
    Compliance date: Covered establishments must comply with the rule 
by December 1, 2015. See section XXIII for more information on the 
effective and compliance dates.
    Comment Date: Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 by December 31, 2014 (see 
section XXVI, the ``Paperwork Reduction Act of 1995'' section of this 
document).

ADDRESSES: To ensure that comments on the information collection are 
received, the Office of Management and Budget (OMB) recommends that 
written comments be faxed to the Office of Information and Regulatory 
Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to 
oira_submission@omb.eop.gov. All comments should be identified with the 
OMB control number 0910-New and title ``Food Labeling: Nutrition 
Labeling of Standard Menu Items in Restaurants and Similar Retail Food 
Establishments.'' Also include the FDA docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Y. Reese, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, email: 
Daniel.Reese@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

Purpose and Coverage of the Final Rule

Summary of the Major Provisions of the Final Rule

Costs and Benefits

I. Background
II. Legal Authority
III. General Comments on the Proposed Rule
    A. Introduction
    B. Description of General Comments and FDA Response
IV. Comments and FDA Response on Proposed Conforming Amendments
    A. Section 11.1(g)--Electronic Signatures
    B. Sections 101.9(j)(1)(i), (j)(2), and (j)(3)--Nutrition 
Labeling of Food
    C. Section 101.10--Nutrition Labeling of Restaurant Foods Whose 
Labels or Labeling Bear Nutrient Content Claims or Health Claims
V. Key Terms That FDA Proposed to Define (Proposed Sec.  101.11(a))
VI. Comments and FDA Response on the Proposed Definitions of Terms 
Related to the Scope of Establishments Covered by the Rule (Proposed 
Sec.  101.11(a))
    A. Introduction
    B. Restaurant or Similar Retail Food Establishment
    C. Restaurant Food and Restaurant-Type Food
    D. Part of a Chain With 20 or More Locations
    E. Doing Business Under the Same Name
    F. Offering for Sale Substantially the Same Menu Items
    G. Authorized Official of a Restaurant or Similar Retail Food 
Establishment
    H. Covered Establishment
    I. Revisions to Several Provisions to Clarify the Applicability 
of the Rule to Those Restaurants and Similar Retail Food 
Establishments That Are Covered Establishments
VII. Comments and FDA Response on the Proposed Definition of Menu or 
Menu Board (Proposed Sec.  101.11(a))
VIII. Comments and FDA Response on the Proposed Definition of Terms 
Related to Foods Covered by the Rule (Proposed Sec.  101.11(a))
    A. Restaurant Food and Restaurant-Type Food
    B. Standard Menu Item
    C. Combination Meal
    D. Variable Menu Item
    E. Food on Display
    F. Self-Service Food
    G. Custom Order
    H. Daily Special
    I. Food That Is Part of a Customary Market Test
    J. Temporary Menu Item
IX. Comments and FDA Response on Proposed Sec.  101.11(b)(1)(i)--
Food Subject to the Labeling Requirements
X. Comments and FDA Response on Proposed Sec.  101.11(b)(1)(ii)--
Food Not Subject to the Labeling Requirements
    A. The Proposed Requirements
    B. Alcohol
    C. Condiments
    D. Daily Specials, Temporary Menu Items, Custom Orders, and Food 
That Is Part of a Customary Market Test
    E. Additional Comments on Food That Is Part of a Customary 
Market Test
XI. Comments and FDA Response on Proposed Sec.  
101.11(b)(2)(i)(A)(1) to (b)(2)(i)(A)(3)--General Requirements for 
Calorie Declaration on Menus and Menu Boards
XII. Additional Format Requirements That Apply When Declaring 
Calories on Menus and Menu Boards for Variable Menu Items, 
Combination Meals, and Toppings (Final Sec.  101.11(b)(2)(i)(A)(4) 
Through (b)(2)(i)(A)(8))
    A. Proposed Format for Declaring Calories for Variable Menu 
Items
    B. Decision To Require Option 4
    C. Requirements That Apply to Individual Variable Menu Items 
(Final Sec.  101.11(b)(2)(i)(A)(4))
    D. Requirements That Apply to a Variable Menu Item That Is 
Offered for Sale With the Option of Adding Toppings Listed on the 
Menu or Menu Board (Final Sec.  101.11(b)(2)(i)(A)(5))
    E. Requirements That Apply to a Combination Meal (Final Sec.  
101.11(b)(2)(i)(A)(6))
    F. Format Requirements for Declaring Calories for an Individual 
Variable Menu Item, a Combination Meal, and Toppings as a Range, if 
Applicable (Final Sec.  101.11(b)(2)(i)(A)(7))
    G. Exception for a Variable Menu Item When There Is No Clearly 
Identifiable Upper Bound to the Range of Calories (Final Sec.  
101.11(b)(2)(i)(A)(8))
    H. Declaring Calories Using Interactive Menus or New Technology
XIII. Additional Requirements That Apply to Beverages That Are Not 
Self-Service or on Display (Final Sec.  101.11(b)(2)(i)(A)(9))
XIV. Comments and FDA Response on Proposed Sec.  
101.11(b)(2)(i)(B)--Succinct Statement That Must Be on Menus and 
Menu Boards To Provide Context About Calories in a Daily Diet
    A. The Proposed Requirements
    B. Principles for Establishing the Succinct Statement

[[Page 71157]]

    C. Wording of the Succinct Statement
    D. Succinct Statement on Menus Targeted to Children
    E. Requirements for the Succinct Statement To Be Prominent, 
Clear, and Conspicuous
    F. Placement of the Succinct Statement on Menus and Menu Boards
XV. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(i)(C)--
Statement That Must Be on Menus and Menu Boards About Availability 
of Written Nutrition Information
    A. Proposed Wording of the Statement of Availability
    B. Requirements for the Statement of Availability To Be 
Prominent and Conspicuous
    C. Placement of the Statement of Availability
XVI. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(ii)--
Nutrition Information That Must Be Made Available in Written Form
    A. Required Nutrients
    B. Manner of Presentation of the Written Nutrition Information
    C. Nutrients in Insignificant Amounts
    D. Variable Menu Items
    E. Form of the Written Nutrition Information
XVII. Comments and FDA Response on Proposed Sec.  
101.11(b)(2)(iii)--Requirements for Food That Is Self-Service or on 
Display
    A. Applicability of Sec.  101.11(b)(2)(i) to Food That Is Self-
Service or on Display
    B. Placement of Calories for Self-Service Foods and Foods on 
Display
    C. Declaring Calories ``Per Item'' or ``Per Serving''
    D. Declaring Calories ``Per Serving'' for Self-Service Beverages
    E. Manner of Declaring Calories for Self-Service Foods and Foods 
on Display
    F. Applicability of Requirements for Written Nutrition 
Information, Succinct Statement, and Statement of Availability to 
Self-Service Foods and Foods on Display
    G. Succinct Statement and Statement of Availability for Self-
Service Foods and Foods on Display
    H. The Written Nutrition Information That Must Be Provided for 
Food That Is Self-Service or on Display
XVIII. Comments and FDA Response on Proposed Sec.  101.11(c)(1) to 
(c)(5)--Determination of Nutrient Content (Final Sec.  101.11(c)(1) 
to (c)(2))
XIX. Comments and FDA Response on Proposed Sec.  101.11(c)(6)--
Substantiation Documentation (Final 101.11(c)(3))
XX. Comments and FDA Response on Proposed Sec.  101.11(d)--Voluntary 
Registration to Elect To Be Subject to the Rule
XXI. Comments and FDA Response on Proposed Sec.  101.11(e)--
Signatures
XXII. Comments and FDA Response on Proposed Sec.  101.11(f)--
Misbranding
XXIII. Comments and FDA Response on Effective Date
    A. Proposed Effective Date and Request for Comment
    B. Comments on Proposed Effective Date
    C. Effective Date and Compliance Date for This Rule
XXIV. Comments and FDA Response on Compliance
XXV. Final Regulatory Impact Analysis
XXVI. Paperwork Reduction Act of 1995
XXVII. Federalism
XXVIII. Environmental Impact
XXIX. References

Executive Summary

Purpose and Coverage of the Final Rule

    More than two thirds of adults and about a third of children in the 
United States are overweight or obese. Overconsumption of calories is 
one of the primary risk factors for overweight and obesity. About half 
of consumers' annual food dollars are spent on, and a third of total 
calories come from, foods prepared outside the home, including foods 
from restaurants and similar retail food establishments. Many people do 
not know, or underestimate, the calorie and nutrient content of these 
foods. To help make nutrition information for these foods available to 
consumers in a direct, accessible, and consistent manner to enable 
consumers to make informed and healthful dietary choices, section 4205 
of the ACA requires that calorie and other nutrition information be 
provided to consumers in restaurants and similar retail food 
establishments that are part of a chain with 20 or more locations doing 
business under the same name and offering for sale substantially the 
same menu items (chain retail food establishment). Section 4205 of the 
ACA also provides that a restaurant or similar retail food 
establishment that is not a chain retail food establishment may elect 
to be subject to section 4205's nutrition labeling requirements by 
registering every other year with FDA.
    To be covered by this rule, an establishment must satisfy several 
criteria. First, the establishment must be a restaurant or similar 
retail food establishment. Under this rule, that means a retail 
establishment that offers for sale restaurant-type food, except if it 
is a school as defined in 7 CFR 210.2 or 220.2. Restaurants and similar 
retail food establishments include bakeries, cafeterias, coffee shops, 
convenience stores, delicatessens, food service facilities located 
within entertainment venues (such as amusement parks, bowling alleys, 
and movie theatres), food service vendors (e.g., ice cream shops and 
mall cookie counters), food take-out and/or delivery establishments 
(such as pizza take-out and delivery establishments), grocery stores, 
retail confectionary stores, superstores, quick service restaurants, 
and table service restaurants.
    The rule defines ``restaurant-type food'' in a way that both 
focuses on the food most like the food offered for sale in restaurants 
and reflects the statutory context of section 4205 of the ACA. The 
table that follows provides examples of foods that generally would be 
considered restaurant-type food (e.g., foods that are usually eaten on 
the premises, while walking away, or soon after arriving at another 
location), as well as examples of foods that generally would be not be 
considered restaurant-type food (e.g., foods that are grocery-type 
items that consumers often store for use at a later time or customarily 
further prepare), for the purposes of this rule.

[[Page 71158]]



    Examples of Foods That Generally Would or Would Not Be Considered
                          Restaurant-Type Food
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                                              Examples of foods that
 Examples of foods that generally would       generally would not be
   be considered restaurant-type food    considered restaurant-type food
------------------------------------------------------------------------
 Food for immediate consumption   Certain foods bought
 at a sit-down or quick service           from bulk bins or cases (e.g.,
 restaurant.                              dried fruit, nuts) in grocery
 Food purchased at a drive-       stores
 through establishment.                   Foods to be eaten over
 Food purchased at a drive-       several eating occasions or
 through establishment.                   stored for later use (e.g.,
 Take-out and delivery pizza;     loaves of bread, bags or boxes
 hot pizza at grocery and convenience     of dinner rolls, whole cakes,
 stores that is ready to eat; pizza       and bags or boxes of candy or
 slice from a movie theater.              cookies)
 Hot buffet food, hot soup at a   Foods that are usually
 soup bar, and food from a salad bar.     further prepared before
 Foods ordered from a menu/menu   consuming (e.g., deli meats
 board at a grocery store intended for    and cheeses)
 individual consumption (e.g., soups,     Foods sold by weight
 sandwiches, and salads).                 that are not self-serve and
 Self-service foods and foods     are not intended solely for
 on display that are intended for         individual consumption (e.g.,
 individual consumption (e.g.,            deli salads sold by unit of
 sandwiches, wraps, and paninis at a      weight such as potato salad,
 deli counter; salads plated by the       chicken salad), either
 consumer at a salad bar; cookies from    prepacked or packed upon
 a mall cookie counter; bagels, donuts,   consumer request
 rolls offered for individual sale).
------------------------------------------------------------------------

    Consistent with the statute, to be covered by the rule, a 
restaurant or similar retail establishment must be ``part of a chain 
with 20 or more locations doing business under the same name 
(regardless of the type of ownership of the locations) and offering for 
sale substantially the same menu items.'' A restaurant or similar 
retail food establishment that does not satisfy these criteria may 
choose to be covered by the rule by registering with FDA using a 
process established in the rule.
    Under the rule, ``location'' means a fixed position or site. 
Transportation venues such as trains and airplanes are not covered by 
the rule because they do not have a fixed position or site. ``Doing 
business under the same name'' means a restaurant or similar retail 
food establishment must share the same name as other establishments in 
the chain (regardless of the type of ownership of the locations, e.g., 
individual franchises). The term ``name'' refers to either the name of 
the establishment presented to the public or, if there is no name of 
the establishment presented to the public (e.g., an establishment with 
the generic descriptor ``concession stand''), the name of the parent 
entity of the establishment. ``Offering for sale substantially the same 
menu items'' means offering for sale a significant proportion of menu 
items that use the same general recipe and are prepared in 
substantially the same way with substantially the same food components, 
even if the name of the menu item varies.
    The nutrition labeling requirements of the rule apply to standard 
menu items offered for sale in covered establishments. ``Standard menu 
item'' means a restaurant-type food that is routinely included on a 
menu or menu board or routinely offered as a self-service food or food 
on display. The nutrition labeling requirements are not applicable to 
certain foods, including foods that are not standard menu items, such 
as condiments, daily specials, temporary menu items, custom orders, and 
food that is part of a customary market test; and self-service food and 
food on display that is offered for sale for less than a total of 60 
days per calendar year or fewer than 90 consecutive days in order to 
test consumer acceptance. In addition, the rule exempts alcohol 
beverages that are food on display and are not self-service food (e.g., 
bottles of liquor behind the bar used to prepare mixed drinks) from the 
labeling requirements that apply to food on display.

Summary of the Major Provisions of the Final Rule

    The rule includes provisions that:
     Define terms, including terms that describe criteria for 
determining whether an establishment is subject to the rule;
     Establish which foods are subject to the nutrition 
labeling requirements and which foods are not subject to these 
requirements;
     Require that calories for standard menu items be declared 
on menus and menu boards that list such foods for sale;
     Require that calories for standard menu items that are 
self-service or on display be declared on signs adjacent to such foods;
     Require that written nutrition information for standard 
menu items be available to consumers who ask to see it;
     Require, on menus and menu boards, a succinct statement 
concerning suggested daily caloric intake (succinct statement), 
designed to help the public understand the significance of the calorie 
declarations;
     Require, on menus and menu boards, a statement regarding 
the availability of the written nutrition information (statement of 
availability);
     Establish requirements for determination of nutrient 
content of standard menu items;
     Establish requirements for substantiation of nutrient 
content determined for standard menu items, including requirements for 
records that a covered establishment must make available to FDA within 
a reasonable period of time upon request; and
     Establish terms and conditions under which restaurants and 
similar retail food establishments not otherwise subject to the rule 
could elect to be subject to the requirements by registering with FDA.

Costs and Benefits

    The statute requires nutrition labeling for standard menu items on 
menus and menu boards for certain restaurants and similar retail food 
establishments and calorie labeling for food sold from certain vending 
machines. FDA is issuing two separate final rules (one for menu 
labeling and one for vending machine labeling) to implement those 
labeling requirements. Taken together the labeling requirements (of the 
menu labeling and vending machine labeling rules combined) are 
estimated to have benefits exceeding costs by $477.9 million on an 
annualized basis (over 20 years discounted at 7 percent).

[[Page 71159]]



                    Summary of Costs and Benefits of Menu Labeling and Vending Machine Rules
                                                  [In millions]
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                                                                     Potential       Estimated
                                                          Rate       benefits          costs       Net benefits
----------------------------------------------------------------------------------------------------------------
Total for Labeling (menu and vending rules) over 20            3        $9,221.3        $1,697.9        $7,523.4
 years*...............................................
                                                               7         6,752.8         1,333.9         5,418.9
Annualized for Labeling (menu and vending rules) over          3           601.9           110.8           491.1
 20 years*............................................
                                                               7           595.5           117.6           477.9
Total for Menu Labeling over 20 years.................         3         9,221.3         1,166.8         8,054.5
                                                               7         6,752.8           932.8         5,820.0
Annualized for Menu Labeling over 20 years............         3           601.9            76.9          525.01
                                                               7           595.5            84.5          510.99
----------------------------------------------------------------------------------------------------------------
* Benefits for the vending machine labeling rule are not quantified and are not counted in these values.

I. Background

    More than two thirds of adults and about a third of children in the 
United States are overweight or obese (Refs. 1 and 2). Overconsumption 
of calories is one of the primary risk factors for overweight and 
obesity (Ref. 3). About half of consumers' annual food dollars are 
spent on, and a third of total calories come from, foods prepared 
outside the home, including foods from restaurants and similar retail 
food establishments (Refs. 4 to 6). Research indicates that many people 
do not know, or underestimate, the calorie and nutrient content of 
these foods (Ref. 7).
    Since the early 1990s, the Nutrition Labeling and Education Act of 
1990 (NLEA) and our regulations in Sec.  101.9 (21 CFR 101.9) 
implementing the NLEA have required that the labeling for many foods 
bear nutrition information, including calorie information. However, as 
we noted in the proposed rule (76 FR 19192 at 19193; April 6, 2011), 
the NLEA left a gap in the Federal requirements for nutrition labeling 
through certain exemptions. The NLEA included an exemption for 
nutrition labeling for food that is ``served in restaurants or other 
establishments in which food is served for immediate human 
consumption'' or ``sold for sale or use in such establishments'' 
(section 403(q)(5)(A)(i) of the FD&C Act) (21 U.S.C. 343(q)(5)(A)(i)). 
The NLEA also included an exemption for food of the type described in 
section 403(q)(5)(A)(i) that is primarily processed and prepared in a 
retail establishment, ready for human consumption, ``offered for sale 
to consumers but not for immediate human consumption in such 
establishment and which is not offered for sale outside such 
establishment'' (section 403(q)(5)(A)(ii) of the FD&C Act). However, 
these exemptions were contingent on there being no nutrient content 
claims or health claims made on the label or labeling, or in the 
advertising, for the food. Current provisions in Sec.  101.10 (21 CFR 
101.10) require restaurants and other establishments in which food is 
offered for human consumption that make either a nutrient content claim 
(defined in Sec.  101.13 (21 CFR 101.13)) or health claim (defined in 
21 CFR 101.14) to provide certain nutrition information upon request. 
For example, if a menu lists an entree as being low in fat, information 
about the amount of fat in the entree must be available upon request 
(Sec.  101.10).
    Section 101.9(j)(2) of our regulations implementing the NLEA 
includes examples of restaurants or other establishments in which food 
sold for immediate human consumption generally was exempted from 
nutrition labeling requirements under the NLEA. Section 101.9(j)(3) of 
these regulations includes examples of food sold in establishments in 
which food is processed and prepared, ready for human consumption, 
offered for sale to consumers but not for immediate consumption, and 
not offered for sale outside of the establishments.
    Several State and local governments enacted their own laws 
requiring nutrition labeling on menus and menu boards to fill the gap 
in the Federal requirements. However, these State and local 
requirements vary significantly in their substantive requirements and 
the set of establishments to which they apply.
    On March 23, 2010, the ACA (Pub. L. 111-148) was signed into law. 
Section 4205 of the ACA amends section 403(q) of the FD&C Act, which 
governs nutrition labeling requirements, and section 403A of the FD&C 
Act (21 U.S.C. 343-1), which governs Federal preemption of State and 
local food labeling requirements. As amended, section 403(q)(5)(H) of 
the FD&C Act requires chain retail food establishments with 20 or more 
locations to provide calorie information for standard menu items, 
including food on display and self-service food, and to provide, upon 
consumer request, additional written nutrition information for standard 
menu items (21 U.S.C. 343(q)(5)(H)(i) to (iii)). Section 403(q)(5)(H) 
of the FD&C Act also provides that a restaurant or similar retail food 
establishment not otherwise subject to the requirements of section 
403(q)(5)(H) (e.g., a restaurant that is not part of a chain with 20 or 
more locations) may elect to be subject to the requirements of section 
403(q)(5)(H) by registering every other year with FDA (21 U.S.C. 
343(q)(5)(H)(ix)). Thus, ``covered establishments'' include both chain 
retail food establishments and other restaurants or similar retail food 
establishments that voluntarily register to be subject to the rule. A 
standard menu item offered for sale in a covered establishment is 
deemed to be misbranded if the requirements of section 403(q)(5)(H) are 
not met.
    Section 4205 of the ACA became effective on the date the law was 
signed, March 23, 2010; however, FDA must issue rules before some 
provisions can be required. On July 7, 2010, we published a notice in 
the Federal Register to solicit comments and suggestions on the new law 
(2010 docket notice) (75 FR 39026). On August 25, 2010, we published 
for public comment a draft guidance entitled ``Draft Guidance for 
Industry: Questions and Answers Regarding Implementation of the Menu 
Labeling Provisions of Section 4205 of the Patient Protection and 
Affordable Care Act of 2010'' (draft implementation guidance) (Ref. 8) 
(75 FR 52426), describing which provisions became requirements upon 
enactment of the law, which provisions we would implement through 
rulemaking, and draft interpretations of certain provisions, including 
a broad interpretation of the scope of establishments covered. On 
January 25, 2011, we published in the Federal Register a notice 
withdrawing the draft implementation guidance (76 FR 4360) and 
announcing our intent to exercise our enforcement discretion until we

[[Page 71160]]

complete the notice and comment rulemaking process.
    In the Federal Register of April 6, 2011 (76 FR 19192), we issued a 
proposed rule (proposed rule) to implement the requirements of section 
4205 of the ACA for the nutrition labeling of standard menu items in 
certain restaurants and similar retail food establishments. We 
requested public comments on the proposed requirements and some 
alternatives by June 6, 2011. In the Federal Register of May 24, 2011 
(76 FR 30050), we issued a document (correction document) correcting 
errors in the proposed rule, including errors in cross-references, an 
incomplete address, and a typographical error in the codified section 
of the document. In the Federal Register of May 24, 2011 (76 FR 30051), 
we extended the comment period until July 5, 2011.
    In the proposed rule, we described both the provisions that became 
requirements upon enactment (i.e., they are self-executing) and the 
provisions that depend on FDA to issue rules before they can become 
effective (76 FR 19192 at 19194). We also noted that we had published 
the draft implementation guidance and described the issues addressed by 
the draft implementation guidance. In the proposed rule, we reiterated 
that we intended to exercise enforcement discretion for the self-
executing provisions of section 4205 of the ACA and described our 
reasons for doing so (76 FR 19192 at 19194).
    After considering comments to the proposed rule, we are issuing 
this final rule to implement the requirements of section 4205 of the 
ACA for the nutrition labeling of standard menu items in certain chain 
restaurants and similar retail food establishments.
    In addition to the nutrition labeling requirements for standard 
menu items, other amendments made by section 4205 of the ACA to the 
FD&C Act (specifically, section 403(q)(5)(H)(viii)(I)) establish 
calorie disclosure requirements for certain articles of food sold from 
vending machines. We published a proposed rule to implement the vending 
machine provisions of section 403(q) of the FD&C Act on April 6, 2011 
(76 FR 19238; the proposed vending machine rule). Elsewhere in this 
issue of the Federal Register, we are issuing a final rule to implement 
the vending machine provisions of section 403(q)(5)(H)(viii)(I) of the 
FD&C Act.

II. Legal Authority

    On March 23, 2010, the ACA was signed into law. Section 4205 of the 
ACA amended section 403(q)(5) of the FD&C Act by amending section 
403(q)(5)(A) and by creating new clause (H), which requires, in 
relevant part, covered establishments to provide certain nutrient 
declarations for standard menu items in the labeling for such foods. 
Under section 403(f) of the FD&C Act, any word, statement, or other 
information required by or under authority of the FD&C Act to appear on 
the label or labeling of a food is required to be prominently placed 
thereon with such conspicuousness (as compared with other words, 
statements, designs, or devices, in the labeling) and in such terms as 
to render it likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use. Under 
section 403(a)(1) of the FD&C Act, food labeling must be truthful and 
non-misleading. Because food that is not in compliance with section 403 
is deemed misbranded, food to which these requirements apply is deemed 
misbranded if these requirements are not met. In addition, under 
section 201(n) of the FD&C Act (21 U.S.C. 321(n)), the labeling of a 
food is misleading if it fails to reveal facts that are material in 
light of representations made in the labeling or with respect to 
consequences that may result from use. Section 403(q)(5)(H)(x) of the 
FD&C Act requires that the Secretary of Health and Human Services 
(Secretary) issue regulations to carry out requirements in section 
403(q)(5)(H). Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) vests 
the Secretary with the authority to issue regulations for the efficient 
enforcement of the FD&C Act. Thus, we have the authority to issue this 
final rule under sections 201(n), 403(a)(1), 403(f), 403(q)(5)(H), and 
701(a) of the FD&C Act.
    We have revised our labeling regulations by adding new Sec.  101.11 
to require that covered establishments provide calorie and other 
nutrition information for standard menu items, including food on 
display and self-service food. Also, we are establishing the terms and 
conditions for voluntary registration by establishments that are not 
otherwise subject to the requirements of section 4205 of the ACA but 
elect to become subject to such requirements.

III. General Comments on the Proposed Rule

A. Introduction

    We received approximately 900 submissions on the proposed rule by 
the close of the comment period, each containing one or more comments. 
We received submissions from consumers; consumer groups; trade 
organizations; industry (including restaurants, entertainment venues, 
food service operations, and grocery stores); public health 
organizations; public advocacy groups; contractors; Congress; Federal, 
State, and local Government Agencies; and other organizations.
    We describe and respond to the comments in sections III, IV, VI 
through XXIV, and XXVII of this document. To make it easier to identify 
comments and our responses, the word ``Comment,'' in parentheses, 
appears before the comment's description, and the word ``Response,'' in 
parentheses, appears before our response. We have also numbered each 
comment and response to help distinguish between different comments and 
responses. The number assigned to each comment is purely for 
organizational purposes and does not signify the comment's value or 
importance or the order in which it was received.

B. Description of General Comments and FDA Response

    Many comments made general remarks supporting or opposing the rule 
and did not focus on a particular section of the rule. The majority of 
these comments expressed general support for nutrition labeling of 
standard menu items in covered establishments, and we do not discuss 
them in detail. In the following paragraphs, we discuss general 
comments that did not support the rule as proposed.
    (Comment 1) Some comments stated that people do not need to be told 
what to eat. Some comments asserted that calorie disclosure on menus 
will either cause eating disorders or affect those with eating 
disorders. Other comments asserted that the menu labeling requirements 
will not affect consumer behavior, there will be information overload, 
and people will ignore the information. Some comments considered that 
the menu labeling requirements will promote healthier choices, whereas 
other comments considered that the menu labeling requirements will not 
promote healthier choices. Some comments supported the menu labeling 
requirements but considered that education is needed to fight obesity.
    (Response 1) The rule does not tell consumers what they should or 
should not eat. The nutrition labeling required by section 4205 of the 
ACA will provide nutrition information to consumers in covered 
establishments in a direct, accessible, and consistent manner to enable 
consumers to make informed choices about the foods they purchase in 
such establishments.

[[Page 71161]]

    About half of consumers' annual food dollars are spent on, and a 
third of total calories come from, foods prepared outside of the home, 
including foods from restaurants or similar retail food establishments 
(Refs. 4 to 6). Further, research indicates that many people do not 
know, or underestimate, the calorie and nutrient content of these foods 
(Ref. 7). Accordingly, providing direct access to nutrition information 
for these foods will enable consumers to make informed decisions within 
the context of nutrition regarding the foods they purchase in 
restaurants or similar retail food establishments. Providing nutrition 
information to consumers for standard menu items offered for sale in 
covered establishments will give consumers much needed access to 
essential nutrition information for a large and growing number of the 
foods they purchase and consume. In addition, it will allow consumers 
to make informed nutritional comparisons between different foods and 
informed purchase decisions. Further, section 4205 of the ACA and this 
rule require covered establishments to post, on menus and menu boards, 
a succinct statement concerning suggested daily caloric intake designed 
to enable consumers to understand, in the context of a total daily 
diet, the significance of the calorie information provided on menus and 
menu boards. This statement, along with the required calorie 
information, will enable consumers to better understand the 
significance of the calorie information provided on menus and menu 
boards and the potential impacts of overconsumption of calories. As a 
result, the information will enable consumers to assess their calorie 
intake during short- or long-term settings and better understand how 
the foods that they purchase at covered establishments fit within their 
daily caloric and other nutritional needs.
    The comments provided no evidence that the provision of nutrition 
labeling at the point of purchase causes or adversely affects those 
with eating disorders. For nearly two decades, consumers have had 
access to this type of information on the labels of packaged foods that 
bear the Nutrition Facts label in accordance with Sec.  101.9. We are 
not aware of data or other information demonstrating that the 
availability of nutrition information through the Nutrition Facts Panel 
has either caused eating disorders or negatively impacted persons with 
eating disorders. In addition, Congress, through section 4205 of the 
ACA, requires covered establishments to provide calorie and other 
nutrition information for standard menu items. This rulemaking 
implements that Congressional mandate.
    (Comment 2) Some comments considered that the requirements are 
unnecessary because most ``fast food'' restaurants have the information 
already. One comment considered that the proposed requirements 
constitute a tax increase designed to relieve the individual of 
personal responsibility.
    (Response 2) Section 4205 of the ACA requires covered 
establishments to provide calorie and other information for standard 
menu items on menus, menu boards, signs adjacent to self-service foods 
and foods on display and additional nutrition information for standard 
menu items in written form, available on the premises, to consumers on 
request. Therefore, section 4205 of the ACA requires covered 
establishments to provide nutrition information to consumers in a 
direct, accessible, and consistent manner, typically at points of 
purchase, where consumers make order selections. While some ``fast 
food'' establishments may already have some nutrition information 
available to consumers in some fashion, these establishments are a 
subset of the establishments required to comply with the requirements 
of this rule, and these establishments may not be providing nutrition 
information to consumers in the manner required by section 4205 of the 
ACA.
    Regarding the comment asserting that the proposed requirements 
somehow negate personal responsibility, we reiterate that the 
requirements do not tell consumers what they should or should not eat 
or otherwise interfere with a consumer's ability to purchase foods. In 
fact, as we noted previously, this rule requires covered establishments 
to provide accurate nutrition information to consumers in a direct and 
accessible manner to enable consumers to make informed and healthful 
dietary choices.
    (Comment 3) Some comments addressed concerns related to 
enforcement. One comment expressed concern that the proposed rule did 
not set forth a clear ``chain of liability'' for food that is 
misbranded under the rule and related provisions of the FD&C Act, 
specifically sections 201(n), 403(a), or 403(q) of the FD&C Act. The 
comment stated that it is unclear whether FDA might impose vicarious 
liability on the franchisor or licensor of a restaurant for such 
misbranded food, particularly where the franchisor or licensor retains 
power over the menus and menu boards used by the restaurants. The 
comment also expressed concern that restaurants that ``unwittingly 
'misbrand' their menu offerings'' will be held liable for their food 
that is misbranded under this rule and related provisions of the FD&C 
Act.
    (Response 3) Persons exercising authority and supervisory 
responsibility over a restaurant or similar retail food establishment 
can be held responsible for violations under the FD&C Act. See United 
States v. Park, 421 U.S. 658, 659 (1978). (``The Act imposes upon 
persons exercising authority and supervisory responsibility reposed in 
them by a business organization not only a positive duty to seek out 
and remedy violations but also, and primarily, a duty to implement 
measures that will insure that violations will not occur . . . .'') 
(citing United States v. Dotterweich, 320 U.S. 277 (1943)). Agency 
decisions regarding enforcement actions will be determined on a case by 
case basis.
    (Comment 4) Some comments addressed issues unrelated to the 
specific nutrition labeling requirements of section 4205 of the ACA, 
such as labeling of genetically engineered foods, allergens, gluten, 
food additives (including preservatives), artificial sweeteners, 
ingredients, pesticides, and organic foods; labeling to indicate 
whether a food has been irradiated; labeling of alcohol as a toxin; 
labeling the country of origin; and labeling the ``gender of meat 
products.''
    (Response 4) Section 4205 of the ACA requires covered 
establishments to provide certain nutrition information for standard 
menu items. It does not address the labeling issues raised in these 
comments. Therefore, we do not address these issues in this document.
    (Comment 5) Some comments directed to what establishments would be 
covered by the rule pointed to a report submitted by a U.S. House of 
Representatives Appropriations Committee explaining an appropriations 
bill for Agriculture, Rural Development, Food and Drug Administration, 
and Related Agencies for fiscal year 2012 (Ref. 9). The comments quoted 
an excerpt from the report (``. . . and the Committee believes that the 
FDA should define the term restaurant to mean only restaurants doing 
business marketed under the same name or retail establishments where 
the primary business is the selling of food for immediate consumption . 
. .'') to signify Congressional intent on the scope of establishments 
subject to section 4205 of the ACA or as evidence supporting their own 
recommendations regarding the establishments that should be covered by 
the rule. (We note that some comments reported the date of the report 
as June 3, 2011, and one comment reported the date of the report

[[Page 71162]]

as May 27, 2011. We identified a report dated June 3, 2011 (Ref. 9), 
but did not identify a report dated May 27, 2011. For the purpose of 
this document, we assume that the comments are referring to the report 
dated June 3, 2011.)
    (Response 5) We disagree that an Appropriations Committee report 
from a Congress subsequent to the Congress that passed section 4205 of 
the ACA can be used as evidence of the intent of the previous Congress 
that passed section 4205. The Appropriations Committee report cited by 
the comments is dated after the ACA was passed, so it is not part of 
the relevant legislative history and carries no interpretive weight on 
this issue (see, e.g., Bruesewitz v. Wyeth, 131 U.S. 1068, 1081 
(2011)).

IV. Comments and FDA Response on Proposed Conforming Amendments

A. Section 11.1(g)--Electronic Signatures

    Proposed Sec.  11.1(g) (21 CFR 11.1(g)) would provide that 21 CFR 
part 11 regarding electronic signatures does not apply to electronic 
signatures obtained under the voluntary registration provision for 
covered restaurants and similar retail food establishments at proposed 
Sec.  101.11(d).
    We received no comments on this proposed provision and are 
finalizing it without change.

B. Sections 101.9(j)(1)(i), (j)(2) and (j)(3)--Nutrition Labeling of 
Food

    Our proposed amendment to Sec.  101.9(j)(1)(i) would specify that 
claims or other nutrition information subject the food to the nutrition 
labeling provisions of Sec.  101.11 as well as Sec.  101.9 or Sec.  
101.10 (nutrition labeling of restaurant foods), as applicable.
    Our proposed amendments to Sec.  101.9(j)(2) and (j)(3) would 
change the introductory text of paragraphs (j)(2) and (j)(3) to add the 
phrase ``Except as provided in Sec.  101.11, food products that are:''.
    We received no comments on these proposed provisions and are 
finalizing them without change. However, we also are adding a 
conforming amendment to add the phrase ``Except as provided in Sec.  
101.11'' to the beginning of the first sentence in Sec.  101.9(j)(4). 
As with Sec.  101.9(j)(2) and (j)(3), Sec.  101.9(j)(4) needs to be 
revised to exclude standard menu items sold in covered establishments 
and reference the special labeling requirements for those foods in 
Sec.  101.11 (see Sec.  101.11(b)(2)(ii)(B)).

C. Section 101.10--Nutrition Labeling of Restaurant Foods Whose Labels 
or Labeling Bear Nutrient Content Claims or Health Claims

    Our proposed amendment to Sec.  101.10 would provide that the 
information in the written nutrition information required by Sec.  
101.11(b)(2)(ii)(A) for standard menu items that are offered for sale 
in covered establishments (as defined in Sec.  101.11(a)) will serve to 
meet the requirements of Sec.  101.10.
    We received no comments on this proposed provision. Given our 
removal of the term ``restaurant food'' and our revision of the term 
``restaurant-type food'' in Sec.  101.11, we are adding a conforming 
amendment to ensure that the use of the term ``restaurant foods'' in 
Sec.  101.10, which predates the ACA, is not confusing. We are 
inserting three sentences between the current first and second 
sentences of Sec.  101.10, to clarify that the scope of Sec.  101.10 
includes those foods described in section 403(q)(5)(A)(i) and (ii) of 
the FD&C Act. These sentences describe that, for the purposes of Sec.  
101.10, restaurant food includes two categories of food. The first 
category of food is that which is served in restaurants or other 
establishments in which food is served for immediate human consumption 
or which is sold for sale or use in such establishments. The second 
category of food is that which is processed and prepared primarily in a 
retail establishment, which is ready for human consumption, which is of 
the type described in the first category, and which is offered for sale 
to consumers but not for immediate consumption in such establishment 
and which is not offered for sale outside such establishment. This 
scope is reflected in numerous prior Agency statements, including in 
the preamble to our final rule entitled ``Food Labeling: Nutrient 
Content Claims, General Principles, Petitions, Definition of Terms; 
Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and 
Cholesterol Content of Food'' (58 FR 2302, 2386, January 6, 1993), and 
in our 2008 ``Guidance for Industry: A Labeling Guide for Restaurants 
and Other Retail Establishments Selling Away-From-Home Foods'' (Ref. 
10). This change does not alter the meaning or applicability of Sec.  
101.10.

V. Key Terms That FDA Proposed To Define (Proposed Sec.  101.11(a))

    To establish the scope of establishments, labeling, and food 
covered by section 4205 of the ACA, we proposed to define key terms 
(proposed Sec.  101.11(a)). We also proposed to establish that the 
definitions in section 201 of the FD&C Act apply when used in Sec.  
101.11 (proposed Sec.  101.11(a)). We received no comments regarding 
the use of statutory definitions in section 201 of the FD&C Act, and we 
are finalizing that provision without change.
    In the next section of this document, we discuss the final 
definitions and related comments, organized into three categories: (1) 
Terms related to the scope of establishments covered by the rule, (2) 
the terms menu and menu board, and (3) terms related to foods covered. 
This organization is consistent with our discussion of our proposed 
terms in the preamble to the proposed rule.

VI. Comments and FDA Response on the Proposed Definitions of Terms 
Related to the Scope of Establishments Covered by the Rule (Proposed 
Sec.  101.11(a))

A. Introduction

    To specify establishments that would be subject to the nutrition 
labeling requirements of section 4205 of the ACA, we proposed to define 
``covered establishment'' to mean a restaurant or similar retail food 
establishment that is a part of a chain with 20 or more locations doing 
business under the same name (regardless of the type of ownership, 
e.g., individual franchises) and offering for sale substantially the 
same menu items, as well as a restaurant or similar retail food 
establishment that is registered to be covered under section 
403(q)(5)(H)(ix) of the FD&C Act. (Emphasis added).
    Importantly, the definition of ``covered establishment'' includes 
several terms, identified in italics, that are defined in the rule. In 
addition, the proposed definition of one of these terms--i.e., 
``restaurant or similar retail food establishment''--includes other 
terms we proposed to define--i.e., ``restaurant food'' and 
``restaurant-type food.'' Thus, any revisions we make to the proposed 
definitions of any of these terms may affect whether a particular 
establishment is a ``covered establishment'' for the purposes of this 
rule. As discussed more fully in sections VI.B, VI.C, VI.D, VI.E, and 
VI.F:
     We have revised the definition of ``restaurant or similar 
retail food establishment'' to mean a retail establishment that offers 
for sale restaurant-type food, except if it is a school as defined in 7 
CFR 210.1 or 220.2;
     We have revised the definition of the term ``restaurant-
type food'' to focus on the food most like the food offered for sale in 
restaurants;

[[Page 71163]]

     We are adding a definition of ``locations'' to clarify our 
interpretation of ``part of a chain with 20 or more locations'';
     We have revised the definition of ``doing business under 
the same name'' so that the term ``name'' refers to either (1) the name 
of the establishment presented to the public or (2), if there is no 
name of the establishment presented to the public (e.g., an 
establishment with the generic descriptor ``concession stand''), the 
name of the parent entity of the establishment; and
     We have revised the definition of ``offering for sale 
substantially the same menu items'' to add a qualitative description of 
the number of menu items that must be shared in order for the criterion 
of ``offering for sale substantially the same menu items'' to be met.
    We proposed to define the term ``gross floor area'' because we 
proposed that it be used in the definition of restaurant or similar 
retail food establishment. While we received comments on this proposed 
definition, as discussed in section VI.B.2 the definition of restaurant 
or similar retail food establishment in this rule no longer considers 
gross floor area. Therefore, we are deleting the proposed definition of 
``gross floor area'' because it is no longer relevant to the scope of 
establishments covered by this rule.

B. Restaurant or Similar Retail Food Establishment

1. The Proposed Definition
    Proposed Sec.  101.11(a) would define ``restaurant or similar 
retail food establishment'' as a retail establishment that offers for 
sale restaurant or restaurant-type food, where the sale of food is the 
primary business activity of that establishment. Proposed Sec.  
101.11(a) would provide that the sale of food is the retail 
establishment's primary business activity if the establishment presents 
itself, or has presented itself publicly as a restaurant (primary 
purpose 1), or a total of more than 50 percent of that retail 
establishment's gross floor area is used for the preparation, purchase, 
service, consumption, or storage of food (primary purpose 2). (See 
Figure 1 in the proposed rule (76 FR 19192 at 19201), in which we 
coined the terms ``primary purpose 1'' and ``primary purpose 2.'' We 
did not include these coined terms in the regulatory text of the 
definition. In this document, we are using these coined terms to 
simplify the discussion. We also are coining the term ``primary 
business test'' to simplify the discussion of the criterion for the 
primary business activity of the establishment.) Under an alternative 
approach we discussed in the proposed rule (76 FR 19192 at 19197) (the 
alternative revenue approach), ``primary purpose 2'' would be that more 
than 50 percent of the retail establishment's gross revenues are 
generated by the sale of food rather than that more than 50 percent of 
the retail establishment's gross floor area is used for the 
preparation, purchase, service, consumption, or storage of food.
    In the proposed rule (76 FR 19192 at 19198), we also discussed an 
alternative (the restaurant-type food alternative) in which the sale of 
restaurant or restaurant-type food (rather than the sale of food in 
general) would be the primary business activity of the establishment. 
Under the restaurant-type food alternative, ``primary purpose 2'' would 
be that a total of more than 50 percent of a retail establishment's 
gross floor area is used for the preparation, purchase, service, 
consumption, or storage of restaurant or restaurant-type food or its 
ingredients.
    In the proposed rule (76 FR 19192 at 19198), we acknowledged that 
many facilities that sell restaurant or restaurant-type food are 
located within larger retail establishments, such as coffee shops in 
bookstores or concession stands in movie theaters. We considered that 
some of these facilities would be separate retail establishments, while 
others would be part of their larger retail establishments. We 
explained that if a facility that is inside a larger establishment is 
part of a chain with locations outside of the chain of the larger 
establishment, the facility would be considered a separate 
establishment. For example, if a coffee shop in a bookstore is part of 
a chain of coffee shops with locations outside of the chain of 
bookstores, the coffee shop would be considered a separate retail 
establishment. By contrast, if a facility is not part of a chain with 
locations outside of the chain of the larger establishment, the 
facility would be considered part of the larger establishment. Thus, a 
movie theater concession stand that appears only in other movie 
theaters in that particular chain of movie theaters would not be 
considered a separate establishment for the purposes of this proposed 
rule.
    As an example of how all of the elements of the proposed definition 
of restaurant or similar retail food establishment fit together, movie 
theaters would not have met the proposed definition of restaurant or 
similar retail food establishment. Movie theaters usually do not 
present themselves as restaurants. In addition, movie theaters usually 
neither dedicate more than 50 percent of their gross floor area to the 
sale of food, nor generate more than 50 percent of their gross revenues 
from the sale of food. Thus, under the proposed definition of 
``restaurant or similar retail food establishment,'' movie theater 
concession stands generally would not have been covered regardless of 
whether ``primary purpose 2'' is based on the percent of gross floor 
area dedicated to the sale of food or on the alternative revenue 
approach based on the percent of gross revenues from the sale of food.
    In the proposed rule (76 FR 19192 at 19197 to 19199), we 
acknowledged that the statutory language is ambiguous with respect to 
the scope of establishments covered by section 4205 of the ACA, and 
asked for comments on:
     Whether we should use ``primary business activity,'' or a 
different test, as a basis for determining whether an establishment is 
a restaurant or similar retail food establishment;
     Whether we should use the sale of food in general, or the 
sale of restaurant-type food, as the criterion for ``primary business 
activity'';
     Whether we should use the alternative revenue approach, 
rather than a floor space approach, in ``primary purpose 2'';
     Whether we should choose a different number for the cutoff 
for the percent of gross floor area for determining the primary 
business activity of the retail establishment;
     Whether we should choose a different criteria for 
determining primary business activity, such as whether the consumer 
pays for admission to the establishment; and
     Whether a facility selling restaurant or restaurant-type 
food that is not part of a chain with locations outside of the chain of 
a larger retail establishment should be included within the definition 
of restaurant or similar retail food establishment. We particularly 
requested comment on this approach with respect to larger retail 
establishments such as movie theaters, other entertainment-type venues, 
and superstores that offer restaurant or restaurant-type food.
    In the following paragraphs, we discuss comments on the proposed 
definition of ``restaurant or similar retail food establishment.'' 
After considering these comments, we have revised the proposed 
definition to eliminate the primary business test.
    Importantly, the proposed definition of ``restaurant or similar 
retail food establishment'' included the terms ``restaurant and 
restaurant-type food'' and, thus, revisions to those terms also may 
affect whether a particular establishment is a ``restaurant or similar

[[Page 71164]]

retail food establishment'' for the purposes of this rule. As discussed 
more fully in section VI.C, we are deleting the term ``restaurant 
food'' throughout the rule and establishing a revised definition of 
``restaurant-type food'' that better reflects the food most like the 
food offered for sale in restaurants.
    With these changes, in this rule ``restaurant or similar retail 
food establishment'' means a retail establishment that offers for sale 
restaurant-type food, except if it is a school as defined in 7 CFR 
210.2 or 220.2. Establishments such as bakeries, cafeterias, coffee 
shops, convenience stores, delicatessens, food service facilities 
located within entertainment venues (such as amusement parks, bowling 
alleys, and movie theatres), food service vendors (e.g., ice cream 
shops and mall cookie counters), food take-out and/or delivery 
establishments (such as pizza take-out and delivery establishments), 
grocery stores, retail confectionary stores, superstores, quick service 
restaurants, and table service restaurants would be restaurants or 
similar retail food establishments if they sell restaurant-type food.
2. Primary Business Test
    (Comment 6) A few comments generally opposed having any primary 
business test within the definition of ``restaurant or similar retail 
food establishment.'' One of these comments recommended that the 
primary purpose of the definition be related to ``whether the 
establishment optimizes the nation's health through their food 
distribution channels, rather than a profit/commerce approach.'' This 
comment acknowledged that a ``profit/commerce approach'' may be more 
tangibly measured but believed that the definition of restaurant or 
similar retail food establishment should reflect what the comment 
considered to be the purpose of the ACA: To inform consumers on healthy 
food choices. Another comment considered that the floor space test we 
proposed as ``primary purpose 2'' is not a rational basis for defining 
a restaurant or similar retail food establishment. Another comment 
asserted that both the proposed definition of ``restaurant or similar 
retail food establishment'' and the ``alternative revenue approach'' 
would have covered grocery stores but not superstores, putting grocery 
stores at a competitive disadvantage.
    One comment recommended that we define a restaurant or similar 
retail food establishment as any chain establishment selling restaurant 
or restaurant-type food. The comment asserted that this broader 
interpretation is consistent with the language in the statute. The 
comment pointed out that the statute does not include text to suggest 
that in order to qualify as a retail food establishment, an entity must 
have the sale of food as its primary business activity.
    One comment recommended that the definition cover all of the 
establishments exempted from nutrition labeling by the NLEA. Some 
comments referred to examples of covered establishments that we had 
included in our draft implementation guidance (which we withdrew on 
January 25, 2011) and agreed that these types of establishments should 
be covered by the rule. The examples in the draft implementation 
guidance included table service restaurants, quick service restaurants, 
coffee shops, delicatessens, food take-out and/or delivery 
establishments (e.g., pizza take-out and delivery establishments), 
grocery stores, convenience stores, movie theaters, cafeterias, 
bakeries/retail confectionary stores, food service vendors (e.g., lunch 
wagons, ice cream shops, mall cookie counters, and sidewalk carts), and 
transportation carriers (e.g., airlines and trains). These examples 
reflected the establishments that sell certain food previously exempted 
from nutrition labeling by the NLEA under sections 403(q)(5)(A)(i) and 
(ii) of the FD&C Act, including those mentioned in Sec.  101.9(j)(2) 
and (j)(3) as well as some additional examples (i.e., similar food 
served in coffee shops, grocery stores, and movie theaters). Some of 
the establishments that would have been covered under the draft 
implementation guidance (such as transportation carriers and facilities 
located within movie theaters) would be excluded under a definition 
that includes any primary business test presented in the proposed rule 
(i.e., regardless of whether the criterion is the proposed criterion 
based on the sale of food in general or the restaurant-type food 
alternative based on the sale of restaurant-type food, and regardless 
of whether ``primary purpose 2'' relates to gross floor area or gross 
revenue). Other examples (such as grocery stores and convenience 
stores) would be excluded from coverage under the restaurant-type food 
alternative but not under the proposed criterion based on the sale of 
food in general.
    Several comments recommended that we define a restaurant or similar 
retail food establishment using the restaurant-type food alternative. 
Some comments that opposed coverage of grocery and convenience stores 
asserted that selling prepared foods does not make grocery stores 
similar to restaurants or food court facilities that have on-premises 
consumption. According to some of these comments, the primary purpose 
of grocery stores is to sell packaged food, which is already labeled 
with nutrition information. One comment that opposed covering 
convenience stores considered that the proposed criterion for a primary 
business activity based on the sale of food in general, including 
prepackaged food, is an activity in which restaurants do not engage. 
The comment recommended that we view the phrase ``similar retail food 
establishment'' as a single cohesive term and define those that are in 
fact similar to restaurants.
    Some comments opposed ``primary purpose 1'' of the proposed primary 
business test because it would be difficult to enforce. One comment 
asserted that some bowling alleys list themselves as restaurants in the 
phone book or have signs indicating that they serve as a restaurant, 
whereas others do not. The comments maintained that FDA and State and 
local inspectors would have to determine how many establishments in the 
chain present themselves as restaurants, which would make enforcement 
difficult.
    One comment agreed with the proposed criterion for ``primary 
purpose 2''--i.e., that greater than 50 percent of a retail 
establishment's gross floor area is used for the preparation, purchase, 
service, consumption, or storage of food. One comment asserted that the 
amount of floor space used for the preparation, purchase, service, 
consumption, or storage of food would be difficult to determine. 
Another comment considered that ``primary purpose 1'' is sufficient for 
determining whether an establishment is covered, but considered that 
the floor space criterion would be a more accurate approach than the 
alternative revenue approach if a second approach for ``primary 
business activity'' is needed. One comment asked us to clarify that 
``gross floor area'' includes outdoor space for parks as part of the 
calculation of the percentage of gross floor area used for the 
preparation, purchase, service, consumption, or storage of food. A few 
comments recommended that seating areas, including outside seating, be 
included in the floor space.
    A few comments preferred the alternative revenue approach for 
``primary purpose 2.'' One comment reported that the Internal Revenue 
Service uses revenue to determine a business's primary activity. One 
comment suggested that we add to the proposed definition ``or a total 
of more than 50 percent of that retail establishment's revenues are 
generated by the sale of food.''

[[Page 71165]]

    A few comments opposed the alternative revenue approach for 
``primary purpose 2.'' These comments considered that it would be 
difficult for FDA and the States to ascertain the revenue of a 
restaurant or similar retail food establishment and the revenue may 
change from day to day. One comment noted that the proposed rule did 
not include a defined time period for revenue. Another comment asserted 
that basing ``primary purpose 2'' on revenue would be complicated when 
a primary non-food related service or good is paired with an ancillary 
service such as the sale of food in one price. The comment asserted 
that it would be difficult to distinguish or separate the percentage of 
the fee for the non-food related service or good from the percentage of 
the fee for the food.
    A few comments suggested a lower cutoff (20 to 25 percent) for the 
alternative revenue approach but provided no rationale for the lower 
cutoff. One comment, which also supported the coverage of movie 
theaters, stated that movie theaters derive much of their revenue from 
food in concession stands.
    Some comments agreed with our discussion in the proposed rule that 
a facility within a larger facility should not be considered to be a 
separate establishment if it is not part of a chain outside that 
establishment. Some comments specifically agreed that facilities 
located within movie theaters and other entertainment venues should not 
be covered by the provisions of section 4205 of the ACA. However, many 
comments opposed a definition of ``restaurant or similar retail food 
establishment'' that would exclude facilities located within a larger 
facility, specifically facilities in movie theaters and other 
entertainment venues. Some of these comments provided the following 
reasons for including such facilities:
     Excluding facilities located within movie theaters removes 
information from consumers, which defeats the very purpose of the law.
     Food in entertainment venues is high in calories and some 
of these venues cater to children and have many less healthy options 
(e.g., fries, ice cream, cotton candy).
     Covering facilities located within movie theaters would 
not be burdensome for them because they have limited menu options and 
many packaged foods that have Nutrition Facts.
     Movie theaters derive large revenue from the sale of food; 
some much more than chain restaurants. It is irresponsible to send the 
message that consumption of calories in popcorn offered for sale at 
movie theaters is not as important as consumption of calories in menu 
items offered for sale at drive-through restaurants.
     Movies attract sedentary people.
     Congress intended that the law apply to movie theaters, 
bowling alleys, bookstore cafes, and other establishments; the phrase 
``and similar retail establishments'' was used to reach beyond 
restaurants.
     Excluding facilities located within movies theatres and 
other entertainment venues is unfair to competing venues.
     Providing other services or entertainment does not affect 
the need for nutrition information.
     Menu labeling is feasible in venues not covered by the 
proposed rule. Movie theaters in California, New York City, and 
counties in New York are providing this information with no problem. To 
capriciously exempt movie theaters defeats the purpose of the law. One 
comment asserted that there is 98 percent compliance for menu labeling 
by movie theaters in New York City.
     Excluding such venues raises equal protection concerns 
(U.S. Const. 14 Amend. section 1 for similarly situated entities).
    One comment considered that we would have to broaden the scope of 
covered establishments to include other places (such as bowling alleys, 
airlines, trains, and hotels), regardless of whether they fit the 
proposed definition of a restaurant or similar retail food 
establishment, if the rule covered establishments such as facilities 
located within movie theaters. This comment argued that there is no 
mention in the legislative history, committee reports, or Congressional 
floor debates of facilities located within movie theaters being 
covered. The comment considered that no one would associate ``chain 
retail food establishment'' with movie theaters because the primary 
purpose of going to movies or other entertainment venues is not to eat 
food and noted that many States and localities do not include these 
establishments in their laws. Another comment suggested that we add the 
following statement to our proposed definition: ``This definition does 
not include businesses or establishments that sell food incidental to 
their primary purpose of providing or hosting entertainment at venues 
such as movie and live theaters, arenas, amusement parks, sports 
facilities, concert venues, and other similar establishments.''
    (Response 6) We have revised the definition of ``restaurant or 
similar retail food establishment'' to eliminate the primary business 
test. Most of the comments opposed one or more aspects associated with 
our proposal to include a primary business test, and we are persuaded 
by them. The comments we received were diverse and raised important 
considerations, including issues related to fairness; public health 
impact; accessibility of nutrition information; enabling informed 
decision-making; statutory purpose and Congressional intent; 
enforcement challenges; and feasibility of complying with the rule. We 
are convinced that any primary purpose test presented in the proposed 
rule will be problematic.
    Congress did not define the term ``restaurant or similar retail 
food establishment'' in section 4205 of the ACA or elsewhere in the 
FD&C Act. As we stated in the proposed rule, we look to statutory 
context as a starting point for the regulatory definition of 
``restaurant or similar retail food establishment.'' As we noted, the 
1990 NLEA amendments exempted two categories of food relevant for this 
discussion: (1) Food ``which is served in restaurants or other 
establishments in which food is served for immediate human consumption 
or which is sold for sale or use in such establishments,'' (termed 
``restaurant food'' in the proposed rule); and (2) food ``which is 
processed and prepared primarily in a retail establishment, which is 
ready for human consumption, which is of the type described in [(1)] 
and which is offered for sale to consumers but not for immediate human 
consumption in such establishment and which is not offered for sale 
outside such establishment'' (termed ``restaurant-type food'' in the 
proposed rule). Section 4205 of the ACA amended both of these statutory 
exemptions. In determining the scope of section 4205 of the ACA, we 
must determine which of these foods should remain wholly exempt from 
Federal nutrition labeling requirements and which should be covered by 
the new nutrition labeling requirements in this rule.
    Instead of using a primary purpose test within the definition of 
restaurant or similar retail food establishment to set the scope of the 
new law, we are finalizing a broader definition of restaurant or 
similar retail food establishment, consistent with many of the 
comments. In response to concerns about overreaching in establishments 
that sell a significant amount of food that is not typical of food sold 
in restaurants, such as grocery and convenience stores (see also 
discussion in section VI.B.3), we are narrowing the set of food covered 
by removing the term ``restaurant food'' from this rule and redefining 
``restaurant-type food'' to

[[Page 71166]]

include only the set of food described in sections 403(q)(5)(A)(i) and 
(ii) of the FD&C Act that is most like the food served in restaurants 
(see discussion in section VI.C). Retail food establishments that offer 
for sale this type of food are either restaurants or are relevantly 
similar to restaurants in that they offer for sale the kind of food 
that restaurants do. Therefore, the final definition focuses on those 
establishments that offer for sale food that is most like food served 
in restaurants; overall, it is generally broader than the definition 
provided in the proposed rule, but narrower than what we put forward in 
the draft implementation guidance.
    Most of the comments that addressed the floor space approach or the 
alternative revenue approach to ``primary purpose 2'' expressed a 
preference for one or the other without providing strong and convincing 
arguments as to why their preferred alternative is superior to the 
alternative that they opposed. Several comments identified challenges 
to enforcing the rule if the definition of ``restaurant or similar 
retail food establishment'' included either the floor space approach or 
the alternative revenue approach.
    We agree with several points made by the comments about facilities 
within entertainment venues such as movie theaters and amusement 
parks--e.g., that providing nutrition information to consumers at such 
venues will make such nutrition information available to consumers in a 
direct and accessible manner to enable consumers to make informed and 
healthful dietary choices; food in entertainment venues is similar to 
food offered for sale in other restaurants or similar retail food 
establishments; and covering entertainment venues would create a level 
playing field. Under the revised definition of ``restaurant or similar 
retail food establishment,'' such facilities in entertainment venues 
will be covered by the rule if they offer for sale restaurant-type food 
and satisfy the other criteria in the definition of ``covered 
establishment''--i.e., part of a chain with 20 or more locations, doing 
business under the same name, and offering for sale substantially the 
same menu items. Similarly, some superstores that may not have been 
covered under the proposed definition likewise may be considered a 
``restaurant or similar retail food establishment'' under the final 
definition established in the rule. Under the definition of 
``restaurant or similar retail food establishment'' in this rule, a 
superstore, like a grocery store, would be covered if it sells 
restaurant-type food and is part of a chain with 20 or more locations, 
doing business under the same name, and offering for sale substantially 
the same menu items. Hotel restaurants are another type of 
establishment that we stated generally would not have been covered 
under the proposed rule (76 FR 19192 at 19198), but would be covered 
under the final rule if they sell restaurant-type food and are part of 
a chain of hotel restaurants with 20 or more fixed locations, doing 
business under the same name, and offering for sale substantially the 
same menu items.
    We disagree that the legislative history of section 4205 of the ACA 
demonstrates any express intent of Congress to exclude facilities 
located within entertainment venues such as movie theaters and bowling 
alleys from the rule. The legislative history of section 4205 of the 
ACA is very sparse; the section was discussed on few occasions, and 
when it was discussed, few specifics were mentioned, including 
specifics about the scope of the law.
    We discuss transportation venues later in this document (see 
Response 27).
    (Comment 7) One comment considered the proposed requirement that 
the sale of food be the retail establishment's primary business to be 
at odds with the approach taken in the proposed vending machine rule. 
The comment pointed out that we concluded that only 5,000 of 10,000 
vending machine operators operate vending machines as their primary 
business, yet the proposed vending machine rule would apply to those 
with 20 or more machines, which includes all 10,000 of the vending 
machine operators.
    (Response 7) The provisions of the proposed vending machine rule, 
including criteria for determining coverage of that rule, are not 
relevant to the criteria for determining coverage of this rule. 
Regardless, this comment is moot because the definition of ``restaurant 
or similar retail food establishment'' established in this rule no 
longer includes a primary business test.
    (Comment 8) A few comments recommended that we separately define 
``restaurant'' and ``similar retail food establishment.'' One of these 
comments recommended that we define ``restaurant'' separately from 
``similar retail food establishment'' because Congress uses the word 
``or'' in the phrase ``restaurant or similar retail food 
establishment,'' and thus ``restaurants'' and ``similar retail food 
establishments'' are clearly two separate things. Another comment 
recommended that we define a restaurant as one that uses greater than 
50 percent gross floor space for preparation, purchase, service, 
consumption of restaurant food and a similar retail food establishment 
as an establishment that meets the same standard but does not present 
itself as a restaurant.
    (Response 8) We disagree that we should separately define 
``restaurant'' and ``similar retail food establishment.'' As an initial 
matter, while Congress does use the word ``or'' between ``restaurant'' 
and ``similar retail food establishment'' in some places, it also uses 
the word ``and'' between them in others. For example, section 
403(q)(5)(H)(i) of the FD&C Act contains both constructions (``General 
requirements for restaurants and similar retail food establishments'' 
and ``the restaurant or similar retail food establishment shall 
disclose''). We interpret the choice of the words ``and'' and ``or'' in 
section 403(q)(5)(H) of the FD&C Act to be a function of appropriate 
grammar, not to indicate Congressional intent to conceptualize 
``restaurants'' separately from ``similar retail food establishments.'' 
Moreover, given that the requirements in section 403(q)(5)(H) of the 
FD&C Act are the same for restaurants and similar retail food 
establishments, we see no practical reason to create separate 
regulatory definitions.
    (Comment 9) One comment recommended that we include as part of the 
regulation table 1 from the proposed rule to help the public interpret 
the regulation.
    (Response 9) In the proposed rule (77 FR 19192 at 19198 and 19199), 
tables 1 and 2 identify establishments that generally would, or would 
not, be a ``restaurant or similar retail food establishment'' for the 
purposes of this rule. We included these tables to demonstrate the 
likely impact for many establishments of the proposed and alternative 
criteria for a ``primary business test'' within the definition of 
``restaurant or similar retail food establishment.'' The definition of 
``restaurant or similar retail food establishment'' established in this 
rule no longer has a primary business test. Any establishment that 
sells restaurant-type food is a ``restaurant or similar retail food 
establishment'' for the purposes of this rule. Therefore, we see no 
value added in including such tables in this final rule.
3. Coverage of Grocery Stores and Convenience Stores
    (Comment 10) Several comments recommended that grocery stores be 
covered. Some of these comments considered that grocery stores should 
be covered because they sell a great deal of food for immediate 
consumption. One

[[Page 71167]]

of these comments referred to the ``Food Marketing Institute's 2010 
U.S. Grocery Shopper Trends'' (Ref. 11) as evidence that the number of 
consumers who express interest in supermarket ready-to-eat food is at 
its highest point in 4 years. One comment asserted that the law does 
not exempt grocery stores or take-out food.
    (Response 10) We agree with these comments. Grocery stores that 
sell restaurant-type food and are part of a chain with 20 or more 
locations doing business under the same name and offering for sale 
substantially the same menu items are covered by the rule.
    (Comment 11) One comment argued that the plain meaning of section 
4205 of the ACA precludes including grocery stores as ``restaurants and 
similar retail food establishments.'' The comment stated that Congress 
used other words elsewhere in the FD&C Act to refer to the set of 
establishments that include grocery stores, such as ``food retailer'' 
and ``retail establishment'' in section 403(q) of the FD&C Act. In 
addition, our regulation at 21 CFR 1.227 defines ``retail food 
establishment'' to include grocery stores for the purposes of food 
facility registration. Given that Congress chose a different term here, 
the comment argued that we must assume ``similar retail food 
establishments'' has a different meaning.
    (Response 11) We disagree with this comment. We do interpret the 
phrase ``similar retail food establishment'' to have a different 
meaning than the terms ``food retailer'' and ``retail establishment'' 
that appear elsewhere in section 403(q) of the FD&C Act or ``retail 
food establishment'' in 21 CFR 1.227. Both our proposed and final 
definitions are different from the definitions of these other terms. If 
a retail food establishment does not offer for sale restaurant-type 
food, it would not be a ``restaurant or similar retail food 
establishment'' for the purposes of section 403(q)(5)(H) of the FD&C 
Act, even though it could be a ``food retailer'' or a ``retail 
establishment'' or ``retail food establishment.''
    (Comment 12) One comment argues that the heading of section 4205 of 
the ACA, ``Nutrition Labeling of Standard Menu Items at Chain 
Restaurants,'' indicates that ``restaurants or similar retail food 
establishments'' is an ambiguous term, and should be interpreted 
narrowly to exclude grocery stores.
    (Response 12) We disagree with this comment. First, while we 
recognize that the heading of a statute may be considered part of a 
section's legislative history, the heading is not part of the law 
itself (Ref. 12). Second, it is clear that the heading is not meant to 
describe the scope of the requirements in section 4205 of the ACA, 
given that section 4205 includes requirements for ``restaurants and 
similar retail food establishments'' and requirements for vending 
machine operators.
    (Comment 13) One comment argued that the legislative history of 
section 4205 of the ACA demonstrates that grocery stores should not be 
included in the menu labeling requirements. The comment cited a floor 
speech by Senator Harkin where he favorably compares the nutrition 
information available in grocery stores to the lack of nutrition 
information available at restaurants. For example, ``It makes no sense 
that American consumers can go to a grocery store and find nutrition 
information on just about anything, but then they are totally in the 
dark when they go to a restaurant for dinner.'' (Ref. 13) The comment 
also argued that the legislative history does not include any hearing 
or debate indicating that we were being given authority to regulate 
chain grocery stores through section 4205 of the ACA.
    Some comments stated that some State and local jurisdictions did 
not cover grocery stores. One comment remarked that State and local 
laws related to menu labeling referred to in the legislative history of 
section 4205 of the ACA did not cover grocery stores. Specifically, the 
comment mentions that the New York City Health Code provisions on menu 
labeling, which the comment characterizes as the first and most 
extensively discussed law cited by Senator Harkin, does not regulate 
supermarkets.
    (Response 13) We disagree that the legislative history demonstrates 
that grocery stores should not be included in the nutrition labeling 
requirements of this rule. First, the most straightforward 
interpretation of Senator Harkin's statements is that the food in 
grocery stores he had in mind was packaged food already required to 
bear nutrition information under Federal law.
    Second, the fact that none of the State or local jurisdictions with 
menu labeling requirements explicitly covered grocery stores does not 
mean that Congress did not intend to cover grocery stores under the 
Federal law. Many State and local jurisdictions with menu labeling 
requirements predating the ACA did not cover self-service food or food 
on display, which is most likely to be the type of food in grocery 
stores covered by this rule. However, it is clear that Congress 
intended for self-service food and food on display to be covered, 
because section 403(q)(5)(H)(iii) explicitly establishes statutory 
requirements specific to self-service food and food on display. In 
addition, for at least some local governments, including New York City, 
the regulation of grocery stores fell outside of their jurisdiction 
(Ref. 14). So, the fact that grocery stores were not covered by New 
York City cannot be assumed to be a choice by local authorities.
    Finally, we recognize that the legislative history of section 4205 
of the ACA does not include any hearing or debate indicating 
specifically mentioning chain grocery stores. However, this does not 
imply that Congress intended for grocery stores to be excluded. As 
already noted, the legislative history of section 4205 of the ACA is 
very sparse; the section was discussed on few occasions, and when it 
was discussed, few specifics were raised, including specifics about the 
scope of the law. The comment does not provide evidence to the 
contrary. Our final rule represents a reasonable interpretation of the 
statute, given the language of section 4205 of the ACA and the scant 
legislative history.
    (Comment 14) Some comments asserted that if Congress had intended 
broad application, it would have overhauled 21 U.S.C. 343(q)(5)(A)(i) 
and (ii) of the FD&C Act rather than letting those stand and adding 21 
U.S.C. 343(q)(5)(H). Further, these comments stated that if Congress 
had wanted to include all establishments exempted by the NLEA, it would 
have cross-referenced to the NLEA exemption or just removed the 
exemption.
    (Response 14) We agree with some of these comments and disagree 
with others. We agree that Congress did not intend for all 
establishments exempted by the NLEA to be covered by section 4205 of 
the ACA. Under the rule, there are many establishments, including 
establishments that meet the regulatory definition of restaurant or 
similar retail food establishment, that will not be covered. For 
example, food described in section 403(q)(5)(A)(i) of the FD&C Act 
served in certain sit-down restaurants that are not part of a chain of 
20 or more locations will continue to be exempt from the Federal 
nutrition labeling requirements in sections 403(q)(1) to (4). In 
addition, section 403(q)(5)(A)(i) and (ii) of the FD&C Act continue to 
exempt all food that is described in sections 403(q)(5)(A)(i) and (ii), 
including food offered for sale in restaurants and similar retail food 
establishments, from the nutrition labeling requirements in sections 
403(q)(3) and (4). Therefore, irrespective of the breadth of section 
403(q)(5)(H) of the FD&C Act, Congress's amendment to sections 
403(q)(5)(A)(i) and (ii) leaves a large portion of the exemption 
intact. Congress could not

[[Page 71168]]

have removed the exemption in sections 403(q)(5)(A)(i) and (ii) of the 
FD&C Act and achieved the same result.
    Instead, Congress amended sections 403(q)(5)(A)(i) and (ii) of the 
FD&C Act to cross-reference section 403(q)(5)(H). The cross-references 
to section 403(q)(5)(H) of the FD&C Act in sections 403(q)(5)(A)(i) and 
(ii) indicate that the requirements in 403(q)(5)(H) must apply to at 
least a subset of those foods described in both sections 
403(q)(5)(A)(i) and (ii). Congress did not provide a statutory 
definition of ``restaurant or similar retail food establishment'' in 
section 403(q)(5)(H) of the FD&C Act, leaving ambiguity in the statute 
as to the breadth of the set of establishments covered. Our definition 
of restaurant or similar retail food establishment is a reasonable 
interpretation of this ambiguous term, and is consistent with section 
4205's amendments to section 403(q)(5)(A)(i) and (ii) of the FD&C Act.
    (Comment 15) One comment argued that the restaurant industry 
supported section 4205 of the ACA, because the law would provide them 
with a nationally uniform regulatory scheme. The comment asserted that 
grocery stores ``did not ask for this law,'' and should therefore not 
be covered.
    (Response 15) In general, whether an industry asks to be regulated 
is not determinative of whether that industry should be regulated. In 
addition, grocery stores are increasingly offering for sale restaurant-
type food, including food for immediate consumption that is prepared 
and processed on the premises.
    (Comment 16) A few comments maintained that there is too much 
variability in grocery store food because food is seasonal and grocery 
stores make prepared food from food in the store. Some comments also 
noted that some grocery stores offer unique menu items, such as a 
unique chicken salad based on the personal recipe of a chef at a 
particular grocery store's location, that are not available at all 
grocery stores in the chain. These comments asserted that it would be 
difficult to calculate the nutrient information if grocery stores were 
covered under the final rule.
    (Response 16) A grocery store is required to make calorie 
declarations for its standard menu items if it meets the definition of 
``covered establishment'' in this rule; including, in relevant part, 
that the grocery store is ``offering for sale substantially the same 
menu items'' as other grocery stores in the chain (see section VI.F for 
discussion on ``offering for sale substantially the same menu items''). 
However, if a food is not routinely included on a menu or menu board or 
routinely offered as a self-service food or food on display at a 
covered establishment, it is not a standard menu item at that 
establishment and therefore not covered by this rule (see section 
VIII.B for discussion on the definition of standard menu item). For 
example, if a food's ingredients and recipe changes daily based on food 
available in the store, it is likely that such food would not be a 
standard menu item. However, for food offerings that are standard menu 
items, even if unique to only one location in the chain, a covered 
establishment has many options for determining nutrient content, 
including, for example, calculating the required nutrient information 
from the recipe for the food offering using nutrient databases (see 
Sec.  101.11(c)). Per the statute, in those cases where seasonal 
availability is limited to less than 60 days, the food offering may be 
exempt from the nutrition labeling requirements of this rule as a 
temporary menu item or a self-service food and food on display that is 
offered for sale for less than a total of 60 days per calendar year.
    (Comment 17) One comment maintained that menu labeling is needed in 
small grocery stores and convenience stores because of the disparity in 
low-income neighborhoods that do not have many large grocery stores or 
superstores but do have small grocery stores and convenience stores. 
According to the comment, grocery stores, convenience stores, and drug 
store chains have expanded their businesses to include ready-to-eat 
food offerings. The comment maintained that these establishments are in 
direct competition with restaurants and have grown so rapidly over the 
past decade that some are being called ``grocerants.''
    (Response 17) Small grocery stores and convenience stores are 
covered by the rule if they sell restaurant-type food and are part of a 
chain with 20 or more locations, doing business under the same name, 
and offering for sale substantially the same menu items.
    (Comment 18) One comment considered that grocery stores should not 
be covered by the menu labeling requirements because they do not have 
menus and menu boards.
    (Response 18) We disagree with this comment. First, the comment 
suggests that no grocery stores have menus or menu boards. However, 
some grocery stores do have menus and menu boards, including for 
example, menus and menu boards for sandwiches that are prepared upon 
the consumer's request. Second, the comment implies that a restaurant 
or similar retail food establishment must have a menu or menu board in 
order to be covered by this rule. This is not the case. Consistent with 
section 403(q)(5)(H) of the FD&C Act, this rule requires that covered 
establishments provide certain nutrition information for standard menu 
items, even the standard menu items that do not appear on menus or menu 
boards. For example, section 403(q)(5)(H)(iii) of the FD&C Act requires 
nutrition labeling for standard menu items that are self-service foods 
and foods on display, irrespective of whether they are listed on a menu 
or menu board.
4. Confectionery Stores
    (Comment 19) A few comments recommended that confectionery stores 
not be covered because they do not sell restaurant food. According to 
one of these comments, most candy sold in retail confectionery stores 
is not generally consumed immediately where purchased or while walking 
away. Instead, the comment stated, most candy sold in retail 
confectionery stores is either prepackaged (e.g., boxed chocolates) or 
selected by the consumer and placed in a box or other packaging for 
consumption at a later time. Thus, according to this comment, food 
served in retail confectionery stores without facilities for 
consumption on the premises would continue to be covered by the 
nutrition labeling requirements in Sec.  101.9. Another comment 
acknowledged that some confectionary stores do sell some restaurant-
type foods, such as chocolate from display cases, shakes, and specialty 
items dipped in chocolate, but that the primary focus of the business 
was the sale of packaged food such as ``gift box'' packaged chocolates.
    (Response 19) We disagree that confectionery stores, as a class of 
retail food establishments, should not be covered. Based on these 
comments, some foods sold in some confectionery stores are restaurant-
type foods. As discussed in section VI.C, we are establishing a revised 
definition of ``restaurant-type food'' that would cover food that is 
usually eaten on the premises, while walking away, or soon after 
arriving at another location (see Response 24). A prepackaged box of 
candy sold in a confectionery store is not likely to be a restaurant-
type food, because a box of candy is not usually eaten on the premises, 
while walking away, or soon after arriving at another location. 
However, individual pieces of candy sold to a consumer from a display 
case, shakes, and specialty items dipped in chocolate likely would be 
restaurant-type foods, because they are generally consumed on the 
premises, while walking away, or soon after arriving at

[[Page 71169]]

another location. Under this rule, a confectionery store that sells 
restaurant-type food would be covered if it is part of a chain with 20 
or more locations doing business under the same name and offering for 
sale substantially the same menu items. We note that the only foods 
covered by this rule in a covered establishment are restaurant-type 
foods that are standard menu items.
5. Facilities Within Facilities
    (Comment 20) One comment asked us to clarify that the independent 
franchise restaurant that operates within an amusement park is liable 
for adherence to the final regulation, not the park. The comment 
maintained that the park would have no way of knowing if the franchisee 
is compliant.
    (Response 20) The covered establishment bears the responsibility to 
comply with the rule. In addition, see Response 3.
6. Schools
    (Comment 21) One comment asked us to clarify whether a school food 
service contractor that uses a central kitchen or cooks the same food 
for 20 schools would be covered. One comment stated that these 
establishments should provide calories on menu boards, online menus, 
and menus sent home to parents.
    (Response 21) We have decided not to include schools in the 
definition of ``restaurant or similar retail food establishment'' for 
the purposes of this rule. As previously discussed (see Response 6) 
Congress did not define the term ``restaurant or similar retail food 
establishment'' in section 4205 of the ACA or elsewhere in the FD&C 
Act. The term is ambiguous, and we look to statutory context as a 
starting point for our regulatory definition. As discussed in section I 
of this document, while the NLEA required that the labeling of many 
foods bear nutrition information, it exempted certain food from such 
nutrition labeling requirements, including food that is ``served in 
restaurants or other establishments in which food is served for 
immediate human consumption'' (section 403(q)(5)(A)(i) of the FD&C 
Act). In FDA's regulations implementing the NLEA, we included schools 
among the list of examples of ``other establishments in which food is 
served for immediate human consumption'' (Sec.  101.9(j)(2)) Section 
4205 of the ACA amended this statutory exemption, among others, to 
account for new nutrition labeling requirements for standard menu items 
in restaurants and similar retail food establishments. Therefore, we 
must determine whether standard menu items in schools should remain 
wholly exempt from FDA nutrition labeling requirements or whether they 
should be eligible to be covered by the new nutrition labeling 
requirements in this rule.
    Traditionally, the U.S. Department of Agriculture (USDA) has 
exercised a primary role in setting the standards for foods served in 
schools through school lunch and breakfast programs. USDA regulates 
such foods, under various Federal statutes, including the Child 
Nutrition Act of 1996 and the Richard B. Russell National School Lunch 
Act. Given the traditional and long-standing role of USDA in setting 
standards, including nutrition requirements, for foods served in 
schools through school lunch and breakfast programs, as established by 
Federal legislation and implemented by Federal Agencies, we conclude 
that it is reasonable to interpret the term ``restaurant or similar 
retail food establishment'' to not include schools. Therefore, we have 
revised the definition ``restaurant or similar retail food 
establishment'' to mean a retail establishment that offers for sale 
restaurant-type food, except if it is a school as defined in 7 CFR 
210.2 or 220.2.

C. Restaurant Food and Restaurant-Type Food

    A key term in the final definition of ``restaurant or similar 
retail food establishment'' is the term ``restaurant-type food.'' The 
terms ``restaurant food'' and ``restaurant-type food'' also were 
important to the proposed definition of ``restaurant or similar retail 
food establishment.'' Proposed Sec.  101.11(a) would define 
``restaurant food'' as food that is served in restaurants or other 
establishments in which food is served for immediate human consumption, 
i.e., to be consumed either on the premises where that food is 
purchased or while walking away; or which is sold for sale or use in 
such establishments. (As a typographical error, the proposed rule 
incorrectly stated ``where that the food is purchased'' rather than 
``where that food is purchased.'') Proposed Sec.  101.11(a) would 
define ``restaurant-type food'' as food of the type described in the 
definition of ``restaurant food'' that is ready for human consumption, 
offered for sale to consumers but not for immediate consumption, 
processed and prepared primarily in a retail establishment, and not 
offered for sale outside of that establishment.
    In the following paragraphs, we discuss comments on these proposed 
definitions. After considering comments, we are deleting the proposed 
definition of ``restaurant food'' and establishing a revised definition 
of ``restaurant-type food'' that better reflects the food most like the 
food offered for sale in restaurants. As conforming amendments, we are 
deleting the term ``restaurant food'' from other proposed definitions 
that had included this term--i.e., the proposed definitions for ``food 
on display,'' ``restaurant or similar retail food establishment,'' 
``self-service food,'' and ``standard menu item.''
    (Comment 22) One comment recommended that food be covered if 
prepared for immediate human consumption regardless of whether 
consumers choose to consume on or off the premises. The comment 
recommended that we remove the term ``walking away'' from the 
definition of restaurant food because it would be clearer to state 
simply that foods that are served in restaurants or similar retail food 
establishments and are prepared for immediate human consumption are 
covered, whether customers choose to consume them on or off the 
premises. The comment considered that whether foods are actually 
consumed on or off the premises should not be a determining factor as 
to whether a food or facility is covered by the rule. The comment asked 
us to clarify that food from facilities serving take-away food that 
meet the other criteria are covered.
    (Response 22) We decline the specific suggestion that we replace 
our proposed criterion that food may be ``consumed either on the 
premises where the food is purchased or while walking away'' with a 
criterion mentioning that consumers may consume the food ``on or off 
the premises.'' The comment did not disagree that restaurant food 
should include food that is consumed while walking away but rather 
suggested communicating this differently.
    While restaurants do offer for sale food that is consumed off the 
premises, in general that food is consumed while walking away or upon 
arriving at another location. Other foods, like groceries, are also 
consumed ``off the premises'' of the store that sells them (e.g., a 
grocery or convenience store), but they are often consumed at a later 
time or over a period of days. Our aim is to cover the food most like 
the food offered for sale in restaurants, and not food that is more 
similar to food traditionally thought of as groceries. Therefore, the 
phrase ``on or off the premises'' is too broad for our final definition 
of restaurant-type food.
    In general, take-away food is consumed while walking away or upon 
arriving at another location. Therefore, take-away food is likely to be 
``restaurant-type food,'' and retail

[[Page 71170]]

establishments that offer for sale take-away food are likely to meet 
the definition of restaurant or similar retail food establishment. 
Take-away food that satisfies the definition of ``restaurant-type 
food'' established in this rule would be subject to the nutrition 
labeling requirements of this rule if it is a standard menu item that 
is offered for sale in a covered establishment.
    (Comment 23) One comment recommended that the phrase ``not offered 
for sale outside that establishment'' be deleted from the definition of 
restaurant food because some restaurants market frozen meals from their 
restaurants.
    (Response 23) We are retaining the phrase ``not offered for sale 
outside such establishment'' in the definition of restaurant-type food. 
This phrase comes from section 403(q)(5)(A)(ii) of the FD&C Act. FDA 
previously has interpreted this phrase (see 58 FR 2079 at 2146 (January 
6, 1993)). The frozen meals described by the comment appear to be 
packaged foods. Most packaged foods are subject to the labeling 
requirements of Sec.  101.9. The sale of such packaged, frozen food 
outside of a restaurant, e.g., in a grocery store, will not affect 
whether the food in a restaurant is covered by this rule.
    (Comment 24) One comment urged us to remove the term ``restaurant-
type food'' from the rule and recognize that the sale of food to 
consumers for immediate consumption is a primary distinguishing factor 
of a restaurant. The comment contended that our definition of 
restaurant or similar retail food establishment is overly broad because 
it includes an establishment that sells not only restaurant food but 
also restaurant-type food. The comment maintained that we did not 
explain our rationale for including restaurant-type food in the 
proposed rule, especially when our existing regulation on restaurants 
refers only to restaurant food.
    A few comments were concerned that because of the definition of 
restaurant-type food grocery stores would have to label prepared foods 
for immediate consumption as well as every loaf of bread, roll, cookie 
and deli item except cold cuts; these comments estimated that 
approximately 6,400 service deli, prepared foods, and bakery items 
would be included, which would be very costly. One comment contended 
that the increase in cost may limit the items that grocery stores would 
carry, which would limit sales growth. According to a few comments 95 
percent of items in grocery stores have Nutrition Facts and the costs 
to cover the remaining 5 percent vastly outweighs benefits.
    (Response 24) We agree that sale of food to consumers for immediate 
consumption is a common characteristic of restaurants but disagree that 
it follows that only ``restaurant food'' is relevant to this 
rulemaking. In the proposed rule, we explained that section 4205 of the 
ACA amended both sections 403(q)(5)(A)(i) and (ii) of the FDA&C Act. 
Under section 403(q)(5)(A)(ii) of the FD&C Act, except as provided in 
section 403(q)(5)(H)(ii)(III) of the FD&C Act (i.e., the requirement 
for written nutrition information for food covered by this rule) the 
nutrition labeling requirements of section 403(q)(1), (2), (3), and (4) 
of the FD&C Act shall not apply to food which is processed and prepared 
primarily in a retail establishment, which is ready for human 
consumption, which is of the type described in section 403(q)(5)(A)(i), 
and which is offered for sale to consumers but not for immediate human 
consumption in such establishment and which is not offered for sale 
outside such establishment (emphasis added). To implement the phrase 
``except as provided in section 403(q)(5)(H)(ii)(III)'' of the FD&C 
Act, some set of food described in section 403(q)(5)(A)(ii)--that is 
not for immediate consumption--is covered by this rule.
    We acknowledge that the proposed definition of restaurant-type food 
includes some foods that are sold in grocery or convenience stores that 
are not generally offered for sale in restaurants, foods that are more 
like groceries, and we have amended that definition in the final rule. 
After considering all of the comments directed to the proposed 
definitions of ``restaurant food'' or ``restaurant-type food,'' in 
addition to the comments related to the scope of the rule more 
generally, given the relationship between these terms and the 
definition of restaurant or similar retail food establishment, we are 
convinced that this rule should cover only those foods described in 
sections 403(q)(5)(A)(i) and (ii) of the FD&C Act that are most like 
the food sold in restaurants and should not cover foods that are more 
commonly considered to be groceries. Therefore, we are deleting the 
proposed definition of ``restaurant food'' and establishing a revised 
definition of ``restaurant-type food'' that reflects the food most like 
the food offered for sale in restaurants. Under that new definition, 
restaurant-type food means food that is (1) usually eaten on the 
premises, while walking away, or soon after arriving at another 
location; and (2) either (i) served in restaurants or other 
establishments in which food is served for immediate human consumption 
or which is sold for sale or use in such establishments; or (ii) 
processed and prepared primarily in a retail establishment, ready for 
human consumption, of the type described in (i), and offered for sale 
to consumers but not for immediate human consumption in such 
establishment and which is not offered for sale outside such 
establishment. The first part of this definition focuses on the food 
most like the food offered for sale in restaurants, while the second 
part of this definition reflects the statutory context of sections 
403(q)(5)(A)(i) and (ii) of the FD&C Act. The new definition includes 
food for immediate consumption at a sit-down or quick service 
restaurant; food purchased at a drive-through establishment; take-out 
and delivery pizza; hot pizza at grocery and convenience stores that is 
ready to eat; pizza slice from a movie theater; hot buffet food, hot 
soup at a soup bar, and food from a salad bar; foods ordered from a 
menu/menu board at a grocery store intended for individual consumption 
(e.g., soups, sandwiches, and salads); and self-service foods and foods 
on display that are intended for individual consumption (e.g., 
sandwiches, wraps, and paninis at a deli counter; salads plated by the 
consumer at a salad bar; cookies from a mall cookie counter; bagels, 
donuts, rolls offered for individual sale). Foods that are similar to 
grocery items that may be ready for immediate consumption but that 
consumers usually store for use at a later time or customarily further 
prepare would not be included within the meaning of ``restaurant-type 
food.'' Foods that we therefore would not consider to be within the 
meaning of ``restaurant-type food'' include foods to be eaten over 
several eating occasions or stored for later use (e.g., loaves of 
bread, bags or boxes of dinner rolls, whole cakes, and bags or boxes of 
candy or cookies); foods sold by weight that are not self-serve and are 
not intended solely for individual consumption (e.g., deli salads sold 
by unit of weight such as potato salad, chicken salad), either 
prepacked or packed upon consumer request; and foods that are usually 
further prepared before consuming (e.g., deli meats and cheeses).
    (Comment 25) One comment asked us to clarify that only food offered 
``for sale'' in a restaurant or similar retail food establishment 
should be considered in determining whether an establishment is a 
covered establishment. The comment noted that the statute expressly 
limits the

[[Page 71171]]

application of food labeling to items that are ``offered for sale,'' 
and considered that the menu labeling regulations should adopt a 
similar limitation.
    (Response 25) The rule only applies to food offered for sale.

D. Part of a Chain With 20 or More Locations

    In the proposed rule (76 FR 19192 at 19195), we noted that we did 
not propose a definition of the statutory criterion ``part of a chain 
with 20 or more locations'' and that we were assuming the common 
meaning of the words in the phrase. However, we requested comment on 
whether the phrase should be defined in the final rule, and 
particularly on whether the terms ``chain'' and ``location'' should be 
defined in context of the various types of corporate or other business 
arrangements that may be relevant, including contracting arrangements.
    In the following paragraphs, we discuss comments on the terms 
``chain'' and ``location.'' After considering these comments, we are 
adding a definition of ``locations'' to clarify our interpretation of 
``part of a chain with 20 or more locations.''
    (Comment 26) A few comments responded to our request for comment on 
the term ``chain.'' One comment recommended that we define ``chain'' as 
a covered establishment doing business under the same name as those 
that share the same name under the ownership, control, and operation of 
a single corporate entity. This comment considered that this is 
consistent with the commonly accepted dictionary definition of a chain 
as ``a group of enterprises or institutions of the same kind or 
function under a single ownership, management, or control.'' Another 
comment cited the following dictionary definition for ``chain'': ``A 
range of retail outlets which share a brand and central management, 
usually with standardized business methods''. This comment also cited 
the following dictionary definition for ``restaurant chain'': ``A set 
of restaurants, usually with the same name in many different locations 
either under shared corporate ownership or franchising agreements. 
Typically, the restaurants within a chain are built to a standard 
format and offer a standard menu.''
    (Response 26) Section 4205 of the ACA covers restaurants or similar 
retail food establishments that are part of a chain with 20 or more 
locations doing business under the same name ``regardless of the type 
of ownership of the locations.'' Both definitions suggested by comments 
refer to management structure, corporate control, and/or ownership. 
Because the statute directs us to disregard the type of ownership of 
the locations when determining whether an establishment is ``part of a 
chain with 20 or more locations doing business under the same name,'' 
neither of these definitions for the word ``chain'' is appropriate.
    According to the dictionary definitions, the word ``chain'' means, 
among other things, ``a group of enterprises, establishments, 
institution, or constructions of the same kind or function linked 
together into a single system'' (Ref. 15), a ``series or group of 
things or people that are connected to each other in some way'' (Ref. 
15), and ``a series of closely linked or connected things'' (Ref. 16). 
In section 403(q)(5)(H)(i) of the FD&C Act, Congress provides the ways 
in which restaurants or similar retail food establishments must be 
connected to or linked to each other in order to be covered by the new 
law: They must be doing business under the same name and offering for 
sale substantially the same menu items, and there must be 20 or more 
locations of them. Therefore, we continue to use the common meaning of 
the word ``chain'' and do not consider an additional regulatory 
definition necessary for this broad term. The statute specifies the 
particular criteria for the set of chains that are relevant for this 
rulemaking, and we provide regulatory definitions for those criteria 
specifically.
    (Comment 27) One comment recommended that we not rely solely on the 
terms ``chain'' and ``location'' because some restaurants and food 
establishments have locations at the same address, such as a mall. The 
comment asked us to either use the term ``selling post'' or to clarify 
that the location includes chains with restaurants in the same physical 
building. Another comment asked us to clarify that mobile facilities 
(such as food trucks) are covered. Some comments noted that 
transportation venues have menus that look like those in sandwich 
shops. Other comments noted that it is feasible for transportation 
venues to comply with the rule.
    (Response 27) We disagree that we should add the term ``selling 
post'' to the definition to specify restaurants and similar retail food 
establishments that are part of the same chain and are located in the 
same shopping mall or otherwise in the same physical building. However, 
this comment demonstrates that there is a need to define the term 
``locations,'' even assuming its common meaning. Unlike ``chain,'' 
where a definition is unnecessary given that we are establishing 
definitions for more specific, relevant criteria, we are convinced that 
establishing a regulatory definition of ``locations'' would provide 
clarity and facilitate a better understanding of regulatory 
expectations.
    The dictionaries define ``location'' to mean, among other things, 
``a position or site occupied . . . a tract of land designated for a 
purpose'' (Ref. 17); ``an area or tract of land'' (Ref. 18); ``a place 
where something is or could be located; a site . . . a tract of land 
that has been surveyed and marked off'' (Ref. 19). This evidences that 
the common meaning of the word ``location'' involves a specific or 
fixed position on land or portion of land. For clarity, we are defining 
``location'' to mean ``a fixed position or site.'' Therefore, for the 
purposes of determining whether an establishment is part of a chain 
with ``20 or more locations,'' we would consider each of the 
establishments occupying separate fixed positions or sites within the 
same shopping mall or physical building as separate establishments. One 
result of this definition of ``location'' is to exclude food facilities 
that do not have a fixed position or site, such as trains and 
airplanes. Additionally, mobile food operations such as food trucks 
without a fixed position or site are not covered by the rule.

E. Doing Business Under the Same Name

    Proposed Sec.  101.11(a) would define ``doing business under the 
same name'' as sharing the same name, where ``same name'' would include 
names that are either exactly the same, or are slight variations of 
each other, for example, due to the region, location, or size (e.g., 
``New York Ave. Burgers'' and ``Pennsylvania Ave. Burgers'' or ``ABC'' 
and ``ABC Express''). In the proposed rule (76 FR 19192 at 19199), we 
requested comment on whether the term should be understood to refer to 
the underlying name of ownership such as the name of the parent 
company, or the name of the entity conducting corporate business on 
behalf of the establishment, e.g., the name of a contractor operating 
the establishment, regardless of the public name used by the individual 
establishment.
    In the following paragraphs, we discuss comments on this proposed 
definition. After considering comments, we have revised the definition 
to clarify that the term ``name'' refers to either (a) the name of the 
establishment presented to the public or (b), if there is no name of 
the establishment presented to the public (e.g., an establishment with 
the generic descriptor ``concession stand''),

[[Page 71172]]

the name of the parent entity of the establishment.
    (Comment 28) Several comments supported the proposed definition. 
One comment recommended that the definition be broadened to include 
those with the same underlying name of ownership (parent company or 
contractor). A few comments recommended that the definition not be 
based on the underlying name of ownership. Based on the language of the 
statute, the comments considered that ``regardless of . . . ownership'' 
means that the ownership is not determinative and, therefore, the term 
should refer to the name used when doing business with the public and 
not the parent company, franchise owner, or other ownership entity. One 
comment argued that the phrase ``regardless of . . . ownership'' means 
that the corporate structure should not be considered when determining 
coverage; instead, the determining factor should be whether the name of 
the restaurant is the same. Another comment maintained that to include 
the underlying name of ownership in the definition would stifle 
investment in smaller locally based restaurants, i.e., it would place a 
cap on the number of restaurants an investor or entity could have 
before subjecting them to menu labeling.
    One comment recommended that the definition not be based on the 
name of the parent company because the name of the parent company has 
no bearing on the similarity of menu offerings. The comment argued that 
to do so would ignore the plain language of the statute, which clearly 
meant the public name of the location. One comment asserted that our 
proposed definition would expand the definition beyond the statutory 
language and Congress' express intent by covering smaller restaurant 
chains that offer creative menus and, thus, thwart the purpose and 
intent behind thoughtfully designed restaurants.
    (Response 28) We agree with comments that considered that the 
statutory phrase ``regardless of the type of ownership of the 
locations'' means that the type of ownership is not determinative. We 
also agree that ``doing business under the same name'' should, in 
general, refer to the name used when doing business with the public 
(e.g., the branded name that appears on the establishment's signage) 
rather than the name of the person or legal entity that owns the 
establishment. However, we are aware that some establishments have no 
specific name presented to the public. For example, concession stands 
in entertainment venues or cafeterias in office buildings may simply 
have a sign with a general descriptor, such as ``Hot Dogs'' or 
``Concession Stand'' or ``Building 1 Caf[eacute],'' or they may have no 
sign at all. In instances where there is no specific name presented to 
the public, we find it reasonable to conclude that the name under which 
they are doing business is the name of the parent entity of the 
facility. Consequently, we have revised the definition of the term 
``doing business under the same name'' in Sec.  101.11(a) to add that 
the term ``name'' refers to the name of the facility presented to the 
public or, if there is no name of the facility presented to the public 
(e.g., a facility with the generic descriptor ``concession stand''), 
the name of the parent entity of the facility.
    (Comment 29) One comment addressed the examples we included in the 
proposed definition of establishments doing business under the same 
name. As discussed in the proposed rule (76 FR 19192 at 19199), these 
examples include names that are slight variations on each other due, 
for example, to the region, location, or size. The comment asserted 
that it is inappropriate to imply that same name means slight 
variation. Another comment recommended that the rule apply to 
facilities in grocery stores with 20 or more locations even if the 
facilities' names vary from store to store.
    (Response 29) We disagree that the examples we included in the 
proposed definition of establishments doing business under the same 
name are inappropriate. Establishments that are part of large chains 
have slight variations in the name, e.g., to reflect a limited menu 
based on the space that the establishment occupies. For example, 
``XYZ'' chain may have ``XYZ'' restaurant in a free-standing store and 
``XYZ Express'' in an airline terminal, food court in a shopping mall, 
or grocery store. Even though the names are slight variations of each 
other, they are sufficiently similar that it is clear that the 
establishments are affiliated with one another. Generally, these 
establishments also have the same trade dress (e.g., trade name, logo, 
graphics and other distinctive elements of a brand) as the other 
establishments in the chain.
    (Comment 30) One comment recommended that we require that a chain 
remain covered if it initially is subject to the rule but the parent 
company changes the name of some locations to get below 20.
    (Response 30) Individual restaurants and similar retail food 
establishments would be subject to the rule if they satisfy the 
criteria for a ``covered establishment.'' If a restaurant or similar 
retail food establishment satisfies all the criteria for a covered 
establishment, and subsequently changes its name, it must reconsider 
whether it continues to satisfy all the criteria for a covered 
establishment, including whether it ``is part of a chain with 20 or 
more locations doing business under the same name.'' We anticipate that 
the benefits to an establishment to continue to do business under the 
same name as other establishments in the chain will keep establishments 
from changing their names in order to avoid being covered by this rule.

F. Offering for Sale Substantially the Same Menu Items

    Proposed Sec.  101.11(a) would define ``offering for sale 
substantially the same menu items'' as offering for sale menu items 
that use the same general recipe and are prepared in substantially the 
same way with substantially the same food components, even if the name 
of the menu item varies (e.g. ``Bay View Crab Cake'' and ``Ocean View 
Crab Cake''). Under the proposed definition, ``menu items'' would refer 
to food items that are listed on a menu or menu board or that are 
offered as self-service food or food on display. The proposed 
definition would also provide that restaurants and similar retail food 
establishments that are part of a chain can still be offering for sale 
substantially the same menu items if the availability of some menu 
items varies within the chain.
    In the following paragraphs, we discuss comments on this proposed 
definition. After considering comments, we have revised the definition 
to:
     Add a qualitative description of the number of menu items 
that must be shared in order for the criterion of ``offering for sale 
substantially the same menu items'' to be met; and
     Add a statement that having the same name may indicate, 
but does not necessarily guarantee, that menu items are substantially 
the same.
    (Comment 31) Several comments supported the definition. One comment 
asserted that the proposed rule was not clear on what ``substantially'' 
the same menu items means quantitatively and suggested that it could 
mean anywhere between 51 and 99 percent. Another comment asked us to 
clarify what constitutes ``offering for sale menu items that use the 
same general recipe and are prepared with substantially the same food 
components even if the name varies.'' This comment pointed out that 
some restaurants in a chain may have some unique items or may vary the 
recipes and therefore, it is not clear if the restaurant is ``offering 
for sale substantially the same menu items.''

[[Page 71173]]

The comment gave as an example a kosher restaurant that uses the same 
name as non-kosher restaurants that are part of the same chain. The 
comment noted that due to the kosher restaurant's following of the 
kosher laws, the kosher restaurant may offer for sale some menu items 
that vary from the menu items offered for sale in a non-kosher 
restaurant in the chain. In addition, the comment noted that the kosher 
restaurant may offer for sale unique menu items, such as schwarma, that 
are not offered for sale in the non-kosher restaurants in the chain. 
This comment requested an exemption for franchise restaurants that 
offer specialty menu items or items altered to accommodate a specific 
dietary practice (e.g., kosher).
    One comment pointed out that menu items in chain restaurants and 
similar retail food establishments vary between States and within 
States to accommodate local tastes, even if the menu items have the 
same name. The comment cited chili as an example, stating that in 
Cincinnati it is common for chili to be made with cocoa and cinnamon 
thinned out with finely ground meat over spaghetti, whereas in Texas, 
chili is made with large chunks of meat, often with beans, served alone 
in a bowl.
    One comment stated that some food service contractors provide 
clients with menus that may change daily, weekly, or monthly and with 
rotating cycle menus that can use up to several hundred recipes with 
cycle menus that vary from 3, 4, or 5 week cycles and from 5, 6, or 7 
day service weeks. Due to the variability in menus in locations that 
rely on contract food services, the comment recommended that the 
definition of ``offering for sale substantially the same menu item'' be 
changed to ``establishments in a chain that offer standard menus 
comprised of menu items that use the same general recipes and are 
prepared in substantially the same ways with substantially the same 
food components, even if the name of the menu item varies.''
    (Response 31) We decline to name a proportion or percentage of menu 
items that must be shared between establishments. Restaurants and 
similar retail food establishments regularly offer new and reformulated 
menu items in their establishments. It would be burdensome and 
impractical for establishments and inspectors to continually evaluate 
all of the establishments in the chain to count the numbers of standard 
menu items in common in order to determine whether a given 
establishment is covered. In addition, some establishments that are 
part of a large chain may not offer for sale all of the standard menu 
items offered in other locations of that chain. For example, some 
chains have a handful of locations in airports or other venues notated 
by the term ``Express'' added to the name, that sell a subset of the 
foods that are carried by the larger establishments in the chain. 
Finally, as the comments point out, some restaurants that are part of 
large chains have some unique or regional items or may vary recipes in 
a unique way. These types of minor variations should not exclude 
establishments from the requirements of this rule.
    Based on the comments and on the considerations discussed 
previously in this document, we are not finalizing a specific 
proportion or percentage of menu items that covered establishments 
within a chain must share. However, we understand from the comments 
that our definition should speak to the number of menu items that must 
be shared more clearly. Therefore, we are adding a qualitative, not 
quantitative, description of the number of menu items that must be 
shared in order for the criterion of ``offering for sale substantially 
the same menu items'' to be met. Given the statutory language, along 
with the practicalities of and variations within the industry, we are 
adding ``offering for sale a significant proportion of menu items'' to 
the definition of ``offering for sale substantially the same menu 
items.'' For example, if establishments only share one or two menu 
items, those establishments would not meet the criterion of ``offering 
for sale substantially the same menu items.''
    We recognize that some establishments in a chain may have some menu 
items with ingredients that vary based on regional taste or source. 
Some menu items may be designed or prepared to meet certain dietary 
practices (e.g., Kosher or Halal) or contain a ``secret ingredient.'' 
This is why our definition of ``offering for sale substantially the 
same menu items'' includes the criteria ``us[ing] the same general 
recipe, prepared in substantially the same way, with substantially the 
same food components.'' By ``the same general recipe,'' we mean that 
the establishments share a recipe, even if one establishment 
subsequently tweaks that recipe due to regional tastes or dietary 
practices. By ``prepared in substantially the same way,'' we mean to 
include slight deviations from the recipe, because of, for example, 
food service worker variability. By ``with substantially the same food 
components,'' we mean to include situations where ingredients may vary 
based on local availability or sourcing, including those used to 
conform to certain dietary practices (e.g., Kosher meat).
    We also agree with comments that having the same name may indicate 
that the menu items are substantially the same, but it does not always 
do so. As comments pointed out, menu items that reflect regional 
differences may be so different that the name of the menu item sheds 
little light on whether the menu items use the same general recipe and 
are prepared in substantially the same way with substantially the same 
food components. For example, in some regions of the United States a 
menu item named ``barbecue'' may refer to a food prepared from pulled 
pork, whereas in other regions a menu item named ``barbecue'' may refer 
to a food prepared from beef ribs. Therefore, we have revised the 
definition to add a new sentence stating that having the same name may 
indicate, but does not necessarily guarantee, that menu items are 
substantially the same.
    The definition for ``substantially the same menu items'' would also 
apply to establishments relying on food contractors. If such an 
arrangement caused menu rotations, the relevant question would still be 
whether those establishments are offering for sale substantially the 
same menu items, including whether they are selling a significant 
proportion of menu items that use the same general recipe and are 
prepared in substantially the same way with substantially the same food 
components, even if not necessarily at the same time. In other words, 
the focus is on whether the menu items are substantially the same, not 
on whether the menus or menu boards are substantially the same. We 
decline to accept the suggestion from the comment to revise the 
definition to include ``establishments in a chain that offer standard 
menus comprised of menu items that . . .'' because it reflects a 
misunderstanding that an establishment needs to have a menu, or a 
``standard menu'' more specifically, to be covered by the new law.
    (Comment 32) One comment maintained that convenience stores in a 
chain do not have identical business plans and the same food; the food 
varies per establishment and is not prepared to corporate policy as it 
is in restaurants.
    (Response 32) As explained previously in this document, 
establishments can be ``offering for sale substantially the same menu 
items'' even if not all of their menu items are exactly the same. 
Depending on the extent to which the menu items vary, a convenience 
store may or may not meet the criterion of offering for sale

[[Page 71174]]

substantially the same menu items as defined in the rule.
    (Comment 33) One comment described itself as a family-owned 
restaurant operator with 25 restaurants located entirely within a 
single State. Two of its restaurants also contain sushi operations, 
each under a different name and with entirely different menus than the 
larger establishment. The comment asked us to confirm that the rule 
would not apply to these sushi operations.
    (Response 33) Based on the information in the comment, the two 
sushi operations do not appear to be covered by the rule because they 
are neither doing business under the same name (see section VI.E) nor 
offering for sale substantially the same menu items as 18 other 
establishments.

G. Authorized Official of a Restaurant or Similar Retail Food 
Establishment

    Proposed Sec.  101.11(a) would define ``Authorized official of a 
restaurant or similar retail food establishment'' as the owner, 
operator, agent in charge, or other person authorized by the owner, 
operator, or agent in charge to register the restaurant or similar 
retail food establishment, which is not otherwise subject to section 
403(q)(5)(H) of the FD&C Act, with FDA for the purposes of Sec.  
101.11(d). (Section 101.11(d) pertains to voluntary registration to 
become subject to the requirements of section 403(q)(5)(H) of the FD&C 
Act.)
    We received no comments on the proposed definition and are 
finalizing it without change.

H. Covered Establishment

    As already noted in section VI.A, proposed Sec.  101.11(a) would 
define ``covered establishment'' as a restaurant or similar retail food 
establishment that is a part of a chain with 20 or more locations doing 
business under the same name (regardless of the type of ownership, 
e.g., individual franchises) and offering for sale substantially the 
same menu items, as well as a restaurant or similar retail food 
establishment that is registered to be covered under section 
403(q)(5)(H)(ix) of the FD&C Act. (Emphasis added).
    In the following paragraphs, we discuss general comments on this 
proposed definition. We are finalizing the definition of ``covered 
establishment'' without change, except to refer to Sec.  101.11(d) 
instead of section 403(q)(5)(H)(ix) of the FD&C Act. However, as 
already discussed (see sections VI.B, VI.C, VI.D, VI.E, and VI.F), 
changes we are making to other terms (i.e., adding a definition of 
``location,'' revising the definition of ``restaurant or similar retail 
food establishment,'' revising the definition of ``restaurant-type 
food,'' revising the definition of ``doing business under the same 
name,'' and revising the definition of ``offering for sale 
substantially the same menu items'') affect the overall set of covered 
establishments.
1. General Comments on the Definition of Covered Establishment
    (Comment 34) One comment considered that our proposed definition 
would make it conceivable for the requirements to apply to a single, 
completely unique ``restaurant concept'' that is owned by a chain with 
20 or more other restaurants. The comment described a ``restaurant 
concept'' as separate and distinct operations by virtue of the 
individual restaurant's menu offerings or recipes, name, decor, and 
other distinguishing characteristics such as different dining 
experiences with higher quality food and different menu items that may 
be unrecognizable to the average diner as being operated by the larger 
chain. This comment also considered that applying the menu labeling 
requirements to these individual ``restaurant concepts'' would not be 
consistent with the statute or intent of Congress. Another comment 
expressed concern that a person who operates more than 20 chain retail 
food establishments and wants to start a ``new concept'' would be 
required to provide nutrition information if this ``new concept'' is 
only in one location.
    (Response 34) We disagree that we need to revise the definition of 
a covered establishment to prevent a misinterpretation that a single, 
completely unique ``restaurant concept'' that is owned by a chain with 
20 or more other restaurants generally would be covered by the rule. An 
establishment that is ``single'' and a ``completely unique restaurant 
concept'' is unlikely to have ``20 or more locations'' and be 
``offering for sale substantially the same menu items'' as 20 or more 
other restaurants. Thus, such an establishment is unlikely to satisfy 
the criteria in the proposed definition to be a ``covered 
establishment'' as it is currently written. Likewise, if a person 
operates more than 20 chain retail food establishments and starts a 
``new concept,'' that ``new concept'' establishment would not be a 
covered establishment unless it is part of a chain with 20 or more 
locations doing business under the same name and offering for sale 
substantially the same menu items. We are retaining our definition, 
which, as we described in the proposed rule, is derived from sections 
403(q)(5)(H)(i) and (xi)(I) of the FD&C Act (76 FR 19192 at 19195).
    (Comment 35) One comment recommended that we revise the definition 
of covered establishment to use the following language from its State's 
regulation: ``A food establishment that: (1) Is engaged in the business 
of preparing and selling food items for immediate human consumption on 
the premises or off the premises, . . . and (2) offers for sale 
substantially the same menu items, utilizing menus, menu boards or food 
item tags, in servings that are standardized for portion size and 
content, and (3) is one of a group of . . . food establishments . . . 
that (a) operates under common ownership or control, or (b) operates as 
franchised outlets of a parent business, or (c) does business under the 
same name.'' The comment cited only those portions of its regulation 
relevant to the questions raised by the definition of covered 
establishment in our proposed rule, and used ellipses to indicate text 
that was in the State regulation but not being offered as part of the 
definition of ``covered establishment'' in this rule.
    (Response 35) We disagree with this comment and are not revising 
the definition of ``covered establishment'' to incorporate its 
suggestions. Our definition of covered establishment is derived from 
the Federal statutory language. The only basis offered by the comment 
was that the suggestions are used in a State law; the comment did not 
state why these changes were necessary from a policy perspective or 
legally justified under the Federal law.
    (Comment 36) One comment recommended that the rule apply to most 
restaurants, and not just those with more than 20 locations, possibly 
excluding only establishments with a very small seating capacity. The 
comment contended that consumers already know that fast food is ``bad 
for you'' and they need to know the nutrition information about the 
food in other restaurants.
    (Response 36) This rule implements section 4205 of the ACA, which, 
in general, covers only restaurants and similar retail food 
establishments that are part of a chain with 20 or more locations. 
Section 4205 of the ACA allows other restaurants and similar retail 
food establishments to register with FDA to become subject to the 
Federal requirements, but it does not require them to do so.
    (Comment 37) One comment asked us to clarify whether the rule would 
apply to foreign establishments of a particular chain that has 20 or 
more establishments in the United States, and also has an establishment 
located in a foreign location, such as Italy.

[[Page 71175]]

    (Response 37) The rule applies to locations in the United States, 
including any State or Territory of the United States, the District of 
Columbia, and the Commonwealth of Puerto Rico. This geographic scope is 
consistent with the definitions of ``State'' and ``Territory'' in 
section 201(a) of the FD&C Act.
    (Comment 38) A few comments asked us to clarify that contractors 
and managed food service operations would be covered if they offer for 
sale substantially the same menu items.
    (Response 38) Whether any other specific contractor or managed food 
service would be subject to the rule would depend on whether it 
satisfied all criteria established within the definition of ``covered 
establishment.'' Thus, to be a covered establishment, an establishment 
operated by a contractor or managed food service must be a restaurant 
or similar retail food establishment that is a part of a chain with 20 
or more locations doing business under the same name and offering for 
sale substantially the same menu items. We expect that some 
establishments operated by contractors and managed food services will 
satisfy all of these criteria.
2. Cooperatives
    (Comment 39) Some comments addressed cooperatives and discussed 
multiple aspects related to the definition of ``covered 
establishment,'' including ``part of a chain,'' ``doing business under 
the same name,'' and ``offering for sale substantially the same menu 
items.'' One comment considered that cooperatives should not be exempt 
because the law expressly states ``regardless of . . . ownership.'' One 
comment considered that the type of ownership of grocery stores, such 
as a cooperative, is irrelevant to whether a store is part of a chain. 
This comment maintained that the law clearly requires chains operating 
under the same name to disclose calories, regardless of the type of 
ownership. This comment also maintained that grocery store cooperatives 
face a similar situation as that faced by independent franchise owners 
of chain restaurants.
    Other comments generally expressed the view that cooperatives 
should not be covered by the rule. One comment asserted that 
establishments associated with the same wholesaler or cooperative 
should not be considered ``part of a chain'' regardless of whether they 
operate under the same ``banner'' or under a different ``banner.'' The 
comment considered that cooperatives are the opposite of chains because 
they are owned by individual members, operate independently, and are 
not bound by franchise agreements, whereas chains are centrally 
controlled with little say or choice by participants. The comment asked 
us to recognize that independent grocers are not part of a chain of 20, 
doing business under same name and selling the same items, even if we 
believe cooperatives are similar retail food establishments.
    A few comments maintained that the definition for ``doing business 
under the same name'' does not apply to cooperatives because they are 
independent and exercise their independence more than franchised 
restaurants. According to one comment, independent retailers own, 
control, and operate their stores independently as customers of 
voluntary wholesalers and members of cooperatives. The comment 
explained that the food distribution system allows independent 
retailers to take advantage of economies of scale when procuring goods 
and services, as well as marketing and advertising, thus helping 
independent operators effectively compete with large national chain 
stores. The comment also explained that these entities are 
independently owned and operated businesses that often compete with 
other stores under the same banner name, and that menu items can have 
different general recipes and be prepared in substantially different 
ways with substantially different food components.
    One comment asked us to recognize that members of cooperatives are 
not ``doing business under the same name.'' For example, the comment 
considered that ``Fred's Thriftway'' is not the same as ``Bob's 
Thriftway.'' The comment considered that ``Thriftway'' signals that 
these establishments are part of a cooperative but maintained that they 
are two different stores.
    One comment contended that the term ``offering for sale 
substantially the same menu items'' may not apply to some foods, such 
as brownies or potato salad, made in grocery store cooperatives, 
although those foods may be offered for sale under the same name in 
those stores. According to the comment, ``Bob's Thriftway'' and 
``Mike's Thriftway'' may both sell brownies made from the same general 
recipe, (e.g., flour, sugar, eggs, chocolate and butter); however, 
because independent grocers compete with each other, each is likely to 
include a secret ingredient, and as a result, the brownies are not the 
same.
    (Response 39) We agree with some comments that the type of 
ownership of an establishment is not relevant to whether it is covered. 
To be subject to the rule, a cooperative must satisfy all the criteria 
in the definition of ``covered establishment.'' In other words, to be 
subject to the rule a cooperative must be a restaurant or similar 
retail food establishment that sells restaurant-type food and is a part 
of a chain with 20 or more locations doing business under the same name 
(regardless of the type of ownership, e.g., individual franchises) and 
offering for sale substantially the same menu items. As we explain in 
section VI.D., we are not defining the term ``chain'' in this 
rulemaking. In addition, for the reasons we provide in section VI.E., 
we continue to define doing business under the same name to include 
names that are slight variations of each other. Independent businesses 
that are cooperatives, even those that are similarly named, are not 
covered establishments if, for example, they are only connected insofar 
as they take advantage of economies of scale when procuring goods and 
services, or for marketing and advertising purposes, but are not 
``offering for sale substantially the same menu items.''
    However, given the way cooperatives generally are structured, we do 
not expect that two cooperatives would be offering for sale 
substantially the same menu items. Unless a food such as a brownie 
offered for sale in Bob's Thriftway has the same general recipe, 
prepared in substantially the same way, with substantially the same 
food components as a brownie offered for sale in Mike's Thriftway, the 
two cooperatives' brownies would not be ``substantially the same.'' 
However, if Bob's Thriftway and Mike's Thriftway share a recipe such as 
a brownie recipe, and the only difference between the two brownie 
recipes is that Mike's Thriftway has added a ``secret ingredient,'' the 
brownies could be considered substantially the same menu item, 
depending on the importance of that ingredient. Note that even in this 
circumstance, Bob's Thriftway and Mike's Thriftway would not be 
``offering for sale substantially the same menu items'' if the brownie 
is the only menu item that the two cooperatives share.
    In addition, we note that a cooperative that is a restaurant or 
similar retail food establishment and does not satisfy all of the 
criteria to be a covered establishment, but voluntarily registers to be 
covered in accordance with Sec.  101.11(d), would be subject to the 
rule.

[[Page 71176]]

I. Revisions to Several Provisions To Clarify the Applicability of the 
Rule to Those Restaurants and Similar Retail Food Establishments That 
Are Covered Establishments

    This rule applies to restaurants and similar retail food 
establishments that satisfy the definition of ``covered establishment'' 
in this rule. Several provisions of the proposed rule that would apply 
to ``covered establishments'' used the term ``restaurant or similar 
retail food establishment'' rather than ``covered establishment.'' To 
make clear that those provisions only apply to those restaurants and 
similar retail food establishments that satisfy the definition of 
``covered establishment,'' we are replacing the term ``restaurant or 
similar retail food establishment'' with ``covered establishment'' in 
those provisions. The affected provisions are:
     The definition of ``custom order'' (Sec.  101.11(a));
     The definition of ``menu or menu board'' (Sec.  
101.11(a));
     The introductory text of Sec.  101.11(b)(2)(ii) regarding 
nutrition information for a standard menu item that must be available 
in written form;
     The introductory paragraph of proposed Sec.  101.11(c)(6) 
(which we are establishing in Sec.  101.11(c)(3)) regarding information 
that must be provided to FDA substantiating nutrient information; and
     A subparagraph of proposed Sec.  101.11(c)(6) regarding 
specific substantiation documentation (i.e., proposed paragraph 
(c)(6)(ii)(D), which we are establishing as paragraph (c)(3)(ii)(D)).
    We note these changes in our discussion of each of these specific 
provisions.

VII. Comments and FDA Response on the Proposed Definition of Menu or 
Menu Board (Proposed Sec.  101.11(a))

    Proposed Sec.  101.11(a) would define ``menu or menu board'' as the 
primary writing of the restaurant or similar retail food establishment 
from which a customer makes an order selection, including, but not 
limited to, breakfast, lunch, and dinner menus; dessert menus; beverage 
menus; children's menus; other specialty menus; electronic menus; and 
menus on the Internet. The proposed definition would also provide that 
menus may be in different forms, e.g., booklets, pamphlets, or single 
sheets of paper and that menu boards include those inside a restaurant 
or similar retail food establishment as well as drive-through menu 
boards at restaurants or similar retail food establishments.
    In the proposed rule, we stated that given the importance for all 
consumers to have access to nutrition information when making order 
selections, ``primary writing'' should be interpreted from a consumer's 
vantage point (76 FR 19192 at 19202). For example, while a printed menu 
may be the ``primary writing'' of a restaurant used by a customer 
ordering food while dining inside the restaurant itself, a menu mailed 
as a flyer to another customer's home could be the ``primary writing'' 
of the restaurant used by that customer ordering take-out or delivery 
from the same restaurant. Both the printed menu and the menu flyer 
would meet the definition of ``menu'' or ``menu board'' under proposed 
Sec.  101.11(a).
    In the following paragraphs, we discuss comments on this proposed 
definition. We have revised the definition by replacing the term 
``restaurant or similar retail food establishment'' with ``covered 
establishment'' in three locations in the definitions for clarity (see 
explanation in section VI.I). We are also including factors used to 
determine whether a writing is or is part of the primary writing from 
which a consumer makes an order selection.
    (Comment 40) Many comments supported the proposed definition and 
agreed that ``primary writing'' should be interpreted from the 
perspective of consumers, so that each writing of the establishment 
that is the primary writing used by consumers in making order 
selections would be considered a menu or menu board. Several comments 
asserted that consumers need to see calorie information when making 
order selections in order for the information to be useful to them. One 
comment noted that Congress did not intend for covered establishments 
to only provide calorie declarations on a single medium in each 
establishment, as evidenced by the fact that section 4205 of the ACA 
requires calorie declarations on drive-through menu boards and menus 
and menu boards located inside establishments. Another comment 
suggested that we emphasize that any list or display of a standard menu 
item that is primary to the consumer placing an order would constitute 
a menu or menu board.
    One comment considered that a single store that has multiple menus 
or menu boards should be able to select the menu on which the calories 
must be disclosed. For example, a single store might have more than one 
menu board--with one such board being handwritten and highlighting 
specific special options. As long as every food offered for sale in the 
establishment is listed on one menu board and that menu board includes 
the necessary information, the comment considered that requiring 
calories on that one menu board should be sufficient. Alternatively, 
the comment suggested that the calorie declaration be required on the 
``menu board of prominence,'' which the comment considered to be the 
menu board from which the order is placed.
    Another comment similarly asserted that covered establishments must 
post the required information on the menu used most often rather than 
on all menus. Alternatively, the comment suggested that we provide an 
exemption for menus not commonly used by customers. In support of its 
suggestion, the comment pointed out that the statute uses the singular 
term ``writing'' and not a plural term. The comment stated that 90 
percent of pizza customers order over the phone or the Internet or may 
order from memory. The comment asserted that to require nutrient 
information on every menu, menu board, Internet menu, or other writing 
is expensive, time consuming, and burdensome. The comment stated that 
it already uses in-store brochures to provide nutrition information to 
the small percentage of in-store customers. Although each franchisee in 
the applicable chain is required to carry certain menu items, the 
comment considered that each franchisee has the latitude to add items 
to the menu. Because the franchisee can add menu items to its menu, the 
comment asserted that it would be costly to a franchisee to change menu 
boards, because the franchisee will be required to order new menu 
boards and request calorie information for the new menu items.
    One comment referred to an ``industry proposal'' for posting 
calories only on menus and menu boards that have the highest percentage 
of sales for that particular establishment, e.g., Web sites used for 
Internet ordering and paper menus for phone ordering. This comment was 
opposed to any such proposal. The comment asserted that this approach 
would be an unfair business advantage for certain restaurants because 
it would allow some restaurants to provide calorie declarations on less 
expensive menus such as paper take-out menus or Internet Web sites 
while others would have to provide calorie declarations for more 
expensive in-restaurant menus and menu boards. The comment also 
expressed concern that any requirement for a covered establishment to 
declare calories on only the menus that listed substantially all menu 
items would exclude children's menus and dessert menus.

[[Page 71177]]

    (Response 40) We agree with the comments in support of the proposed 
definition. We disagree that the required information should only be 
posted on the menu or menu board most often used by consumers in a 
covered establishment, the ``menu board of prominence,'' or only on the 
menus and menu boards that have the highest percentage of sales for a 
particular covered establishment. The critical factor is whether 
written material is or is part of the primary writing of a covered 
establishment from which a customer makes an order selection. It is not 
a matter of physical prominence of a menu, or the proportion of 
customers who order from a menu. Some consumers may want to select from 
a subset of standard menu items sold in the covered establishment. For 
example, if a consumer wanted to order only a dessert, he or she may 
ask for a dessert menu. As raised by one comment, if calorie 
information is listed only on the dinner menu, the consumer would not 
have access to the calorie information for the desserts if he or she is 
ordering from the dessert menu. As we stated in the proposed rule, 
given the importance for all consumers to have access to nutrition 
information when making order selections, we believe that the term 
``primary writing'' should be interpreted from a consumer's vantage 
point (76 FR 19192 at 19202).
    In addition, in the proposed rule, we tentatively concluded that a 
``menu'' or ``menu board'' includes any writing of the covered 
establishment that is the primary writing from which a consumer makes 
an order selection (76 FR 19192 at 19201). We affirm this conclusion. 
The ``primary writing'' of an establishment can include more than one 
form of written material, such as a paper menu, a delivery menu, and a 
menu board; the critical factor is whether the written material is or 
is part of the primary writing of a covered establishment from which a 
customer makes an order selection. Further, we clarify that determining 
whether a writing is or is part of the primary writing from which a 
consumer makes an order selection depends on a number of factors, 
including whether the writing, such as a paper menu, delivery menu, or 
sign, lists the name of a standard menu item (or an image depicting the 
standard menu item) and the price of the standard menu item, and 
whether the writing can be used by a consumer to make an order 
selection at the time the consumer is viewing the writing (e.g., the 
writing is posted at the cash register in a covered establishment, or 
the writing lists the phone number or email address of a covered 
establishment for purposes of placing an order).
    Accordingly, a writing of a covered establishment that contains the 
name (or image) and price of a standard menu item, and that can be used 
by a consumer to make an order selection from the establishment at the 
time the consumer is viewing the writing would be a menu or menu board 
regardless of whether, for example, the writing is not the menu used 
most often by consumers. Another writing, such as a poster on a 
storefront, a banner or billboard located along a road or highway, or a 
tray-liner or table-tent at a quick-service restaurant, could be 
considered a ``secondary'' writing within this context and would not 
meet the definition of a ``menu or menu board,'' provided that such 
writing does not contain the name (or image) and price of a standard 
menu item, and cannot be used by a consumer to make an order selection 
at the time the consumer is viewing the writing.
    We interpret the comment asserting that section 403(q)(5)(H)(xi) of 
the FD&C Act uses the singular term ``writing'' in defining the term 
``menu or menu board'' as raising the question of what Congress 
intended ``primary writing'' to mean within the context of section 
403(q)(5)(H)(xi) of the FD&C Act. In construing section 
403(q)(5)(H)(xi) of the FD&C Act, FDA is confronted with two questions. 
First, has Congress directly spoken to the precise question presented 
(Chevron step one)? (Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 
842 (1984).) If the ``intent of Congress is clear,'' an Agency ``must 
give effect to the unambiguously expressed intent of Congress.'' (Id. 
at 843.) However, if ``Congress has not directly addressed the precise 
question at issue,'' and the statute is ``silent or ambiguous with 
respect to the specific issue,'' then our interpretation of the term 
``primary writing'' will be upheld as long as it is based on a 
``permissible construction of the statute (Chevron step two). (Chevron, 
467 U.S. at 842-43; FDA v. Brown & Williamson Tobacco Corp, 529 U.S. 
120, 132 (2000).) To find no ambiguity, Congress must have clearly 
manifested its intention with respect to the particular issue. (See 
e.g., Young v. Community Nutrition Institute, 476 U.S. 974, 980 
(1986).)
    We have determined that, in enacting section 403(q)(5)(H)(xi) of 
the FD&C Act, Congress did not speak directly and precisely to the 
meaning of ``primary writing'' within the definition of ``menu or menu 
board.'' In conducting the Chevron step one analysis, we began with the 
language of section 403(q)(5)(H)(xi) of the FD&C Act. (See e.g., Touche 
Ross & Co. v. Redington, 442 U.S. 560, 568 (``[A]s with any case 
involving the interpretation of a statute, our analysis must begin with 
the language of the statute itself.'').) The term ``primary writing'' 
is not defined in section 403(q)(5)(H) of the FD&C Act or elsewhere in 
the FD&C Act. In general, a term that is undefined in a statute carries 
its ordinary meaning. (See e.g., Perrin v. United States, 444 U.S. 37, 
42 (1979) (``A fundamental canon of statutory construction is that, 
unless otherwise defined, words will be interpreted as taking their 
ordinary contemporary, common meaning.'').) One common definition of 
the term ``writing'' is ``something written, especially (a) meaningful 
letters or characters that constitute readable matter . . . (b) a 
written work, especially a literary composition'' (Ref. 20). Similarly, 
another common definition of the term ``writing'' is ``something 
written: As (a) letters or characters that serve as visible signs of 
ideas, words, or symbols; (b) a letter, note, or notice used to 
communicate or record; (c) a written composition.'' (Ref. 21; see also 
Ref. 22).
    One common definition of the term ``primary'' is ``first or highest 
in rank or importance; principal'' (Ref. 23; see also Refs. 24 and 25). 
Another common definition of the term ``primary'' is ``functioning or 
transmitting without intermediary: Direct'' (Ref. 25; see also Ref. 
24).
    Where, as here, the statutory language on its face does not clearly 
establish Congressional intent, it is appropriate to also consider 
other traditional tools of statutory construction, including other 
language in the section, the language, design, and purpose of the 
statute as whole, and legislative history. (See e.g., Pharmaceutical 
Research & Manufacturers of America v. Thompson, 251 F.3d 219, 224 
(D.C. Cir. 2001); Davis v. Michigan Department of Treasury, 489 U.S. 
803, 809 (1989); Martini v. Federal National Mortgage Association, 178 
F.3d 1336, 1345 (D.C. Cir. 1999).) The other language in section 
403(q)(5)(H)(xi) of the FD&C Act indicates that the writing at issue is 
writing of the establishment ``from which a consumer makes an order 
selection.'' Further, other provisions within section 403(q)(5)(H) of 
the FD&C Act indicate that requirements apply to more than one form of 
writing within a covered establishment. (See sections 
403(q)(5)(H)(ii)(I) and (II) of the FD&C Act.) In addition, a general 
purpose of section 4205 of the ACA is to make calorie and other 
nutrition information available to consumers in a direct and

[[Page 71178]]

accessible manner to enable consumers to make informed and healthful 
dietary choices. Lastly, the legislative history does not suggest that 
Congress intended to limit the term to only one writing of the 
establishment.
    Having determined that the meaning of ``primary writing'' in 
section 403(q)(5)(H)(xi) of the FD&C Act is ambiguous, we have 
determined that the final rule's interpretation of ``primary writing'' 
is a permissible construction of the statute (Chevron step two). In 
conducting the Chevron step two analysis, the same tools of statutory 
construction are available as those for the step one analysis.
    First, the interpretation in the final rule is consistent with the 
plain meaning of the statute (Ref. 26). (See also Perrin v. United 
States, 444 U.S. 37, 42 (1979).) Under the final rule, a ``primary 
writing'' is ``something written,'' such as letters or characters on a 
sign or board. Further, determining whether the ``writing'' is 
``primary,'' meaning of the most relevance or importance within this 
context or functioning without intermediary, or direct, depends on a 
number of factors, including whether the writing lists the name of a 
standard menu item (or an image depicting the standard menu item) and 
the price of the standard menu item, and whether the writing can be 
used by a consumer to make an order selection at the time the consumer 
is viewing the writing. In developing these factors, we considered 
other language in section 403(q)(5)(H)(xi) of the FD&C Act, 
specifically that the writing of the establishment is one ``from which 
a consumer makes an order selection.'' We also considered other 
language within section 403(q)(5)(H) of the FD&C Act, including 
sections 403(q)(5)(H)(i) and (ii)(I) and (II) of the FD&C Act, which 
together require a covered establishment to post calorie and other 
information on a menu and menu board. Further, in considering the 
general purpose of the section 4205 of the ACA, we determined that 
construing the term ``primary writing'' within the meaning of section 
403(q)(5)(H)(xi) of the FD&C Act so as to include more than one form of 
writing, dependent on specific factors, would better serve the purposes 
of section 4205.
    For all of these reasons, Sec.  101.11(a) continues to specify that 
a menu or menu board is defined as the primary writing of the 
restaurant or similar retail food establishment from which a consumer 
makes an order selection.
    In response to the comment regarding costs related to adding new 
menu items to a menu or menu board, we first note that section 
403(q)(5)(H)(ii) of the FD&C Act requires covered establishments to 
declare calories on menus and menu boards for standard menu items 
listed on such menu and menu boards. Therefore, to the extent a covered 
establishment adds a new standard menu item to the establishment's menu 
or menu board, the establishment would be required to declare calories 
on the menu or menu board for the new standard menu item. Further, a 
covered establishment that decides to add a new menu item to a menu or 
menu board has already decided to incur the cost of redesigning or 
replacing the menu or menu board for such change--i.e., to display the 
new standard menu item. In this situation, the additional cost to the 
establishment is the cost for determining the calorie information that 
must be declared for the new standard menu item.
    Regarding costs related to determining nutrition information for 
standard menu items, we note that this rule also provides flexibility 
in order to minimize such costs. As discussed in section XVIII, section 
403(q)(5)(H)(iv) of the FD&C Act provides that a restaurant or similar 
retail food establishment must have a reasonable basis for its nutrient 
content disclosures. As also discussed in section XVIII, this rule 
provides that a covered establishment can satisfy the requirements of 
403(q)(5)(H)(iv) of the FD&C Act by various means, including use of 
nutrient databases, cookbooks, laboratory methods, and other reasonable 
means, including the use of Nutrition Facts on labels on packaged foods 
that comply with the nutrition labeling requirements of section 
403(q)(1) of the FD&C Act and Sec.  101.9, FDA nutrient values for raw 
fruits and vegetables in Appendix C of part 101 (21 CFR part 101), or 
FDA nutrient values for cooked fish in Appendix D of part 101 (see 
Sec.  101.11(c)(1)). In addition, this rule provides that a covered 
establishment can satisfy the requirements of 403(q)(5)(H)(iv) of the 
FD&C Act by relying on nutrition information for a standard menu item 
determined by the establishment's corporate headquarters or parent 
entity (see Sec.  101.11(c)(3)(i)(F), (c)(3)(iii)(D), and 
(c)(3)(iv)(D)). In some cases, a corporate headquarters or parent 
entity could decide to maintain a nutrient database and use it to 
determine nutrition information for specialty standard menu items 
offered for sale by one or a few individual establishments in the 
chain. Therefore, this rule provides flexibility for covered 
establishments in order to minimize costs while also helping to ensure 
that calorie and other nutrition information is made available to 
consumers in a direct and accessible manner to enable consumers to make 
informed and healthful dietary choices.
    (Comment 41) A few comments appeared to believe that the proposed 
rule would require covered establishments to post or otherwise have 
menu boards for disclosing calorie information. These comments asked 
for other options for disclosing calories. One comment suggested that 
large menu boards should not be required because they will obscure the 
consumers' view of the preparation of their food and thereby create a 
food safety issue. One comment suggested that we consider 
``technological solutions'' instead of menu boards, e.g., use of a 
kiosk near the point of sale. The comment also suggested that we 
provide flexibility to cover alternative sources such as a daily 
feature board.
    One comment asked us to provide flexibility for facilities that 
operate in locations too small to display a menu board by allowing 
establishments to choose among several different options for display 
methods. As one alternative to the traditional menu board, the comment 
asked us to permit the use of a display terminal to provide nutrition 
information for menu items or allow ``menu identifiers'' (a term the 
comment did not define) at the point of selection, and to permit 
nutrition information to be displayed adjacent to the food item in 
cafeteria and buffet type settings.
    (Response 41) Some comments may have misinterpreted the proposed 
rule. We did not propose to require that covered establishments post or 
otherwise have menu boards. Rather, within this context, we proposed to 
define the terms ``menu'' and ``menu board,'' based on the statutory 
definition at section 403(q)(5)(H)(xi) of the FD&C Act, and to provide 
direction regarding what information must be disclosed on menus and 
menu boards for covered establishments that have menus and menu boards. 
That proposed definition relies on the concept of a primary writing. If 
an electronic display is the primary writing of the covered 
establishment from which a customer makes an order selection, it would 
satisfy our definition of a menu or menu board. As such, electronic 
menus may be used by covered establishments, and we have retained 
electronic menus as an example of menus in the definition of menu or 
menu board in Sec.  101.11(a).
    Standard menu items offered for sale in covered establishments with 
cafeteria- and buffet-type settings are most likely foods on display or 
self-service foods. As discussed in section XVII.B, for a food on 
display or a self-

[[Page 71179]]

service food, section 403(q)(5)(H)(iii) of the FD&C Act and Sec.  
101.11(b)(2)(iii) require covered establishments to place a sign 
adjacent to the food listing calories per displayed food item or per 
serving. This rule provides flexibility for covered establishments by 
providing a number of options for meeting the requirements of section 
403(q)(5)(H)(iii) of the FD&C Act and Sec.  101.11(b)(2)(iii). For 
example, covered establishments are permitted to declare calories for a 
food on display or a self-service food by posting calorie declarations 
on signs adjacent to the food, on a sign attached to a sneeze guard, or 
on a single sign or placard (Sec.  101.11(b)(2)(iii)(A)). Therefore, 
this rule provides flexibility, as requested by some comments, for 
covered establishments to choose among several options for declaring 
calorie information for standard menu items, including self-service 
foods or foods on display in cafeteria and buffet-type settings.
    (Comment 42) In the proposed rule, we noted that many consumers 
order restaurant-type food from restaurants or similar retail food 
establishments over the phone or Internet. We tentatively concluded 
that if consumers can order from a covered establishment online, over 
the phone, or by fax, using a writing of the covered establishment on 
the Internet as the primary writing from which he or she makes his or 
her order selection, then the writing on the Internet is a menu for the 
purposes of section 403(q)(5)(H) of the FD&C Act (76 FR 19192 at 
19202). Some comments asked us to keep in mind the need to keep up with 
technology and not have a rigid standard.
    (Response 42) The definition of ``menu or menu board'' clearly 
specifies that menus may be in different forms and does not establish a 
standard for the technology used on a menu or menu board. The 
definition lists a number of examples of primary writings that may be 
menus or menu boards, including electronic menus and menus on the 
Internet, that are not meant to be all-inclusive, as indicated by use 
of the terms ``including, but not limited to'' before the examples. 
Because a menu or menu board is defined as the primary writing of the 
covered establishment from which a customer makes an order selection, 
the definition is adequate to capture methods and media other than 
those specifically listed in that definition, so long as such methods 
and media otherwise satisfy the criteria in the definition.
    (Comment 43) Several comments noted that some local zoning laws do 
not permit restaurants with drive-through windows to build larger menu 
boards. These comments expressed concern about how to comply with the 
new requirements for menu boards in light of State or local size 
restrictions. One comment asked us to provide more flexibility for 
compliance, including permitting the use of a pamphlet next to the 
drive-through menu board. Some comments suggested that we allow 
nutrition information on a large poster adjacent to the menu board.
    A few comments supported the use of stanchions (i.e., free-standing 
boards that are not connected to the menu board and are often placed 
near drive-through menu boards) to post calorie information. One 
comment maintained that restaurants and similar retail food 
establishments have a vested interest in customer satisfaction in the 
context of drive-through windows and have concluded that clear and 
organized space, presented within the framework of a known brand, is 
the most critical success factor in presenting information to consumers 
on menu boards. This comment considered that stanchions adjacent or 
close to menu boards are ``complete thoughts'' if the information is 
relevant, well organized, and clearly marked, and that such stanchions 
will help consumers with their menu choices. The comment considered 
that in many cases information on stanchions is more clear and 
conspicuous than on menu boards. The comment noted that calorie 
information is provided on stanchions in some jurisdictions that 
require nutrition labeling on menus and menu boards, including 
Montgomery County (Maryland), New York City, Philadelphia, and certain 
counties in New York. The comment maintained that the current use of 
stanchions in some jurisdictions is evidence of its effectiveness, and 
noted that some States and localities permit stanchions because 
information is hard to read on already crowded drive-through menu 
boards.
    A comment from a quick-service restaurant chain asserted that 
stanchions are less costly to update and replace than menu boards. The 
chain had conducted a consumer survey of customers who purchased food 
from the chain's drive-through windows in 13 of the chain's restaurants 
that use stanchions, as permitted in King County, Washington, and 
submitted a report of this survey to the docket for this rule (Ref. 
27). For the 128 customers surveyed, the comment reported that 92 
percent felt it was easy to find calories, 98 percent felt calories 
were easy to understand, 95 percent thought the stanchion location was 
clearly visible to consumers, 95 percent noted nothing blocked view of 
stanchion, and 76 percent felt they had adequate time to review before 
ordering.
    One comment considered that while ``the statute'' refers to menus 
and menu boards, it also gives us authority to define those terms. (We 
assume this comment is referring to section 4205 of the ACA.) The 
comment stated that we could include stanchions as a method to 
communicate calorie information that is clear and conspicuous.
    Several comments agreed with our tentative conclusion that 
stanchions inadequately convey calorie information. The comments 
asserted that it is challenging for consumers to read different 
information in different locations at a drive-through window especially 
when trying to read the information from a car, where consumers have 
limited mobility and a limited field of vision. The comments also 
asserted that, even with different zoning laws, drive-through menu 
boards have enough room for calories, although photos and other 
marketing information may need altering. One comment pointed out that 
separate stanchions would not comply with section 403(q)(5)(H)(ii) of 
the FD&C Act, which requires that calories be on the menu board itself.
    (Response 43) We disagree that the rule should provide for 
declaration of calorie information in pamphlets or on posters or 
stanchions, rather than on the menu board at a drive-through in a 
covered establishment. In the proposed rule, we tentatively concluded 
that stanchions inadequately convey calorie information because a 
situation in which customers need to look to one board (the menu board) 
for important food-selection information, such as price, and another 
(the stanchion) for calories, is likely to be more difficult for 
customers attempting to use the declared calorie information at the 
point of selection (76 FR 19192 at 19206). We also tentatively 
concluded that this is particularly true in the drive-through context, 
where customers have a restricted field of vision from their car 
windows, and may have a relatively short time to consider the menu 
board prior to ordering, because customers often cannot view the full 
menu while waiting in line. As discussed further in the following 
paragraphs, the comments provide insufficient basis for us to conclude 
otherwise, and as a result, we affirm our conclusion from the proposed 
rule.
    In addition, section 403(q)(5)(H)(ii)(II)(aa) of the FD&C Act 
requires the number of calories contained in standard menu items to be 
disclosed on the menu board itself.

[[Page 71180]]

Section 403(q)(5)(H)(xi) of the FD&C Act defines ``menu'' or ``menu 
board'' as ``the primary writing of the restaurant or similar retail 
food establishment from which a customer makes an order selection.'' 
Because a stanchion is a free-standing board that is not connected to a 
drive-through menu board and therefore typically is not used by 
consumers to make order selections, we do not consider it to meet the 
definition of ``menu'' or ``menu board'' as defined in this rule and 
section 403(q)(5)(H)(xi) of the FD&C Act. Accordingly, we concluded 
that a stanchion cannot be the means by which a covered establishment 
discloses calorie declarations on menus and menu boards as required 
under section 403(q)(5)(H)(ii) of the FD&C Act and this rule.
    We considered the consumer survey results provided with one comment 
and did not find the information adequate to overcome the concerns we 
raised in the proposed rule regarding the use of stanchions (Ref. 28). 
Although the participants expressed favorable impressions of the 
stanchions, the survey data:
     Did not provide a comparison with other calorie displays, 
including calorie declarations on drive-through menu boards without 
stanchions;
     Did not show whether participants would have more or less 
favorable impressions of calorie declarations on drive-through menu 
boards without stanchions.
     Only showed that the participants liked the display and 
not whether the display was useful for them in making their order 
selections; and
     Did not assess the use of stanchions in situations where 
the consumer needs to make quick decisions because other consumers are 
in the drive-through line behind them.
    For all of the reasons discussed in response to this comment, this 
rule does not provide for declaration of calories in a pamphlet or on a 
stanchion at a drive-through of a covered establishment as a means of 
satisfying the requirement that the number of calories contained in a 
standard menu item be disclosed on the menu and the menu board, as 
required by section 403(q)(5)(H)(ii) of the FD&C Act and Sec.  
101.11(b)(2)(i).
    (Comment 44) Some comments asserted that the proposed rule allows 
the Secretary to amend the nutrition information that must be disclosed 
and that this will further burden restaurants to replace drive-through 
and interior menu boards multiple times.
    (Response 44) We interpret the comments as referring to section 
403(q)(5)(H)(vi) of the FD&C Act. Under section 403(q)(5)(H)(vi) of the 
FD&C Act, the Secretary (and, by delegation, FDA) may, by regulation, 
require the disclosure of a nutrient, other than a nutrient required 
under section 403(q)(5)(H)(ii)(III) of the FD&C Act, in the written 
nutrition information that is available to consumers upon request if 
FDA determines that the nutrient information should be disclosed for 
the purpose of providing information to assist consumers in maintaining 
healthy dietary practices. If this is indeed what the comments mean, 
the comments appear to have confused section 403(q)(5)(H)(vi) of the 
FD&C Act with the requirements in section 403(q)(5)(H)(ii)(I)(aa) 
related to the disclosure of calories on a menu or menu board. The 
statutory authority in section 403(q)(5)(H)(vi) of the FD&C Act for FDA 
to require disclosure in the written nutrition information of a 
nutrient other than one required under section 403(q)(5)(H)(ii)(III) of 
the FD&C Act does not address the calories declarations that must be on 
a menu or menu board.
    (Comment 45) In the proposed rule, we stated that we recognize that 
some establishments may send menus as a form of advertising. We 
tentatively concluded that advertisements for food fall outside the 
scope of section 4205 of the ACA. However, take-out and delivery menus, 
which include all or a significant portion of items offered for sale 
and serve as the primary writing from which consumers make their order 
selections, would be menus under the proposed rule (76 FR 19192 at 
19201).
    Several comments considered that the proposal did not adequately 
distinguish between menus and menu boards and advertisements or 
promotional material. One comment considered that it is not appropriate 
to require calorie disclosure in advertising, such as a postcard 
announcing a new restaurant that has pictures of a few sample dishes. 
However, the comment also considered that when the advertising is the 
menu itself and can be used as the ``primary writing'' a customer uses 
to make an order, calorie disclosure should be required. The comment 
recommended that the test be whether customers can use the menu as a 
primary writing for making their selection, not the way in which the 
menu is presented or delivered to the customers by the restaurant or 
similar retail food establishment. One comment asked us to clarify that 
calorie disclosure should be on any menu regardless of whether the menu 
also serves as a marketing tool. One comment stated that any list of 
covered food items that is the primary vehicle from which a customer 
places his or her order constitutes a menu. The comment noted that in 
some instances, an in-store sign that looks like an advertisement 
(e.g., promotional poster) for a menu item is the primary vehicle from 
which the customer orders the menu item when the menu item is not 
included on the menu but is included only on that sign. This comment 
asked us to make clear that a sign listing a menu item that is only 
listed on that sign makes it a menu board.
    One comment asked us to make clear that covered menus include 
individualized order sheets used at certain restaurants. Another 
comment asked us to make clear that take-out menus are included and 
suggested that a take-out menu be added as an example to the definition 
in the regulation.
    Some comments asked us to make a clear statement that 
advertisements and promotional material such as table top stands, 
newspaper advertisements and flyers, tray liners and point of purchase 
marketing materials are not menus, even if they list some names and 
prices. One comment noted that, in the proposed rule, we tentatively 
concluded that ``advertisements for food fall outside the scope of 
section 4205'' but did not include this statement in the proposed 
definition. The comment asserted that we hinted at potential grounds 
for excluding some menus from coverage, when we stated that ``take-out 
and delivery menus, which include all or a significant portion of items 
offered for sale and serve as the primary writing from which consumers 
make their order selections, would be menus under the proposed rule'' 
(76 FR 19192 at 19202; emphasis added by comment). The comment 
expressed concern that, without specific language in the final 
regulation that advertisements are not menus and thus fall outside the 
scope of section 4205 of the ACA, the terms ``menu'' or ``menu board'' 
could be construed to encompass materials that list menu items but that 
are in fact used as advertisements. The comment maintained that this 
clarity is needed to ensure consistent enforcement. The comment also 
recommended that we expand on our statement that such promotional 
materials are menus subject to the menu labeling requirements if they 
``include all or a significant portion of items offered for sale.'' The 
comment asserted that limiting labeling requirements, for example, to 
only menus listing more than a certain percentage of standard menu 
items sold by the restaurant would have the practical effect of 
limiting the number of pieces covered, excluding many promotional items 
(such as door hangers and pizza box tops) and creating an

[[Page 71181]]

objective standard that could guide both restaurant behavior and 
enforcement. The comment considered that requiring calorie disclosures 
on promotional material is especially burdensome for some of the 
franchises who pay for this promotional material.
    One comment stated that circular advertisements should not be 
menus. Another comment recommended that grocery store signs that 
highlight the attributes of a food in the store not be considered a 
menu or menu board. One comment supported including nutrition 
information on any food advertisement that makes a health claim.
    (Response 45) As discussed previously in this document, the term 
``menu'' or ``menu board'' includes any writing of the covered 
establishment that is the primary writing from which a consumer makes 
an order selection. As discussed in Response 40, determining whether a 
writing is or is part of the primary writing from which a consumer 
makes an order selection depends on a number of factors, including 
whether the writing, such as a take-out menu, sign, or poster, lists 
the name of a standard menu item (or an image depicting the standard 
menu item) and the price of the standard menu item, and whether the 
writing can be used by a consumer to make an order selection at the 
time the consumer is viewing the writing (e.g., the writing is posted 
at the cash register in a covered establishment, or the writing lists 
the phone number or email address of a covered establishment for 
purposes of placing an order). Accordingly, a writing of a covered 
establishment that contains the name (or image) and price of a standard 
menu item, and that can be used by a consumer to make an order 
selection from the establishment at the time the consumer is viewing 
the writing would be a menu or menu board regardless of whether, for 
example, the writing is mailed to a consumer's home or is posted inside 
a covered establishment. In contrast, written material of an 
establishment that does not satisfy this criteria, such as a poster on 
a storefront, a coupon or other promotional material, banners, tray 
liners, billboards, and stanchions, could be considered a ``secondary 
writing'' of an establishment.
    We recognize that, in the proposed rule, we tentatively concluded 
that take-out and delivery menus would be considered menus within the 
meaning of section 403(q)(5)(H)(xi) of the FD&C Act to the extent that 
such menus include all or a significant portion of items offered for 
sale (76 FR 19192 at 19201). However, we are not affirming this 
conclusion for a number of reasons. First, we agree with the comment 
asserting that the critical factor should be whether the take-out or 
delivery menu is or is part of the primary writing from which a 
consumer makes an order selection, not the way in which the menu is 
presented or delivered to consumers.
    Second, as discussed previously in this document, in this rule we 
clarified the factors to be considered in determining whether a writing 
is or is part of the primary writing from which a consumer makes an 
order selection, and these factors help clarify whether a writing 
constitutes a menu or menu board or an advertisement or promotional 
material, as requested by several comments. Further, in light of these 
factors, if we were to conclude that delivery or take-out menus would 
only be considered menus if they included all or a significant portion 
of items offered for sale, that conclusion would be inconsistent with 
how we will be determining whether other written material constitutes a 
primary writing of an establishment from which a consumer makes an 
order selection, particularly since consumers can use take-out and 
delivery menus to make order selections in generally the same way as 
they would use dine-in menus.
    In addition, menus vary in size and selection. A covered 
establishment that has a single menu for daily use, including menu 
offerings for breakfast, lunch, and dinner, may nonetheless have 
separate take-out menus directed only to breakfast, lunch, or dinner. 
We see no reason to treat a take-out menu that only includes menu 
offering for breakfast any differently than we would treat a breakfast 
menu used by consumers to order and consume breakfast while seated at 
the establishment.
    For these reasons, in this rule we are not affirming the proposed 
rule's tentative conclusion that take-out and delivery menus would be 
considered menus within the meaning of section 403(q)(5)(H)(xi) of the 
FD&C Act to the extent that such menus include all or a significant 
portion of items offered for sale. Instead, in this document we 
identify factors we would use to determine whether a writing is the 
primary writing from which a consumer makes an order selection--i.e., 
the name (or image) and price of the standard menu item food and a 
means to make an order selection at the time the consumer is viewing 
the writing. Accordingly, determining whether a writing is a menu or 
menu board does not depend on how many items are listed. If a writing 
constitutes a menu or menu board within the meaning of section 
403(q)(5)(H)(xi) of the FD&C Act and Sec.  101.11(a), it must contain 
the information required under section 403(q)(5)(H) of the FD&C Act and 
Sec.  101.11(b), regardless of the number of items on that menu or menu 
board.
    Any written material that is or is part of the primary writing from 
which a consumer makes an order selection, whether it is an 
individualized order sheet or a take-out menu, would be a menu for 
purposes of this rule if it includes the name (or image) and price of a 
standard menu item and a means by which a consumer can make an order 
selection from the establishment at the time the consumer is viewing 
the writing. Providing calorie and other required information on menus 
and menu boards will make such information available to consumers in a 
direct and accessible manner to enable consumers to make informed and 
healthful dietary choices.
    Using these factors, other writings of a covered establishment, 
such as newspaper ads, circular advertisements, banners, or postcards 
that announce a new restaurant and provide pictures of sample dishes 
generally would not be menus or menu boards. Although it is possible 
that such writings could include the name (or image) and price of 
standard menu items, they generally would not provide a means by which 
a consumer can make an order selection at the time the consumer is 
viewing the writing and therefore such a writing would not constitute a 
primary writing from which a consumer makes an order selection within 
the meaning of section 403(q)(5)(H)(xi) of the FD&C Act. Likewise, a 
sign in a grocery store that highlights attributes of a standard menu 
item (e.g., by the name or image of the menu item), without including 
the price, would not be a menu or menu board.
    While a writing may constitute a menu or menu board, not all of the 
menu items listed on such writing would require calorie declarations. 
For example, if the requirements of section 4205 of the ACA do not 
apply to a food (e.g., as a daily special, temporary menu item, or 
customary market test item), a covered establishment would not be 
required to declare calories or other nutrition information for such 
food under this rule, meaning that a writing listing a daily special or 
temporary menu item would not be required to bear a calorie declaration 
for such item. Further, as discussed later in this document (see 
Response 79), for certain ``mix and match'' situations, where the menu 
or menu board describes an opportunity for a consumer to combine 
standard menu items for a special price

[[Page 71182]]

(e.g., ``Combine Any Sandwich with Any Soup or Any Salad for $8.99''), 
and the calories for each standard menu item, including each size 
option if applicable, available for the consumer to combine are 
declared elsewhere on the menu or menu board, a covered establishment 
would not be required to declare the calories for such item (see Sec.  
101.11(b)(2)(i)(A)(6)(iv)).
    The comment supporting nutrition information on any food 
advertisement that makes a health claim is outside the scope of this 
rule, which establishes requirements for declaring nutrition 
information for standard menu items offered for sale in establishments 
covered by the requirements of section 4205 of the ACA. We note, 
however, that material that constitutes food labeling within the 
meaning of section 201(m) of the FD&C Act would be subject to the 
requirements in Sec.  101.10. Under section 201(m) of the FD&C Act, the 
term ``labeling'' means all labels and other written, printed, or 
graphic matter (1) upon any article or any of its containers or 
wrappers, or (2) accompanying such article.
    (Comment 46) One comment recommended that menu labeling 
requirements apply to airline magazines that include menus.
    (Response 46) In the proposed rule, we tentatively concluded that 
most airplanes would not satisfy the definition of ``restaurant or 
similar retail food establishment'' because, in general, they do not 
present themselves to the public as restaurants, nor are they likely to 
meet the floor space (or revenue) threshold. As discussed in section 
VI.D, under the definition of ``covered establishment'' established in 
this rule airplanes are not covered establishments that must comply 
with the rule. Therefore, the nutrition labeling requirements of this 
rule do not apply to airline magazines that include menus.

VIII. Comments and FDA Response on the Proposed Definition of Terms 
Related to Foods Covered by the Rule (Proposed Sec.  101.11(a))

A. Restaurant Food and Restaurant-Type Food

    As discussed in section VI.C, after considering comments, we are 
deleting the proposed definition of ``restaurant food'' and 
establishing a revised definition of ``restaurant-type food'' that 
better reflects the food most like the food offered for sale in 
restaurants. We discussed these changes to two terms related to foods 
covered by the rule within section VI because the definition of 
``restaurant-type food'' established in this rule is one of several 
terms related to the scope of establishments covered by the rule.

B. Standard Menu Item

    Proposed Sec.  101.11(a) would define ``standard menu item'' as a 
restaurant or restaurant-type food that is routinely included on a menu 
or menu board or routinely offered as a self-service food or food on 
display. In the following paragraphs, we discuss comments on this 
proposed definition. We are finalizing it without change, except to 
revise ``restaurant or restaurant-type food'' to ``restaurant-type 
food'' to conform with our deletion of the term ``restaurant food'' 
throughout the rule (see section VI.C).
    (Comment 47) Several comments supported the proposed definition. 
One comment opposed the proposed definition because it is 
``incomplete'' and misunderstands the meaning of ``standard'' within 
the context of a chain of 20 or more restaurants and similar retail 
food establishments doing business under the same name and offering for 
sale substantially the same menu items. The comment argued that it is 
not the regularity with which a menu item is sold at a given restaurant 
that renders the item ``standard'' within the context of a restaurant 
chain; rather, it is the fact that the menu item is offered across many 
establishments in the chain, in substantially the same form, and is 
prepared according to the same recipe and using the same ingredients. 
The comment maintained that when foods are standardized, nutrition 
information can be derived. On the other hand, according to the 
comment, if foods do not have a common recipe, nutrition information 
would be determined case-by-case, which is impractical and cost 
prohibitive. The comment suggested the following definition: ``A menu 
item that appears on the menus of substantially all restaurants in a 
chain that uses the same general recipe and that is prepared in 
substantially the same way with substantially the same food components, 
even if the name of the menu item varies.''
    The comment also recommended that, for a chain that prints a single 
standardized menu for all its restaurants or establishments or for 
those in a given region, the term ``standard menu item'' be interpreted 
to refer to menu items that appear on those centrally printed and 
distributed menus. The comment maintained that adopting this definition 
would harmonize the terms ``standard menu item'' and ``covered 
establishment'' and ensure that the requirements apply to the foods 
that are subject to the type of standardization that would allow them 
to be consistently prepared. The comment also requested that a covered 
establishment be allowed but not required to provide the nutrition 
information in writing at the point of sale for menu items offered for 
sale in only some establishments in a chain if we decide to include 
such menu items within the definition of standard menu item in the 
final rule. Otherwise, the comment considered that a chain retail food 
establishment would have to include, in nutrition brochures, 
information on many menu items that are sold in a small percentage of 
stores, which could be confusing and costly.
    (Response 47) We disagree that the definition of ``standard menu 
item'' should be based on whether the menu item is offered across 
substantially all of the establishments within the chain, in 
substantially the same form, and is prepared according to the same 
recipe and using the same ingredients. Section 403(q)(5)(H)(i) of the 
FD&C Act provides, in relevant part, that ``in the case of food that is 
a standard menu item that is offered for sale in a restaurant or 
similar retail food establishment that is part of a chain with 20 or 
more locations doing business under the same name . . . and offering 
for sale substantially the same menu items, the restaurant or similar 
retail food establishment shall disclose the [required] information. . 
. .''. The statutory language does not indicate that a menu item must 
be offered for sale in all of the restaurants or similar retail food 
establishments within a chain in order for it to be a ``standard menu 
item'' at a particular covered establishment. Indeed, it would be 
burdensome and impractical for establishments and inspectors to 
continually evaluate all of the menu items offered by a chain to 
determine which items are offered by all establishments in the chain in 
order to determine whether a given menu item is a standard menu item 
subject to requirements of this rule. In addition, we have no evidence 
that it would be impractical and cost prohibitive to require covered 
establishment to provide the nutrition required by this rule for menu 
items that they routinely offer. We continue to believe that it is 
reasonable to interpret ``standard menu item'' to mean a restaurant-
type food routinely included on a menu or menu board or routinely 
offered as a self-service food or food on display in a given covered 
establishment.
    We would not object to central printing of a single, standardized 
menu for use by all covered establishments within a chain, provided 
that the

[[Page 71183]]

centrally printed menu complies with the requirements of this rule and 
applicable provisions of the FD&C Act. However, if an individual 
covered establishment offers for sale an additional standard menu item 
that is not offered by every establishment in the chain and, therefore, 
is not included on the centrally printed menu, that establishment still 
must comply with all applicable requirements of this rule for that 
standard menu item, including where and how the nutrition information 
must be disclosed.
    We disagree that a covered establishment would have to include, in 
nutrition brochures, information on many menu items that are sold in a 
small percentage of stores. A covered establishment need only provide 
the required information for the standard menu items it offers for 
sale.
    (Comment 48) A few comments stated that grocery stores use items 
from other departments within the grocery store (e.g., meat department, 
produce department) to make its prepared food items. The ingredients 
for a given prepared food can vary significantly depending on the 
availability of items in the store. These comments argued that labeling 
and determining calorie information for these items would be difficult.
    (Response 48) If a prepared food item varies significantly 
depending on what ingredients a covered establishment happens to have 
available, the item may not meet the definition of standard menu item. 
For example, if a grocery store with a hot soup bar offers a different 
vegetable soup every day based on whatever vegetables the store happens 
to have in surplus (e.g., cabbage and tomatoes soup one day, carrots 
and leeks the next, spinach and squash on a third day), and if none of 
these vegetable soups is offered for sale routinely, then none of the 
vegetable soups would meet the definition of standard menu item. Even 
if the grocery store names each version of the soup as ``vegetable 
soup,'' the item would not be considered a standard menu item, because 
the soup's ingredients significantly differ daily.

C. Combination Meal

    Proposed Sec.  101.11(a) would define ``combination meal'' as a 
standard menu item that consists of more than one food item, for 
example a meal that includes a sandwich, a side dish, and a drink. The 
proposed definition would further provide that a combination meal may 
be represented on the menu or menu board in narrative form, 
numerically, or pictorially. Some combination meals may include a 
variable menu item (or be a variable menu item as defined in Sec.  
101.11(a)) where the components may vary. For example, the side dish 
may vary among several options (e.g., fries, salad, or onion rings) or 
the drinks may vary (e.g., soft drinks, milk, or juice) and the 
customer selects which of these items will be included in the meal.
    Comments that addressed the proposed definition agreed with it. 
Therefore, we are finalizing it without change, except to correct a 
typographical error by removing an open parenthesis mark between ``may 
include a variable menu item'' and ``or be a variable menu item . . .''

D. Variable Menu Item

    Proposed Sec.  101.11(a) would define ``variable menu item'' as a 
standard menu item that comes in different flavors, varieties, or 
combinations, and is listed as a single menu item. In the following 
paragraphs, we discuss comments on this proposed definition. We are 
finalizing it without change.
    (Comment 49) Several comments considered that the term ``variable 
menu item'' does not include items listed on a menu that can be 
assembled in varying combinations, such as pizza. These comments 
suggested that the definition of variable menu item be revised to ``a 
standard menu item that comes in different flavors, varieties, or 
combinations, and is listed as a single menu item. It does not include 
foods, beverages, or meals that are listed as separate menu items but 
could be combined in a variety of combinations or that are different 
sizes of the same menu item.''
    Several comments asked that we clarify that the definition for 
``variable menu item'' does not mean different sizes. They maintained 
that each size should be accompanied by a calorie declaration. In 
contrast, one comment opposed the posting of calories for different 
sizes, maintaining that providing calorie information for each size 
would take too much space and might force the reduction in font size. 
This comment asked us to permit covered establishments to provide a 
range of calories to reflect the calorie content range from the 
smallest to the largest size for beverages offered as standard menu 
items. This comment considered that the statute provides us discretion 
to allow covered establishments to provide calorie information for 
different sized beverages using ranges, as long as the calorie 
information is clear and conspicuous.
    (Response 49) We disagree that variable menu items do not include 
foods such as pizza. Our proposed definition is consistent with section 
403(q)(5)(H)(v) of the FD&C Act, which expressly includes pizza as an 
example of a standard menu item that comes in different flavors, 
varieties, or combinations, but is listed as a single menu item. For 
example, a menu or menu board can list a pizza with a particular price 
and up to four toppings. This is an example of a food that comes in 
different varieties because the consumer has the choice of various 
toppings.
    We agree with the comments asserting that different sizes of a 
standard menu item are not variable menu items, but disagree with the 
comment opposing the posting of calories for different sizes. Section 
403(q)(5)(H)(v) of the FD&C Act provides, in relevant part, that FDA 
shall establish by regulation standards for disclosing the nutrient 
content for standard menu items that come in different flavors, 
varieties, or combinations, but which are listed as single menu items. 
When a standard menu item, including a beverage, is listed on a menu or 
menu board by name with different sizes, or each size has its own 
price, each size would constitute a standard menu item rather than a 
different flavor, variety, or combination, and each standard menu item 
must include a calorie declaration.

E. Food on Display

Proposed Sec.  101.11(a) would define food on display as restaurant or 
restaurant-type food that is visible to the customer before the 
customer makes a selection, so long as there is not an ordinary 
expectation of further preparation by the consumer before consumption. 
In the following paragraphs, we discuss comments on this proposed 
definition. After considering comments, we are finalizing the 
definition without changes, except to revise ``restaurant or 
restaurant-type food'' to ``restaurant-type food'' to conform with our 
deletion of the term ``restaurant food'' throughout the rule (see 
section VI.C).
    (Comment 50) A few comments agreed with the proposed definition. 
Other comments suggested modifications to the definition. Some comments 
recommended that the definition clarify that the food can be self-serve 
or served by the restaurant staff and that the food could be in the 
open or behind glass. The comments suggested that the following 
language be added to the proposed definition: ``It includes food that 
is served by restaurant staff or self-served by customers and foods 
with Nutrition Facts labels that customers cannot examine without 
assistance. Food on display can be behind glass or other

[[Page 71184]]

material or in an open display accessible to consumers.''
    (Response 50) We decline the requests to revise the proposed 
definition. The definition applies regardless of whether the food is 
self-serve or served by the restaurant staff, whether it is in the open 
or behind glass, or whether it has a Nutrition Facts label that can be 
examined by a consumer without assistance. In addition, we do not want 
to appear to limit the definition to only those foods described in the 
language suggested by the comment.
    (Comment 51) One comment asserted that food on display, such as 
deli meats and cheeses, should be covered even if there is an 
expectation that there will be further preparation before consuming. A 
few comments asked that we clarify that foods on display and self-
service food do not include fresh breads, cheese wheels, bulk olives, 
bulk sauces, condiments, and salads sold by the pound like ``tuna 
salad, egg salad, chicken salad, etc.'' One comment recommended that 
grocery stores provide calories for bakery items, prepared deli foods 
such as salads and sandwiches, prepared meals and side dishes, freshly 
cooked pizza, fountain drinks, salad bars, and other foods sold for 
immediate consumption. One comment requested an exemption for certain 
food items prepared for home consumption, such as fruit slices, fruit 
cups, fruit salads, containers of fresh-cut fruit, fresh squeezed 
juices, bulk or packaged nuts, seeds, or dried fruit, and similar items 
that are packaged (or in the case of bulk products, are sold in 
containers that are available for self-packaging).
    (Response 51) As discussed in section VI.C, we are establishing a 
revised definition of ``restaurant-type food'' that better reflects the 
food most like the food offered for sale in restaurants (see Comment 24 
and Response 24). Because restaurants typically sell food that is fully 
prepared, deli meats and cheese generally will not meet the definition 
of ``restaurant-type food,'' and therefore generally will not be 
covered. However, certain foods offered for sale in grocery stores that 
are visible to the consumer before the consumer makes a selection, such 
as prepared sandwiches, freshly cooked pizza, and salad and hot food 
bars would meet the definition of restaurant type food and do not have 
an ordinary expectation of further preparation by the consumer before 
consumption. These foods meet the definition of foods on display. Other 
foods commonly offered for sale by grocery stores are not within the 
definition of ``restaurant-type food'' and would not be subject to the 
nutrition disclosure requirements of this rule (e.g., foods such as 
dried fruit and nuts bought from bulk bins or cases; foods such as 
loaves of bread, bags or boxes of dinner rolls, whole cakes, bags or 
boxes of candy or cookies to be eaten over several eating occasions or 
stored for later use; foods such as deli salads sold by unit of weight 
that are not self-serve and are not intended solely for individual 
consumption, either prepacked or packed upon consumer request).

F. Self-Service Food

    Proposed Sec.  101.11(a) would define ``self-service food'' as 
restaurant or restaurant-type food that is available at a salad bar, 
buffet line, cafeteria line, or similar self-service facility and that 
is served by the customers themselves. Self-service food also includes 
self-service beverages. Comments that addressed the proposed definition 
supported it. We are finalizing it without changes, except to revise 
``restaurant or restaurant-type food'' to ``restaurant-type food'' to 
conform with our deletion of the term ``restaurant food'' throughout 
the rule (see section VI.C).

G. Custom Order

    Proposed Sec.  101.11(a) would define ``custom order'' as a food 
order that is prepared in a specific manner based on an individual 
customer's request, which requires the restaurant or similar retail 
food establishment to deviate from its usual preparation of a menu 
item, e.g., a club sandwich without the bacon if the establishment 
usually includes bacon in its club sandwich. In the following 
paragraphs, we discuss comments on this proposed definition. We are 
finalizing it without change, except for two clarifications. First, we 
are clarifying that the deviation is from the usual preparation of a 
standard menu item (emphasis added). Second, we are replacing the term 
``restaurant or similar retail food establishment'' with ``covered 
establishment'' to clarify the applicability of the definition (see the 
discussion in section VI.I).
    (Comment 52) Several comments agreed with the proposed definition. 
Some comments considered that the custom order exemption should apply 
to custom birthday cakes and sandwiches made to order, because they 
have no standard preparation from which to deviate.
    One comment maintained that supermarkets often preprint labels or 
previously affix them to packaging (e.g., a paper bag for a sandwich or 
bread) to improve efficiency or to save costs. Because consumers may 
request that toppings be added or removed from a food item that is sold 
in the prelabeled packaging, the comment considered that this would be 
a custom order that would be exempt from the menu labeling 
requirements. The comment asked us to clarify that the product would 
not be misbranded if the packaging contained nutrition information 
based on the standard preparation.
    (Response 52) If a custom birthday cake that is made to order is 
not routinely included on a menu or menu board or routinely offered as 
a self-service food or food on display, it would not be covered by the 
rule, because it is not a standard menu item.
    We agree that a sandwich that is made to order can be a custom 
order if the sandwich is prepared in a specific manner based on an 
individual customer's request, which requires the covered establishment 
to deviate from its usual preparation of a standard menu item. However, 
some sandwiches that are made to order can be variable menu items, 
depending on how the food is depicted on a menu or menu board or 
otherwise offered for sale. We discuss the definition of variable menu 
item in section VIII.D.
    We also agree that if a customer asks that toppings be changed or 
removed from a standard menu item, and the standard menu item normally 
includes certain toppings, the customer's order is a custom order. In 
response to the question regarding the use of a preprinted label on a 
food product, which is subject to modification, we first note that a 
food order that is prepared in a specific manner based on an individual 
customer's request, which requires a covered establishment to deviate 
from its usual preparation of a standard menu item, is a custom order 
and is not subject to the requirements of section 403(q)(5)(H) of the 
FD&C Act and this rule. Nevertheless, food labeling, including 
nutrition labeling, for a food must be truthful and not misleading 
(section 403(a)(1) of the FD&C Act). If a label on a food bears 
nutrition information for such food that is false or is otherwise 
misleading, the food would be misbranded under section 403(a)(1) of the 
FD&C Act. Accordingly, if a custom order, such as a club sandwich 
without the bacon if the establishment usually includes bacon in its 
club sandwich, bears nutrition information in a preprinted label that 
is false or is otherwise misleading, such food could be misbranded 
under the FD&C Act. We recommend that covered establishments refrain 
from affixing preprinted labels on custom orders unless the information

[[Page 71185]]

included on such labels is truthful and not misleading.

H. Daily Special

    Proposed Sec.  101.11(a) would define ``daily special'' as a menu 
item that is prepared and offered for sale on a particular day, that is 
not routinely listed on a menu or offered by the covered establishment, 
and that is promoted by the covered establishment as a special menu 
item for that particular day.
    Comments that addressed the proposed definition agreed with it. 
Therefore, we are finalizing it without change, except to add ``or menu 
board'' after ``not routinely listed on a menu.'' We inadvertently 
omitted ``or menu board'' in the proposed definition.

I. Food That Is Part of a Customary Market Test

    Proposed Sec.  101.11(a) would define ``food that is part of a 
customary market test'' as food that is marketed in a covered 
establishment for fewer than 90 consecutive days in order to test 
consumer acceptance of the product. Comments that addressed the 
proposed definition agreed with it. Therefore, we are finalizing it 
without change, except for changes to clarify that food that is part of 
a customary market test is food ``that appears on a menu or menu board 
for less than 90 consecutive days'' rather than food ``that is marketed 
in a covered establishment for fewer than 90 consecutive days.'' These 
changes are consistent with section 403(q)(5)(H)(vii)(I)(cc) of the 
FD&C Act, our description of ``food that is part of a customary market 
test'' in the proposed rule (76 FR 19192 at 19205), and with the 
definition for ``temporary menu item'' in Sec.  101.11(a).

J. Temporary Menu Item

    Proposed Sec.  101.11(a) would define ``temporary menu item'' as a 
food that appears on a menu or menu board for less than a total of 60 
days per calendar year. Proposed Sec.  101.11(a) would explain that the 
60 days includes the total of consecutive and non-consecutive days the 
item appears on the menu. In the following paragraphs, we discuss 
comments on this proposed definition. We are finalizing it without 
change.
    (Comment 53) Several comments agreed with the proposed definition. 
One comment agreed that the 60 days need not be consecutive, but 
considered that seasonal items (such as the pumpkin-flavored latte 
example we included in the proposed rule (76 FR 19192 at 19205)) should 
not be exempt if they are routinely offered each year.
    One comment recommended that we change the definition for temporary 
menu item to shorten the time period from 60 to 45 days, to discourage 
restaurants from continuously changing menus to avoid calorie 
disclosure.
    (Response 53) The proposed definition for ``temporary menu item'' 
focused on the explicit statutory language in section 403(q)(5)(H)(vii) 
of the FD&C Act, which provides in relevant part that the requirements 
of section 403(q)(5)(H)(i) through (vi) of the FD&C Act do not apply to 
``temporary menu items appearing on the menu for less than 60 days per 
calendar year.'' Accordingly, we decline to shorten the 60-day time 
period for temporary menu items to 45 days, as suggested by the 
comment, because doing so would not be consistent with section 
403(q)(5)(H)(vii) of the FD&C Act. We did not propose to go beyond the 
language of section 403(q)(5)(H)(vii) of the FD&C Act by developing a 
new category of foods called ``seasonal items.'' We disagree that 
seasonal items should not be exempt if they are routinely offered each 
year. Whether a ``seasonal item'' would be exempt would be determined 
by whether the seasonal item satisfied the definition of a ``temporary 
menu item'' as determined by the total number of consecutive and non-
consecutive days per calendar year that the menu item appears on the 
menu or menu board.

IX. Comments and FDA Response on Proposed Sec.  101.11(b)(1)(i)--Food 
Subject to the Labeling Requirements

    Proposed Sec.  101.11(b) would establish requirements for nutrition 
labeling of food sold in covered establishments. Proposed Sec.  
101.11(b)(1)(i) would provide that the labeling requirement would apply 
to standard menu items offered for sale in covered establishments. We 
are finalizing it without change.
    Most comments we received about how the nutrition labeling 
requirements of the rule apply to standard menu items addressed 
specific labeling requirements (e.g., the provisions of Sec.  
101.11(b)(2)(i) for what must be provided on menus and menu boards), 
and we discuss these comments as they relate to such specific 
requirements. Immediately following, we discuss one comment more 
generally directed to the applicability of the labeling requirements of 
this rule.
    (Comment 54) One comment recommended that foods that are preordered 
and picked up at a later date, such as birthday cakes, boxed lunches, 
deli trays, and sandwich platters, not be covered by the menu labeling 
requirements because they are not foods on display, standard menu 
items, restaurant-type foods, or ordered from a menu or menu board. The 
comment asserted that restaurant foods are ordered for consumption 
within a proximate time from when they are ordered, and the person 
ordering the food intends to eat a portion of the food, whereas catered 
foods are ordered on behalf of a larger group of people and further 
ahead of time.
    (Response 54) The rule applies to standard menu items offered for 
sale in covered establishments. The rule defines standard menu item as 
restaurant-type food that is routinely included on a menu or menu board 
or routinely offered as a self-service food or food on display (see 
Sec.  101.11(a)). The definition of ``restaurant-type food'' in Sec.  
101.11(a) captures the time when the food will be eaten relative to 
when it is purchased or picked up (i.e., usually eaten on the premises, 
while walking away, or soon after arriving at another location) but 
when the food is ordered in relation to when it is picked up, and how 
many people will share the food, have no bearing on the applicability 
of the rule.

X. Comments and FDA Response on Proposed Sec.  101.11(b)(1)(ii)--Food 
Not Subject to the Labeling Requirements

A. The Proposed Requirements

    Proposed Sec.  101.11(b)(1)(ii) would provide that the labeling 
requirements would not apply to alcohol beverages; items such as 
condiments that are placed on the table for general use; daily 
specials; temporary menu items; custom orders; and food that is part of 
a customary market test. In sections X.B through X.E of this document, 
we discuss comments on this proposed provision. After considering 
comments, we are:
     Narrowing the proposed exemption of alcohol beverages from 
all of the new requirements for nutrition labeling;
     Clarifying that the exemption applies to condiments that 
are for general use, including those placed on the table or on or 
behind the counter; and
     Clarifying that the labeling requirements of paragraph (b) 
do not apply to self-service food and food on display that is offered 
for sale for less than a total of 60 days per calendar year or fewer 
than 90 consecutive days in order to test consumer acceptance.

B. Alcohol

1. Alcoholic Beverages
    (Comment 55) Some comments agreed with our proposal that alcoholic

[[Page 71186]]

beverages should not be covered. Some comments stated that alcoholic 
beverages should not be considered food within the context of menu 
labeling. Some comments supporting FDA's proposal to exclude alcoholic 
beverages referenced Alcohol and Tobacco Tax and Trade Bureau's (TTB's) 
oversight of alcoholic beverage labels, which includes premarket 
approval. One comment referred to the district court decision cited in 
FDA's proposed rule (76 FR 19192 at 19203), Brown-Forman Distillers 
Corp. v. Mathews, 435 F. Supp. 5 (W.D.Ky. 1976), as evidence that TTB 
has jurisdiction over the labeling of alcoholic beverages under the 
Federal Alcohol Administration Act (FAA Act). Another comment argued 
that requiring calorie declarations for alcoholic beverages will not 
affect obesity, because obesity is the result of years of poor diet and 
lack of exercise. Another comment mentioned a 2011 survey of adult 
consumers and stated that it showed that most consumers do not want to 
see calorie counts on drink menus and want to order what they want. The 
comment did not include or provide a reference for the survey.
    In contrast, many comments argued that alcoholic beverages should 
be covered in the final rule. Some comments asserted that it was not 
the intent of Congress to exclude alcoholic beverages from the menu 
labeling requirements. According to these comments, Congress excluded 
some foods from menu labeling, but did not exclude alcoholic beverages. 
One comment, referring to a press release of two Senators (Ref. 29), 
contended that Congress rejected lobbyists who wanted to exclude 
alcoholic beverages.
    Several comments argued that FDA has jurisdiction to require menu 
labeling for alcoholic beverages and not TTB. According to these 
comments, Congress directed FDA to require menu labeling for all food, 
including alcoholic beverages. Some comments maintained that FDA 
currently has exclusive authority to regulate labeling of certain 
alcoholic beverages (such as wines containing less than 7 percent 
alcohol by volume and some beers), and another comment stated that FDA 
had asserted its authority over alcoholic beverages when FDA and the 
Federal Trade Commission took action on caffeinated alcohol drinks. One 
comment maintained that in the absence of a specific prohibition or 
direct conflict, each Agency can regulate alcoholic beverages in line 
with its mandate. Another comment stated that the U.S. Supreme Court 
has noted, ``The courts are not at liberty to pick and choose among 
congressional enactments, and when two statutes are capable of 
coexistence, it is the duty of the courts, absent a clearly expressed 
congressional intention to the contrary, to regard each as effective,'' 
citing Morton v. Mancari, 417 U.S. 535, 551 (1974). Thus, this comment 
asserted that there is no need to pick and choose between the FAA Act 
and section 4205 of the ACA because these statutes are capable of 
coexistence in that they apply to different groups and different 
practices.
    Several comments questioned the applicability of the Brown-Forman 
Distillers v. Matthews case to section 4205 of the ACA and contended 
that Brown-Forman addressed the FAA Act and FDA's authority to impose 
ingredient labeling on alcoholic beverage labels, not nutrition 
labeling on menus.
    Some comments also argued that FDA's proposed position with regard 
to alcoholic beverage menu labeling contrasts markedly with its 
position on meat and poultry menu items, the labels for which are 
regulated by the USDA. One comment remarked that alcohol used in non-
beverage foods, such as bananas foster, would be covered under the 
proposed rule, so not covering alcohol in foods that are beverages 
would not be consistent.
    Comments supported covering alcoholic beverages on public health 
grounds. Some comments argued that excluding alcoholic beverages is 
problematic because it may give the false impression that alcoholic 
drinks do not contribute to the overall caloric consumption of 
consumers, working against the underlying goal of section 4205 of the 
ACA. Other comments remarked that alcoholic beverages contribute a 
substantial portion of average total calories consumed by Americans, 
representing the fifth leading source of calories in American adults' 
diets. One comment stated that alcoholic beverages provide more 
calories per day on average than many of the food items required to be 
labeled under this law including pizza, hamburgers, and fried potatoes. 
Another comment argued that calories in alcoholic beverages count 
toward overweight and obesity just like calories in foods and other 
beverages.
    According to some comments, if some drinks are labeled and some are 
not, consumers might be confused, and they would not have the 
information to compare beverage options and make informed choices. 
Comments also stated that the calorie content of alcoholic beverages 
can vary widely and cited studies indicating that consumers are likely 
to have difficulty identifying lower calorie options. Comments argued 
that failing to provide consumers with calorie information for 
alcoholic beverages will make it more difficult for them to follow the 
2010 Dietary Guidelines' advice to control total calorie intake to 
manage body weight.
    (Response 55) The final rule does not provide a general exemption 
for alcoholic beverages. As we stated in the proposed rule, alcoholic 
beverages are ``food'' under the FD&C Act. Section 201 of the FD&C Act 
defines ``food'' to include ``articles used for . . . drink for man,'' 
``for the purposes of this Act.'' The nutrition labeling requirements 
of section 403(q)(5)(H) of the FD&C Act apply to ``food that is a 
standard menu item.'' In addition, as some comments indicated, section 
403(q)(5)(H)(vii) of the FD&C Act deems the requirements of section 
403(q)(5)(H) of the FD&C Act inapplicable to certain foods, and 
alcoholic beverages are not one of them.
    While section 4205 of the ACA amends section 403(q) of the FD&C 
Act, which generally provides nutrition labeling requirements for 
certain foods, the nutrition labeling requirements in section 4205 are 
directed specifically toward standard menu items sold in covered 
restaurants or similar retail food establishments. Within this context, 
providing nutrition information for an alcoholic beverage for which 
other labeling is also regulated by TTB provides the same public health 
benefit as providing the information for other foods. The provisions of 
section 4205 of the ACA do not apply to and have no effect on the 
labels of food products sold in packaged form, including alcoholic 
beverages regulated by TTB.
    Thus, we conclude that the nutrient content disclosure requirements 
in amended section 403(q)(5) of the FD&C Act for standard menu items 
offered for sale in covered establishments apply to alcoholic 
beverages, even though the labeling of alcoholic beverage containers 
under the FAA Act is regulated by TTB.
    FDA's decision to include alcoholic beverages in the menu labeling 
regulations is not inconsistent with the Brown-Forman decision, which 
addressed the labeling of containers of distilled spirits, wines, and 
malt beverages subject to the requirements of the FAA Act. This 
conclusion will not subject the regulated alcohol beverage industry 
``to `duplication and inconsistent standards,' '' a key basis for the 
Brown-Forman decision. (Brown-Forman at 14, citing United States v. 
National Ass'n of Securities Dealers, 422 U.S. 694, 735 (1975)). The 
requirements we are finalizing here do not directly conflict with any 
TTB requirements. As comments pointed out, the nutrition labeling 
requirements

[[Page 71187]]

of section 4205 of the ACA do not apply to and have no effect on the 
labels of alcoholic beverage containers. In addition, this final rule 
applies to covered establishments, while the FAA Act's labeling and 
advertising regulations generally apply to distillers, brewers, 
rectifiers, blenders, producers, importers, wholesalers, bottlers, and 
warehousemen of alcoholic beverages (see 27 U.S.C. 205). In short, the 
two regulatory schemes address different labeling and different actors; 
they are ``capable of coexistence.'' (See Manconi, cited previously in 
this document.)
    We also recognize that applying this final rule to alcoholic 
beverages also regulated by TTB is more consistent with the inclusion 
of meat, poultry, and egg products that are also regulated by USDA.
    From a public health perspective, we agree that requiring nutrition 
labeling of alcoholic beverages that are standard menu items is more 
likely to enable consumers to compare beverage options and make 
informed order selections in covered establishments. In addition, while 
obesity may be related to poor diet generally and a lack of exercise, 
calories in alcoholic beverages contribute to obesity and overweight 
just like calories in other foods. Alcoholic beverages contribute a 
substantial portion of average total calories consumed by American 
adults (Ref. 3). Table 2-2 in the 2010 Dietary Guidelines for Americans 
(``2010 Dietary Guidelines''), jointly developed and issued by HHS and 
the USDA, reports that alcoholic beverages rank sixth in a list of the 
top 25 food sources of calories among Americans ages 2 years and older, 
and fifth in a list of the top 25 food sources of calories among adult 
Americans ages 19 years and older (Ref. 3). The 2010 Dietary Guidelines 
also discuss alcohol in Chapter Three, entitled ``Foods and Food 
Components to Reduce'' (Ref. 3).
    As to the 2011 survey mentioned in one comment, FDA is unable to 
draw regulatory conclusions from such a survey without being able to 
evaluate the survey itself.
    (Comment 56) Several comments argued that providing calorie and 
other nutrition labeling for alcoholic beverages on menus is feasible, 
and one comment provided an example of a menu which included nutrient 
content disclosures for alcoholic beverages.
    (Response 56) We agree with these comments. We see no basis for why 
providing calorie and other nutrient content information for alcoholic 
beverages on menus would be less feasible for covered establishments 
than providing that same information for most other standard menu 
items.
    (Comment 57) Some comments noted that TTB and FDA currently work 
together through a Memorandum of Understanding (MOU) and asserted that 
under this MOU, TTB ensures adequate and non-misleading labeling, and 
FDA ensures safety. One comment that mentioned this MOU indicated that 
FDA should not begin to regulate the labeling of alcoholic beverages, 
while another comment that mentioned the MOU indicated that FDA's 
coverage of alcoholic beverages would not be inconsistent with the 
specific language of the MOU.
    (Response 57) We agree that FDA's coverage of alcoholic beverages 
in this context does not affect the delineation of responsibilities 
between FDA and TTB articulated in the MOU. FDA and TTB continue to 
work together under the MOU, and FDA has consulted with TTB during this 
rulemaking.
    (Comment 58) A few comments maintained that establishing menu 
labeling requirements for alcoholic beverages could lead to 
inconsistencies with TTB requirements. One comment pointed out that TTB 
has rulemaking underway for ``serving facts'' on alcoholic beverage 
labels and asserted that, if FDA establishes menu labeling requirements 
for alcoholic beverages, there could be inconsistencies between 
nutrition information on labels and menus.
    At the time that the proposed rule was issued, alcoholic beverages 
subject to the labeling regulations under the FAA Act were required to 
include a statement of average analysis if the label or advertisement 
made a claim with regard to the calorie or carbohydrate content of the 
product, and were allowed to include a statement of average analysis 
for any product. The statement of average analysis listed the number of 
calories and the number of grams of carbohydrates, fat, and protein per 
serving (see TTB Ruling 2004-1). In the Federal Register of July 31, 
2007 (72 FR 41860), TTB published a proposed rule to amend its 
regulations to require a Serving Facts statement, which would include a 
statement of calories, carbohydrates, fat, and protein per serving, on 
alcohol beverage labels. As of December 1, 2014, the TTB proposed rule 
has not been finalized. On May 28, 2013, TTB issued a ruling (TTB 
Ruling 2013-2) (Ref. 30) that allows alcohol beverage industry members 
to provide consumers with nutritional information on alcoholic beverage 
container labels by using the format of a statement of average analysis 
or a Serving Facts statement.
    The comment stated that TTB's rulemaking should be completed before 
FDA takes further action or FDA should exclude alcoholic beverages from 
the menu labeling requirements permanently. According to another 
comment, the labels currently approved by TTB with a statement of 
average analysis apply to a small portion of the total volume of beers 
produced by small brewers. The comment stated that the format is not 
consistent with FDA's proposed rule, because TTB only requires the 
disclosure of calories, carbohydrates, protein, and fat, while FDA's 
proposed rule would require disclosure of additional nutrients. Without 
agreement on formats, the comment asserted, compliance with FDA 
proposed menu labeling could contradict TTB guidance. This comment also 
stated that without a final rule from TTB, beer sold in bottles and 
cans on display in covered establishments will not be required to bear 
nutrition information. Comments stated that if FDA decides to cover 
alcoholic beverages in its menu labeling rule, FDA should coordinate 
with TTB to ensure consistency.
    Some comments that were against including alcoholic beverages 
maintained that the cost of laboratory analysis for alcoholic 
beverages, which they assumed would fall on the alcoholic beverage 
manufacturers, would be significant, especially for alcoholic beverage 
manufacturers that are small businesses. One comment asserted that the 
number of brands and styles of beer produced by small brewers varies 
dramatically in comparison to large brewers, and without in-house 
laboratories, which the comment believed large breweries would have, 
covering alcoholic beverages would have a disproportionate effect on 
small brewers. Several comments argued that sufficiently accurate 
calorie values for various types of alcohol are readily available from 
easily accessible databases, such as the USDA's National Nutrient 
Database for Standard Reference. One comment suggested allowing covered 
establishments to list estimated or approximate calorie values by 
category on wine lists rather than by each brand, recognizing that some 
types of alcoholic beverages, like red or white wines, contain 
substantially the same calories regardless of variety.
    (Response 58) We agree with some comments and disagree with others. 
As previously mentioned, the nutrition labeling requirements finalized 
here do not apply to and have no effect on the labels of alcoholic 
beverage containers. In addition, the new requirements apply

[[Page 71188]]

to covered establishments, not to alcoholic beverage manufacturers. In 
contrast, TTB's ``Serving Facts'' rulemaking would establish new 
requirements for disclosures on alcoholic beverage labels and would 
apply to alcoholic beverage bottlers and importers.
    Under this final rule, covered establishments have significant 
flexibility in choosing a reasonable basis for their nutrient content 
disclosures, which can include a database such as the USDA's National 
Nutrient Database for Standard Reference (see Sec.  101.11(c) and the 
discussion in sections XVIII and XIX). The USDA's National Nutrient 
Database for Standard Reference includes the categories, ``alcoholic 
beverage, wine, table, red,'' ``alcoholic beverage, wine, table, 
white,'' among several other general categories for alcoholic 
beverages. Consistent with our treatment of other standard menu items 
(see section XVIII of this document), we will allow covered 
establishments to use these entries as the bases for their nutrient 
content disclosures for alcoholic beverages that are standard menu 
items.
    In addition, we recognize that statements of average analysis and 
nutrient content disclosures under current TTB guidance include four 
nutrients, and our final rule requires that covered establishments make 
additional nutrient content disclosures for most standard menu items. 
However, we do not see these differences as conflicts. Nutrient content 
information on alcoholic beverage labels that is required by or 
consistent with TTB regulations or guidance could be a reasonable basis 
for a covered establishment's corresponding nutrient content 
disclosures. In addition, many alcoholic beverages will be eligible for 
the simplified format (see discussion re: Sec.  
101.11(b)(2)(ii)(B)(2)). As provided in Sec.  101.11(c)(1), covered 
establishments may also choose to use a database such as the USDA 
National Nutrient Database for Standard Reference as the reasonable 
basis for making their nutrient content disclosures, including 
disclosures for nutrients that do not currently appear on alcoholic 
beverage labels. This should address the comment's concerns about malt 
beverages or other alcoholic beverages that do not currently include 
nutrient information. FDA has consulted with TTB on this rulemaking and 
intends to continue to consult with TTB in the future.
    (Comment 59) Some comments recommended that drinks that are ordered 
by customers at the bar and that are not listed on the menu should be 
exempt from this rule.
    (Response 59) We agree with these comments. The final rule covers 
alcoholic beverages that are standard menu items that are listed on a 
menu or menu board. However, we are finalizing the proposed exemption 
for a subset of alcoholic beverages that are not listed on a menu or 
menu board. Specifically, Sec.  101.11(b)(1)(ii)(B) of the final rule 
provides that the labeling requirements of Sec.  101.11(b)(2)(iii) do 
not apply to those alcoholic beverages that are food on display. Our 
reasons follow. Because these reasons do not apply equally to alcoholic 
beverages that are self-service foods, Sec.  101.11(b)(1)(ii)(B) of the 
final rule clarifies that alcoholic beverages that are self-service 
foods are covered.
    First, it is unclear whether covered establishments could provide 
nutrient content disclosures for alcoholic beverages on display behind 
a bar that would assist consumers in making informed and healthful 
order selections. Covered establishments often serve such beverages in 
mixed drinks, and the amount of each alcoholic beverage and other 
mixers they serve to consumers may vary depending on the drink ordered. 
Section 403(q)(5)(H)(iii) of the FD&C Act requires that calories for 
self-service food and food on display be declared per serving or per 
item. Examples of other food on display include: Burrito fillings 
behind a counter at a burrito restaurant where burritos are made to 
order and salad ingredients behind a counter at a quick-service salad 
restaurant where salads are made to order. An employee generally adds a 
standard serving of each burrito filling or salad ingredient when asked 
by the customer, e.g., a standard measured weight of meat or a standard 
spoonful of beans. Nutrient content declarations based on those 
standardized servings are directly applicable to consumers' order 
selections.
    Even for some foods on display that have servings that vary, e.g., 
ice cream (where a customer can order one, two, or three scoops) or 
burrito fillings (where a customer can order extra cheese), the amount 
the customer receives is generally a simple multiple of a base serving. 
Ice cream would likely be labeled per scoop and cheese would likely be 
labeled per standard portion, with extra cheese being double the 
standard portion.
    In contrast, covered establishments with bottles of alcoholic 
beverages on display behind a bar generally serve varying amounts of 
alcohol and mixers depending on the establishment's recipes for the 
various beverages ordered. For example, at a given covered 
establishment, a martini recipe might have 2 ounces (oz.) of gin and 
0.5 oz. vermouth; a cosmopolitan recipe might have 3.5 oz. vodka, a 
dash of triple sec, a dash of cranberry juice, 1 tsp of sugar, and 1 
oz. of lime juice; and a grasshopper recipe might have 1 oz. white 
cr[egrave]me de cacao, 1 oz. green cr[egrave]me de menthe, and milk or 
cream to fill the glass (Ref. 31). As a result, the covered 
establishment does not have a standard serving on which to base a 
nutrient content declaration for each ingredient that will be directly 
applicable to all routinely ordered mixed drinks. In addition, recipes 
for even well-known drinks, like margaritas, may differ from one chain 
of restaurants to another, and consumers are unlikely to know a 
particular establishment's recipe while ordering (Ref. 31). It is 
difficult to see how a consumer would use an establishment's nutrient 
content disclosure on a bottle of alcohol behind a bar in choosing 
which mixed drink to order.
    Section 403(q)(5)(H)(x)(II)(aa) of the FD&C Act requires FDA to 
``consider standardization of recipes and methods of preparation'' and 
``variations in ingredients'' in issuing these regulations. Therefore, 
in finalizing the exemption for alcoholic beverages that do not appear 
on menus or menu boards, we considered that recipes and methods of 
preparation for alcoholic mixed drinks are not standardized throughout 
the industry. In addition, we considered the variations of the amounts 
of alcoholic beverages and other mixers served in mixed drinks in a 
given covered establishment.
    Alcoholic beverages that are on display differ from other food on 
display in additional relevant ways. Alcoholic beverages that are on 
display, particularly bottles of alcohol that are behind a bar, often 
appear to be on display primarily for decoration or storage, not to aid 
consumers in selecting among food options. This contrasts with most 
food that is on display, which is on display in order to aid consumers 
in selecting among food options (e.g., food choices at a salad bar, 
cookie varieties at a mall cookie counter). Once covered establishments 
comply with these new regulations, consumers in covered establishments 
who look at food on display to decide which displayed food they would 
like to consume will be able to consider calorie information on signs 
adjacent to the food and adjust their selection if they choose.
    In contrast, bottles of alcoholic beverages often are displayed 
very close together, layered on top of each other, staged in low 
lighting or back lighting, or placed very high. In other words,

[[Page 71189]]

they are displayed in a manner that does not enable consumers to easily 
identify the particular alcoholic beverages available to assist them in 
making their selections. In addition, bartenders often use bottles of 
alcoholic beverages under the bar--that are not on display--to mix 
alcoholic drinks. Finally, at many covered establishments that serve 
alcoholic beverages, mixed drinks and other alcoholic beverages that 
are not on menus or menu boards are ordered by customers sitting at 
tables, from which the bar could be completely out of sight.
    Based on the above considerations, we are exempting alcoholic 
beverages that are food on display and are not self-service food. 
Because these considerations do not apply readily to self-service 
alcoholic beverages (e.g., bottles of beer in a cooler near the 
register at a quick service restaurant), self-service alcoholic 
beverages are covered by the final rule. Therefore, Sec.  
101.11(b)(1)(ii)(B) of the final rule provides that the labeling 
requirements of Sec.  101.11(b)(2)(iii) for standard menu items that 
are self-service or on display do not apply to alcoholic beverages that 
are foods on display and are not self-service foods.

C. Condiments

    (Comment 60) Several comments recommended that covered 
establishments provide calorie information for all condiments. Other 
comments maintained that calorie information should be provided for 
condiments if they are part of the standard menu item. One comment 
recommended that the following be added to the provision: ``Condiments 
and sauces included as an ingredient or standard accompaniment to a 
menu item must be included in the nutrition information calculated for 
that item.''
    Another comment asked us to clarify that if condiments are provided 
for optional use, they should not be included in the calorie 
declaration. As an example, if a container of ketchup is provided on 
the side with a hamburger and the consumer can decide whether to use 
it, the container of ketchup should be treated the same as a bottle on 
the table and be exempted from calorie declaration. Another comment 
asked that the words ``on the table'' be removed from the provision and 
that the statute be interpreted to encompass condiments and other items 
kept behind the counter for general use. This comment explained that 
its establishment does not typically have tables as most of the 
business is take-out, and the condiments are kept behind the counter 
and available to the consumer upon request.
    One comment suggested that the exemption for condiments include 
only those self-serve items that are calorie free or that have a 
Nutrition Facts label. Another comment recommended that self-serve 
restaurants have the flexibility to determine which items can 
reasonably be considered condiments for general use, noting that many 
of its restaurants have an extensive ``spice bar'' that contains dozens 
of different spices, seasonings, and other condiments that any customer 
can use, regardless of that customer's order or food selections. The 
comment maintained that the regulation should be clear that all spices 
and seasonings fall in this exempt category.
    (Response 60) We are clarifying the exemption for condiments. 
Section 403(q)(5)(H)(vii)(I)(aa) of the FD&C Act provides that the 
requirements of section 403(q)(5)(H) of the FD&C Act do not apply to 
``items that are not listed on a menu or menu board (such as condiments 
and other items placed on the table or counter for general use).'' We 
affirm our tentative conclusion in the proposed rule that, given the 
phrase ``for general use,'' it is reasonable to interpret section 
403(q)(5)(H)(vii)(I)(aa) of the FD&C Act to apply to foods, such as 
many condiments, that are available for use by any customer in the 
covered establishment, regardless of the customer's particular order or 
food selection (76 FR 19192 at 19205). For example, it is reasonable to 
apply section 403(q)(5)(H)(vii)(I)(aa) of the FD&C Act to maple syrup 
that is provided in a bulk container or bottles of ketchup that are 
available for any customer to add to his or her food.
    However, we agree that the calorie declaration for a standard menu 
item must include the number of calories in the condiment if the 
condiment is used as a component in the standard menu item, as usually 
prepared and offered for sale. In such situation, the nutrient 
declarations for the standard menu item in the written nutrition 
information required by section 403(q)(5)(H)(ii)(III) of the FD&C Act 
and Sec.  101.11(b)(2)(ii) must also include the nutrient amounts from 
the condiment because the condiment is used as a component in the 
standard menu item. The exemption in section 403(q)(5)(H)(vii)(I)(aa) 
of the FD&C Act does not apply to condiments that are part of a 
standard menu item, as the standard menu item is usually prepared and 
offered for sale. For example, if a covered establishment ordinarily 
offers for sale burgers containing ketchup and mayonnaise added by the 
establishment, the ketchup and mayonnaise would be part of the standard 
menu item as usually prepared and offered for sale, and the calorie 
declaration for the standard menu item would include the calories in 
the ketchup and mayonnaise. Likewise, if a covered establishment 
ordinarily provides each customer who orders pancakes with a single 
serving container of maple syrup, the maple syrup would be part of the 
standard menu item as usually prepared and offered for sale, and the 
calorie declaration for the standard menu item would include the 
calories in the single serving container of maple syrup. Similarly, as 
noted previously in this document, in these situations, the nutrient 
declarations for the standard menu item in the written nutrition 
information required by section 403(q)(5)(H)(ii)(III) of the FD&C Act 
and Sec.  101.11(b)(2)(ii) must also include the nutrient amounts from 
the condiment because the condiment is used as a component in the 
standard menu item.
    We see no difference between a condiment brought to the table for 
general use and a condiment kept behind the counter for general use 
(and then provided to a customer who requests it), provided that such 
condiments are not listed on the menu or menu board separately or as 
part of a standard menu item. Therefore, we agree that condiments that 
are behind the counter for general use are exempt from the nutrition 
labeling requirements of section 403(q)(5)(H) of the FD&C Act under 
section 403(q)(5)(H)(vii)(I)(aa) of the FD&C Act. For clarity, we have 
revised Sec.  101.11(b)(1)(ii) to explicitly provide that the labeling 
requirements in paragraph (b) do not apply to items such as condiments 
that are for general use, including those placed on the table or on or 
behind the counter. (Emphasis added.) As revised, Sec.  
101.11(b)(1)(ii) includes condiments placed ``on'' the counter in 
accordance with section 403(q)(5)(H)(vii)(I)(aa) of the FD&C Act and in 
order to take into account varying business practices.
    We disagree that the exemption for condiments should include only 
those self-serve items that are calorie free or that have a Nutrition 
Facts label. The exemptions under Sec.  101.11(b)(1)(ii) are based on 
the language of section 403(q)(5)(H)(vii) of the FD&C Act. Section 
403(q)(5)(H)(vii) of the FD&C Act generally provides that the nutrition 
labeling requirements of section 403(q)(5)(H) of the FD&C Act do not 
apply to certain foods, including certain condiments. Section 
403(q)(5)(H)(vii) of the FD&C Act does not qualify such exemptions 
based on the caloric content of the food or the fact that some food 
would be available in packaged form that provides a Nutrition Facts 
label.

[[Page 71190]]

However, we note that under Sec.  101.11(b)(2)(iii)(C), a covered 
establishment would not be required to provide the written nutrition 
information required by section 403(q)(5)(H)(ii)(III) of the FD&C Act 
and Sec.  101.11(b)(2)(ii) for a self-service food or food on display 
that is a packaged food insofar as it bears nutrition labeling 
information required by and in accordance with Sec.  101.11(b)(2)(ii) 
and the packaged food, including its label, can be examined by a 
consumer before purchasing the food.
    We also note that spices and seasonings (such as crushed dried 
peppers) are considered condiments that are exempt from the 
requirements of section 403(q)(5)(H) of the FD&C Act under section 
403(q)(5)(H)(vii)(I)(aa) of the FD&C Act, provided that they are for 
general use by customers regardless of their particular order 
selection.

D. Daily Specials, Temporary Menu Items, Custom Orders, and Food That 
Is Part of a Customary Market Test

    (Comment 61) Several comments agreed with the proposed exemption 
for daily specials. One comment disagreed with the proposed exemption 
because the burden to calculate the calories and other nutrition 
information is not so great for daily specials to justify this 
exemption. The comment maintained that consumers often buy what is on 
sale and that excluding daily specials from the requirements of section 
403(q)(5)(H) of the FD&C Act would undermine the purpose of the 
statute.
    One comment opposed the proposed exemption for temporary menu items 
because temporary menu items represent a large portion of what is 
ordered on a single day at some establishments.
    Several comments agreed with the proposed exemption for food that 
is part of a customary market test. One comment opposed the proposed 
exemption because chain restaurants test market their menu items 
carefully before they mass market menu items and the determination of 
the nutrient content should be part of that process. The comment 
asserted that disclosing the calorie content of the food may impact the 
consumer's decision to purchase the food and may impact the 
establishment's decision whether to include that food on the regular 
menu.
    (Response 61) We are retaining in Sec.  101.11(b)(1)(ii) the 
exemptions for daily specials, temporary menu items, custom orders, and 
food that is part of a customary market test. Section 403(q)(5)(H)(vii) 
of the FD&C Act specifically exempts such items from the requirements 
of section 403(q)(5)(H) of the FD&C Act regardless of the factors 
identified by the comments, such as how the burden to calculate 
calories for these items compares to the burden to calculate calories 
for standard menu items; the tendency of consumers to buy what is on 
sale; and whether a chain restaurant could determine nutrition 
information.
    Section 403(q)(5)(H)(vii) of the FD&C Act generally provides that 
the nutrition labeling requirements of section 403(q)(5)(H) of the FD&C 
Act do not apply to certain foods, including daily specials, temporary 
menu items appearing on the menu for less than 60 days per calendar 
year, custom orders, and food that is part of a customary market test 
appearing on the menu for less than 90 days under terms and conditions 
established by FDA. Accordingly, Sec.  101.11(b)(1)(ii) provides that 
the labeling requirements of Sec.  101.11(b) do not apply to such foods 
and Sec.  101.11(a) defines the terms for such foods. We note that, as 
discussed in Response 62, self-service food and food on display that 
are temporary menu items or part of a customary market test, but do not 
appear on a menu, are also exempt from the requirements of section 
403(q)(5)(H) of the FD&C Act because these foods are not standard menu 
items.
    However, neither section 403(q)(5)(H) of the FD&C Act nor this rule 
would prevent a covered establishment from voluntarily declaring 
calories or providing written nutrition information for condiments, 
daily specials, temporary menu items, or food that is part of a 
customary market test.
    Regarding daily specials, we note that we would not consider an 
item that is offered every week on a particular day (e.g., the Monday 
special) to be a ``daily special'' because it is being routinely 
offered for sale (i.e., every Monday). In addition, we would not 
consider a standard menu item, as defined in this rule, to be a ``daily 
special'' if it is offered at a discounted price on a particular day 
(e.g., a turkey club sandwich that is a standard menu item and normally 
costs 5 dollars, but is specially advertised as costing only 4 dollars 
on Fridays).
    (Comment 62) In the proposed rule (76 FR 19192 at 19205), we noted 
that self-service food and food on display that do not appear on menus 
or menu boards would not be considered temporary menu items or food 
that is part of a customary market test. Therefore, even if a self-
service food or food on display that does not appear on a menu or menu 
board is only offered by a covered establishment for a limited time, 
such as a pumpkin spice muffin available only in November, we 
tentatively concluded that the nutrition information declaration 
requirements in section 403(q)(5)(H) of the FD&C Act would still apply.
    Several comments that addressed the exemption in proposed Sec.  
101.11(b)(1)(ii) for temporary menu items and food that is part of a 
customary market test considered that this exemption should apply to 
self-service food and food on display even though such foods may not 
``appear[ ] on a menu'' as described in section 403(q)(5)(H)(vii) of 
the FD&C Act. These comments said that Congress excluded temporary menu 
items and customary market test items from the nutrition labeling 
requirements of section 403(q)(5)(H) of the FD&C Act because it 
recognized that restaurants should be able to test products (many of 
which fail and are discontinued quickly) without incurring the 
significant costs associated with changing their menu and compiling 
nutritional information. The comments considered that this same 
reasoning applies to temporary menu items and customary market test 
items offered in self-service restaurants (whether the restaurant 
displays items on a menu, menu board, or individual signs). The 
comments asserted that for buffet-type restaurants, there would be 
significant costs in attempting to improve and change their menus for 
temporary menu items and food that is being market tested and that 
these costs would not be incurred by other kinds of non-buffet-type 
restaurants.
    (Response 62) We agree with these comments that the statutory 
exemptions for temporary menu items appearing on the menu for less than 
60 days per calendar year and customary market test items appearing on 
the menu for less than 90 days apply to self-service foods and foods on 
display that fall into those categories, as defined in Sec.  101.11(a). 
We also agree that a self-service food and food on display that does 
not appear on a menu or menu board but otherwise meets the definition 
for temporary menu items or food that is part of a customary market, in 
that the food is offered for sale in a covered establishment for less 
than a total of 60 days per calendar year or fewer than 90 consecutive 
days in order to test consumer acceptance, should not be required to 
comply with the requirements of section 403(q)(5)(H) of the FD&C Act 
and Sec.  101.11. The requirements of section 403(q)(5)(H) of the FD&C 
Act and Sec.  101.11 apply to foods that are standard menu items. 
However, self-service foods and foods on display that do not appear on 
a menu or menu board, but otherwise meet the definitions for temporary 
menu items or

[[Page 71191]]

food that is part of customary market test, along with the foods 
described in section 403(q)(5)(H)(vii) of the FD&C Act, do not meet the 
definition for a standard menu item in Sec.  101.11(a) because such 
self-service foods and foods on display are neither ``routinely 
included on a menu or menu board'' nor ``routinely offered as a self-
service food or food on display.'' Like temporary menu items or food 
that is part of a customary market test appearing on a menu or menu 
board, as described in section 403(q)(5)(H)(vii) of the FD&C Act, self-
service foods and foods on display that do not appear on a menu or menu 
board but otherwise meet the definitions for temporary menu items or 
food that is part of a customary market are offered for a limited time 
and are subject to variation and discontinuation depending on the 
seasonality and consumer response. Thus, these foods, like the foods 
described in section 403(q)(5)(H)(vii) of the FD&C Act, are not 
standard menu items and the requirements of this rule do not apply to 
such foods.
    For these reasons, we are modifying Sec.  101.11(b)(1)(ii)(A). 
First, we are specifying in Sec.  101.11(b)(1)(ii)(A) that the labeling 
requirements in paragraph (b) do not apply to foods that are not 
standard menu items. Second, we are specifying in Sec.  
101.11(b)(1)(ii)(A)(1) that such foods that are not standard menu items 
include items such as condiments that are for general use, including 
those placed on the table or on or behind the counter; daily specials; 
temporary menu items; custom orders; and food that is part of a 
customary market test. Third, we are specifying in Sec.  
101.11(b)(1)(ii)(A)(2) that such foods that are not standard menu items 
also include self-service food and food on display that is offered for 
sale for less than a total of 60 days per calendar year or fewer than 
90 consecutive days in order to test consumer acceptance.

E. Additional Comments on Food That Is Part of a Customary Market Test

    (Comment 63) Some comments asked us to clarify that if a food is 
tested in more than one location, the 90-day period is applied to each 
location. These comments maintained that it is common for restaurants 
and similar retail food establishments to conduct iterative tests to 
evaluate the performance of a menu item and change the menu in light of 
test results. For example, the results of iterative tests may lead to 
``changes in product makeup, including size, shape, taste profile, and 
preparation,'' with accompanying changes to the underlying nutrient 
content. The comment asked us to clarify that a food that changes in 
such a manner during a market test is a new food, and the 90-day period 
would begin again. One comment asked us to confirm that a market test 
may be conducted in multiple locations and that the 90-day period 
starts when the testing begins in a particular location.
    (Response 63) As we discussed in the proposed rule (76 FR 19192 at 
19205) and as suggested by the comments, in some cases, a chain of 
restaurants and similar retail food establishments may test a new 
product in different locations within the chain and in more than one 
region of the country at different times. We conclude that a 
``customary market test,'' for the purposes of Sec.  101.11, refers to 
a test in a single covered establishment. Therefore, we agree with the 
comments that the 90-day period for the food that is part of a 
customary market test applies to each covered establishment that offers 
for sale food that is part of a customary market test.
    Further, we recognize that restaurants and similar retail food 
establishments may change the foods that they are market testing in an 
iterative process. Therefore, we agree that if a food changes in ways 
such as those noted in the comments (e.g., changes in product makeup, 
including size, shape, taste profile, and preparation), it would be a 
new food and the 90-day period would begin again. We would consider the 
food to be a new food if it is not made with the same general recipe or 
same ingredients or otherwise has a significant change in the nutrient 
profile during the market test. For example, we would consider a soup 
prepared without meat, and a soup prepared with added sausage, to be 
different foods and would expect differences between the nutrient 
profiles of these different foods.

XI. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(i)(A)(1) 
to (b)(2)(i)(A)(3)--General Requirements for Calorie Declaration on 
Menus and Menu Boards

    Proposed Sec.  101.11(b)(2)(i)(A)(1) to (b)(2)(i)(A)(3) would 
require that covered establishments declare the number of calories 
contained in each standard menu item listed on the menu or menu board, 
as usually prepared and offered for sale in the following manner:
     The number of calories must be listed adjacent to the name 
or the price of the associated standard menu item, in a type size no 
smaller than the name or the price of the associated standard menu 
item, whichever is smaller, in the same color, or a color at least as 
conspicuous as the name of the associated standard menu item, and with 
the same contrasting background as the name of the associated standard 
menu item (proposed Sec.  101.11(b)(2)(i)(A)(1)).
     The calories must be declared to the nearest 5-calorie 
increment up to and including 50 calories and to the nearest 10-calorie 
increment above 50 calories, except that amounts less than 5 calories 
may be expressed as zero (proposed Sec.  101.11(b)(2)(i)(A)(2)).
     The term ``Calories'' or ``Cal'' must appear as a heading 
above a column listing the number of calories for each standard menu 
item or adjacent to the number of calories for each standard menu item. 
If the term ``Calories'' or ``Cal'' appears as a heading above a column 
of calorie declarations, the term must be in a type size no smaller 
than the smallest type size of the name or price of any menu item on 
that menu or menu board in the same color or a color at least as 
conspicuous as that name or price and in the same contrasting 
background as that name or price. If the term ``Calories'' or ``Cal'' 
appears adjacent to the number of calories for the standard menu item, 
the term ``Calories'' or ``Cal'' must appear in the same type size and 
in the same color and contrasting background as the number of calories 
(proposed Sec.  101.11(b)(2)(i)(A)(3)).
    In the following paragraphs, we discuss comments on these proposed 
provisions. After considering the comments, we are:
     Revising Sec.  101.11(b)(2)(i)(A) to specify that in the 
case of multiple-serving standard menu items, the calorie declaration 
must be for the whole menu item as listed on the menu or menu board, as 
usually prepared and offered for sale (e.g., ``pizza pie: 1600 
calories''), or per discrete serving unit as long as the discrete 
serving unit (e.g., pizza slice) and total number of discrete serving 
units are declared on the menu or menu board, and the menu item is 
usually prepared and offered for sale divided in discrete serving units 
(e.g., ``pizza pie: 200 cal/slice, 8 slices'').
     Revising Sec.  101.11(b)(2)(i)(A)(1) to provide additional 
flexibility for the contrasting background used for the calorie 
declaration;
     Making a conforming editorial change to the requirement 
for the color used for the calorie declaration for grammatical 
consistency; and
     Making an editorial correction for clarity to insert ``the 
type size of'' between ``no smaller than'' and ``the name or the 
price'' in Sec.  101.11(b)(2)(i)(A)(1).
    (Comment 64) Many comments regarding the proposed requirement that 
the number of calories contained in each standard menu item listed on 
the

[[Page 71192]]

menu or menu board be declared as usually prepared and offered for sale 
addressed the discussion in the proposed rule regarding how the calorie 
labeling requirements on menus and menu boards would apply to multiple-
serving foods that are standard menu items (76 FR 19192 at 19203-
19204). Many comments agreed with the view we expressed in the proposed 
rule that section 403(q)(5)(H) of the FD&C Act requires that calories 
be declared for standard menu items regardless of how many servings are 
included in the item (76 FR 19192 at 19203). The comments asserted that 
servings vary by product and by portions taken by consumers. One 
comment considered that if a menu item is to be shared, it would be 
easier for consumers to determine how many people will share the item 
and divide the calories accordingly than for the restaurant to choose 
how many servings are in a menu item. The comment said that we should 
not allow restaurants to choose how many servings are in a menu item.
    Many other comments opposed listing the calories for the entire 
standard menu item and instead supported the listing of calories per 
serving. Some comments asserted that listing calories per serving would 
be less confusing, would be consistent with calorie declarations on 
packaged food, and would not require consumers to do a calculation. One 
comment agreed with our determination that a multiple-serving food is a 
standard menu item but disagreed with our tentative conclusion that the 
calorie declaration should be for the entire multiple-serving food 
because providing calories for the entire multiple-serving food would 
not be helpful and would be detrimental for those who need the 
information per serving (e.g., diabetics). A few comments asked us to 
provide an option to permit either the declaration of calories for the 
entire multiple-serving menu item, or the declaration of the number of 
servings and the calories per serving. As an example, one comment 
suggested that a restaurant selling a four-serving family-style platter 
of pasta could comply either by disclosing that the whole menu item 
contains 2,000 calories, or by disclosing that the menu item consists 
of 4 servings, 500 calories per serving.
    One comment pointed out that if we required calorie declaration for 
an entire multiple-serving food, nutrition information would be 
inconsistent in some instances. For example, a cheesecake from a 
display case would have different nutrition information than the same 
cheesecake in prepackaged form, because the first would list calories 
for the entire item whereas the second would list calories per serving. 
One comment suggested that, for foods that are not appetizers or 
desserts that are intended to serve more than one person, calorie 
disclosure should include the number of persons intended to be served 
and the calorie content per serving.
    A few comments recommended that calories for pizza be listed per 
slice. One comment reported that it received complaints when it 
provided calorie information for the entire listed pizza. The comment 
provided a report of consumer research showing that 60 percent of 
consumers preferred calorie information per slice. The report of this 
survey was submitted with the comment (Ref. 32). Some comments referred 
to our previous statements that nutrition information should be 
declared per serving. For example, in our proposed rule on ``Food 
Labeling: Serving Sizes,'' we stated that for ``[f]oods in large 
discrete units,'' ``the household measure most meaningful for these 
products is a fraction of the whole unit.'' (56 FR 60394 at 60410, 
November 27, 1991). Another comment referred to statements in our 2008 
``Guidance for Industry: A Labeling Guide for Restaurants and Other 
Retail Establishments Selling Away-From-Home Foods (the 2008 restaurant 
labeling guide) (Ref. 10) that generally the nutrition information 
should be presented on a per serving basis. For example, the 2008 
restaurant labeling guide states that ``[i]t is especially important 
that the basis be declared when a food is available in more than one 
size serving (e.g., pizza that is available whole and by slice). . . . 
The restaurant may provide additional information, such as `8 slices 
per medium 16-inch pizza, 1 slice contains . . .' to help consumers put 
nutrition information in context.''
    Other comments urged us to clarify that a covered establishment can 
voluntarily provide nutrition information per serving. These comments 
suggested that we revise the rule to indicate that fact. These comments 
suggested adding the following to Sec.  101.11(b)(2)(i)(A): ``(5) For 
items that could serve more than one person, such as a large pizza or a 
bucket of chicken, calories must be listed per standard menu item as 
offered for sale and listed on the menu or menu board or as placed on 
display. In addition, restaurants and similar retail food 
establishments may also voluntarily provide nutrition information per 
serving.''
    (Response 64) Listing calories for multiple-serving standard menu 
items as usually prepared and offered for sale by a covered 
establishment is consistent with section 403(q)(5)(H) of the FD&C Act. 
As discussed in the proposed rule, section 403(q)(5)(H) of the FD&C Act 
requires covered establishments to disclose calorie information for 
standard menu items as usually prepared and offered for sale, 
regardless of how many servings are included in the menu item (76 FR 
19192 at 19203).
    Based on the comments that supported calorie declarations for 
multiple-serving standard menu items ``per serving,'' the complexity of 
consumer eating habits and preferences described by the comments, and 
the variety of ways that covered establishments may choose to usually 
prepare and offer their foods for sale, we have revised the rule's 
calorie declaration requirements for multiple-serving standard menu 
items on menus and menu boards.
    Where a multiple-serving standard menu item is usually prepared and 
offered for sale divided in discrete serving units (e.g., slices of 
pizza), we are allowing covered establishments to provide the calorie 
declaration per discrete serving unit, subject to some additional 
requirements. If a covered establishment declares calories for a 
multiple-serving standard menu item per discrete serving unit, the 
establishment must also declare the discrete serving unit and the total 
number of discrete serving units in the menu item on the menu or menu 
board so that the consumer can make a fully-informed decision before 
selecting the item.
    We are allowing calorie declarations per discrete serving unit for 
multiple-serving standard menu items that are usually prepared and 
offered for sale divided in discrete serving units because such 
division will likely enable consumers to easily identify the discrete 
serving unit (e.g., pizza slice) and therefore keep track of the number 
of serving units consumed. Pizza slices that come in a pie, or 
breadsticks that come in a bunch (e.g., ``pizza pie: 200 cal/slice, 8 
slices;'' ``breadsticks: 150 cal/stick, 5 sticks'') are examples of 
multiple-serving standard menu items that are usually prepared and 
offered for sale divided in discrete serving units. If consumers share 
such a menu item, the discrete serving units provide a distinct 
division along which portions can be divided, thereby allowing 
consumers to keep track of calories consumed by either adding or 
multiplying the per discrete serving unit calorie declaration based on 
the number of serving units consumed. Providing the number of calories 
per discrete serving unit and the total number of discrete serving unit 
contained in the menu item for

[[Page 71193]]

multiple-serving standard menu items that are usually prepared and 
offered for sale divided in discrete units enables consumers to 
determine the number of calories they may actually consume and 
therefore enables consumer to make informed dietary choices.
    However, where a multiple-serving standard menu item is not usually 
prepared and offered for sale divided in discrete serving units, 
covered establishments must declare calories for the entire menu item 
listed on the menu or menu board, as usually prepared and offered for 
sale. We disagree with the comment that said a calorie declaration for 
a whole multiple-serving standard menu item would be unhelpful or 
detrimental. If consumers decide to share a multiple-serving standard 
menu item, they can divide the total number of calories by the number 
of individuals sharing it. We clarify--as one comment suggested--that 
for multiple-serving standard menu items that are not usually prepared 
and offered for sale divided in discrete serving units, we would not 
object if a covered establishment decided to voluntarily declare 
calories per serving, in addition to the calories for the entire 
standard menu item.
    (Comment 65) A few comments recommended that calories be declared 
per reference amount customarily consumed (RACC) or by household 
measure. A RACC represents the amount of food customarily consumed at 
one eating occasion (Sec.  101.12 (21 CFR 101.12)). A few comments 
considered that listing calories per serving based on the RACC would be 
consistent with the labeling of packaged food. One comment noted that 
customers are used to seeing information per serving even though actual 
consumption may not be aligned with the RACC.
    (Response 65) We assume that ``household measure'' refers to 
measures such as ``cups'' or ``tablespoons.'' RACCs represent the 
amount of food customarily consumed at one eating occasion and are 
calculated for a variety of foods purchased by consumers in 
establishments such as grocery stores (see Sec.  101.12). RACCs are 
based on data set forth in national food consumption surveys and other 
sources of information on serving sizes of food, including serving 
sizes used in dietary guidance recommendations or recommended by other 
authoritative systems or organizations, serving sizes used by 
manufacturers and grocers, and serving sizes used by other countries 
(Sec.  101.12(a)). We developed RACCs as the basis for determining 
serving sizes for specific products for the purpose of declaration of 
nutrition information on product labels.
    We disagree that calories for standard menu items should be 
declared per RACC or by household measure. Section 403(q)(5)(H) of the 
FD&C Act requires covered establishments to disclose the number of 
calories contained in a standard menu item ``as usually prepared and 
offered for sale.'' Although many standard menu items may have an 
associated RACC, others may not. Even if some standard menu items have 
an associated RACC, each covered establishment is free to choose the 
amount of food offered for sale in its standard menu items, and section 
403(q)(5)(H) of the FD&C Act does not require covered establishments to 
prepare and offer standard menu items in particular amounts, such as 
RACCs.
    (Comment 66) Some comments considered that calories should be 
declared for each size of a menu item (such as ``upgrades'' or 
``upsized options'' and ``downsized options'') offered on menus and 
menu boards. Some comments linked the requirement to declare calories 
for different sizes to different prices--e.g., by considering that 
calories must be declared for any size option that has a distinct price 
on the menu or menu board. Some comments specifically addressed fixed 
combination meals and considered that calories should be declared for 
fixed combination meals available in multiple sizes.
    One comment asked us to allow the restaurant to list calories for a 
6-inch version of a sandwich and provide a statement on the menus and 
menu boards that the 12-inch sandwich is double that amount.
    (Response 66) The calorie labeling requirements of Sec.  
101.11(b)(2)(i)(A) apply to each standard menu item listed on the menu 
or menu board, as usually prepared and offered for sale. Thus, if a 
standard menu item (such as fries or onion rings) is listed on the menu 
or menu board in more than one size (such as ``small'' and ``large''), 
the menu or menu board must provide calories for each size, following 
the format requirements of Sec.  101.11(b)(2)(i)(A)(1), 
(b)(2)(i)(A)(2), and (b)(2)(i)(A)(3). Likewise, if a fixed combination 
meal (i.e., a meal consisting of components that are not subject to a 
consumer's selection, such as a burger and fries) is listed on the menu 
or menu board in more than one size (e.g., a hamburger with small fries 
or large fries), the menu or menu board must provide calories for each 
size of the fixed combination meal, also following the format 
requirements of Sec.  101.11(b)(2)(i)(A)(1), (b)(2)(i)(A)(2), and 
(b)(2)(i)(A)(3).
    If a 6-inch sandwich and a 12-inch sandwich are both standard menu 
items listed on a menu or menu board, or are on display in a covered 
establishment, the establishment must disclose the number of calories 
for each sandwich size, following the format requirements of Sec.  
101.11(b)(2)(i)(A)(1), (b)(2)(i)(A)(2), and (b)(2)(i)(A)(3) or Sec.  
101.11(b)(2)(iii) as applicable, unless the sandwich is exempt from the 
nutrition labeling requirements under section 403(q)(5)(H)(vii) of the 
FD&C Act.
    (Comment 67) One comment interpreted the phrase ``as usually 
prepared'' within ``as usually prepared and offered for sale'' in 
proposed Sec.  101.11(b)(2)(i)(A) to be a ``standard formula,'' 
``recommended formula,'' ``standard build,'' or any other term that 
means a predetermined method of preparation designed to ensure that all 
menu offerings are nutritionally consistent and uniform throughout all 
covered establishments in a chain.
    One comment agreed that the number of calories for a standard menu 
item should be measured based on how the standard menu item is usually 
prepared and offered for sale, but expressed concern about build-as-
you-go menu items. The comment explained that, a covered establishment 
might post the number of calories for a build-as-you-go menu item as an 
``undressed'' sandwich (the comment did not define this term), giving 
the false impression that the sandwich has fewer calories than it may 
actually contain as prepared by the covered restaurant and then 
consumed by a customer. This comment contended that this type of 
sandwich should be considered a variable menu item with calories posted 
as a range (i.e., in accordance with proposed Sec.  
101.11(b)(2)(i)(A)(4)) that includes the undressed sandwich and the 
fully built one, because there is standardization with respect to the 
specific amount of each particular food item or condiment that 
consumers can add to the build-as-you-go menu item. As evidence for 
this view, the comment referred to the standard extra charge for items 
such as an extra scoop of guacamole.
    (Response 67) We agree that ``standard build'' or ``recommended 
formula'' is consistent with the term ``as usually prepared and offered 
for sale.'' However, it is the build that is standard to any given 
covered establishment, rather than recommendations or standards by or 
from the chain as a whole, that dictates the nutrition information that 
would be required to be declared for standard menu items in a 
particular covered establishment.
    Regarding the comment expressing concern about build-as-you-go menu

[[Page 71194]]

items, we first note that a build-as-you-go menu item, such as a 
sandwich with the option of adding different fixings, that is a 
standard menu item, likely would be considered a variable menu item. As 
discussed previously in this document (see sections VIII.B and VIII.D), 
Sec.  101.11(a) defines the terms, ``standard menu item'' and 
``variable menu item.'' A variable menu item is defined in Sec.  
101.11(a) as a standard menu item that comes in different flavors, 
varieties, or combinations, and is listed as a single menu item. A 
variable menu item is one type of standard menu item. In the proposed 
rule, we provided examples of ``standard menu items''--e.g., a 
hamburger, a combination meal, a specific type of pizza (e.g., deluxe 
pizza), potato salad that is routinely offered at a salad bar, pancakes 
that are routinely offered at a buffet, and pudding that is routinely 
offered at a cafeteria line (76 FR 19192 at 19203). We also provided 
examples of variable menu items--i.e., foods that may have flavoring 
options (e.g., a milkshake that is available in vanilla, chocolate, or 
strawberry flavors) or topping options (e.g., pizza prepared with a 
selection of toppings) (76 FR 19192 at 19204). In the following 
paragraphs, we provide additional examples relevant to build-as-you-go 
menu items and explain how the calorie labeling requirements of Sec.  
101.11(b)(2)(i)(A) would apply.
    A standard menu item that is listed on a menu or menu board that is 
not a variable menu item, in that it does not come in different 
flavors, varieties, or combinations that are listed as a single menu 
item, (e.g., a turkey and Swiss cheese sandwich on whole wheat bread 
with mustard), would be subject to the calorie declaration format 
requirements of Sec.  101.11(b)(2)(i)(A)(1) to (b)(2)(i)(A)(3), but 
would not be subject to the additional format requirements for variable 
menu items (proposed Sec.  101.11(b)(2)(i)(A)(4)), established in this 
rule as Sec.  101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(8); see the 
discussion of the additional format requirements for variable menu 
items in section XII). However, a standard menu item that comes in 
different flavors, varieties, or combinations, and is listed as a 
single menu item on a menu or menu board (e.g., a ``turkey and cheese 
sandwich,'' with different options for the type of bread (e.g., whole 
wheat or white), cheese (e.g., Swiss, provolone, cheddar), fixings 
(e.g., onions, lettuce, tomato), and condiments (mustard, ketchup, 
mayonnaise)) would be a variable menu item subject to both the general 
calorie declaration format requirements of Sec.  101.11(b)(2)(i)(A)(1) 
to (b)(2)(i)(A)(3) for all standard menu items and the additional 
format requirements for variable menu items as applicable in Sec.  
101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(8).
    (Comment 68) Several comments agreed with proposed Sec.  
101.11(b)(2)(i)(A)(2) and the flexibility in proposed Sec.  
101.11(b)(2)(i)(A)(3) to permit the abbreviation ``Cal'' for calories.
    Several comments addressed the placement provisions for the calorie 
declarations in proposed Sec.  101.11(b)(2)(i)(A)(1) and 
(b)(2)(i)(A)(3). A few comments agreed that the number of calories be 
posted next to the name or price of the menu item (proposed Sec.  
101.11(b)(2)(i)(A)(1)) and that the term ``Calories'' or ``Cal'' be 
next to the number of calories (proposed Sec.  101.11(b)(2)(i)(A)(3)). 
One comment found that customers in its restaurants confused calorie 
declarations with price declarations and noted that declaring calories 
in the same font, size, and contrast as the price would create 
confusion, even if the color is different.
    Another comment from a chain restaurant found that consumers in its 
restaurants were confused when calories were posted next to the name of 
the menu item and thought the number of calories was the order number; 
to address this confusion, the restaurant put the number of calories 
after the price and in a different color, font, and size. This comment 
emphasized its 3 years of experience with posting calorie declarations 
and provided examples of its menu boards to demonstrate how it 
communicates calorie information about its menu offerings. This comment 
agreed that calorie information should be listed in a manner that 
allows the customer to easily identify the calories associated with a 
particular menu item, but disagreed that listing calories adjacent to a 
menu item is the only way (or even the best way) for customers to 
understand the information associated with their menu choice. This 
comment asserted that it had specifically learned from practical 
application and guest feedback that this generally is not the most 
useful method of providing caloric information. This comment suggested 
that the rule require a logical and clear association between the menu 
item and calorie declaration, but provide flexibility for how that 
logical and clear association occurs.
    (Response 68) We appreciate receiving the sample menu boards from 
the comment as a means of sharing experience with us. However, we are 
retaining in Sec.  101.11(b)(2)(i)(A)(1) the requirement that the 
number of calories be listed adjacent to the name or the price of the 
associated standard menu item. This requirement is consistent with 
section 403(q)(5)(H)(ii)(I)(aa) of the FD&C Act, which requires that 
the calorie declaration be ``adjacent to the name of the standard menu 
item, so as to be clearly associated with the standard menu item.'' 
Placing calorie declarations adjacent to the names of standard menu 
items provides a clear and logical association between the standard 
menu item and the calorie declaration and helps to ensure that 
consumers are able to see the declarations. In addition, Sec.  
101.11(b)(2)(i)(A)(3) provides that the term ``Calories'' or ``Cal'' 
must appear as a heading above a column listing the number of calories 
for each standard menu item or adjacent to the number of calories for 
each standard menu item. As such, Sec.  101.11(b)(2)(i)(A)(3) helps to 
further ensure that the calorie declaration is clearly associated with 
a particular standard menu item, and the required use of the term 
``Calories'' or ``Cal'' will help inform consumers that the number 
listed refers to calories. Section 101.11(b)(2)(i)(A)(1) also provides 
flexibility by requiring a covered establishment to declare calories 
adjacent to either the name or the price of the standard menu item. 
This flexibility is consistent with what one comment described doing in 
a restaurant. As finalized, Sec.  101.11(b)(2)(i)(A)(1) also provides 
sufficient flexibility to accommodate different types of menus and menu 
boards and the various ways that standard menu items may be listed on 
menus and menu boards. Specifically, in this rule Sec.  
101.11(b)(2)(i)(A)(1):
     Provides flexibility to use a color ``at least as 
conspicuous'' as that of the name of the associated standard menu item 
and, thus, allows for the use of a different color;
     Provides flexibility to use a contrasting background ``at 
least as conspicuous'' as that used for the name of the associated 
standard menu item and, thus, allows for the use of a different 
contrasting background (see Response 73);
     Provides flexibility to use a type size ``no smaller than 
the type size of the name or price'' of the associated standard menu 
item and, thus, allows for the use of a different type size; and
     Does not restrict the font style.
    We also note that the sample menu boards of the chain restaurant 
provided in the comment generally followed the provisions of the 
proposed rule in terms of type size and placement of calorie 
declarations. For example, the menu boards listed calorie declarations

[[Page 71195]]

adjacent to the names of standard menu items in a type size no smaller 
than the name or the price of the associated standard menu item, 
whichever is smaller, in a column with a heading ``Calories.'' 
Therefore, while the comment opposed the requirement that calorie 
declarations be placed adjacent to the names of standard menu items on 
menus and menu boards, the menu boards of the chain restaurant, 
nevertheless, generally used the same method of calorie declaration on 
menus and menu boards as required by this rule.
    (Comment 69) In the proposed rule, we tentatively concluded that 
some packaged foods offered for sale in covered establishments are 
covered by the menu labeling requirements (see 76 FR 19192 at 19217, 
proposed Sec.  101.11(b)(2)(iii)(C)). For example, a covered 
establishment may list ``chips'' on its menu board, referring to 
packaged bags of chips that are available as self-service foods or 
foods on display within the establishment. In this situation, the 
establishment would be required to disclose on the menu board calorie 
information for the packaged chips. In addition, if a covered 
establishment lists on its menu or menu board a combination meal that 
includes a packaged food, the establishment would be required to 
disclose the total calorie information for the combination meal, 
including the packaged food.
    One comment agreed with requiring the total calorie information of 
a combination meal that includes a packaged food to include the 
calories for the packaged food. Another comment disagreed that calories 
should be declared on a menu or menu board for packaged foods, 
particularly packaged soft drinks.
    (Response 69) As required by section 403(q)(5)(H) of the FD&C Act, 
covered establishments must provide calorie information for all 
standard menu items, including foods that are packaged. In addition, 
sections 403(q)(5)(H)(ii)(I)(aa) and (II)(aa) of the FD&C Act requires 
that covered establishments disclose the number of calories contained 
in a standard menu item, ``as usually prepared and offered for sale.'' 
As such, we agree that a covered establishment that lists on its menu 
or menu board a combination meal that includes a packaged food must 
disclose the total number of calories in the combination meal, 
including the calories for the packaged food.
    (Comment 70) One comment stated that the total calorie declaration 
for a standard menu item must include all ingredients of a standard 
menu item, as it is usually prepared and offered for sale, e.g., for a 
teaspoon of sugar added to oatmeal and salad dressings served on or 
with salad.
    (Response 70) We agree that the total calorie declaration for a 
standard menu item must include all ingredients of the standard menu 
item, as it is usually prepared and offered for sale, e.g., for a 
teaspoon of sugar added to oatmeal and salad dressings served on or 
with salad. As with the scenario discussed in Response 69 for a 
combination meal that includes a packaged food, doing so is required by 
section 403(q)(5)(H) of the FD&C Act and by sections 
403(q)(5)(H)(ii)(I)(aa) and (II)(aa) of the FD&C Act.
    (Comment 71) One comment suggested that we require that covered 
establishments provide the Reference Daily Intakes (RDIs) of calories, 
fat, cholesterol, and ``salt'' on menus and menu boards. The comment 
acknowledged that there is no RDI for sugar, but requested that it 
nonetheless be included on menus and menu boards. The comment also 
recommended that menus and menu boards only list percent Daily Value 
(DV) of calories, fat, cholesterol, sugar, and ``salt'' and not list 
vitamins and minerals because ``too many details may lead to 
information overload and defeat the purpose.''
    (Response 71) We disagree with the comment's suggestions, and we 
are not requiring covered establishments to include RDIs or percent DVs 
for certain nutrients on menus and menu boards. On menus and menu 
boards, we are requiring the number of calories contained in standard 
menu items, as usually prepared and offered for sale, and a succinct 
statement concerning suggested daily caloric intake, as required by 
sections 403(q)(5)(H)(ii)(I) and (II) of the FD&C Act. The succinct 
statement will adequately enable the public to understand, in the 
context of a total daily diet, the significance of the caloric 
information provided on menus or menu boards. We further note that 
percent DVs cannot be expressed for sugar or calories because Daily 
Reference Values (DRVs) have not been established for these nutrients. 
(See Sec.  101.9(c)(9), which lists DRVs for fat, cholesterol, sodium, 
and other food components.) The term Reference Daily Intake (RDI) 
applies to a vitamin or mineral but does not apply to calories, fat, 
cholesterol, sugar, or salt. (See Sec.  101.9(c)(8)(iv), which lists 
the RDIs for vitamins and minerals that are essential for human 
nutrition.) For the Nutrition Facts Label, the amount of a nutrient is 
calculated as a percentage of the RDI or DRV, as appropriate, and 
expressed using the same term--i.e., percent DV. Because ``salt'' can 
be either a general term applicable to substances such as calcium 
chloride or potassium chloride, or a synonym for the specific food 
substance ``sodium chloride,'' and because nutrition information 
generally is directed to information about the sodium content of food, 
we considered the request of the comment to be directed to the 
declaration of percent DV for ``sodium'' rather than to ``salt.''
    (Comment 72) A few comments agreed with the proposed requirement 
(in proposed Sec.  101.11(b)(2)(i)(A)(1)) that the type size for the 
calorie disclosure be no smaller than the name or the price of the 
associated standard menu item, whichever is smaller. Other comments 
considered that the proposed type size requirements are too 
prescriptive and recommended that we require only that the type size be 
``clear and conspicuous.'' One comment stated that restaurants located 
in one State have already complied with a clear and conspicuous 
standard; therefore, to move to a type size no smaller than the smaller 
of the name or price of the menu item would require changes. Another 
comment asked us to provide guidance that if the calorie declaration is 
as large as the name, price, or description of the menu item, whichever 
is smaller, it is presumptively clear and conspicuous and complies with 
section 4205 of the ACA, rather than require a specific font size 
relative to the price or name; as an alternative, the type size of the 
calorie declaration could be the same size as the description of the 
menu item (rather than the name of the menu item) (emphasis added). One 
comment recommended that any required minimum type size for the calorie 
declaration be half the size of the name or price, whichever is 
smaller. Another recommended that the calorie declaration be the same 
size and font as either the name or price.
    A few comments recommended that we require that the calorie 
declaration be at least as large as (or no smaller than) the name or 
price, whichever is larger. One comment recommended that the type size 
of the calorie declaration be no less than 10 point font on menus and 
no less than 22 point font on menu boards or a type size equal to the 
type size of the food listed.
    (Response 72) We are retaining the type size requirements for the 
calorie declaration without change. We disagree that the requirements 
for the type size of the calorie declaration are too prescriptive. Some 
type size requirements suggested in the comments would be more 
restrictive than what we proposed. This would be true for those 
comments specifying a

[[Page 71196]]

type size at least as large as (or no smaller than) the name or price, 
whichever is larger; a type size the same as the type size of the name 
or price; a type size the same size as the description of the menu 
item; or a specific type size. Such type size requirements would not 
take into consideration the various types and sizes of menus and menu 
boards that may be used in covered establishments. We have concerns 
that a type size that is half the size of the name or price, whichever 
is smaller, would result in a calorie declaration that is not clear and 
conspicuous and, therefore, not compliant with sections 
403(q)(5)(H)(ii)(I) and (II) and 403(f) of the FD&C Act. Sections 
403(q)(5)(H)(ii)(I) and (II) of the FD&C Act require, in relevant part, 
that calorie declarations required on menus and menu boards be clear 
and conspicuous and clearly associated with the corresponding standard 
menu item. Further, section 403(f) of the FD&C Act provides that a food 
shall be deemed misbranded ``if any word, statement, or other 
information required by or under authority of this Act to appear on the 
label or labeling is not prominently placed thereon with such 
conspicuousness (as compared with other words, statements, designs, or 
devices, in the labeling) and in such terms as to render it likely to 
be read and understood by the ordinary individual under customary 
conditions of purchase and use.'' The calorie declaration specified in 
Sec.  101.11(b)(2)(i)(A)(1) is tied to the name and price of the 
standard menu item, which typically are included on menus and menu 
boards and are two primary features of a menu or menu board typically 
used by consumers to make order selections. The type size requirements 
for calorie declarations balance the statutory requirements of sections 
403(q)(5)(H)(ii)(I) and (II) and 403(f) of the FD&C Act that calorie 
declarations be clear and conspicuous with the mandate in section 
403(q)(5)(H)(x)(II)(aa) of the FD&C Act to consider space on menus and 
menu boards and, thus, provide flexibility for different covered 
establishments.
    (Comment 73) A few comments discussed the proposed requirements (in 
proposed Sec.  101.11(b)(2)(i)(A)(1)) for the color and contrasting 
background of the calorie declaration. Some comments suggested changes 
to the proposed requirements for color and contrasting background. One 
comment emphasized that some menus and menu boards may have different 
contrasting background colors and provided two suggestions to 
accommodate such menus and menu boards. One suggestion was that we 
require that the calorie declaration have the same contrasting 
background, or a background at least as contrasting as the background 
used for the name of the associated standard menu item on the menu or 
menu board. As an alternative, the comment suggested that we could 
require that the calorie declaration have a background at least as 
contrasting as that used for the price and that menus using the same 
contrasting background as the price of the standard menu item will be 
presumed to comply.
    One comment asserted that the color and contrast requirements are 
too restrictive and maintained that many menu boards have a variety of 
colors to enhance customer experiences. One comment suggested that the 
color of the calorie declaration should not be fainter or less obvious 
than that of the other items on the menu. Another comment asked us to 
permit the calorie declaration to be in the same color as the subtext 
that lists ingredients. One comment that opposed the proposed 
requirement for color asserted that ``the eye becomes overwhelmed'' 
when all copy is the same size and color, and the consumer misses the 
information or gives up looking for the information. This comment 
requested flexibility in color and ``weight of calorie information'' (a 
term the comment did not define). This comment also asked us to clarify 
whether ``type'' is limited to font type (e.g., Arial) or whether it 
also includes text effects (e.g., bold, italics, color).
    One comment stated that the proposal was written with menu boards 
in mind and noted that some restaurants use translites (lighted boxes) 
where the name and price are in ``oversized type'' for marketing 
purposes. It asked us to permit the use of ``reverse type'' (which is 
white or light colored type printed on a dark background) and varied 
backgrounds if translites are used.
    (Response 73) We have revised the contrasting background portion of 
Sec.  101.11(b)(2)(i)(A)(1) to require that the number of calories be 
in the same contrasting background, or a background at least as 
contrasting as that used for the name of the associated standard menu 
item. We agree that this revision provides additional flexibility 
related to the prominence requirements to take into account that there 
may be different backgrounds on a single menu or menu board.
    We disagree that the color requirements of the calorie declarations 
should be revised. Section 403(q)(5)(H)(ii) of the FD&C Act requires 
that the calories be disclosed in a clear and conspicuous manner and 
clearly associated with the standard menu item. Further, section 403(f) 
of the FD&C Act provides that a food shall be deemed misbranded ``if 
any word, statement, or other information required by or under 
authority of this Act to appear on the label or labeling is not 
prominently placed thereon with such conspicuousness (as compared with 
other words, statements, designs, or devices, in the labeling) and in 
such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use.'' 
Requiring the calorie declaration to be in the same color, or in a 
color at least as conspicuous as the color of the name of the 
associated standard menu item helps ensure that the calorie 
declarations are clear and conspicuous, prominently placed on the menu 
or menu board with such conspicuousness as compared to other words on 
the menu or menu board and likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use, and 
clearly associated with the standard menu item. However, to match the 
grammatical construction of the revised requirement for the contrasting 
background used for the calorie declaration, we are making a conforming 
editorial change to require that the color used for the calorie 
declaration be in the same color, or a color at least as conspicuous as 
that used for the name of the associated standard menu item (emphasis 
added).
    In addition, we are not requiring calorie declarations to be in a 
specific font or to include particular text effects because we 
recognize that menus and menu boards come in a variety of sizes and 
include different fonts and type sizes. We are providing flexibility by 
taking into consideration the space on menus and menu boards (see 
section 403(q)(5)(H)(x)(II)(aa) of the FD&C Act), along with the fonts 
and type sizes already in use by the covered establishments, while also 
establishing requirements that help ensure calorie declarations are 
disclosed in a manner that is clear and conspicuous and that otherwise 
satisfies the requirements of applicable sections of the FD&C Act.
    We would not object to reverse type and varied backgrounds on 
translites, provided that the calorie declarations are clear and 
conspicuous and satisfy the requirements of applicable sections of the 
FD&C Act and Sec.  101.11. Calorie declarations on translites would be 
subject to the same general requirements as disclosures on other types 
of menu boards, as specified in Sec.  101.11(b)(2)(i)(A).

[[Page 71197]]

    (Comment 74) Some comments asked us to require a comma for 
declaring more than 1,000 calories because consumers are accustomed to 
seeing a comma in numbers of one thousand or greater. The comments 
suggested that we revise proposed Sec.  101.11(b)(2)(i)(A) to include a 
new subparagraph to state ``(4) Calorie numbers over 1,000 must include 
a comma after the thousands place.''
    (Response 74) We would not object to the voluntary use of a comma 
for calorie declarations of 1,000 or more, but decline to revise the 
rule to require a comma. The requirements we have established in Sec.  
101.11(b)(2)(i)(A) adequately ensure that calorie declarations are 
disclosed in a clear and conspicuous manner, as required by section 
403(q)(5)(H) of the FD&C Act, and render the calorie declarations 
likely to be read and understood by the ordinary individual under 
customary conditions of purchase and use, as required by section 403(f) 
of the FD&C Act. A covered establishment may choose to declare numbers 
over 1,000 with or without a comma.
    (Comment 75) One comment suggested that we accommodate vision-
impaired consumers by providing for alternate menus and availability of 
other nutrition information. This comment asserted that vision-impaired 
consumers suffer more from hypertension, heart problems, and diabetes.
    (Response 75) We recognize that vision-impaired consumers should 
have access to nutrition information for standard menu items in covered 
establishments. However, we are only implementing the nutrition 
labeling requirements specified in section 403(q)(5)(H) of the FD&C 
Act, at this time. Covered establishments may voluntarily provide 
visually impaired individuals with nutrition information for standard 
menu items in a way that is accessible to them. For example, we would 
not object to a covered establishment providing nutrition information 
for standard menu items through a Braille menu or a menu that gives 
information about menu items orally, in addition to providing nutrition 
information in accordance with Sec.  101.11.

XII. Additional Format Requirements That Apply When Declaring Calories 
on Menus and Menu Boards for Variable Menu Items, Combination Meals, 
and Toppings (Final Sec.  101.11(b)(2)(i)(A)(4) Through 
(b)(2)(i)(A)(8))

A. Proposed Format for Declaring Calories for Variable Menu Items

    Section 403(q)(5)(H)(v) of the FD&C Act requires FDA to establish 
by regulation standards for determining and disclosing the nutrient 
content for variable standard menu items that are listed as a single 
menu item ``through means determined by the Secretary, including 
ranges, averages, or other methods.'' (See the discussion of the 
definition of the term ``variable menu item'' in section VIII.D) In the 
proposed rule, we considered five options for implementing this 
statutory provision, and selected Option 2 (76 FR 19192 at 19207-
19209). Consistent with Option 2, proposed Sec.  101.11(b)(2)(i)(A)(4) 
would require, in relevant part, that for variable menu items, the 
calories must be declared as a range, in the format ``xx-yy'' where 
``xx'' is the caloric content of the lowest calorie variety, flavor, or 
combination, and ``yy'' is the caloric content of the highest calorie 
variety, flavor, or combination. The other options we considered were 
as follows:
     Option 1. Single value; either in the form of an average 
(obtained by summing up the calorie content of all options and then 
dividing by the number of options) or a median of all options (obtained 
by determining the ``middle'' number of calories from the list of 
options).
     Option 3. Hybrid combining averages and ranges; 
declaration of a single average value for variable menu items whose 
calorie ranges fall within specified bounds and declaration of a range 
for variable menu items whose calorie ranges fall outside those bounds.
     Option 4. If only 2 options are available for an item 
(e.g., a sandwich with fries or with fruit), provide both numbers with 
a forward slash between (e.g., 450/350). If three or more options are 
available, provide the range in calories.
     Option 5. If only 2 options are available for an item 
(e.g., a sandwich with fries or with fruit), provide both numbers with 
a forward slash between (e.g., 450/350). If three or more options are 
available, use one of the hybrid approaches outlined in Option 3.
    We also proposed specific requirements that would apply when a 
variable menu item appears on the menu or menu board and is a self-
service food or food on display, and there is no clearly identifiable 
upper bound to the range, e.g., all-you-can-eat buffet. In the 
following paragraphs, we discuss comments on these proposed provisions. 
After considering these comments, we have revised the provisions to:
     Require Option 4 instead of Option 2;
     Specify additional format requirements that apply when 
declaring calories on menus and menu boards for variable menu items, 
combination meals, and toppings (Sec.  101.11(b)(2)(i)(A)(4) through 
(b)(2)(i)(A)(7)); and
     Redesignate the requirements that apply to a variable menu 
item when there is no clearly identifiable upper bound to the range of 
calories to Sec.  101.11(b)(2)(i)(A)(8) and clarify that such item is 
otherwise exempt from the requirements of Sec.  101.11(b)(2)(i)(A) for 
what must be provided on menus and menu boards.

B. Decision To Require Option 4

    (Comment 76) Several comments supported our proposal to require 
Option 2 because they considered that ranges provide more detailed 
information. Several comments addressed one or more of the other four 
options we described. One comment stated that the use of ranges does 
not require customers to make calculations as would be the case for 
medians and means. This comment asserted that declaring calories in 
mixed options and hybrids would be confusing because consumers would 
need to understand why and when a single value (e.g., mean) is used 
rather than a range. One comment asserted that if single calorie values 
for each flavor and size were used rather than ranges, the menu board 
would be unreadable and consumers would be confused by too much 
information or would ignore the information. Another comment asserted 
that without a range, a single value calorie declaration for a variable 
menu item would be false.
    Other comments supported the use of hybrid approaches (such as in 
Options 3 and 5) that would provide calorie information in both ranges 
and averages. One comment recommended that Sec.  101.11(b)(2)(i)(A)(4) 
be revised to include specific exceptions that would limit the use of 
ranges--i.e., (1) very low or no calorie beverages should be listed 
separately from other beverages; (2) the mean must be used for menu 
items that come in different flavors, varieties, or combination meals 
if all options are within 40 calories of each other and all of the 
options contain fewer than 400 calories, or if all options are within 
80

[[Page 71198]]

calories of each other and one or more options contain more than 400 
calories; and (3) if there is a fixed or default option for a 
combination meal, calories should be posted for that option. This 
comment explained that it suggested the 40-calorie range because 40 
calories is used as the basis for low calorie claims, and that it 
suggested a cut-off of 400 calories because 400 is 20 percent of a 
2,000 calorie diet and is high according to our labeling principles.
    One comment recommended that a covered establishment be able to 
declare one range for a variable menu item that comes in different 
sizes only if the difference between the upper and lower limits is less 
than 5 percent. This comment did not explain the basis for its 
recommendation to use 5 percent to limit the use of ranges.
    One comment stated a preference for Option 4, but also requested 
that we limit the use of calorie ranges, within the constraints of 
Option 4. This comment considered that ranges are not particularly 
useful to customers in putting their choices into context. Several 
other comments opposed Option 4 because they considered that it would 
be confusing.
    (Response 76) After considering all five options in light of the 
totality of the comments and the advantages and disadvantages of each 
option as described in the proposed rule (76 FR 19192 at 19207 through 
19209), we are requiring Option 4, rather than Option 2, as the format 
for declaring calories for variable menu items on menus and menu 
boards.
    Option 4 is similar to proposed Sec.  101.11(b)(2)(i)(A)(4) in that 
it continues to provide for the declaration of calories using a range, 
which some comments supported. However, Option 4 also provides for the 
use of a different communication tool--i.e., a slash (e.g., 110/230)--
that is more tailored to a situation in which there are only two 
options available for a variable menu item. Using a slash instead of a 
dash (e.g., 110-230) better reflects the fact that there are only two 
options for a variable menu item available (see the discussion in 76 FR 
19192 at 19209), and more accurately informs consumers about the 
calories for each of the two options, whereas using a range represented 
by a dash is more appropriate when there are more than two options. As 
we discussed in the proposed rule, we recognize that in some instances, 
a calorie range may be so wide that a consumer may still need the 
calorie information for the particular menu item before he or she can 
make a fully informed purchase decision (76 FR 19192 at 19209). For 
example, the potential calorie range for a variable menu item that is 
offered for sale with the option of adding toppings (e.g., pizza) may 
be very wide. We are establishing specific requirements for such 
variable menu items when the toppings are listed on a menu or menu 
board in Sec.  101.11(b)(2)(i)(A)(5), in part to address the 
potentially large variation in calories and to provide more specific 
calorie information to consumers regarding their order selections.
    In general, however, we agree with the comments that use of a range 
is less confusing than hybrids and single values where consumers may 
not understand how a single value is derived if a median or mean is 
used. Requiring a range for variable menu items where three or more 
options are available gives consumers a consistent format across such 
variable menu items and may allow covered establishments to save some 
space on menus and menu boards.
    We disagree that we should limit the use of ranges to calorie 
declarations for variable menu items where the difference between the 
upper and lower limits is less than 5 percent. While this approach may 
provide for smaller range variations, such limitations likely would 
require additional calorie declarations on menus and menu boards and 
significant redesigns of menus and menu boards. Taking into 
consideration the space on menus and menu boards and the fact that 
calorie declarations for individual variable menu items will be 
included in the written nutrition information required under section 
403(q)(5)(H)(ii)(III) of the FD&C Act and Sec.  101.11(b)(2)(ii), we 
are not requiring limits on the use of ranges where the difference 
between the upper and lower limits is less than 5 percent, at this 
time. Further, the comment provided no basis to use 5 percent to limit 
the use of ranges.
    For these reasons, we have revised Sec.  101.11(b)(2)(i)(A)(4) to 
require Option 4 for the declaration of calories on the menu or menu 
board for variable menu items. Requiring the declaration of calories of 
each option for a variable menu by using a slash where only two options 
are available will reduce or limit the number of times that calories 
are declared as a range, as requested by some comments, while also 
providing specific calorie information about each option. If there are 
three or more options available, the calories must be provided in a 
range in the format ``xx-yy,'' where ``xx'' is the caloric content of 
the lowest calorie variety, flavor, or combination, and ``yy'' is the 
caloric content of the highest calorie variety, flavor, or combination. 
The use of a slash to declare calories for each option for a variable 
menu item where only two options are available and the use of a range 
where three or more options are available satisfy the requirements of 
section 403(q)(5)(H)(v) of the FD&C Act.
    We have revised Sec.  101.11(b)(2)(i)(A)(4) to specify, in 
subparagraphs (b)(2)(i)(A)(4) through (b)(2)(i)(A)(7):
     Specific requirements that apply to individual variable 
menu items (Sec.  101.11(b)(2)(i)(A)(4));
     Specific requirements that apply to a variable menu item 
that is offered for sale with the option of adding toppings listed on 
the menu or menu board (Sec.  101.11(b)(2)(i)(A)(5));
     Specific requirements that apply to a combination meal 
(Sec.  101.11(b)(2)(i)(A)(6)); and
     Specific format requirements for declaring calories for an 
individual variable menu item, a combination meal, and toppings as a 
range, if applicable (Sec.  101.11(b)(2)(i)(A)(7)).
    We discuss these specific requirements in sections XII.C through 
XII.F.
    We note that variable menu items that are self-service food or food 
on display are subject to the calorie declaration requirements, in 
Sec.  101.11(b)(2)(iii), for food that is self-service or on display, 
as discussed in section XVII.B.

C. Requirements That Apply to Individual Variable Menu Items (Final 
Sec.  101.11(b)(2)(i)(A)(4))

    (Comment 77) One comment stated that the proposed rule suggests 
that a calorie range is only appropriate when a general term such as 
``soda'' is used for a set of beverages, but not when specific flavors 
or brands are also named. The comment considered that the proposed rule 
therefore would require a calorie declaration for each specific size or 
each specific brand of a beverage listed on the menu. The comment 
referred to a discussion in the proposed rule (76 FR 19192 at 19216) 
where we compared individually listed beverages to individually listed 
flavors of ice cream and indicated that calorie declarations must be 
provided on menus and menu boards for the individually listed flavors. 
The comment contended that there is not enough space to list the 
calorie content for each size of each beverage offered for sale in the 
required type size. The comment also stated that this requirement will 
force covered establishments to refrain from listing the beverage 
options.
    (Response 77) We are establishing in Sec.  101.11(b)(2)(i)(A)(4)(i) 
through (b)(2)(i)(A)(4)(iii) requirements for

[[Page 71199]]

declaring calories on the menu or menu board for individual variable 
menu items. First, we are establishing in Sec.  
101.11(b)(2)(i)(A)(4)(i) the principle, discussed in the proposed rule, 
that calorie declarations must be provided on menus and menu boards for 
the individually listed flavors (76 FR 19192 at 19216). Section 
403(q)(5)(H)(v) of the FD&C Act provides, in relevant part, that FDA 
shall establish by regulation standards for disclosing the nutrient 
content for standard menu items that come in different flavors, 
varieties, or combinations, but which are listed as a single menu item 
through means determined by FDA, including ranges, averages, or other 
methods. Accordingly, Sec.  101.11(b)(2)(i)(A)(4)(i) specifies that 
when the menu or menu board lists flavors or varieties of an entire 
individual variable menu item (such as soft drinks, ice cream, 
doughnuts, dips, and chicken that can be grilled or fried), the 
calories must be declared separately on the menu or menu board for each 
listed flavor or variety.
    We acknowledge the comment's concern about space on menus and menu 
boards. However, a covered establishment could group together varieties 
or flavors that have the same number of calories (after rounding in 
accordance with Sec.  101.11(b)(2)(i)(A)(2)) and declare the calories 
for that group as a single calorie declaration, specifying that the 
calorie declaration represents the calorie amount for each individual 
flavor or variety (e.g., ``Diet Lemon Lime or Diet Cola (0 cal); Cola 
or Lemon Lime (150 cal)''). We have revised Sec.  
101.11(b)(2)(i)(A)(4)(i) to include this option for grouping flavors 
and varieties that have the same calorie amounts. We discuss in more 
detail the specific requirements for calorie declarations for self-
service beverages in section XVII.E.3.
    Flavors or varieties of variable menu items such as soft drinks, 
ice cream, doughnuts, dips, and chicken are not always listed on the 
menu or menu board. When the menu or menu board does not list flavors 
or varieties for an entire individual variable menu item, and only 
includes a general description of the variable menu item (e.g. ``soft 
drinks''), Sec.  101.11(b)(2)(i)(A)(4)(ii) specifies that the calories 
must be declared for each option with a slash between the two calorie 
declarations where only two options are available (e.g., ``150/250 
calories'') or as a range in accordance with the requirements of Sec.  
101.11(b)(2)(i)(A)(7) where more than two options are available (e.g., 
``100-250 calories''). As discussed in section XII.F, Sec.  
101.11(b)(2)(i)(A)(7) specifies the format requirements for declaring 
calories as a range.
    Some menus or menu boards describe flavors or varieties for only 
part of an individual variable menu item (such as different types of 
cheese offered in a sandwich). To address these types of variable menu 
items, Sec.  101.11(b)(2)(i)(A)(4)(iii) specifies that when the menu or 
menu board describes flavors or varieties for only part of an 
individual variable menu item (such as different types of cheese 
offered in a grilled cheese sandwich (e.g., ``Grilled Cheese (Cheddar 
or Swiss)'')), the calories must be declared for each option with a 
slash between the two calorie declarations where only two options are 
available (e.g., ``450/500 calories'') or as a range in accordance with 
the requirements of Sec.  101.11(b)(2)(i)(A)(7) where more than two 
options are available (e.g., ``450-550 calories'').

D. Requirements That Apply to a Variable Menu Item That Is Offered for 
Sale With the Option of Adding Toppings Listed on the Menu or Menu 
Board (Final Sec.  101.11(b)(2)(i)(A)(5))

    (Comment 78) A few comments recommended that the calories either be 
declared as a range as proposed or be declared for the basic 
preparation of the item together with a separate calorie declaration 
for each topping. These comments supported separate calorie 
declarations for sauces and dressings served on the side.
    One comment appeared to believe that covered establishments must 
list a range providing calories for pizzas with no toppings and pizzas 
with everything on them. The comment asserted that this calorie range 
would be too wide and ``useless.'' The comment also asserted that 
measuring toppings is not an ``exact science.'' The comment recommended 
that calories be disclosed on menus and menu boards for the standard 
build pizzas but not for toppings, because the nutrient information for 
the toppings would be required in the written nutrition information. 
However, the comment suggested that a single calorie listing for all 
toppings as a range from lowest to highest would be appropriate if we 
require calorie disclosures for pizza toppings on menus and menu 
boards.
    One comment recommended that ranges not be the only option for 
pizza. The comment asserted that pizzas can have up to 34 million 
combinations with a range as wide as 1,610 calories. The entity 
submitting the comment said it had received complaints from consumers 
in one jurisdiction where calorie information for pizza is provided by 
a range and found that the customers questioned the usefulness of a 
wide range of calories for a whole pizza. This comment stated that some 
jurisdictions have attempted to address this problem by requiring that 
the covered establishments list calories per each component or topping. 
The comment asserted that listing calories for each component or 
topping would not be useful for pizza because each topping has a 
different portioning based on the size of the pizza and the total 
number of toppings on the pizza. The comment explained that the amount 
of an individual topping selection (e.g., pepperoni, sausage, 
mushrooms, green peppers) added to a pizza is reduced based on the 
total number of individual toppings selections ordered. For example, a 
one-topping medium pizza where ham is the topping may have 10 grams of 
ham per slice (adding 10 calories from the ham per slice) whereas a 
medium pizza with ham as a topping and three other toppings may have 6 
grams of ham per slice (adding 5 calories from the ham per slice). 
Therefore, the comment contended that individual labeling of toppings 
would lead to large calorie ranges that would not be useful information 
for the consumer. This comment stated that under one State law, pizza 
is a custom order and nutrition information is not required for 
toppings. The comment maintained that the best way to make calorie 
declarations for pizza is to declare calorie information for the 
standard build and provide calorie information for other customizations 
in a brochure or an online calculator.
    One comment noted that, in the proposed rule, we discussed the 
possibility of listing calories for both the standard preparation of 
pizza and for each topping (76 FR 19192 at 19207) but did not codify 
this as we did for the written nutrition information. One comment asked 
us to clarify that calories should be listed for each separate pizza 
topping. Another comment recommended that calories for items such as 
pizzas and sundaes be posted for the standard preparation only if 
calories for each topping or option are also listed.
    (Response 78) In Sec.  101.11(b)(2)(i)(A)(5)(i) through 
(b)(2)(i)(A)(5)(iv), we are specifying format requirements that apply 
to a variable menu item that is offered for sale with the option of 
adding toppings listed on the menu or menu board. Doing so is 
consistent with section 403(q)(5)(H)(v) of the FD&C Act, responds to 
the comments making specific suggestions for how to declare calories 
for toppings such as those used

[[Page 71200]]

on pizza and sundaes, and acknowledges some of the unique 
characteristics of such toppings (e.g., that the amount of each topping 
added to a menu item such as pizza may decrease with the total number 
of toppings ordered).
    As noted by the comments, the proposed rule acknowledged that some 
comments received in response to the 2010 docket notice recommended 
that the calorie information for items such as pizza be displayed for 
the standard preparation of the item, with the standard preparation of 
the item clearly noted on the menu, menu board, or food tag or next to 
the food on display. The calorie content for each additional food 
component would then be displayed on the menu, menu board, food tag, or 
next to the food on display for each food component (76 FR 19192 at 
19207). In light of these comments to the 2010 docket notice and the 
comments received to the proposed rule, Sec.  101.11(b)(2)(i)(A)(5)(i) 
specifies that when the menu or menu board lists toppings that can be 
added to a menu item (such as pizza or ice cream), the calories must be 
declared for the basic preparation of the menu item as listed (e.g., 
``small pizza pie,'' or ``single scoop ice cream''). Section 
101.11(b)(2)(i)(A)(5)(ii) specifies that the calories must be 
separately declared for each topping listed on the menu or menu board 
(e.g., pepperoni, sausage, green peppers, onions on pizza; fudge, 
almonds, sprinkles on ice cream), and the menu or menu board must 
specify that the calories are added to the calories contained in the 
basic preparation of the menu item. For example:

                        Ice Cream Scoop: 300 cal
------------------------------------------------------------------------
                        Toppings                             Added cal
------------------------------------------------------------------------
Almonds.................................................              25
Fudge...................................................              50
------------------------------------------------------------------------

    Furthermore, a covered establishment could group toppings that have 
the same calorie amounts (after rounding in accordance with Sec.  
101.11(b)(2)(i)(A)(2)), and declare the calories for such toppings as a 
single calorie declaration adjacent to the toppings, specifying that 
the calorie declaration represents the calorie amount for each 
individual topping (e.g., ``Red Peppers or sweet onions (adds 10 
cal);'' ``Red peppers, sweet onions (adds 10 cal per topping)''). We 
have revised Sec.  101.11(b)(2)(i)(A)(5)(ii) to include this option for 
grouping toppings that have the same calorie amounts.
    We note that if the general term, ``toppings'' is used on a menu or 
menu board, but the individual toppings are not listed, then the format 
requirements of Sec.  101.11(b)(2)(i)(A)(4)(ii) would apply (i.e., the 
calories must be declared for each option with a slash between the two 
calorie declarations where only two options are available (e.g., ``150/
250 calories'') or as a range where more than two options are available 
(e.g., ``100-250 calories'').
    Foods such as pizza and ice cream are often offered for sale in 
different sizes (e.g., a small, medium, or large pizza pie, and ice 
cream dishes that contain one, two, or three scoops of ice cream). As 
mentioned by a comment, the amount of a topping added to a variable 
menu item may vary based on the size of the variable menu item ordered 
by a consumer. The calorie content of each topping will likely vary 
accordingly, depending on the size of the variable menu item ordered. 
To account for the potential variability in calorie content of each 
topping based on the size of the variable menu item ordered, Sec.  
101.11(b)(2)(i)(A)(5)(iii) specifies that the calories for the basic 
preparation of the menu item must be declared for each size of the menu 
item, and the calories for each topping listed on the menu or menu 
board must either be declared separately for each size of the menu 
item, or declared using a slash between the two calorie declarations 
for each topping where only two sizes of the menu item are available 
(e.g., ``adds 150/250 cal'') or as a range for each topping in 
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of the 
rule where more than two sizes of the menu item are available (e.g., 
``adds 100-250 cal''). If a slash between two calorie declarations or a 
range of calorie declarations is used, the menu or menu board must 
indicate that the variation in calories for each topping arises from 
the size of the menu item to which the toppings are added. For example:

  Plain Pizza Pie: Small (12'') 500 cal * Medium (14'') 750 cal * Large
                             (16'') 1000 cal
------------------------------------------------------------------------
                                                      Added cal
                 Toppings                  -----------------------------
                                              Small      Med      Large
------------------------------------------------------------------------
Pepperoni.................................       200       300       400
Sausage...................................       250       350       450
Green Peppers.............................        15        20        25
------------------------------------------------------------------------

or

  Plain Pizza Pie: Small (12'') 500 cal * Medium (14'') 750 cal * Large
                             (16'') 1000 cal
------------------------------------------------------------------------
                                                          Added cal (S/M/
                        Toppings                              L pie)
------------------------------------------------------------------------
Pepperoni...............................................         200-400
Sausage.................................................         250-450
Green Peppers...........................................           15-25
------------------------------------------------------------------------

    In the proposed rule, we requested comment on complexities that may 
be raised by certain variable menu items, such as those offered for 
sale with the option of adding toppings (such as pizza or ice cream) 
(76 FR 19192 at 19209). As mentioned by the comments, the amount of a 
topping added to a variable menu item, and therefore the calorie 
content of each topping, may vary not only based on the size of the 
menu item, but also based on the total number of toppings ordered by a 
consumer. Specifically, the amount of each topping added to a variable 
menu item may decrease as the total number of toppings ordered by a 
consumer increases.
    Therefore, to address this complexity, we have established a 
specific calorie declaration requirement in Sec.  
101.11(b)(2)(i)(A)(5)(iv) for variable menu items offered for sale with 
the option of adding toppings listed on the menu or menu board, where 
the amount of the topping included on the basic preparation of the menu 
item decreases based on the total number of toppings ordered (such as 
sometimes is the case with pizza toppings). In such situation, the 
calories for each topping listed on the menu or menu board must be 
declared as single values representing the calories for each topping 
when added to a one-topping menu item, and the menu or menu board must 
specify that the calorie declaration is for the topping when added to a 
one-topping menu item. The following table provides an example of 
calorie declarations that would satisfy the requirements of Sec.  
101.11(b)(2)(i)(A)(5)(i) through (iv):

  Plain Pizza Pie: Small (12'') 500 cal * Medium (14'') 750 cal * Large
                             (16'') 1000 cal
------------------------------------------------------------------------
                                                             Added cal
                                                              (single
                        Toppings                           topping S/M/L
                                                               pie)
------------------------------------------------------------------------
Pepperoni...............................................         200-400
Sausage.................................................         250-450
Green peppers...........................................           15-25
------------------------------------------------------------------------

    Structuring the requirement in this way helps ensure that consumers 
are given accurate and consistent information about the calories of 
each

[[Page 71201]]

topping that are added to the calories contained in the basic 
preparation of the menu item. We would not object if a covered 
establishment voluntarily includes a statement on the menu or menu 
board explaining how the calories per topping might fluctuate if 
ordering multiple toppings; for example, for a pizza pie, the statement 
might say, ``Calories per topping may decrease as the number of 
toppings per pizza increases.''
    In Sec.  101.11(b)(2)(i)(A)(5)(i) through (b)(2)(i)(A)(5)(iv), we 
are establishing requirements for declaring calorie information for 
variable menu items with toppings listed on a menu or menu board, and 
specifying the format and manner of such declarations, as required by 
sections 403(q)(5)(H)(v) and (x)(II)(bb) of the FD&C Act. Because the 
requirements in Sec.  101.11 (b)(2)(i)(A)(5)(iii) and 
(b)(2)(i)(A)(5)(iv) address the potential variability in calorie 
content of each topping based on the size of the menu item, and the 
total number of toppings ordered, the required calorie declarations 
will provide accurate calorie information to consumers regarding the 
calorie content of each topping they order. In addition, the 
requirement in Sec.  101.11(b)(2)(i)(A)(5)(iii) for toppings added to 
menu items that come in different sizes provides covered establishments 
with flexibility to choose one of two options that best fits their 
establishments and menus and menu boards. Allowing covered 
establishments to use a range for each topping to represent the added 
calories across various sizes of the menu item may save some space on 
menus and menu boards while still providing the necessary calorie 
information for consumers to make informed dietary choices.
    We disagree that pizza with toppings generally would be a custom 
order for the purposes of this rule and that nutrition information is 
not required for such foods for a number of reasons. First, the 
requirements of section 403(q)(5)(H) of the FD&C Act and this rule 
apply to standard menu items. This rule defines a standard menu item as 
restaurant-type food that is routinely included on a menu or menu board 
or routinely offered as a self-service food or food on display. To the 
extent a pizza with toppings meets the definition of a standard menu 
item, the requirements of section 403(q)(5)(H) of the FD&C Act and 
Sec.  101.11(b) would apply to such pizza.
    Second, while section 403(q)(5)(H)(vii) of the FD&C Act exempts 
from the nutrition labeling requirements of section 403(q)(5)(H) of the 
FD&C Act items that are custom orders, a pizza with toppings that meets 
the definition of a standard menu item would not be a custom order 
within the meaning of Sec.  101.11. Under the definition of ``custom 
order'' in Sec.  101.11(a), a custom order is a food order that is 
prepared in a specific manner based on an individual consumer's 
request, which requires the covered establishment to deviate from its 
usual preparation of a menu item. For example, if a covered 
establishment offers a ``Meat Lovers'' pizza containing ground meat and 
sausage as a standard menu item, and a customer orders a ``Meat 
Lover's'' pizza without sausage, that order could be considered a 
custom order. In contrast, a pizza with toppings routinely listed on 
the menu or menu board of a covered establishment would meet the 
definition of a standard menu item, and toppings can be added to a 
pizza as part of the establishment's usual preparation of the menu 
item.
    Third, pizza is explicitly identified in section 403(q)(5)(H)(v) of 
the FD&C Act as a variable menu item for which the nutrition 
information must be disclosed. If Congress had meant for pizza, 
including pizza with toppings, not to be covered by the requirements of 
section 403(q)(5)(H) of the FD&C Act, it would not have had reason to 
specifically include pizza as an example of the foods described in 
section 403(q)(5)(H)(v) of the FD&C Act.
    We also disagree that calorie declarations for different toppings 
should not be required on menus or menu boards because these calorie 
declarations will be provided in the written nutrition information or 
can be provided in a brochure. When toppings are listed on a menu or 
menu board, consumers can use such information to make order 
selections. Accordingly, when toppings are listed on a menu or menu 
board, a covered establishment must declare calories for each topping 
on the menu or menu board in accordance with Sec.  
101.11(b)(2)(i)(A)(5)(ii) through (b)(2)(i)(A)(5)(iv). Requiring 
calorie declarations for toppings when they are listed on the menu or 
menu board helps to inform consumers' decisions by providing the 
calorie content of menu items before consumers make their order 
selections. Further, providing such information will enable consumers 
to make informed and healthful dietary choices.

E. Requirements That Apply to a Combination Meal (Final Sec.  
101.11(b)(2)(i)(A)(6))

    (Comment 79) Some comments recommended that, when practicable, 
calorie amounts for all components of a variable menu item that is a 
combination meal be listed on the menu or menu board. One comment 
provided an example of a variable menu item for a pancake combination 
meal with a choice of bacon strips or pork sausages to accompany 
pancakes, eggs, and hash browns. In the comment's example, the calories 
for the two options ranged from 1,200 to 1,420 calories, and the 
comment stated that the covered establishment could list the calories 
as ``Two pancakes (600 calories) served with two eggs (200 calories), 
hash browns (300 calories) and your choice of 2 bacon strips (100 
calories) or 2 pork sausages (320 calories).''
    A few comments acknowledged that ranges are a better mechanism for 
presenting calorie information about variable menu items that are 
combination meals than are medians or means, but also pointed out that 
ranges have a disadvantage in that they do not sufficiently convey the 
necessary information to the consumer. One comment maintained that its 
consumer research shows that calorie ranges are confusing and not 
informative for variable menu items. Another comment recommended that 
if calorie ranges are used, the calories for the menu options that are 
included in that range must be disclosed, either on the menu, through 
signs for foods on display, or through the device used to provide the 
other written nutrition information required in section 
403(q)(5)(H)(ii)(III) of the FD&C Act.
    Another comment provided sample menu boards that offered for sale 
menu items in a meal described as ``You Pick 2'' (YP2), such as a meal 
consisting of a half sandwich and a half salad. For each menu item, the 
sample menu boards declared the number of calories in the menu item 
when ordered by a consumer individually and when ordered as one of the 
components of the ``You Pick 2'' meal, if available as a ``You Pick 2'' 
component (e.g., ``Chicken Caesar Salad, YP2 360, Whole 720''). The 
comment asserted that declaring calories for each menu item 
individually, rather than declaring the calories for all possible 
combinations of its ``You Pick 2'' menu items in a range, was the best 
way to ensure that consumers have the necessary information to make 
choices about their calorie consumption.
    (Response 79) We disagree that we should require calories to be 
listed on a menu or menu board for each component of a variable menu 
item that is a combination meal. In many cases, one or more components 
of a variable menu item (such as the pancakes, eggs,

[[Page 71202]]

hash browns, bacon, and pork sausages in the comment's example) are 
also included on a menu or menu board as standard menu items, and the 
calories for such components would already be on the menu or menu board 
when this is the case. However, we would not object if a covered 
establishment voluntarily lists the calories for each component of a 
variable menu item that is a combination meal, provided that the 
covered establishment also complies with the format requirements for 
declaring calories for variable menu items on menus and menu boards in 
Sec.  101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(7).
    Section 403(q)(5)(H)(v) of the FD&C Act provides, in relevant part, 
that FDA shall establish standards for disclosing the nutrient content 
for standard menu items that come in different flavors, varieties, or 
combinations, but which are listed as a single menu item through means 
determined by FDA, including ranges, averages, or other methods. 
Accordingly, Sec.  101.11(b)(2)(i)(A)(6)(i) through 
(b)(2)(i)(A)(6)(iii) require calorie declarations for combination 
meals. Consistent with our selection of Option 4 for declaring calories 
for variable menu items generally (see discussion in section XII.B), 
Sec.  101.11(b)(2)(i)(A)(6)(i) specifies that when the menu or menu 
board lists two options for menu items in a combination meal (e.g., a 
sandwich with a side salad or chips), the calories must be declared for 
each option with a slash between the two calorie declarations (e.g., 
``350/450 calories''). Section 101.11(b)(2)(i)(A)(6)(ii) specifies that 
when the menu or menu board lists three or more options for menu items 
in a combination meal (e.g., a sandwich with chips, a side salad, or 
fruit), the calories must be declared as a range in accordance with the 
requirements of Sec.  101.11(b)(2)(i)(A)(7) (e.g., ``350-500 
calories'').
    As such, the requirements for calorie declarations for combinations 
meals in Sec.  101.11(b)(2)(i)(A)(6)(i) through (b)(2)(i)(A)(6)(iii) 
are consistent with the view of comments asserting that ranges are a 
better mechanism for presenting calorie information than are medians or 
means. The requirements in Sec.  101.11(b)(2)(i)(A)(6)(i) 
through(b)(2)(i)(A)(6)(iii) also address the concerns of other comments 
that ranges do not sufficiently convey the necessary information to the 
consumer by limiting the use of a range to combination meals with three 
or more options, and providing specific calorie information about each 
option of a combination meal where only two options are available. In 
addition, we find that the small sample size (n = 127) of the consumer 
research submitted with one comment limits it as support for the 
comment's assertion that calorie ranges are confusing and not 
informative for variable menu items (Ref. 33). Further, although this 
small study suggests possible consumer preference among different 
declaration formats, it does not provide evidence about how consumers 
understand and use the formats (Ref. 33).
    Immediately following, in Response 80, we discuss the third 
provision we are establishing in Sec.  101.11(b)(2)(i)(A)(6) regarding 
the format of declaring calories on the menu or menu board for 
combination meals--i.e., for ``upsize'' and ``downsize'' options for 
combination meals.
    Regarding the ``You Pick 2'' meal described by one comment, we note 
that the sample menu board provided by the comment had a separate 
section describing an opportunity for a consumer to combine standard 
menu items for a special price, such as by combining any half sandwich 
with any half salad. The comment's sample menu board declared the 
number of calories for each standard menu item available for consumers 
to combine for a special price (e.g., ``Chicken Caesar Salad, YP2 360, 
Whole 720''). Generally, the calories for a combination meal must be 
declared as a range in accordance with Sec.  101.11(b)(2)(i)(A)(7) as 
required by Sec.  101.11(b)(2)(i)(A)(6)(ii) if the menu or menu board 
lists three or more options for the menu items in the combination meal. 
However, in the sample menu boards provided by the comment, the section 
describing an opportunity for a consumer to combine standard menu items 
merely informed consumers of a special price when standard menu items 
separately listed on the menu board, each with declared calories, are 
combined in a ``mix and match'' situation. In this type of ``mix and 
match'' situation, as displayed in the sample menu board provided by 
the comment, a consumer would have the calorie information for each 
standard menu item available for the consumer to combine before he or 
she selects one or more standard menu items. Because the covered 
establishment would be providing calorie declarations for each standard 
menu item available for the consumer to combine on the menu or menu 
board that would be visible to consumers when making order selections, 
and taking into consideration space on menus and menu boards, we agree 
with the comment that requiring the disclosure of additional calorie 
ranges in such a situation, particularly where there are a large number 
of combinations available, likely would not be necessary. For these 
reasons, in this type of ``mix and match'' situation, where the menu or 
menu board describes an opportunity for a consumer to combine standard 
menu items for a special price (e.g., ``Combine Any Sandwich with Any 
Soup or Any Salad for $8.99''), and the calories for each standard menu 
item, including each size option as described in Sec.  
101.11(b)(2)(i)(A)(6)(iii) if applicable, available for the consumer to 
combine are declared elsewhere on the menu or menu board, we would not 
require a covered establishment to also declare the calories for the 
combination in a range. To make this clear, Sec.  
101.11(b)(2)(i)(A)(6)(iv) of the final rule specifies that where the 
menu or menu board describes an opportunity for a consumer to combine 
standard menu items for a special price (e.g., ``Combine Any Sandwich 
with Any Soup or Any Salad for $8.99''), and the calories for each 
standard menu item, including each size option as described in Sec.  
101.11(b)(2)(i)(A)(6)(iii) if applicable, available for the consumer to 
combine are declared elsewhere on the menu or menu board, the 
requirements of Sec.  101.11(b)(2)(i)(A)(6)(i), (ii), and 
(b)(2)(i)(A)(6)(iii) do not apply.
    In establishing Sec.  101.11(b)(2)(i)(A)(6)(iv), we have considered 
space on menus and menu boards and how to minimize the burden on 
covered establishments to comply with this rule while ensuring that the 
requirements of section 403(q)(5)(H) of the FD&C Act and other 
applicable sections of the FD&C Act are satisfied and nutrition 
information for standard menu items is made available to consumers in a 
direct and accessible manner. Further, our approach to this ``mix and 
match'' situation is similar to our approach to a situation where a 
covered establishment includes packaged food (such as chips) as part of 
a combination meal. As discussed later in this document (see section 
XVII.H), a packaged food that is a food on display that bears Nutrition 
Facts information, including the nutrition information specified in 
section 403(q)(5)(H)(ii)(III) of the FD&C Act and Sec.  
101.11(b)(2)(ii) satisfies the calorie disclosure requirement for self-
service food or food on display in section 403(q)(5)(H)(iii) of the 
FD&C Act and Sec.  101.11(b)(2)(iii), so long as a consumer is able to 
examine the calorie information on the label prior to purchase.
    (Comment 80) As another example of complexities that may be raised 
by certain variable menu items, we noted in the proposed rule that some 
menus with combination meals list an option to increase the size of 
components of those

[[Page 71203]]

meals for a discounted additional price (76 FR 19192 at 19209). ``Add 
25 cents to Upgrade to Large Fries & Large Drink'' is an example of 
such an option. We stated that we were considering whether those 
listings should be labeled with the number or range of calories they 
add to the standard combination meal, and requested comment on this 
issue.
    Several comments responded to this request for comment. In general, 
these comments considered that calories should be declared for each 
size of a menu item (such as ``upgrades'' or ``upsized options'' and 
``downsized options'') offered on menus and menu boards. Some comments 
linked the requirement to declare calories for different sizes to 
different prices--e.g., by considering that calories must be declared 
for any size option that has a distinct price on the menu or menu 
board. Some comments addressed combination meals, including fixed 
combination meals and combination meals that are variable menu items 
and considered that calories should be declared for fixed or variable 
combination meals available in multiple sizes.
    (Response 80) We previously addressed comments directed to standard 
menu items other than variable menu items when the menu or menu board 
lists an option to change the size of the standard menu item (see 
Response 66). Here, we focus on calorie declarations for ``upsized 
options'' and ``downsized options'' for combination meals that are 
variable menu items. Consistent with our selection of Option 4 (see 
discussion in section XII.B), Sec.  101.11(b)(2)(i)(A)(6)(iii) 
specifies that when the menu or menu board includes a choice to 
increase or decrease the size of a combination meal, the calorie 
difference must be declared for the increased or decreased size with a 
slash between two calorie declarations (e.g., ``Adds 100/150 
calories,'' ``Subtracts 100/150 calories'') if the menu or menu board 
lists two options for menu items in the combination meal, or as a range 
in accordance with the requirements of Sec.  101.11(b)(2)(i)(A)(7) 
(e.g., ``Adds 100-250 calories,'' ``Subtracts 100-250 calories'') if 
the menu or menu board lists three or more options for menu items in 
the combination meal.
    For example, if a covered establishment offers for sale a 
combination meal that is a variable menu item consisting of a sandwich 
with fries or with onion rings, and the menu or menu board includes a 
choice to increase the size of the fries or the onion rings, the number 
of calories added by the larger size must be declared using a slash 
(e.g., ``Adds 250/300 calories'') since there are only two options for 
menu items in the combination meal (e.g., fries or onion rings).
    As another example, if a covered establishment offers for sale a 
combination meal that is a variable menu item consisting of a sandwich 
with fries, onion rings, or tater tots, and the menu or menu board 
includes an option to increase the size of the fries, onion rings, or 
tater tots, the number of calories added by the larger size must be 
declared as a range in accordance with the requirements of Sec.  
101.11(b)(2)(i)(A)(7) (e.g., ``Adds 250-450 calories''), because there 
are three options for menu items in the combination meal (e.g., fries, 
onion rings, or tater tots).
    (Comment 81) A few comments requested flexibility and recommended 
that the rule allow a covered establishment to choose the option for 
declaring calories for variable menu items that best fits its business 
and menu, and display calories for variable menu items in the best way, 
as determined by the establishment, that allows consumers to choose 
healthier options. One comment presented a series of specific 
recommendations for disclosing calories, including specific 
recommendations that did not fit squarely within any of the five 
options for disclosing calories for variable menu items discussed in 
the proposed rule. This comment recommended that calories for variable 
menu items be disclosed by (1) providing an average or range, for each 
size or price of the variable menu item accompanied by the term ``Avg. 
Cal''; (2) declaring calories for the flavors, components, or toppings 
that make up that variable menu item elsewhere on the primary writing; 
or (3) displaying the calorie amount for one preset ``build'' of the 
variable menu item. Under the comment's third option, the ``build'' 
would be representative of a finished version of the typical order and 
could not be a rarely ordered base product to which additional fixings 
are added. The comment also recommended that a covered establishment 
declare the calories for the additional options available for the 
variable menu item in a separate writing (such as an electronic kiosk, 
a nutrition brochure, a menu addendum, a nutrition poster, or an online 
nutrition application) available before or at the point of sale.
    For combination meals that are fixed, this comment recommended that 
calories be disclosed by (1) providing total calories for the fixed 
combination meal or (2) providing calories for each item or component 
of the fixed combination meal elsewhere on the primary writing. For 
combination meals that contain variable menu items, the comment 
recommended that calories be disclosed by (1) providing calories as a 
range reflecting the lowest and highest total meal calorie content 
among the variations available; (2) providing a median or average 
accompanied by the term ``Avg. Cal'' if the calories for all variations 
within a variable combination meal are within 20 percent of the median 
calorie value; (3) providing calorie information for each item of the 
variable combination meal elsewhere on the primary writing; or (4) 
providing the calories for one specified variation of the variable 
combination meal. A covered establishment that elects to provide 
calories for one specified variation of the combination meal would 
identify the items in the variation specified, and disclose calories 
for the other variations of the variable combination meal in a separate 
writing available at the point of sale.
    (Response 81) We decline the requests of these comments to allow a 
covered establishment to determine the method for declaring calories 
for variable menu items based on factors determined by the 
establishment. While this rule provides flexibility where appropriate, 
taking into account different business practices, standard menu items, 
and menus and menu boards, it also provides for uniform nutrition 
labeling requirements to be applied in covered establishments. Such 
consistency was one of the primary purposes of section 4205 of the ACA 
(see e.g., section 4205(c)). Further, section 403(q)(5)(H)(v) of the 
FD&C Act specifically directs FDA to establish by regulation 
requirements for disclosing nutrition information for variable menu 
items through means determined by FDA. In addition, section 
403(q)(5)(H)(x)(II)(bb) of the FD&C Act directs FDA to issue 
regulations specifying the format and manner of the nutrition 
information disclosure requirements of section 403(q)(5)(H) of the FD&C 
Act. This rule establishes requirements for disclosing the nutrition 
information required under section 403(q)(5)(H) of the FD&C Act while 
also providing flexibility. For example, we are establishing specific 
format requirements for calorie declarations for individual variable 
menu items, toppings listed on a menu or menu board, and combination 
meals (Sec.  101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(7)), and we 
also are providing an exemption from the requirements for calorie 
declarations for combination meals in Sec.  101.11(b)(2)(i)(A)(6)(i) 
through

[[Page 71204]]

(b)(2)(i)(A)(6)(iii) under the circumstances described in Sec.  
101.11(b)(2)(i)(A)(6)(iv). In addition, Sec.  101.11(b)(2)(i)(A)(3) 
provides flexibility on where to place the term ``Calories'' or ``Cal'' 
on a menu or menu board, and Sec.  101.11(b)(2)(i)(A)(1) provides 
flexibility for the color and contrasting background of calorie 
declarations. The calorie declaration requirements for variable menu 
items in this rule help ensure that consumers get consistent 
information when ordering from different covered establishments and 
even when ordering within a single covered establishment. For example, 
the approach suggested by the comments could lead to an inconsistent 
presentation on the same menu or menu board within a single 
establishment if a covered establishment determined that one approach 
worked best for some of its menu items and another approach worked best 
for other menu items.
    (Comment 82) A few comments recommended that calories for 
combination meals be declared for the standard, ``default,'' or most 
popular build. As an example, one comment recommended that calories 
declared for a combination meal include the calories for fries if the 
meal is depicted on a menu board as including fries. As another 
example, the comment recommended that calories declared for a 
combination meal include the calories in a full-calorie drink if more 
than 50 percent of a covered establishment's combination meals are sold 
with a full-calorie drink. One comment considered that the standard or 
default is the meal depicted that accounts for more than a majority (51 
percent) of the sales for that meal.
    (Response 82) We disagree with the comments in part. A combination 
meal, including those described by the comments, could be listed on a 
menu or menu board as a variable menu item, meaning that it could be 
listed as a single menu item that comes in different flavors, 
varieties, or combinations. Where a combination meal is listed on a 
menu or menu board as a variable menu item, the meal would not have a 
typical ``default build'' because some components that make up the meal 
(e.g., hamburger, fries or onion rings, soft drink) come in different 
flavors, varieties, or combinations that consumers are able to select. 
Section 403(q)(5)(H)(v) of the FD&C Act requires, in relevant part, 
that FDA establish by regulation standards for disclosing the nutrient 
content for variable menu items, through means determined by FDA, 
including ranges, averages, or other methods. Accordingly, we have 
established the requirements for calorie declarations for variable menu 
items that are combination meals in Sec.  101.11(b)(2)(i)(A)(6)(i) 
through (b)(2)(i)(A)(6)(iii). These calorie declaration requirements 
communicate the variability of calorie content in the combination meal 
to consumers by providing the calorie information for each option when 
there are only two options available or in a range when there are three 
or more options available. In contrast, the methods for declaring 
calories for combination meals that are variable menu items suggested 
by the comments would not inform consumers that the calorie content of 
their order selection may vary based on the options selected in the 
combination meal.
    Where a combination meal is not listed on a menu or menu board as a 
variable menu item, but is instead listed as a menu item that comes in 
only one flavor, variety, or combination, the combination meal would 
have a ``default build.'' As with a combination meal that comes in 
different sizes, in this situation, Sec.  101.11(b)(2)(i)(A) requires a 
covered establishment to provide the number of calories contained in 
the combination meal listed on the menu or menu board, as usually 
prepared and offered for sale. (See discussion about fixed combination 
meals offered for sale in different sizes in Response 66.)

F. Format Requirements for Declaring Calories for an Individual 
Variable Menu Item, a Combination Meal, and Toppings as a Range, if 
Applicable (Final Sec.  101.11(b)(2)(i)(A)(7))

    As discussed previously in this document (see section XII.B), we 
are revising Sec.  101.11(b)(2)(i)(A)(4) to require Option 4. One such 
revision (established in Sec.  101.11(b)(2)(i)(A)(7)) specifies the 
format requirements that must be followed when declaring calories as a 
range. Under Sec.  101.11(b)(2)(i)(A)(7), calories that are declared as 
a range must be in the format ``xx-yy,'' where ``xx'' is the caloric 
content of the lowest calorie variety, flavor, or combination, and 
``yy'' is the caloric content of the highest calorie variety, flavor, 
or combination. We are establishing these specific format requirements 
as a separate subparagraph so that the rule does not need to include 
this format information each time the rule requires use of a range.

G. Exception for a Variable Menu Item When There Is No Clearly 
Identifiable Upper Bound to the Range of Calories (Final Sec.  
101.11(b)(2)(i)(A)(8))

    Proposed Sec.  101.11(b)(2)(i)(A)(4) would require, in relevant 
part, that if a variable menu item appears on the menu or menu board 
and is a self-service food or food on display, and there is no clearly 
identifiable upper bound to the range, e.g., all-you-can-eat buffet, 
then the menu or menu board must include a statement, adjacent to the 
name or price of the item, referring customers to the self-service 
facility for calorie information, e.g., ``See buffet for calorie 
declarations.'' This statement must appear in a type size no smaller 
than the name or price of the variable menu item, whichever is smaller, 
and in the same color or a color at least as conspicuous as that name 
or price, with the same contrasting background as that name or price.
    Comments that addressed this proposed provision supported it. 
Therefore, we are finalizing it without change, except to:
     Redesignate it as Sec.  101.11(b)(2)(i)(A)(8) and clarify 
that it is an ``exception'' to the requirements of Sec.  
101.11(b)(2)(i)(A) for calorie declarations that must be provided on 
menus and menu boards;
     Make a conforming change to Sec.  101.11(b)(2)(i)(A) to 
acknowledge the exception in Sec.  101.11(b)(2)(i)(A)(8);
     Provide the same flexibility for the contrasting 
background used for the statement referring customers to the self-
service facility for calorie declarations as for the calorie 
declaration in Sec.  101.11(b)(2)(i)(A)(1);
     Make the same conforming editorial change to the 
requirement directed to the color of this statement as for the calorie 
declaration in Sec.  101.11(b)(2)(i)(A)(1);
     Make an editorial correction for clarity to insert ``the 
type size of'' between ``no smaller than'' and ``the name or price.''
    Characterizing the provisions of Sec.  101.11(b)(2)(i)(A)(8) as an 
``exception'' will clarify that the requirements of Sec.  
101.11(b)(2)(i)(A)(1) through (b)(2)(i)(A)(7) do not apply when a 
variable menu item appears on the menu or menu board and is a self-
service food or food on display, and there is no clearly identifiable 
upper bound to the range of calories. Providing the same flexibility 
for the contrasting background as for the contrasting backgrounds for 
calorie declarations in Sec.  101.11(b)(2)(i)(A)(1) will provide a 
consistent approach to background requirements on menus and menu

[[Page 71205]]

boards. Making the conforming editorial change to the requirement 
directed to the color will promote consistency in terminology in the 
rule.
    With these changes, Sec.  101.11(b)(2)(i)(A)(8) specifies that if a 
variable menu item appears on the menu or menu board and is a self-
service food or food on display, and there is no clearly identifiable 
upper bound to the range, e.g., all-you-can-eat buffet, the menu or 
menu board must include a statement, adjacent to the name or price of 
the item, referring customers to the self-service facility for calorie 
information, e.g., ``See buffet for calorie declarations.'' This 
statement must appear in a type size no smaller than the type size of 
the name or price of the variable menu item, whichever is smaller, and 
in the same color or a color at least as conspicuous as that used for 
that name or price, with the same contrasting background or a 
background at least as contrasting as that used for that name or price.

H. Declaring Calories Using Interactive Menus or New Technology

    (Comment 83) In the proposed rule, we recognized that the Internet 
may allow for the use of different methods for disclosing calories, 
such as by providing a calorie tracker in the ordering frame to tally 
calories as customers make order selections (76 FR 19192 at 19209). We 
requested comment on whether different methods should be used for 
nutrient content declarations for interactive Internet menus in general 
(76 FR 19192 at 19209). One comment asked that we acknowledge the 
potential for advances in technology and establish a petition process 
to request alternative methods of nutrition information disclosure via 
technological innovations, e.g., via smart phone applications. The 
comment also asked us to establish a process to approve methods that 
reflect technological advances that we did not anticipate but that 
comply with the statute.
    (Response 83) We are not establishing a petition process to approve 
future methods for calorie declarations at this time. As suggested by 
the comment, we specifically acknowledged that potential technological 
advances may allow for the use of different methods in disclosing 
calories in covered establishments and requested comments on such 
methods. To the extent that the technological advances described by the 
comment provide methods for declaring calorie information in accordance 
with section 403(q)(5)(H) of the FD&C Act and Sec.  101.11, such 
methods would be permissible. We will continue to consider whether 
specific advances in technology may result in alternative methods for 
nutrient content declarations under section 403(q)(5)(H) of the FD&C 
Act.
    Later in this document (see Comment 113 and Response 113 in section 
XVI.E), we address a similar comment from the perspective of new 
technologies for providing written nutrition information.

XIII. Additional Requirements That Apply to Beverages That Are Not 
Self-Service or on Display (Final Sec.  101.11(b)(2)(i)(A)(9))

    (Comment 84) One comment noted that the proposed rule did not 
address the issue of ice fill for the declaration of calories for 
beverages. The comment asked us to permit covered establishments to 
calculate calories based on their standard ice fill as long as the 
level of ice fill is disclosed to consumers. The comment recommended 
that we expressly permit, regardless of whether there is a standard ice 
fill, the following statement regarding ice fill: ``Calorie content may 
vary based on the amount of ice used.''
    (Response 84) For beverages that are standard menu items and are 
dispensed by an employee of a covered establishment (and, thus, are not 
self-service), we acknowledge that some of the beverage would be 
displaced by any ice added by the covered establishment. In addition, 
the amount of beverage displaced may vary based on the amount and type 
of added ice (e.g., crushed, cubed, shaved). Whereas some covered 
establishments may dispense a standard beverage fill (i.e., a fixed 
amount that is less than the full volume of the cup per cup size), 
others may not. Likewise, whereas some covered establishments may have 
a standard ice fill (i.e., a fixed amount of ice per cup size), others 
may not. Accordingly, Sec.  101.11(b)(2)(i)(A)(9) of the final rule 
requires that, for beverages that are not self-service, calories must 
be declared based on the full volume of the cup served without ice, 
unless the covered establishment ordinarily dispenses and offers for 
sale a standard beverage fill (i.e., a fixed amount that is less than 
the full volume of the cup per cup size) or dispenses a standard ice 
fill (i.e., a fixed amount of ice per cup size). If the covered 
establishment usually prepares and offers for sale a beverage using a 
standard beverage fill or dispenses a standard ice fill, the covered 
establishment must declare calories based on such standard beverage 
fill or standard ice fill. Section 101.11(b)(2)(i)(A)(9) of the final 
rule does not require a covered establishment to set a standard 
beverage fill or standard ice fill. Instead, Sec.  
101.11(b)(2)(i)(A)(9) requires the covered establishment to disclose 
the number of calories contained in a beverage with a standard beverage 
fill or ice fill ``as usually prepared and offered for sale,'' as 
required by section 403(q)(5)(H)(ii) of the FD&C Act. The rule also 
does not specify how a covered establishment should dispense a standard 
beverage fill or standard ice fill. A covered establishment may choose 
a method that is suited to its establishment--e.g., by using equipment 
that automatically dispenses a volume specified by the establishment, 
by using cups that have markings that enable an employee to manually 
add a certain volume of beverage or ice, or by using a particular ice 
scoop.
    Section 101.11(b)(2)(i)(A)(9) is consistent with section 
403(q)(5)(H)(ii) of the FD&C Act, which requires covered establishments 
to declare on menus and menu boards the number of calories contained in 
standard menu items listed on such menus and menu boards, as usually 
prepared and offered for sale. In establishing Sec.  
101.11(b)(2)(i)(A)(9), we considered among other things, reasonable 
variations in serving sizes used by covered establishments, and 
therefore are allowing covered establishments to disclose calories 
based on the full volume of the cup served without ice, unless the 
covered establishment ordinarily dispenses and offers for sale a 
standard beverage fill or dispenses a standard ice fill. We do not 
expect that a statement that the calorie content of the beverage may 
vary based on the amount of ice used, such as the one suggested by the 
comment, will be necessary in light of the requirements of Sec.  
101.11(b)(2)(i)(A)(9).
    In section XVII.D, we discuss ice fill for self-service beverages.

XIV. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(i)(B)--
Succinct Statement That Must Be on Menus and Menu Boards To Provide 
Context About Calories in a Daily Diet

A. The Proposed Requirements

    Proposed Sec.  101.11(b)(2)(i)(B) would require the following 
statement designed to enable consumers to understand, in the context of 
a total daily diet, the significance of the calorie information 
provided on menus and menu boards: A 2,000 calorie daily diet is used 
as the basis for general nutrition advice; however, individual calorie 
needs may vary.
    In the proposed rule, we referred to the statement in this 
provision as the ``succinct statement'' and discussed principles that 
should be met to help

[[Page 71206]]

ensure that the succinct statement is designed to enable consumers to 
understand, in the context of a total daily diet, the significance of 
the calorie information provided on menus and menu boards (76 FR 19192 
at 19210). These principles are:
     The succinct statement should be succinct;
     The succinct statement should be in plain language that 
consumers can understand;
     The total caloric value should be framed appropriately so 
that it is not viewed as a recommendation for daily intake for every 
consumer;
     The succinct statement should give consumers a means to 
compare the calorie declaration for a menu item to total calories; and
     The succinct statement should inform consumers that 
individual needs vary.
    In the following paragraphs, we discuss comments on this proposed 
provision. After considering these comments, we are:
     Revising the succinct statement; and
     Providing for an optional succinct statement (which this 
document refers to as the ``children's succinct statement'') for use on 
menus and menu boards targeted to children as a substitute for, or in 
addition to, the succinct statement.

B. Principles for Establishing the Succinct Statement

    (Comment 85) Several comments supported the principles we discussed 
in the proposed rule for establishing the succinct statement.
    (Response 85) We acknowledge these comments.

C. Wording of the Succinct Statement

    (Comment 86) In the proposed rule, we signaled an intent to conduct 
consumer research to evaluate consumer response to the proposed 
succinct statement as well as to alternative succinct statements (which 
we discussed in the proposal) (76 FR 19192 at 19210). One comment 
supported such research, but suggested that more research should be 
done to assess if there is a permanent behavioral change.
    (Response 86) Although the proposed rule contemplated consumer 
research to guide the design of the succinct statement, we are 
foregoing such research at this time in light of the number of comments 
providing useful insight regarding the proposed succinct statement, 
related principles, and whether we should provide a succinct statement 
for children.
    (Comment 87) Several comments supported the proposed wording of the 
succinct statement. Other comments opposed the proposed wording of the 
succinct statement. Some comments considered that the information that 
calorie needs vary should not be included because it is obvious, it 
will clutter menus and menu boards, and there is no such phrase on 
packaged food. Another comment expressed concern about the use of 2,000 
calories in the succinct statement and recommended that the succinct 
statement be better phrased to emphasize ``individual needs may vary,'' 
e.g., by including information that many adults need fewer than 2,000 
calories. This comment opposed adding phrases about the amount of 
exercise needed to burn a particular number of calories. One comment 
asserted that the proposed succinct statement is not specific enough 
and recommended that it focus on suggested calorie intake rather than 
on a typical caloric intake.
    (Response 87) We are retaining the use of 2,000 calories as an 
appropriate reference value to include in the succinct statement. As 
discussed in the proposed rule, the Nutrition Facts on packaged foods 
uses 2,000 calories as a reference amount on which to base recommended 
intake for some nutrients for individuals 4 years of age and older, and 
the Nutrition Facts on packaged foods have been required for nearly 20 
years. Moreover, a 2,000-calorie reference value is close to the 
midpoint of the range of energy requirements for sedentary adults (76 
FR 19192 at 19209).
    We also are retaining information that individual calorie needs may 
vary, albeit in shortened form (calorie needs vary). As discussed in 
the proposed rule and emphasized by the comments, although 2,000 
calories is an appropriate reference value, not everyone should eat 
2,000 calories per day (76 FR 19192 at 19210). As a result, a factor 
that FDA considered in establishing a succinct statement was whether 
the succinct statement should be framed appropriately so that it is not 
viewed as a recommendation for daily intake for every consumer because 
individual calorie needs vary. For these reasons, we conclude that the 
succinct statement should inform consumers that calorie needs vary.
    (Comment 88) Several comments suggested specific revisions to the 
succinct statement as follows:
     ``Most adults should eat less than 2,000 calories a day, 
or less than 600 calories per meal.'' (A few comments cited New York 
State Department of Health focus groups that showed participants 
preferred per meal calorie messages over daily calorie messages. The 
comments stated that consumers could not calculate the distribution of 
a daily calorie budget between meals.)
     ``2,000 calories a day is an estimate of what adults need, 
but individual needs vary.''
     ``Consumption of 2,000 calories each day is used as the 
basis for general nutrition advice; however, individual daily calorie 
needs may be higher or lower.''
     ``The recommended caloric intake for a day varies from 
___-- to ___-- for adolescents and adults, from ___-- to ___-- for 
school-age children, and from ___-- to ____-- for preschool children 
above age 2 years, although diets may vary.''
     ``2,000 calories a day is used for general nutrition 
advice, but calorie needs vary.''
     ``A 2,000 calorie daily diet is recommended for most 
adults; however, individual needs vary depending on age, gender, and 
physical activity.''
     ``To maintain a healthy diet, most adults need no more 
than 2,000 calories per day. Caloric needs for most children and less 
active adults range from 1,200 to 1,600 calories.'' One comment noted 
that this statement reflects a separate range for children and 
recommended that the statement with the range for children be on all 
menus, not only children's menus.
    (Response 88) We have revised Sec.  101.11(b)(2)(i)(B) to require 
that the following succinct statement be posted on menus and menu 
boards: 2,000 calories a day is used for general nutrition advice, but 
calorie needs vary. Most of the suggested alternatives were variations 
of the succinct statement we proposed. The alternative we selected 
captures the principles discussed in the proposed rule in a more 
concise fashion than the succinct statement that we proposed.
    We disagree that the succinct statement should include the amount 
of calories per meal because individuals can choose many different ways 
to distribute their caloric intake throughout the day, and simply 
dividing the total calories into three meals does not acknowledge this 
variation or give consumers flexibility to distribute their own caloric 
intake. In addition, section 403(q)(5)(H) of the FD&C Act applies to 
standard menu items offered for sale in a variety of covered 
establishments, including establishments that do not serve foods that 
may constitute meals, such as chain ice cream shops and chain pretzel 
vendors.
    We disagree that the succinct statement required on the menu or 
menu board should include specific reference calorie intake values or 
ranges for different ages or should specify the

[[Page 71207]]

types of factors (such as age, gender, and physical activity) that 
impact the caloric needs of individuals. Such details are adequately 
captured by the phrase ``calorie needs vary'' and would unnecessarily 
increase the wordiness of the statement (i.e., make it less 
``succinct''). Because the Nutrition Facts label on packaged foods has 
been required for nearly 20 years, and the Nutrition Facts uses 2,000 
calories as a reference amount, consumers are already familiar with 
this single reference amount for daily calorie consumption for 
individuals 4 years of age and older. However, as discussed later in 
this document (see Comment 90 and Response 90), we are providing for 
the optional use of a children's succinct statement on a menu or menu 
board targeted to children as a substitute for, or in addition to, the 
succinct statement.
    (Comment 89) One comment noted that ``a 2,000 calorie diet'' may be 
misleading without the terms ``daily'' or ``per day.'' The comment also 
recommended adding a message that calorie content alone is not the only 
nutritional factor to consider when choosing a diet for optimal health, 
because a focus on calories may incorrectly lead consumers to choose 
options that are nutrient poor instead of nutrient rich.
    (Response 89) We agree that the succinct statement should provide 
the context that 2,000 calories refers to a daily diet and the succinct 
statement we are establishing in the final rule provides this context 
by informing consumers that ``2,000 calories a day is used for general 
nutrition advice.'' However, we disagree that the succinct statement 
should state that calorie content alone is not the only nutritional 
factor to consider. Sections 403(q)(5)(H)(ii)(I) and (II) of the FD&C 
Act specifically require a covered establishment to disclose the number 
of calories contained in standard menu items and post a ``succinct 
statement concerning suggested daily caloric intake'' on menus or menu 
boards. The succinct statement we are establishing in the final rule 
adequately enables consumers to understand, in the context of a total 
daily diet, the significance of the calorie information provided on the 
menu or menu board, as required by sections 403(q)(5)(H)(ii)(I)(bb) and 
(II)(bb) of the FD&C Act. By allowing consumers to compare the caloric 
content of a standard menu item to the reference value of 2,000 
calories a day, the succinct statement will enable consumers to make 
informed and healthful dietary choices and highlight the potential 
effects of additional calorie consumption throughout the day.
    Further, as required by sections 403(q)(5)(H)(ii)(III) and (IV) of 
the FD&C Act, a covered establishment must also provide, in a written 
form and upon consumer request, additional nutrition information, and 
post on the menu or menu board a prominent, clear, and conspicuous 
statement regarding the availability of this additional nutrition 
information. Consumers therefore will have access to additional 
nutrition information and are notified of the availability of this 
information on the menu or menu board so that they are able to use the 
information to make informed and healthful dietary choices.

D. Succinct Statement on Menus Targeted to Children

    (Comment 90) In the proposed rule, we requested comment on whether 
we should require a different succinct statement on menus that are 
targeted to children (76 FR 19192 at 19210). One comment opposed a 
separate succinct statement for children and a few comments recommended 
such a statement. One comment recommended a separate children's 
succinct statement if there is a separate children's menu. Another 
comment recommended a different succinct statement for children's menus 
to inform consumers that calorie needs differ because of age, sex, or 
activity (the comment stated that calorie needs are about 1,000 to 
1,400 calories for 2- to 3-year old children, and can be up to 2,200 to 
2,700 calories for 14- to 18-year old active boys).
    The comments suggested the following succinct statements for 
children:
     ``Most children 4 to 8 years old need 1,500 calories a 
day, or less than 500 calories a meal.''
     ``The daily calorie requirement for children 4 to 8 years 
is about 1,500 calories, though individual needs vary.''
     ``Calorie needs for young children range from 1,000 to 
2,000 calories per day and vary based on age and physical activity 
levels.''
     ``Most children 4 to 8 years old need about 1,500 calories 
a day including snacks, or fewer than 500 calories a meal.''
    One comment suggested that we conduct consumer research on the 
following succinct statements:
     ``Most children 4 to 8 years old need 1,500 calories a 
day, or less than 500 calories a meal. Most children 2 to 3 years old 
need 1,200 calories a day, or less than 400 calories a meal.''
     ``Children need smaller food portions than adults. Calorie 
needs vary by child. For information on healthy eating, go to 
www.choosemyplate.gov.''
     ``Children's calorie needs vary by age and the individual 
child's nutrition and health status. Please consult your child's 
physician or health care professional.''
    (Response 90) We have revised Sec.  101.11(b)(2)(i)(B) to provide 
for the optional use of either of the following children's succinct 
statements on menus and menu boards targeted to children as a 
substitute for, or in addition to, the succinct statement:
     1,200 to 1,400 calories a day is used for general 
nutrition advice for children ages 4 to 8 years, but calorie needs 
vary.
     1,200 to 1,400 calories a day is used for general 
nutrition advice for children ages 4 to 8 years and 1,400 to 2,000 
calories a day for children 9 to 13 years, but calorie needs vary.
    Under Sec.  101.11(b)(2)(i)(B), a covered establishment may use one 
of these children's succinct statements on a menu or menu board 
targeted to children (e.g., on a standalone children's menu or menu 
board, or in the children's section of a general menu or menu board) as 
a substitute for, or in addition to, the succinct statement required in 
Sec.  101.11(b)(2)(i)(B). To ensure consistency, a covered 
establishment that includes a children's succinct statement on a menu 
or menu board may only use the children's succinct statements listed in 
Sec.  101.11(b)(2)(i)(B). If the covered establishment chooses not to 
use the children's succinct statements listed in Sec.  
101.11(b)(2)(i)(B), it must use the succinct statement required in 
Sec.  101.11(b)(2)(i)(B).
    We realize that many covered establishments offer food selections 
that may only be purchased for children under a certain age specified 
by the covered establishment (e.g., under 9 years). Some of these 
children's food selections are offered on separate children's menus, 
while others are included on the general menu or menu board along with 
items for all consumers. We have concluded that covered establishments 
should have the option of providing a succinct statement more relevant 
to children on menus and menu boards that provide food selections 
targeted to children. Childhood obesity is an important public health 
concern, and a succinct statement specifically targeted to the calorie 
needs of children may enable parents and children to make informed 
dietary choices.
    We considered whether covered establishments should be required to 
provide both the 2,000-calorie succinct statement and an additional 
children's succinct statement on menus and menu boards. Sections 
403(q)(5)(H)(ii)(I)(bb)

[[Page 71208]]

and (II)(bb) of the FD&C Act require that covered establishments post 
on menus and menu boards ``a succinct statement concerning suggested 
daily caloric intake . . . designed to enable the public to understand, 
in the context of a total daily diet, the significance of the [calorie] 
information'' provided on menus and menu boards. (Emphasis added.) 
Therefore, it is reasonable to interpret these sections to only require 
one succinct statement on menus and menu boards, and we are providing 
for the optional use by a covered establishment of a children's 
succinct statement on menus or menu boards targeted to children. 
Accordingly, the rule does not require that a covered establishment 
that includes a children's succinct statement on a menu or menu board 
targeted to children also include the succinct statement required by 
Sec.  101.11(b)(2)(i)(B) on that menu or menu board.
    To develop the children's succinct statement, we used the 2010 
Dietary Guidelines as the reference for the estimated calorie needs of 
children (Ref. 3). The 2010 Dietary Guidelines are based on the review 
of scientific evidence by a committee of scientific experts. The 2010 
Dietary Guidelines provide information and advice for choosing a 
healthy eating pattern that focuses on nutrient-dense foods and 
beverages, and that contributes to achieving and maintaining a healthy 
weight. One goal of the 2010 Dietary Guidelines is to aid policymakers 
in designing and carrying out nutrition-related programs. As such, the 
2010 Dietary Guidelines are well suited to serve as the reference for 
the estimated calorie needs of children for the purpose of this rule.
    As the comments noted, there is broad variability in the daily 
caloric needs of children, and this variability is captured in table 2-
3 in the 2010 Dietary Guidelines. Table 2-3 reports the estimated 
calorie needs per day by age, gender, and physical activity level. The 
relevant data and information in table 2-3, which we used to develop 
the children's succinct statement, covers four age groups (ages 2 to 3 
years, 4 to 8 years, 9 to 13 years, and 14 to 18 years) and three 
activity levels (sedentary, moderately active, and active). Male and 
female children are grouped together in the group aged 2 to 3 years but 
reported separately in the groups aged 4 to 8 years, 9 to 13 years, and 
14 to 18 years. Although most comments suggesting specific wording for 
the children's succinct statement focused on the calorie needs of 
children ages 8 and younger, some covered establishments may offer food 
selections targeted to somewhat older children--e.g., for ``kids under 
12.'' Therefore, we focused on estimated caloric needs for children 
aged 4 to 8 and children aged 9 to 13. We did not focus on the 
estimated caloric needs for the youngest age group (aged 2 to 3 years) 
and the oldest age group (aged 14 to 18 years). Although one comment 
suggested that we include the youngest age group (aged 2 to 3 years), 
we considered a number of factors and ultimately decided not to include 
the youngest age group (aged 2 to 3 years) and the oldest age group 
(aged 14 to 18 years). First, we considered space on menus and menu 
boards, the types of standard menu items offered in covered 
establishments, and different practices among covered establishments. 
Second, we were concerned that a children's succinct statement with 
four age groups would cross a reasonable threshold for one of the 
principles governing the succinct statement--i.e., that it be succinct. 
Third, we concluded that covered establishments might be deterred from 
voluntarily posting a children's succinct statement on menus and menu 
boards if such statement was not succinct. Fourth, children's menus are 
typically not targeted to the youngest and the oldest age groups.
    In developing the specific language of the two options for the 
children's succinct statement, we considered the principles that apply 
to the succinct statement, the comments, data and information discussed 
in the proposed rule, and the wording established in Sec.  
101.11(b)(2)(i)(B) for the succinct statement. As with the succinct 
statement, we concluded that the children's succinct statement should 
be directed to an estimated daily caloric need rather than the amount 
of calories per meal.
    In contrast to the succinct statement, which uses a single 
reference value (2,000 calories) regardless of age group, we concluded 
that the children's succinct statement needed to both reflect a range 
of calories and link that range of calories to a specific age group to 
adequately enable parents and possibly some children to understand the 
significance of the calorie information in the context of their total 
daily diet. We focused on estimated caloric needs for sedentary 
children and did not focus on additional calories consumed by active 
children. This is consistent with our approach to the succinct 
statement, where the 2,000 calorie daily diet does not take into 
account additional calories consumed by persons such as athletes or 
persons with a regular fitness regime. As with the succinct statement, 
the children's succinct statement addresses the differential caloric 
consumption associated with activity and other factors by informing 
consumers that ``calorie needs vary.''
    Table 2-3 in the 2010 Dietary Guidelines reports the same estimated 
daily caloric needs for sedentary males and females aged 4 to 8 years 
(i.e., 1,200 to 1,400 calories) and, thus, we selected 1,200 to 1,400 
calories as the range to include for children aged 4 to 8 years in each 
of the two options listed in Sec.  101.11(b)(2)(i)(B) for the 
children's succinct statements. Table 2-3 in the 2010 Dietary 
Guidelines reports different estimated daily caloric needs for 
sedentary males aged 9 to 13 years (i.e., 1,600 to 2,000 calories) and 
sedentary females aged 9 to 13 years (i.e., 1,400 to 1,600 calories). 
For the option listed in Sec.  101.11(b)(2)(i)(B) for a children's 
succinct statement that includes the estimated caloric needs of 
children aged 9 to 13 years, we simply reported the range as the lowest 
estimated caloric needs for sedentary males and females aged 9 to 13 
years (i.e., 1,400 calories for females) and the highest estimated 
caloric needs for sedentary males and females aged 9 to 13 years (i.e., 
2,000 calories for males). Thus, the listed option that includes the 
group aged 9 to 13 years reports the range of estimated caloric needs 
as 1,400 to 2,000 calories.
    (Comment 91) One comment suggested that children's menus may 
benefit from a traffic light concept (e.g., green, yellow, and red 
signage) that indicates which foods should be eaten more or less 
frequently.
    (Response 91) Section 403(q)(5)(H) of the FD&C Act generally 
requires covered establishments to provide calorie declarations for 
standard menu items on menus, menu boards, and signs adjacent to self-
service food and food on display, and other nutrition information in a 
written form. Section 403(q)(5)(H) also requires covered establishments 
to post on menus and menu boards a succinct statement concerning daily 
caloric intake and a statement regarding the availability of the 
written nutrition information. FDA is establishing requirements to 
implement only what is specified in section 403(q)(5)(H) of the FD&C 
Act and information that is necessary for the efficient enforcement of 
such requirements.

E. Requirements for the Succinct Statement To Be Prominent, Clear, and 
Conspicuous

    Proposed Sec.  101.11(b)(i)(2)(B)(1) would require that the 
succinct statement be posted prominently and in a clear and conspicuous 
manner in a type size no

[[Page 71209]]

smaller than the smallest calorie declaration appearing on the same 
menu or menu board and in the same color or in a color at least as 
conspicuous as the calorie declarations and with the same contrasting 
background as the calorie declarations. In the proposed rule, we 
recognized that some restaurants and similar retail food establishments 
may have menu boards that list very few items in very large font. We 
asked for comment on whether the succinct statement and statement of 
availability should be tied to the type size for some menus that have 
few items and that may be listed in large type size (76 FR 19192 at 
19211).
    In the following paragraphs, we discuss comments on this proposed 
provision. After considering these comments, we are:
     Revising the proposed provision to provide additional 
flexibility for the contrasting background of the succinct statement;
     Making a conforming editorial change to the requirement 
for the color used for the succinct statement for grammatical 
consistency; and
     Making an editorial correction for clarity to insert ``the 
type size of'' between ``no smaller than'' and ``the smallest calorie 
declaration.''
    (Comment 92) One comment suggested that the size of the succinct 
statement be ``no smaller than the menu description or what any 
ordinary person can read without any trouble.'' Due to space 
limitations on menus, this comment considered that the succinct 
statement should not be tied to the type size on menus that list 
relatively few items that are listed in very large type size. One 
comment asked us to permit a type size smaller than the smallest 
calorie declaration appearing on the menu or menu board due to the 
limited space on menu boards and the amount of text required to be 
included in the statement. Another comment maintained that the succinct 
statement takes up too much space and would force covered 
establishments to decrease the type size used for calories. A few 
comments suggested that we require the succinct statement to be no 
smaller than the type size most frequently used throughout the menu and 
in the same color and contrast, or in color and contrast at least as 
conspicuous and contrasting as the color and contrast most frequently 
used throughout the menu for the names of standard menu items.
    (Response 92) We agree, in part, and disagree, in part, with these 
comments. As a practical matter, the type size of the succinct 
statement would, as requested by the comments, likely be no smaller 
than the menu description or what any ordinary person can read without 
any trouble, because Sec.  101.11(b)(2)(i)(B)(1) requires that the type 
size for the succinct statement be no smaller than the smallest type 
size of any calorie declaration and, under Sec.  101.11(b)(2)(i)(A)(1), 
the type size of the calorie declaration would be in a type size no 
smaller than the type size of the name or the price of the associated 
standard menu item, whichever is smaller. Because consumers typically 
view the name and/or price of a standard menu item to place an order, 
our decision to anchor the type size of the succinct statement to the 
type size of information already on the menu or menu board acts, in 
essence, as an objective and measurable performance standard and helps 
ensure, among other things, that the succinct statement will be clear 
and conspicuous to consumers and posted prominently, as required by 
sections 403(q)(5)(H)(ii) and 403(f) of the FD&C Act.
    We disagree that the type size, color, and contrast should be tied 
to the type size, color, and contrast most frequently used throughout 
the menu. Section 101.11(b)(2)(i)(A)(1) provides flexibility for the 
type size, color, and contrasting background used for the calorie 
declaration (and, accordingly, Sec.  101.11(b)(2)(i)(B)(1) provides 
flexibility for the type size, color, and contrasting background used 
for the succinct statement), by anchoring these three parameters to the 
name or price of standard menu items. The suggestion in this comment 
would establish an additional burden for a covered establishment, 
particularly when a covered establishment has more than one menu or 
menu board, to determine the type size most frequently used. The 
comment provided no basis, such as apparent benefit for either the 
restaurant or the consumer, to justify this additional burden.
    However, we agree that we should provide additional flexibility for 
the contrasting background of the succinct statement by permitting the 
statement to be in a background at least as contrasting as that used 
for the calorie declarations. Consequently, we have revised Sec.  
101.11(b)(2)(i)(B)(1) to do so. We also are making a conforming 
editorial change to the grammatical construction of the requirement for 
the color used for the succinct statement to match the grammatical 
construction of the revised requirement for the contrasting background 
used for the succinct statement. With these changes, Sec.  
101.11(b)(2)(i)(B)(1) requires that the succinct statement be posted 
prominently and in a clear and conspicuous manner in a type size no 
smaller than the smallest type size of any calorie declaration 
appearing on the same menu or menu board and in the same color or in a 
color at least as conspicuous as that used for the calorie 
declarations, and with the same contrasting background or a background 
at least as contrasting as that used for the calorie declarations 
(emphasis added).

F. Placement of the Succinct Statement on Menus and Menu Boards

    For menus, proposed Sec.  101.11(b)(2)(i)(B)(2) would require that 
the succinct statement appear on the bottom of each page of the menu. 
On menu pages that also bear the statement regarding the availability 
of the written nutrition information required in Sec.  
101.11(b)(2)(i)(C), proposed Sec.  101.11(b)(2)(i)(B)(2) also would 
require that the succinct statement appear directly above the statement 
of availability required in Sec.  101.11(b)(2)(i)(C). For menu boards, 
proposed Sec.  101.11(b)(2)(i)(B)(3) would require that the succinct 
statement appear on the bottom of the menu board, immediately above the 
statement of availability required in Sec.  101.11(b)(2)(i)(C).
    In the following paragraphs, we discuss comments on these proposed 
provisions. After considering these comments, we have revised the 
proposed provisions for placement of the succinct statement to provide 
additional flexibility for the succinct statement to appear immediately 
above, below, or beside the statement of availability of the written 
nutrition information.
    (Comment 93) Several comments agreed with the proposed placement 
requirements for the succinct statement. One comment recommended that 
covered establishments be permitted to put the succinct statement on a 
separate sign near the menu boards because of space constraints.
    (Response 93) We are not revising the rule to allow a covered 
establishment to post the succinct statement on a separate sign near a 
menu board as suggested by the comment. First, we are concerned that if 
a covered establishment were to post the succinct statement on a 
separate sign, the statement would not be posted prominently, and 
therefore, consumers would not be able to use the statement to 
understand, in the context of a total daily diet, the significance of 
the calorie information that is provided on the menu board. Second, 
this rule provides flexibility regarding posting calorie declarations 
and other information on

[[Page 71210]]

menus and menu boards, including flexibility regarding the size of the 
calorie declarations and placement of the statement of availability of 
additional written nutrition information, such that covered 
establishments have a number of ways to satisfy the requirements based 
on their menus and menu boards and business operations. Lastly, 
sections 403(q)(5)(H)(ii)(I)(bb) and (II)(bb) of the FD&C Act require 
that covered establishments post the succinct statement on menus and 
menu boards prominently and in a clear and conspicuous manner. The 
comment's request would be inconsistent with the express requirements 
of sections 403(q)(5)(H)(ii)(I)(bb) and (II)(bb) of the FD&C Act. Later 
in this document, we discuss the requirements for placement of the 
succinct statement on small signs for self-service food and food on 
display that may meet the definition of a ``menu'' or ``menu board'' in 
section 403(q)(5)(H)(xi) of the FD&C Act, in that such signs are the 
primary writings of the establishment from which consumers make order 
selections (see the discussion of Sec.  101.11(b)(2)(iii)(B) in section 
XVII.G).
    (Comment 94) A few comments expressed concern about the space that 
the succinct statement would take on menus and the proposed requirement 
that the statement appear on every page, in light of other statements 
on menus (such as the advisory statements in our Food Code, footnotes 
regarding daily availability of various menu items, and footnotes 
referencing ``net weight before cooking''). The comments asserted that 
menus would become cluttered. One comment asserted that the message we 
want to convey would ``get lost in the noise at the bottom of each 
page.'' The comments agreed that the succinct statement should appear 
at the bottom of menus and menu boards, but asked us to clarify that it 
would appear only once on each menu or menu board and not on each page 
or panel. The comments recommended that for menus, the succinct 
statement must appear either on the first or last page. One comment 
suggested that the succinct statement need only appear on one panel of 
the main menu board that is visible at all times to consumers.
    One comment asserted that because space is finite, adding the 
required succinct statement to multiple pages of a menu would lead to 
removal of ``optional information,'' such as some menu offerings. This 
comment expressed concern that menu items, such as seafood dishes, will 
be dropped from menus to make room for this additional information to 
appear on each page of the menu. The comment noted that the 2010 
Dietary Guidelines have outlined the importance of including seafood in 
a healthy diet, and that roughly 67 percent of the seafood consumed in 
the United States is consumed away from the home.
    (Response 94) We disagree that the succinct statement needs to 
appear only once on menus. In particular, we are concerned that for 
large multi-paged menus, consumers may not read the entire menu and 
instead may turn to a specific section of the menu (e.g., the section 
for burgers and sandwiches). Unless the succinct statement is on the 
page for that particular section, it is possible that consumers could 
miss the succinct statement and therefore be unable to use the 
statement ``to understand, in the context of a daily diet, the 
significance of the caloric information that is provided on the menu,'' 
as specified by section 403(q)(5)(H)(I)(bb) of the FD&C Act. Therefore, 
in Sec.  101.11(b)(2)(i)(B)(2), we are requiring the succinct statement 
to appear on the bottom of each page of the menu.
    However, we agree that the succinct statement needs to appear only 
once on a menu board, including a menu board consisting of more than 
one panel in one physical location (a multi-paneled menu board). For 
the purpose of this rule, we consider such a multi-paneled menu board 
to be a single menu board, provided that the entire multi-paneled menu 
board is visible to consumers when consumers are placing order 
selections for the standard menu items listed on such menu board. A 
multi-paneled menu board is different from a menu with multiple pages 
because all panels are visible to consumers when they place an order, 
regardless of the specific panel containing the menu item the consumer 
selects. A succinct statement on a single panel of a multi-paneled 
board is likely to be clear and conspicuous to the consumer and posted 
prominently, provided that the type size, color, and background of the 
succinct statement meet the applicable requirements in Sec.  
101.11(b)(2)(i)(B)(1) and the entire multi-paneled menu board is 
visible to consumers when consumers are placing order selections for 
the standard menu items listed on such menu board.
    Regarding one comment's assertion that requiring the succinct 
statement to appear on each page of a menu could lead to the removal 
from a menu or menu board of information that a covered establishment 
views as optional, we note that a decision to remove ``optional 
information'' or to drop certain menu items from menus belongs to the 
covered establishment. The succinct statement is necessary on the 
bottom of each page of a menu that includes standard menu items and 
calorie information because the succinct statement is designed to 
enable consumers ``to understand, in the context of a total daily diet, 
the significance of the caloric information that is provided on the 
menu,'' as required by section 403(q)(5)(H)(I)(bb) of the FD&C Act. 
However, we have also considered the space on menus and therefore 
provided flexibility where appropriate. For example, in addressing 
comments on the statement of availability of written nutrition 
information, we concluded that this statement of availability need 
appear only once on a menu or menu board. In reaching that conclusion, 
we considered the goals of the succinct statement and the statement of 
availability, which are different (see the discussion of Sec.  
101.11(b)(2)(i)(C) in section XV.C).
    (Comment 95) A few comments maintained that the proposed order of 
the succinct statement (i.e., in relation to the statement of 
availability of additional written nutrition information) limits 
flexibility. The comments asserted that both statements could be just 
as clear and conspicuous if they were placed in some other way.
    (Response 95) We agree with the comments, and are providing 
flexibility for the placement of the succinct statement in relation to 
the statement of availability of the written nutrition information. 
Consequently, we have revised Sec.  101.11(b)(2)(i)(B)(2) and 
(b)(2)(i)(B)(3) to provide that on menu pages that also bear the 
statement of availability and on menu boards, the succinct statement 
must appear immediately above, below, or beside the statement of 
availability. In addition, as an editorial change for consistency 
throughout Sec.  101.11, we have revised the cross-references within 
Sec.  101.11(b)(2)(i)(B)(2) and (b)(2)(i)(B)(3) referring to the 
statement of availability to read ``the statement required by paragraph 
(b)(2)(i)(C) of this section'' (i.e., Sec.  101.11(b)(2)(i)(C)). With 
these changes, Sec.  101.11(b)(2)(i)(B)(2) requires that for menus, the 
succinct statement must appear on the bottom of each page of the menu. 
On menu pages that also bear the statement required by Sec.  
101.11(b)(2)(i)(C), the succinct statement must appear immediately 
above, below, or beside the statement required by Sec.  
101.11(b)(2)(i)(C). In addition, with these changes Sec.  
101.11(b)(2)(i)(B)(3) requires that for menu boards, the succinct 
statement must appear on the bottom of the menu board, immediately 
above, below, or

[[Page 71211]]

beside the statement required by Sec.  101.11(b)(2)(i)(C).

XV. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(i)(C)--
Statement That Must Be on Menus and Menu Boards About Availability of 
Written Nutrition Information

A. Proposed Wording of the Statement of Availability

    Proposed Sec.  101.11(b)(2)(i)(C) would require the following 
statement regarding the availability of the additional written 
nutrition information required in Sec.  101.11(b)(3)(i) on all forms of 
the menu or menu board: Additional nutrition information available upon 
request. In a correction document, we corrected the regulatory 
designation of the requirement for the statement of availability to be 
Sec.  101.11(b)(2)(ii) rather than Sec.  101.11(b)(3)(i) (76 FR 30050 
at 30051).
    One comment supported the wording of the statement of availability 
and no comments opposed the wording. We are finalizing the proposed 
wording of the statement of availability without change.

B. Requirements for the Statement of Availability To Be Prominent and 
Conspicuous

    Proposed Sec.  101.11(b)(2)(i)(C)(1) would require that the 
statement of availability be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest calorie 
declaration appearing on the same menu or menu board and in the same 
color or in a color at least as conspicuous as the caloric 
declarations, and with the same contrasting background as the caloric 
declarations.
    In the following paragraphs, we discuss comments on this proposed 
provision. After considering these comments, we are:
     Revising the proposed provision to provide additional 
flexibility for the contrasting background used for the statement of 
availability;
     Making a conforming editorial change to the requirement 
for the color used for the statement of availability for grammatical 
consistency; and
     Making an editorial correction for clarity to insert 
``type size of any'' between ``no smaller than the smallest'' and 
``calorie declaration.''
    (Comment 96) One comment recommended that the type size of the 
statement of availability ``be no smaller than the menu description or 
what any ordinary person can read without any trouble.'' Some comments 
recommended that we permit a smaller type size for the statement of 
availability. A few comments suggested that we require the statement of 
availability to be in a type size no smaller than the type size most 
frequently used throughout the menu. Some comments suggested that the 
statement of availability be in the same color or a color at least as 
conspicuous as the color most frequently used throughout the menu for 
the names of standard menu items and with the same contrasting 
background or a contrasting background at least as contrasting as the 
background most frequently used throughout the menu for the names of 
standard menu items.
    (Response 96) These comments on the proposed requirements for type 
size, color, and contrasting background of the statement of 
availability are analogous to certain comments on the proposed 
requirements for the succinct statement (see Comment 92), and our 
response to these comments is analogous to our response to Comment 92 
(see Response 92). Specifically, we disagree that a smaller type size 
should be used for the statement of availability for the reasons 
discussed in Response 92. We disagree that the type size, color, and 
contrasting background of the statement of availability should be tied 
to the type size, color, and contrasting background most frequently 
used throughout the menu for the names of standard menu items for the 
reasons discussed in Response 92. However, we agree that we should 
provide additional flexibility for the contrasting background of the 
statement of availability by permitting the statement to be in a 
background at least as contrasting as that used for the calorie 
declarations. Consequently, we have revised Sec.  101.11(b)(2)(i)(C)(1) 
to do so. In addition, we are making a conforming editorial change to 
the grammatical construction of the requirement used for the color of 
the statement of availability to match the grammatical construction of 
the revised requirement for the contrasting background used for the 
statement of availability. We also are making an editorial correction 
for clarity to insert ``type size of any'' between ``no smaller than 
the smallest'' and ``calorie declaration.'' With these changes, Sec.  
101.11(b)(2)(i)(C)(1) requires that the statement of availability be 
posted prominently and in a clear and conspicuous manner in a type size 
no smaller than the smallest type size of any calorie declaration 
appearing on the same menu or menu board and in the same color or in a 
color at least as conspicuous as that used for the caloric 
declarations, and with the same contrasting background or a background 
at least as contrasting as that used for the caloric declarations. 
(Emphasis added.) We conclude that the type size, color, and 
contrasting background requirements for the statement of availability 
in Sec.  101.11(b)(2)(i)(C)(1) will help ensure that the statement of 
availability is prominent, clear, and conspicuous, as required by 
sections 403(q)(5)(H)(ii)(IV) and 403(f) of the FD&C Act.

C. Placement of the Statement of Availability

    For menus, proposed Sec.  101.11(b)(2)(i)(C)(2) would require that 
the statement of availability appear on the bottom of the first page 
with menu items. For menus with more than two pages, it would also 
require that the statement of availability appear either at the bottom 
of every page with menu items (proposed Sec.  
101.11(b)(2)(i)(C)(2)(i)), or at the bottom of only the first page with 
menu items, as long as a symbol (e.g., asterisk) clearly referring to 
the required statement appearing on the first page of the menu follows 
the term `Calories' or `Cal,' where the term first appears on each page 
after the page with the statement (proposed Sec.  
101.11(b)(2)(i)(C)(2)(ii)). For menu boards, proposed Sec.  
101.11(b)(2)(i)(C)(3) would require that the statement of availability 
appear on the bottom of the menu board immediately above or below the 
succinct statement. In the following paragraphs, we discuss comments on 
these proposed provisions. After considering these comments, we are:
     Revising proposed Sec.  101.11(b)(2)(i)(C)(2) to require 
that the statement of availability appear on the first page of a menu 
with menu items and to delete the proposed provisions that would have 
required the statement of availability, or a symbol referring to the 
statement of availability, on subsequent menu pages;
     Revising both proposed Sec.  101.11(b)(2)(i)(C)(2) and 
(b)(2)(i)(C)(3) to provide that the statement of availability must 
appear immediately above, below, or beside the succinct statement; and
     Making additional editorial changes for consistency.
    (Comment 97) Some comments supported the proposed requirements for 
placement of the statement of availability. A few comments disagreed 
with our proposal that a symbol (e.g., asterisk) can be used to refer 
to the statement of availability on the first page, if the statement 
does not appear on every page. These comments considered that requiring 
the placement

[[Page 71212]]

of asterisks on each subsequent page in reference to a disclosure on 
the first page with menu items would only confuse a reader who, upon 
seeing an asterisk, has been trained since elementary school to look 
for the associated footnote at the bottom of the page on which the 
asterisk appears.
    A few comments expressed concern about the space that the statement 
of availability would take in light of other statements on menus (such 
as consumer advisories), and recommended that the statement of 
availability appear only once on the menu, either on the first or last 
page. The comments agreed that the statement of availability should 
appear at the bottom of menus and menu boards, but recommended that we 
require that the statement appear only once on menus and menu boards, 
and not on each page or panel. One comment recommended that covered 
establishments be able to put the statement of availability on a 
separate sign near the menu boards.
    (Response 97) We are not revising the rule to allow a covered 
establishment to post the statement of availability on a separate sign 
near a menu board as suggested by the comment. This comment is 
analogous to a comment on the proposed requirements for the placement 
of the succinct statement (see Comment 93), and our response to this 
comment is analogous to our response to Comment 93 (see Response 93). 
Section 403(q)(5)(H)(ii)(IV) of the FD&C Act requires that covered 
establishments post a prominent, clear, and conspicuous statement of 
availability on menus and menu boards. The comment's request is 
inconsistent with the express statutory direction. Later in this 
document, we discuss the requirements for placement of the statement of 
availability on small signs for self-service food and food on display 
that may meet the definition of a ``menu'' or ``menu board'' in section 
403(q)(5)(H)(xi) of the FD&C Act, in that such signs are the primary 
writings of the establishment from which consumers make order 
selections (see the discussion of Sec.  101.11(b)(2)(iii)(B) in section 
XVII.G).
    We agree that an asterisk referring to a statement on the first 
page of a menu may confuse consumers. We also agree that the statement 
of availability only needs to appear on one page of a menu. Unlike the 
succinct statement, which is designed to enable the public to 
understand the significance of the caloric information in the context 
of a total daily diet and is therefore needed on each page of a menu 
that includes standard menu items and calorie information, the 
statement of availability informs consumers that there is additional 
written nutrition information available on the premises of the covered 
establishment upon request. We believe that posting the statement of 
availability on one page of a menu will be adequate to achieve that 
goal. Consequently, we have revised Sec.  101.11(b)(2)(i)(C)(2) to 
require that the statement of availability appear on the first page of 
a menu with menu items and to delete the proposed provisions that would 
have required the statement of availability, or an asterisk referring 
to the statement of availability, on subsequent menu pages.
    (Comment 98) A few comments maintained that the proposed order of 
the statement of availability in relation to the succinct statement 
limits flexibility. The comments contended that both statements would 
be just as clear and conspicuous if they were to appear in some other 
position such as side by side or in some other place on the page.
    (Response 98) For menu boards, we note that there was an 
inconsistency in the proposed rule between the preamble and the 
codified regarding the proposed order of the statement of availability 
in relation to the succinct statement. According to the preamble, the 
statement of availability would have been required to appear 
immediately below the succinct statement (76 FR 19192 at 19211), while 
in the codified text, proposed Sec.  101.11(b)(2)(i)(C)(3) would 
require that the statement of availability appear on the bottom of the 
menu board immediately above or below the succinct statement. For both 
menus and menu boards, we agree with the comments and are providing 
additional flexibility for the placement of the statement of 
availability of the written nutrition information in relation to the 
succinct statement. We have revised proposed Sec.  
101.11(b)(2)(i)(C)(2) and (b)(2)(i)(C)(3) to provide that for menus and 
menu boards, the statement of availability must appear immediately 
above, below, or beside the succinct statement. For clarity and 
consistency, we are specifying the placement of the statement of 
availability in Sec.  101.11(b)(2)(i)(C)(2) in relation to the succinct 
statement even though proposed Sec.  101.11(b)(2)(i)(C)(2) did not do 
so.

XVI. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(ii)--
Nutrition Information That Must Be Made Available in Written Form

A. Required Nutrients

    Proposed Sec.  101.11(b)(2)(ii) would require, in relevant part, 
that:
     Certain nutrition information for a standard menu item be 
available in written form on the premises of the restaurant or similar 
retail food establishment and provided to the customer upon request;
     The nutrition information be presented in the order listed 
and using the measurements listed, except as provided in Sec.  
101.11(b)(2)(ii)(B);
     Rounding of these nutrients be in compliance with Sec.  
101.9(c); and
     Covered establishments include the following nutrition 
information in the written form, as specified in Sec.  
101.11(b)(2)(ii)(A)(1) through (b)(2)(ii)(A)(11):
    1. Total number of calories derived from any source (cal)
    2. Total number of calories derived from the total fat (fat cal)
    3. Total fat (g)
    4. Saturated fat (g)
    5. Trans fat (g)
    6. Cholesterol (mg)
    7. Sodium (mg)
    8. Total carbohydrate (g)
    9. Dietary fiber (g)
    10. Sugars (g)
    11. Protein (g)
    In the following paragraphs, we discuss comments on this proposed 
provision. After considering these comments, we have revised the 
provision to:
     Replace the terms ``total number of calories derived from 
any source'' and ``total number of calories derived from the total 
fat'' with the terms ``total calories'' and ``calories from fat'';
     Provide that covered establishments may use the 
abbreviations allowed for Nutrition Facts for certain packaged foods in 
Sec.  101.9(j)(13)(ii)(B); and
     Clarify that the information must be provided on the 
premises of the ``covered establishment'' rather than the ``restaurant 
or similar retail food establishment'' (see the discussion in section 
VI.I).
    (Comment 99) One comment suggested that we come up with a standard 
list of abbreviations for the nutrients for consistency and consumer 
understanding. This comment pointed out that we proposed ``Cal'' as an 
abbreviation for calories but did not suggest abbreviations for the 
other nutrients.
    (Response 99) We agree with this comment. Providing abbreviations 
for the written nutrition information will improve the consistency of 
the written nutrition information provided by different covered 
establishments. Therefore, we have revised Sec.  101.11(b)(2)(ii) to 
provide that covered establishments may use the abbreviations allowed 
for Nutrition

[[Page 71213]]

Facts for certain packaged foods in Sec.  101.9(j)(13)(ii)(B) for the 
nutrient information required to be disclosed in the written nutrition 
information under section 403(q)(5)(H)(ii)(III) of the FD&C Act. For 
example, a covered establishment may use ``sat fat'' for saturated fat 
and ``cholest'' for cholesterol.
    (Comment 100) One comment suggested that ``total number of calories 
derived from any source'' (required under section 403(q)(1)(C) of the 
FD&C Act) be changed to ``total number of calories,'' which, according 
to the comment, is clear and concise.
    (Response 100) We agree with the comment's suggestion that the term 
``total number of calories derived from any source'' can be revised to 
be more concise. Specifically, we are replacing the term ``total number 
of calories derived from any source'' (which had been specified by 
section 403(q)(1)(C) of the FD&C Act) with ``total calories.'' This 
change is consistent with how the ``total number of calories derived 
from any source'' is disclosed in the Nutrition Facts under Sec.  
101.9. For consistency, we are making an analogous revision to replace 
the term ``total number of calories derived from the total fat'' with 
``calories from fat.'' This change is consistent with section 
403(q)(1)(C) of the FD&C Act, and the declaration of ``total calories'' 
and ``calories from fat'' will be consistent with the terms used for 
nutrition labeling for packaged food (see Sec.  101.9(c)).
    (Comment 101) Several comments supported the proposed nutrients 
that must be listed in the written nutrition information. Some comments 
suggested that the written nutrition information also include the 
weight in grams of the standard menu item. These comments considered 
that the weight of the standard menu item is an important indicator of 
portion size and allows consumers to compare similar products more 
easily, and that including the weight of the standard menu item would 
be consistent with the Nutrition Facts for packaged foods.
    (Response 101) We disagree that we should require that the written 
nutrition information include the weight in grams for each standard 
menu item. Section 403(q)(5)(H)(ii)(III) of the FD&C Act specifically 
requires covered establishments to provide in a written form, available 
on the premises of the covered establishment and to the consumer upon 
request, the nutrition information required under clauses (C) and (D) 
of section 403(q)(1) of the FD&C Act. We are only requiring that 
covered establishments provide in the written nutrition information the 
nutrition information specified in section 403(q)(5)(H)(ii)(III) of the 
FD&C Act, along with trans fat, for standard menu items as usually 
prepared and offered for sale, or in the case of standard menu items 
that are self-service food or food on display, by displayed food item 
or per serving. Although the weight of a standard menu item may give 
some indication of portion sizes, it does not necessarily correlate 
with how many calories are contained in a food or with what nutrients 
are in a food. For example, some foods may weigh less than other 
similar foods but have more calories because of the source of the 
calories. At this time, we conclude that the written nutrition 
information required by Sec.  101.11(b)(2)(ii)(A) will allow consumers 
to make comparisons between menu items and help inform their dietary 
choices. A covered establishment may voluntarily provide the weight of 
the standard menu item in the written nutrition information. We also 
note that for some foods, the weight is already provided as part of the 
name or description of the standard menu item on the menu or menu 
board, e.g., a 10-ounce steak versus a 12-ounce steak.
    (Comment 102) One comment recommended that the written nutrition 
information include calcium, potassium, and phosphorus because patients 
with kidney disease may have diabetes, hypertension, or both. The 
comment suggested that covered establishments give information on the 
need to limit these nutrients and to limit sodium.
    (Response 102) We disagree with these comments. Section 
403(q)(5)(H)(ii)(III) of the FD&C Act requires in relevant part that 
covered establishments provide, in written form, the nutrition 
information required under clauses (C) and (D) of section 403(q)(1) of 
the FD&C Act. Sections 403(q)(1)(C) and (D) of the FD&C Act do not 
require the disclosure of calcium, potassium, and phosphorus in food 
labeling. Section 403(q)(5)(H)(vi) of the FD&C Act provides that ``[i]f 
the Secretary determines that a nutrient, other than a nutrient 
required under [section 403(q)(5)(H)(ii)(III) of the FD&C Act], should 
be disclosed for the purpose of providing information to assist 
consumers in maintaining healthy dietary practices, the Secretary may 
require, by regulation, disclosure of such nutrient in the written form 
required under [section 403(q)(5)(H)(ii)(III) of the FD&C Act].'' 
However, the comment did not provide any supporting information showing 
that the disclosure of calcium, potassium, and phosphorus in the 
written nutrition information will assist consumers in maintaining 
healthy dietary practices. At this time, we conclude that the nutrition 
information specified in section 403(q)(5)(H)(ii)(III) of the FD&C Act, 
along with trans fat information, is sufficient to assist consumers in 
maintaining healthy dietary practices within the context of section 
403(q)(5)(H) of the FD&C Act. If we determine that other nutrient 
information should be disclosed in the written form required under 
section 403(q)(5)(H)(ii)(III) of the FD&C Act, we will make changes to 
such requirements as appropriate. We note that consumers who have a 
particular disease or health-related condition may be able to use the 
written nutrition information to follow advice they have received from 
a health care professional concerning dietary practices relevant to 
their conditions.
    (Comment 103) One comment asked us to permit voluntary declaration 
of micronutrients such as vitamins and minerals.
    (Response 103) We would not object to the voluntary declaration of 
vitamins and minerals that may be declared on the Nutrition Facts Label 
of a packaged food (see Sec.  101.9(c)(8)(ii)), provided that the 
declaration is truthful and not misleading, as required by section 
403(a)(1) of the FD&C Act.
    (Comment 104) One comment recommended that if future changes are 
made to the Nutrition Facts of packaged foods, then the requirements 
for the written nutrition information should be made consistent with 
such changes.
    (Response 104) If future changes are made to the requirements 
regarding the Nutrition Facts for packaged foods, we will consider 
whether changes should also be made to the requirements regarding the 
written nutrition information required by this rule.
    (Comment 105) One comment recommended that the nutrient values in 
the written nutrition information be reviewed and updated yearly or 
when changes are made.
    (Response 105) We agree, in part, and disagree, in part, with this 
comment. Under Sec.  101.11(c), a covered establishment must have a 
reasonable basis for its nutrient content declarations. Under section 
403(a)(1) of the FD&C Act, covered establishments must also ensure that 
their nutrient content declarations are truthful and not misleading. To 
do so, a covered establishment would need to update the written 
nutrition information when certain changes are made, e.g., as a result 
of a recipe change that affects the nutrient content of a standard menu 
item. However, we see no reason why nutrition information for a 
standard

[[Page 71214]]

menu item must be updated on a recurring basis (such as yearly) when 
there are no changes to the standard menu item or its method of 
preparation.
    (Comment 106) One comment recommended that covered establishments 
provide references for their nutrient values to consumers on request.
    (Response 106) We are not requiring a covered establishment to 
provide supporting references for the nutrient values in its written 
nutrition information to consumers upon request. Section 403(q)(5)(H) 
of the FD&C Act generally requires covered establishments to provide 
calorie and other nutrition information for standard menu items. 
Further, as required by section 403(q)(5)(H)(iv) of the FD&C Act, a 
covered establishment must have a reasonable basis for its nutrient 
content disclosures. Covered establishments must also ensure that their 
nutrient content disclosures are truthful and not misleading in 
accordance with section 403(a)(1) of the FD&C Act. Section 403(q)(5)(H) 
of the FD&C Act does not require that covered establishments provide 
supporting references for their nutrient content disclosures to 
consumers. However, we would not object if a covered establishment 
provides this information voluntarily.
    (Comment 107) Several comments generally agreed that trans fat must 
be included with the written nutrition information. Some comments 
expressed the view that providing information about trans fat is 
warranted because of concern with partially hydrogenated vegetable 
oils.
    Comments that opposed including trans fat in the written nutrition 
information generally focused on the distinction between ``industrial 
trans fat'' (i.e., trans fat chemically manufactured from vegetable 
oils) and trans fat naturally occurring in food such as ruminant 
animals. Some comments expressed concern that listing such naturally 
occurring trans fat in the written nutrition information, particularly 
when it is present in small amounts, could lead to problems in States 
and localities that have banned the use of trans fat in restaurants, or 
could lead consumers to think that a covered establishment is breaking 
State or local law. These comments stated that eliminating the 
requirement to list trans fat in the written nutrition information, or 
limiting the listing for trans fat to industrial trans fat, would 
prevent such problems. Other comments expressed the view that the 
health effects of naturally occurring trans fat from ruminants may be 
different from the health effects of trans fat chemically manufactured 
from vegetable oils. Some comments stated that, in Europe, scientists 
and regulators have not singled out ruminant trans fat for pejorative 
labeling. Some comments stated that naturally occurring trans fats 
derived from high fat ruminant animal products (namely, beef and dairy 
products) are converted to conjugated linoleic acid, which the comments 
reported have been associated with health benefits. These comments 
considered that industrial and naturally occurring trans fat should 
therefore be distinguished on food nutrition labels and menus to give 
consumers a more accurate assessment of nutritional quality.
    (Response 107) We disagree that we should require the declaration 
of only ``industrial trans fat'' in the written nutrition information. 
For purposes of the current Nutrition Facts label, our regulatory 
definitions of nutrients (such as for trans fat, total fat, or 
saturated fat) have traditionally been based on chemical definitions. 
For example, under Sec.  101.9(c)(2)(ii), the declaration of nutrition 
information on the label and in labeling of a food must contain a 
statement of the number of grams of trans fat in a serving, defined as 
the sum of all unsaturated fatty acids that contain one or more 
isolated (i.e., nonconjugated) double bonds in a trans configuration. 
Analytically, this definition captures all trans fatty acid isomers 
that have isolated bonds, regardless of the origin of the trans fatty 
acid. For example, vaccenic acid (one of the most abundant trans fatty 
acids in ruminant fat) is included in the chemical definition of trans 
fat. Therefore, listing the sum of all unsaturated fatty acids that 
contain one or more isolated double bonds in a trans configuration 
regardless of the source of such trans fat is consistent with the 
requirements for declaring the amount of trans fat in a packaged food 
on the label for such food (see Sec.  101.9(c)(2)(ii)). Further, in the 
rulemaking to require the declaration of trans fat, we responded to 
comments regarding functional or metabolic aspects of trans fatty acids 
(e.g., their metabolic transformations to other types of fatty acids) 
rather than on their actual chemical structures, including potential 
differences between trans fat from industrial sources and trans fat 
from ruminant sources. We concluded that we should define trans fat 
based on its chemical definition rather than any functional attributes 
(68 FR 41434 at 41461, July 11, 2003). The comments provided 
insufficient information to overturn the conclusion we previously 
reached about declaring trans fat on the label of packaged food.
    We also decline to require the declaration of ``industrial trans 
fat'' in the written nutrition information because declaration of 
ruminant trans fat may lead inspectors or consumers to believe that 
covered establishments are violating State or local requirements in 
jurisdictions that ban artificial trans fat. We recognize that, in the 
United States, some jurisdictions, such as the State of California 
(Ref. 34), New York City (Ref. 35), the City of Baltimore (Ref. 36), 
and Montgomery County, Maryland (Ref. 37) have imposed restrictions on 
the use of industrial trans fat ingredients in food service 
establishments. However, a trans fat declaration of 0.5 grams or more 
for a standard menu item in the written nutrition information of a 
covered establishment does not necessarily mean that the covered 
establishment is violating a State or local requirement that prohibits 
industrial trans fat ingredients. So long as such standard menu item 
does not contain the restricted trans fat ingredients and is otherwise 
in compliance with the applicable State or local trans fat requirement, 
a trans fat declaration of 0.5 grams or more for such standard menu 
item could mean that the menu item contains a certain amount of 
naturally occurring trans fat. States and localities would be able to 
continue to enforce requirements restricting artificial trans fat 
ingredients relying on the same measures they already use to determine 
if establishments under their jurisdiction are using a prohibited 
ingredient.
    We also note that we recently published a tentative determination 
that partially hydrogenated oils, the source of industrially produced 
trans fat, are not generally recognized as safe for any use in food 
based on current scientific evidence establishing the health risks 
associated with the consumption of trans fat (78 FR 67169, November 8, 
2013). If this determination is finalized, we will consider whether the 
trans fat requirements of this rule should be amended.

B. Manner of Presentation of the Written Nutrition Information

    Proposed Sec.  101.11(b)(2)(ii) would require, in relevant part, 
that the written nutrition information be presented in a clear and 
conspicuous manner. We received several comments on this proposed 
provision. After considering these comments, we have revised the 
provision to specify that the written nutrition information must be 
``clear and conspicuous,'' including in a color, type size, and in a 
contrasting

[[Page 71215]]

background that render the information likely to be read and understood 
by the ordinary individual under customary conditions of purchase and 
use.
    (Comment 108) One comment supported the proposed requirements that 
the written nutrition information be clear and conspicuous. Some 
comments asked us to give more guidance on format and on the standard 
for the written nutrition information to be presented in a clear and 
conspicuous manner--e.g., that it be easy to read, have a large enough 
font, have a contrasting background, and not use all capital letters 
for the names of standard menu items. One comment recommended that we 
include specifications for font size.
    (Response 108) We disagree that we should specify the particular 
type size and contrasting background that must be used in the written 
nutrition information, and prohibit the use of all capital letters for 
the names of standard menu items in the written nutrition information. 
Section 403(q)(5)(H)(ii) of the FD&C Act requires covered 
establishments to provide the written nutrition information required by 
section 403(q)(5)(H)(ii)(III) of the FD&C Act in a clear and 
conspicuous manner. As discussed later in this document (see the 
discussion of Sec.  101.11(b)(2)(ii)(D) in section XVI.E), we are 
providing covered establishments with the flexibility to use different 
types of media (e.g., flyers, posters, booklets, kiosks) to provide the 
written nutrition information. Whether the written nutrition 
information is clear and conspicuous depends on the media through which 
a covered establishment chooses to provide the written nutrition 
information. For example, a specific type size and contrasting 
background may result in written nutrition information that is clear 
and conspicuous on a tray liner or brochure, but not on a poster that a 
consumer may view from several feet away. Thus, we are not establishing 
specific requirements for type size, contrasting background, or use of 
capital letters for the written nutrition information so that covered 
establishments have the flexibility to provide the written nutrition 
information in a clear and conspicuous manner based on the particular 
media through which the information is presented.
    However, we agree that some guidance is needed on the requirement 
that the written nutrition information be provided in a clear and 
conspicuous manner. Section 403(f) of the FD&C Act provides that a food 
will be deemed to be misbranded ``[i]f any word, statement, or other 
information required by or under authority of this Act to appear on the 
label or labeling is not prominently placed thereon with such 
conspicuousness (as compared with other words, statements, designs, or 
devices, in the labeling) and in such terms as to render it likely to 
be read and understood by the ordinary individual under customary 
conditions of purchase and use.'' Accordingly, we conclude that in 
order for the written nutrition information to be clear and 
conspicuous, the information must be presented in a manner that renders 
it likely to be read and understood by the ordinary individual under 
customary conditions of purchase and use. Specifically, we have revised 
Sec.  101.11(b)(2)(ii) to require that the written nutrition 
information be presented in a clear and conspicuous manner, including 
using a color, type size, and contrasting background that render the 
information likely to be read and understood by the ordinary individual 
under customary conditions of purchase and use. We are also revising 
Sec.  101.11(f) to state that a standard menu item offered for sale in 
a covered establishment shall be deemed misbranded under sections 
201(n), 403(a), 403(f), and/or 403(q) of the FD&C Act if its label or 
labeling is not in conformity with paragraph (b) or (c) of the section.
    (Comment 109) One comment asked us to require that standard menu 
items in the written nutrition information be listed in the same order 
as they are on menus and menu boards.
    (Response 109) We disagree that we should require covered 
establishments to list standard menu items in the written nutrition 
information in the same order as on menus and menu boards. The comment 
provided no basis for why this particular order of listing standard 
menu items is the only order that would be useful to consumers. We are 
providing flexibility for a covered establishment to list its standard 
menu items in the written nutrition information in a manner that is 
best suited to its menu offerings, and conclude that the written 
nutrition information can enable consumers to make informed dietary 
choices regardless of the order in which the standard menu items are 
listed.
    (Comment 110) One comment responded to our request for comment on 
whether to require that nutrients that are particularly important for 
consumers with obesity and diabetes to monitor in order to maintain 
healthy dietary practices (e.g., total calories, total fat, sodium, 
sugar) be bolded or placed in a separate table of nutritional content 
(76 FR 19192 at 19214-19215). This comment opposed such measures 
because doing so would highlight the negative aspects of food even 
though the food also has positive nutrients. Another comment supported 
the bolding of nutrients of concern to consumers with obesity and 
diabetes, such as saturated fat and sodium.
    (Response 110) We disagree that we should decide whether to require 
measures for highlighting nutrient declarations important to maintain 
healthy dietary practices for consumers with obesity and diabetes based 
on a concern that doing so would highlight the ``negative'' aspects of 
a menu item even though the menu item also has ``positive'' aspects. 
However, we did not receive sufficient information in the comments to 
warrant adding a requirement to emphasize certain nutrients, and we are 
not requiring such a requirement in this rule. The requirements for the 
written nutrition information in Sec.  101.11(b)(2)(ii) make nutrition 
information available to consumers in a direct and accessible manner to 
enable consumers to make informed and healthful dietary choices.

C. Nutrients in Insignificant Amounts

    Proposed Sec.  101.11(b)(2)(ii)(B) would provide that if a standard 
menu item contains insignificant amounts of all the nutrients required 
to be disclosed in Sec.  101.11(b)(2)(ii)(A), the establishment is not 
required to include nutrition information regarding the standard menu 
item in the written form. Proposed Sec.  101.11(b)(2)(ii)(B) would 
explain, however, that if the covered establishment makes a nutrient 
content claim or health claim, the establishment is required to provide 
nutrition information on the nutrient that is the subject of the claim 
in accordance with Sec.  101.10. Proposed Sec.  101.11(b)(2)(ii)(B) 
would provide that covered establishments may present the written 
nutrition information in a simplified format for standard menu items 
that contain insignificant amounts of six or more of the required 
nutrients and proposed Sec.  101.11(b)(2)(ii)(B)(1) would define what 
is an insignificant amount.
    We note that there is an inconsistency regarding the nutrients that 
must be included in the simplified format between the preamble 
discussion and the regulatory text in proposed Sec.  
101.11(b)(2)(ii)(B)(2). In the preamble discussion, we stated: ``In 
addition, we are proposing that the simplified format must include 
information on the nutrients required in Sec.  101.9(f)(2)(i) and (ii) 
(i.e., total calories, total fat, total carbohydrate, protein, and 
sodium).'' (76 FR 19192 at 19213). However, proposed Sec.  
101.11(b)(2)(ii)(B)(2)

[[Page 71216]]

specified that the simplified format must include information on total 
carbohydrates, total fat, protein, and sodium, calories from fat, and 
any other nutrients identified in Sec.  101.11(b)(2)(ii)(A) that are 
present in more than insignificant amounts. Proposed Sec.  
101.11(b)(2)(ii)(B)(2) did not specify that the simplified format must 
include information on total calories, as we intended. In addition, 
proposed Sec.  101.11(b)(2)(ii)(B)(2) did not make it clear that the 
simplified format must include calories from fat only if calories from 
fat are present in more than insignificant amounts, as would be 
consistent with Sec.  101.9(f)(2)(ii). We have revised and 
redesignating Sec.  101.11(b)(2)(ii)(B)(2) so that it contains three 
separate subparagraphs that more clearly communicate the requirements. 
As revised, Sec.  101.11(b)(2)(ii)(B)(2) requires that the simplified 
format must include information, in a column, list, or table, on the 
nutrients specified in Sec.  101.11(b)(2)(ii)(B)(2)(i) and (ii). 
Section 101.11(b)(2)(ii)(B)(2)(i) specifies that the simplified format 
must include information on total calories, total fat, total 
carbohydrates, protein, and sodium. Section 101.11(b)(2)(ii)(B)(2)(ii) 
specifies that the simplified format must include calories from fat and 
any other nutrients identified in Sec.  101.11(b)(2)(ii)(A) that are 
present in more than insignificant amounts. Section 
101.11(b)(2)(ii)(B)(3) specifies that if the simplified format is used, 
the statement ``Not a significant source of ____--'' (with the blank 
filled in with the names of the nutrients required to be declared in 
the written nutrient information and calories from fat that are present 
in insignificant amounts) must be included at the bottom of the list of 
nutrients.
    In the following paragraphs, we discuss comments on proposed Sec.  
101.11(b)(2)(ii)(B)(2). We are finalizing it without change other than 
to revise Sec.  101.11(b)(2)(ii)(B)(2) to correct the discrepancy 
between the description of the proposed requirement in the preamble and 
the regulatory text and to clarify the requirements.
    (Comment 111) One comment recommended that the simplified format we 
proposed in Sec.  101.11(b)(2)(ii)(B)(2), when a standard menu item 
contains insignificant amounts of more than one-half of the nutrients 
required to be declared in the written nutrition information, include 
information on fiber. The comment contended that fiber is an important 
element in considering the overall nutritional value of a certain food, 
both in addressing obesity and diabetes. The comment stated that only 
knowing information on the total carbohydrates without information on 
the fiber will not allow consumers to make sufficiently healthy choices 
or will undermine their intent to do so.
    (Response 111) If a standard menu item has an insignificant amount 
of six or more of the required nutrients, the simplified format must 
include information on total calories, total fat, total carbohydrates, 
protein, and sodium (Sec.  101.11(b)(2)(ii)(B)(2)(i)) as well as 
information on calories from fat and any other nutrient that is present 
in the food in more than insignificant amounts (Sec.  
101.11(b)(2)(ii)(B)(2)(ii)). Thus, if fiber is present in a standard 
menu item at a level that is more than insignificant (i.e., one gram or 
more), the amount of fiber must appear in the simplified format. On the 
other hand, if an insignificant amount of fiber is present in a 
standard menu item, the simplified format must disclose this 
information through the statement, ``Not a significant source of ____--
'' (with the blank filled in with ``fiber'' since fiber is required to 
be declared in the written nutrition information) (Sec.  
101.11(b)(2)(ii)(B)(3)). Therefore, the simplified format for the 
written nutrition information already must include information on 
fiber, and there is no need to revise proposed Sec.  
101.11(b)(2)(ii)(B) to include fiber as recommended by the comment.

D. Variable Menu Items

    Proposed Sec.  101.11(b)(2)(ii)(C) would require that, for variable 
menu items, the nutrition information listed in Sec.  
101.11(b)(2)(ii)(A) must be declared as follows for each size offered 
for sale:
    (1) The nutrition information required in Sec.  101.11(b)(2)(ii)(A) 
must be declared for the basic preparation of the item and, separately, 
for each topping, flavor, or variable component.
    (2) If the calories and other nutrients are the same for different 
flavors, varieties, and substitutable components of the combination 
meal, each variety, flavor, and substitutable component of the 
combination meal is not required to be listed separately. All items 
that have the same nutrient levels could be listed together with the 
nutrient levels listed only once.
    In the proposed rule, we considered the following options for 
providing the nutrition information in the written form for a variable 
menu item:
     Option 1. List the nutrition information for each nutrient 
in the variable menu item as a range.
     Option 2. List the nutrition information for each 
component in the variable menu item (the proposed requirement).
     Option 3. If a standard menu item only has two variations 
(e.g. a sandwich with fruit or with fries), provide both numbers for 
each nutrient in each option with a forward slash between (e.g., 450/
700). If three or more options are available, provide the range in 
calories.
    In the proposed rule, we stated that option 2 provides the consumer 
with all the required nutrient information for each flavor or variety 
of a variable item, or each component of a combination meal in a format 
that facilitates quick comparisons between different menu items (76 FR 
19192 at 19213). In the following paragraphs, we discuss comments on 
this proposed provision. We are making no changes in response to these 
comments.
    However, similar to the specific format requirements we established 
for declaring calories on a menu or menu board for toppings listed on a 
menu or menu board, where the amount of the topping on the menu item 
decreases based on the total number of toppings ordered, we are 
establishing in Sec.  101.11(b)(2)(ii)(C)(2) specific format 
requirements for providing the written nutrition information for 
toppings if the amount of the topping included on the basic preparation 
of the menu item decreases based on the total number of toppings 
ordered for the menu item (such as is sometimes the case with pizza 
toppings). Section 101.11(b)(2)(ii)(C)(2) of the final rule specifies 
that if the amount of the topping included on the basic preparation of 
the menu item decreases based on the total number of toppings ordered 
for the menu item, the nutrients for each topping must be declared as 
single values representing the nutrients for each topping when added to 
a one-topping menu item, specifying that the nutrient declaration is 
for the topping when added to a one-topping menu item. The nutrients 
for each topping must also be declared for each size of the menu item 
offered for sale, as required by Sec.  101.11(b)(2)(ii)(C). We are 
establishing requirements for providing the written nutrition 
information for variable menu items offered for sale with the option of 
adding toppings, and specifying the format and manner of such nutrient 
content disclosures, as required by sections 403(q)(5)(H)(v) and 
(x)(II)(bb) of the FD&C Act. Section 101.11(b)(2)(ii)(C)(2) helps 
ensure that consumers are given accurate and consistent information 
about the nutrient of each topping on a menu item. We would not object 
if a covered establishment voluntarily includes a statement on the 
written nutrition information explaining how the nutrients per topping 
might fluctuate if ordering multiple toppings; for example,

[[Page 71217]]

such a statement regarding a pizza pie might say, ``Nutrient values per 
topping may decrease as the number of toppings per pizza increases.'' 
Section 101.11(b)(2)(ii)(C)(2) is therefore consistent with the 
requirements for declaring calories for toppings listed on the menu or 
menu board, where the amount of the topping on the menu item decreases 
based on the total number of toppings ordered.
    Because we added this requirement in Sec.  101.11(b)(2)(ii)(C)(2) 
to address the potential variation in nutrient content for each topping 
based on the total number of toppings ordered, proposed Sec.  
101.11(b)(2)(ii)(C)(2), which allows items that have the same nutrient 
values to be listed together with the nutrient values listed only once, 
is renumbered for the final rule as Sec.  101.11(b)(2)(ii)(C)(3). We 
are replacing the phrase ``substitutable component'' in two places in 
the first sentence of Sec.  101.11(b)(2)(ii)(C)(3) with ``variable 
component.'' We are making this change for consistency with the term 
used in Sec.  101.11(b)(2)(ii)(C)(1). We also are replacing the phrase 
``nutrient levels'' in two places in the final sentence of Sec.  
101.11(b)(2)(ii)(C)(3) with ``nutrient values.'' We are making this 
change for consistency with Sec.  101.11(c), which we have revised to 
consistently use the term ``values'' in the requirements for 
determination of nutrient content.
    (Comment 112) A few comments supported option 2. Some comments 
opposed the use of slashes for different flavors and considered that 
slashes would be confusing and unclear because consumers are not used 
to nutrition information in restaurants.
    (Response 112) We are retaining Option 2 in the rule for providing 
the written nutrition information for variable menu items generally. 
Option 2 does not specify the use of the slashes opposed by some 
comments.

E. Form of the Written Nutrition Information

    Proposed Sec.  101.11(b)(2)(ii)(D) would permit the written 
nutrition information required in Sec.  101.11(b)(2)(ii)(A) to be 
provided on a counter card, sign, poster, handout, booklet, loose leaf 
binder, or electronic device such as a computer, or in a menu, or in 
any other form that similarly permits the written declaration of the 
required nutrient content information for all standard menu items. 
Proposed Sec.  101.11(b)(2)(ii)(D) would explain that if the written 
information is not in a form that can be given to the customer upon 
request, it must be readily available in a manner and location on the 
premises that allows the customer/consumer to review the written 
nutrition information upon request.
    In the proposed rule, we discussed the flexibility provided by 
proposed Sec.  101.11(b)(2)(ii)(D) for the written nutrition 
information and requested comment on whether we should be more 
prescriptive in the format and manner of providing the written 
nutrition information in order to ensure they are useful to consumers 
(76 FR 19192 at 19214). We also stated that we would not object to the 
use of tray liners or wrappers as a means to provide nutrition 
information, as long as the tray liners or wrappers are available upon 
request to the consumers, and the tray liner or wrapper contains 
nutrition information for all standard menu items offered for sale at 
the covered establishment (76 FR 19192 at 19214).
    In the following paragraphs, we discuss comments on this proposed 
provision. We are finalizing it without change, except for an editorial 
change from ``written information'' to ``written nutrition 
information'' in the final sentence. With this editorial change, Sec.  
101.11(b)(2)(ii)(D) will consistently use the same phrase (``written 
nutrition information'').
    (Comment 113) One comment supported our proposal to permit 
flexibility in how the written nutrition information would be provided 
but questioned the use of wrappers, arguing that it is unlikely that 
there would be enough room on a wrapper to list the nutrition 
information for all standard menu items in a covered establishment and 
to make the information easily readable. Another comment recommended 
that Sec.  101.11(b)(2)(ii)(D) specify the media allowed for the 
written nutrition information, with a petition and approval process for 
alternate media, rather than include a ``catch-all phrase'' such as 
``any other form that similarly permits the written declaration of the 
required nutrient content information for all standard menu items,'' 
which was included in proposed Sec.  101.11(b)(2)(ii)(D). Another 
comment recommended that we expressly recognize that Nutrition Facts 
labels can be used to convey the written nutrition information.
    (Response 113) Section 101.11(b)(2)(ii) specifies that the written 
nutrition information must be provided in a clear and conspicuous 
manner, including using a color, type size, and contrasting background 
that render the information likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use. A 
covered establishment could use a wrapper if the written nutrition 
information for all standard menu items offered for sale at the covered 
establishment can be presented in a clear and conspicuous manner on the 
wrapper, is available upon request to the consumers, in accordance with 
Sec.  101.11(b)(2)(ii), and otherwise complies with the applicable 
sections of the FD&C Act and Sec.  101.11(b)(2)(ii). For example, there 
may be enough room on a wrapper to include the written nutrition 
information for all standard menu items in a clear and conspicuous 
manner when a covered establishment offers for sale a small number of 
standard menu items.
    In addition, Sec.  101.11(b)(2)(ii) ensures that the written 
nutrition information is presented in a clear and conspicuous manner 
without prescribing a list of allowed media or the exact format of the 
written nutrition information. If we amended Sec.  101.11(b)(2)(ii)(D) 
to specify the particular types of media that can be used by covered 
establishments to provide the required written nutrition information, 
as recommended by one comment, Sec.  101.11(b)(2)(ii)(D) would limit 
the types of media that can be used by covered establishments, 
including those developed based on technological advancements. Further, 
Sec.  101.11(b)(2)(ii) would need to amended every time a covered 
establishment sought to use a type of media not specified. Rather than 
specify the media allowed for the written nutrition information, we 
conclude that the public health goal of this rule would be better 
served by providing flexibility to covered establishments to use any 
media to provide the written nutrition information in the way that is 
best suited to their establishments, as long as the written nutrition 
information is available on the premises of the covered establishment 
and to the consumer upon request, is clear and conspicuous, and 
otherwise complies with the requirements of the applicable sections of 
the FD&C Act and Sec.  101.11(b)(2)(ii). Providing such flexibility 
satisfies the requirements of section 403(q)(5)(H)(ii)(III) of the FD&C 
Act while taking into consideration the varying practices at different 
covered establishments. With this flexibility, the petition and 
approval process suggested by the comment is unnecessary.
    We agree that Nutrition Facts labels can be used to provide the 
written nutrition information required under Sec.  101.11(b)(2)(ii) for 
packaged foods, and this rule provides flexibility to do so (see the 
discussions of Sec.  101.11(b)(2)(iii)(C) in Response 133, and of Sec.  
101.11(c)(1) in section XVIII).
    (Comment 114) Some comments stated that the written nutrition 
information should not have to be

[[Page 71218]]

provided with carry out menus. The comments recommended that carry out 
menus could contain a link to the covered establishment's Internet menu 
where the written nutrition information may be found. Another comment 
stated that the written nutrition information should be permitted on 
Internet menus but not required.
    (Response 114) We agree with the comments stating that the written 
nutrition information should not be required with carry out menus. We 
are not requiring a specific manner for providing the written nutrition 
information, as long as the written nutrition information is available 
on the premises of the covered establishment and provided to the 
consumer upon request, is disclosed in a clear and conspicuous manner, 
and otherwise complies with the applicable sections of the FD&C Act and 
Sec.  101.11(b)(2)(ii). If a consumer who orders from a menu such as a 
carry out menu or an Internet menu requests the written nutrition 
information, the covered establishment must provide the information to 
the consumer. For example, if a covered establishment delivers a menu 
item to a consumer, the covered establishment could deliver the written 
nutrition information with the menu item if the consumer requests the 
information. As another example, if a consumer orders from an Internet 
menu, a covered establishment could provide the written nutrition 
information on its Web site or include a link directing the consumer to 
a Web site providing the written nutrition information. Similarly, as 
suggested by the comments, a covered establishment could provide a link 
on carry out menus that directs consumers to a Web site providing the 
written nutrition information. We note that all menus, including carry 
out menus, and menu boards must include a prominent, clear, and 
conspicuous statement regarding the availability of the written 
nutrition information, as required by section 403(q)(5)(H)(ii)(IV) of 
the FD&C Act.
    (Comment 115) Some comments recommended that we require that the 
written nutrition information be readily available upon request to 
consumers before ordering. The comments also recommended that the 
information be provided in a manner that allows consumers to compare 
the information between different menu items before ordering and 
without losing their place in line or having to leave the table. The 
comments stated that if the written nutrition information is not in a 
form that can be given to the consumer upon request, it must be readily 
available in a manner and location on the premises that allows the 
consumer to review the written nutrition information when ordering 
(i.e., the consumer should be able to see and review both the menu or 
menu board and the written nutrition information at the same time). One 
comment recommended that the information be provided at the place where 
consumers place their orders and not upon request. One comment 
recommended that we ensure that all consumers have access to the 
information. The comment maintained that information on a poster or on 
a computer in a fixed location may not be accessible to the mobility 
impaired.
    (Response 115) We decline to require that covered establishments 
make the written nutrition information readily available to consumers 
where consumers place their orders rather than providing such 
information to consumers upon request. Section 403(q)(5)(H)(ii)(III) of 
the FD&C Act specifically requires covered establishments to provide 
the written nutrition information ``to the consumer upon request.'' In 
addition, nothing in Sec.  101.11(b)(2)(ii) would preclude consumers 
from requesting the written nutrition information before ordering. We 
disagree that the rule must require a format and manner of providing 
the written nutrition information that ensures that a consumer who 
requests written nutrition information will avoid losing a place in an 
ordering line or leaving a table. A covered establishment has 
flexibility to use a format (e.g., a poster) that may be readily seen 
by consumers even if they do not specifically ask to see it.
    We agree that covered establishments must make the written 
nutrition information available to all consumers, including consumers 
with mobility impairment, upon request, and must ensure that the 
information is presented in a clear and conspicuous manner to all 
consumers. Section 101.11(b)(2)(ii)(D) specifically identifies formats 
such as on a counter card, sign, poster, handout, booklet, loose leaf 
binder, or electronic device such as a computer, or in a menu through 
which a covered establishment may provide the written nutrition 
information.

XVII. Comments and FDA Response on Proposed Sec.  101.11(b)(2)(iii)--
Requirements for Food That Is Self-Service or on Display

A. Applicability of Sec.  101.11(b)(2)(i) to Food That Is Self-Service 
or on Display

    Under sections 403(q)(5)(H)(ii)(I)(aa) and (II)(aa) of the FD&C 
Act, we proposed to establish requirements for the declaration of 
calories for standard menu items on menus and menu boards in proposed 
Sec.  101.11(b)(2)(i). Under section 403(q)(5)(H)(iii), we proposed to 
establish requirements for the declaration of calories for self-service 
food and food on display in proposed Sec.  101.11(b)(2)(iii). In the 
proposed rule, we tentatively concluded that when self-service foods 
and food on display appear on menus or menu boards, the menus or menu 
boards must bear the calorie declarations required by sections 
403(q)(5)(H)(ii)(I)(aa) and (II)(aa) of the FD&C Act (76 FR 19192 at 
19216). In other words, we tentatively concluded that self-service food 
and food on display that appear on a menu or menu board are subject to 
both requirements for the declaration of calories--i.e., the 
requirements in Sec.  101.11(b)(2)(i) applicable to declaration on a 
menu or menu board and the requirements in Sec.  101.11(b)(2)(iii) 
applicable to self-service food and food on display.
    (Comment 116) One comment disagreed with our tentative conclusion 
that the proposed requirements for calorie declaration of standard menu 
items on menus and menu boards (Sec.  101.11(b)(2)(i)(A)) apply to food 
on display and self-service food that is also listed on menus and menu 
boards. The comment asserted that this tentative conclusion is against 
the plain language of section 403(q)(5)(H) of the FD&C Act and that to 
require covered establishments to label menu boards and display cases 
is unnecessary. The comment asserted that only requiring calorie 
labeling on signs adjacent to food on display and self-service food 
would provide information at the point of ordering and therefore would 
be more consistent with the requirement of section 403(q)(5)(H) of the 
FD&C Act that calorie information be provided on menus and menu boards, 
as defined in section 403(q)(5)(H)(xi) of the FD&C Act (``the primary 
writing of the . . . establishment from which a consumer makes an order 
selection'').
    (Response 116) We disagree with this comment. The plain language of 
section 403(q)(5)(H)(i) of the FD&C Act provides that ``in the case of 
food that is a standard menu item . . . [the covered] establishment 
shall disclose the information described in subclauses (ii) and (iii)'' 
(emphasis added). As discussed in the proposed rule, the word ``and'' 
between the references to subclause (ii) and subclause (iii) indicates 
that for each standard menu item, including self-service food and food 
on display, covered establishments must follow the requirements in 
section 403(q)(5)(H)(ii) of the FD&C Act as applicable and section 
403(q)(5)(H)(iii) of the FD&C Act as applicable. Further,

[[Page 71219]]

if Congress had meant for section 403(q)(5)(H)(ii) of the FD&C Act not 
to apply to self-service food and food on display, it could have 
included an exception for such foods within that section, as it did for 
foods described in section 403(q)(5)(H)(vii) of the FD&C Act, but it 
did not include such an exception. See e.g., Russello v. U.S., 464 U.S. 
16, 23 (1983) (``[W]here Congress includes particular language in one 
section of a statute but omits it in another section of the same 
[statute], it is generally presumed that Congress acts intentionally 
and purposely in the disparate inclusion or exclusion.'') (internal 
citations omitted). In addition, a consumer may make his or her order 
selection by using information provided on a traditional menu or menu 
board or on a sign adjacent to a self-service food or food on display. 
Disclosing calorie information for self-service food and food on 
display on traditional menus and menu boards, where such menus and menu 
boards list self-service food and food on display, and on signs 
adjacent to self-service food and food on display would help ensure 
that consumers are able to see the calorie declarations before making 
order selections and is consistent with the plain language of sections 
403(q)(5)(H)(ii) and (iii) of the FD&C Act.
    Therefore, when a self-service food or food on display is listed on 
a menu or menu board, the food is subject to both Sec.  101.11(b)(2)(i) 
for declaration of calories on menus and menu boards and to Sec.  
101.11(b)(2)(iii) for foods on display.

B. Placement of Calories for Self-Service Foods and Foods on Display

    Proposed Sec.  101.11(b)(2)(iii)(A) would require that when a self-
service food or food on display is already accompanied by an individual 
sign, adjacent to the food, that provides the food's name, price, or 
both, the calories per item or per serving must be provided on the 
sign. When a self-service food or food on display is not already 
accompanied by an individual sign, adjacent to the food, that provides 
the food's name, price, or both, the covered establishment must place a 
sign adjacent to each food with the number of calories per serving or 
per item in a clear and conspicuous manner.
    In the following paragraphs, we discuss comments on this proposed 
provision. After considering these comments, we have revised the 
provision to provide more options for the declaration of calories for 
self-service food and food on display and to require that if the 
individual sign does not already include the serving, the amount of the 
serving on which the calories are based must also be provided on the 
sign, e.g., ``150 calories per scoop.''
    We also are correcting the introductory text in Sec.  
101.11(b)(2)(iii) by inserting a hyphen between ``self'' and 
``service.''
    (Comment 117) Several comments supported the requirements in 
proposed Sec.  101.11(b)(2)(iii). Some comments recommended that foods 
on display be labeled with calorie information regardless of whether 
the food is served by the customer or employee. Some comments asked us 
to clarify that a calorie declaration is also required for displayed 
foods such as pastries and doughnuts at bakeries and ice cream behind a 
glass case in an ice cream shop.
    (Response 117) The definition of ``self-service food'' includes 
restaurant-type food that is served by the customers themselves, and 
the definition of ``foods on display'' includes restaurant-type food 
that is visible to the customer before the customer makes a selection. 
In general, pastries, donuts, and ice cream on display, such as behind 
a glass case, meet the definition of food on display. Under these 
definitions, the requirements in proposed Sec.  101.11(b)(2)(iii) apply 
to standard menu items that are foods served by the customers 
themselves as well as to standard menu items that are foods such as 
pastries, donuts, and ice cream that are behind a glass case or in an 
ice cream shop and are served by an employee.
    (Comment 118) Some comments requested flexibility to determine the 
placement of calorie information that works best for them. Some 
comments recommended that the calorie declaration be permitted to be 
placed on a single sign, or electronically via kiosks or touch screen 
computers, and not on all individual signs. One comment asserted that, 
for buffets, the layout and number of items make it difficult to 
display signs for hundreds of items without cluttering the space or 
obstructing the view. The comment also asserted that customers may 
inadvertently move the signs, and therefore, the calorie declaration 
should instead appear on counters or in display cases.
    Some comments stated that buffets are unique because foods vary and 
change often. For example, according to one comment, a restaurant may 
have as many as 175 different menu items in a meal period. One comment 
stated that the foods are changed multiple times a day, the items may 
change from day to day, and the rotation of foods would create 
confusion if the food signs are not accurately changed with each new 
menu item.
    One comment stated that the location and size of the food signs are 
affected by health and safety regulations because the food signs could 
lead to contamination of the food and because food signs adjacent to 
heated areas or grills for food items cooked to order could create a 
hazard. Moreover, the comment noted that multiple menu items may be 
simultaneously prepared to order on open grills. This comment 
recommended that these types of restaurants be permitted to place the 
calorie information on individual signs adjacent to or in close 
proximity to the food by using a variety of options (e.g., sneeze 
guards; partition or placard; menu board or placard adjacent to the 
buffet with all the items listed with nutrition content; pamphlet 
adjacent to the buffet; written or electronically displayed information 
using kiosks; tablet computers; or touch screen computers).
    (Response 118) We agree that placing individual signs adjacent to a 
self-service food or food on display may pose a hazard in certain 
circumstances, such as when there is an open heat source (such as a 
grill) in close proximity to the sign that could create a fire hazard. 
We also agree that more flexibility is needed for foods that are 
constantly being replenished or changed. Therefore, to provide more 
flexibility and reduce the potential for a sign used to declare 
calories for self-service food or food on display to create a hazard, 
we have revised Sec.  101.11(b)(2)(iii)(A) to allow covered 
establishments to declare calories for standard menu items that are 
self-service or on display, and the serving or unit used to determine 
the calorie content (e.g., ``per scoop'' or ``per muffin''), using one 
of the following options:
     On a sign, adjacent to and clearly associated with the 
corresponding food item;
     On a sign attached to a sneeze guard with the calorie 
declaration and the serving or unit used to determine the calorie 
content above each specific menu item so that the consumer can clearly 
associate the calorie declaration with the standard menu item. For 
example, if a buffet has several menu items in the serving display case 
including, in particular, a broccoli and cheese casserole, the sign 
attached to the sneeze guard right above the broccoli and cheese 
casserole may declare the calories, e.g., ``200 calories

[[Page 71220]]

per scoop.'' If it is not clear to which food the calorie declaration 
and serving or unit refers, then the sign must also include the name of 
the food, e.g., ``Broccoli and cheese casserole--200 calories per 
scoop;'' or
     On a single sign or placard listing the calorie 
declaration for several menu items along with the names of the menu 
items, so long as the sign or placard is located where a consumer can 
view the name, calorie declaration, and serving or unit of a particular 
menu item while the consumer is selecting that item. The sign must list 
the names of the menu items along with their corresponding calorie 
declarations. For example, for a soup station, the sign or placard must 
list all the soups that are available at that station along with each 
calorie declaration, e.g., ``chicken noodle soup, 125 calories per 
cup,'' ``minestrone soup, 100 calories per cup.'' This sign may be 
placed on the wall behind the station, on a sign at the beginning or 
end of the station, or at another location so long as the consumer can 
read the name, calorie declaration, and serving or unit of a particular 
menu item while selecting the menu item.
    Each option, when implemented appropriately, associates the calorie 
declaration with the appropriate food on display or self-service food 
to help ensure that consumers can see such declarations when making 
their selections.
    (Comment 119) In the proposed rule, we stated that placing a 
separate sign with calorie information adjacent to a food that is 
already accompanied by a sign bearing its name, price, or both, could 
make it more difficult for consumers to clearly associate the calorie 
information with its corresponding self-service food or food on display 
(76 FR 19192 at 19215). We requested comment on whether establishments 
that already provide an individual sign identifying each food on 
display or self-service food with its name, price, or both should have 
the option of providing a separate individual sign for each food on 
display or self-service food for the calorie declaration, so long as 
the sign with the calorie declaration is adjacent to and clearly 
associated with its corresponding food.
    One comment recommended that calories appear on the same sign as 
the name or price of the food rather than on a separate sign, because 
more than one sign could cause confusion.
    (Response 119) We acknowledge the comment's concern, which mirrored 
a concern we raised in the proposed rule. However, in light of the 
recommendations in the comments describing the need for more 
flexibility in declaring calories for self-service foods and foods on 
display, we have concluded that there are a number of ways in which a 
covered establishment can comply with section 403(q)(5)(H)(iii) of the 
FD&C Act to provide calorie declarations for self-service foods and 
foods on display based on the establishment's particular operations, 
including the use of a separate sign placed adjacent to a self-service 
food or food on display that is clearly associated with the food (see 
Comment 118 and Response 118). Therefore, we have revised Sec.  
101.11(b)(2)(iii)(A) by removing the sentence requiring that when a 
self-service food or food on display is already accompanied by an 
individual sign, adjacent to the food, that provides the food's name, 
price, or both, the calories per item or per serving must be provided 
on the sign. In addition, we have revised Sec.  101.11(b)(2)(iii)(A) by 
providing options for a covered establishment to provide calorie 
declarations on signs for self-service food and food on display, 
including the options described in Response 118. We are making these 
changes based on the reasons discussed in Response 118 and because we 
recognize that existing individual signs for these foods may be quite 
small and either not have enough space for the calorie declaration, or 
cause the sign to be so crowded that the calorie declaration may not be 
easily read or clear and conspicuous enough for the consumer to read 
the information. (See, e.g., the discussions in Comment 126 and 
Response 126, and in Comment 127 and Response 127, about the 
requirements for type size of the calorie declaration when a self-
service food or food on display is already accompanied by a sign with 
the food's name, price, or both.)

C. Declaring Calories ``Per Item'' or ``Per Serving''

    Proposed Sec.  101.11(b)(2)(iii)(A)(1) would specify that for 
purposes of Sec.  101.11(b)(2)(iii)(A), ``per item'' means per each 
discrete unit offered for sale, for example, a bagel, a slice of pizza, 
a muffin, or a multi-serving food such as a whole cake. Proposed Sec.  
101.11(b)(2)(iii)(A)(2) would specify that for purposes of Sec.  
101.10(b)(2)(iii)(A), ``per serving'' means: (1) Per each common 
household measure, e.g., cup, scoop, tablespoon, offered for sale as 
dispensed using a serving instrument such as a scoop, ladle, cup, or 
measuring spoon; or (2) per unit of weight offered for sale, e.g., per 
half pound or pound.
    In the following paragraphs, we discuss comments on these proposed 
provisions. After considering these comments, we are:
     Deleting ``a multi-serving food such as a whole cake'' 
from the list of examples of what the rule means by ``per item.'' As 
discussed in section VI.C, the definition of ``restaurant-type food'' 
established in the rule includes food that is usually eaten on the 
premises, while walking away, or soon after arriving at another 
location, and whole cakes that are self-service food or food on display 
are not likely to meet this definition.
     Providing the options to declare calories ``per serving 
instrument'' or ``per common household measure'' in separate 
subparagraphs, rather than in the same subparagraph, to emphasize that 
these are distinct alternatives for declaration of calories ``per 
serving.''
     Revising the examples of what we mean by ``per unit of 
weight offered for sale'' to be ``per quarter pound'' or ``per 4 
ounces.'' We are making this change because examples of a quarter pound 
or 4 ounces are more likely to reflect a serving of self-service food 
or food on display.
     Changing Sec.  101.11(b)(2)(iii)(A)(1) and 
(b)(2)(iii)(A)(2) to read ``paragraph (b)(2)(iii)(A) of this section'' 
rather than ``Sec.  101.11(b)(2)(iii)(A)'' to be more consistent with 
FDA's general practice. We note that the proposed rule had identified 
the cross-reference as ``Sec.  101.10(b)(2)(ii)(A).'' We revised this 
to ``Sec.  101.11(b)(2)(iii)(A)'' in the correction document, but did 
not identify the format change at that time.
    (Comment 120) One comment suggested that the portion of the 
standard menu item used to calculate the calorie content also be 
clearly displayed in the same font, color, and size as the item name 
and be posted on or next to the available food on display or self-
service food.
    (Response 120) We agree that the serving or unit of a standard menu 
item that is a self-service food or food on display used to determine 
the calorie content for such food must be included in the calorie 
declaration. Without information about the serving or unit of a self-
service food or food on display, the consumer would not be able to 
ascertain the calorie content of the amount of food that would be 
consumed. This would defeat the purpose of the calorie declaration. 
Therefore, we have revised Sec.  101.11(b)(2)(iii)(A) to require that 
the calorie declaration for foods on display and self-service food 
include the serving or unit on which the calorie content is based. The 
requirements in

[[Page 71221]]

Sec.  101.11(b)(2)(iii)(A)(3)(ii) for font size and color will apply to 
the entire calorie declaration, including the serving or unit used to 
determine calorie content. (See the discussion of Sec.  
101.11(b)(2)(iii)(A)(3)(ii) in section XVII.E.2.)
    (Comment 121) One comment asked us to allow a covered establishment 
to list nutrition information for standard menu items that are self-
service or on display per serving size and requested clarification on 
how the RACC would be used in this case. The comment asked us to keep 
in mind that many retailers would like to align their calorie 
declarations for menu items with serving sizes for packaged food so as 
not to have two different serving sizes.
    (Response 121) In Response 65 in section XI, we explained why a 
calorie declaration for a multiple-serving standard menu item that is 
not self-service or on display must declare ``the number of calories 
contained in the standard menu item, as usually prepared and offered 
for sale'' instead of per RACC (to the extent that there is a RACC for 
such standard menu item). Similarly, we disagree that a calorie 
declaration for a standard menu item that is a self-service food or 
food on display should be declared per RACC or per serving size used on 
packaged food, unless such RACC or serving size is the portion or 
serving used by the covered establishment to display or otherwise offer 
such standard menu item for sale. Self-service food and food on display 
may be portioned differently than a RACC or serving size used on 
packaged food. Section 403(q)(5)(H) of the FD&C Act does not require a 
covered establishment to prepare and offer standard menu items in 
particular sizes or amounts, such as RACCs or serving sizes used on 
packaged foods. Instead, section 403(q)(5)(H)(iii) of the FD&C Act 
expressly requires covered establishments to disclose the number of 
calories for self-service foods and foods on display ``per displayed 
food item or per serving.'' Accordingly, a covered establishment may 
choose the portion or serving of the food that it offers for sale, and 
must base the calorie declaration for a self-service food or food on 
display per displayed item (e.g., ``per muffin'') or per serving (e.g., 
``per scoop'') as offered for sale.
    (Comment 122) A few comments expressed concern with portion sizes 
and with declaring nutrient values for items that vary in size and 
content (e.g., baked potato, chicken breast). Some comments asked for 
guidance on serving sizes for calorie declarations pertaining to foods 
on display. One comment asked us to clarify that the calories should be 
declared per item or serving as offered for sale and not for a portion 
of a food item that is smaller than the food offered for sale. For 
example, a covered establishment that offers a large muffin for sale 
should be required to declare calories per item (i.e., the large 
muffin) and should not be permitted to declare calories per serving and 
describe the large muffin as containing two servings.
    One comment maintained that calories of foods at salad bars should 
be declared per cup and not per serving. Several comments asked us to 
require that calories be based on serving utensil sizes where possible. 
One comment recommended that we require the same serving size as for 
packaged food if no utensil is used. The comment suggested that 
calories be declared per cup if tongs are used for lettuce at a salad 
bar. The comment suggested that the rule be revised to include:
    (iii) The following must be provided for food that is self-service 
or on display.
    ``(1) Calories must be provided for each standard serving size 
offered, e.g., each beverage cup size offered for a fountain beverage 
dispenser or each container size available for a deli salad.
    (2) For purposes of Sec.  101.10(b)(2)(iii)(A), ``per item''' means 
per each discrete unit offered for sale--for example, a bagel, a 
muffin, a sandwich, or a multi-serving food, such as a whole cake.
    (3) If the item is not sold as a discrete unit, it can be labeled 
per serving. For purposes of Sec.  101.10(b)(2)(iii)(A), ``per 
serving''' means:
    (i) Per each scoop or container as dished up using the serving 
instrument provided, such as a ladle, cup, or measuring spoon, or per 
weight or container-size offered, such as a quarter pound of potato 
salad or a container of soup.
    (ii) If the item is not served using a ladle or other measuring 
instrument or per container size, the item must be labeled in the 
common household measure closest to the Reference Amount Customarily 
Consumed (RACC) for that item, e.g., per cup or tablespoon.''
    (Response 122) We agree that a calorie declaration for a self-
service food or food on display per displayed food item should be 
declared for the entire item as offered for sale and not based on a 
portion of the food item that is smaller than the food item offered for 
sale. For example, if a covered establishment offered a muffin for sale 
as a self-service food or food on display, the establishment should 
declare calories for the entire muffin rather than just a portion of 
the muffin (e.g., one-half or one-third of the muffin) because the 
entire muffin is the standard menu item offered for sale by the 
establishment.
    We also agree with the comment asserting that the rule should be 
revised to require that when a self-service food or food on display is 
offered for sale per displayed food item, meaning per a discrete unit 
offered for sale, such as a bagel, a slice of pizza, or a muffin, the 
calorie declaration for such food should be based on the discrete unit 
offered for sale rather than another amount. In the proposed rule, we 
tentatively concluded that for self-service food or food on display 
that is displayed per item, where the item represents one serving, the 
calorie declaration should be per item (76 FR 19215). We affirm this 
conclusion.
    We also agree with the comment asserting that the rule should be 
revised to require that when a self-service food or food on display is 
not offered for sale per displayed food item, the calorie declaration 
for such food should be based on the serving offered for sale. In the 
proposed rule, we tentatively concluded that for self-service food or 
food on display that is not displayed per item (e.g., potato salad at a 
buffet or ice cream at an ice cream parlor), the calorie declaration 
should be per serving (76 FR 19215). We affirm this conclusion.
    For these reasons, we have revised Sec.  101.11(b)(2)(iii)(A) to 
further specify that a covered establishment must declare calories for 
a self-service food or food on display per displayed food item, or if 
the food is not sold in a discrete unit, per serving as offered for 
sale. Under Sec.  101.11(b)(2)(iii)(A)(1), ``per displayed food item'' 
means per each discrete unit offered for sale, for example, a bagel, a 
slice of pizza, or a muffin. Accordingly, if a covered establishment 
offers a food that is self-service or on display for sale in a discrete 
unit, such as a muffin, the establishment would have to declare 
calories for the food per such discrete unit offered for sale, and not 
based on a different amount.
    As discussed in Response 65 and Response 121, we disagree that the 
rule should require that calories for self-service food and food on 
display be declared per RACC and, therefore, we are not revising Sec.  
101.11(b)(2)(iii)(A)(2) to require that an item that is not served 
using a measuring instrument be labeled in the common household measure 
closest to the RACC for that item. However, we agree that specifying 
that calories for a self-service food or food on display be disclosed 
per displayed food item, if applicable, and providing other options to 
declare calories ``per serving

[[Page 71222]]

instrument'' and ``per common household measure'' in separate 
subparagraphs, as suggested by this same commenter, would provide a 
clearer framework regarding how calorie declarations must be provided 
for self-service foods and foods on display. Therefore, in addition to 
the revisions we made to Sec.  101.11(b)(2)(iii)(A)(1) as described 
previously, we have revised Sec.  101.11(b)(2)(iii)(A)(2)(i) to specify 
that, for the purposes of Sec.  101.11(b)(2)(iii)(A), ``per serving'' 
means (1) per serving instrument used to dispense the food offered for 
sale, provided that the serving instrument dispenses a uniform amount 
of the food (e.g., a scoop or ladle); or (2) if a serving instrument 
that dispenses a uniform amount of food is not used to dispense the 
food, per each common household measure (e.g., cup or tablespoon) 
offered for sale or per unit of weight offered for sale (e.g., per 
quarter pound or per 4 ounces). As revised, Sec. Sec.  
101.11(b)(2)(iii)(A)(1), and (b)(2)(iii)(A)(2)(i) to 
(b)(2)(iii)(A)(2)(ii) establish a logical hierarchy for determining how 
to declare calories for a self-service food or food on display. For 
example, if a covered establishment offered a self-service food for 
sale in a discrete unit, such as a muffin, the establishment would have 
to declare calories for the muffin as a whole. If the covered 
establishment offered another self-service food for sale, but the food 
was not offered for sale in a discrete unit, such as pasta salad, the 
establishment would have to declare calories for the food ``per 
serving'' as defined in Sec.  101.11(b)(2)(iii)(A)(2). Under Sec.  
101.11(b)(2)(iii)(A)(2)(i), the covered establishment would have to 
declare calories for the pasta salad per serving instrument used to 
dispense the pasta salad if the serving instrument dispensed a uniform 
amount of the food (e.g., per scoop or ladle). If the covered 
establishment used a serving instrument that does not dispense a 
uniform amount of the food, such as tongs, declaring calories per that 
serving instrument used to dispense the food would not be appropriate 
because the calorie declarations would not always be consistent with 
the amount of food dispensed, and therefore the covered establishment 
would look to the remaining options to declare calories, which include 
declaring calories per common household measure or per unit of weight 
offered for sale (in Sec.  101.11(b)(2)(iii)(A)(2)(ii)). If a covered 
establishment offers food for sale per unit of weight, and the unit of 
weight offered for sale is in ounces, then it would be required to 
declare calories per ounce (or per some number of ounces)--i.e., using 
the same unit of weight (ounces) as the unit of weight offered for 
sale.
    We disagree that we should establish specific examples of portion 
sizes in the rule or add details such as specifying that a ``container 
of soup'' is an appropriate portion size for soup. A covered 
establishment has flexibility to establish the portion sizes for 
standard menu items offered for sale in such establishment.
    As discussed in section VI.C, the definition of ``restaurant-type 
food'' generally covers food that usually is eaten on the premises, 
while walking away, or soon after arriving at another location. Foods 
(such as whole cakes and deli salads that are sold from a display case 
rather than from a salad bar) that are grocery-type items that 
consumers usually store for use at a later time or customarily further 
prepare would not be included within the meaning of ``restaurant-type 
food.'' Thus, we have deleted ``a multi-serving food such as a whole 
cake'' from Sec.  101.11(b)(2)(iii)(A)(1). We decline to add ``deli 
salad'' as an example in what we mean by ``per serving'' because doing 
so could incorrectly imply that a deli salad sold at a deli counter as 
a grocery-type item is likely to be covered by the rule. We are adding 
Sec.  101.11(b)(2)(iii)(A)(2)(iii) to specify what we mean by ``per 
serving'' for self-service beverages--i.e., per total number of fluid 
ounces in the cup in which a self-service beverage is served and, if 
applicable, the description of the cup size (e.g., ``140 calories per 
12 fluid ounces (small)''). See Response 125 in the next section of 
this document for an explanation of this new provision.
    (Comment 123) One comment noted that some foods on display are 
offered in different flavors or varieties such as ice cream or 
doughnuts. The comment asked us to clarify that a covered establishment 
may disclose the nutrition information for such items by using a range 
per serving (or one of the other options being considered for other 
variable menu items).
    (Response 123) A standard menu item on display may meet the 
definition for a variable menu item in Sec.  101.11(a) when it is 
offered for sale in different flavors, varieties, or combinations, and 
is listed on a menu or menu board as a single menu item. When this is 
the case, the format requirements for variable menu items in Sec.  
101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(8) would apply to calories 
declared on the menu or menu board. Accordingly, to the extent that 
standard menu items on display offered for sale in different flavors or 
varieties are listed as single menu items on menus or menu boards, a 
covered establishment would be required to declare calories on such 
menus and menu boards for such foods using the same methods applicable 
to other variable menu items, including ranges, as specified in Sec.  
101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(8). However, when these 
foods are on display, they would also be subject to the requirements of 
section 403(q)(5)(H)(iii) of the FD&C Act and Sec.  101.11(b)(2)(iii). 
For a standard menu item that is a self-service food or food on 
display, section 403(q)(5)(H)(iii) of the FD&C Act requires the covered 
establishment to ``place adjacent to each food offered a sign that 
lists the calories per displayed food item or per serving'' (emphasis 
added). Typically, a standard menu item that is on display is presented 
to the consumer as a unique menu item, in that the food is made visible 
to the consumer, and the consumer can see what other standard menu 
items are available, including other standard menu items that come in 
different flavors, varieties, or combinations, such as various muffins 
or pastries in a display case. Because these standard menu items 
typically are on display in a manner that allows consumers to see each 
menu item individually, as well as the other menu items available, 
including menu items offered in different flavors or varieties, the way 
in which these items are offered for sale is not analogous to standard 
menu items that come in different flavors or varieties but are listed 
as a single menu item on a menu or menu board. For example, a covered 
establishment may offer for sale different flavors of ice cream (e.g., 
vanilla, chocolate, strawberry) in individual containers in a display 
case visible to consumers. In this situation, because the consumer can 
see each flavor of ice cream offered for sale, the consumer should also 
be able to see the number of calories contained for each flavor of ice 
cream offered for sale. As a result, the covered establishment would be 
required to place a sign adjacent to each flavor of ice cream in the 
display case that lists the calories per each individual displayed food 
item or per serving in accordance with Sec.  101.11(b)(iii).

D. Declaring Calories ``Per Serving'' for Self-Service Beverages

    In the proposed rule, we discussed the serving size of beverages 
following our discussion of the declaration of calories for self-
service food and food on display ``per item'' and ``per serving'' (76 
FR 19192 at 19216). We recognized that covered establishments may have 
different sizes for beverages that are

[[Page 71223]]

listed on the menu as small, medium, and large and stated that we were 
considering whether the amount of calories declared should be based on 
the number of ounces. In the proposed rule, we anticipated that if we 
adopt this view in the final rule, we would not object to the covered 
establishment listing the number of ounces as part of the size 
declaration, e.g., ``140 calories per 12 ounces (small).'' We requested 
and received comment on this issue. After considering these comments, 
we are establishing a new provision to specify that, for beverages that 
are self-service or on display, ``per serving'' means per total number 
of fluid ounces in the cup in which a self-service beverage is served 
and, if applicable, the description of the cup size (e.g., ``140 
calories per 12 fluid ounces (small)'') (Sec.  
101.11(b)(2)(iii)(A)(2)(iv)). As an operational companion to new Sec.  
101.11(b)(2)(iii)(A)(2)(iii), we also are establishing a new provision 
(Sec.  101.11(b)(2)(iii)(A)(3)(iii)) to require that calorie 
declarations for self-service beverages be accompanied by the term 
``fluid ounces'' and, if applicable, the description of the cup size 
(e.g., ``small,'' ``medium''). (See also Response 129 in section 
XVII.E.3 of this document.)
    (Comment 124) One comment noted that the proposed rule did not 
address the issue of ice fill for the declaration of calories for 
beverages. The comment asked us to permit covered establishments to 
calculate calories based on their standard ice fill as long as the 
level of ice fill is disclosed to consumers. The comment recommended 
that we expressly permit, regardless of whether there is a standard ice 
fill, the following statement regarding ice fill: ``Calorie content may 
vary based on the amount of ice used.''
    (Response 124) We previously addressed this comment with respect to 
beverages that are not self-service (see the discussion of Sec.  
101.11(b)(2)(i)(A)(9) in section XIII). Under section 403(q)(5)(H)(iii) 
of the FD&C Act, calories for standard menu items that are self-service 
foods and foods on display, including ``soft drinks,'' must be declared 
``per displayed food item or per serving'' (emphasis added). For 
beverages that are self-service, the actual amount of a beverage 
dispensed by consumers will vary depending on the size of the cup and 
the amount of ice or beverage that a consumer may add to the cup. For 
these reasons, the provisions we are establishing in this rule for 
self-service beverages require declaration of calories based on the 
full volume of the cup (i.e., without ice), and do not provide for the 
declaration of calories based on a standard beverage fill or standard 
ice fill. (See discussion of Sec.  101.11(b)(2)(iii)(A)(2)(iii) of the 
final rule immediately following.)
    We would not object to a covered establishment posting a statement 
(at the self-service beverage dispenser, on the menu or menu board, or 
both) indicating that the calories for the self-service beverages may 
vary depending on the amount of ice dispensed (e.g., ``calorie content 
may vary based on the amount of ice used'').
    (Comment 125) One comment asserted that calories for self-service 
beverages should not be listed for an ``appropriate serving size'' such 
as 12 ounces because this may not correspond to the sizes that are 
actually sold in the covered establishment.
    (Response 125) We agree that the number of ounces in a beverage cup 
may vary between covered establishments and we agree that the rule 
should not establish ``an appropriate serving size'' for self-service 
beverages. We also agree that consumers should be given calorie 
information based on the number of ounces in the cup which the consumer 
uses to dispense a self-service beverage. Section 403(q)(5)(H)(iii) of 
the FD&C Act provides that calories for self-service foods and foods on 
display be declared ``per displayed food item or per serving'' 
(emphasis added). For self-service beverages, the serving units depend, 
in part, on the cups provided by the covered establishment to consumers 
for use at the self-service beverage dispenser. The actual amount of 
beverage dispensed by consumers will vary based on the size of the cup 
and the amount of beverage that a consumer dispenses into the cup. As 
already discussed in Response 124, the actual amount of beverage 
dispensed by consumers also will vary based on the amount of ice that a 
consumer may add to the cup, and in contrast to some non-self-service 
beverages offered for sale by a covered establishment, self-service 
beverage dispensers typically do not have a standard beverage fill or 
standard ice fill. In addition, for any given establishment, the cups 
provided for self-service beverages may be in a single size or may be 
in different sizes, e.g., in cups labeled ``small,'' ``medium,'' or 
``large.'' Further, as already noted, covered establishments may have 
different sizes for beverages that are listed on menus as small, 
medium, and large. For these reasons, we are specifying that, for self-
service beverages, calories ``per serving'' within the meaning of 
section 403(q)(5)(H)(iii) of the FD&C Act must be based on the number 
of ounces in the cup in which the beverage is served.
    Therefore, Sec.  101.11(b)(2)(iii)(A)(2)(iii) of the final rule 
specifies that, for purposes of Sec.  101.11(b)(2)(iii)(A), ``per 
serving'' means, for beverages that are self-service, per total number 
of fluid ounces in the cup in which a self-service beverage is served 
and, if applicable, the description of the cup size (e.g., ``140 
calories per 12 fluid ounces (small)''). As an operational companion to 
Sec.  101.11(b)(2)(iii)(A)(2)(iii), we also are establishing specific 
format requirements applicable to the declaration of calories for self-
service beverages.
    Section 101.11(b)(2)(iii)(A)(3)(iii) of the final rule requires 
that, for self-service beverages, calorie declarations must be 
accompanied by the term ``fluid ounces'' and, if applicable, the 
description of the cup size (e.g., ``small,'' ``medium''). By providing 
the number of fluid ounces in the cup in which the self-service 
beverage is served and a description of the size of the cup, if 
applicable, along with the calories for the self-service beverage, the 
calorie declaration will provide necessary context regarding the amount 
of the beverage (i.e., the number of fluid ounces dispensed) upon which 
to base the number of calories for the self-service beverage. This 
information will enable consumers to determine how many calories are 
contained in a serving of the self-service beverage in a direct and 
consistent manner.

E. Manner of Declaring Calories for Self-Service Foods and Foods on 
Display

1. Increments of Calories
    Proposed Sec.  101.11(b)(2)(iii)(A)(3)(i) would require that 
calories for self-service food and food on display be declared to the 
nearest 5-calorie increment up to and including 50 calories and to the 
nearest 10-calorie increments above 50 calories except that amounts 
less than 5 calories may be expressed as zero.
    We received no comments on this proposed provision and are 
finalizing it without change, except for an editorial change to express 
``nearest 10-calorie increments'' in the singular (i.e., ``nearest 10-
calorie increment'').
2. Requirements for Declaration of Calories To Be Clear and Conspicuous
    Proposed Sec.  101.11(b)(2)(iii)(A)(3)(ii) would require that if 
the food is not already accompanied by a sign with the food's name, 
price, or both, the calorie declaration, accompanied by the term 
``Calories'' or ``Cal'', must appear on a

[[Page 71224]]

sign adjacent to the standard menu item in a clear and conspicuous 
manner if the food is not already accompanied by a sign with the food's 
name, price or both. If the food is already accompanied by a sign with 
the food's name, price, or both, the calorie declaration and the term 
``Calories'' or ``Cal'' must appear on that sign in a type size no 
smaller than the name or price of the menu item whichever is smaller, 
in the same color or a color that is at least as conspicuous as that 
name or price using the same contrasting background. Proposed Sec.  
101.11(b)(2)(iii)(A)(3)(ii) inadvertently included the clause ``if the 
food is not already accompanied by a sign with the food's name, price, 
or both'' in two locations within the provision.
    In the proposed rule, we requested comment on whether additional or 
more specific formatting requirements are necessary (76 FR 19192 at 
19215). In the following paragraphs, we discuss comments on the 
proposed provision. We also discuss comments in response to our 
specific request on whether additional or more specific formatting 
requirements are necessary. After considering these comments, we are 
finalizing it with the following changes:
     For consistency with the provisions we are establishing in 
Sec.  101.11(b)(2)(iii)(A), we are specifying that the calorie 
declarations must include the amount of the serving on which the 
calories are based.
     For consistency with the provisions we are establishing in 
Sec.  101.11(b)(2)(iii), we are making a series of changes to address 
options that a covered establishment can use to declare calories for 
self-service food or food on display, including the use of an 
additional sign even if a food is already accompanied by a sign with 
the food's name, price, or both.
     To provide for a consistent approach to the requirements 
for a contrasting background throughout the rule, we are providing 
additional flexibility for the contrasting background used for the 
calorie declaration and making a conforming editorial change to the 
grammatical construction of the requirement for the color used for the 
calorie declaration.
     As an editorial correction for clarity, we are inserting 
``the type size of'' between ``no smaller than'' and ``the name or 
price.''
    (Comment 126) One comment recommended that we require the calorie 
declaration to be clear and conspicuous but not in a type size as large 
as the food's name or price. The comment maintained that if these foods 
already have signs, there is likely no room for calorie declarations.
    One comment pointed out that fountain machines have small signs or 
``valve decals'' on which the name is placed. According to the comment 
these valve decals can be as small as 0.7 x 1 inches to 5.25 x 5.25 
inches and these signs do not have enough space to list the calorie 
declarations. The comment recommended that a covered establishment not 
have to list the calories adjacent to the dispenser if calories for 
fountain drinks are listed on menus and menu boards and the written 
nutrition information is available, because to do so would be 
burdensome.
    One comment asked us to allow a covered establishment to use a sign 
or placard placed adjacent to the fountain beverage machine that lists 
the calories. Another comment recommended that calorie declarations for 
self-serve beverages be posted on menus, menu boards, or brochures, and 
not at the dispensers. One comment recommended that calorie 
declarations be listed both on the menu boards and the dispenser for 
each type of beverage dispensed.
    One comment noted that brand names are stylized and therefore the 
names of beverages may be in different type sizes. The comment 
maintained that tying the type size of the calories to the name of the 
beverage would result in differing sizes for calories, which could be 
confusing.
    (Response 126) Section 403(q)(5)(H)(iii) of the FD&C Act requires 
covered establishments to place adjacent to each standard menu item 
that is a self-service food or food on display, including self-service 
beverages, a sign that lists calories per displayed food item or per 
serving. As discussed previously in this document (see Response 116), a 
covered establishment must also declare calories on a menu or menu 
board, and follow all applicable requirements of Sec.  101.11(b)(2)(i) 
for declaration of calories on the menu or menu board, when self-
service food or food on display is listed on the menu or menu board.
    We acknowledge that there may be space limitations on signs used 
for self-service food (including valves used for self-service 
beverages) and foods on display. As already discussed in section 
XVII.B, we have revised Sec.  101.11(b)(2)(iii)(A) to provide more 
options for the declaration of calories for self-service food and food 
on display, including the use of additional signs, signs attached to a 
sneeze guard, or a single sign or placard listing the calorie 
information for several standard menu items that are self-service or on 
display provided that certain conditions are met. These options provide 
additional flexibility for a covered establishment that offers self-
service foods, including self-service beverages, to declare the 
calories in a manner that works best for it. For example, a covered 
establishment has an option to declare the calories on a sign separate 
from the sign containing the food's name and price, provided the 
calories are clearly associated with the particular food item. Doing so 
would no longer link the type size requirements for a self-service 
beverage to those for the name of the beverage. As a result, we have 
revised Sec.  101.11(b)(2)(iii)(A)(3)(ii) to provide that if a calorie 
declaration for a self-service food or food on display is provided on a 
sign that includes the food's name, price, or both, the calorie 
declaration, accompanied by the term ``Calories'' or ``Cal'' and the 
amount of the serving or displayed food item on which the calorie 
declaration is based, must be in a type size no smaller than the type 
size of the name or price of the food, whichever is smaller, in the 
same color, or a color that is at least as conspicuous as that used for 
the name or price, using the same contrasting background, or a 
background at least as contrasting.
    (Comment 127) One comment addressed the different proposed 
requirement for self-service food and food on display depending on 
whether the food is already accompanied by a sign with the food's name, 
price, or both. If the food is already accompanied by such a sign, the 
comment said that the proposed provision would be prescriptive with 
respect to type size, color, and contrast requirements for the calorie 
declarations, whereas if the food is not already accompanied by such a 
sign, the proposed provision would be less prescriptive by merely 
requiring that calorie declarations be ``clear and conspicuous.'' The 
comment asked us to revise the rule to establish the less prescriptive 
requirement that the calorie information be clear and conspicuous 
regardless of whether the food is accompanied by a sign with the name 
or price of the food. The comment considered that a prescriptive 
requirement linked to type size, color, and contrast requirements of 
the food's name, price, or both would be misleading because it would 
imply that the number of calories in a food, which is just one 
attribute of the food, is as important as the name of a food.
    One comment stated that the type size of calorie declarations 
should be no smaller than the name or price, whichever is larger. 
Another comment stated that the calories for food on display should be 
permitted to be

[[Page 71225]]

displayed in a font that is smaller than the font size of the name of 
the menu item. (By ``menu item,'' we assume that the comment means the 
food's name, price, or both.) One comment suggested that the provision 
be revised to include ``The calorie information on the sign must be 
readable from the point where consumers are choosing their food, and it 
must be readily apparent which sign labels which item, both by 
proximity and by including the name of the product on the sign.''
    (Response 127) We disagree that we should require the type size of 
the calorie declaration for food on display to be no smaller than the 
type size of the name or price, whichever is larger. All other 
requirements of this rule that anchor a type size to information 
already presented to consumers allow a covered establishment to use a 
type size no smaller than (rather than no larger than) the type size of 
the information already presented, and the comment provided no basis 
for why the rule should have a different standard for calorie 
declarations on signs for food on display and self-service food.
    We also disagree that calories for food on display and self-service 
food should be permitted to be displayed in a font that is smaller than 
the font size of the name or price of the menu item. Because consumers 
need to see the name and price to place an order, anchoring the type 
size of the calorie declaration to the type size of information already 
on the sign acts, in essence, as an objective and measurable 
performance standard for whether a disclosure is clear, conspicuous, 
and prominent. Thus, we do not agree that a smaller type size should be 
used for the calorie declaration, because doing so would no longer 
provide for such an objective and measurable performance standard. 
Therefore, we are retaining the type size requirements for the calorie 
declaration for food on display and self-service food that are already 
accompanied by individual signs. However, to be consistent with changes 
we are making to other provisions of the rule, we have revised Sec.  
101.11(b)(2)(iii)(A)(3)(ii) to provide additional flexibility for the 
contrasting background of the calorie declaration by permitting the 
calorie declaration to be in a background at least as contrasting as 
that used for the name or price of the menu item. We also are making a 
conforming editorial change to the grammatical construction of the 
requirement for the color used for the calorie declaration to match the 
grammatical construction of the revised requirement for the contrasting 
background used for the calorie declaration. We also are making an 
editorial correction to insert ``the type size of'' between ``no 
smaller than'' and ``the name or price.''
    No comments suggested specific formatting requirements for calorie 
declarations when there are no pre-existing signs with the name or 
price of the food to which the calorie declaration can be anchored. 
Covered establishments have the flexibility to post the calorie 
information in a manner that ensures that it is clear, conspicuous, and 
prominent.
3. Manner of Declaring Calories for Self-Service Beverages
    In the proposed rule, we stated that the self-service beverage 
dispenser itself must have calorie declarations for each flavor or 
variety offered, such that the calorie declaration is clearly 
associated with its corresponding flavor or variety (76 FR 19192 at 
19216). We received comment on calorie declarations for self-service 
beverages. After considering these comments, we are adding a new 
provision to require, for self-service beverages, that calorie 
declarations be accompanied by the term ``fluid ounces'' and, if 
applicable, the description of the cup size (e.g., ``small,'' 
``medium'').
    (Comment 128) A few comments recommended that calories be posted at 
self-service fountain dispensers for each beverage size offered in the 
covered establishment. One comment asked us to permit a sign or placard 
placed adjacent to a fountain beverage machine to separate calorie 
ranges for specific subcategories, e.g., regular soda, diet soda, milk, 
coffees, teas, juice by cup size. A few comments recommended that 
calorie declarations should provide the amount of calories as a range 
per size.
    (Response 128) We agree that calories must be posted at self-
service fountain dispensers for each beverage size offered in the 
covered establishment. As noted previously, section 403(q)(5)(H)(iii) 
of the FD&C Act requires covered establishments to place adjacent to 
each standard menu item that is a self-service food or food on display, 
including self-service beverages, a sign that lists calories per 
displayed food item or per serving. As already discussed (see section 
XVII.B), Sec.  101.11(b)(2)(iii)(A) provides several options for where 
and how a covered establishment could place a sign or placard.
    Earlier in this document, we discussed another comment directed to 
the declaration of calories for self-service beverages (see Comment 126 
and Response 126). A self-service standard menu item, including a self-
service beverage, is subject to Sec.  101.11(b)(2)(i) (in addition to 
Sec.  101.11(b)(2)(iii)) when such food is listed on a menu or menu 
board (see Comment 116 and Response 116). The format requirements for 
variable menu items in Sec.  101.11(b)(2)(i)(A)(4) through 
(b)(2)(i)(A)(7) would apply to calorie declarations on a menu or menu 
board. Accordingly, to the extent that self-service beverages offered 
for sale in different flavors or varieties are listed as single menu 
items on menus or menu boards (e.g., ``soft drinks''), a covered 
establishment would be required to declare calories on such menus and 
menu boards for such foods using the same methods applicable to other 
variable menu items, including ranges, as specified in Sec.  
101.11(b)(2)(i)(A)(4) through (b)(2)(i)(A)(8). However, at the point of 
self-service, a self-service beverage would be subject to the 
requirements of section 403(q)(5)(H)(iii) of the FD&C Act and Sec.  
101.11(b)(2)(iii). For a standard menu item that is a self-service 
food, such as a self-service beverage, section 403(q)(5)(H)(iii) of the 
FD&C Act requires the covered establishment to ``place adjacent to each 
food offered a sign that lists the calories per displayed food item or 
per serving.'' Typically, a self-service fountain beverage machine 
separately dispenses each flavor or variety of beverage from individual 
valves or dispensers that list the flavor or variety of the beverage 
(such as orange soda, cola, diet cola), and the consumer can see what 
beverage flavors and varieties are available. Otherwise, consumers 
would not be able to determine which flavor or variety of beverage is 
dispensed from a particular valve or dispenser at the self-service 
fountain beverage machine. Because these self-service beverages 
typically are presented in a manner that allows consumers to see each 
beverage individually, as well as the other beverages available, 
including other beverages offered in different flavors or varieties, 
the way in which these standard menu items are offered for sale is not 
analogous to standard menu items that come in different flavors or 
varieties but are listed as a single menu item on a menu or menu board. 
Further, because consumers can see flavor or variety of self-service 
beverage offered for sale, the consumer should also be able to see the 
number of calories contained in each flavor or variety offered for sale 
at the self-service machine. For these reasons, calories must be 
declared for each specific flavor or type of beverage available at a 
self-service machine rather than declared as a range.

[[Page 71226]]

    (Comment 129) A few comments recommended that covered establishment 
should declare the amount of calories for self-service beverages based 
on the number of ounces served. A few other comments opposed declaring 
the number of calories per ounces served. These comments contended that 
it is more practical to estimate the size of a beverage with a 
household measure than to guess the ounces without measuring the 
beverage. The comments maintained that calories per ounce would be 
confusing. One comment stated that there is not enough space on menus 
for declaring the number of calories per ounce served.
    (Response 129) We disagree that declaring calories based on the 
volume in fluid ounces for self-service beverages, as required by Sec.  
101.11(b)(2)(iii)(A)(2)(iii) of the final rule, would be overly 
confusing. Fluid ounces are commonly used to describe the volume of 
beverages in packaged food sold in the United States and, thus, 
consumers who purchase beverages likely would be familiar with ``fluid 
ounces'' in the context of beverages. Further, as discussed previously 
(see Response 125), Sec.  101.11(b)(2)(iii)(A)(2)(iii) of the final 
rule specifies that, for self-service beverages, ``per serving'' means 
per total number of fluid ounces in the cup in which a self-service 
beverage is served and, if applicable, the description of the cup size 
(e.g., ``140 calories per 12 fluid ounces (small)''). As an operational 
companion to Sec.  101.11(b)(2)(iii)(A)(2)(iii), we also are 
establishing in Sec.  101.11(b)(2)(iii)(A)(3)(iii) of the final rule 
specific format requirements applicable to the declaration of calories 
for self-service beverages. Section 101.11(b)(2)(iii)(A)(3)(iii) of the 
final rule requires that, for self-service beverages, calorie 
declarations must be accompanied by the term ``fluid ounces'' and, if 
applicable, the description of the cup size (e.g., ``small,'' 
``medium''). For example, calories could be declared as ``small Orange 
Fizz (12 fluid ounces)--150 calories.'' Accordingly, the calorie 
declaration will provide information regarding the number of fluid 
ounces served, and in some cases, the size of the cup, along with the 
number of calories. Typically, self-service beverages are offered for 
sale, including listed or otherwise separated by price, based on size 
(e.g., ``small--$1.59,'' ``12 ounces--$1.59''), and the sizes are 
described using general descriptors (e.g., ``small,'' ``medium,'' or 
``large,'') or by fluid ounces. Therefore, in such situations, 
consumers will have further context regarding the number of fluid 
ounces served in a self-service beverage, and, in some cases, the size 
of the cup.

F. Applicability of Requirements for Written Nutrition Information, 
Succinct Statement, and Statement of Availability to Self-Service Foods 
and Foods on Display

    In the proposed rule, we tentatively concluded that covered 
establishments must provide written nutrition information for self-
service foods and foods on display that are standard menu items as 
required by section 403(q)(5)(H)(ii)(III) of the FD&C Act (76 FR 19192 
at 19216).
    (Comment 130) One comment argued that applying certain requirements 
of section 403(q)(5)(H)(ii) of the FD&C Act to self-service food and 
food on display is not a reasonable construction of the statute, given 
that calorie disclosure requirements for self-service food and food on 
display appear ``in a wholly different subclause.'' The comment 
asserted that because the ``subclause'' (section 403(q)(5)(H)(iii)) of 
the FD&C Act) does not require additional written nutrition information 
or a succinct statement concerning suggested daily caloric intake and 
section 403(q)(5)(H)(ii) of the FD&C Act does, Congress deliberately 
omitted those requirements from section 403(q)(5)(H)(iii) of the FD&C 
Act. The comment argued that, given that every word excluded from a 
statute must be presumed to have been excluded intentionally, it is not 
permissible to interpret the statute to require covered establishments 
to provide additional written nutrition information and a succinct 
statement concerning suggested daily caloric intake for self-service 
food and food on display.
    (Response 130) We agree in part, and disagree in part, with the 
comment. As we discussed in the proposed rule and Response 116, section 
403(q)(5)(H)(i) of the FD&C Act states, ``in the case of food that is a 
standard menu item . . . [the covered] establishment shall disclose the 
information described in subclauses (ii) and (iii)'' (emphasis added). 
The word ``and'' between the references to subclauses (ii) and (iii), 
as opposed to a disjunctive ``or,'' indicates that covered 
establishments must follow the requirements in subclause (ii) for all 
standard menu items, as applicable, and subclause (iii) for all 
standard menu items, as applicable.
    We acknowledge that a principle of statutory interpretation is that 
``where Congress includes particular language in one section of a 
statute but omits it in another section of the same [statute], it is 
generally presumed that Congress acts intentionally and purposely in 
the disparate inclusion or exclusion.'' Russello v. U.S., 464 U.S. 16, 
23 (1983) (internal citations omitted). We considered this principle 
when interpreting section 403(q)(5)(H) of the FD&C Act. Section 
403(q)(5)(H)(ii)(III) of the FD&C Act--the section requiring additional 
written nutrition information--omits certain important words. Sections 
403(q)(5)(H)(ii)(I), (II), and (IV) of the FD&C Act specify that 
certain disclosures must appear ``on the menu,'' ``on the menu board,'' 
and ``on the menu or menu board,'' respectively. Section 
403(q)(5)(H)(ii)(III) of the FD&C Act does not mention menus or menu 
boards at all. Because section 403(q)(5)(H)(i) of the FD&C Act states 
that covered establishments must disclose the information in section 
403(q)(5)(H)(ii) and (iii) of the FD&C Act for standard menu items, it 
is reasonable to apply section 403(q)(5)(H)(ii)(III) of the FD&C Act to 
standard menu items, regardless of whether they appear on menus or menu 
boards. Therefore, the rule requires that covered establishments 
provide the additional written nutrition information described in 
section 403(q)(5)(H)(ii)(III) of the FD&C Act for all standard menu 
items, including self-service food and food on display regardless of 
whether such standard menu items appear on menus or menu boards.
    We agree that the succinct statement concerning suggested daily 
caloric intake is required only on menus or menu boards, based on the 
plain language of sections 403(q)(5)(H)(ii)(I)(bb) and 
403(q)(5)(H)(ii)(II)(bb) of the FD&C Act. Similarly, the statement of 
availability of the written nutrition information is only required on 
menus or menu boards, based on the plain language of section 
403(q)(5)(H)(ii)(IV) of the FD&C Act.
    We discuss the specific requirements related to the succinct 
statement and statement of availability for self-service food and food 
on display in the next section. We discuss the specific requirements 
related to the written nutrition information for self-service food and 
food on display in section XVII.H.

G. Succinct Statement and Statement of Availability for Self-Service 
Foods and Foods on Display

    Proposed Sec.  101.11(b)(2)(iii)(B) would require that for food on 
display identified by a menu (meaning an identifying sign) adjacent to 
the food itself, the statement that puts the calorie

[[Page 71227]]

information in the context of a recommended total daily caloric intake 
as required by Sec.  101.11(b)(2)(i)(B) and the statement regarding the 
availability of the additional written nutrition information required 
by Sec.  101.11(b)(2)(i)(C) must be provided in one of two ways. 
Proposed Sec.  101.11(b)(2)(iii)(B) would permit these two statements 
to appear either on the sign adjacent to the standard menu item or on a 
separate, larger sign, in close proximity to the food on display, that 
can be easily read as the consumer is making order selections. Proposed 
Sec.  101.11(b)(2)(iii)(B) would explain that this requirement is 
satisfied if the two statements appear on a large menu board that can 
be easily read as the consumer is viewing the food on display.
    In the following paragraphs, we discuss comments on this proposed 
provision. After considering these comments, we have revised the 
provision to clarify that the requirements to provide the statement 
that puts the calorie information in the context of a recommended total 
daily caloric intake (also referred to as the ``succinct statement'') 
and the statement of availability for foods on display apply to all 
types of food on display, including those that are self-service. 
Further, we are also providing further flexibility for how to satisfy 
those requirements.
    (Comment 131) In the proposed rule, we noted that signs identifying 
food on display placed adjacent to such foods meet the definition of a 
``menu'' or ``menu board'' within the meaning of section 
403(q)(5)(H)(xi) of the FD&C Act, in that such signs are the primary 
writings of the establishment from which consumers make order 
selections (76 FR 19192 at 19217). Further, we noted that, as a result, 
the requirements to disclose the succinct statement and statement of 
availability on menus and menu boards under sections 
403(q)(5)(H)(ii)(I)(bb), (II)(bb), and (IV) of the FD&C Act would apply 
to such small signs (76 FR 19192 at 19217). However, we noted that the 
requirements to post the statements on small signs seem to pose 
difficulties given the size of such signs, and from a consumer's 
perspective, it is probably unnecessary for the two statements to 
appear on every single individual identifying sign.
    Taking these issues into consideration, along with the space on 
small signs that constitute menus and menu boards, as provided in 
section 403(q)(5)(H)(x) of the FD&C Act, we tentatively concluded that 
each individual sign could be considered its own menu, but that a set 
of signs that are in close proximity to each other, such as those that 
might identify items in a bakery display counter, could be viewed 
together as the primary writing from which consumers choose among those 
items to order (76 FR 19192 at 19217). As a result, we proposed in 
Sec.  101.11(b)(2)(iii)(B) that covered establishments may place the 
succinct statement and statement of availability on individual specific 
signs or on a separate, larger sign, in close proximity to food on 
display, that can be easily read as the consumer is making his or her 
order selection (76 FR 19192 at 19217). In addition, we tentatively 
concluded that signs identifying food on display that are the primary 
writing from which consumers select the corresponding items to order 
and are in close proximity to the menu board, such that the menu board 
can be easily read as the consumer is viewing the food on display, 
could be considered part of that menu board.
    One comment asserted that menu boards, tags, and other signs within 
an establishment are used by consumers to identify standard menu items 
and make order selections. The comment argued, however, that tags or 
other signs should not be considered menus or menu boards because a 
menu board lists multiple items from which a consumer can make an order 
selection.
    One comment argued that if the succinct statement and statement of 
availability already appeared on a menu board, they should not have to 
appear again on signs adjacent or in close proximity to self-service 
foods or foods on display. The comment stated that the final rule 
should provide that posting the statement of availability and the 
succinct statement on the menu board of the covered establishment is 
sufficient to inform consumers who are selecting food on display and 
self-service food.
    (Response 131) We agree that an individual small sign adjacent to a 
self-service food or food on display that contains the name (or image) 
and price of a standard menu item, and that can be used by a consumer 
to make an order selection from the establishment at the time the 
consumer is viewing the sign would meet the definition of a menu or 
menu board within the meaning of section 403(q)(5)(H)(xi) of the FD&C 
Act. As a result, the requirements of sections 403(q)(5)(H)(ii)(I)(bb), 
(II)(bb), and (IV) of the FD&C Act for a succinct statement and 
statement of availability apply to such signs. However, as we noted in 
the proposed rule, the obligation to provide the succinct statement and 
statement of availability on every individual small sign likely would 
pose difficulties given the small size of these individual signs, and 
it likely would not be necessary, from a consumer's perspective, for 
the two statements to appear on every individual sign (76 FR 19192 at 
19217). Considering these factors and the limited space on these 
individual small signs that constitute menus or menu boards, as 
described by section 403(q)(5)(H)(x)(II) of the FD&C Act, we conclude 
that, while each individual sign could be considered its own menu, a 
set of signs that are in close proximity to each other could also be 
viewed together as the primary writing from which consumers choose 
among items in making order selections. Further, we conclude that a 
covered establishment can satisfy the requirements for posting a 
succinct statement and statement of availability for self-service foods 
and foods on display by posting such statements on the individual sign 
adjacent to the food itself, on a separate, larger sign, in close 
proximity to the food that can be easily read as the consumer is making 
an order selection, or on a large menu board that can be easily read as 
the consumer is ordering the food. Accordingly, we are retaining Sec.  
101.11(b)(2)(iii)(B) and making revisions for clarity. We have revised 
Sec.  101.11(b)(2)(iii)(B) to clarify that the provision applies to 
food that is self-service or on display and is identified by an 
individual sign adjacent to the food itself where such sign meets the 
definition of a menu or menu board under paragraph (a) of this section. 
As an inadvertent error, proposed Sec.  101.11(b)(2)(iii)(B) opened 
with the clause ``For food on display'' and did not specifically 
identify food that is self-service as being covered by the proposed 
requirements for providing the succinct statement and statement of 
availability on signs that are menus. As a practical matter, food that 
is ``self-service'' is ``on display'' and, thus, the requirements apply 
to ``self-service food'' regardless of whether ``self-service food'' is 
specified or not. Comments that addressed proposed Sec.  
101.11(b)(2)(iii)(B) from the perspective of both food on display and 
self-service food implicitly acknowledged that self-service foods would 
be subject to proposed Sec.  101.11(b)(2)(iii)(B). Moreover, Sec.  
101.11(b)(2)(iii)(B) is a subparagraph of Sec.  101.11(b)(2)(iii), 
which establishes requirements for ``food that is self-service or on 
display.'' For clarity, and to ensure that covered establishments are 
aware that Sec.  101.11(b)(2)(iii)(B) and the flexibility it provides 
applies to self-service foods identified by a menu adjacent to the food 
itself, we have revised the opening clause of

[[Page 71228]]

Sec.  101.11(b)(2)(iii)(B) to read ``For food that is self-service or 
on display . . .'' We also are making associated edits throughout the 
provision to remove any narrow reference only to food that is on 
display.

H. The Written Nutrition Information That Must Be Provided for Food 
That Is Self-Service or on Display

    Proposed Sec.  101.11(b)(2)(iii)(C) would require that the 
nutrition information in written form required by Sec.  
101.11(b)(2)(ii) be provided for food that is self-service or on 
display, except for packaged food that bears nutrition labeling 
information required by Sec.  101.9 if the packaged food, including its 
label, can be examined by a consumer before purchasing the food. In the 
following paragraphs, we discuss comments on this proposed provision. 
After considering these comments, we have revised Sec.  
101.11(b)(2)(iii)(C) to clarify the regulatory requirements that apply 
to the nutrition labeling information on the packaged food.
    (Comment 132) One comment asked us to provide more detail on what 
format establishments may use to provide the written nutrition 
information for foods on display and self-service food to ensure that 
the information is readily available and easily readable.
    (Response 132) Section 101.11(b)(2)(ii) both requires that written 
nutrition information be available for standard menu items and 
establishes format requirements for that written nutrition information. 
With one exception, the format requirements of Sec.  101.11(b)(2)(ii) 
apply to standard menu items that are self-service food or food on 
display. See Sec.  101.11(b)(2)(ii) and the discussion of Sec.  
101.11(b)(2)(ii) in section XVI. The exception is for packaged foods, 
insofar as they bear nutrition labeling required by section 
403(q)(5)(H)(ii)(III) of the FD&C Act and Sec.  101.11(b)(ii)(2)(D). We 
discuss this exception further in Response 133.
    (Comment 133) Two comments asked us to broaden the exception in 
Sec.  101.11(b)(2)(iii)(C) for packaged food in compliance with Sec.  
101.9, regardless of whether the nutrition information can be examined 
prior to purchase. One comment pointed out that some packaged 
confectioneries may be placed near the cash register in a covered 
establishment. The comment stated that these confectioneries may be 
exempt from the nutrition labeling requirements of Sec.  101.9 because 
they have fewer than 12 square inches of available label space or may 
be in gift packages. This comment stated that if a food is subject to 
and in compliance with Sec.  101.9, it should not also be subject to 
Sec.  101.11. The comment maintained that a food should be required to 
comply with one nutrition labeling regulation or the other, but not 
both. Another comment stated that some foods, such as food in small 
packages, foods with insignificant amounts of all the nutrients 
required on the labels of packaged food (e.g., bottled water) and foods 
sold in gift packages, which may provide the nutrition information 
inside the box or package, should be exempt from the menu labeling 
requirements even though their nutrient content cannot be examined by 
consumers prior to purchase. The comment also stated that if these 
foods included front of package labeling, they would lose the exemption 
from nutrition labeling.
    (Response 133) Section 403(q)(5)(H) of the FD&C Act does not 
establish any new requirements regarding the labels of packaged food. 
Furthermore, to clarify that the requirements of Sec.  101.11 do not 
affect the exemptions from nutrition labeling under Sec.  101.9(j)(2) 
and (j)(3), we proposed conforming amendments to Sec.  101.9(j)(2) and 
(j)(3). As discussed in the proposed rule, the NLEA amendments to the 
FD&C Act included an exemption, at sections 403(q)(5)(A)(i) and (ii) of 
the FD&C Act, for nutrition labeling for food that is ``served in 
restaurants or other establishments in which food is served for 
immediate human consumption'' or ``sold for sale or use in such 
establishments'' (76 FR 19192 at 19193 (citing 21 U.S.C. 
343(q)(5)(A)(i)). The NLEA amendments also included an exemption for 
food of the type described in section 403(q)(5)(A)(i) of the FD&C Act 
that is primarily processed and prepared in a retail establishment, 
ready for human consumption, ``offered for sale to consumers but not 
for immediate human consumption in such establishment and which is not 
offered for sale outside such establishment.'' (21 U.S.C. 
343(q)(5)(A)(ii)). We issued regulations for these exemptions at Sec.  
101.9(j)(2) and (j)(3); however, these exemptions were contingent on 
there being no nutrient content claims or other nutrition information 
in any context on the labeling or in the labeling or advertising. As 
discussed in section IV.B, we are finalizing the conforming amendments 
to Sec.  101.9(j)(2) and (j)(3). Likewise, as discussed in section 
IV.B, we also have made a conforming amendment to Sec.  101.9(j)(4), 
which applies to foods that contain insignificant amounts of nutrients 
and food components required to be included in the declaration on 
nutrition information under Sec.  101.9(c). As a result, a food that is 
exempt from the requirements of Sec.  101.9 under Sec.  101.9(j)(2), 
(j)(3), and (j)(4) would not fall out of such exemption by complying 
with the requirements of Sec.  101.11. We also note that, for a 
standard menu item that contains insignificant amounts of all of the 
nutrients required in Sec.  101.11(b)(2)(ii)(A), including, if 
applicable, a packaged food, a covered establishment generally would 
not be required to provide written nutrition information for that 
standard menu item (see Sec.  101.11(b)(2)(ii)(B)).
    Section 101.11 does not change the food label requirements under 
Sec.  101.9(h)(3) for food products with separately packaged 
ingredients or foods where a package contains a variety of foods, or an 
assortment of foods, and is in a form intended to be used as a gift. 
Similarly, Sec.  101.11 does not change the exception at Sec.  
101.9(j)(13)(i) for foods in small packages that have a total surface 
area of less than 12 square inches of available label space. To the 
extent that such foods are offered for sale in covered establishments, 
they generally would fall within the exceptions at Sec.  101.9(j)(2) 
and (j)(3); when this is the case, the conforming amendments to Sec.  
101.9(j)(2) and (j)(3) would preserve the pre-existing exemptions under 
Sec.  101.9 for such foods.
    While section 403(q)(5)(H) of the FD&C Act does not establish any 
new requirements regarding the labels of packaged food, there may be 
some situations in which a covered establishment (rather than the 
manufacturer of a packaged food) must disclose nutrition information 
for a food on display or a self-service food that is a packaged food, 
such as a packaged food that is offered for sale at a cash register in 
a covered establishment. For example, if a standard menu item, such as 
a package of chips, is on display (e.g., a package of chips that is 
part of a combination meal or listed individually on a menu or menu 
board and is available at a cash register), the covered establishment 
would be required to post a calorie declaration on a sign adjacent to 
the package of chips and provide written nutrition information for the 
package of chips unless the label for the chips bears calorie and 
certain other nutrition information and can be examined by the consumer 
prior to purchase. Further, the covered establishment would be required 
to post a calorie declaration for the package of chips on a menu and 
menu board to the extent the package of chips is listed on such menu 
and menu board.
    In the proposed rule, we tentatively concluded that a packaged food 
that is self-service or food on display that bears

[[Page 71229]]

nutrition information required by section 403(q)(1) of the FD&C Act and 
Sec.  101.9 satisfies the calorie disclosure requirement for self-
service food or food on display in section 403(q)(5)(H)(iii) of the 
FD&C Act and the written nutrition information requirement of section 
403(q)(5)(H)(ii)(III) of the FD&C Act (see 76 FR 19192 at 19217 and 
19235). In addition, we tentatively concluded that, in such a 
situation, a covered establishment would still be required to post 
calorie declarations on menus and menu boards for packaged foods that 
are standard menu items and are listed on such menus and menu boards 
(e.g., where ``chips'' is listed on a menu board and refers to packaged 
bags of chips that are available as self-service foods or foods on 
display) (76 FR 19192 at 19217). We affirm these conclusions; however, 
we have revised the exception at Sec.  101.11(b)(2)(iii)(C).
    Under proposed Sec.  101.11(b)(2)(iii)(C), self-service food and 
food on display would be subject to the written nutrition information 
requirement of Sec.  101.11(b)(2)(ii), except for packaged food that 
bears nutrition labeling information required by Sec.  101.9 if the 
packaged food can be examined by a consumer before purchasing. In 
response to comments regarding a food that is in compliance with Sec.  
101.9 but does not otherwise bear nutrition labeling, we have revised 
the exception at Sec.  101.11(b)(2)(iii)(C) to clarify in relevant part 
that a covered establishment is not required to provide the written 
nutrition information in Sec.  101.11(b)(2)(ii) for a packaged food, 
insofar as that packaged food bears the nutrition information specified 
in section 403(q)(5)(H)(ii)(III) of the FD&C Act and the written 
nutrition information requirements of Sec.  101.11(b)(2)(ii). For 
example, if the package of chips described previously includes 
Nutrition Facts information, including the nutrition information 
specified in section 403(q)(5)(H)(ii)(III) of the FD&C Act and Sec.  
101.11(b)(2)(ii), a covered establishment would not be required to 
provide written nutrition information for the chips as required by 
Sec.  101.11(b)(2)(ii), provided that the packaged food, including its 
label, can be examined by a consumer before purchasing the food. 
However, if the package of chips does not bear the nutrition 
information specified in section 403(q)(5)(H)(ii)(III) of the FD&C Act 
and Sec.  101.11(b)(2)(ii) (e.g., because it is exempt from the 
nutrition label requirements of Sec.  101.9, such as a food in a small 
package that has fewer than 12 square inches of available label space 
as provided by Sec.  101.9(j)(13)), the covered establishment would be 
required to provide written nutrition information for the chips as 
required by Sec.  101.11(b)(2)(ii). Moreover, if the package of chips 
does not bear the nutrition information specified in section 
403(q)(5)(H)(ii)(III) of the FD&C Act and Sec.  101.11(b)(2)(ii), the 
food would not satisfy the calorie disclosure requirement for self-
service food or food on display in section 403(q)(5)(H)(iii) of the 
FD&C Act, and the covered establishment would be required to disclose 
the number of calories contained in the package of chips on a sign 
adjacent to the food, in accordance with Sec.  101.11(b)(2)(iii). In 
either situation, the establishment would be required to post a calorie 
declaration for the package of chips on the menu and menu board to the 
extent the package of chips is listed on such menu and menu board, as 
required by Sec.  101.11(b)(2)(i).

XVIII. Comments and FDA Response on Proposed Sec.  101.11(c)(1) to 
(c)(5)--Determination of Nutrient Content (Final Sec.  101.11(c)(1) to 
(c)(2))

    Under section 403(q)(5)(H)(iv) of the FD&C Act, a covered 
establishment must have a reasonable basis for its nutrient content 
disclosures, including nutrient databases, cookbooks, laboratory 
analyses, and other reasonable means, as described in Sec.  101.10. 
Proposed Sec.  101.11(c)(1) would establish this reasonable basis 
requirement in this rule.
    In addition, proposed Sec.  101.11(c)(2), (c)(3), (c)(4), and 
(c)(5) would establish requirements for determining compliance with 
proposed Sec.  101.11(c)(1). As discussed in the proposed rule, because 
the nutrition information that is required to be disclosed by covered 
establishments is a subset of the nutrition information required in 
Sec.  101.9, we modeled proposed Sec.  101.11(c)(2), (c)(3), (c)(4), 
and (c)(5) after our regulation for compliance with the nutrition 
labeling requirements for packaged foods in Sec.  101.9(g) (76 FR 19192 
at 19218). In brief, for purposes of compliance, proposed Sec.  
101.11(c)(2), (c)(3), (c)(4), and (c)(5) would establish the following:
     Proposed Sec.  101.11(c)(2) would define two classes of 
nutrients. ``Class I'' nutrients would be ``added'' nutrients and 
``Class II'' nutrients would be ``naturally occurring'' (indigenous) 
nutrients in standard menu items;
     Proposed Sec.  101.11(c)(3) would establish conditions 
under which a standard menu item with a nutrient declaration of 
protein, total carbohydrate, or dietary fiber would be deemed to be 
misbranded under section 403(a) of the FD&C Act, including a 
requirement that, for Class II protein, total carbohydrate, or dietary 
fiber, the nutrient content of an appropriate composite of a standard 
menu item not be less than 80 percent of the declared value;
     Proposed Sec.  101.11(c)(4) would establish conditions 
under which a standard menu item with a nutrient declaration of 
calories, sugars, total fat, saturated fat, trans fat, cholesterol, or 
sodium would be deemed to be misbranded under section 403(a) of the 
FD&C Act, including a requirement that the nutrient content of an 
appropriate composite of a standard menu item not be more than 20 
percent in excess of the declared value; and
     Proposed Sec.  101.11(c)(5) would allow for reasonable 
excesses of protein, total carbohydrate, dietary fiber and reasonable 
deficiencies of calories, sugars, total fat, saturated fat, trans fat, 
cholesterol, or sodium.
    Comments commonly referred to the combined provisions of proposed 
Sec.  101.11(c)(3) and (c)(4) as ``the 80/120 rule.''
    In the following paragraphs, we discuss comments on proposed Sec.  
101.11(c)(1), (c)(2), (c)(3), (c)(4), and (c)(5). After considering 
these comments, we are:
     Finalizing Sec.  101.11(c)(1) with several changes and 
making a companion change to the substantiation requirements of 
proposed Sec.  101.11(c)(6) (which is being established in Sec.  
101.11(c)(3));
     Replacing proposed Sec.  101.11(c)(2), (c)(3), (c)(4), 
and(c)(5) with a new Sec.  101.11(c)(2); and
     Establishing revised certification requirements (in Sec.  
101.11(c)(3)(i)(G), (c)(3)(ii)(D), (c)(3)(iii)(E), and (c)(4)(iv)(E)) 
directed to reasonable steps that a covered establishment takes to 
ensure that the method of preparation (e.g., types and amounts of 
ingredients in the recipe, cooking temperatures) and amount of a 
standard menu item offered for sale adhere to the factors on which the 
nutrient values were determined.
    (Comment 134) One comment asserted that the menu labeling 
requirements would have an impact on the manufacturers of foods sold to 
covered establishments, because covered establishments would look to 
the food manufacturers to supply them with the nutrition information 
that the covered establishments must provide to consumers. For the most 
part, food manufacturers do not currently provide restaurants and 
similar retail food establishments with this information. The comment 
maintained that some manufacturers may elect to provide the nutrition 
information in inserts and

[[Page 71230]]

other forms of labeling, which will require development of guidelines 
on how the nutrition information should be provided to restaurant 
customers.
    One comment asked us to consider nutritional information provided 
by a producer to a covered establishment to be a reasonable basis for 
the covered establishment's nutrition declarations. Another comment 
maintained that because food suppliers are not required to provide 
nutrition information to retailers, compliance with the rule will be 
challenging for covered establishments. The comment asked us to 
consider requiring suppliers to provide nutrition information to 
covered establishments.
    (Response 134) The nutrition labeling provisions of this rule only 
apply to covered establishments as specified in Sec.  101.11(a). 
Section 4205 of the ACA does not require distributors of food sold to 
covered establishments to provide nutrition information to those 
establishments. In addition, section 4205 of the ACA did not remove or 
amend section 403(q)(5)(G) of the FD&C Act, which provides that the 
nutrition labeling requirements of section 403(q)(1) through (4) of the 
FD&C Act do not apply to ``food which is sold by a food distributor if 
the distributor principally sells food to restaurants and other 
establishments in which food is served for immediate human consumption 
and does not manufacture, process, or repackage the food it sells.'' 
Accordingly, this rule does not require distributors of food sold to 
covered establishments to provide nutrition information to covered 
establishments. Nevertheless, we have revised Sec.  101.11(c)(1), in 
relevant part, to expressly specify that the use of Nutrition Facts on 
labels on packaged foods that comply with the nutrition labeling 
requirements of section 403(q)(1) of the FD&C Act and Sec.  101.9 is an 
additional means that may be used as a reasonable basis to determine 
nutrient values.
    We encourage cooperation between food distributors and covered 
establishments so that covered establishments are able to efficiently 
comply with the requirements of this rule. We would consider nutrition 
information otherwise provided by food distributors to covered 
establishments for food sold by such distributors to be captured within 
the provision that nutrient values may be determined by using ``other 
reasonable means'' provided that such nutrition information is truthful 
and not misleading and otherwise in compliance with the requirements of 
sections 403(a)(1) and (q)(5)(H) of the FD&C Act and Sec.  101.11.
    We also have revised Sec.  101.11(c)(1) to include another example 
of ``other reasonable means''--i.e., FDA nutrient values for raw fruits 
and vegetables in Appendix C of part 101 and FDA nutrient values for 
cooked fish in Appendix D of part 101. We developed this nutrition 
information to encourage retail stores that sell raw fruits, 
vegetables, and cooked fish to participate in the voluntary point-of-
purchase nutrition program (Sec. Sec.  101.42 through 101.45).
    (Comment 135) Many comments agreed that a covered establishment 
must have a reasonable basis for its nutrient content disclosures and 
the means for determining them, which include nutrient databases, 
cookbooks, laboratory analyses, and other reasonable means, as 
described in Sec.  101.10. Some comments suggested that we replace the 
language in proposed Sec.  101.11(c) with the language in Sec.  
101.13(q)(5)(ii). Section 101.13(q)(5) sets forth requirements for 
nutrient content claims for food served in restaurants or other 
establishments in which food is served for immediate consumption or 
which is sold for sale or use in such establishments. Section 
101.13(q)(5)(ii) provides that for nutrient content claims made for 
such food, in lieu of analytical testing, compliance may be determined 
using a reasonable basis for concluding that the food that bears the 
claim meets the definition for the claim. It continues by stating that 
this reasonable basis may derive from recognized databases for raw and 
processed foods, recipes, and other means to compute nutrient levels in 
the foods or meals and may be used provided reasonable steps are taken 
to ensure that the method of preparation adheres to the factors on 
which the reasonable basis was determined (e.g., types and amounts of 
ingredients, cooking temperatures). Furthermore, according to Sec.  
101.13(q)(5)(ii), firms making claims on foods based on this reasonable 
basis criterion are required to provide to appropriate regulatory 
officials on request the specific information on which their 
determination is based and reasonable assurance of operational 
adherence to the preparation methods or other basis for the claim.
    (Response 135) We agree that some aspects of Sec.  101.13(c)(5)(ii) 
that we did not include in Sec.  101.11(c) should be added to the rule. 
In particular, Sec.  101.13(c)(5)(ii) requires that reasonable steps be 
taken to ensure that the method of preparation adheres to the factors 
on which the reasonable basis was determined (e.g., types and amounts 
of ingredients, cooking temperatures) when the reasonable basis for a 
nutrient disclosure is derived using databases for raw and processed 
foods, recipes, or other means (e.g., means other than analytical 
testing). As discussed later in this document (see Comment 136), 
several comments opposed our proposal for using a compliance approach 
for determining compliance modeled after Sec.  101.9(g) and some 
comments discussed the problems that can occur when the preparation of 
a menu item does not adhere to a recipe or deviates from the parameters 
used as the reasonable basis. In Response 136, we discuss the 
provisions of Sec.  101.11(c)(2) that we are establishing in this rule 
in lieu of the provisions of proposed Sec.  101.11(c)(2), (c)(3), 
(c)(4), and (c)(5) that were modeled after Sec.  101.9(g). Those new 
provisions specify, in relevant part, that a covered establishment must 
take reasonable steps to ensure that the method of preparation (e.g., 
types and amounts of ingredients, cooking temperatures) and amount of a 
standard menu item offered for sale adhere to the factors on which its 
nutrient values were determined.
    We also agree that Sec.  101.11(c) should require, among other 
things, that a covered establishment provide to FDA on request specific 
information about the basis for its nutrient declarations and 
reasonable assurance of operational adherence to the preparation 
methods used as the basis for its nutrient declarations. As discussed 
in Response 136, we have revised the rule to establish these 
requirements.
    We disagree that Sec.  101.11(c) need specify that a reasonable 
basis may derive from recognized databases for raw and processed foods, 
recipes, and other means to compute nutrient levels in the foods or 
meals ``in lieu of analytical testing.'' Proposed Sec.  101.11(c)(1) 
already provides for the use of databases, cookbooks, and ``other 
reasonable means'' in addition to analytical testing. However, we 
acknowledge that this may not have been clear in part because we used 
the conjunction ``and'' in proposed Sec.  101.11(c)(1). To make clear 
that any of the listed means for determining nutrient content may be 
used, we have revised Sec.  101.11(c)(1) to replace the conjunction 
``and'' with the conjunction ``or'' in the second sentence.
    As a companion change, we have revised proposed Sec.  
101.11(c)(6)(iv)(A) (which is renumbered as Sec.  101.11(c)(3)(iv)(A) 
in the final rule), which addresses the information that must be 
provided to FDA, within a reasonable period of time upon request,

[[Page 71231]]

when ``other reasonable means are used to provide the nutrition 
information.'' To emphasize that ``other reasonable means'' does not 
require analytical testing, Sec.  101.11(c)(3)(iv)(A)) now requires a 
detailed description of the ``means'' (rather than the ``method'') used 
to determine the nutrition information.
    We are finalizing Sec.  101.11(c)(1) with the following additional 
changes:
     We are substituting the term ``nutrient declarations'' for 
the term ``nutrient disclosures'' for consistency in terms used 
throughout Sec.  101.11. For example, Sec.  101.11(b)(2)(i)(A) 
establishes requirements to ``declare'' calories, and Sec.  
101.11(b)(2)(i)(A)(3) refers to calorie ``declarations.''
     We are clarifying that nutrient databases may be used to 
determine nutrient values regardless of whether they use computer 
software programs. For example, a covered establishment may use a 
nutrient database that both lists nutrient values for certain food 
items and provides software that a covered establishment could use to 
calculate nutrient values for a standard menu item prepared with 
several of the listed foods in varying amounts. Alternatively, a 
covered establishment may use a nutrient database that lists nutrient 
values for certain food items, but does not provide such software. In 
such a circumstance, a covered establishment would perform and document 
its own calculations.
     We are substituting the term ``nutrient values'' for the 
proposed term ``nutrient levels.'' We are making this change throughout 
Sec.  101.11(c), as well as throughout the rule, to consistently use 
the single term ``nutrient values.''
     We are deleting ``as described in Sec.  101.10.'' Section 
403(q)(5)(H)(iv) of the FD&C Act provides that a restaurant or similar 
retail food establishment shall have a reasonable basis for its 
nutrient content disclosures, including nutrient databases, cookbooks, 
laboratory analyses, and other reasonable means, as described in 21 CFR 
101.10 (or any successor regulation) or in a related FDA guidance. 
Section 101.10 requires nutrition labeling for a restaurant food that 
bears a nutrient content or health claim, except that information on 
the nutrient amounts that are the basis for the claim may serve as the 
functional equivalent of complete nutrition information. Under Sec.  
101.10, nutrient levels may be determined by nutrient databases, 
cookbooks, or analyses or by other reasonable bases that provide 
assurance that the food or meal meets the nutrient requirements for the 
claim. In this rule, Sec.  101.11(c)(1) is patterned after Sec.  
101.10, as required by section 403(q)(5)(H)(iv) of the FD&C Act, in 
that it provides for nutrient values to be determined by nutrient 
databases, cookbooks, or analyses or by other reasonable bases. 
However, given that we incorporated the applicable regulatory text from 
Sec.  101.10 into Sec.  101.11(c)(1), there is no need to refer to 
Sec.  101.10 within Sec.  101.11(c)(1). Indeed, including ``as 
described in Sec.  101.10'' within Sec.  101.11(c)(1) could mistakenly 
signal, to both covered establishments and investigators who would 
evaluate compliance with this rule, that a covered establishment must 
look to Sec.  101.10 to determine how to fully comply with Sec.  
101.11(c)(1).
    As finalized, Sec.  101.11(c)(1) states that a covered 
establishment must have a reasonable basis for its nutrient 
declarations. Nutrient values may be determined by using nutrient 
databases (with or without computer software programs), cookbooks, 
laboratory analyses, or other reasonable means, including the use of 
Nutrition Facts on labels on packaged foods that comply with the 
nutrition labeling requirements of section 403(q)(1) of the FD&C Act 
and Sec.  101.9, FDA nutrient values for raw fruits and vegetables in 
Appendix C of part 101 of the chapter, or FDA nutrient values for 
cooked fish in Appendix D of part 101 of the chapter.
    (Comment 136) One comment agreed with our proposal for using an 
approach for determining compliance modeled after Sec.  101.9(g). The 
comment recognized that the proposed approach is consistent with the 
accuracy standards for Nutrition Facts information and stated that even 
relatively small variances can be significant in influencing 
cardiovascular health.
    The majority of comments opposed our proposal for using an approach 
for determining compliance modeled after Sec.  101.9(g), particularly 
with respect to using the ``80/120 rule'' for compliance purposes. Some 
comments maintained that the proposed criteria for compliance modeled 
after Sec.  101.9(g) are not consistent with Sec.  101.10. Some 
comments stated that use of the ``80/120 rule'' for determining 
compliance with the menu labeling requirements of section 403(q)(5)(H) 
of the FD&C Act contradicts 20 years of FDA precedence regarding 
determining compliance for nutrient content claims made for restaurant 
foods. The comments referred to our statements in the final rule 
establishing Sec.  101.10 regarding claims for restaurant food (58 FR 
2302 at 2387, January 6, 1993) and in our 2008 guidance for restaurant 
food (Ref. 10). Based on these statements, the comments asserted that 
we understood the difficulty in determining compliance for restaurant 
foods making nutrient content claims or health claims and acknowledged 
the variations unique to restaurant foods (e.g., by recognizing that 
restaurant foods are generally hand assembled and, therefore, subject 
to individual product variation), and therefore did not require that 
restaurants conduct nutrient analyses for such claims. The comments 
asserted that reasons such as these led us to require in Sec.  101.10 
that restaurants have a reasonable basis for making a nutrient content 
or health claim, and that the proposed rule did not provide any factual 
basis or evidence that the circumstances that justified the original 
``reasonable basis standard'' have changed.
    Some comments asserted that using the ``80/120 rule'' for 
determining compliance with the menu labeling requirements of section 
403(q)(5)(H) of the FD&C Act was not the intent of Congress. Some 
comments considered that use of the ``80/120 rule'' would make the 
reasonable basis statutory provision at section 403(q)(5)(H)(iv) of the 
FD&C Act irrelevant. Some comments asserted that use of the ``80/120 
rule'' in the proposed rule contradicts the plain language of section 
403(q)(5)(H)(iv) of the FD&C Act, and therefore, violates the 
Administrative Procedure Act (APA). One comment asserted that section 
4205 of the ACA proposes a specific standard at section 
403(q)(5)(H)(iv) of the FD&C Act for determining nutrient content 
disclosures under section 4205, and such a specific standard ``does not 
permit an agency to impose a more rigorous standard than one required 
by Congress.'' The comment stated that under the framework articulated 
in Chevron, U.S.A., Inc. v. Natural Resource Defense Counsel, 467 U.S. 
837 (1984), ``courts ask as the threshold question of `whether Congress 
has directly spoken to the precise question at issue,'' and ``[i]f the 
intent of Congress is clear, that is the end of the matter.'' The 
comment stated that section 4205 of the ACA is unambiguous ``in 
adopting the pre-existing reasonable basis standard'' in Sec.  101.10 
to determine compliance with the nutrition labeling requirements of 
section 4205, and ``this reflects a clear directive to FDA which does 
not contemplate, nor permit, any deviation of the kind contemplated in 
the proposed rule.''
    Some comments asserted that Congress expressly directed us to 
consider ``standardization of recipes and methods of preparation, 
reasonable variation in serving size and

[[Page 71232]]

formulation of menu items . . . inadvertent human error, training of 
food service workers, variations in ingredients, and other factors'' in 
issuing regulations to implement section 4205 of the ACA, including 
those regarding reasonable basis. The comments maintained that by 
including this language in section 403(q)(5)(H)(x) of the FD&C Act and 
directing us to consider such factors, Congress demonstrated its 
familiarity with the challenges involved in requiring nutrition 
labeling for restaurant food, identifying many of the same factors that 
led us to implement the reasonable basis standard in Sec.  101.10.
    Some comments maintained that it is not practical to require a 
compliance standard for covered establishments that is the same as had 
been developed for packaged food manufacturers that use modern 
manufacturing calibrated equipment and methods for which the ``80/120 
rule'' is appropriate. Some comments asserted that restaurant food is 
not standardized like packaged food. For example, some comments 
explained that the mere addition of five to seven extra French fries in 
an order of small fries would increase calories more than 20 percent 
and make the food product misbranded under the ``80/120 rule.'' The 
comment stated, as an example, that cheese sticking together and an 
extra squirt of mayonnaise in a food are not negligent practices, but 
would make the nutrient content declaration for the food out of 
compliance. Another comment stated that if a lobster tail is 6 ounces 
rather than 5 ounces, the calories would be 20 percent higher. Some 
comments asserted that using the ``80/120 rule'' for compliance is 
impractical and will require frequent analysis that will add costs. 
Some comments contrasted manufacturers that test for nutrient 
variations at a single point or a handful of points of manufacture with 
restaurants that have thousands of points of manufacture, each of which 
would require separate analysis. One comment asserted that the ``80/120 
standard'' was not practicable and is inflexible for covered 
establishments and would create increased and unnecessary compliance 
and litigation costs for covered establishments.
    One comment asked us to provide flexibility for variations in 
portion size and recipes and allow for disparities between the amount 
of a food used to calculate the calories and the actual size that might 
be served to or taken by customers. This comment recommended that the 
final rule create specific guidelines for displaying caloric 
information for non-uniform menu items (e.g. fresh fruit or pieces of 
chicken).
    Some comments pointed to the variability in the nutrient content of 
restaurant foods based on changes in ingredients and recipes, and 
seasonal changes in the ingredients as reasons for why complying with 
the ``80/120 rule'' would be difficult. One comment noted that moisture 
leaves hot foods at hot-food bars after a certain period of time and as 
a result nutrient values for such foods change from those values listed 
in recipe books. The comment asked us to expand the tolerance by 10 
percent at both ends if we kept compliance requirements similar to the 
``80/120 rule'' rather than a more flexible ``reasonable basis'' 
standard. Some comments pointed out that there is variability in menu 
items due to using locally grown ingredients and that the nutrient 
content of these ingredients can vary by region. One comment asserted 
that if we do not account for this variation in the final rule, it will 
be a disincentive to covered establishments to use local farmers and 
suppliers.
    One comment asserted that use of the ``80/120 rule'' will 
discourage voluntary opting in by restaurants and similar retail food 
establishments not covered by section 403(q)(5)(H) of the FD&C Act, 
which would lead to less national uniformity. The comment stated that 
many State and local restaurant menu labeling laws measure compliance 
using a standard akin to ``the Federal reasonable basis standard'' and 
even where no State nutrition labeling laws apply, a restaurant making 
nutrient content claims would be subject to the ``reasonable basis 
standard'' under 21 U.S.C. 343(r) (i.e., Sec.  101.10). Therefore, 
according to the comment, under the proposed rule, small-chain 
restaurants voluntarily registering with us to be subject to the 
Federal requirements would subject themselves to more potential 
liability under the ``Federal 80/120 standard'' and would thus be less 
likely to voluntarily participate in the Federal menu labeling scheme. 
The comment maintained that in turn, there would be less national 
uniformity in menu labeling, consumers would see less consistent 
nutrition information on menus, and State and local inspectors would 
have to apply a more complex patchwork of regulatory schemes.
    One comment asserted that the ``80/120 rule'' imposes a stricter 
compliance standard for foods with smaller amounts of a particular 
nutrient that should be consumed in limited quantities (e.g., fat and 
cholesterol) because the ``80/120 rule'' measures compliance as a 
percentage of the declared nutrient levels. For example, a deviation of 
1 gram of fat in a salad declared to have 3 grams of fat would make the 
covered establishment out of compliance. The comment asserted that this 
is a disincentive for low fat, low sodium foods and is contrary to the 
purpose of the rule.
    One comment recommended that the amount of protein, total 
carbohydrates, and dietary fiber contained in an appropriate composite 
of a standard menu item be equal to the declared value, not at least 80 
percent of the declared value.
    (Response 136) Proposed Sec.  101.11(c)(2), (c)(3), (c)(4), and 
(c)(5) were modeled after Sec.  101.9(g), including use of the ``80/120 
rule.'' Based on what the comments said, we believe that some comments 
misinterpreted the proposed rule as requiring covered establishments to 
determine nutrition information through laboratory analyses only. We 
did not intend to suggest such a limited requirement. Laboratory 
analysis was merely one of several options we proposed to establish in 
Sec.  101.11(c)(1) to satisfy the requirement for a reasonable basis 
for nutrient levels. Instead, proposed Sec.  101.11(c)(2), (c)(3), 
(c)(4), and (c)(5), were provisions modeled after Sec.  101.9(g), 
including use of the ``80/120 rule,'' explaining how we would determine 
whether a covered establishment is in compliance with the requirement 
(in proposed Sec.  101.11(c)(1)) for a covered establishment to have a 
reasonable basis for its nutrient disclosures. We did not intend for 
proposed Sec.  101.11(c)(2), (c)(3), (c)(4), and (c)(5) to require a 
covered establishment to use laboratory analyses in all circumstances 
to determine nutrition information for standard menu items. A covered 
establishment would have been free to choose any reasonable basis so 
long as it produced accurate results.
    While we do not agree with some of the comments, particularly those 
asserting that our proposal to use the ``80/120 rule'' to determine 
compliance would violate the APA, we agree that using the ``80/120 
rule'' for determining compliance with the nutrition labeling 
requirements likely would raise practical problems such as some of 
those described in the comments. Given these practical problems, we 
have replaced proposed Sec.  101.11(c)(2), (c)(3), (c)(4), and (c)(5) 
with other requirements in a new Sec.  101.11(c)(2). First, Sec.  
101.11(c)(2) specifies that nutrient declarations for standard menu 
items must be accurate and consistent with the specific basis used to 
determine nutrient values. For example, for a nutrient declaration to 
be accurate, a covered establishment that relies on a

[[Page 71233]]

nutrient database for a list of nutrient values, and then uses those 
nutrient values to perform its own calculation of the nutrient values 
in a standard menu item, must correctly add the nutrient values for all 
ingredients in the standard menu item taking into consideration the 
recipe and ingredient amounts used to prepare the standard menu item 
among other factors. Second, Sec.  101.11(c)(2) also specifies that a 
covered establishment must take reasonable steps to ensure that the 
method of preparation (e.g., types and amounts of ingredients in the 
recipe, cooking temperatures) and amount of a standard menu item 
offered for sale adhere to the factors on which its nutrient values 
were determined. Accordingly, under Sec.  101.11(c)(2), a covered 
establishment that selects a recipe from a cookbook and relies on the 
cookbook's nutrition information for such recipe as a basis for the 
establishment's nutrient declarations must take reasonable steps to 
ensure that employees who prepare the standard menu item do not depart 
from that recipe, including the recipe's instructions and ingredient 
amounts. For example, if a covered establishment determines nutrition 
information for a turkey sandwich based on a recipe along with 
nutrition information provided in a cookbook for the turkey sandwich, 
and the recipe specifies using one tablespoon of mayonnaise, the 
establishment must take reasonable steps to ensure that its employees 
use one tablespoon of mayonnaise when preparing the turkey sandwich--
e.g., through appropriate instruction about the importance of the 
consistent application of one tablespoon of mayonnaise to satisfy the 
requirements of this rule.
    Although we recognize inadvertent human error and variations in 
ingredients, covered establishments must ensure that the nutrient 
declarations are truthful and not misleading in part by having standard 
methods of preparation for standard menu items and taking reasonable 
steps to ensure that the methods of preparation used for a standard 
menu item adhere to the factors on which the nutrient levels were 
determined. To make clear that a covered establishment has this 
responsibility, we are also replacing each of the proposed requirements 
(in proposed Sec.  101.11(c)(6)(i)(H), (c)(6)(ii)(D), (c)(6)(iii)(D), 
and (c)(6)(iv)(E)) for a certification statement regarding the recipe 
used to prepare the standard menu item with a requirement for a 
statement signed and dated by a responsible individual employed at the 
covered establishment certifying that the covered establishment has 
taken reasonable steps to ensure that the method of preparation (e.g., 
types and amounts of ingredients in the recipe, cooking temperatures) 
and amount of a standard menu item offered for sale adhere to the 
factors on which its nutrient values were determined. These provisions 
are in Sec.  101.11(c)(3)(i)(G), (c)(3)(ii)(D), (c)(3)(iii)(E), and 
(c)(3)(iv)(E) of the final rule. (See the discussion of these 
provisions in section XIX.)
    We acknowledge that the calorie content of non-uniform menu items 
such as whole fresh fruit and pieces of chicken vary depending on the 
size and, in some cases composition (e.g., chicken breast, thigh, or 
drumstick) of the items. A covered establishment may take such 
variation into consideration when determining the calorie content and 
calorie declaration for the menu item. For example, a covered 
establishment could base its nutrient declarations on the average size 
of a piece of fruit, or on a weighted average of nutrient values for a 
box of chicken that contains a fixed number of chicken breasts, thighs, 
or drumsticks.
    In assessing compliance with Sec.  101.11(c), we will consider the 
factors and criteria specified in both Sec.  101.11(c)(1) and (c)(2), 
including whether the establishment took reasonable steps to ensure 
that the method of preparation for a standard menu item adheres to the 
factors on which the reasonable basis was determined. We will assess 
compliance on a case by case basis, taking into consideration a number 
of factors, including the covered establishment's nutrition labeling, 
the method (e.g., laboratory analysis, nutrient database, cookbook, or 
nutrient information provided on the labels of packaged food) used by 
the covered establishment to determine nutrition information, and the 
steps taken by the establishment to ensure that the method of 
preparation and amount of a standard menu item adhered to the factors 
on which its nutrient values were determined. Further, we may conduct 
our own analysis, including laboratory analysis, as needed, including 
if we find that nutrient declarations appear to be false or misleading 
or the basis upon which the covered establishment based its nutrient 
declaration appears to be unreasonable or is otherwise questionable.

XIX. Comments and FDA Response on Proposed Sec.  101.11(c)(6)--
Substantiation Documentation (Final Sec.  101.11(c)(3))

    Proposed Sec.  101.11(c)(6) would require that a restaurant or 
similar retail food establishment provide to FDA, within a reasonable 
period of time upon request, information substantiating nutrient values 
including the method and data used to derive these nutrient levels. 
Proposed Sec.  101.11(c)(6) would require that covered establishments 
provide the following information:
     For nutrient databases:
    [cir] The identity of the database used.
    [cir] The recipe or formula used as a basis for the nutrient 
declarations. The recipe posted on the database must be identical to 
that used by the restaurant or similar retail food establishment to 
prepare the menu item.
    [cir] For the specified amounts of each ingredient identified in 
the recipe, a detailed listing (e.g., printout) of the amount of each 
nutrient that that ingredient contributes to the menu item.
    [cir] If this information is not available because the nutrition 
information was derived from a computer program, which is designed to 
provide only a final list of nutrient values for the recipe, a 
certificate of validation attesting to the accuracy of the computer 
program.
    [cir] A detailed listing (e.g., printout) of the nutrient values 
determined for each menu item.
    [cir] If this information is not derived through the aid of a 
computer program which provides a final nutrient analysis for the menu 
item, worksheets used to determine the nutrient values for each of 
these menu items.
    [cir] Any other information pertinent to the final nutrient levels 
of the menu item (e.g., information about what might cause slight 
variations in the nutrient profile such as moisture variations).
    [cir] A statement signed by a responsible individual employed by 
the covered establishment that can certify that the information 
contained in the nutrient analysis is complete and accurate and that 
the recipe used to prepare the menu item is identical to that used for 
the nutrient analysis.
     For published cookbooks that contain nutritional 
information for recipes in the cookbook:
    [cir] The name, author, and publisher of the cookbook used.
    [cir] If available, information provided by the cookbook about how 
the nutrition information for the recipes was obtained.
    [cir] A copy of the recipe used to prepare the menu item and a copy 
of the nutrition information for that menu item as provided by the 
cookbook.

[[Page 71234]]

    [cir] A statement signed by a responsible individual employed by 
the covered establishment certifying that the recipe used to prepare 
the menu item by the restaurant or similar retail food establishment is 
the same recipe provided in the cookbook. (Recipes may be divided as 
necessary to accommodate differences in the portion size derived from 
the recipe and that are served as the menu item but no changes may be 
made to the proportion of ingredients used.).
     For analyses:
    [cir] A copy of the recipe for the menu item used for the nutrient 
analysis.
    [cir] The identity of the laboratory performing the analysis.
    [cir] Copies of analytical worksheets used to determine and verify 
nutrition information.
    [cir] A statement signed by a responsible individual employed by 
the covered establishment that can certify that the information 
contained in the nutrient analysis is complete and accurate and an 
additional signed statement certifying that the recipe used to prepare 
the menu item is identical to that used for the nutrient analysis.
     For nutrition information provided by other reasonable 
means:
    [cir] A detailed description of the method used to determine the 
nutrition information.
    [cir] Documentation of the validity of that method.
    [cir] A recipe or formula used as a basis for the nutrient 
determination. The recipe used in determining these nutrient values 
must be the same recipe used by the restaurant and similar retail food 
establishment to prepare the item.
    [cir] Any data derived in determining the nutrient values for the 
menu item; and
    [cir] A statement signed by a responsible individual employed by 
the covered establishment that can certify that the information 
contained in the nutrient analysis is complete and accurate and that 
the recipe used to prepare the menu item is identical to that used for 
the nutrient analysis.
    In the following paragraphs, we discuss comments on the proposed 
substantiation requirements. After considering comments, including 
comments (discussed in the previous section of this document) that 
caused us to remove proposed Sec.  101.11(c)(2), (c)(3), (c)(4), and 
(c)(5), we are:
     Redesignating proposed Sec.  101.11(c)(6) as Sec.  
101.11(c)(3);
     Clarifying the applicability of the requirements by 
replacing the term ``restaurant or similar retail food establishment'' 
with ``covered establishment'' in the introductory paragraph in Sec.  
101.11(c)(3) and in the subparagraph in Sec.  101.11(c)(3)(ii)(D).
     Providing that the statement certifying that the 
information contained in the nutrient analysis is complete and accurate 
may be signed by a responsible individual employed by ``the covered 
establishment or its parent entity'' (proposed Sec.  
101.11(c)(6)(i)(H), (c)(6)(iii)(D), and (c)(6)(iv)(E), redesignated as 
Sec.  101.11(c)(3)(i)(F), (c)(3)(iii)(D), and (c)(6)(iv)(D), 
respectively);
     Requiring a certification that the covered establishment 
has taken reasonable steps to ensure that the method of preparation 
(e.g., types and amounts of ingredients, cooking temperatures in the 
recipe) and amount of a standard menu item offered for sale adhere to 
the factors on which its nutrient values were determined;
     Requiring that all certification statements be dated as 
well as signed;
     Specifying what we mean by ``the identity of the database 
used'' in proposed Sec.  101.11(c)(6)(i)(A) (redesignated as Sec.  
101.11(c)(3)(i)(A));
     Combining and replacing certain proposed details of the 
substantiation documentation when nutrient databases are used (i.e., 
proposed Sec.  101.11(c)(6)(i)(C), (c)(6)(i)(D), and (c)(6)(i)(F)) with 
requirements (in Sec.  101.11(c)(3)(i)(C)) to present the requirements 
in a simplified and streamlined format;
     Specifying what we mean by ``the identity of the 
laboratory performing the analysis'' in proposed Sec.  
101.11(c)(6)(iii)(B) (redesignated as Sec.  101.11(c)(3)(iii)(B));
     Specifying that copies of analytical worksheets used to 
determine and verify nutrition information must include the analytical 
method in proposed Sec.  101.11(c)(6)(iii)(C) (redesignated as Sec.  
101.11(c)(3)(iii)(C));
     Revising proposed Sec.  101.11(c)(6)(iv)(A) (redesignated 
as Sec.  101.11(c)(3)(iv)(A)) to require a detailed description of the 
``means'' (rather than the ``method'') used to determine the nutrition 
information ``by other reasonable means'';
     Deleting proposed Sec.  101.11(c)(6)(iv)(B) and 
redesignating proposed Sec.  101.11(c)(6)(iv)(C), (c)(6)(iv)(D) and 
(c)(6)(iv)(E) as Sec.  101.11(c)(3)(iv)(B), (c)(3)(iv)(C), and 
(c)(3)(iv)(D), respectively; and
     Revising proposed Sec.  101.11(c)(6)(iv)(D) (redesignated 
as Sec.  101.11(c)(3)(iv)(C)) to provide an example of any ``data 
derived in determining the nutrient values.''
    In addition, as nonsubstantive editorial changes we are:
     Replacing all instances of the term ``nutrient levels'' 
with the term ``nutrient values'' to consistently use the same term 
throughout Sec.  101.11(c);
     Replacing all instances of the term ``menu item'' with 
``standard menu item'' to emphasize that the requirements for 
determination of nutrient content apply only to standard menu items; 
and
     Adding the conjunction ``and'' between Sec.  
101.11(c)(3)(i)(F) and Sec.  101.11(c)(3)(i)(G), between Sec.  
101.11(c)(3)(ii)(C) and Sec.  101.11(c)(3)(ii)(D), between Sec.  
101.11(c)(3)(iii)(D) and Sec.  101.11(c)(3)(iii)(E), and between Sec.  
101.11(c)(3)(iv)(D) and Sec.  101.11(c)(3)(iv)(E), to clarify that all 
of the items listed under Sec.  101.11(c)(3)(i), Sec.  
101.11(c)(3)(ii), Sec.  101.11(c)(3)(iii), and Sec.  101.11(c)(3)(iv) 
are required.
    (Comment 137) As discussed in more detail in section XVIII (see 
Comment 136), several comments opposed the nutrient determination 
requirements in proposed Sec.  101.11(c)(2), (c)(3), (c)(4), and 
(c)(5).
    (Response 137) As discussed in more detail in section XVIII (see 
Response 136), we are deleting those requirements from the rule. Some 
comments misinterpreted these provisions, e.g., by concluding that we 
intended to require the use of laboratory analysis as a reasonable 
basis in all circumstances. To reduce the potential for future 
misunderstanding about the substantiation provisions in the final rule, 
we have made the following revisions to the requirements for 
substantiation documentation.
    First, we have revised proposed Sec.  101.11(c)(6)(iii) 
(redesignated as Sec.  101.11(c)(3)(iii) in the final rule) to clarify 
that the analyses governed by the provision are ``laboratory 
analyses.'' Some of the specific requirements of Sec.  
101.11(c)(3)(iii)) (such as for analytical worksheets) may not apply to 
other means used by a covered establishment as a reasonable basis for 
its nutrient determinations.
    Second, we are providing more specific information about the 
requirements for substantiation information. Specifically:
     We have revised proposed Sec.  101.11(c)(6)(i)(A) 
(redesignated as Sec.  101.11(c)(3)(i)(A) in the final rule) to specify 
that substantiation documentation for nutrient databases must include 
the name and version (including the date of the version) of the 
database, and, as applicable, the name of the applicable software 
company and any Web site address for the database. The name and version 
of a database would include the name and version of

[[Page 71235]]

the computer software, if applicable. Any database suitable for use as 
a reasonable basis for the purposes of Sec.  101.11 would have a name 
and version number; in some cases, the version number is a date. The 
version number is necessary to fully identify a database because 
databases may be updated to reflect more recent data and information, 
and nutrient values generated with one version of a database may be 
different from nutrient values generated by a different database. If, 
for example, a covered establishment used ``version x'' of a database 
for its nutrient determinations, and we used ``version y'' of that 
database to evaluate compliance with the nutrient determination 
requirements of rule, we inadvertently could conclude that the covered 
establishment is out of compliance with the rule if the nutrient values 
we obtained using ``version y'' do not match those obtained using 
``version x.'' Some databases may be provided by a public source (such 
as USDA), whereas others may be provided by a private vendor. If we 
have any questions about the database, we may need to contact the 
public source or private vendor. Some databases are available on the 
Internet; the Web site address would enable us to obtain any necessary 
followup information on an Internet-based database.
     We have revised proposed Sec.  101.11(c)(6)(iii)(B) 
(redesignated as Sec.  101.11(c)(3)(iii)(B) in the final rule) to 
specify that substantiation documentation for laboratory analyses must 
include the name and address of the laboratory. Some laboratories that 
conduct nutrient analyses have more than one facility, and the name of 
the laboratory alone would not be sufficient to identify the laboratory 
that conducted the analysis.
     We have revised proposed Sec.  101.11(c)(6)(iv)(D) 
(redesignated as Sec.  101.11(c)(3)(iv)(C) in the final rule) to 
provide ``nutrition information about the ingredients used, including 
the source of the nutrient information'' as an example of what we mean 
by any ``data derived in determining nutrient values.''
    Third, we are reorganizing and combining the provisions of proposed 
Sec.  101.11(c)(6)(i)(C), (c)(6)(i)(D), and (c)(6)(i)(F) (in Sec.  
101.11(c)(3)(i)(C)) to simplify the requirements and make them more 
clear. In particular, we reorganized the requirements to clarify that 
the substantiation documentation that would be provided to FDA can vary 
depending on characteristics of the database. For example, in some 
cases, the information and calculations provided by a database are 
transparent to a person using the database, whereas, in other cases, 
such information and calculations are not transparent to the user. 
Section Sec.  101.11(c)(3)(i)(C) addresses these different situations 
in separate subparagraphs (i.e., in Sec.  101.11(c)(3)(i)(C)(1) and 
(c)(3)(i)(C)(2)). Under Sec.  101.11(c)(3)(i)(C)(1), the substantiation 
information for nutrient databases must include information on: (1) The 
amount of each nutrient that the specified amount of each ingredient 
identified in the recipe contributes to the menu item; and (2) How the 
database was used including calculations or operations (e.g., 
worksheets or computer printouts) to determine the nutrient values for 
the standard menu items. Under Sec.  101.11(c)(3)(i)(C)(2), if the 
information in Sec.  101.11(c)(3)(i)(C)(1) is not available, the 
substantiation documentation for nutrient databases must include 
certification attesting that the database will provide accurate results 
when used appropriately and that the database was used in accordance 
with its instructions.
    Fourth, we have revised proposed Sec.  101.11(c)(6)(iii)(C) 
(redesignated as Sec.  101.11(c)(3)(iii)(C) in the final rule) to 
specify that copies of analytical worksheets used to determine and 
verify nutrition information must include the analytical method used to 
determine and verify nutrition information. An analytical worksheet 
cannot be evaluated for compliance purposes unless the method is 
identified. A key aspect of evaluating analytical results is 
determining whether the procedure was carried out correctly, by 
comparing the data in the work sheets to the procedure in the 
applicable analytical method.
    (Comment 138) One comment recommended that covered establishments 
provide references for their nutrient values to consumers on request. 
Another comment recommended that establishments be required to maintain 
the reasonable basis verification only at headquarters, ``and not in-
store and available upon customer request or online.'' This comment 
considered that providing hard copies on site at many locations would 
be costly, administratively burdensome, and environmentally 
unsustainable.
    (Response 138) We did not propose to require that the 
substantiation documentation be available to consumers in a covered 
establishment or online. The provisions for making substantiation 
documentation available to us were directed to our enforcement of the 
rule rather than to informing consumers. Hard copies of the 
substantiation documentation would only need to be provided to FDA 
``within a reasonable period of time upon request.'' Thus, a covered 
establishment need not generate any hard copies of the substantiation 
information until we request the information. We would request 
substantiation documentation from individual covered establishments 
during inspections. However, a covered establishment could wait to 
physically obtain substantiation documentation generated by its 
corporate headquarters or parent entity until we ask for it, provided 
that the covered establishment can obtain the information within a 
reasonable period of time.
    (Comment 139) One comment stated that it was unclear whether each 
independently operated unit, including a franchisee, will have to 
substantiate the accuracy of the nutrient information. Some comments 
disagreed that the responsible person of the covered establishment 
needs to sign a statement certifying that the nutrient analysis is 
complete and accurate and that recipes used to prepare menu items are 
identical to those used for the nutrient analysis. The comments 
asserted that this information is mostly gathered at corporate 
headquarters and there is no comparable requirement for packaged food.
    (Response 139) We agree, in part, and disagree, in part, with these 
comments. We agree that the responsible individual certifying that the 
nutrient analysis is complete and accurate need not be employed at the 
covered establishment; instead, the individual could be employed at the 
establishment's corporate headquarters or parent entity. Whether such 
individual is employed at the covered establishment or the 
establishment's corporate headquarters or parent entity, it is critical 
that the individual who signs the certification has a factual basis for 
certifying that the nutrient analysis is complete and correct.
    We disagree that a responsible individual employed at the covered 
establishment's corporate headquarters or parent entity, rather than a 
responsible individual employed at the covered establishment, could 
sign a certification regarding the use of a recipe within a covered 
establishment. A responsible individual employed at the establishment's 
corporate headquarters or parent entity likely would not have a factual 
basis for certifying the actions of a specific covered establishment 
because the individual would not be present in the establishment where 
the standard items are prepared, and, thus, likely could not certify 
the actions the establishment takes to comply with the rule.

[[Page 71236]]

    After considering these comments, we have revised the requirements 
for certification statements (i.e., proposed Sec.  101.11(c)(6)(i)(H), 
(c)(6)(ii)(D), (c)(6)(iii)(D), and (c)(6)(iv)(E), which we have 
renumbered in the final rule as described in the following sentences) 
to distinguish certifications that must be signed and dated by a 
responsible individual employed at the covered establishment from 
certifications that may be signed and dated by a responsible individual 
employed at either the covered establishment or at its corporate 
headquarters or parent entity. First, Sec.  101.11(c)(3)(i)(F), 
(c)(3)(iii)(D), and (c)(6)(iv)(D) of the final rule require a statement 
signed and dated by a responsible individual, employed at the covered 
establishment or its corporate headquarters or parent entity, who can 
certify that the information contained in the nutrient analysis is 
complete and accurate. We are using the term ``parent entity'' in 
addition to ``corporate headquarters'' because some business entities 
may not be ``corporations.''
    Second, Sec.  101.11(c)(3)(i)(G), (c)(3)(ii)(D), (c)(3)(iii)(E), 
and (c)(6)(iv)(E) of the final rule require a statement signed and 
dated by a responsible individual employed at the covered establishment 
certifying that the covered establishment has taken reasonable steps to 
ensure that the method of preparation (e.g., types and amounts of 
ingredients in the recipe, cooking temperatures) and amount of a 
standard menu item offered for sale adhere to the factors on which its 
nutrient values were determined.
    We are requiring that all certification statements be dated as well 
as signed. A date is standard practice on such documents and would be 
necessary, for example, to establish whether a certification signed in 
advance by a responsible individual at the parent entity can address 
nutrient analyses conducted over time.
    (Comment 140) One comment opposed the proposed requirement that a 
covered establishment turn over its recipes to a governmental agency, 
because a covered establishment cannot be assured that its proprietary 
information will be protected and will not make it into the hands of 
competitors or unscrupulous governmental employees looking to sell or 
pass on trade secrets.
    (Response 140) While we understand that some establishments may 
have concerns about the confidentiality of information inspected by FDA 
under Sec.  101.11, we emphasize that we protect confidential 
information from disclosure, consistent with applicable statutes and 
regulations. Our disclosure of information is subject to the Freedom of 
Information Act (FOIA) (5 U.S.C. 552), the Trade Secrets Act (18 U.S.C. 
1905), the FD&C Act, and our implementing disclosure regulations under 
part 20 (21 CFR part 20), which include protection for confidential 
commercial or financial information and trade secrets. To the extent 
that the comment is asserting that we have no procedures in place to 
protect the confidentiality of proprietary information, we disagree. We 
receive trade secret or confidential information on a regular and 
recurring basis. As noted previously, trade secrets and commercial or 
financial information that are privileged or confidential are protected 
from disclosure under the FOIA, the Trade Secrets Act, the FD&C Act, 
and our implementing disclosure regulations (see, e.g., 21 U.S.C. 
331(j), 18 U.S.C. 1905; 21 CFR 20.61(c)). Our disclosure regulations 
set forth specific procedures for assuring such protection (see part 
20). A covered establishment that provides substantiation documentation 
to us may identify any information in such documentation that the 
establishment considers to be trade secret or confidential commercial 
or financial information (21 CFR 20.61(d)). Information so marked will 
not be disclosed to the extent such information is protected under the 
FOIA and our disclosure regulations (part 20).
    (Comment 141) A few comments asserted that the proposed requirement 
that a responsible individual of the covered establishment certify that 
the recipe used for the standard menu item is identical to that used 
for the nutrient analysis is unreasonable and beyond the scope of the 
law. The comments considered that Congress directed us (in section 
403(q)(5)(H)(x)(II)(aa) of the FD&C Act) to consider standardization of 
recipes, reasonable variation in serving size and formulation of menu 
items, inadvertent human error, training of food service workers, 
variations in ingredients, and other factors. One comment noted that 
this certification is not required by statute, and considered that it 
is not clear what regulatory purpose it would serve. The comments 
asserted that it is unreasonable to expect a covered establishment to 
prepare a standard menu item in a manner that is identical to the 
recipe on each given day. A few comments opposed asking employees to 
attest that they have followed recipes exactly and considered such a 
requirement to be unfair to employees because there are several factors 
that affect the recipe such as seasonal variations, market availability 
of certain ingredients, and modifying recipes to accommodate regional 
taste preferences. One comment suggested deleting the following 
proposed requirements in Sec.  101.11(c)(6):
     For nutrient databases
    [cir] The recipe posted on the database must be identical to that 
used by the restaurant or similar retail food establishment to prepare 
the menu item.
    [cir] For the specified amounts of each ingredient identified in 
the recipe, a detailed listing (e.g., printout) of the amount of each 
nutrient that that ingredient contributes to the menu item.
    [cir] If this information is not available because the nutrition 
information was derived from a computer program, which is designed to 
provide only a final list of nutrient values for the recipe, a 
certificate of validation attesting to the accuracy of the computer 
program.
    [cir] A statement signed by a responsible individual employed by 
the covered establishment that can certify that the information 
contained in the nutrient analysis is complete and accurate and that 
the recipe used to prepare the menu item is identical to that used for 
the nutrient analysis.
     For published cookbooks that contain nutritional 
information for recipes in the cookbook:
    [cir] A copy of the recipe used to prepare the menu item and a copy 
of the nutrition information for that menu item as provided by the 
cookbook.
    [cir] A statement signed by a responsible individual employed by 
the covered establishment certifying that the recipe used to prepare 
the menu item by the restaurant or similar retail food establishment is 
the same recipe provided in the cookbook. (Recipes may be divided as 
necessary to accommodate differences in the portion size derived from 
the recipe and that are served as the menu item but no changes may be 
made to the proportion of ingredients used.)
     For analyses:
    [cir] A statement signed by a responsible individual employed by 
the covered establishment that can certify that the information 
contained in the nutrient analysis is complete and accurate and an 
additional signed statement certifying that the recipe used to prepare 
the menu item is identical to that used for the nutrient analysis.
     For nutrition information provided by other reasonable 
means:
    [cir] The word ``detailed'' from the provision in Sec.  
101.11(c)(6)(iv)(A).
    [cir] Documentation of the validity of that method.
    [cir] A statement signed by a responsible individual employed by 
the covered establishment that can certify that the

[[Page 71237]]

information contained in the nutrient analysis is complete and accurate 
and that the recipe used to prepare the menu item is identical to that 
used for the nutrient analysis.
    (Response 141) As discussed in Response 136, we are replacing each 
requirement (in proposed Sec. Sec.  101.11(c)(6)(i)(H), (c)(6)(ii)(D), 
(c)(6)(iii)(D), and (c)(6)(iv)(E)) that a responsible individual of the 
covered establishment certify that the recipe used for the standard 
menu item is identical to that used for the nutrient analysis used to 
prepare the standard menu item with a requirement for a statement 
signed and dated by a responsible individual employed at the covered 
establishment certifying that the establishment has taken reasonable 
steps to ensure that the method of preparation (e.g., types and amounts 
of ingredients in the recipe, cooking temperatures) and amount of a 
standard menu item offered for sale adhere to the factors on which its 
nutrient values were determined. Therefore, Sec.  101.11(c) will not 
require a responsible individual of the covered establishment to 
certify that the recipe used for the standard menu item is identical to 
that used for the nutrient analysis used to prepare the standard menu 
item; nor will it require that a covered establishment prepare a 
standard menu item using a recipe that is identical to that used in a 
database (as proposed in Sec.  101.11(c)(6)(i)(B)). Nevertheless, a 
covered establishment must ensure that its nutrition labeling is 
truthful and not misleading and that it has a reasonable basis for its 
nutrient content disclosures, as further discussed in Response 136.
    As requested in Comment 136 and discussed in Response 136, we have 
revised the rule to require (in Sec.  101.11(c)(2)) that the covered 
establishment take reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined. As discussed in Response 135, we have revised proposed 
Sec.  101.11(c)(6)(iv)(A) (which is renumbered as Sec.  
101.11(c)(3)(iv)(A) in the final rule), which addresses the information 
that must be provided to FDA, within a reasonable period of time upon 
request, when ``other reasonable means are used to provide the 
nutrition information.'' To emphasize that ``other reasonable means'' 
does not require analytical testing, Sec.  101.11(c)(3)(iv)(A)) 
requires a detailed description of the ``means'' (rather than the 
``method'') used to determine the nutrition information.
    We also have removed proposed Sec.  101.11(c)(6)(iv)(B), which 
would have required documentation of the validity of the method for 
``nutrition information provided by other reasonable means.'' As 
evidenced by the examples we now provide of ``other reasonable means'' 
in Sec.  101.11(c)(1), ``documentation of validity of that method'' 
generally would not apply to ``other reasonable means'' that are 
reasonably foreseeable.
    Other than by removing proposed Sec.  101.11(c)(6)(iv)(B) and the 
proposed provisions requiring that the recipe used to prepare a 
standard menu item be identical to the recipe used to determine the 
nutrition information for the standard menu item described previously, 
we are not deleting the remaining specific proposed provisions that one 
comment recommended deleting. The comment provided no explanation or 
basis for deleting those specific provisions. Further, these provisions 
establish requirements for substantiating determination of nutrient 
content for standard menu items provided by covered establishments. As 
we discussed in the proposed rule (76 FR 19192 at 19219), to determine 
whether a covered establishment has a reasonable basis for its nutrient 
content disclosures, as required by section 403(q)(5)(H) of the FD&C 
Act, and whether a standard menu item is otherwise misbranded under 
section 403(a)(1) of the FD&C Act, we must have access to the 
information substantiating the covered establishment's determination of 
nutrient content. Without these requirements, which provide access to 
substantiation documentation, we would not be able to efficiently 
determine whether a covered establishment's nutrition labeling is 
truthful and not misleading. Further, without access to substantiation 
documentation of the basis of a covered establishment's nutrient 
content disclosures, including recipe and ingredient information, we 
would not be able to determine whether an establishment has a 
reasonable basis for its nutrition content disclosures, as required by 
section 403(q)(5)(H)(iv) of the FD&C Act. Accordingly, such 
requirements are necessary for the efficient enforcement of the FD&C 
Act.

XX. Comments and FDA Response on Proposed Section 101.11(d)--Voluntary 
Registration To Elect To Be Subject to the Rule

    Proposed Sec.  101.11(d)(1) would provide that a restaurant or 
similar retail food establishment that is not part of a chain with 20 
or more locations doing business under the same name and offering for 
sale substantially the same menu items could voluntarily register to 
provide the nutrition information required by Sec.  101.11(b), and that 
in doing so they would no longer be subject to non-identical State or 
local nutrition labeling requirements. Proposed Sec.  101.11(d)(2) 
would provide that the authorized official of a restaurant or similar 
retail food establishment as defined, may register with FDA. Proposed 
Sec.  101.11(d)(3) would list the types of information (in brief, the 
contact information of each restaurant or similar retail food 
establishment, as well as contact information of an official onsite, 
trade names the restaurant or similar retail food establishment uses, 
preferred mailing address, and certification) that a restaurant or 
similar retail food establishment would need to provide to us in order 
to register voluntarily. Proposed Sec.  101.11(d)(3) and (d)(4) would 
also describe the mechanism for submission by email, fax, mail, or 
online form. Finally, proposed Sec.  101.11(d)(5) would require re-
registration every other year within 60 days prior to the expiration of 
the current registration with FDA, and would provide that registration 
will automatically expire if not renewed.
    In the following paragraphs, we discuss comments on these proposed 
provisions. We are finalizing them with the following changes for 
clarity.
     We are amending the titles of Sec.  101.11(d)(4) and 
(d)(5) by replacing the question mark in each title with a period 
because these titles are not questions.
     We are deleting the revision date of Form FDA 3757 (i.e., 
7/10) from Sec.  101.11(d)(3). The FDA form number is sufficient to 
identify the form. Moreover, the revision date may change as a result 
of the renewal of the form every 3 years under the Paperwork Reduction 
Act.
     We are moving proposed Sec.  101.11(d)(3)(vi) and 
(d)(3)(vii) to be subparagraphs of Sec.  101.11(d)(4) rather than Sec.  
101.11(d)(3) and redesignating them as Sec.  101.11(d)(4)(i) and 
(d)(4)(ii), respectively. These provisions are directed to ``How to 
register'' rather than to ``What information is required?''
     For clarity, we are adding the form number (i.e., Form FDA 
3757) to the second sentence of Sec.  101.11(d)(4).
     For completeness, we have added ``.gov'' to the end of the 
email address provided for voluntary registration under Sec.  
101.11(d)(4)(i). The complete email address now reads 
``menulawregistration@fda.hhs.gov.''
     We have revised the format of the cross-reference, within 
Sec.  101.11(d)(4) to Sec.  101.11(d)(3) to read ``paragraph (d)(3)

[[Page 71238]]

of this section'' rather than ``Sec.  101.11(d)(3).'' We note that the 
proposed rule had identified the cross-reference as ``Sec.  
101.11(c)(3).'' We revised this to ``Sec.  101.11(d)(3)'' in the 
correction document, but did not revise the format at that time.
    (Comment 142) One comment supported the proposed registration 
requirements. One comment recommended that retail food establishments 
not covered by section 403(q)(5)(H) of the FD&C Act, regardless of 
whether they have fewer than 20 locations or if the sale of food is not 
the primary business activity, be allowed to elect to become subject to 
the requirements of section 403(q)(5)(H) of the FD&C Act by registering 
biannually with us. One comment referred to our discussions in the 
proposed rule that establishments such as cafeterias in schools and 
hospitals would not be covered by the rule under the proposed 
definition of ``restaurant or similar retail food establishment'' (see 
Footnote 1 at 76 FR 19192 at 19197 and discussion at 19230). This 
comment asked us to clarify whether there are some establishments 
(e.g., hospitals or school cafeterias) that are not restaurants or 
similar retail food establishments and therefore cannot voluntarily 
register to be subject to the Federal menu labeling requirements. The 
comment also asked us to clarify whether certain food service 
contractor facilities can voluntarily register even if other facilities 
in the overall set of operations do not. The comment recommended that 
we allow a restaurant or similar retail food establishment to 
voluntarily register on an establishment-by-establishment basis and not 
require the chain or company to make a single corporate-wide 
determination. The comment asked us to allow a food service contract 
business to register some of their establishments in order to make 
well-informed decisions on whether to register the other establishments 
and modify their establishments and contracts accordingly (``rolling 
adoption''). The comment also asked if there were requirements for 
opting out of the Federal requirements after voluntarily registering. 
The comment asked whether a restaurant or similar retail food 
establishment is required to be covered by the menu labeling 
requirements for a specific length of time, once it has voluntarily 
registered.
    (Response 142) The final rule defines ``restaurant or similar 
retail food establishment'' to mean a retail establishment that offers 
for sale restaurant-type food, except if it is a school as defined in 7 
CFR 210.2 or 220.2. Under Sec.  101.11(d), a restaurant or similar 
retail food establishment, as defined in Sec.  101.11(a), that is not 
part of a chain with 20 or more locations doing business under the same 
name and offering for sale substantially the same menu items (and, 
thus, is not subject to the requirements of section 403(q)(5)(H) of the 
FD&C Act) may voluntarily register to be subject to the requirements 
established in this rule. It does not matter whether the sale of food 
is the establishment's primary business activity, because the 
definition of restaurant or similar retail food establishment in this 
rule does not include a primary business test. Many establishments that 
would not have been a ``restaurant or similar retail food 
establishment'' under the definition we proposed (including 
establishments in hospitals) would be a restaurant or similar retail 
food establishment under the definition established in this rule (see 
the discussion of the definition of restaurant or similar retail food 
establishment in section VI.B). Whether any such establishment is 
automatically covered by the rule generally would depend on whether the 
establishment satisfies all other criteria in the definition of 
``covered establishment'' (i.e., part of a chain with 20 or more 
locations doing business under the same name (regardless of the type of 
ownership, e.g., individual franchises) and offering for sale 
substantially the same menu items).
    Section 403(q)(5)(H)(ix) of the FD&C Act provides that an 
authorized official of any restaurant or similar retail food 
establishment not subject to the requirements of section 403(q)(5)(H) 
may elect to become subject to the requirements by registering with 
FDA. Accordingly, any establishment that meets the definition for a 
restaurant or similar retail food establishment, as provided in Sec.  
101.11(a), that is not already subject to the requirements of section 
403(q)(5)(H) of the FD&C Act can voluntarily register to become subject 
to the requirements under Sec.  101.11(d). Establishments that do not 
meet the definition of ``restaurant or similar retail food 
establishment'' (e.g., drug stores that do not offer for sale any 
restaurant-type food) cannot voluntarily register.
    Under Sec.  101.11(d), an authorized official is permitted to 
register an individual restaurant or similar retail food establishment 
on an establishment-by-establishment basis, in that the authorized 
official may register a single restaurant or similar retail food 
establishment or multiple restaurants or similar retail food 
establishments within a chain on a single registration form, provided 
that the individual is authorized to do so for all of the restaurants 
or similar retail food establishments included on the form (Form FDA 
3757) submitted. Whether a decision to register is made on an 
establishment-by-establishment basis or is a corporate-wide decision 
applying to many or all establishments within a chain is a matter for 
the restaurant or similar retail establishments and any corporate 
management to determine. This is as true for restaurants or similar 
retail food establishments operated by contractors as it is for other 
restaurants or similar retail food establishments.
    The rule does not establish a date by which a restaurant or similar 
retail food establishment must register in order to ``opt in'' as a 
covered establishment and, thus, establishments within a chain could 
approach the voluntary registration using the ``rolling adoption'' 
requested by one comment.
    A restaurant or similar retail food establishment that has 
voluntarily registered under Sec.  101.11 must comply with the 
requirements of sections 403(a)(1), 403(f), and 403(q)(5)(H) of the 
FD&C Act and Sec.  101.11 for 2 years after the date of registration 
and may not ``opt out'' until the 2 years has passed. If the restaurant 
or similar retail food establishment wants to ``opt out,'' the 
mechanism to do so would be to let the registration lapse (i.e., not 
re-register) after the 2 years have passed.

XXI. Comments and FDA Response on Proposed Sec.  101.11(e)--Signatures

    Proposed Sec.  101.11(e) would provide that signatures obtained 
under the voluntary registration provisions that meet the definition of 
electronic signatures in Sec.  11.3(b)(7) would be exempt from the 
requirements of part 11 of the CFR (requirements for electronic records 
and signatures).
    We received no comments on this proposed provision and are 
finalizing it without change.

XXII. Comments and FDA Response on Proposed Sec.  101.11(f)--
Misbranding

    Proposed Sec.  101.11(f) would provide that ``a standard menu item 
offered for sale in a covered establishment'' would be ``deemed 
misbranded under sections 201(n), 403(a), and/or 403(q) of the Federal 
Food, Drug, and Cosmetic Act if its label or labeling is not in 
conformity'' with the requirements for nutrition labeling and 
determination of nutrient content at Sec.  101.11(b) and (c).
    While we received no comments on this proposed provision, we are 
finalizing this provision with one change. We are including a reference 
to section 403(f) of the FD&C Act to clarify

[[Page 71239]]

that failure to comply with the requirements of Sec.  101.11(b) could 
cause a food to be misbranded under section 403(f) of the FD&C Act. 
Section 403(f) of the FD&C Act provides that a food shall be deemed 
misbranded ``if any word, statement, or other information required by 
or under authority of this Act to appear on the label or labeling is 
not prominently placed thereon with such conspicuousness (as compared 
with other words, statements, designs, or devices, in the labeling) and 
in such terms as to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use.'' 
For example, as discussed in Response 127, if a calorie declaration for 
a standard menu item that is a self-service food or food on display is 
not declared in a manner that complies with Sec.  
101.11(b)(2)(iii)(A)(3)(ii), in that the declaration is not clear and 
conspicuous, the standard menu item would be misbranded under section 
403(f) of the FD&C Act in addition to section 403(q) of the FD&C Act.

XXIII. Comments and FDA Response on Effective Date

A. Proposed Effective Date and Request for Comment

    The proposed rule specified that the final rule would become 
effective 6 months from the date of its publication in the Federal 
Register (76 FR 19192 at 19219). We noted that compliance is expected 
to yield significant public health benefits because consumers will have 
calorie and other nutrition information when they make menu choices. 
Because of this benefit, we stated that it is reasonable to make the 
requirements effective as soon as practicable. We recognized, however, 
the potential difficulties of implementing the rule in this timeframe, 
and requested comment on whether the effective date should be extended 
for a greater period of time after the publication of the final rule. 
In particular, we requested comment on whether a 9-month or 1-year 
implementation timeframe would be more appropriate.
    We also requested comment, supported by data, concerning how much 
time is needed for covered establishments to come into compliance with 
the rule, including, if possible, data on whether specific provisions 
of the rule can be more quickly implemented than others. We also 
requested comment on whether we should provide for staggered 
implementation based on the size of a chain or of a specific franchisee 
and again requested that suggestions be supported by data.

B. Comments on Proposed Effective Date

    (Comment 143) Many comments supported our proposed 6-month 
effective date. Some comments noted that State and local jurisdictions 
with menu labeling requirements implemented and enforced the 
requirements in 6 or 7 months. One comment stated that many large 
chains have already conducted nutrient analyses for their menu items. 
In contrast, another comment reported the implementation time frames 
for 12 State and local requirements. This comment noted that 
restaurants subject to State or local menu labeling requirements have 
had no less than 6 months to comply with such requirements. This 
comment reported that one city (Philadelphia) provided more than 1 year 
for compliance and one State (Oregon) provided 6 months for 
implementation of Phase 1 of its requirements, and an additional year 
for compliance with Phase 2 of its requirements. This comment urged us 
to allow establishments at least 1 year to come into compliance with 
the Federal requirements.
    Several comments opposed the 6-month effective date and requested 
an effective date of at least 1 year. Some comment noted that an 
effective date of at least 1 year would be necessary for covered 
establishments to develop and install redesigned menus. In particular, 
one comment from national associations representing a number of 
restaurants estimated that there are 250,000 to 275,000 covered 
restaurants in the United States, not including similar retail food 
establishments that would be covered under the rule. This comment 
recommended that we adopt an implementation period of not less than 1 
year after the publication of the final rule and noted that extending 
the time period to 1 year would allow most restaurants to incorporate 
adding calorie declarations to menus and associated menu redesigns with 
regular menu replacement cycles, thereby reducing costs. This comment 
identified several specific steps necessary for covered establishments 
to comply with the rule, including:
     ``Digest the final rule,'' including determining what are 
menus and menu boards, what are standard menu items, what are custom 
orders, and what are temporary menu items or otherwise excluded foods;
     Determine nutrient content levels and ensure that their 
bases for determining such nutrient information are sound;
     Prepare and print written nutrition information;
     Redesign menus and menu boards to include calories;
     Roll out new menus and menu boards simultaneously to chain 
restaurants nationwide;
     Update food preparation procedures to ensure consistency 
and ensure that reasonable steps are in place to ensure standard menu 
items are prepared consistently;
     Create processes where information related to standard 
menu items, e.g., ingredients supplier data, is periodically updated; 
and
     Develop and conduct training.
    This comment also presented the following estimated time frames to 
conduct some of these steps:
     Four weeks to digest the requirements of the rule;
     Twenty-four weeks to design new layouts, obtain reviews 
and approvals, and for production and kitting; and
     Eight weeks for shipping.
    Other comments that supported a 1-year effective date presented 
similar reasons, noting that a 1 year effective date would allow 
restaurants to properly review the final rule, analyze covered food 
items, and incorporate nutrition labeling into their truck stop and 
travel plaza restaurants. Some comments expressed concern that demand 
for menu item nutrient analysis and redesigning menu boards will 
skyrocket upon publication of the final rule, thereby overwhelming 
testing laboratories and companies that design menus and menu boards.
    (Response 143) We agree that covered establishments will need more 
than 6 months to come into compliance with the rule, including making 
changes to menus and menus boards. While some establishments already 
are subject to State or local nutrition labeling requirements for foods 
sold in such establishments, others are not. Moreover, even those 
establishments that already are subject to State or local requirements 
nutrition labeling requirements may not be required to disclose such 
nutrition information in the format and manner specified in section 
403(q)(5)(H) of the FD&C Act and this rule. We carefully considered the 
activities and associated time frames identified by the comments, 
including the comment from national organizations representing 
restaurants, and we agree that the rule should provide for an effective 
date of 1 year to comply with the Federal requirements. Most comments, 
even the comment noting that one State and one local

[[Page 71240]]

government provided more than 1 year for full implementation, requested 
an effective date of ``at least 1 year.''
    We also agree that a time frame that enables establishments to make 
changes to menus and menu boards during a time period that coincides 
with their regular menu replacement cycles would save time and 
resources. In addition, we acknowledge that companies that design and 
produce menu boards will receive many orders to update menu boards to 
comply with the rule. We note that a covered establishment that 
experiences difficulty obtaining new menus or menu boards as a result 
of increased demand as the effective date draws near will have other 
ways to comply with the rule without replacing the menus or menu 
boards. For example, we would not object if a covered establishment 
declares calorie information by applying stickers or pieces of paper to 
menus or menu boards. For packaged foods, we have taken the position 
for some time that the Nutrition Facts label may be printed on a 
sticker and affixed to a package, as long as the sticker adheres to the 
product under the intended storage conditions (Ref. 38; see L16). We 
also have long taken the position that stickers may be used to make 
changes in labeling such as correcting label mistakes provided that the 
final label is correct and complies with all regulations at the time of 
retail sale, the stickers do not cover other mandatory labeling, and 
the stickers adhere tightly (Ref. 38, see L55).
    Likewise, we acknowledge that there could be some increased demand 
for nutrient analysis by testing laboratories as the effective date 
draws near. Importantly, the rule does not require analytical testing 
of standard menu items; analytical testing is merely one option 
available to a covered establishment to determine nutrient values. 
Other options include use of nutrient databases, cookbooks, or other 
reasonable means, including the use of Nutrition Facts on labels on 
packaged foods that comply with the nutrition labeling requirements of 
section 403(q)(1) of the FD&C Act and Sec.  101.9, FDA nutrient values 
for raw fruits and vegetables in Appendix C of part 101, or FDA 
nutrient values for cooked fish in Appendix D (see Sec.  101.11(c)(1)). 
In addition, as noted by the comments, many establishments that are 
part of large chains have already determined nutrient values for their 
menu items. As discussed in Response 138 and Response 139, this rule 
provides that corporate headquarters or a parent entity, rather than 
each individual covered establishment, may determine and certify 
nutrient values, as requested by comments. Thus, to the extent 
establishments' corporate headquarters or parent entity have determined 
nutrient values for standard menu items offered for sale in such 
establishments, individual covered establishments can come into 
compliance with this rule without significantly overwhelming testing 
laboratories, even if such establishments choose analytical testing as 
the means to determine nutrient values.
    For all of these reasons, and as discussed in more detail in 
section XXIII.C, we have established an effective date for this rule 
that is 1 year from the date of publication of this document. Thus, the 
final rule is effective on December 1, 2015.
    (Comment 144) One comment that recommended a minimum of 12 to 18 
months for establishments to comply with the rule provided information 
about its experience from a 2010 rollout of new menu boards for all its 
domestic stores. This comment identified the following steps and 
corresponding time frames for this 2010 rollout:
     2 months to develop new menu board templates for the seven 
types of menu boards for its various types of store locations (mall 
stores, mall kiosks, mall carts, stadium stores, stadium carts, etc.);
     8 months to develop, program, and test an ordering site to 
accommodate more than 850 individual store menus;
     2 months to receive the orders and lay out all custom menu 
boards; and
     2 months to produce and ship new menu boards to its 
stores.
    (Response 144) We appreciate that this comment provided its 
specific experience from a company-wide rollout of new menu boards. The 
steps identified by this comment are similar to the steps identified by 
the comment from national associations representing restaurants, 
although with longer timeframes. However, as discussed in Comment 143 
these national associations also noted that extending the time period 
to 1 year would allow most restaurants to incorporate adding calorie 
declarations to menus and associated menu redesigns with regular menu 
replacement cycles. We therefore disagree that the time frames 
experienced by one entity during a company-initiated rollout of new 
menu boards should determine the time frame for compliance by all 
covered establishments.
    (Comment 145) Some comments requested an effective date of more 
than 12 months. One comment requested an 18-month effective date 
because it considered that many requirements are still unclear. Another 
comment requested an 18-month to 2-year effective date for similar 
retail food establishments, even if there is a shorter time for 
restaurants. According to this comment, establishments need time to 
comply properly with the requirements and rushing through compliance 
could result in mistakes that may be confusing to consumers and would 
require additional industry resources to correct.
    A few comments requested a 2-year effective date. One comment 
asserted that there will be a steep learning curve and time is needed 
to train employees and develop and print display materials. A few 
comments maintained that a 2-year compliance period is appropriate 
because, according to one comment, we used a 2-year uniform compliance 
period when implementing the NLEA. According to another comment, a 2-
year timeframe is reasonable as long as nutrition information is 
available in brochures and online.
    (Response 145) We disagree that an effective date over 1 year (such 
as 18 months or 2 years, as suggested by the comments) is necessary. 
Many comments seeking a longer effective date focused on the need to 
train employees. Such training does not need to wait until all 
implementation activities are complete--e.g., such training can begin 
while an establishment is waiting for delivery of its revised menus and 
menu boards.
    We also disagree with the comment asserting that similar retail 
food establishments need more time than restaurants to comply with the 
rule. The comment provided no basis for why similar retail food 
establishments should be treated differently from restaurants or why 
such establishments would need more time for compliance than 
restaurants.
    We discuss the applicability of the uniform compliance date in 
section XXIII.C.
    (Comment 146) One comment asserted that there will be an unfair 
competitive advantage for larger companies because of the ability of 
larger companies to leverage their market position with the menu board 
producers. One comment requested a grace period to come into compliance 
if a covered establishment has adopted and followed a reasonable 
program to monitor changing nutrient values and update menus and menu 
boards at reasonable intervals coinciding with typical cycles.
    (Response 146) In the proposed rule, we specifically requested that 
comments about whether we should provide for staggered implementation 
based on the size of a chain or of a specific franchisee be supported 
by data. The comment

[[Page 71241]]

asserting that there will be an unfair competitive advantage for larger 
companies (because of their ability to leverage their market position 
with the menu board producers) provided no data for its assertion; 
therefore we have no information that could assist us in considering 
whether or how much additional time might be appropriate. Further, as 
discussed in Response 143, covered establishments can use a number of 
ways to comply with this rule without replacing menus or menu boards; 
for example, they can apply stickers or pieces of paper to menus or 
menu boards. For these reasons, we do not believe there is a sufficient 
basis to establish a staggered implementation period based on the size 
of the chain or of a specific franchise.
    Nevertheless, we can work with establishments that are not in 
compliance by the effective date of this rule on a case-by-case basis, 
taking into consideration a number of factors, including specific steps 
an establishment has taken towards compliance.
    (Comment 147) One comment requested that we allow 1 year for 
implementation, rather than 6 months, to provide covered establishments 
with adequate time to come into compliance given contractual 
requirements. For example, the comment said that it maintains a 
database with over 35,000 recipes which, in turn, may be modified or 
adapted by the specific restaurant or similar retail food establishment 
for local needs and tastes, limitations of the establishment, 
contractual specifications, and other restrictions (e.g., an 
establishment's determinations as to types of offerings). In addition, 
the comment stated that contractors rely on suppliers to provide 
nutritional information and, therefore, we should allow adequate time 
to retrieve data from these sources.
    (Response 147) As discussed in section XXIII.C, we are establishing 
an effective date of 1 year from the date of publication of this rule. 
We note that the comment refers to recipes that may be modified or 
adapted by a specific restaurant or similar retail food establishment. 
In section VI.F, we discuss how such modifications can affect whether 
an establishment is offering for sale substantially the same menu items 
(and, thus, satisfies this criterion in the definition of covered 
establishment).

C. Effective Date and Compliance Date for This Rule

    We are establishing the effective date to be 1 year from the date 
of publication of this document, i.e., the final rule is effective on 
December 1, 2015, (see DATES). We believe that extending the effective 
date from 6 months to 1 year provides sufficient time for covered 
establishments to come into compliance with the requirements without a 
significant negative impact on public health.
    We expect covered establishments to come into compliance with the 
requirements of this rule by December 1, 2015, i.e., the same date as 
the effective date of this rule. Although we are issuing this final 
rule after January 1, 2013, there is sufficient justification for 
establishing a compliance date of December 1, 2015, to enforce the 
provisions of this final rule, rather than January 1, 2016, which FDA 
has established as the next uniform compliance date for other food 
labeling changes required by food labeling regulations that are issued 
between January 1, 2013, and December 31, 2014 (77 FR 70885; November 
28, 2012). Typically, our uniform compliance dates for food labeling 
regulations focus on changes made to the requirements for labels of 
packaged foods and seek to minimize the economic impact of such label 
changes, in relevant part, by allowing manufacturers to come into 
compliance with such regulations by one particular compliance date 
rather than several different dates (e.g., 77 FR 70885; 75 FR 78155 
(December 15, 2010)). By providing one uniform compliance date, we 
enable manufacturers to avoid multiple short-term label revisions that 
would otherwise occur if not for the uniform compliance date. However, 
this rule does not establish requirements for the labels of packaged 
foods, and therefore would not cause food label revisions comparable to 
other food labeling regulations typically addressed by our uniform 
compliance dates. In addition, standard menu items offered for sale in 
covered establishments were not subject to Federal nutrition labeling 
requirements before the enactment of section 4205 of the ACA. As a 
result, unlike packaged foods, standard menu items currently are not 
subject to several different Federal food labeling regulations that may 
provide for different compliance dates. Further, a comment from 
national associations representing restaurants reported that extending 
the time period from the 6 months that we proposed, to 1 year, would 
allow most restaurants to comply with the rule as part of regular menu 
replacement cycles, thereby lessening costs. For these reasons, along 
with the reasons discussed previously, we believe that 1 year is 
sufficient time for covered establishments to come into compliance with 
the requirements of this rule. Waiting until FDA's next uniform 
compliance date of January 1, 2016, would create unnecessary delay in 
the enforcement of this rule and could minimize public health benefits.

XXIV. Comments and FDA Response on Compliance

    In the proposed rule, we noted that some provisions of section 4205 
of the ACA became requirements immediately upon enactment of the law 
and that we intended to exercise enforcement discretion until after we 
had completed notice and comment rulemaking. We encouraged our State 
and local partners to proceed in a similar way. We requested comment on 
how we should implement the rule, including whether specific provisions 
of the rule can be more quickly implemented than others (76 FR 19192 at 
19220).
    (Comment 148) One comment asked us to develop a protocol for 
checking the accuracy of the nutritional information provided by 
covered establishments. One comment recommended that we undertake 
random testing as resources allow. Another comment recommended that 
testing be done annually and kept on a public file to ensure that the 
portions continue to be within 5 percent tolerance of the original 
nutritional information. The comment suggested that if deviations are 
found, the company would either retest in 30 days or pay a penalty fee 
that would be passed to a childhood obesity campaign.
    (Response 148) The rule provides several options for how covered 
establishments can determine nutrition information. While analytical 
testing of standard menu items may be appropriate in some cases (e.g., 
when the reasonable basis that a covered establishment uses to 
determine nutrient values is analytical testing), we expect our routine 
approach to evaluating the accuracy of the nutrition information to be 
based on the particular facts at issue, including the reasonable basis 
used by the covered establishment, which may be means other than 
analytical testing. Consistent with our approach to inspection of food 
processing facilities, we do not expect to establish a public file with 
the results of any testing we conduct. Under the Freedom of Information 
Act and our regulations in part 20, a person who wishes to see the 
results of our inspections may submit a request to do so.
    Regarding the comment suggesting that we develop a protocol for 
checking the accuracy of the nutritional

[[Page 71242]]

information provided by covered establishments, we decline to include 
such a protocol for checking the accuracy of the nutritional 
information in the rule at this time. Section 101.11(c) includes 
requirements for determining nutrient content and section XVII further 
discusses such requirements, including the requirement that nutrient 
declarations be accurate and consistent with the specific basis used to 
determine nutrient values. After we have had experience in evaluating 
compliance with the rule, we will consider whether to develop such a 
protocol.
    (Comment 149) A few comments asked us to clarify our enforcement 
strategy and quickly establish an enforcement protocol. One comment 
stated that the proposed rule is virtually silent on how the menu 
labeling requirements will be enforced and encouraged us to permit the 
industry to comment on our enforcement strategy before it is included 
in the rule. One comment recommended that we issue guidance documents 
to the industry to better clarify matters of uncertainty that will 
persist following issuance of the rule.
    One comment asked us to provide details on the penalties for 
noncompliance. Another comment recommended that we issue warning 
letters prior to instituting civil penalties against a covered 
establishment, particularly if the proposed rule's ambiguities are not 
clarified in the final rule. The comment maintained that a covered 
establishment may have made a good faith effort to comply and that 
warning letters will encourage compliance and inform establishments how 
they have fallen short of compliance. The comment recommended that we 
use a tiered penalty structure, whereby minor violations (e.g., 
inadequate font size of nutrition information) are treated less harshly 
than more serious violations (e.g., a clear lack of effort to place 
calorie information on printed menus). The comment also encouraged us 
to have a progressive penalty system for violations, whereby first 
violations are treated less harshly (e.g., a warning letter) than 
repeated violations. The comment maintained that this is especially 
crucial in the first few years the rules are being implemented as 
covered establishments familiarize themselves with the new 
requirements.
    (Response 149) We are establishing these regulations under sections 
201(n), 403(a)(1), 403(f), and 403(q)(5)(H) of the FD&C Act, as well as 
under section 701(a) of the FD&C Act. As discussed in the proposed rule 
and in section XXII, failure to comply with the rule will render the 
food misbranded under section(s) 201(n), 403(a), 403(f), or 403(q) of 
the FD&C Act (76 FR 19192 at 19219). Penalties are already set forth in 
the FD&C Act, and violations of Sec.  101.11 may result in enforcement 
action consistent with those penalties. For example, introducing, 
delivering for introduction, or receiving a misbranded food in 
interstate commerce, or misbranding a food while it is in interstate 
commerce or being held for sale after shipment in interstate commerce, 
are prohibited acts under section 301 of the FD&C Act (21 U.S.C. 331), 
carrying criminal penalties under section 303 of the FD&C Act (21 
U.S.C. 333). In addition, under section 302 of the FD&C Act (21 U.S.C. 
332), the United States can bring a civil action in Federal court to 
enjoin a person who commits a prohibited action. Under section 
304(a)(1) of the FD&C Act (21 U.S.C. 334(a)(1)), a food that is 
misbranded when introduced into or while in interstate commerce or 
while held for sale after shipment in interstate commerce may be seized 
by order of a Federal court. We expect to issue guidance to help 
covered establishments with compliance.
    The tiered enforcement approach described by the comment is similar 
to the approach we currently take for other misbranded food, and we 
generally expect our enforcement approach to misbranding violations of 
this rule to be similar to that for other misbranded food. 
Nevertheless, enforcement will be considered on a case-by-case basis 
depending on the specific facts and circumstances.
    (Comment 150) One comment asked us to focus our enforcement actions 
on helping with compliance, rather than seeking monetary penalties, at 
least until establishments have an opportunity to fully adopt the 
requirements. This comment maintained that flexibility is needed in the 
initial phases of implementation for facilities that operate under 
Federal Government contracts so that they can continue to comply with 
requirements mandated by specific Government Agencies. As a result, the 
comment recommended that we provide flexibility for contract food 
providers that provide services to Government facilities under a 
specified program.
    (Response 150) We recognize that covered establishments will need 
time to comply with the nutrition labeling requirements of this rule 
during the initial phase of implementation. To provide more time to do 
so, this rule is not becoming effective until 1 year after the date of 
publication of this document (see the discussion in section XXIII.C of 
this document).
    A covered establishment has responsibility to comply with all 
requirements of the rule. We acknowledge that a covered establishment 
may need to update its business and contractual relationships with its 
suppliers in order to do so.
    (Comment 151) One comment asked us to permit stores to register 
points of contact to which we will address enforcement because 
experience shows that involving ``corporate parents'' of individual 
franchises or the owner of multi-store chains is the most effective way 
to manage enforcement issues. The comment recommended that we notify 
these contacts in the event of an enforcement action. Similarly, the 
comment recommended that we designate specific contacts for informal 
guidance and advice and develop a menu labeling hotline telephone 
number or email address to which store operators can ask specific 
questions. The comment considered that doing so would increase 
compliance and ease the administrative burden on its members.
    (Response 151) Each individual restaurant or similar retail food 
establishment is responsible for disclosing the required nutrition 
information for its standard menu items and otherwise complying with 
the requirements of sections 403(q)(5)(H), 403(a)(1), and 403(f) of the 
FD&C Act and Sec.  101.11. Persons exercising authority and supervisory 
responsibility over such establishments may also be held liable for 
violations of the FD&C Act. See Response 3. Our decisions regarding 
enforcement actions will be determined on a case by case basis. In 
general, we intend to notify a ``corporate parent'' as appropriate (see 
e.g., Refs. 39 and 40). Although Sec.  101.11(d) provides for voluntary 
registration for restaurants and similar retail food establishments 
that are not subject to the nutrition labeling requirements of section 
403(q)(5)(H) of the FD&C Act, and requires contact information, these 
requirements only apply to such establishments that would not be 
subject to the rule without registering.
    We already maintain a telephone hotline where industry may contact 
us for questions about compliance with our regulations (1-888-SAFEFOOD 
(1-888-723-3366)). Staff who are assigned to the hotline will have or 
obtain the information to answer questions about this rule. In 
addition, a covered establishment may direct questions to the contact 
person identified in this document (see FOR FURTHER INFORMATION 
CONTACT), to the contact telephone number provided in any subsequent

[[Page 71243]]

guidance, and to a general email mailbox for industry questions 
(industry@fda.gov). A covered establishment also may send written 
inquiries to Center for Food Safety and Applied Nutrition (HFS-009), 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740.
    (Comment 152) A few comments recommended that we preapprove menus 
and menu boards. One of these comments recommended that we do so even 
if a fee was required. The comment maintained that an approval process 
would alleviate covered establishments from having to pay the costs to 
replace menus that they thought met the menu labeling requirements.
    (Response 152) We decline the request of these comments. Section 
403(q)(5)(H) of the FD&C Act does not require that we preapprove menus 
and menu boards, nor do we have the resources to do so at this time. 
Section 403(q)(5)(H) of the FD&C Act and this rule set forth and 
specify the requirements for menus and menu boards such that a covered 
establishment should be able to determine whether its menu or menu 
board meets the applicable requirements. Further, a covered 
establishment may contact us with questions about compliance, as 
discussed previously in Response 151.
    (Comment 153) One comment asked us to clarify that compliance is 
the responsibility of each establishment and that if someone fails to 
comply, only that standard menu item in the particular establishment is 
misbranded. The comment expressed concern that without clarity on this 
point, States and localities may cite franchisors for violations by 
franchisees, and plaintiffs' attorneys may sue franchisors for 
violations by franchisees under consumer protection laws.
    (Response 153) With regard to what food is misbranded if there is a 
failure to comply with the regulations, this would be determined based 
on the particular facts of the situation (see also Response 3).
    (Comment 154) Some comments asked us to allow flexibility for when 
a covered establishment must update menus to reflect changes in 
nutrient content. One of these comments asked us to clarify that any 
temporary inconsistencies resulting from periodic updating will not 
result in a violation of the law. The comment expressed concern that 
nutrient values may change because of ingredient changes, use of 
different suppliers, suppliers updating nutritional analysis with no 
changes in formulation, and reformulation of menu items based on 
consumer feedback. The comment asked us to state that values found not 
current will not raise a compliance issue if the covered establishment 
can demonstrate that it has adopted a reasonable program to monitor 
changing values and that it updates materials at reasonable intervals 
based on the manner and frequency in which it changes menus and other 
labeling. The comment also recommended that covered establishments be 
able to update their menus and menu boards at reasonable intervals 
coinciding with typical cycles to change menus and, at a maximum, 
values that require updating be updated at least once a year. One 
comment asked that the final rule clearly state that covered 
establishments are responsible for maintaining the accuracy of their 
nutrient declarations, including keeping this information up-to-date as 
their menus change.
    (Response 154) Nutrition labeling for a standard menu item must be 
truthful and not misleading, consistent with the specific basis used to 
determine nutrient values, and otherwise in compliance with the 
requirements of sections 403(a)(1), 403(f), and 403(q)(5)(H) of the 
FD&C Act and Sec.  101.11. We recognize that changes in nutrition 
information for standard menu items could cause a covered establishment 
to change a menu or menu board even if the list of menu items has not 
changed. In general, revised nutrition must be posted before serving 
the food. Compliance will be determined on a case-by-case basis 
depending on the specific facts and circumstances. We recommend that a 
covered establishment coordinate changes in menu items that are 
significant enough to affect nutrient content with the introduction of 
new items that also require updating a menu or menu board to help 
minimize costs. As discussed in Response 143, covered establishment may 
also use measures such as stickers to update nutrient content on menus 
or menu boards.
    (Comment 155) Several comments requested clarification on who would 
enforce the rule. One comment asked that delegation of inspection 
authority to the States be explicit, and asserted that the provision in 
21 U.S.C. 337 authorizing States to enforce Federal law has rarely been 
used. This comment stated that we could use 21 U.S.C 372(a)(1)(A) to 
provide technical assistance and funding to States and locals for 
enforcement. The comment suggested that we set up a simple process for 
local health inspectors to report violations to us, e.g., a postcard to 
be filled in and sent to us with a tear off receipt to be left with the 
restaurant manager. The comment also suggested that we develop a system 
to collect and store reports of violations in a database. A few 
comments recommended that the final rule specify that enforcement 
procedures of States are not affected by section 4205 of the ACA.
    One comment recommended that we work with headquarters of chain 
restaurants and similar retail food establishments to ensure compliance 
and then have our District Offices assess compliance in the States.
    One comment stated that States and locals cannot be expected to 
enforce the Federal menu labeling requirements without significant 
funding. The comment stated that the enforcement process in its State 
is already overburdened and, therefore, the Federal Government should 
enforce the requirements. Other comments recommended that we rely on 
States and localities and provide training and funding. A few comments 
stated that historically restaurant inspections are done by the States 
and localities, and one comment recommended that we use the contractual 
regime of food safety inspections used with the enforcement of the 
NLEA. One comment stated that local restaurant inspectors can add the 
enforcement of menu labeling to their current inspections. One comment 
recommended that we enforce fines and penalties for noncompliance and 
direct any resulting funds to inspection programs enforcing the menu 
labeling requirements.
    One comment stated that it is not always practical for States and 
locals to enforce section 4205 of the ACA as delegates of FDA; rather 
we should encourage and support enactment of identical requirements 
that fit into local and State food codes.
    One comment suggested that the rule include specific provisions 
that would be binding on State and local jurisdictions relative to 
enforcing the rule. The comment stated that the right to a notice of a 
violation, the opportunity to cure a violation, and the opportunity to 
have a re-inspection before an adverse decision by the enforcing agent, 
e.g. a citation, vary enormously from jurisdiction to jurisdiction, at 
the State and at the local level. The comment suggested that we include 
specifics such as:
     The enforcement agency at initial inspection provides 
written notice of violations;
     The enforcement agency gives the establishment a period of 
time to cure the violations (e.g., 15-30 days);
     The enforcement agency would re-inspect after cure period; 
and
     If violations are not cured, the enforcement agency would 
issue

[[Page 71244]]

adverse decision applying fine or other action that would apply under 
the enforcement agency's regulations or applicable State or local laws.
    The comment stated that these actions would only apply to calorie 
labeling and not to other violations related to safety.
    (Response 155) Collectively, these comments address three 
mechanisms by which States (and, in some cases, local jurisdictions) 
could have a role in enforcing the provisions of section 403(q)(5)(H) 
of the FD&C Act and this rule:
     In general, a State or political subdivision of a State 
may establish food nutrition labeling requirements that are identical 
to applicable Federal requirements, including the requirements of this 
rule. In this case, the State or local jurisdiction would act on its 
own behalf to enforce its own requirements, albeit requirements that 
are identical to the Federal requirements.
     Under 702(a)(1)(A) of the FD&C Act (21 U.S.C. 
372(a)(1)(A)), FDA is authorized to conduct examinations and 
investigations for the purposes of the FD&C Act through any health, 
food, or drug officer or employee of any State, Territory, or political 
subdivision thereof (such as a locality), duly commissioned to act on 
behalf of FDA. In this case, the State or local representative would 
act on our behalf to enforce the Federal requirements.
     In general, under section 310(b) of the FD&C Act (21 
U.S.C. 337(b)), a State may bring in its own name and within its 
jurisdiction proceedings for the civil enforcement, or to restrain 
violations, of section 403(q) of the FD&C Act, including the nutrition 
labeling requirements for standard menu items under section 
403(q)(5)(H) of the FD&C Act, if the food that is the subject of the 
proceedings is located in the State provided that other requirements 
and conditions are met. In this case, the State acts on its own behalf 
to enforce the Federal requirements.
    We have successfully partnered with States to conduct examinations 
and inspections in other contexts, including inspections of food 
processing facilities on our behalf (Ref. 41). We expect to continue to 
cooperatively leverage the resources of Federal, State, and local 
Government Agencies as we strive to obtain industry-wide compliance 
with this rule.

XXV. Final Regulatory Impact Analysis

    FDA has examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). We have developed a detailed Regulatory Impact Analysis (RIA) 
that presents the benefits and costs of this final rule (Ref. 42) which 
is available at http://www.regulations.gov (enter Docket No. FDA-2011-
F-0172). The full economic impact analyses of FDA regulations are no 
longer (as of April 2012) published in the Federal Register but are 
submitted to the docket and are available at http://www.regulations.gov. We also post the full economic impact analyses of 
FDA regulations at the following Web site: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
    This rule is designated an ``economically'' significant rule, under 
section 3(f)(1) of Executive Order 12866. Accordingly, the rule was 
reviewed by OMB. In particular, Executive Order 12866 directs each 
Agency engaged in rulemaking to ``identify the problem that it intends 
to address''--that is, the essential purpose of the rule. As a separate 
step in its rulemaking, Executive Order 12866 directs the Agency to 
``assess both the costs and the benefits of the intended regulation . . 
. , recognizing that some costs and benefits are difficult to 
quantify.''
    Executive Order 13563 confirms that ``each agency is directed to 
use the best available techniques to quantify anticipated present and 
future benefits and costs as accurately as possible. Where appropriate 
and permitted by law, each Agency may consider (and discuss 
qualitatively) values that are difficult or impossible to quantify.'' 
Here, the essential purpose of the rule is to make nutrition 
information for certain foods available to consumers in a direct, 
accessible, and consistent manner to enable consumers to make informed 
and healthful dietary choices. The full analysis--contained in the 
RIA--of anticipated and quantifiable costs and benefits from the 
promulgation of the rule does not alter this fundamental purpose. Nor 
does it fully capture the unquantifiable benefits of greater consumer 
understanding regarding dietary choices and their impact on health.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. According to our analysis, we believe that the final 
rule will have a significant economic impact on a substantial number of 
small entities, and we have accordingly analyzed regulatory options 
that would minimize the economic impact of the rule on small entities 
consistent with statutory objectives. We have crafted the final rule to 
provide flexibility for compliance.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2013) Implicit 
Price Deflator for the Gross Domestic Product. FDA has determined that 
this final rule has met the threshold under the Unfunded Mandates 
Reform Act.
    The analyses that we have performed to examine the impacts of this 
final rule under Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 
1995 are included in the RIA (Ref. 42).
    We had prepared a ``Preliminary Regulatory Impact Analysis'' (Ref. 
43) in connection with the proposed rule. We also included sections 
titled ``Summary of Preliminary Regulatory Impact Analysis'' and 
``Initial Regulatory Flexibility Analysis'' in the preamble to the 
proposed rule (76 FR 19192 at 19220 through 19225). We received 
comments on our analysis of the impacts presented in those sections, 
and the RIA (Ref. 42) contains our responses to those comments.

XXVI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (the 
PRA) (44 U.S.C. 3501-3520). A description of these provisions is given 
in this section of the document with estimates of the annual reporting, 
recordkeeping, and third-party disclosure burden. Included in each 
burden estimate is the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information.

[[Page 71245]]

    We had included a section titled ``Paperwork Reduction Act of 
1995'' in the preamble to the proposed rule (76 FR 19192 at 19225 
through 19229). We received one comment on our analysis of the burdens 
presented in that section.
    (Comment 156) One comment stated that the recordkeeping burdens of 
the proposed rule would impose millions of dollars in cost per year. 
The comment stated that these burdens are needless.
    (Response 156) We disagree that the burdens are needless. Providing 
accurate, clear, and consistent nutrition information, including the 
calorie content of foods, in restaurants and similar retail food 
establishments will make such nutrition information available to 
consumers in a direct and accessible manner to enable consumers to make 
informed and healthful dietary choices.
    We invite comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Title: Information Collection Provisions of the Final Rule on Food 
Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments

A. Reporting Requirements
    Description of Respondents: The likely respondents to this 
information collection are restaurants and similar retail food 
establishments that voluntarily elect to be subject to the Federal 
requirements of this rule by registering with FDA. These establishments 
include chain retail food establishments and eating and drinking places 
such as full- and limited-service restaurants, snack bars (including, 
for example, ice cream, donut, and bagel shops and similar 
establishments), cafeterias and drinking places, managed food service 
facilities, grocery stores, supermarkets, convenience stores, general 
merchandise stores, lodging facilities, recreational venues, sports 
venues, performing arts venues, and movie theaters.
    Description: Restaurants and similar retail food establishments not 
subject to the ACA's requirements may voluntarily elect to be subject 
to the Federal requirements by registering with FDA. Authorized 
officials for restaurants and similar retail food establishments must 
provide FDA with the following information on Form FDA 3757: Their 
contact information including name, address, phone number, and email 
address for their authorized official; the contact information 
including name, address, phone number, and email address for each 
restaurant or similar retail food establishment being registered, as 
well as the name and contact information for an official onsite, such 
as the owner or manager, for each specific restaurant or similar retail 
food establishment; all trade names the restaurant or similar retail 
food establishment uses; preferred mailing address, if different from 
location address for each establishment; and certification that the 
information submitted is true and accurate, that the person submitting 
it is authorized to do so, and that each registered restaurant or 
similar retail food establishment will be subject to the requirements 
of section 403(q)(5)(H) of the FD&C Act and Sec.  101.11 of the final 
rule.
    To keep the establishment's registration active, the authorized 
official of the restaurant or similar retail food establishment must 
register every other year within 60 days prior to the expiration of the 
establishment's current registration with FDA. Registration will 
automatically expire if not renewed.

                                     Table 1--Estimated Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
                                   Number of     responses per   Total annual    Average burden
        21 CFR part 101           respondents   respondent per     responses    per response (in    Total hours
                                                     year                            hours)
----------------------------------------------------------------------------------------------------------------
Initial Burden (annualized
 over 3 years):
    Sec.   101.11(d) Initial             3,559               1           3,559  2...............           7,118
     Registration.
Annual Burden:
    Sec.   101.11(d)                     5,340               1           5,340  0.5 (30 minutes)           2,670
     Registration Renewal.
                               ------------------------------------------------                  ---------------
    Total Burden Hours........  ..............  ..............  ..............  ................           9,788
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We lack data on the number of restaurants and similar retail food 
establishments that might voluntarily register to comply with this 
final rule. We do not expect the net benefit for voluntary registration 
for many non-covered establishments to be positive and in the RIA (Ref. 
42) we indicate that as of the conducting of this analysis, no 
establishments have voluntarily registered with FDA. Therefore we did 
not estimate a significant burden in the RIA. However, in the event 
that a few register anyway, or find positive incentive to do so, for 
the purposes of this PRA analysis, we estimate the burden such 
establishments will face. We believe that implementation of the final 
rule, and the resulting attention to the nutrition content of standard 
menu items, may give non-covered establishments an incentive to 
voluntarily disclose calorie and other nutrition information. We 
believe that the only types of establishments that would likely face a 
positive incentive to voluntarily register are some restaurants and 
some grocery, convenience, and general merchandise stores that do not 
already provide this information in some form or another at the point 
of purchase. We estimate that 5 percent of these establishments may 
register, or 10,678 [(5% volunteer x 47% no nutrition info x 348,200 
non-covered restaurants) + (5% volunteer x 49,900 non-covered grocery, 
convenience, and general merchandise stores)] (Refs. 44 and 45). We 
estimate it will require approximately 2 hours per initial 
registration. Given 10,678 establishments and one initial registration 
per establishment at 2 hours per registration, we estimate the initial 
hourly burden for these establishments is 21,356 hours (10,678 
establishments x 1 initial registration per establishment x 2 hours per 
registration). Annualizing

[[Page 71246]]

this value over 3 years yields 7,118 hours per year (10,678 
establishments/3 years x 1 initial registration per establishment x 2 
hours per registration). (10,678 establishments/3 years = 3,559 
establishments per year.)
    We expect that renewal registrations will require substantially 
less time because establishments are expected to be able to affirm or 
update the existing information in an online account in a way similar 
to other FDA firm registration systems. We estimate that re-
registration will take 30 minutes (0.5 hours) for each registrant. This 
would indicate that biennial registration would impose a burden of 
5,340 hours (10,678 establishments x 0.5 hours) every 2 years, or 2,670 
hours every year (10,678 establishments/2 years x 0.5 hours).
B. Recordkeeping Requirements
    The preamble to the proposed rule provided an estimate of the 
recordkeeping burden, which consisted of the burden associated with 
nutrition analysis and the burden associated with generating, 
providing, or maintaining records. Upon further consideration, we have 
omitted the burden estimate associated with generating or maintaining 
records previously estimated in the proposed rule because the rule does 
not require restaurants and similar retail food establishments to 
generate or maintain records. This section now includes only the burden 
estimate associated with providing information substantiating nutrient 
values of standard menu items to FDA as required by the final rule. 
Further, as discussed in section C of this analysis, we have included a 
burden estimate for nutrition analysis as part of the third party 
disclosure burden, since the total time, effort, or financial resources 
expended by covered establishments to declare nutrition information 
likely includes time, effort, or financial resources to determine the 
nutrition content of covered menu items.
Description of Respondents
    The likely respondents to this information collection are 
restaurants and similar retail food establishments that are subject to 
the Federal requirements of this rule or that volunteer to be subject 
to the rule. These establishments include chain retail food 
establishments and eating and drinking places such as full- and 
limited-service restaurants, snack bars (including, for example, ice 
cream, donut, and bagel shops and similar establishments), cafeterias 
and drinking places, and managed food service facilities. Chain retail 
food establishments would also include some grocery stores, 
supermarkets, convenience stores, general merchandise stores, lodging 
facilities, recreational venues, sports venues, performing arts venues, 
and movie theaters (Ref. 46).
Description
    The paperwork burden for the recordkeeping requirements of the 
final rule is to provide substantiation of the nutrient values of 
standard menu items to FDA. The likely respondents for the nutrition 
analysis are restaurants and similar retail food establishments that 
are subject to the Federal requirements of this rule or that volunteer 
to be subject to the rule. These establishments must produce records 
with information substantiating nutrient values for their standard menu 
items.
    The likely respondents are the universe of retail food 
establishments and retail chains that are covered by the final rule. 
Our estimate includes eating and drinking places such as full- and 
limited-service restaurants, snack bars including, for example, ice 
cream, donut, and bagel shops and similar establishments, cafeterias 
and drinking places, and managed food service facilities. Covered 
establishments also include some grocery stores, supermarkets, 
convenience stores, general merchandise stores, lodging facilities, 
recreational venues, sports venues, performing arts venues, and movie 
theaters.

                                                       Table 2--Estimated Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Annual
                21 CFR part 101                     Number       frequency per   Total annual               Hours per record                Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Initial Burden (Annualized over 3 years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A) Initial Nutrition              69,017               1          69,017  0.25 (15 minutes).......................          17,254
 Analysis Records.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A) Recurring Nutrition            30,059               1          30,059  0.25 (15 minutes).......................           7,515
 Analysis Records.
                                               ------------------------------------------------                                          ---------------
    Total Burden Hours........................  ..............  ..............  ..............  ........................................          24,769
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Initial Nutrition Analysis
    We estimate the annual number of the largest restaurant chains that 
will need to produce substantiation of their standard menu items to be 
541 (503 covered restaurant chains + 38 voluntary restaurant chains) 
with an average of 117 unique menu items that will require an initial 
nutrition analysis. This leads to 63,297 (541 chains x 117 items) 
individual chains-specific restaurant records. In addition to chain-
level nutrition analysis, each individual restaurant establishment will 
likely have a small variety of standard menu items that are unique to 
the individual establishment. We estimate there are 11,684 restaurants 
establishments (10,866 covered + 818 voluntary) with establishment-
specific items. Each of these restaurant establishments has an average 
of five establishment-specific menu items. This leads to 58,420 (11,684 
establishments x 5 items) individual establishment-specific restaurant 
records.
    In addition to restaurants, other similar retail food 
establishments have both chain-specific and establishment-specific menu 
items. Other covered retail food establishments include: Grocery 
stores, supermarkets, convenience stores, general merchandise stores, 
lodging facilities, recreational venues, sports venues, performing arts 
venues, and movie theaters. We estimate there are 691 grocery, 
convenience, and general merchandise (GCGM) store chains (660 covered + 
31 voluntary) with an average of 40 menu items each (= 27,640 records); 
5,309 GCGM establishments

[[Page 71247]]

(5,060 covered + 249 voluntary) with an average of 5 establishment-
specific menu items each (= 26,545 records); 50 managed food service 
(MFS) chains with an average of 80 menu items (= 4,000 records); 450 
MFS establishments with an average of 5 establishment-specific menu 
items (= 2,250 records); 100 lodging chains with an average of 40 menu 
items (= 4,000 records); 620 lodging establishments with an average of 
5 establishment-specific menu items (= 3,100 records); 250 sports, 
recreation and entertainment (SRE) chains with an average of 59 menu 
items (= 14,750 records); and 610 SRE establishments with an average of 
5 establishment-specific menu times (= 3,050 records). In total, we 
estimate there are 207,052 records (63,297 restaurant chain-level + 
58,420 restaurant establishment-level + 27,640 GCGM chain-level + 
26,545 GCGM establishment-level + 4,000 MFS chain-level + 2,250 MFS 
establishment-level + 4,000 lodging chain-level + 3,100 lodging 
establishment-level + 14,750 SRE chain-level + 3,050 SRE establishment-
level). Annualized over 3 years, this value yields 69,017 (= 207,052 
records/3 years) per year. We estimate that each nutrition analysis 
will require a burden of 15 minutes to produce each record. We estimate 
the total recordkeeping burden for the initial nutrition analysis to be 
17,254.25 hours (= 69,017 records x 0.25 hours per record).
Recurring Nutrition Analysis
    From Mintel Menu Insights data, we estimate that restaurant chains 
introduced, on average, 24 new menu items in 2009 (Ref. 47). Because 
the final requirements do not apply to temporary menu items, daily 
specials, and foods that are part of a customary market test, only a 
fraction of these items will need nutrition analysis. We estimate that 
existing restaurant chains or individual establishments would need new 
nutrition analysis for 25 percent of new standard menu items, or six 
new standard menu items per year. If in addition to these new standard 
menu items, chains need nutrition analysis on 6 reformulated standard 
menu items, there would be a total of 12 nutrition analyses per chain 
needed on an annual basis. Thus we estimate there will be 26,904 annual 
records associated with new or reformulated items of covered chains [= 
(1,151 restaurant chains + 691 GCGM chains + 50 MFS chains + 100 
lodging chains + 250 SRE chains) x 12 menus items].
    In addition we estimate that each year there will be the number of 
covered chains to increase in each category as companies expand. As 
discussed in the final RIA, each year there will be some existing non-
covered chains that, through expansion of their business, will become 
subject to the rule's requirements (for example, a chain expanding from 
19 to 20 locations). We estimate there will be 20 new restaurant 
chains, each with an average of 117 menu items; 5 new GCGM chains each 
with an average of 40 menu items; 3 new MFS chains each with an average 
of 80 menu items; 2 new lodging chains each with an average of 40 menu 
items; 5 new SRE chains each with an average of 59 menu items. Thus we 
estimate there will be 3,155 annual records [= (20 restaurants x 117 
items) + (5 GCGM x 40 items) + (3 MFS x 80 items) + (2 lodging x 40 
items) + (5 SRE x 59 items] associated with nutrition analysis for new 
covered chains.
    Based on data from FDA's Recordkeeping Cost Model, we estimate that 
it will take approximately 15 minutes per standard menu item for 
providing the information of nutrition analysis to FDA (Ref. 48). We 
estimate the total recurring recordkeeping burden for the nutrition 
analysis to be 7,515 hours [(26,899 records for new/reformulated 
standard menu items under existing chains + 3,155 records for items 
under new chains) x 0.25 hours per record)].

C. Third-Party Disclosure Requirements

    Description of Respondents: Restaurants and similar retail food 
establishments that are subject to statutory menu labeling requirements 
or that voluntarily elect to be subject to the Federal requirements by 
registering with FDA.
    Description: There will be five types of third-party disclosure 
burdens under the rule related to: Initial nutrition analysis, initial 
menu replacement, chain-level written nutrition information, 
establishment-level nutrition information, recurring nutrition 
analysis, and recurring menu replacement.

                                                    Table 3--Estimated Third Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Number of                                                                   Total operating
            21 CFR Part 101                 Number of      disclosures    Total annual     Average burden per disclosure      Total     and maintenance
                                           respondents   per respondent    disclosures                                        hours          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Initial Burden (Annualized over 3 years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A) Initial                 69,017               1          69,017  4................................    276,068  .................
 Nutrition Analysis.
Sec.   101.8(c)(2)(i)(A) Initial Menu           106,168               1         106,168  0.5 (30 minutes).................     53,084       $248,767,000
 Replacement.
Sec.   101.8(c)(2)(i)(A) Written                  1,632               1           1,632  3................................      4,896  .................
 Nutrition Information Chain-level.
Sec.   101.8(c)(2)(i)(A) Written                 18,673               1          18,673  0.5 (30 minutes).................      9,337  .................
 Nutrition Information Establishment-
 level.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A) Recurring               30,054               1          30,054  4................................    120,216  .................
 Nutrition Analysis.
Sec.   101.8(c)(2)(i)(A) Recurring Menu             700               1             700  0.5 (30 minutes).................        350           $529,000
 Replacement.
                                        ----------------------------------------------------------------------------------------------------------------
    Total..............................  ..............  ..............  ..............  .................................    463,951       $249,296,000
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 71248]]

Initial Nutrition Analysis
    The first burden is the time and effort expended by restaurants and 
other retail food establishments to determine the nutrition content of 
their covered menu items, which we refer to as ``Nutrition Analysis.'' 
A nutrition analysis entails the burden of determining nutrition 
content for covered and voluntary establishment menus by analyzing the 
food product and summarizing the nutritional information results. Note 
that the recordkeeping portion of this burden was estimated in the 
previous subsection.
    Our estimate for the annual number of the restaurant and similar 
retail food chains and individual establishments that will be burdened 
with initial nutrition analysis is identical to our estimate for the 
chains and establishments under the recordkeeping subsection. The total 
number of respondents estimated for the third-party disclosure burden 
of initial nutrition analysis is 207,052. Annualized over 3 years, this 
value becomes 69,017. We estimate that each nutrition analysis will 
require a burden of 4 hours (this estimate of 4 hours was used in the 
final RIA (Ref. 42)), thus total burden for the initial nutrition 
analysis is 276,068 hours (207,052 records/3 years x 4 hours per 
record).
Recurring Nutrition Analysis
    The second burden is the time and effort expended by restaurants 
and other retail food establishments in recurring nutrition analysis. 
As discussed in the recordkeeping subsection of this PRA, recurring 
nutrition analysis will be required for new and reformulated standard 
menu items. Our estimate for the annual number of the restaurant and 
similar retail food chains and individual establishments that will be 
burdened with recurring nutrition analysis is identical to our estimate 
for the chains and establishments under the recordkeeping subsection. 
The total number of respondents estimated for the third-party 
disclosure burden of recurring nutrition analysis is 30,054. We 
estimate that each nutrition analysis will require a burden of 4 hours 
(this estimate of 4 hours was used in the final RIA (Ref. 42)), thus 
total third party disclosure burden recurring nutrition analysis is 
120,216 hours (30,054 records x 4 hours per record).
Initial Menu Replacement
    The third burden is for the time expended by restaurants and 
similar retail food establishments to physically produce and install 
the menus, menu boards that include the new calorie declarations, which 
we refer to as ``Calorie Declaration Signs.'' As described in the final 
RIA (Ref. 42), chain retail food establishments will need to redesign 
and replace their existing menus and menu boards in order to comply 
with the final requirements. For full service restaurants and drinking 
places with only personal menus and no menu boards, this burden will be 
relatively low. Most menus are replaced frequently anyway as they wear 
out, are lost, or as prices and menu items change. For many of these 
establishments, the burden of updating menus to comply with the final 
requirements would be limited to design and associated administrative 
hours.
    The longer lifespan of menu boards in limited-service eating places 
would likely require the redesign of menu/menu boards and the 
replacement of one or more menu boards. In addition, some chains would 
need to update self-serve and display signs. The number of menus that 
an establishment will keep on hand is highly variable. A full-service 
restaurant, where each order is placed using a menu, will need more 
than a quick-service establishment that uses menus just for takeout 
orders. The number of menus is also tied to the seating capacity of the 
restaurant, and whether the menu is laminated or paper. Because paper 
menus are more fragile and cheaper to print in bulk, an establishment 
may keep a large reserve in stock, whereas establishments using more 
durable and expensive laminated menus may only keep a few extra on 
hand. Estimates for the burden of updating menu boards, other major 
displays that serve as menus, such as electronic displays, or major 
materials needed to disclose calories for self-serve or displayed foods 
to comply with the final requirements, will vary widely across chains 
and establishments because of different menu board and display types.
    As described in the RIA, we estimate that the average full-service 
restaurant establishment must discard and reprint one menu for each 
seat, plus 10 extra, for a total of 91 menus per restaurant each year. 
We estimate that GCGM stores have an average of two menu boards per 
establishment based on public comments that we received. We estimate 
that MFS and SRE establishments will each have an average of one menu 
board. Lodging establishments generally have menus instead of menu 
boards, and we estimate the menu replacement burden for establishments 
in the lodging sector to be 87 menu replacements per establishment. 
Since each covered and voluntarily registered establishment will need 
to replace menus and/or menu boards, we estimate this total value to be 
318,505 (= 248,610 restaurants + 53,095 GCGM + 4,500 MFS + 6,200 
lodging + 6,100 SRE). (In the previous calculation, 248,610 restaurants 
= 231,200 covered restaurants + 17,410 voluntary; and 53,095 GCGM = 
50,600 covered + 2,495 voluntary.) Annualized over 3 years, this value 
becomes 106,168 (= 318,505/3 years). We estimate the labor burden for 
ordering new menus and menu boards to be 30 minutes (0.5 hours) per 
establishment. Thus the total burden for initial menu replacement is 
53,084 hours per year. At an average wage (which includes an extra 50 
percent to account for overhead costs and employee benefits) of $30 per 
hour for managers across the covered industries, the labor burden comes 
to $1,593,000 (= 53,084 hours x $30 per hour). In the final RIA (Ref. 
42), we estimated the total average costs associated with initial menu 
replacement to be $250.36 million. This value takes into consideration 
costs of menu/menu board design, printing, and installation. 
Subtracting the labor costs of ordering new menus, $1,593,000, from the 
total costs for initial menu replacement, $250,360,000, yields total 
initial operating and maintenance costs of $248,767,000.
Recurring Menu Replacement for New Chains
    The fourth burden is for the time expended by new restaurants and 
similar retail food establishments to physically replace menus and menu 
boards that include the new calorie declarations. All restaurants and 
similar retail food chains that become covered as the number of their 
associated establishments grows beyond the coverage threshold of 20 
will need to replace their menus and menu boards. We estimated in the 
final RIA (Ref. 42) that the annual number of new covered restaurants 
and similar retail food establishments is 700. Again, we estimate the 
labor burden for ordering new menus and menu boards to be 30 minutes 
(0.5 hours) per establishment. Thus the total annual burden for 
recurring menu replacement is 350 hours per year. At an average wage 
(which includes an extra 50 percent in overhead costs and employee 
benefits) of $30 per hour for managers across the covered industries, 
the recurring labor burden comes to $11,000 (= 350 hours x $30 per 
hour). In the final RIA, we estimated the total average annual 
operating and maintenance costs associated with recurring menu 
replacement to be $540,000. This value

[[Page 71249]]

takes into consideration costs of menu/menu board design, printing, and 
installation. Subtracting the recurring labor costs of ordering new 
menus, $11,000, from the total costs for recurring menu replacement of 
$540,000, yields total recurring operating and maintenance costs of 
$529,000.
Written Nutrition Information
    The fifth burden is for the time expended by restaurants and 
similar retail food establishments to make written nutrition 
information available to customers upon request. The number of chains 
(and associated establishments) that do not already provide this 
information was estimated in the recordkeeping subsection under initial 
nutrition analysis, or 1,632 chains (503 covered restaurant + 38 
voluntary restaurant + 660 covered GCGM + 31 voluntary GCGM + 50 
covered MFS + 100 covered lodging + 250 covered SRE) and 18,673 
establishments with establishment specific-menu items (10,866 covered 
restaurant + 818 voluntary restaurant + 5,060 covered GCGM + 249 
voluntary GCGM + 450 covered MFS + 620 covered lodging + 610 covered 
SRE). We estimate the time it takes to provide written nutrition 
information at the chain level to be 3 hours per respondent. Since the 
average number of establishment-specific menu items is only five per 
establishment, we estimate the time it takes to provide written 
nutrition information at the establishment level (for those menu items 
that are specific only to the establishment) to be 30 minutes per 
respondent. Thus the total burden hours for chain-level and 
establishment level written nutrition information disclosure are 4,896 
and 9,336.5 hours, respectively. Therefore the total third party 
disclosure burden for the rule is 463,950.5 hours with total operating 
and maintenance costs of $249,296,000.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to oira_submission@omb.eop.gov. All comments should be 
identified with the OMB Control Number 0910-NEW, and title 
``Information Collection Provisions of the Final Rule on Food Labeling: 
Nutrition Labeling of Standard Menu Items in Restaurants and Similar 
Retail Food Establishments.'' Also include the FDA docket number found 
in brackets in the heading of this document.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), we have resubmitted the information collection provisions of 
this final rule to OMB for review, because the final rule provides 
additional modifications to Sec.  101.11. These requirements will not 
be effective until we obtain OMB approval. Interested persons are 
requested to submit comments regarding information collection to OMB 
(see DATES and ADDRESSES).
    Prior to the effective and compliance date of this final rule, we 
will publish a notice in the Federal Register announcing OMB's decision 
to approve, modify, or disapprove the information collection provisions 
in this final rule. An Agency may not conduct or sponsor, and a person 
is not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

XXVII. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires Agencies to ``construe . . . a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts ``any requirement for nutrition labeling of food that is 
not identical to the requirement of section 403(q) [of the FD&C Act] 
[21 U.S.C. 343(q)]'', except that this provision does not apply ``to 
food that is offered for sale in a restaurant or similar retail food 
establishment that is not part of a chain with 20 or more locations 
doing business under the same name (regardless of the type of ownership 
of the locations) and offering for sale substantially the same menu 
items unless such restaurant or similar retail food establishment 
complies with the voluntary provision of nutrition information 
requirements under section 403(q)(5)(H)(ix) [of the FD&C Act].'' In the 
proposed rule, we provided an interpretation of the preemptive 
provisions of section 4205 of the ACA, as well as an alternative 
interpretation (76 FR 19192 at 19203). (21 U.S.C. 343-1(a)(4)). The 
final rule creates requirements for nutrition labeling of food under 
section 403(q) of the FD&C Act that would preempt certain non-identical 
State and local nutrition labeling requirements.
    Section 4205 of the ACA also includes a Rule of Construction 
providing that ``Nothing in the amendments made by [section 4205] shall 
be construed--(1) to preempt any provision of State or local law, 
unless such provision establishes or continues into effect nutrient 
content disclosures of the type required under section 403(q)(5)(H) of 
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)] (as 
added by subsection(b)) and is expressly preempted under subsection 
(a)(4) of such section; (2) to apply to any State or local requirement 
respecting a statement in the labeling of food that provides for a 
warning concerning the safety of the food or component of the food; or 
(3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food, 
Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)(ix)] (as added by 
subsection (b)), to apply to any restaurant or similar retail food 
establishment other than a restaurant or similar retail food 
establishment described in section 403(q)(5)(H)(i) of such Act.'' (See 
Pub. L. 111-148, Sec. 4205(d), 124 Stat. 119, 576 (2010).)
    We interpret the provisions of section 4205 of the ACA related to 
preemption to mean that States and local governments may not impose 
nutrition labeling requirements for food sold in a covered 
establishment, as defined in Sec.  101.11(a), unless the State or local 
requirements are identical to the Federal requirements. In other words, 
States and localities cannot have additional or different nutrition 
labeling requirements for food sold either in (1) chain retail food 
establishments or (2) restaurants and similar retail food 
establishments not subject to the requirements of section 403(q)(5)(H) 
of the FD&C Act that voluntarily elect to be subject to the 
requirements by registering biannually under section 403(q)(5)(H)(ix).
    Otherwise, for certain food that is not subject to the nutrition 
labeling requirements of section 403(q)(5)(H) of the FD&C Act, States 
and localities may establish or continue to impose nutrition labeling 
requirements. First, States and localities can have nutrition labeling 
requirements for food sold in restaurants or similar retail food 
establishments that are not part of a chain with 20 or more locations 
doing business under the same name and offering for sale substantially 
the same menu items that have not voluntarily registered under section 
403(q)(5)(H)(ix) of the FD&C Act.
    Second, States and localities can have nutrition labeling 
requirements for foods offered for sale in other establishments 
described in sections

[[Page 71250]]

403(q)(5)(A)(i) or (ii) of the FD&C Act that are exempt from the 
nutrition labeling requirements of sections 403(q)(1) to (q)(4) of the 
FD&C Act under section 403(q)(5)(A)(i) or (ii) of the FD&C Act, 
provided that such food is not required to have nutrition labeling 
under section 403(q)(5)(H) of the FD&C Act. For example, certain foods 
sold in schools and transportation carriers would not be required to 
have nutrition labeling under sections 403(q)(1) to (q)(4) of the FD&C 
Act (see section 403(q)(5)(A)(i) and (ii) of the FD&C Act and Sec.  
101.9(j)(2) and (j)(3)), or under section 403(q)(5)(H) of the FD&C Act 
because these establishments are not covered establishments within the 
meaning of Sec.  101.11(a). Under our interpretation of the Rule of 
Construction in section 4205(d)(1) of the ACA, nutrition labeling for 
food sold from such establishments would not be ``nutrient content 
disclosures of the type required under section 403(q)(5)(H)(viii) [of 
the FD&C Act]'' and, therefore, would not be preempted. As a result, 
States and localities would be able to continue to require nutrition 
labeling for foods sold from establishments that are exempt from the 
nutrition labeling requirements of section 403(q)(1) to (q)(4) of the 
FD&C Act and not subject to nutrition labeling requirements of section 
403(q)(5)(H) of the FD&C Act.
    In addition, the express preemption provisions of section 
403(A)(a)(4) of the FD&C Act do not preempt any State or local 
requirement respecting a statement in the labeling of food that 
provides for a warning concerning the safety of the food or component 
of the food.
    The preamble to the proposed rule (76 FR 19192 at 19229 to 19230) 
described an alternative interpretation of the preemption provisions of 
section 4205 of the ACA that could leave less room for States and 
localities to require nutrition labeling for food sold in restaurants 
or similar retail food establishments. Under this alternative 
interpretation, State or local nutrition labeling requirements for food 
sold in establishments that are not ``restaurants or similar retail 
food establishments,'' would be ineligible for the exception to the 
preemption in section 403(A)(a)(4) of the FD&C Act, because that 
exception by its literal terms only covers nutrition labeling 
requirements for food offered for sale in certain restaurants or 
similar retail food establishments, specifically those not subject to 
the nutrition labeling requirements of section 403(q)(5)(H) of the FD&C 
Act. Under this alternative interpretation, States and localities could 
not have nutrition labeling requirements for certain foods offered for 
sale in non-restaurants and similar retail food establishments unless 
they successfully petitioned us. Federal law provides that, upon 
petition, FDA may exempt State or local requirements from the express 
preemption provisions of section 403A(a)(4) of the FD&C Act under 
certain conditions. (See 21 U.S.C. 343-1(b).) We have issued 
regulations at Sec.  100.1 (21 CFR 100.1) describing the petition 
process that is available to State and local governments to request 
such exemptions from preemption.
    In addition, under this alternative interpretation, there would be 
foods in certain establishments for which the Federal Government has 
not required nutrition labeling and for which States and localities 
would also be precluded from establishing such labeling requirements 
unless they successfully petitioned us and a rulemaking was completed. 
This approach would risk creating a regulatory gap that would be 
inconsistent with the purposes of section 4205 of the ACA. It would 
also impose a restriction and burden on the States and localities that 
is inconsistent with the Federalism principles expressed in Executive 
Order 13132, as well as a substantial administrative burden on FDA in 
the event States petition for exemption.
    We requested comment on our interpretation of section 4025 of the 
ACA related to preemption, as well as the alternative interpretation. 
We also requested comment on the use of the petition process in this 
context and on other potential interpretations that interested persons 
could identify as appropriate given both the preemption-related 
language of section 4205 of the ACA and the statutory goals.
    (Comment 157) Several comments agreed with our interpretation of 
the preemption provisions of section 4205 of the ACA. A few of these 
comments recommended that the final rule include an explicit statement 
that the scope of the law's preemptive effect is coextensive with the 
law's nutrition labeling requirements; that is, the only State and 
local provisions that are preempted are those that explicitly require 
the type of menu labeling set forth in section 4205 of the ACA at a 
covered establishment. For example, the comments stated that if we 
decide not to cover movie theaters, hospitals, and other establishments 
or decide to exempt alcohol beverages from menu labeling in the final 
rule, then States and localities can enact laws to cover them. Another 
comment stated that an express statement about preemption will 
encourage States and localities to pass laws that fill in the gaps and 
to pass identical laws.
    One comment disagreed with our proposed interpretation of the 
preemption provisions and its outcome. The comment stated that 
narrowing the exception for preemption is consistent with Congress' 
purpose to preempt the growing patchwork of State and local menu 
labeling laws. In addition, the comment stated that, while the 
alternative interpretation would result in a ``regulatory gap'' with 
some establishments not covered by Federal, State, and local menu 
labeling laws, Congress could amend the FD&C Act, if it chose to do so.
    (Response 157) We agree with the comments asserting that the 
preemptive effect of the Federal menu labeling requirements of section 
4205 of the ACA is limited to State and local requirements that impose 
additional or different nutrition labeling requirements for food that 
is covered by the Federal requirements of section 403(q)(5)(H) of the 
FD&C Act and Sec.  101.11. We also agree that the alternative 
interpretation described in the proposed rule (76 FR 19192 at 19230) 
would restrict State and local authorities and create a regulatory gap 
that would be inconsistent with the purposes and language of section 
4205 of the ACA and the Federalism principles expressed in Executive 
Order 13132.
    We disagree with the comment that suggested that the alternative 
interpretation is more consistent with congressional intent to preempt 
the ``patchwork'' of State and local laws on menu labeling and that the 
solution for the ``regulatory gap'' under that interpretation would be 
for Congress to amend the FD&C Act again. Congress did create a uniform 
national menu labeling scheme for certain foods in certain facilities 
described in section 4205 of the ACA. However, nothing in the 
legislative history suggests that Congress intended to create a 
category of foods in establishments for which neither the Federal 
Government nor State or local governments could require menu labeling. 
We think it is more consistent with the purposes of section 4205 of the 
ACA, which provides valuable nutrition information to consumers, to 
allow State and local governments to require menu labeling for food not 
covered by Federal law. The language of section 4205(c) of the ACA 
amending section 403A of the FD&C Act is consistent with our final 
interpretation. This amendment includes an exception from preemption 
for food sold in restaurants or similar retail food establishments that 
are not restaurants or establishments subject to the requirements of 
403(q)(5)(H) of the FD&C Act.

[[Page 71251]]

    For these reasons, we interpret the provisions of section 4205 of 
the ACA related to preemption to mean that State and local governments 
may not establish or continue in effect nutrition labeling requirements 
for food covered by the Federal requirements of section 403(q)(5)(H) of 
the FD&C Act and Sec.  101.11, unless the State or local requirements 
are identical to the Federal requirements of section 403(q)(5)(H) of 
the FD&C Act and Sec.  101.11. In other words, States and localities 
cannot have additional or different nutrition labeling requirements for 
food sold either from: (1) Chain retail food establishments; or (2) 
restaurants and similar retail food establishments not otherwise 
subject to the requirements of section 403(q)(5)(H) and Sec.  101.11 
who voluntarily elect to be subject to those requirements by 
registering biannually with FDA in accordance with section 
403(q)(5)(H)(ix) of the FD&C Act and Sec.  101.11(d). For food sold in 
restaurants and similar retail establishments not subject to the 
nutrition labeling requirements of section 403(q)(5)(H) of the FD&C 
Act, States and localities may impose nutrition labeling requirements.
    (Comment 158) Several comments agreed with our interpretation of 
the Rule of Construction. One comment agreed that warning statements 
are not preempted but asked us to clarify that this does not mean just 
microbiological hazards.
    A few comments recommended that we codify the Rule of Construction. 
The comments asserted that the absence of codified provisions in the 
rule regarding the Rule of Construction could lead to confusion in 
properly interpreting the statute. The comments maintained that the 
lack of codified provisions in the rule for a similar Rule of 
Construction in the NLEA (see 21 U.S.C. 343-1 note) has led to 
confusion and to court decisions that have not taken that rule into 
account. The comments maintained that ensuring that the Rule of 
Construction is explicitly set out in Title 21 of the Code of Federal 
Regulations could help to avoid similar problems with the menu labeling 
law.
    (Response 158) With respect to our interpretation of the Rule of 
Construction in section 4205(d) of the ACA, we reiterate that State or 
local requirements for statements in food labeling providing for 
warnings concerning food safety are not preempted. We agree with the 
comment that food safety in this context is not limited to 
microbiological hazards. We are not persuaded by the comments 
suggesting that we add a codified statement to Sec.  101.11 restating 
the Rule of Construction at section 4205(d) of the ACA. We have 
highlighted the existence of the Rule of Construction and have 
explained our interpretation of section 4205(d) of the ACA both in the 
preamble to the proposed rule and in the preamble to this final rule. 
We do not think that codifying the Rule of Construction in section 
4205(d) in our regulations is needed either to prevent confusion in 
interpreting the statute or to assure that courts consider section 
4205(d) when appropriate.
    (Comment 159) Some comments asked us to address the meaning of 
``identical'' in section 403A(a)(4) of the FD&C Act, which excludes 
from preemption State and local requirements that are identical to 
Federal requirements under section 403(q) of the FD&C Act. The comments 
recommended that the final rule explicitly state that ``identical'' 
refers to the effect of the law and does not mean that a State or local 
requirement must be identical in wording of the law.
    (Response 159) In response to the comments asserting that we revise 
the rule to clarify the meaning of ``identical'' within the context of 
section 403A(a)(4) of the FD&C Act, we note that we have already issued 
a regulation at Sec.  100.1 that explains the meaning of ``not 
identical to'' in the context of section 403A of the FD&C Act in 
describing the petition process available to State and local 
governments to request an exemption from the express preemption 
provisions of section 403A of the FD&C Act under section 403A(b). 
Section 100.1(c)(4) provides in relevant part that, within the context 
of section 403A of FD&C Act, ``not identical to'' does not refer to the 
specific words in the State or local requirement but instead means that 
the State or local requirement directly or indirectly imposes 
obligations or contains provisions concerning the labeling of food 
that: (1) Are not imposed by or contained in the applicable provision 
(including any implementing regulation) of section 403 of the FD&C Act; 
or (2) differ from those specifically imposed by or contained in the 
applicable provision (including any implementing regulation) of section 
403 of the FD&C Act.
    Accordingly, a State or local nutrition labeling requirement for 
food covered by the requirements of section 403(q)(5)(H) of the FD&C 
Act and Sec.  101.11 that directly or indirectly imposes obligations or 
contains labeling provisions that: (1) Are not imposed by or contained 
in section 403(q) of the FD&C Act and Sec.  101.11; or (2) differ from 
those specifically imposed by or contained in section 403(q) of the 
FD&C Act and Sec.  101.11 would be ``not identical to'' the Federal 
requirements and therefore would be preempted under section 403A(a)(4) 
of the FD&C Act. Because the meaning of the phrase ``not identical 
to,'' within the context of section 403A of the FD&C Act, is already 
described in Sec.  100.1 and is further explained here, we decline to 
revise the rule to clarify the meaning of ``identical'' as suggested by 
the comments.
    (Comment 160) A few comments recommended that we support 
development of State and local laws that are identical. The comments 
recommended that we help the States and localities by making staff 
available to help assess the proposed language of State or local law 
for potential conflicts with Federal law and providing model 
legislation, which should be made part of the Model Food Code.
    (Response 160) As discussed in section XXIV, a State or local 
jurisdiction may establish requirements, identical to those established 
in this rule, in its own food codes and then enforce its own food 
codes. Whether we can help States and localities assess the proposed 
language of State or local law for potential conflicts with Federal law 
will depend on resources available at the time of any requests for such 
assistance. However, at this time, we do not expect to have resources 
to provide model legislation for use by States and localities. We 
recommend that States and localities who wish to establish 
requirements, in their own food codes, identical to those established 
in this rule adapt Sec.  101.11 for their own use.
    (Comment 161) One comment asked us to describe the basis on which 
establishments that opt into the program can be assured that preemption 
applies. The comment asserted that if a facility complies with the 
Federal requirements under its food service contract as agreed to by 
the Federal Government, that establishment must be fully protected from 
State and local menu labeling action. The comment also stated that a 
facility's compliance with the terms of a Federal Government contract 
must suffice as certification that the facility is in compliance with 
all FDA menu labeling provisions and the facility should be permitted 
to opt into our program without any additional requirements.
    (Response 161) As provided in 403(q)(5)(H)(ix) of the FD&C Act, 
authorized officials of restaurants and similar retail establishments 
that are not subject to the requirements of section 403(q)(5)(H) may 
elect to be subject to those requirements by registering biannually 
with FDA, as specified in Sec.  101.11(d). Under section 403A(a)(4) of

[[Page 71252]]

the FD&C Act, an establishment that ``complies with the voluntary 
provision of nutrition information requirements of 403(q)(5)(H)(ix)'' 
brings itself within the scope of Federal preemption of State and local 
laws. The comment appears essentially to be seeking FDA's assurances 
that a facility's compliance with the terms of a Federal contract to 
provide food services would (1) suffice for ``opting in'' to the 
voluntary program and (2) guarantee that State and local menu labeling 
action against the facility is prohibited. We decline to provide such 
assurances. The requirements for voluntarily ``opting in'' to be 
subject to the Federal menu labeling requirements are set forth in 
Sec.  101.11(d). Preemption of certain State and local requirements 
follows from voluntarily becoming subject to the requirements of Sec.  
101.11. The effects of following the terms of Federal contracts to 
procure food services are outside the scope of this rulemaking.

XXVIII. Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

XXIX. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified all the Web site addresses in this reference section, but 
FDA is not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register).

1. Flegal, K.M., M.D. Carroll, C.L. Ogden, et al., ``Prevalence and 
Trends in Obesity Among U.S. Adults 1999-2008,'' Journal of the 
American Medical Association, 303:235-241, 2010.
2. Ogden, C.L., M.D. Carroll, L.R. Curtin, et al., ``Prevalence of 
High Body Mass Index in U.S. Children and Adolescents, 2007-2008,'' 
Journal of the American Medical Association, 303:242-249, 2010.
3. U.S. Department of Health and Human Services (DHHS) and USDA, 
``2010 Dietary Guidelines for Americans,'' 7th ed., Washington DC: 
U.S. Government Printing Office, 2010. Available at http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm. Accessed on November 
3, 2014.
4. Lin, B.H., J. Guthrie, and E. Fraz[atilde]o. ``Nutrient 
Contribution of Food Away From Home,'' America's Eating Habits: 
Changes and Consequences, chapter 12, Elizabeth Fraz[atilde]o (ed.), 
USDA Agriculture Information Bulletin No. (AIB-750), pp. 213-242, 
May 1999.
5. FDA Reports & Research Internet Web page: ``Backgrounder--
Keystone Forum on Away-From-Home Foods: Opportunities for Preventing 
Weight Gain and Obesity Report,'' Keystone Center, June 2006.
6. USDA, Economic Research Service, ``Table 10: Food Away From Home 
as a Share of Food Expenditures,'' Food CPI and Expenditures: Food 
Expenditure Tables. Available at http://www.ers.usda.gov/data-products/food-expenditures.aspx. Accessed on November 3, 2014.
7. Burton, S., E.H. Creyer, J. Kees, et al., ``Attacking the Obesity 
Epidemic: The Potential Health Benefits of Providing Nutrition 
Information in Restaurants,'' American Journal of Public Health, 
96(9):1669-1675, September 2006.
8. FDA, ``Draft Guidance for Industry: Questions and Answers 
Regarding Implementation of the Menu Labeling Provisions of Section 
4205 of the Patient Protection and Affordable Care Act of 2010,'' 
2010.
9. 112th Congress, House of Representatives, H. Rept. 112-101, 
``Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Bill, 2012,'' June 3, 2011.
10. FDA, ``Guidance for Industry: A Labeling Guide for Restaurants 
and Other Retail Establishments Selling Away-From-Home Foods,'' 
April 2008.
11. Food Marketing Trends. ``U.S. Grocery Shopper Trends'', 2010.
12. Sutherland Statutes 21.4, 7th ed., 2009.
13. 155 Cong. Rec. S5522 (May 14, 2009) (statement of Senator 
Harkin).
14. Commissioner, New York State Department of Agriculture and 
Markets and Commissioner, New York State Department of Health. 
``Memorandum of Understanding Between the New York State Department 
of Health and the New York State Department of Agriculture and 
Markets Concerning the Inspection of Food Service Establishments and 
Food Processing Establishments'', 2010.
15. Webster's Third New International Dictionary, p. 369, 2002.
16. The American Heritage Online Dictionary. Available at http://ahdictionary.com/word/search.html?q=chain. Accessed on November 3, 
2014.
17. Merriam-Webster Dictionary. Available at http://www.merriam-webster.com/dictionary/chain. Accessed on November 3, 2014.
18. Webster's Third New International Dictionary, pp. 1327-1328, 
2002.
19. The American Heritage Online Dictionary. Available at http://ahdictionary.com/word/search.html?q=location. Accessed on November 
3, 2014.
20. The American Heritage Online Dictionary. Available at http://ahdictionary.com/word/search.html?q=writing. Accessed on November 3, 
2014.
21. Merriam-Webster Dictionary. Available at http://www.merriam-webster.com/dictionary/writing. Accessed on November 3, 2014.
22. Webster's Third New International Dictionary, p. 2641, 2002.
23. Merriam-Webster Dictionary. Available at http://www.merriam-webster.com/dictionary/primary. Accessed on November 3, 2014.
24. The American Heritage Online Dictionary. Available at http://ahdictionary.com/word/search.html?q=primary. Accessed on November 3, 
2014.
25. Webster's Third New International Dictionary, p. 1800, 2002.
26. 2A Sutherland Statutory Construction 137, 7th ed., 2009.
27. McDonald's and North America Consumer and Business Insights, 
``Drive-Thru Caloric Information Online Customer Satisfaction 
Survey'', 2011.
28. FDA Memorandum, Chung-Tung Jordan Lin, to the File, ``Review of 
Comment Submitted by McDonald's USA to Docket No. FDA-2011-F-0172, 
on the Use of Stanchions at Drive-Through Windows to Disclose 
Calories in Standard Menu Items in Restaurants and Similar Retail 
Food Establishments,'' January 27, 2012.
29. Harkin, DeLauro Respond to Proposed Menu Labeling Rules. April 
1, 2011. Available at http://www.harkin.senate.gov/press/release.cfm?i=332329. Accessed on November 3, 2014.
30. U.S. Department of the Treasury, Alcohol and Tobacco Tax and 
Trade Bureau. TTB Ruling Number: 2013-2, May 28, 2013.
31. Cunningham, S.K., The Bartender's Black Book, 10th ed., 2011.
32. Comment from Hyman, Phelps, and McNamara on behalf of Dominoes, 
Appendix 3, 2011.
33. FDA Memorandum, Chung-Tung Jordan Lin, to the File, ``Review of 
Comment Submitted by Culver Franchising Systems, Inc,. to Docket No. 
FDA-2011-F-0172, on the Calorie Declaration Option of Not Using 
Caloric Ranges for Combination Meals and Variable Menu Items,'' 
February 29, 2012.
34. California Health and Safety Code, Section 114377.
35. New York City Health Code, Section 81.08.
36. Baltimore City Health Code Section 6-507.
37. County Council for Montgomery County Maryland, Resolution No. 
16-134, 2007.
38. FDA, ``Guidance for Industry: A Food Labeling Guide,'' 2008.
39. FDA, ``Regulatory Procedures Manual,'' chapter 4.
40 FDA, ``Regulatory Procedures Manual,'' chapter 6, section 5.
41. FDA, ``State Contracts,'' available at http://www.fda.gov/ForFederalStateandLocalOfficials/PartnershipsContracts/StateContracts/default.htm, 2012.
42. FDA, ``Food Labeling: Nutrition Labeling of Standard Menu Items 
in Restaurants

[[Page 71253]]

and Similar Retail Food Establishments. Final Regulatory Impact 
Analysis,'' Docket No. FDA-2011-F-0172, 2014.
43. ``Food Labeling: Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments. Notice of 
Proposed Rulemaking,'' Docket No. FDA-2011-F-0172, Preliminary 
Regulatory Impact Analysis, 2011.
44. U.S. Census Bureau. County Business Patterns, United States 
NAICS 2000-2008. October 18, 2010.
45. Wootan, M.G., M. Osborn. ``Availability of Nutrition Information 
From Chain Restaurants in the United States. American Journal of 
Preventive Medicine, 30(3):266-268, 2006.
46. U.S. Census Bureau. North American Industry Classification 
System. 2007. October 18, 2010.
47. Mintel Menu Insights. New Menu Items at Restaurants. 2010.
48. Eastern Research Group I. Evaluation of Recordkeeping Costs for 
Food Manufacturers, Final Report. Sertkaya, A, A. Berlind, S. Erdem, 
editors. Contract No. 223-01-2461, Task Order Number 5. 2007.

List of Subjects

21 CFR Part 11

    Administrative practice and procedure, Computer technology, 
Reporting and recordkeeping requirements.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
11 and 101 are amended as follows:

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
1. The authority citation for 21 CFR part 11 continues to read as 
follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 262.


0
2. Section 11.1 is amended by adding paragraph (g) to read as follows:


Sec.  11.1  Scope.

* * * * *
    (g) This part does not apply to electronic signatures obtained 
under Sec.  101.11(d) of this chapter.

PART 101--FOOD LABELING

0
3. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.


0
4. Section 101.9 is amended by revising paragraph (j)(1)(i), the 
introductory text of paragraphs (j)(2) and (3), and the first sentence 
of paragraph (j)(4) to read as follows:


Sec.  101.9  Nutrition labeling of food.

* * * * *
    (j) * * *
    (1)(i) Food offered for sale by a person who makes direct sales to 
consumers (e.g., a retailer) who has annual gross sales made or 
business done in sales to consumers that is not more than $500,000 or 
has annual gross sales made or business done in sales of food to 
consumers of not more than $50,000, Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section, Sec.  
101.10, or Sec.  101.11, as applicable.
* * * * *
    (2) Except as provided in Sec.  101.11, food products that are:
* * * * *
    (3) Except as provided in Sec.  101.11, food products that are:
* * * * *
    (4) Except as provided in Sec.  101.11, foods that contain 
insignificant amounts of all of the nutrients and food components 
required to be included in the declaration of nutrition information 
under paragraph (c) of this section, Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. * * *
* * * * *

0
5. Section 101.10 is revised to read as follows:


Sec.  101.10  Nutrition labeling of restaurant foods whose labels or 
labeling bear nutrient content claims or health claims.

    Nutrition labeling in accordance with Sec.  101.9 shall be provided 
upon request for any restaurant food or meal for which a nutrient 
content claim (as defined in Sec.  101.13 or in subpart D of this part) 
or a health claim (as defined in Sec.  101.14 and permitted by a 
regulation in subpart E of this part) is made, except that information 
on the nutrient amounts that are the basis for the claim (e.g., ``low 
fat, this meal provides less than 10 grams of fat'') may serve as the 
functional equivalent of complete nutrition information as described in 
Sec.  101.9. For the purposes of this section, restaurant food includes 
two categories of food. It includes food which is served in restaurants 
or other establishments in which food is served for immediate human 
consumption or which is sold for sale or use in such establishments. It 
also includes food which is processed and prepared primarily in a 
retail establishment, which is ready for human consumption, which is of 
the type described in the previous sentence, and which is offered for 
sale to consumers but not for immediate human consumption in such 
establishment and which is not offered for sale outside such 
establishment. For standard menu items that are offered for sale in 
covered establishments (as defined in Sec.  101.11(a)), the information 
in the written nutrition information required by Sec.  
101.11(b)(2)(ii)(A) will serve to meet the requirements of this 
section. Nutrient levels may be determined by nutrient databases, 
cookbooks, or analyses or by other reasonable bases that provide 
assurance that the food or meal meets the nutrient requirements for the 
claim. Presentation of nutrition labeling may be in various forms, 
including those provided in Sec.  101.45 and other reasonable means.


0
6. Section 101.11 is added to subpart A to read as follows:


Sec.  101.11  Nutrition labeling of standard menu items in covered 
establishments.

    (a) Definitions. The definitions of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this section. In addition, for purposes of this section:
    Authorized official of a restaurant or similar retail food 
establishment means the owner, operator, agent in charge, or other 
person authorized by the owner, operator, or agent in charge to 
register the restaurant or similar retail food establishment, which is 
not otherwise subject to section 403(q)(5)(H) of the Federal Food, 
Drug, and Cosmetic Act, with FDA for the purposes of paragraph (d) of 
this section.
    Combination meal means a standard menu item that consists of more 
than one food item, for example a meal that includes a sandwich, a side 
dish, and a drink. A combination meal may be represented on the menu or 
menu board in narrative form, numerically, or pictorially. Some 
combination meals may include a variable menu item or be a variable 
menu item as defined in this paragraph where the components may vary. 
For example, the side dish may vary among several options (e.g., fries, 
salad, or onion rings) or the drinks may vary (e.g., soft drinks, milk, 
or juice) and the customer selects which of these items will be 
included in the meal.
    Covered establishment means a restaurant or similar retail food 
establishment that is a part of a chain with 20 or more locations doing 
business under the same name (regardless of the type of ownership, 
e.g., individual franchises) and offering for sale substantially the 
same menu

[[Page 71254]]

items, as well as a restaurant or similar retail food establishment 
that is registered to be covered under paragraph (d) of this section.
    Custom order means a food order that is prepared in a specific 
manner based on an individual customer's request, which requires the 
covered establishment to deviate from its usual preparation of a 
standard menu item, e.g., a club sandwich without the bacon if the 
establishment usually includes bacon in its club sandwich.
    Daily special means a menu item that is prepared and offered for 
sale on a particular day, that is not routinely listed on a menu or 
menu board or offered by the covered establishment, and that is 
promoted by the covered establishment as a special menu item for that 
particular day.
    Doing business under the same name means sharing the same name. The 
term ``name'' refers to either:
    (i) The name of the establishment presented to the public; or
    (ii) If there is no name of the establishment presented to the 
public (e.g., an establishment with the generic descriptor ``concession 
stand''), the name of the parent entity of the establishment. When the 
term ``name'' refers to the name of the establishment presented to the 
public under paragraph (i) of this definition, the term ``same'' 
includes names that are slight variations of each other, for example, 
due to the region, location, or size (e.g., ``New York Ave. Burgers'' 
and ``Pennsylvania Ave. Burgers'' or ``ABC'' and ``ABC Express'').
    Food on display means restaurant-type food that is visible to the 
customer before the customer makes a selection, so long as there is not 
an ordinary expectation of further preparation by the consumer before 
consumption.
    Food that is part of a customary market test means food that 
appears on a menu or menu board for less than 90 consecutive days in 
order to test consumer acceptance of the product.
    Location means a fixed position or site.
    Menu or menu board means the primary writing of the covered 
establishment from which a customer makes an order selection, 
including, but not limited to, breakfast, lunch, and dinner menus; 
dessert menus; beverage menus; children's menus; other specialty menus; 
electronic menus; and menus on the Internet. Determining whether a 
writing is or is part of the primary writing of the covered 
establishment from which a customer makes an order selection depends on 
a number of factors, including whether the writing lists the name of a 
standard menu item (or an image depicting the standard menu item) and 
the price of the standard menu item, and whether the writing can be 
used by a customer to make an order selection at the time the customer 
is viewing the writing. The menus may be in different forms, e.g., 
booklets, pamphlets, or single sheets of paper. Menu boards include 
those inside a covered establishment as well as drive-through menu 
boards at covered establishments.
    Offering for sale substantially the same menu items means offering 
for sale a significant proportion of menu items that use the same 
general recipe and are prepared in substantially the same way with 
substantially the same food components, even if the name of the menu 
item varies, (e.g. ``Bay View Crab Cake'' and ``Ocean View Crab 
Cake''). ``Menu items'' in this definition refers to food items that 
are listed on a menu or menu board or that are offered as self-service 
food or food on display. Restaurants and similar retail food 
establishments that are part of a chain can still be offering for sale 
substantially the same menu items if the availability of some menu 
items varies within the chain. Having the same name may indicate, but 
does not necessarily guarantee, that menu items are substantially the 
same.
    Restaurant or similar retail food establishment means a retail 
establishment that offers for sale restaurant-type food, except if it 
is a school as defined by 7 CFR 210.2 or 220.2.
    Restaurant-type food means food that is:
    (i) Usually eaten on the premises, while walking away, or soon 
after arriving at another location; and
    (ii) Either:
    (A) Served in restaurants or other establishments in which food is 
served for immediate human consumption or which is sold for sale or use 
in such establishments; or
    (B) Processed and prepared primarily in a retail establishment, 
ready for human consumption, of the type described in paragraph (ii)(A) 
of this definition, and offered for sale to consumers but not for 
immediate human consumption in such establishment and which is not 
offered for sale outside such establishment.
    Self-service food means restaurant-type food that is available at a 
salad bar, buffet line, cafeteria line, or similar self-service 
facility and that is served by the customers themselves. Self-service 
food also includes self-service beverages.
    Standard menu item means a restaurant-type food that is routinely 
included on a menu or menu board or routinely offered as a self-service 
food or food on display.
    Temporary menu item means a food that appears on a menu or menu 
board for less than a total of 60 days per calendar year. The 60 days 
includes the total of consecutive and non-consecutive days the item 
appears on the menu.
    Variable menu item means a standard menu item that comes in 
different flavors, varieties, or combinations, and is listed as a 
single menu item.
    (b) Requirements for nutrition labeling for food sold in covered 
establishments--(1) Applicability. (i) The labeling requirements in 
this paragraph (b) apply to standard menu items offered for sale in 
covered establishments.
    (ii)(A) The labeling requirements in this paragraph (b) do not 
apply to foods that are not standard menu items, including:
    (1) Items such as condiments that are for general use, including 
those placed on the table or on or behind the counter; daily specials; 
temporary menu items; custom orders; food that is part of a customary 
market test; and
    (2) Self-service food and food on display that is offered for sale 
for less than a total of 60 days per calendar year or fewer than 90 
consecutive days in order to test consumer acceptance.
    (B) The labeling requirements of paragraph (b)(2)(iii) of this 
section do not apply to alcoholic beverages that are foods on display 
and are not self-service foods.
    (2) Nutrition information. (i) Except as provided by paragraph 
(b)(2)(i)(A)(8) of this section, the following must be provided on 
menus and menu boards:
    (A) The number of calories contained in each standard menu item 
listed on the menu or menu board, as usually prepared and offered for 
sale. In the case of multiple-serving standard menu items, this means 
the calories declared must be for the whole menu item listed on the 
menu or menu board as usually prepared and offered for sale (e.g., 
``pizza pie: 1600 cal''); or per discrete serving unit as long as the 
discrete serving unit (e.g., pizza slice) and total number of discrete 
serving units contained in the menu item are declared on the menu or 
menu board, and the menu item is usually prepared and offered for sale 
divided in discrete serving units (e.g., ``pizza pie: 200 cal/slice, 8 
slices''). The calories must be declared in the following manner:
    (1) The number of calories must be listed adjacent to the name or 
the price of the associated standard menu item, in a type size no 
smaller than the type size of the name or the price of the

[[Page 71255]]

associated standard menu item, whichever is smaller, in the same color, 
or a color at least as conspicuous as that used for the name of the 
associated standard menu item, and with the same contrasting background 
or a background at least as contrasting as that used for the name of 
the associated standard menu item.
    (2) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increment above 50 calories, 
except that amounts less than 5 calories may be expressed as zero.
    (3) The term ``Calories'' or ``Cal'' must appear as a heading above 
a column listing the number of calories for each standard menu item or 
adjacent to the number of calories for each standard menu item. If the 
term ``Calories'' or ``Cal'' appears as a heading above a column of 
calorie declarations, the term must be in a type size no smaller than 
the smallest type size of the name or price of any menu item on that 
menu or menu board in the same color or a color at least as conspicuous 
as that used for that name or price and in the same contrasting 
background or a background at least as contrasting as that used for 
that name or price. If the term ``Calories'' or ``Cal'' appears 
adjacent to the number of calories for the standard menu item, the term 
``Calories'' or ``Cal'' must appear in the same type size and in the 
same color and contrasting background as the number of calories.
    (4) Additional requirements that apply to each individual variable 
menu item:
    (i) When the menu or menu board lists flavors or varieties of an 
entire individual variable menu item (such as soft drinks, ice cream, 
doughnuts, dips, and chicken that can be grilled or fried), the 
calories must be declared separately for each listed flavor or variety. 
Where flavors or varieties have the same calorie amounts (after 
rounding in accordance with paragraph (b)(2)(i)(A)(2) of this section), 
the calorie declaration for such flavors or varieties can be listed as 
a single calorie declaration adjacent to the flavors or varieties, 
provided that the calorie declaration specifies that the calorie amount 
listed represents the calorie amounts for each individual flavor or 
variety.
    (ii) When the menu or menu board does not list flavors or varieties 
for an entire individual variable menu item, and only includes a 
general description of the variable menu item (e.g. ``soft drinks''), 
the calories must be declared for each option with a slash between the 
two calorie declarations where only two options are available (e.g., 
``150/250 calories'') or as a range in accordance with the requirements 
of paragraph (b)(2)(i)(A)(7) of this section where more than two 
options are available (e.g., ``100-250 calories'').
    (iii) When the menu or menu board describes flavors or varieties 
for only part of an individual variable menu item (such as different 
types of cheese offered in a grilled cheese sandwich (e.g., ``Grilled 
Cheese (Cheddar or Swiss)''), the calories must be declared for each 
option with a slash between the two calorie declarations where only two 
options are available (e.g., ``450/500 calories'') or as a range in 
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this 
section where more than two options are available (e.g., ``450-550 
calories'').
    (5) Additional requirements that apply to a variable menu item that 
is offered for sale with the option of adding toppings listed on the 
menu or menu board. When the menu or menu board lists toppings that can 
be added to a menu item (such as pizza or ice cream):
    (i) The calories must be declared for the basic preparation of the 
menu item as listed (e.g., ``small pizza pie,'' ``single scoop ice 
cream'').
    (ii) The calories must be separately declared for each topping 
listed on the menu or menu board (e.g., pepperoni, sausage, green 
peppers, onions on pizza; fudge, almonds, sprinkles on ice cream), 
specifying that the calories are added to the calories contained in the 
basic preparation of the menu item. Where toppings have the same 
calorie amounts (after rounding in accordance with paragraph 
(b)(2)(i)(A)(2) of this section), the calorie declaration for such 
toppings can be listed as a single calorie declaration adjacent to the 
toppings, provided that the calorie declaration specifies that the 
calorie amount listed represents the calorie amount for each individual 
topping.
    (iii) The calories for the basic preparation of the menu item must 
be declared for each size of the menu item. The calories for each 
topping listed on the menu or menu board must be declared for each size 
of the menu item, or declared using a slash between the two calorie 
declarations for each topping where only two sizes of the menu item are 
available (e.g., ``adds 150/250 cal'') or as a range for each topping 
in accordance with the requirements of paragraph (b)(2)(i)(A)(7) of 
this section where more than two sizes of the menu item are available 
(e.g., ``adds 100-250 cal''). If a slash between two calorie 
declarations or a range of calorie declarations is used, the menu or 
menu board must indicate that the variation in calories for each 
topping arises from the size of the menu item to which the toppings are 
added.
    (iv) If the amount of the topping included on the basic preparation 
of the menu item decreases based on the total number of toppings 
ordered for the menu item (such as is sometimes the case with pizza 
toppings), the calories for each topping must be declared as single 
values representing the calories for each topping when added to a one-
topping menu item, specifying that the calorie declaration is for the 
topping when added to a one-topping menu item.
    (6) Additional requirements that apply to a combination meal. 
Except as provided in paragraph (b)(2)(i)(A)(6)(iv) of this section:
    (i) When the menu or menu board lists two options for menu items in 
a combination meal (e.g., a sandwich with a side salad or chips), the 
calories must be declared for each option with a slash between the two 
calorie declarations (e.g., ``350/450 calories'').
    (ii) When the menu or menu board lists three or more options for 
menu items in a combination meal (e.g., a sandwich with chips, a side 
salad, or fruit), the calories must be declared as a range in 
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this 
section (e.g., ``350-500 calories'').
    (iii) When the menu or menu board includes a choice to increase or 
decrease the size of a combination meal, the calorie difference must be 
declared for the increased or decreased size with a slash between two 
calorie declarations (e.g., ``Adds 100/150 calories,'' ``Subtracts 100/
150 calories'') if the menu or menu board lists two options for menu 
items in the combination meal, or as a range in accordance with the 
requirements of paragraph (b)(2)(i)(A)(7) of this section (e.g., ``Adds 
100-250 calories,'' ``Subtracts 100-250 calories'') if the menu or menu 
board lists three or more options for menu items in the combination 
meal.
    (iv) Where the menu or menu board describes an opportunity for a 
consumer to combine standard menu items for a special price (e.g., 
``Combine Any Sandwich with Any Soup or Any Salad for $8.99''), and the 
calories for each standard menu item, including each size option as 
described in paragraph (b)(2)(i)(A)(6)(iii) of this section if 
applicable, available for the consumer to combine are declared 
elsewhere on the menu or menu board, the requirements of paragraphs 
(b)(2)(i)(A)(6)(i), (ii), and (iii) of this section do not apply.
    (7) Additional format requirements for declaring calories for an 
individual variable menu item, a combination meal, and toppings as a 
range, if

[[Page 71256]]

applicable. Calories declared as a range must be in the format ``xx-
yy,'' where ``xx'' is the caloric content of the lowest calorie 
variety, flavor, or combination, and ``yy'' is the caloric content of 
the highest calorie variety, flavor, or combination.
    (8) Exception for a variable menu item that has no clearly 
identifiable upper bound to the range of calories: If the variable menu 
item appears on the menu or menu board and is a self-service food or 
food on display, and there is no clearly identifiable upper bound to 
the range, e.g., all-you-can-eat buffet, then the menu or menu board 
must include a statement, adjacent to the name or price of the item, 
referring customers to the self-service facility for calorie 
information, e.g., ``See buffet for calorie declarations.'' This 
statement must appear in a type size no smaller than the type size of 
the name or price of the variable menu item, whichever is smaller, and 
in the same color or a color at least as conspicuous as that used for 
that name or price, with the same contrasting background or a 
background at least as contrasting as that used for that name or price.
    (9) Additional requirements that apply to beverages that are not 
self-service. For beverages that are not self-service, calories must be 
declared based on the full volume of the cup served without ice, unless 
the covered establishment ordinarily dispenses and offers for sale a 
standard beverage fill (i.e., a fixed amount that is less than the full 
volume of the cup per cup size) or dispenses a standard ice fill (i.e., 
a fixed amount of ice per cup size). If the covered establishment 
ordinarily dispenses and offers for sale a standard beverage fill or 
dispenses a standard ice fill, the covered establishment must declare 
calories based on such standard beverage fill or standard ice fill.
    (B) The following statement designed to enable consumers to 
understand, in the context of a total daily diet, the significance of 
the calorie information provided on menus and menu boards: ``2,000 
calories a day is used for general nutrition advice, but calorie needs 
vary.'' For menus and menu boards targeted to children, the following 
options may be used as a substitute for or in addition to the succinct 
statement: ``1,200 to 1,400 calories a day is used for general 
nutrition advice for children ages 4 to 8 years, but calorie needs 
vary.''; or ``1,200 to 1,400 calories a day is used for general 
nutrition advice for children ages 4 to 8 years and 1,400 to 2,000 
calories a day for children ages 9 to 13 years, but calorie needs 
vary.''
    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest type 
size of any calorie declaration appearing on the same menu or menu 
board and in the same color or in a color at least as conspicuous as 
that used for the calorie declarations and with the same contrasting 
background or a background at least as contrasting as that used for the 
calorie declarations.
    (2) For menus, this statement must appear on the bottom of each 
page of the menu. On menu pages that also bear the statement required 
by paragraph (b)(2)(i)(C) of this section, this statement must appear 
immediately above, below, or beside the statement required by paragraph 
(b)(2)(i)(C) of this section.
    (3) For menu boards, this statement must appear on the bottom of 
the menu board, immediately above, below, or beside the statement 
required by paragraph (b)(2)(i)(C) of this section.
    (C) The following statement regarding the availability of the 
additional written nutrition information required in paragraph 
(b)(2)(ii) of this section must be on all forms of the menu or menu 
board: ``Additional nutrition information available upon request.''
    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest type 
size of any calorie declaration appearing on the same menu or menu 
board and in the same color or in a color at least as conspicuous as 
that used for the caloric declarations, and with the same contrasting 
background or a background at least as contrasting as that used for the 
caloric declarations.
    (2) For menus, the statement must appear on the bottom of the first 
page with menu items immediately above, below, or beside the succinct 
statement required by paragraph (b)(2)(i)(B) of this section.
    (3) For menu boards, the statement must appear on the bottom of the 
menu board immediately above, below, or beside the succinct statement 
required by paragraph (b)(2)(i)(B) of this section.
    (ii) The following nutrition information for a standard menu item 
must be available in written form on the premises of the covered 
establishment and provided to the customer upon request. This nutrition 
information must be presented in the order listed and using the 
measurements listed, except as provided in paragraph (b)(2)(ii)(B) of 
this section. Rounding of these nutrients must be in compliance with 
Sec.  101.9(c). The information must be presented in a clear and 
conspicuous manner, including using a color, type size, and contrasting 
background that render the information likely to be read and understood 
by the ordinary individual under customary conditions of purchase and 
use. Covered establishments may use the abbreviations allowed for 
Nutrition Facts for certain packaged foods in Sec.  
101.9(j)(13)(ii)(B):
    (A)(1) Total calories (cal);
    (2) Calories from fat (fat cal);
    (3) Total fat (g);
    (4) Saturated fat (g);
    (5) Trans fat (g);
    (6) Cholesterol (mg);
    (7) Sodium (mg);
    (8) Total carbohydrate (g);
    (9) Dietary fiber (g);
    (10) Sugars (g); and
    (11) Protein (g).
    (B) If a standard menu item contains insignificant amounts of all 
the nutrients required to be disclosed in paragraph (b)(2)(ii)(A) of 
this section, the establishment is not required to include nutrition 
information regarding the standard menu item in the written form. 
However, if the covered establishment makes a nutrient content claim or 
health claim, the establishment is required to provide nutrition 
information on the nutrient that is the subject of the claim in 
accordance with Sec.  101.10. For standard menu items that contain 
insignificant amounts of six or more of the required nutrients, the 
declaration of nutrition information required by paragraph 
(b)(2)(ii)(A) of this section may be presented in a simplified format.
    (1) An insignificant amount is defined as that amount that allows a 
declaration of zero in nutrition labeling, except that for total 
carbohydrates, dietary fiber, and protein, it must be an amount that 
allows a declaration of ``less than one gram.''
    (2) The simplified format must include information, in a column, 
list, or table, on the following nutrients:
    (i) Total calories, total fat, total carbohydrates, protein, and 
sodium; and
    (ii) Calories from fat, and any other nutrients identified in 
paragraph (b)(2)(ii)(A) of this section that are present in more than 
insignificant amounts.
    (3) If the simplified format is used, the statement ``Not a 
significant source of ___--'' (with the blank filled in with the names 
of the nutrients required to be declared in the written nutrient 
information and calories from fat that are present in insignificant 
amounts) must be included at the bottom of the list of nutrients.
    (C) For variable menu items, the nutrition information listed in 
paragraph (b)(2)(ii)(A) of this section must be declared as follows for 
each size offered for sale:
    (1) The nutrition information required in paragraph (b)(2)(ii)(A) 
of this section

[[Page 71257]]

must be declared for the basic preparation of the item and, separately, 
for each topping, flavor, or variable component.
    (2) Additional format requirements for toppings if the amount of 
the topping included on the basic preparation of the menu item 
decreases based on the total number of toppings ordered for the menu 
item (such as is sometimes the case with pizza toppings). The nutrients 
for such topping must be declared as single values representing the 
nutrients for each topping when added to a one-topping menu item, 
specifying that the nutrient declaration is for the topping when added 
to a one-topping menu item.
    (3) If the calories and other nutrients are the same for different 
flavors, varieties, and variable components of the combination meal, 
each variety, flavor, and variable component of the combination meal is 
not required to be listed separately. All items that have the same 
nutrient values could be listed together with the nutrient values 
listed only once.
    (D) The written nutrition information required in paragraph 
(b)(2)(ii)(A) of this section may be provided on a counter card, sign, 
poster, handout, booklet, loose leaf binder, or electronic device such 
as a computer, or in a menu, or in any other form that similarly 
permits the written declaration of the required nutrient content 
information for all standard menu items. If the written nutrition 
information is not in a form that can be given to the customer upon 
request, it must be readily available in a manner and location on the 
premises that allows the customer/consumer to review the written 
nutrition information upon request.
    (iii) The following must be provided for a standard menu item that 
is self-service or on display.
    (A) Calories per displayed food item (e.g., a bagel, a slice of 
pizza, or a muffin), or if the food is not offered for sale in a 
discrete unit, calories per serving (e.g., scoop, cup), and the serving 
or discrete unit used to determine the calorie content (e.g., ``per 
scoop'' or ``per muffin'') on either: A sign adjacent to and clearly 
associated with the corresponding food; (e.g., ``150 calories per 
scoop''); a sign attached to a sneeze guard with the calorie 
declaration and the serving or unit used to determine the calorie 
content above each specific food so that the consumer can clearly 
associate the calorie declaration with the food, except that if it is 
not clear to which food the calorie declaration and serving or unit 
refers, then the sign must also include the name of the food, e.g., 
``Broccoli and cheese casserole--200 calories per scoop''; or a single 
sign or placard listing the calorie declaration for several food items 
along with the names of the food items, so long as the sign or placard 
is located where a consumer can view the name, calorie declaration, and 
serving or unit of a particular item while selecting that item.
    (1) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per 
displayed food item'' means per each discrete unit offered for sale, 
for example, a bagel, a slice of pizza, or a muffin.
    (2) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per 
serving'' means, for each food:
    (i) Per serving instrument used to dispense the food offered for 
sale, provided that the serving instrument dispenses a uniform amount 
of the food (e.g., a scoop or ladle);
    (ii) If a serving instrument that dispenses a uniform amount of 
food is not used to dispense the food, per each common household 
measure (e.g., cup or tablespoon) offered for sale or per unit of 
weight offered for sale, e.g., per quarter pound or per 4 ounces; or
    (iii) Per total number of fluid ounces in the cup in which a self-
service beverage is served and, if applicable, the description of the 
cup size (e.g., ``140 calories per 12 fluid ounces (small)'').
    (3) The calories must be declared in the following manner:
    (i) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increment above 50 calories 
except that amounts less than 5 calories may be expressed as zero.
    (ii) If the calorie declaration is provided on a sign with the 
food's name, price, or both, the calorie declaration, accompanied by 
the term ``Calories'' or ``Cal'' and the amount of the serving or 
displayed food item on which the calories declaration is based must be 
in a type size no smaller than the type size of the name or price of 
the menu item whichever is smaller, in the same color, or a color that 
is at least as conspicuous as that used for that name or price, using 
the same contrasting background or a background at least as contrasting 
as that used for that name or price. If the calorie declaration is 
provided on a sign that does not include the food's name, price, or 
both, the calorie declaration, accompanied by the term ``Calories'' or 
``Cal'' and the amount of the serving or displayed food item on which 
the calorie declaration is based must be clear and conspicuous.
    (iii) For self-service beverages, calorie declarations must be 
accompanied by the term ``fluid ounces'' and, if applicable, the 
description of the cup size (e.g., ``small,'' ``medium'').
    (B) For food that is self-service or on display and is identified 
by an individual sign adjacent to the food itself where such sign meets 
the definition of a menu or menu board under paragraph (a) of this 
section, the statement required by paragraph (b)(2)(i)(B) of this 
section and the statement required by paragraph (b)(2)(i)(C) of this 
section. These two statements may appear on the sign adjacent to the 
food itself; on a separate, larger sign, in close proximity to the food 
that can be easily read as the consumer is making order selections; or 
on a large menu board that can be easily read as the consumer is 
viewing the food.
    (C) The nutrition information in written form required by paragraph 
(b)(2)(ii) of this section, except for packaged food insofar as it 
bears nutrition labeling information required by and in accordance with 
paragraph (b)(2)(ii) of this section and the packaged food, including 
its label, can be examined by a consumer before purchasing the food.
    (c) Determination of nutrient content. (1) A covered establishment 
must have a reasonable basis for its nutrient declarations. Nutrient 
values may be determined by using nutrient databases (with or without 
computer software programs), cookbooks, laboratory analyses, or other 
reasonable means, including the use of Nutrition Facts on labels on 
packaged foods that comply with the nutrition labeling requirements of 
section 403(q)(1) of the Federal Food, Drug, and Cosmetic Act and Sec.  
101.9, FDA nutrient values for raw fruits and vegetables in Appendix C 
of this part, or FDA nutrient values for cooked fish in Appendix D of 
this part.
    (2) Nutrient declarations for standard menu items must be accurate 
and consistent with the specific basis used to determine nutrient 
values. A covered establishment must take reasonable steps to ensure 
that the method of preparation (e.g., types and amounts of ingredients, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined.
    (3) A covered establishment must provide to FDA, within a 
reasonable period of time upon request, information substantiating 
nutrient values including the method and data used to derive these 
nutrient values. This information must include the following:
    (i) For nutrient databases:
    (A) The name and version (including the date of the version) of the 
database,

[[Page 71258]]

and, as applicable, the name of the applicable software company and any 
Web site address for the database. The name and version of a database 
would include the name and version of the computer software, if 
applicable;
    (B) The recipe or formula used as a basis for the nutrient 
declarations;
    (C)(1) Information on:
    (i) The amount of each nutrient that the specified amount of each 
ingredient identified in the recipe contributes to the menu item; and
    (ii) How the database was used including calculations or operations 
(e.g., worksheets or computer printouts) to determine the nutrient 
values for the standard menu items;
    (2) If the information in paragraph (c)(3)(i)(C)(1) of this section 
is not available, certification attesting that the database will 
provide accurate results when used appropriately and that the database 
was used in accordance with its instructions;
    (D) A detailed listing (e.g., printout) of the nutrient values 
determined for each standard menu item.
    (E) Any other information pertinent to the final nutrient values of 
the standard menu item (e.g., information about what might cause slight 
variations in the nutrient profile such as moisture variations);
    (F) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (G) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined.
    (ii) For published cookbooks that contain nutritional information 
for recipes in the cookbook:
    (A) The name, author, and publisher of the cookbook used;
    (B) If available, information provided by the cookbook or from the 
author or publisher about how the nutrition information for the recipes 
was obtained;
    (C) A copy of the recipe used to prepare the standard menu item and 
a copy of the nutrition information for that standard menu item as 
provided by the cookbook; and
    (D) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined. (Recipes may be divided as necessary to accommodate 
differences in the portion size derived from the recipe and that are 
served as the standard menu item but no changes may be made to the 
proportion of ingredients used.)
    (iii) For laboratory analyses:
    (A) A copy of the recipe for the standard menu item used for the 
nutrient analysis;
    (B) The name and address of the laboratory performing the analysis;
    (C) Copies of analytical worksheets, including the analytical 
method, used to determine and verify nutrition information;
    (D) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined.
    (iv) For nutrition information provided by other reasonable means:
    (A) A detailed description of the means used to determine the 
nutrition information;
    (B) A recipe or formula used as a basis for the nutrient 
determination;
    (C) Any data derived in determining the nutrient values for the 
standard menu item, e.g., nutrition information about the ingredients 
used with the source of the nutrient information;
    (D) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were 
determined.
    (d) Voluntary registration to be subject to the menu labeling 
requirements--(1) Applicability. A restaurant or similar retail food 
establishment that is not part of a chain with 20 or more locations 
doing business under the same name and offering for sale substantially 
the same menu items may voluntarily register to be subject to the 
requirements established in this section. Restaurants and similar 
retail food establishments that voluntarily register will no longer be 
subject to non-identical State or local nutrition labeling 
requirements.
    (2) Who may register? The authorized official of a restaurant or 
similar retail food establishment as defined in paragraph (a) of this 
section, which is not otherwise subject to paragraph (b) of this 
section, may register with FDA.
    (3) What information is required? Authorized officials for 
restaurants and similar retail food establishments must provide FDA 
with the following information on Form FDA 3757:
    (i) The contact information (including name, address, phone number, 
and email address) for the authorized official;
    (ii) The contact information (including name, address, phone 
number, and email address) of each restaurant or similar retail food 
establishment being registered, as well as the name and contact 
information for an official onsite, such as the owner or manager, for 
each specific restaurant or similar retail food establishment;
    (iii) All trade names the restaurant or similar retail food 
establishment uses;
    (iv) Preferred mailing address (if different from location address 
for each establishment) for purposes of receiving correspondence; and
    (v) Certification that the information submitted is true and 
accurate, that the person submitting it is authorized to do so, and 
that each registered restaurant or similar retail food establishment 
will be subject to the requirements of section 403(q)(5)(H) of the 
Federal Food, Drug, and Cosmetic Act and this section.
    (4) How to register. Authorized officials of restaurants and 
similar retail food establishments who elect to be subject to 
requirements in section 403(q)(5)(H) of the Federal Food, Drug, and 
Cosmetic Act can register by visiting http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm217762.htm. FDA has 
created a form (Form 3757) that contains fields requesting the 
information in paragraph (d)(3) of this section and made the form 
available at

[[Page 71259]]

this Web site. Registrants must use this form to ensure that complete 
information is submitted.
    (i) Information should be submitted by email by typing complete 
information into the form (PDF), saving it on the registrant's 
computer, and sending it by email to menulawregistration@fda.hhs.gov.
    (ii) If email is not available, the registrant can either fill in 
the form (PDF) and print it out (or print out the blank PDF and fill in 
the information by hand or typewriter), and either fax the completed 
form to 301-436-2804 or mail it to FDA, CFSAN Menu and Vending Machine 
Registration, White Oak Building 22, Rm. 0209, 10903 New Hampshire 
Ave., Silver Spring, MD 20993.
    (5) When to renew the registration. To keep the establishment's 
registration active, the authorized official of the restaurant or 
similar retail food establishment must register every other year within 
60 days prior to the expiration of the establishment's current 
registration with FDA. Registration will automatically expire if not 
renewed.
    (e) Signatures. Signatures obtained under paragraph (d) of this 
section that meet the definition of electronic signatures in Sec.  
11.3(b)(7) of this chapter are exempt from the requirements of part 11 
of this chapter.
    (f) Misbranding. A standard menu item offered for sale in a covered 
establishment shall be deemed misbranded under sections 201(n), 403(a), 
403(f) and/or 403(q) of the Federal Food, Drug, and Cosmetic Act if its 
label or labeling is not in conformity with paragraph (b) or (c) of 
this section.

    Dated: November 19, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27833 Filed 11-25-14; 8:45 am]
BILLING CODE 4164-01-P


