
[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Proposed Rules]
[Pages 11879-11987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04387]



[[Page 11879]]

Vol. 79

Monday,

No. 41

March 3, 2014

Part II





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 101





Food Labeling: Revision of the Nutrition and Supplement Facts Labels; 
Proposed Rule

  Federal Register / Vol. 79 , No. 41 / Monday, March 3, 2014 / 
Proposed Rules  

[[Page 11880]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]
RIN 0910-AF22


Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to amend its labeling regulations for conventional foods and 
dietary supplements to provide updated nutrition information on the 
label to assist consumers in maintaining healthy dietary practices. The 
updated information is consistent with current data on the associations 
between nutrients and chronic diseases or health-related conditions, 
reflects current public health conditions in the United States, and 
corresponds to new information on consumer behavior and consumption 
patterns. We are proposing to update the list of nutrients that are 
required or permitted to be declared; provide updated Daily Reference 
Values and Reference Daily Intake values that are based on current 
dietary recommendations from consensus reports; amend requirements for 
foods represented or purported to be specifically for children under 
the age of 4 years and pregnant and lactating women and establish 
nutrient reference values specifically for these population subgroups; 
and revise the format and appearance of the Nutrition Facts label.

DATES: Submit either electronic or written comments on the proposed 
rule by June 2, 2014. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 by April 2, 2014 (see the 
``Paperwork Reduction Act of 1995'' section of this document). See 
section III of this document for the proposed effective date of a final 
rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1210, and/or Regulatory Information Number (RIN) 0910-AF22, by any of 
the following methods, except that comments on information collection 
issues under the Paperwork Reduction Act of 1995 must be submitted to 
the Office of Information and Regulatory Affairs, Office of Management 
and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section 
of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5360 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2012-N-1210 and RIN 0910-AF22 for this rulemaking. 
All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For 
additional information on submitting comments, see the ``Comments'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-5429, email: 
NutritionProgramStaff@fda.hhs.gov.
    With regard to the information collection: Domini Bean, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400T, Rockville, MD 20850, Domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

I. Background
    A. Legal Authority
    B. Need To Update the Nutrition Facts and Supplement Facts 
Labels
    1. Rates of Chronic Disease
    2. Dietary Recommendations, Consensus Reports, and National 
Survey Data
    3. Consumer Use and Understanding of the Nutrition Facts Label
    4. Other Relevant Considerations
    5. Citizen Petitions
    6. Advance Notices of Proposed Rulemaking (ANPRMs)
    7. Impact on Other Regulations
    C. Factors for Mandatory or Voluntary Declaration of Non-
Statutory Nutrients
    1. Factors Considered
    2. Approach for Mandatory Declaration
    3. Approach for Voluntary Declaration
II. The Proposed Rule
    A. Calories
    1. Calories From Fat
    2. Calories From Saturated Fat
    3. Two Thousand Calories as the Reference Caloric Intake Level
    4. Percent DV Declaration for Calories
    B. Fat
    1. Total Fat
    2. Saturated Fat
    3. Trans Fat
    4. Polyunsaturated Fat
    5. Monounsaturated Fat
    C. Cholesterol
    1. Mandatory Declaration
    2. DRV
    D. Carbohydrate
    1. Total Carbohydrate
    2. Sugars
    3. Added Sugars
    4. Sugar Alcohols
    5. Dietary Fiber
    6. Other Carbohydrate
    E. Protein
    1. Mandatory and Voluntary Declaration
    2. Analytical Methods
    3. DRV
    F. Sodium
    1. Mandatory Declaration
    2. DRV
    G. Fluoride
    1. Voluntary Declaration
    2. DRV
    H. Essential Vitamins and Minerals of Public Health Significance
    1. Essential Vitamins and Minerals That Are Mandatory
    2. Essential Vitamins and Minerals That Are Voluntary
    3. Other Essential Vitamins and Minerals
    4. Summary
    I. Reference Daily Intakes for Vitamins and Minerals
    1. Need To Update RDIs
    2. Approach To Setting RDIs: EAR Versus RDA
    3. Approach To Setting RDIs: Adequate Intake
    4. Approach To Setting RDIs: Tolerable Upper Intake Level
    5. Approach To Setting RDIs: Population-Weighted Versus 
Population-Coverage
    6. Declaration of the Absolute Amounts of Vitamins and Minerals
    7. Issues Concerning Specific Vitamins and Minerals
    J. Units of Measure, Analytical Methods, and Terms for Vitamins 
and Minerals
    1. Sodium, Potassium, Copper, and Chloride
    2. Folate and Folic Acid
    3. Vitamins A, D, and E
    K. Labeling of Foods for Infants, Young Children, and Pregnant 
or Lactating Women
    1. Age Range for Infants and Young Children
    2. Mandatory Declaration of Calories and Statutorily Required 
Nutrients

[[Page 11881]]

    3. Declaration of Non-Statutory Nutrients Other Than Essential 
Vitamins and Minerals
    4. Declaration of Essential Vitamins and Minerals
    5. DRVs and RDIs for Infants 7 Through 12 Months of Age
    6. DRVs and RDIs for Children 1 Through 3 Years of Age
    7. DRVs and RDIs for Pregnant and Lactating Women
    L. Dietary Supplements
    1. Mandatory Dietary Ingredients
    2. Folate and Folic Acid
    3. Units of Measure
    4. Order of Nutrients Declared on the Label
    5. Subpopulations
    6. Footnote
    M. Format
    1. Increasing the Prominence of Calories and Serving Size
    2. Changing the Order of the ``Serving Size'' and ``Servings Per 
Container'' Declarations and Increasing the Prominence of ``Servings 
Per Container''
    3. Right-Justifying the Quantitative Amounts Declared in the 
``Serving Size''
    Statement
    4. Changing the ``Amount Per Serving'' Statement
    5. Declaration of ``Calories From Fat''
    6. Presentation of Percent DVs
    7. Placement of ``Added Sugars''
    8. Declaration of Absolute Amounts of Vitamins and Minerals
    9. Single and Dual Column Labeling
    10. The Footnote
    11. Use of Highlighting With a Type Intermediate Between Bold or 
Extra Bold and Regular Type
    12. Addition of Horizontal Line Beneath the Nutrition Facts 
Heading
    13. Replacing ``Total Carbohydrate'' With ``Total Carbs''
    14. Alternative Visual Formats/Fonts
    N. Compliance
    1. Level of Variance Allowed for the Label Declaration of 
Specific Nutrients
    2. Methods Used To Determine Compliance
    3. Records Requirements
    4. Inclusion of Potassium as a Mineral
    5. Requirements for Other Carbohydrate, Soluble and Insoluble 
Fiber, Added Sugars, and Sugar Alcohols
    O. Technical Amendments
    1. Changing the Name of the Program Office
    2. Changing the Publication Date of Report Incorporated by 
Reference
    3. Plain Language Edits
III. Proposed Effective and Compliance Dates
IV. Analysis of Impacts
V. Paperwork Reduction Act of 1995
VI. Analysis of Environmental Impact
VII. Federalism
VIII. Comments
IX. References

Executive Summary

Purpose of the Regulatory Action

    FDA is proposing to amend the regulations for the nutrition 
labeling of conventional foods and dietary supplements to assist 
consumers in maintaining healthy dietary practices.
    Following the passage of the Nutrition Labeling and Education Act 
(NLEA) of 1990 (the 1990 amendments) (Pub. L. 101-535), which added 
section 403(q) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 343(q)), we issued various regulations related to 
nutrition information on food labels, including the declaration of 
nutrients, the format for nutrition labeling, reference values for use 
in declaring the nutrient content, and allowances for certain specified 
products to be exempt from nutrition labeling (Sec.  101.9 (21 CFR 
101.9)). In addition, following the passage of the Dietary Supplement 
Health and Education Act (DSHEA) of 1994 (Pub. L. 103-417 and 21 U.S.C. 
321(ff)), we amended our food labeling regulations to establish 
requirements for nutrition labeling of dietary supplements (Sec. Sec.  
101.9(j)(6) and 101.36). Section 403(q) of the FD&C Act specifies 
certain nutrients to be declared in nutrition labeling, and authorizes 
the Secretary of Health and Human Services to require other nutrients 
to be declared if the Secretary determines that a nutrient will provide 
information regarding the nutritional value of such food that will 
assist consumers in maintaining healthy dietary practices. The 
Secretary also has discretion under section 403(q) of the FD&C Act to 
remove, by regulation and under certain circumstances, nutrient 
information that is otherwise explicitly required in food labeling 
under this section.
    We are proposing to revise our regulations to provide updated 
nutrition information on the label and improve how the nutrition 
information is presented to consumers, in light of current scientific 
evidence, dietary recommendations of most recent consensus reports, and 
public comments received in response to advance notices of proposed 
rulemaking. FDA invites comment on its use of the most recent consensus 
reports and whether the information and data on which FDA relies from 
such reports for proposed changes is consistent with current scientific 
information.
Summary of the Major Provisions of the Regulatory Action in Question
    We discuss the need to update the Nutrition Facts and Supplement 
Facts labels in section I.B., and our scientific considerations for 
mandatory and voluntary declaration of nutrients are presented in 
section I.C. In sections II.A. through II.K., we discuss provisions 
related to the declaration, reference values, analytical methods, and 
definitions of nutrients that are required or permitted to be declared 
on the Nutrition Facts label of conventional foods, whereas 
corresponding changes to the Supplement Facts label of dietary 
supplements are presented in section II.L. We present our 
considerations related to the format of the Nutrition Facts and 
Supplement Facts labels in section II.M., and discuss issues related to 
compliance with the proposed requirements in section II.N. Some of the 
key proposed actions and considerations of the proposed rule are 
highlighted in this document.
    Among other amendments related to declaration of nutrients, we are 
proposing to remove the declaration of ``Calories from fat'' because 
current science supports a view that the type of fat is more relevant 
than overall total fat intake in increased risk of chronic diseases. In 
addition, removal of the ``calories from fat'' disclosure had no effect 
on consumers' judgments of product healthfulness, accuracy in 
identifying nutrient contents of products, or perceptions in FDA's 
consumer research.
    Considering current science and recommendations related to added 
sugars, we are also proposing to require the declaration of ``added 
sugars,'' that will provide consumers with information they need to 
implement the dietary recommendations of the Dietary Guidelines for 
Americans, 2010 (2010 DGA).
    We are also proposing to update the list of vitamins and minerals 
of public health significance. We currently require the mandatory 
declaration of percent Daily Values (DVs) of vitamins A and C, calcium 
and iron. We analyzed the nutrient inadequacy for vitamins and minerals 
based on biomarker data and total dietary intake (conventional foods 
and dietary supplements) using National Health and Nutrition 
Examination Survey (NHANES) data and other factors for mandatory and 
voluntary declaration discussed in section I.C. to determine which 
essential vitamins and minerals should be included as nutrients of 
public health significance. Based on this analysis, we are not 
proposing any changes to the current requirement for mandatory 
declaration of calcium and iron. In addition, we are proposing to 
require the declaration of vitamin D and potassium, and to permit, 
rather than require, the declaration of vitamins A and C.
    With respect to reference values used to declare percent DVs of 
nutrients, since 1993, new reports from the Institute of Medicine (IOM) 
and other consensus and policy reports (for example, the 2010 DGA and 
the Report of the Dietary Guidelines Advisory Committee on the Dietary 
Guidelines for

[[Page 11882]]

Americans) have been published that update the quantitative intake 
recommendations of nutrients as well as their association with chronic 
disease and health-related conditions. We are using these new data to 
update, as appropriate, the reference values used in the declaration of 
percent DVs of nutrients on the Nutrition Facts and Supplement Facts 
labels.
    Among other amendments to reference values, we are proposing an 
updated reference value for the declaration of percent DV for sodium 
from the current value of 2,400 mg (milligrams) to 2,300 mg based on a 
consideration of current science and IOM's report that set Dietary 
Reference Intakes (DRIs) for sodium, including a Tolerable Upper Intake 
Level of 2,300 mg/day (d) as a reference intake level not to exceed.
    A primary change that we are proposing to the format of the 
Nutrition Facts and Supplement Facts labels is to increase the 
prominence of the ``Calories,'' numeric value of calories, ``Servings 
per container,'' and numeric value of servings per container 
declarations. Research suggests that these proposed changes may 
increase consumers' attention to the information, and in certain 
situations, help consumers to accurately identify the number of 
calories in a product. We are also proposing to move the ``% DV'' to 
the left side of the label in order to highlight the information for 
consumers. We are also proposing to remove the requirement for the 
footnote table listing the reference values for certain nutrients for 
2,000 and 2,500 calorie diets. We intend to continue to perform 
consumer research during this rulemaking process to evaluate how 
variations in label format may affect consumer understanding and use of 
the Nutrition Facts label. We intend to publish the results of our 
research for public review and comment.
[GRAPHIC] [TIFF OMITTED] TP03MR14.001

    We are also proposing to require the maintenance of records to 
support the declarations of certain nutrients under specified 
circumstances. Currently, there are no analytical methods that can 
distinguish between dietary fiber (soluble and insoluble fiber) and 
non-digestible carbohydrates that do not meet the definition of dietary 
fiber; added and naturally occurring sugars; the various forms of 
vitamin E; or folate and folic acid and there are no analytical methods 
that can determine the amount of added sugar in specific foods 
containing added sugars alone or in combination with naturally 
occurring sugars, where the added sugars are subject to fermentation. 
Therefore, for products that contain non-digestible carbohydrates that 
do not meet the definition of dietary fiber, more than one source of 
sugar, added sugars that undergo fermentation, various forms of vitamin 
E, or folate and folic acid, we are proposing that manufacturers must 
make and keep certain written records to verify their declarations of 
each of these nutrients in the labeling of the food associated with 
such records. We are also proposing that records must be kept for a 
period of at least 2 years after introduction or delivery for 
introduction of the food into interstate commerce and

[[Page 11883]]

may be kept as original records, as true copies, or electronically, and 
manufacturers must provide those records to us for inspection and 
copying upon request during an inspection.
    We anticipate that consumer education efforts would be needed to 
help with consumer understanding and use of information presented under 
the changes to the Nutrition Facts and Supplement Facts labels proposed 
in this rule. We plan to use the results of our consumer research to 
help inform our future actions on this issue.
    Finally, we are proposing an effective date of 60 days after the 
date of the final rule's publication in the Federal Register with a 
compliance date 2 years after the effective date. We invite comment on 
the proposed compliance date. In addition to the proposed compliance 
date, we invite comment on various other issues, as summarized in 
section XI.
Costs and Benefits
    We have developed one comprehensive preliminary regulatory impact 
analysis that presents the benefits and costs of this proposed rule as 
well as the proposed rules entitled Food Labeling: Serving Sizes of 
Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual 
Column Labeling; Updating, Modifying, and Establishing Certain 
Reference Amounts Customarily Consumed; Serving Size for Breath Mints; 
and Technical Amendments taken together. The cumulative impact of these 
two nutrition labeling proposals, taken as a whole, is shown in the 
following table.

                                          Summary of Costs and Benefits
                                             [In billions of 2011 $]
----------------------------------------------------------------------------------------------------------------
                                                                Benefits            Costs         Net benefits
----------------------------------------------------------------------------------------------------------------
Present Value (PV):
    3%....................................................             $31.4              $2.3             $29.1
    7%....................................................              21.1               2.3              18.8
Annualized (3% PV Amount)
    3%....................................................               2.0               0.2               1.8
Annualized (7% PV Amount)
    7%....................................................               1.9               0.2               1.7
----------------------------------------------------------------------------------------------------------------
Notes: Compliance period is 24 months. Costs include relabeling and reformulation costs, which are one-time
  costs, as well as recordkeeping costs, which recur. Present values of relabeling and reformulation costs are
  equivalent at 3 or 7 percent because we conservatively assume that these one-time costs are incurred upon
  publication of the rule instead of at the end of the compliance period. Recordkeeping costs, because of their
  recurring nature, differ by discount rate; however, such costs comprise a very small percentage of total
  costs.

I. Background

    The 1990 amendments added section 403(q) to the FD&C Act, which 
specifies, in part and with certain exceptions, that food is deemed 
misbranded unless its label or labeling bears nutrition information for 
certain nutrients. To implement the 1990 amendments, on January 6, 
1993, FDA issued several rules, including ``Food Labeling: Mandatory 
Status of Nutrition Labeling and Nutrient Content Revision, Format for 
Nutrition Label (the 1993 nutrient content final rule)''; ``Food 
Labeling; Reference Daily Intakes and Daily Reference Values (1993 RDI/
DRV final rule)''; and ``Food Labeling: Serving Sizes'', to modify how 
nutrition information is presented on food labels (58 FR 2079; 58 FR 
2206; 58 FR 2229, respectively). FDA published regulations related to: 
(1) Declaration of nutrients on food labeling, including nutrients that 
are required or permitted to be declared and the format for such 
declaration; (2) label reference values for use in declaring the 
nutrient content of a food on its label or labeling; (3) two types of 
reference values, Reference Daily Intakes (RDIs) for vitamins and 
minerals and Daily Reference Values (DRVs) for certain nutrients, which 
are used to declare nutrient contents as percent DVs on the Nutrition 
Facts label; (4) exemptions for certain specified products; and (5) a 
simplified form of nutrition labeling and the circumstances in which 
such simplified nutrition labeling can be used. (See Sec.  101.9.) 
Elsewhere in this issue of the Federal Register, we are publishing a 
proposed rule that will amend the definition of a single-serving 
container, require dual column labeling for certain containers, update 
the reference amounts customarily consumed and serving sizes for 
several food product categories and amend the serving size for breath 
mints.
    In 1994, DSHEA became law. Among other things, DSHEA amended 
section 403(q)(5)(F) of the FD&C Act by adding specific requirements 
that relate to the labeling of dietary supplement products. 
Accordingly, we amended our food labeling regulations to establish 
requirements for nutrition labeling of dietary supplements (Sec. Sec.  
101.9(j)(6) and 101.36).
    The regulatory history, our rationale for existing requirements, 
and FDA activities related to nutrition labeling of foods and dietary 
supplements are described in Reference 1.

A. Legal Authority

    We are proposing to update the Nutrition Facts label and Supplement 
Facts label, as set forth in this proposed rule, consistent with our 
authority in section 403(q) of the FD&C Act. Section 403(q)(1) of the 
FD&C Act states that a food shall be deemed to be misbranded if, with 
certain exceptions, it fails to bear nutrition labeling and identifies 
specific nutrient and calorie information required in labeling. Section 
403(q)(2)(A) of the FD&C Act provides the Secretary, and by delegation, 
FDA, with discretion to require by regulation nutrition information 
about nutrients other than those specified in section 403(q)(1) of the 
FD&C Act to assist consumers in maintaining healthy dietary practices. 
Section 403(q)(2)(B) of the FD&C Act permits the Secretary, and by 
delegation, FDA, to remove information relating to a nutrient required 
by section 403(q)(1) or 403(q)(2)(A) of the FD&C Act if the Secretary 
determines that it is not necessary to assist consumers in maintaining 
healthy dietary practices. Consistent with these authorities, we are 
proposing to revise certain nutrient declarations in the Nutrition 
Facts label and Supplement Facts label. In addition, FDA's authority 
includes section 2(b)(1) of the 1990 amendments (21 U.S.C. 343 note). 
Specifically, section 2(b)(1)(A) of the 1990 amendments requires 
nutrition label information be conveyed in a manner that enables the 
public to readily observe and comprehend the information and to 
understand its relative significance in the context of a total daily 
diet. Such section states that such information should be consistent

[[Page 11884]]

with current scientific knowledge about nutrients and health. We are 
proposing changes to DVs (RDIs and DRVs, as applicable) for some 
nutrients, which values are used to calculate the percent DV for use on 
food labels. The use of reference values based on current science and 
the use of such values to calculate the percent DV assists consumers in 
comprehending the nutrition information and its relative significance 
in a total daily diet. We are also proposing changes to the format 
pertaining to information on the percent DV value. Further, section 
2(b)(1)(C) of the 1990 amendments stipulates that regulations ``shall 
permit the label or labeling of food to include nutrition information 
which is in addition to the information required by such section 403(q) 
[of the FD&C Act] and which is of the type described in subparagraph 
(1)(or (2) of such section . . . .'' We are proposing changes to the 
voluntary declaration of certain nutrients in the Nutrition Facts label 
consistent with such authority.
    Other relevant authorities include sections 701(a), 403(a)(1) and 
201(n) of the FD&C Act (21 U.S.C. 371(a), 21 U.S.C. 343(a)(1), and 21 
U.S.C. 321(n), respectively). Under section 701(a) of the FD&C Act, the 
Agency may issue regulations for the efficient enforcement of the FD&C 
Act in order to ``effectuate a congressional objective expressed 
elsewhere in the Act'' (Association of American Physicians and 
Surgeons, Inc. v FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm. 
Mfrs. Ass'n. v FDA, 484 F. Sup. 1179, 1183 (D. Del. 1980).)
    We are relying on our authority under sections 403(q), 403(a), 
201(n) and 701(a) of the FD&C Act, to propose record requirements to 
support nutrient declarations in labeling for added sugars, dietary 
fiber, soluble fiber, insoluble fiber, vitamin E, and folate/folic 
acid, under certain circumstances, so that we can determine compliance 
with labeling requirements and take enforcement action, as needed. For 
these nutrients, as explained in section II.N., there is no AOAC 
official method of analysis of AOAC International or other reliable or 
appropriate analytical procedure, otherwise required by Sec.  101.9(g), 
available for FDA to quantify the declared amount of the nutrient, 
under certain circumstances. Section 101.9(g) sets forth the standards 
for accuracy of the amount statements of nutrients on food labels. 
Failing to accurately state the amounts of nutrients on the label under 
Sec.  101.9(g) would result in a product being misbranded. Under 
section 403(q) of the FD&C Act, a food must bear, in its label or 
labeling, the amount of the nutrient the food contains. Moreover, the 
nutrient declaration must be truthful and not misleading under sections 
403(a)(1) and 201(n) of the FD&C Act. Thus, when a food product 
contains dietary fiber (whether soluble, insoluble, or a combination of 
both) and added non-digestible carbohydrate(s) that does not meet the 
definition of dietary fiber, we are proposing to require manufacturers 
to make and keep certain written records to verify the amount of added 
non-digestible carbohydrate that does not meet the definition of 
dietary. When vitamin E is present in a food as a mixture of all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol, we are proposing 
to require manufacturers to make and keep written records to verify the 
amount of all rac-[alpha]-tocopherol acetate added to the food and RRR-
[alpha]-tocopherol in the finished food. When a mixture of folate and 
folic acid is present in a food, we are proposing to require 
manufacturers to make and keep records to verify the amount of folic 
acid added to the food and folate in the finished food. When added 
sugars as well as naturally occurring sugars are present in a food, we 
are proposing to require manufacturers to make and keep records to 
verify the declared amount of added sugars in the food. Finally, we are 
proposing to require manufacturers to make and keep records to verify 
the declared amount of added sugars in specific foods, alone or in 
combination with naturally occurring sugars, where the added sugars are 
subject to fermentation.
    The proposed record requirements for these nutrients, under the 
circumstances described, are designed to ensure that the nutrient 
declarations are accurate, truthful and not misleading, based on 
information known only to the manufacturer, and to facilitate efficient 
and effective action to enforce the requirements when necessary. Our 
authority to establish records requirements has been upheld under other 
provisions of the FD&C Act where FDA has found such records to be 
necessary (National Confectioners Assoc. v Califano, 569 F.2d 690, 693-
94 (D.C. Cir. 1978). The records we propose to require are only for 
foods for which an adequate analytical method is not available. The 
records would allow us to verify the declared amount of each of these 
nutrients and that such amount is truthful and not misleading. Thus, 
the proposed records requirements would help in the efficient 
enforcement of the FD&C Act.
    The authority granted to FDA under sections 701(a), 403(q), 
403(a)(1) and 201(n) of the FD&C Act not only includes authority to 
establish records requirements, but also includes access to such 
records. Without such authority, the nutrient declarations for these 
specific nutrients that FDA has determined are necessary to assist 
consumers in maintaining healthy dietary practices under section 
403(q)(2)(A) of the FD&C Act are, practically speaking, not 
enforceable. Without access to such records, FDA would not know whether 
the amount declared on the label or in the labeling of each these 
nutrients, under the circumstances described, is truthful and not 
misleading under sections 403(a)(1) and 201(n) of the FD&C Act. The 
introduction or delivery for introduction into interstate commerce of a 
misbranded food is a prohibited act under section 301(a) of the FD&C 
Act (21 U.S.C. 331(a)). Thus, to determine whether the food is 
misbranded and the manufacturer has committed a prohibited act, we must 
have access to the manufacturer's records that we are requiring be made 
and kept under sections 403(q), 403(a)(1), 201(n) and 701(a) of the 
FD&C Act. Failure to make and keep records and provide the records to 
FDA, as described in proposed Sec.  101.9(g)(10) and (g)(11), would 
result in the food being misbranded under sections 403(q) and 403(a)(1) 
of the FD&C Act.

B. Need To Update the Nutrition Facts and Supplement Facts Labels

    FDA first issued regulations related to the Nutrition Facts label 
in 1993. We have not updated the Nutrition Facts label since the 2003 
trans fat rulemaking (68 FR 41434; July 11, 2003) or established new or 
updated DVs for nutrients since 1995 (60 FR 67164; December 28, 1995). 
Since that time, the public health profile of the U.S. population has 
changed (e.g., increase in obesity), new information has become 
available about nutrient definitions (e.g., vitamin E), reference 
intake values, and analytical methods, and new dietary recommendations 
(see section I.B.2.) have been published. As a result, we are 
reconsidering what nutrients we should require or permit to be listed 
on the Nutrition Facts label and what nutrient reference intake values 
we should use as a basis for calculating the percent DVs in food 
labeling. We also considered corresponding changes to the Supplement 
Facts labels. We discuss specific nutrient declarations in greater 
detail in section II. Section I.B. includes an overview of information 
we considered when forming our tentative conclusions, including 
scientific and technical data and recommendations, citizen petitions 
submitted to us, and public comments to previous requests

[[Page 11885]]

for comment in advance notices of proposed rulemaking on topics related 
to this proposed rule. We also considered the role of nutrition 
labeling to assist consumers in maintaining healthy dietary practices 
and consumers' use and understanding of the Nutrition Facts label.
1. Rates of Chronic Disease
    Chronic diseases, such as heart disease, cancer and stroke are the 
leading causes of death and disability in the United States, and 
account for 70 percent of all deaths in the United States (Ref. 2). In 
2005, 133 million Americans, almost one out of every two adults, had at 
least one chronic illness (Ref. 2). An estimated 37 percent of 
Americans suffer from cardiovascular disease (CVD) (Ref. 3), 11.3 
percent of the population 20 years and older has diabetes, 35 percent 
of adults has pre-diabetes (Ref. 4), and 41 percent of the population 
is predicted to be diagnosed with cancer during their lifetime (Ref. 
5). While the causes of these chronic diseases are multifactorial, poor 
diet is a contributing factor associated with morbidity and mortality 
(Ref. 6). Many nutrients are associated with chronic disease risk. For 
example, diets low in saturated fat and cholesterol, and/or sodium are 
associated with a decreased risk of CVD (58 FR 2739; January 6, 1993, 
and 58 FR 2820; January 6, 1993). Adequate or increased intake of 
calcium and vitamin D may decrease the risk of osteoporosis (73 FR 
56477; September 29, 2008).
    Obesity rates have increased dramatically over the last three 
decades. Between 1976 and 1980 and 2007 and 2008, obesity rates 
increased more than twofold (from 15 to 34 percent) in adults and more 
than threefold (from 5 to 17 percent) among children and adolescents 
(Refs. 6 to 8). Data published by the U.S. Centers for Disease Control 
and Prevention (CDC) indicate that 68 percent of adults and about 32 
percent of children aged 2 to 19 years in the U.S. population are 
overweight or obese (Refs. 7 and 8). Excessive body weight is a risk 
factor for chronic diseases such as heart disease, some forms of 
cancer, and type II diabetes (Ref. 9). The 2010 DGA affirmed the role 
of over consumption of calories and physical inactivity as the primary 
risk factors contributing to an epidemic of overweight and obesity in 
this country, and urged for a focus on improved nutrition and physical 
activity choices among Americans (Ref. 6).
    Elevated blood pressure, an important risk factor for CVD (Ref. 
10), affects about one-third of the U.S. adult population (Ref. 2). 
High intakes of sodium are directly associated with elevated blood 
pressure (Ref. 10). Average sodium intake for the U.S. population 4 
years of age and older is approximately 3,650 mg/d (Ref. 11). Almost 
all Americans consume more sodium than the levels recommended by the 
2010 DGA (Ref. 12)
    Furthermore, while concerns in recent years have largely shifted 
away from nutritional deficiencies, some population subgroups may 
consume excess calories but still consume inadequate amounts of certain 
micronutrients such as iron, vitamin D, calcium and potassium (see 
section II.H.).
    The mandatory declaration of nutrients that have public health 
significance, the use of updated DVs based on current scientific 
evidence, and the use of a format for the Nutrition Facts label to 
assist with consumer use and understanding can help consumers make 
informed food choices to consume a nutritionally adequate diet while 
monitoring calorie intake and lowering their risk of some chronic 
diseases.
2. Dietary Recommendations, Consensus Reports, and National Survey Data
    a. IOM Dietary Reference Intakes Reports (IOM DRI Reports)--In 
1994, the Food and Nutrition Board (FNB) of the Institute of Medicine 
(IOM) identified principles for the development of a new set of 
reference values that could expand and replace the IOM's Recommended 
Dietary Allowances (RDAs) of 1989 (Refs. 13 and 14). A comprehensive 
review and application of a growing body of nutritional science 
research resulted in the development of a set of reference values, 
collectively known as DRIs, published from 1997 to 2010 (Ref. 15). The 
DRIs represent a shift in the way that reference values are established 
or intended for use. In contrast to previous editions of RDAs (e.g., 
the 1968 and 1989 RDAs), which involved establishing single values for 
each nutrient with appropriate adjustments for age, sex and 
physiological status, the new DRI framework consisted of four 
categories of reference values. These categories include the Estimated 
Average Requirement (EAR), RDA, Adequate Intake (AI) and Tolerable 
Upper Intake Level (UL). For macronutrients--carbohydrates, fats, and 
protein--the IOM developed a new set of reference values called the 
Acceptable Macronutrient Distribution Ranges (AMDRs).
    The EAR is the average daily nutrient intake level that is 
estimated to meet the requirements of half of the healthy individuals 
in a particular life stage and gender group. EARs are used for 
assessing the statistical probability of adequacy of nutrient intakes 
of groups of people. The RDA is an estimate of the average intake level 
that meets the nutrient requirements of nearly all (97 to 98 percent) 
healthy individuals in a particular life stage and gender group. The 
RDA is set using the EAR. In general, the RDA is the EAR plus two times 
the standard deviation of the EAR. The RDA is used to plan nutrient 
intakes for individuals to ensure a low probability of inadequacy. 
Nutrients with EARs and RDAs include carbohydrate, protein, vitamin A, 
vitamin C, vitamin E, thiamin, riboflavin, niacin, vitamin 
B6, folate, vitamin B12, copper, iodine, iron, 
magnesium, phosphorus, selenium, zinc, calcium and vitamin D.
    An AI is the level determined for an essential nutrient or a 
nutrient that is beneficial for human health when there is insufficient 
evidence to calculate an EAR for that nutrient, and therefore 
insufficient evidence on which to establish an RDA. AIs can be based on 
a variety of data, including scientific evidence about the essentiality 
of a nutrient (i.e., choline, biotin, fluoride), experimental data on 
risk reduction of chronic disease (i.e., dietary fiber, potassium), and 
median intakes of a nutrient using national survey data (i.e., vitamin 
K, pantothenic acid, chromium, manganese, linoleic acid, and [alpha]-
linolenic acid). Although there is less certainty about an AI value 
than about an RDA value, the AI is similarly designed to cover the 
needs of nearly all individuals. The IOM Dietary Planning Report and 
Dietary Assessment Report noted that ``the AI should be used with less 
confidence if it has not been established as the mean intake of a 
healthy group.''
    The UL is the highest average daily intake level likely to pose no 
risk of adverse health effects for nearly all people in a particular 
group. The UL is not intended to be a recommended level of intake. The 
UL is used to assess the risk of adverse health effects from excessive 
nutrient intake. As intake above the UL increases, so does the 
potential for risk of adverse health effects. Nutrients with ULs 
include vitamin A, vitamin C, vitamin D, vitamin E, niacin, vitamin 
B6, folate, choline, calcium, copper, fluoride, iodine, 
iron, magnesium, manganese, molybdenum, phosphorus, selenium, zinc, 
sodium, and chloride.
    Moreover, while the previous RDAs primarily focused on reducing the 
incidence of diseases of nutrient deficiency in the population, the 
DRIs

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now take into consideration data on chronic disease risk, such as heart 
disease, and developmental abnormalities, such as teratogenicity, 
rather than only the signs of deficiency. Finally, where sufficient 
data exist, the DRIs take into account the potential benefit or risk to 
health of substances that are not essential (such as dietary fiber and 
fluoride) that are in addition to the macronutrients of total 
carbohydrate, protein, and fat, and the micronutrient vitamins and 
minerals permitted or required on the Nutrition Facts label (Ref. 15). 
Beginning in 1997, the IOM began publishing its DRIs for those 
vitamins, minerals, and macronutrients that are essential in humans or 
provide a beneficial role in human health (Refs. 16 to 22). In 
addition, the IOM also set AMDRs for carbohydrates, fat, and protein 
(Ref. 23). The AMDR for a macronutrient is based on the amount of the 
macronutrient that is associated with a reduced risk of chronic disease 
while providing adequate intakes of essential nutrients. The AMDR is 
expressed as a range of percent energy intake (e.g., 20 to 35 percent 
of calories from total fat for adults over 18 years of age). The DRIs 
and AMDRs were set for the following life stage groups: Infants (0 to 6 
and 7 to 12 months); toddlers (1 to 3 years); boys and girls (4 to 8 
years); adolescent boys and girls (9 to 13 and 14 to 18 years); adult 
men and women (19 to 30, 31 to 50, 51 to 70, and greater than 70 
years); and pregnant and lactating women.
    b. IOM Dietary Fiber Report--In 2001, the IOM Panel on the 
Definition of Dietary Fiber (the IOM Dietary Fiber Panel) responded to 
our request to provide definitions for dietary fiber based on its role 
in human physiology and health. The IOM Dietary Fiber Panel developed 
two categories of definitions of fiber: ``Dietary Fiber'' and ``Added 
Fiber'' in its report Dietary Reference Intakes: Proposed Definition of 
Dietary Fiber (the IOM Dietary Fiber Report) (Ref. 24).
    c. IOM Dietary Assessment Report--In 2000, the IOM Subcommittee on 
Interpretation and Uses of Dietary Reference Intakes (IOM uses 
Committee) published the report, DRIs Application in Dietary Assessment 
(IOM Dietary Assessment report) on how to use the DRIs for dietary 
assessment of individuals and groups.
    d. IOM Labeling Report--In 2003, the IOM Committee on nutrition 
labeling (IOM Labeling Committee) considered how the DRIs can be used 
to develop appropriate reference values for nutrition labeling and 
published its report, co-funded by FDA, DRI Guiding Principles for 
Nutrition Labeling and Fortification (the IOM Labeling Report) (Ref. 
25), with the goal of having an updated nutrition label that consumers 
can use to make informed dietary choices.
    e. IOM Dietary Planning Report--In 2003, the IOM Subcommittee on 
interpretation and uses of DRIs (IOM Uses Committee) published a 
report, DRIs Application in Dietary Planning (IOM Dietary Planning 
Report) (Ref. 26) on how to use the DRIs for planning intakes of 
individuals and groups. This report discusses the use of the DRIs for 
food and supplement labels.
    f. IOM Sodium Strategies Report--In 2008, the IOM convened a 
Committee on Strategies to Reduce Sodium Intake in the United States to 
address a Congressional request for recommendations about various means 
that could be employed to reduce dietary sodium intake to levels 
recommended by the 2005 DGA (less than 2,300 mg/d and no more than 
1,500 mg/d for African-Americans, people with hypertension, and middle-
aged and older adults). The Committee's report, Strategies to Reduce 
Sodium Intake in the United States (IOM Sodium Strategies Report), 
published in 2010, among other strategies, discusses how the labeling 
of sodium on foods can serve as a supporting strategy for reducing 
sodium intake (Ref. 27).
    g. IOM Front-Of-Package Nutrition Rating Systems and Symbols Phase 
I and Phase II Reports--In 2010, the IOM Committee on Front-of-Package 
(FOP) Nutrition Rating Systems and Symbols reviewed the existing FOP 
systems and their underlying nutrition criteria. In the Phase I report, 
the IOM identified the nutrients for which there was sufficient 
evidence of their role in chronic disease risk and which should be 
included in a FOP label (Ref. 28). In 2012, the IOM published its phase 
II report that recommended developing a single standardized FOP rating 
system and updated their recommendations for nutrients to be included 
on the FOP label (Ref. 29).
    h. IOM Sodium Intake in Populations Report--In 2012 the IOM 
convened a Committee to review and assess the benefits and adverse 
outcomes (if any) of reducing the sodium intake in the population, 
particularly in the range of 1,500 to 2,300 mg/d. The Committee was 
also asked to specifically emphasize relevant subgroups in the analysis 
including those 50 years of age and older, African Americans, and those 
with diabetes, chronic kidney disease, and congestive heart failure. 
The Report was published in May of 2013 and focused its findings and 
conclusions on evidence for associations between sodium intake and the 
risk of CVD-related events and mortality.
    i. Dietary Guidelines for Americans (DGA), 2010--The 2010 DGA, 
developed jointly by the U.S. Department of Agriculture (USDA) and the 
U.S. Department of Health and Human Services (HHS), provide several key 
recommendations including recommendations about dietary patterns, as 
well as quantitative intake recommendations with respect to 
micronutrients and macronutrients, most of which are based on the IOM 
DRI reports (Ref. 6). In a few cases, the 2010 DGA provided 
quantitative intake recommendations for certain nutrients (i.e., 
cholesterol and saturated fat) that were not provided by the IOM DRI 
reports (Ref. 6). The 2010 DGA emphasized the importance of meeting 
food and nutrient recommendations while balancing calorie needs (Ref. 
6). More information regarding the scientific basis that informed the 
development of the 2010 DGA can be found in the Report of the Dietary 
Guidelines Advisory Committee on the Dietary Guidelines for Americans, 
2010 (2010 DGAC) (Ref. 30). An important note related to the 2010 DGA 
is the specified intended audience for its recommendations (Ref. 6). 
From the 1980s until 1995, the DGAs were targeted toward healthy 
Americans and designed to provide advice to healthy individuals about 
food choices that promote health and prevent disease (Refs. 31 to 34). 
In 2000, the recommendations specified an audience of ``healthy 
children ages 2 years and older and adults of any age,'' and the 2005 
DGA provided recommendations for the ``general public age 2 years and 
older.'' (Refs. 35 and 36). While the DGAs have always taken into 
account the needs of subpopulations, the most recent 2010 DGA goes 
beyond the traditional target of a ``healthy'' audience to provide 
chronic disease,'' noting ``the reality that a large percentage of 
Americans are overweight or obese and/or at risk of various chronic 
diseases'' (Ref. 6).
    j. National Health and Nutrition Examination Survey (NHANES)--The 
NHANES provides the primary source of information on the health and 
nutritional status of adults and children in the United States. The 
survey examines a nationally representative sample of about 5,000 
persons each year. These persons are located in counties across the 
country. The survey combines interviews, which include demographic, 
socioeconomic, dietary, and health-related questions, and physical 
examinations, which consist of

[[Page 11887]]

medical, dental, and physiological measurements, as well as laboratory 
tests administered by highly trained medical personnel (Ref. 37).
3. Consumer Use and Understanding of the Nutrition Facts Label
    The Nutrition Facts label is intended to help consumers make 
informed food choices and maintain healthy dietary practices. Consumers 
became increasingly aware of the new label in the years following 
implementation of the 1990 amendments, and reported using food labels 
more often in their purchasing decisions compared to their use before 
the introduction of the Nutrition Facts label (Ref. 38).
    Data from a nationally representative sample of U.S. adults 
collected through FDA's Health and Diet Surveys suggest that the 
frequency of food label use among consumers progressively increased 
between 2002 and 2008 (Refs. 39 to 41). For example, the percentage of 
consumers reporting that they ``often'' read a food label the first 
time they purchase a food product rose from 44 percent in 2002 to 54 
percent in 2008. Among those indicating they read food labels when 
purchasing a product for the first time, two-thirds of them in 2008 
reported using the label to see how high or low the food was in 
calories, salt, vitamins or fat, while more than half said they used 
labels to get a general idea of the nutritional content of the product. 
A similar increase in reported use of food labels has also been shown 
using data from the National Health and Nutrition Examination Surveys 
2007-2008 and 2009-1010. The percent of working age adults that 
reported using the Nutrition Facts Panel (NFP) always or most of the 
time when shopping for food increased to 42% in 2009-2010 from 34% in 
2007-2008. Among older adults the percentage increased to 57% in 2009-
2010 from 51% in 2007-2008. (Ref. 42).
    Consumer research data suggest that, despite the widespread use of 
food labels, certain elements of the Nutrition Facts label may need 
improvement. For example, some consumers have difficulty understanding 
the concept of percent DV (Refs. 43 and 44) or are confused by the 
label footnote that lists DVs for certain nutrients based on a 2,000 
and 2,500 calorie diet (Ref. 45).
    Section 2(b)(1)(A) of the 1990 amendments mandated that FDA 
regulations implementing section 403(q) of the FD&C Act require that 
nutrition labeling must be conveyed to the public in a manner which 
enables the public to readily observe and comprehend such information 
and to understand its relative significance in the context of a total 
daily diet. In particular, the percent DV of a nutrient present in food 
is declared on food labels to help consumers understand the relative 
significance of nutrition information in the context of a total daily 
diet, compare the nutritional values of food products, and to plan 
general diets (58 FR 2206 at 2213; January 6, 1993). We also noted that 
the percent DV information advises the consumer how much of a 
recommended intake of that nutrient is provided by the food (58 FR 2079 
at 2123; January 6, 1993). We developed the term ``Daily Value'' to 
refer to all reference values on the nutrition label (DRVs and RDIs). 
We noted that some of the reference values were intended to guide 
consumers relative to maximum intakes (DRVs) (e.g., saturated fat), 
while others were intended to serve as the basis for planning general 
diets to meet nutrient requirements (RDIs) (e.g., vitamin C) (58 FR 
2079 at 2124). Our research at the time showed that the term ``Daily 
Value'' was generally understood by consumers as a point of reference 
(58 FR 2079 at 2125).
    In order to determine a nutrition labeling format that could be 
used most effectively by consumers, we conducted consumer research and 
evaluated research conducted by others in considering requirements for 
the nutrition label format (58 FR 2079 at 2115-2121). When available, 
we used empirical data on how consumers use and understand the label in 
proposing what information should be declared on the label and how. We 
used focus group data to inform what we would test in experimental 
studies, but did not rely on such data to make policy decisions. 
Several comments to the ANPRMs submitted focus group data. However, we 
are not relying on focus group data for the proposed changes to the 
Nutrition Facts label because focus groups do not yield meaningful 
quantitative findings and are not able to support conclusions about the 
relationships between the presentation of label information and 
consumer responses. As such, they cannot be used to drive the 
development of policies, programs, and services. Policy makers and 
educators can use focus groups findings to test and refine their ideas, 
but should then conduct further research before making important 
decisions such as adopting new policies and allocating or redirecting 
significant resources to support these policies.
    We have completed one study that examined dual-column labels and 
ways to increase prominence of certain label information, and intend to 
continue to perform research during this rulemaking process to evaluate 
how variations in label format may affect consumer understanding and 
use of the Nutrition Facts label. Issues to be addressed include how a 
declaration of ``Added Sugars'' and alternative footnote statement may 
influence consumer use of the label.
    The overall goal of these studies is to assess a consumer's ability 
to use the Nutrition Facts label and assess a consumer's preferences 
related to proposed modifications of the Nutrition Facts label format. 
In addition, the studies will help us focus our efforts on consumer 
education as well as enhance our understanding of whether modifications 
to the Nutrition Facts label format could help consumers make more 
informed choices based on their perceptions of the nutritional 
attributes and overall healthfulness of a food product. (See also 
discussion in section II.M.)
4. Other Relevant Considerations
    In developing this proposed rule, we considered changes that would 
assist consumers in maintaining healthy dietary practices and recognize 
that it is important for the updated Nutrition Facts label to be useful 
and relevant to the American population. While the Nutrition Facts 
label information has never been nor is it now targeted to individuals 
with acute or chronic disease, we are considering the large portion of 
the U.S. population that is at risk for chronic disease in proposing 
changes to the label's content and format. The population at risk for 
chronic disease includes those who are overweight, and therefore at 
increased risk of certain chronic diseases, or those who are obese, 
leading to a variety of complications including diabetes and CVD. This 
approach is consistent with the new IOM DRIs, which are for healthy 
individuals, including those at-risk of disease, but not for 
individuals with acute or chronic disease or nutrient deficiencies 
(Ref. 15). Similarly, the DGAs are for Americans ages 2 years and 
older, including those at risk of chronic disease. While consumers with 
acute or chronic disease, such as obesity, CVD, or diabetes, may be 
able to use quantitative information on the label to follow advice they 
have received from a health care professional concerning their 
conditions, the nutrient declarations and percent DVs on the label are 
to help consumers make more informed choices to consume a healthy diet 
and not intended for the clinical management of an existing disease. In 
addition, we recognize the importance of federal regulations reflecting 
the most current science. In developing this proposed rule, we

[[Page 11888]]

considered new scientific evidence and dietary recommendations about 
the relationship between nutrients and health.
    Finally, we recognize that the goal of assisting consumers in 
maintaining healthy dietary practices requires that we consider certain 
practicalities. For example, as we noted in the 1993 nutrient content 
final rule (58 FR 2079 at 2107), while the 1990 amendments permit the 
Secretary of Health and Human Services to include in the Nutrition 
Facts label any information about a nutrient that will assist consumers 
in maintaining healthy dietary practices, there is not room on the 
label for all information that may be related to maintaining healthy 
dietary practices. Space constraints on the label of most foods make 
declaring all essential nutrients impractical. In addition, having a 
large amount of information on the label could interfere with 
consumers' abilities to use the information that has the greatest 
public health significance. Therefore, not only are we aware of the 
amount and format of mandatory information on the label, but we 
recognize that limits to the voluntary information are necessary, so 
that voluntary information does not clutter the label, does not 
mislead, confuse, or overwhelm the consumer, and does not take away 
prominence of and emphasis on the required information.
5. Citizen Petitions
    Since 1993, we received a number of citizen petitions requesting 
that FDA make various changes to the Nutrition and Supplement Facts 
labels. We are addressing a number of issues raised in the following 
petitions within this proposed rule: (1) The Calorie Control Council 
submitted a citizen petition on April 13, 1995 (Docket No. FDA-1995-P-
0142) requesting that FDA permit the use of the term ``polyols'' in 
lieu of sugar alcohols on the Nutrition Facts label (http://www.regulations.gov/#!docketDetail;D=FDA-1995-P-0142); (2) the American 
Cocoa Research Institute submitted a citizen petition on April 4, 1996 
(Docket No. FDA-1996-P-0035) recommending the accurate communication of 
the scientific fact that stearic acid does not affect blood cholesterol 
(http://www.regulations.gov/#!docketDetail;D=FDA-1996-P-0035); (3) 
Nabisco, Inc. submitted a citizen petition on May 8, 1997 (Docket No. 
FDA-1997-P-0476) requesting that FDA amend the definition of ``total 
fat'' and ``saturated fat'' in its food labeling regulations to clarify 
that acetic, propionic, and butyric acids may be excluded when 
calculating the amount of fat in a food product (http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0476); (4) the Calorie 
Control Council submitted a citizen petition on February 13, 1998 
(Docket No. FDA-1997-P-0232) requesting that the caloric value of 
soluble fiber be no more than 2 kcal/g (http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0232); (5) the Center for Science in the 
Public Interest (CSPI) submitted a citizen petition on August 4, 1999 
(Docket No. FDA-1999-P-0158) requesting that FDA establish a DV for 
added sugars and require the amount of added sugar, and the percent DV 
that represents, to be declared on food labels (http://www.regulations.gov/#!docketDetail;D=FDA-1999-P-0158); (6) Protein 
Technologies International, Inc. submitted a citizen petition on 
December 21, 2000 (FDA-2000-P-0569) requesting that FDA modify the 
reference to the method used to calculate protein content (http://www.regulations.gov/#!docketDetail;D=FDA-2000-P-0569); (7) the National 
Starch and Chemical Company (``National Starch'') submitted a citizen 
petition on July 8, 2004 (Docket No. FDA-2004-P-0094) requesting that 
dietary fiber content be excluded from the ``total carbohydrate'' 
declaration on the Nutrition Facts label (http://www.regulations.gov/#!docketDetail;D=FDA-2004-P-0094); (8) the Sugar Association submitted 
a citizen petition on August 15, 2005 (Docket No. FDA-2005-P-0373) 
requesting, in part, that FDA amend regulations related to the labeling 
of sugar and alternative sweeteners (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0373); (9) CSPI submitted a citizen 
petition on November 8, 2005 (Docket No. FDA-2005-P-0196) requesting, 
in part, that FDA lower the DV for sodium from 2,400 to 1,500 mg/day 
(http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0196); (10) an 
individual submitted a citizen petition on May 25, 2005 (Docket No. 
FDA-2005-P-0126) requesting that FDA preclude the declaration of 
[beta]-carotene in supplements as vitamin A (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0126); (11) an 
individual submitted a citizen petition on January 17, 2007 (Docket No. 
FDA-2007-P-0404) requesting that FDA amend the definition of trans fat 
in its food labeling regulations to express the value of ``zero'' for 
trans fat when there are ``absolutely no trans fats at all'' and 
require the use of a symbol (e.g., ``~'') to indicate when there is 
``more than zero but less than 0.5 grams (g) of trans fat per 
tablespoon'' (http://www.regulations.gov/#!docketDetail;D=FDA-2007-P-
0404); and (12) CSPI submitted a citizen petition on February 13, 2013 
(Docket No. FDA-2013-P-0217) requesting, in part, that FDA revise the 
``Sugars'' line on the Nutrition Facts label to address ``added 
sugars'' (http://www.regulations.gov/#!docketDetail;D=FDA-2013-P-0217).
    We address the specific requests identified previously for each 
citizen petition related to the labeling of conventional foods and 
dietary supplements in the appropriate sections in this document. 
Requests in these citizen petitions that are unrelated to the content 
of the Nutrition Facts label are outside of the scope of this 
rulemaking and we will address those requests separately from this 
rulemaking.
6. Advance Notices of Proposed Rulemaking (ANPRMs)
    We also published three ANPRMs seeking public comment on issues 
relevant to updating the Nutrition Facts label.
    a. ANPRM on Trans Fat--In the Federal Register of July 11, 2003 (68 
FR 41507), we published an ANPRM (the 2003 ANPRM) to solicit 
information and data that potentially could be used to establish new 
nutrient content claims about trans fatty acids; to establish 
qualifying criteria for trans fat in nutrient content claims for 
saturated fatty acids and cholesterol, lean and extra lean claims, and 
health claims that contain a message about cholesterol-raising lipids; 
and, in addition, to establish disclosure and disqualifying criteria to 
help consumers make heart-healthy food choices. We also requested 
comments on whether we should consider statements about trans fat, 
either alone or in combination with saturated fat and cholesterol, as a 
footnote in the Nutrition Facts label or as a disclosure statement in 
conjunction with claims to enhance consumer understanding about 
cholesterol-raising lipids and how to use the information to make 
healthy food choices. On March 1, 2004 (69 FR 9559), we reopened the 
comment period for the 2003 ANPRM to receive comments that considered 
the information in the IOM Labeling Report (Ref. 25) published in the 
interim that addressed the labeling of trans fat. On April 19, 2004 (69 
FR 20838), we extended the comment period for the 2003 ANPRM to receive 
comments that considered the information in the 2004 meeting of the 
Nutrition Subcommittee of the Food Advisory Committee (Ref.

[[Page 11889]]

46), which addressed whether the available scientific evidence 
supported listing the percent DV for saturated fat and trans fat 
together or separately on the Nutrition Facts label and what the 
maximal daily intake of trans fat may be.
    In response to the 2003 ANPRM, we received about 120 comments. We 
consider the comments related to determining a DV for trans fat in 
section II.B.3. (see also accompanying Ref. 47). Other issues raised by 
comments that are unrelated to the DV for trans fat will be addressed 
in a separate rulemaking at a future time.
    b. ANPRM on Prominence of Calories--In the Federal Register of 
April 4, 2005 (70 FR 17008), we published an ANPRM on the prominence of 
calories on the food label (the 2005 ANPRM). The 2005 ANPRM was issued 
in response to recommendations from the Obesity Working Group created 
by the Commissioner of Food and Drugs to develop an action plan to 
address the growing incidence of obesity in the United States. The 2005 
ANPRM, in part, requested comments on whether giving more prominence to 
the declaration of calories per serving would increase consumer 
awareness of the caloric content of the packaged food. We also sought 
comment on whether providing a percent DV for total calories would help 
consumers understand the caloric content of the packaged food in the 
context of a 2,000 calorie diet. In addition, we also requested 
comments on questions concerning the declaration of ``Calories from 
fat'' (70 FR 17008 at 17010).
    We received about 400 comments to the 2005 ANPRM, each containing 
one or more issues, from industry, trade associations, consumer groups, 
individual consumers, government, and academia. We consider the 
comments in sections II.A. and II.M. (see also accompanying Ref. 47).
    c. ANPRM on Food Labeling: Revision of Reference Values and 
Mandatory Nutrients--In the Federal Register of November 2, 2007 (72 FR 
62149), we published an ANPRM regarding the revision of reference 
values and mandatory nutrients (the 2007 ANPRM). The 2007 ANPRM 
requested comment on various aspects of nutrition labeling, including 
what new reference values we should use to calculate the percent DV in 
the Nutrition Facts and Supplement Facts labels and what factors we 
should consider in establishing such new reference values. In addition, 
we requested comments on whether we should require that certain 
nutrients be added or removed from the Nutrition Facts and Supplement 
Facts labels.
    In response to the 2007 ANPRM, we received about 820 comments, from 
industry, trade associations, consumer groups, individual consumers, 
government, and academia. We consider these comments in each of the 
relevant individual nutrient sections in this document (see also 
accompanying Ref. 47).
7. Impact on Other Regulations
    We recognize that changes to the list of nutrients declared on the 
Nutrition Facts label or the RDIs or DRVs of nutrients will likely 
affect other FDA regulations, including certain labeling requirements 
for foods in 21 CFR part 101. For example, the DVs are used to 
determine, in part, whether a food or dietary supplement is eligible to 
bear nutrient content claims or health claims (see for example 
Sec. Sec.  101.14, 101.54, 101.76, 101.78, and 101.79). In addition, 
our fortification policy refers to RDIs and certain DRVs that are 
specified in Sec.  101.9 in describing principles for the rational 
addition of nutrients to foods (Sec.  104.20 (21 CFR 104.20)). We plan 
to evaluate the impact of the proposed changes to the Nutrition Facts 
and Supplement Facts labels, if finalized, on other FDA regulations. We 
intend to address, as appropriate, the impact on other FDA regulations 
in future separate rulemakings. Thus, issues related to nutrient 
content claims and health claims are outside the scope of this 
rulemaking.

C. Factors for Mandatory or Voluntary Declaration of Non-Statutory 
Nutrients

    Under section 403(q)(1)(C) and (D) of the FD&C Act, nutrition 
information in food labeling must include the total number of calories, 
derived from any source and derived from the total fat, and the amounts 
of total fat, saturated fat, cholesterol, sodium, total carbohydrates, 
complex carbohydrates, sugars, dietary fiber, and total protein. For 
purposes of this proposed rule, we consider the nutrients that are 
explicitly required by the FD&C Act to be declared on the Nutrition 
Facts label as ``statutorily required nutrients.'' Section 403(q)(2)(B) 
of the FD&C Act permits the Secretary, and by delegation, FDA, to 
remove a statutorily required nutrients from the label or labeling of 
food, by regulation, if the Secretary determines the information 
related to that nutrient is not necessary to assist consumers in 
maintaining healthy dietary practices. FDA regulations require the 
declaration of the following statutorily required nutrients: Total 
calories, calories from fat, total fat, saturated fat, cholesterol, 
sodium, total carbohydrates, sugars, dietary fiber, and total protein 
(See Ref. 1 for information on regulatory history). As part of the 
effort to update the Nutrition Facts label, we reconsidered the 
declaration of these statutorily required nutrients. Our considerations 
and tentative conclusions on these nutrients are presented within the 
discussion of individual nutrients in section II.
    Section 403(q)(2)(A) of the FD&C Act provides that the Secretary 
(and by delegation FDA) may, by regulation, require other nutrients to 
be declared if the Secretary determines that a nutrient will provide 
information regarding the nutritional value of such food that will 
assist consumers in maintaining healthy dietary practices. For purposes 
of this proposed rule, we consider such nutrients that are not 
statutorily required but subject to our discretion under section 
403(q)(2)(A) of the FD&C Act, as ``non-statutory nutrients'' to 
distinguish such nutrients from those expressly required by the 
statute. In the 1993 nutrient content final rule (58 FR 2079), we 
considered the existence of a quantitative intake recommendation 
highlighted in U.S. consensus reports and the public health 
significance of the nutrient in exercising our discretion to determine 
which non-statutory nutrients to require or permit on the Nutrition 
Facts label. Based on these considerations, with respect to non-
statutory nutrients, we (1) required the declaration of certain 
essential vitamins and minerals for which an RDI was established and 
that were determined to have public health significance (i.e., vitamins 
A and C, iron, and calcium); and (2) permitted the declaration of the 
remaining essential vitamins and minerals for which there was an 
established RDI or DRV (i.e., vitamin E) or that had public health 
significance, as well as permitted the declaration of certain 
subcategories of macronutrients for which a DRV was not established 
(including monounsaturated fat, polyunsaturated fat, soluble fiber, 
insoluble fiber, sugar alcohol, and other carbohydrate) (58 FR 2079).
    In this section, we describe our current thinking related to 
considerations used to determine whether a non-statutory nutrient 
should be required or permitted to be declared on the Nutrition Facts 
label. Applying this current thinking, in section II, we are proposing 
the mandatory declaration of certain non-statutory nutrients, voluntary 
declaration of others, and proposing to remove the mandatory 
declaration of another nutrient. For purposes of this proposed rule, we 
use the term ``nutrient'' to refer to

[[Page 11890]]

substances that are currently included or that we are considering for 
inclusion on the Nutrition Facts label, including carbohydrate, fat, 
and protein and their subcomponents (e.g., added sugars, sugar 
alcohols, saturated fat), micronutrients (vitamins and minerals), and 
to calories, including calories from fat.
1. Factors Considered
    We updated the information that we consider for determining whether 
the declaration of a non-statutory nutrient should be mandatory or 
voluntary. This update responds to several developments. Since the 1993 
nutrient content final rule was published, (1) new scientific data have 
provided additional evidence of the role of certain nutrients in 
chronic disease risk, health-related conditions, or health-related 
physiological endpoints and, in some cases, based on the review of this 
evidence, DRIs are now available from the IOM that can be used as 
quantitative intake recommendations (i.e., RDA and AI), as well as for 
assessing the inadequacy and adequacy of essential vitamins and 
minerals in the U.S. population (i.e., EAR and AI); (2) the rates of 
certain diseases or health-related conditions have either changed or 
remained high; and (3) the process for evaluating the relationship 
between a nutrient and chronic disease risk, a health-related 
condition, or a health-related physiological endpoint has been refined 
based on the use of systematic evidence-based reviews for a number of 
nutrients (e.g., 2010 DGA, FDA health claims).
    We continue to be mindful of past factors we considered as part of 
our deliberations related to the Nutrition Facts label, such as the 
number of nutrients that could be listed in nutrition labeling, that 
some individuals could interpret a long list of nutrients as implying 
that a food has greater nutritional significance than is the case, and 
that there is limited space for nutrition information on the label (55 
FR 29487 at 29493; July 19 1990).
    To help us determine whether a non-statutory nutrient should be a 
required or permitted declaration, we are considering the same general 
types of information used in 1993 when the nutrient content final rule 
was published: (1) Existence of quantitative intake recommendations; 
and (2) public health significance. We discuss each of these factors in 
greater detail in this document.
    a. Quantitative Intake Recommendations--Quantitative intake 
recommendations are reference intake levels provided in consensus 
reports that can be used to set a DRV or RDI. We expect these consensus 
reports to be published for the purpose of setting quantitative intake 
recommendations (e.g., the IOM DRI reports). If DRIs are not available 
for nutrients, other than essential vitamins and minerals, then we 
consider science-based recommendations from other U.S. consensus 
reports or the DGA policy reports. Such recommendations may be 
identified as a conclusion, key recommendation, or reported in the 
executive summary of the consensus report.
    b. Public Health Significance--For the purposes of nutrition 
labeling of foods and dietary supplements, we consider public health 
significance to refer to two elements. First we consider whether there 
is evidence of a relationship between the nutrient and a chronic 
disease, health-related condition, or health-related physiological 
endpoint. This can be demonstrated either by well-established evidence 
or, for essential vitamins and minerals, recommendations regarding the 
health consequences of inadequacy of the nutrient. Second we consider 
whether there is evidence of a problem related to health in the general 
U.S. population. This needs to be demonstrated by both evidence of a 
problem with the intake of the nutrient in the general U.S. population 
and evidence of the prevalence of the chronic disease, health-related 
condition, or health-related physiological endpoint that is linked to 
that nutrient in the general U.S. population. We consider public health 
significance to refer to the following: (1) Existence of ``well-
established'' scientific evidence from U.S. consensus reports that 
there is a relationship between a nutrient and chronic disease risk, a 
health-related condition, or a health-related physiological endpoint 
and where the intake of such nutrient is of general importance in the 
general U.S. population, e.g., where intakes are generally too low or 
too high among the U.S. population. U.S. consensus reports are those 
reports that provide consensus conclusions or recommendations by a 
group of experts as requested by U.S. Government Agencies (e.g., IOM 
reports, the DGAs, National Institutes of Health (NIH) consensus 
reports). We generally consider scientific evidence to be ``well-
established'' when such consensus reports have determined the evidence 
to be ``conclusive,'' ``documented,'' or ``strong.'' Evidence that 
meets the significant scientific agreement standard in section 
403(r)(3)(B)(i) of the FD&C Act in support of those nutrients and 
disease or health-related conditions for which we have authorized a 
health claim would be considered ``well-established'' evidence for the 
purposes of what public health significance refers to in this proposed 
rule; or (2) nutrients for which there are DRIs set by the IOM (i.e., 
RDA or AI) that are based on chronic disease risk (e.g., osteoporosis), 
a health-related condition (e.g., blood pressure) or a nutrient 
deficiency with clinical significance (e.g., low iron storage leading 
to iron deficiency anemia) for which inadequate intakes of these 
nutrients are likely to have important clinical consequences. The 
nutrients for which this may occur are essential vitamins and minerals; 
and (3) for all nutrients, there is evidence of inadequate or excess 
intake of the nutrient based on national nutritional survey data or 
U.S. consensus reports, and that a substantial prevalence exists in the 
general U.S. population of the chronic disease, health-related 
condition, or health-related physiological endpoint that was linked to 
the particular nutrient (e.g., soluble fiber and coronary heart disease 
(CHD) risk, calcium and risk of osteoporosis). Because we remain 
concerned about the large number of nutrients that could be listed as 
mandatory or voluntary, for essential vitamins and minerals, we are 
proposing for mandatory declaration, those for which inadequacy has the 
greatest impact on public health because of their association with a 
risk of chronic disease, a health-related condition, or a nutrient 
deficiency with clinical significance (e.g., iron deficiency anemia).
    The methods used in the evaluation of public health significance of 
essential vitamins and minerals are discussed in greater detail in 
section II.H. and the accompanying reference document (Ref. 48).
2. Approach for Mandatory Declaration
    In general, we continue to consider mandatory declaration 
appropriate when there is public health significance and a quantitative 
intake recommendation that can be used for setting a DV (DRV or RDI). 
However, we have also considered mandatory declaration based, in part, 
on evidence highlighting the role of a nutrient in chronic disease 
risk. For example, in 2003, we published a final rule requiring trans 
fat declaration on the Nutrition Facts label (68 FR 41434). We 
considered data and information related to the risk of coronary heart 
disease from consumption of trans fat. In addition, we considered the 
public health significance of trans fat intake

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based on consensus reports and federal policy statements.
    Information related to nutrient intake and its effect on health is 
not static. Recommendations from various scientific bodies of the U.S. 
Government that are responsible for public health protection or 
research directly relating to human nutrition may change or evolve over 
time. We include, as part of our review of nutrient information in this 
proposed rule, the current recommendations from such scientific bodies. 
In section D.3, we specifically consider recommendations from the 2010 
DGA related to the intake of added sugars in the diet and the role of 
such information in assisting consumers to maintain healthy dietary 
practices. Our review is not based on the factors we have traditionally 
considered for mandatory declaration that are related to chronic 
disease, health-related condition, or health-related physiological 
endpoint linked to the particular nutrient. Instead, our review is 
based on the need for nutrient information for consumers to implement 
key dietary recommendations to assist consumers to maintain healthy 
dietary practices and the need for consumers to be able to readily 
observe and comprehend the information and to understand its relative 
significance in the context of a total daily diet.
3. Approach for Voluntary Declaration
    For nutrients that are not essential vitamins and minerals (e.g., 
fluoride, soluble and insoluble fiber, monounsaturated fatty acids and 
polyunsaturated fatty acids), we consider voluntary declaration to be 
appropriate when the nutrient either has a quantitative intake 
recommendation but does not have public health significance, or does 
not have a quantitative intake recommendation available for setting a 
DRV but has public health significance. In addition, we consider that 
voluntary declaration should be permitted for essential vitamins or 
minerals that we determine do not fit within our considerations for 
mandatory declaration, but that have an RDI.
    We invite comment on the factors for considering mandatory and 
voluntary declaration of non-statutory nutrients.

II. The Proposed Rule

    In this proposed rule, we address issues related to the information 
declared on the Nutrition Facts label, i.e., declaration of nutrients, 
definitions, analytical methods, RDIs and DRVs, format, and compliance 
with declared values. Sections II.A. through II.E. discuss issues 
related to calories and macronutrients (including fat, fatty acids, 
cholesterol, carbohydrates, sugars, fiber, and protein), whereas 
sections II.F. through II.J. discuss issues related to vitamins and 
minerals, and sections II.K. and II.L. discuss nutrition labeling 
requirements applicable to certain population subgroups and dietary 
supplements, respectively. Section II.M. covers issues related to the 
format of the Nutrition Facts label, followed by section II.N., which 
focuses on provisions related to compliance and verification. Finally, 
section II.O. describes technical amendments to existing provisions in 
Sec.  101.9.
    As discussed in this document, our evaluation of these issues was 
informed by current scientific evidence, dietary recommendations, and 
conclusions of current consensus reports. We took into account any 
related requests from petitioners and public comments.

A. Calories

    Section 403(q)(1)(C) of the FD&C Act requires the declaration of 
the total number of calories derived from any source. Correspondingly, 
FDA regulations require the total caloric content of a food to be 
declared on the Nutrition Facts label (Sec.  101.9(c)(1)). We are not 
proposing to modify the requirement to declare total calories. However, 
we are reconsidering a number of other requirements related to the 
declaration of information about calories. The requirements related to 
``Calories from fat,'' ``Calories from saturated fat,'' the 2,000 
reference calorie intake level, and a percent DV for calories are 
discussed in section II.A., whereas requirements related to prominence 
of the calorie declaration and the footnote statement and table of DVs 
for 2,000 and 2,500 calorie diets are discussed in section II.M.
1. Calories From Fat
    The declaration of ``Calories from fat'' is mandatory (Sec.  
101.9(c)(1)(ii)). Section 403(q)(1)(C)(ii) of the FD&C Act requires 
total calories from fat to be declared on the label or labeling of 
food. Section 403(q)(2)(B) of the FD&C Act provides the Secretary of 
Health and Human Services (and by delegation, FDA) with discretion to 
remove the requirement by regulation if the Secretary determines that 
it is not necessary to assist consumers in maintaining healthy dietary 
practices. We reviewed current scientific evidence and recommendations 
in current consensus reports in determining whether information on 
calories from fat is necessary to assist consumers in maintaining 
healthy dietary practices. We also considered comments (Ref. 47) to the 
2005 and 2007 ANPRMs, in which we requested comment on various 
questions related to ``Calories from fat'' declared on the Nutrition 
Facts label. Unlike dietary recommendations that we relied on during 
the 1993 rulemaking, current dietary recommendations no longer 
emphasize total fat. Certain fatty acids are understood to be 
beneficial, while others are understood to have negative health 
effects, particularly related to cardiovascular disease (Refs. 6, 36, 
and 49). Accordingly, the 2005 DGA shifted its focus from total fat 
reduction to reduction in certain types of fatty acids and their 
influence on the risk of cardiovascular disease (Ref. 36). The 2002 IOM 
Macronutrient Report (Ref. 49) set an AMDR for total fat at 20 to 35 
percent of calories, recognizing that there were some benefits to 
consuming moderate amounts of fat (Ref. 49). The 2002 IOM Macronutrient 
Report and the 2010 DGA (Refs. 6 and 49) concluded that the type of fat 
consumed was more relevant in reducing the risk of CHD than overall 
total fat intake.
    Based on the these dietary recommendations and consensus reports 
that emphasize intake of total calories and the type of fat consumed, 
as well as comments to the 2005 and 2007 ANPRMs that supported 
eliminating the declaration of ``Calories from fat'' in order to place 
greater emphasis on total calories (Ref. 47), we tentatively conclude 
that declaration of ``Calories from fat'' is not necessary to assist 
consumers in maintaining healthy dietary practices. Therefore, we are 
proposing to no longer require, and to not allow voluntarily, the 
declaration of ``Calories from fat'' on the Nutrition Facts label. 
While eliminating the declaration of ``Calories from fat'' may appear 
to be a loss of information on the amount of fat being consumed, as 
some comments suggested, the amount of fat being consumed can still be 
obtained from the total fat declaration elsewhere on the Nutrition 
Facts label, and consumers can still use the percent DV for total fat 
to put fat content in the context of a total daily diet, compare 
products, and plan diets. Therefore, we are proposing to remove current 
Sec.  101.9(c)(1)(ii) to remove the requirement for declaration of 
calories from fat (and redesignate Sec.  101.9(c)(1)(iii) as proposed 
Sec.  101.9(c)(1)(ii)). We invite comment on the tentative conclusion 
to no longer require, and to not allow voluntarily the declaration of 
``Calories from fat'' on the Nutrition Facts label.

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2. Calories From Saturated Fat
    The declaration of ``Calories from saturated fat'' is voluntary 
(Sec.  101.9(c)(1)(iii)). The 2010 DGA continues to recommend that 
Americans should consume less than 10 percent of calories from 
saturated fat (Ref. 6). Saturated fat is known to increase the risk of 
cardiovascular disease and, unlike ``Calories from fat,'' which could 
include calories attributable to fatty acids that decrease or increase 
the risk of certain diseases, ``Calories from saturated fat'' would 
provide information about calories from a source known to increase 
disease risk (Ref. 49). We considered the recommendations in current 
consensus reports as well as the comments (Ref. 47) received in 
response to the 2007 ANPRM requesting comment on whether the 
declaration of ``Calories from saturated fat'' should continue to be 
voluntary or whether it should be mandatory.
    Based on the recommendations in current consensus reports and 
supported by many comments, we tentatively conclude that mandatory 
declaration of ``Calories from saturated fat'' is not necessary because 
the amount of saturated fat being consumed can still be obtained from 
the total saturated fat declaration elsewhere on the Nutrition Facts 
label. Additionally, as with total fat, consumers can still use the 
percent DV for saturated fat to put saturated fat content in the 
context of a total daily diet, compare products, and plan diets. 
However, because there is strong evidence associating higher intakes of 
saturated fat with higher low-density lipoprotein (LDL) cholesterol 
levels, information on ``Calories from saturated fat'' can assist 
consumers in maintaining healthy dietary practices. Therefore, we are 
not proposing to change the current voluntary labeling of ``Calories 
from saturated fat'' in the Nutrition Facts label as specified in Sec.  
101.9(c)(1)(iii). However, considering our proposal to eliminate the 
declaration of ``Calories from fat'' on the Nutrition Facts label (see 
section II.A.1.), we are proposing to revise Sec.  101.9(c)(1)(iii) and 
(d)(5) to specify that the statement ``Calories from saturated fat,'' 
when declared, must be indented under the statement of calories. In 
addition, we are proposing to redesignate Sec.  101.9(c)(1)(iii) as 
proposed Sec.  101.9(c)(1)(ii).
3. Two Thousand Calories as the Reference Caloric Intake Level
    Per FDA regulations, a reference calorie intake level of 2,000 
calories is used to set DRVs for total fat, saturated fat, total 
carbohydrate, protein, and dietary fiber (Sec.  101.9(c)(9)). In 
addition, we require a footnote on the Nutrition Facts label that 
states, ``Percent Daily Values are based on a 2,000 calorie diet. Your 
daily values may be higher or lower depending on your calorie needs,'' 
followed by a table with certain DVs based on 2,000 and 2,500 calorie 
diets (Sec.  101.9(c)(9)). In reconsidering the 2,000 calories 
reference intake level, we considered relevant recommendations from the 
IOM macronutrient report that provided estimated energy requirements 
(EERs) and the IOM Labeling Report (Refs. 25 and 50). We also 
considered comments (Ref. 47) received in response to the 2007 ANPRM, 
in which we asked whether 2,000 calories should continue to be used as 
the reference calorie intake level and asked questions related to the 
use of the EERs.
    An EER is a DRI set by the IOM for energy intake and is defined as 
the dietary energy intake that is predicted to maintain energy balance 
in a healthy adult of defined age, gender, weight, height, and level of 
physical activity consistent with good health. The IOM set EERs for all 
life-stage and gender groups and based these EERs on normal weight 
individuals (i.e., BMI < 25) (Ref. 50). The IOM Labeling Committee 
considered whether there was a basis to use the EERs for developing a 
new reference calorie intake level for macronutrients in nutrition 
labeling. The IOM Labeling Committee noted that using the EER to derive 
a reference calorie intake level would require making assumptions about 
height, weight, and physical activity level. Furthermore, the equations 
used to calculate the EERs were based on normal weight individuals; 
however, the American population has a high prevalence of overweight 
and obesity. Thus, the IOM Labeling Committee found that the data 
necessary to use the EER concept as the basis for a reference calorie 
intake level for nutrition labeling were incomplete and it could not 
recommend the approach (Ref. 25). The IOM Labeling Committee concluded 
that retaining the current 2,000 reference calorie intake level would 
be the best approach as it would provide continuity and would not 
encourage higher calorie intake and overconsumption of energy (Ref. 
25).
    We agree with the IOM Labeling Report and comments in response to 
the 2007 ANPRM (Ref. 47) that the EERs do not provide an appropriate 
basis for the derivation of a reference calorie intake level for the 
purpose of nutrition labeling. The EERs are influenced by various 
parameters such as age, gender, height, weight, and physical activity 
level (PAL), which makes it challenging to combine the EERs into a 
single reference calorie intake level applicable to the general 
population. Further, all of the comments supported the use of the 2,000 
calorie reference intake level.
    Therefore, we are not proposing any changes to the current use of 
2,000 reference calorie intake level as the basis for setting DRVs for 
total fat, saturated fat, total carbohydrate, dietary fiber, and 
protein, as specified in Sec.  101.9(c)(9).
4. Percent DV Declaration for Calories
    Current regulations do not provide for a DRV for calories. Setting 
a DRV for calories would necessitate the determination of a 
quantitative intake recommendation for calories. To determine an 
appropriate DRV for calories, we reviewed recommendations in current 
consensus reports. We also considered comments (Ref. 47) received in 
response to the 2005 and 2007 ANPRMs, in which we asked whether 
providing a percent DV disclosure for total calories would assist 
consumers in understanding the caloric content of the packaged food in 
the context of a 2,000 calorie diet. The IOM macronutrient report is 
the most recent consensus report that provides quantitative intake 
recommendations for calories (Ref. 50), and those quantitative intake 
recommendations are the EERs. For the same reasons that EERs are not 
appropriate for setting the reference calorie intake level as described 
previously, these EERs are not appropriate for setting a DV for 
calories. First, the EERs do not apply to overweight individuals, and 
are therefore not applicable to a substantial portion of the general 
population. Second, combining the EERs into a single, meaningful 
reference value is challenging because they vary by age, gender, 
height, weight, and PAL. In addition, DRVs were established for those 
nutrients that are important in diet and health interrelationships and/
or based on caloric intake (55 FR 29476 at 29479; July 19, 1990). 
Accordingly, most of the DRVs have been based on quantitative intake 
recommendations associated with chronic disease risk or a health-
related condition (e.g., total fat, saturated fat, cholesterol, and 
dietary fiber). In contrast, the EERs are neither associated with 
chronic disease risk or a health-related condition, nor are they 
intended to be treated as a single recommended value that can be 
applied to the general U.S. population. Thus, we tentatively conclude 
that there is no appropriate quantitative intake recommendation and we 
are not aware of any other data or information on which a DRV for 
calories can be determined. Although a majority of

[[Page 11893]]

comments to the ANPRMs supported the addition of a percent DV for total 
calories, we are not persuaded to propose to require or permit such 
declaration due to the lack of an appropriate quantitative intake 
recommendation or other data or information on which FDA could rely to 
establish a DRV for calories. We invite comment on the tentative 
conclusion not to establish a DRV for calories and include a percent DV 
for the declaration of calories.
    Therefore, we are not proposing to set a DRV for calories and, as a 
result, a percent DV declaration for calories would be neither required 
nor permitted.

B. Fat

    In section II.B., we discuss considerations related to definitions, 
declaration, and DRVs for total fat, saturated fat, trans fat, 
monounsaturated fat, and polyunsaturated fat.
1. Total Fat
    a. Definition--FDA defines ``fat, total'' or ``total fat'' in Sec.  
101.9(c)(2) as a statement of the number of g of total fat in a serving 
defined as total lipid fatty acids and expressed as triglycerides.
    In 1997, we received a citizen petition from Nabisco, Inc. (Docket 
No. FDA-1997-P-0476) requesting that FDA amend the definitions of 
``total fat'' and ``saturated fat'' in its food labeling regulations to 
clarify that acetic, propionic, and butyric acids may be excluded when 
calculating the amount of fat in a food product (http://www.regulations.gov/# !docketDetail;D=FDA-1997-P-0476). The 
petitioner's requests related to the definition and labeling of total 
fat are presented here and the petitioner's requests related to the 
definition of saturated fat are discussed in section II.B.2.
    With respect to total fat, the petitioner requested that we amend 
Sec.  101.9(c)(2) to read as follows: ``Fat, total'' or ``Total fat'': 
A statement of the number of g of total fat in a serving defined as 
total lipid fatty acids, excluding acetic (C:2), propionic (C:3), and 
butyric (C:4) acids and expressed as triglycerides . . .'' The 
petitioner stated that acetic, propionic, and butyric acids (``the 
acids''), which have very short two, three, and four carbon chains, 
respectively, are organic acids that should not be considered fatty 
acids for food labeling purposes for the following reasons: (1) The 
acids are chemically different from fatty acids because they are water 
soluble; (2) the digestion and absorption of the acids are distinctly 
different from those of fatty acids; (3) the acids are metabolized 
differently than fatty acids and are biochemically and physiologically 
more closely related to carbohydrates than to fat; and (4) the acids do 
not cause the adverse health effects associated with fat and may even 
have benefits that make them distinct from fat. The petitioner noted 
that excluding the acids from the definition of fat would not affect 
current labeling practices because they are found in such small amounts 
in the food supply. In addition, the petitioner asserted that 
analytical methods would not be affected because approved AOAC methods 
for total fat measurement do not detect the acids.
    We disagree with the petitioner that the acids are chemically 
different from fatty acids because they are water soluble and that 
insolubility in water is the essential chemical property of a fat. 
Fatty acids are monocarbonic acids with chain lengths between 1 and 
nearly 30 carbon atoms (Ref. 51). The chain length of a fatty acid 
determines its physical properties (Ref. 51). Short-chain fatty acids 
are compounds that are soluble in water. As the chain length increases, 
water-solubility decreases (Ref. 51). Short chain acids such as acetic, 
propionic, and butyric acids are still considered fatty acids although 
they are water soluble. Furthermore, the characteristic feature of a 
fatty acid is a terminal carboxyl group attached to a chain of alkyl 
groups containing carbon atoms of which these short chain acids are 
composed (Ref. 52).
    We determine the amount of the major macronutrients (carbohydrate, 
fat, and protein) in a food product by their chemical composition. We 
tentatively conclude that the petitioner did not provide a scientific 
basis on which we could rely to propose to exclude acetic, propionic, 
and butyric acids from the definition of total fat based on differences 
in chemical composition. Moreover, the petitioner did not explain why 
we should define total fat based on physiological differences 
identified for such fatty acids compared to other fatty acids, even if 
true, and not retain our current approach to define total fat based on 
chemical composition. Therefore, we are not proposing any changes to 
the current definition of ``total fat.'' We request comment on our 
tentative conclusion that acetic, propionic, and butyric acids should 
not be excluded from the definition of ``total fat.''
    To clarify what we consider to be a fatty acid, we are proposing to 
define ``fatty acids'' in Sec.  101.9(c)(2) as ``aliphatic carboxylic 
acids consisting of a chain of akyl groups and characterized by a 
terminal carboxyl group.'' This definition is consistent with other 
similar definitions found in nutrition and chemistry references (Refs. 
51 to 54). We request comment on the proposed definition of fatty 
acids.
    b. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act 
requires the declaration of the amount of total fat on food labels. 
Consequently, the Nutrition Facts label includes the mandatory 
declaration of the gram amount for total fat in Sec.  101.9(c)(2).
    The 2010 DGA recognizes that the types of fatty acids consumed are 
more important in influencing the risk of CVD than the total amount of 
fat in the diet (Ref. 6). Current dietary recommendations and clinical 
guidelines encourage replacing saturated and trans fatty acids with 
beneficial fats, such as polyunsaturated and monounsaturated fatty 
acids (Refs. 6 and 55). A high intake of most types of saturated fatty 
acids, trans fatty acids, and cholesterol can increase LDL cholesterol 
levels, which in turn may increase the risk of CHD (Ref. 49). While 
there is a significant amount of evidence showing that a diet high in 
saturated or trans fatty acids may be detrimental to health, there is 
also evidence that consumption of less than 20 percent of calories from 
fat can lead to an increased risk of insufficient intake of vitamin E 
and essential fatty acids (Ref. 49). In addition, consumption of a low 
fat diet that is high in carbohydrate can lead to a reduction in high 
density lipoprotein cholesterol concentration and an increase in blood 
triglycerides, which can result in an increased risk of CHD (Ref. 49).
    We concur with the 2010 DGA that consuming a diet low in saturated 
fatty acids and cholesterol is more important for reducing CVD risk 
than consuming a diet low in total fat. This finding is consistent with 
the conclusions in the IOM Macronutrient Report (Ref. 49), as well as 
with current practice guidelines such as the National Heart, Lung, and 
Blood Institute (NHLBI) Third Report of the Expert Panel on Detection, 
Evaluation, and Treatment of High Blood Cholesterol in Adults (Ref. 
55). Total fat is a calorie-yielding macronutrient and an important 
piece of the macronutrient profile of a food. However, consumption of 
inadequate amounts of total fat is also associated with an increased 
risk of impaired growth and consumption of excessive amounts of total 
fat is associated with an increased risk of chronic diseases, such as 
CHD and diabetes (Ref. 49). In addition, the IOM noted that high fat 
diets are usually accompanied by increased intakes of saturated fatty 
acids which can increase the risk of CHD (Ref. 49). Thus, we 
tentatively conclude that

[[Page 11894]]

mandatory declaration of total fat on the Nutrition Facts label 
continues to be necessary to assist consumers in maintaining healthy 
dietary practices. Therefore, we are not proposing any changes to the 
current requirement for mandatory declaration of total fat on the 
Nutrition Facts label.
    c. DRV--The DRV for total fat is 30 percent of calories (65 g/d) 
(Sec.  101.9 (c)(9)). In developing the DRIs for various nutrients, the 
IOM cited a lack of data sufficient to determine a defined level of fat 
intake at which no risk of inadequacy or prevention of chronic disease 
occurs, and therefore, decided to establish neither an AI nor an RDA 
for total fat (Ref. 49). Instead, the IOM established an AMDR for total 
fat intake of 20 to 35 percent of energy for adults and an AMDR of 25 
to 35 percent of energy for children age 4 to 18 years. The AMDRs are 
associated with reduced risk of chronic diseases, such as CHD, while 
providing for adequate intake of essential nutrients. The 2010 DGA 
acknowledged the IOM's AMDR and noted that total fat intake should fall 
within the AMDRs set by the IOM (Ref. 6). The IOM Labeling Committee 
recommended that AMDRs should be the basis for DVs for protein, total 
carbohydrate, and total fat (72 FR 62149 at 62164). Accordingly, for 
total fat, the IOM Labeling Committee recommended a population-weighted 
midpoint of the AMDR since AMDRs vary with age. A population-weighted 
mid-point of the AMDR for adults, i.e., 20 to 35 percent, yields a DRV 
of 28 percent or 62 g of total fat. The use of the upper level (35 
percent of energy) of the AMDR would increase the DRV from 65 g to 78 g 
for a 2,000 calorie diet.
    Considering the recommendations of the IOM Labeling Committee, we 
requested comment, in the 2007 ANPRM, on: (1) Whether a population-
weighted midpoint of the AMDR (e.g., 28 percent for adults) should be 
used, as suggested in the IOM Labeling Report and (2) whether the upper 
level of AMDR of 35 percent (78 g) should be used.
    We reviewed the IOM Labeling Committee's recommendations, IOM DRIs, 
and comments in response to the 2007 ANPRM (Ref. 47). We tentatively 
conclude that changing the DRV for total fat to the lower end of 20 
percent of 2,000 calories would not be appropriate because: (1) It 
would not be appropriate for children 4 to 18 years of age because it 
falls below the lower end of the AMDR (i.e., 25 to 35 percent of 
energy) and (2) scientific evidence supports consumption of greater 
than 20 percent of total calories from total fat for reduction in risk 
of chronic diseases, such as CHD and diabetes (Ref. 49).
    We also conclude that the upper level of the AMDR of 35 percent of 
2,000 calories as the basis for a DRV would provide no meaningful 
health benefit and that a population-weighted mid-point of 28 percent 
of the AMDR (28 percent of calories) as the basis for the DRV is not 
significantly different from a public health outcome standpoint than 
the current value of 30 percent of calories. Using the population-
weighted AMDR midpoint approach would result in an insignificant 
reduction from the DRV of 65 g (rounded from 30 percent of a 2,000 
calorie diet) to 60 g (rounded from 28 percent of calories), which may 
imply a greater level of precision in a DRV than is actually true.
    Furthermore, the DRV for total fat is linked to the DRVs for total 
carbohydrate and protein. For reasons discussed in sections II.D. and 
II.E., we are not proposing to change the DRVs for carbohydrate or 
protein at this time. Because the DRV for carbohydrate is determined by 
difference, an increase in the DRV for fat would result in a decrease 
in the DRV for carbohydrate.
    The DRV of 30 percent of calories fits within the AMDR and 
represents a moderate value that is not close to the upper or lower 
levels of the AMDR. A majority of comments supported maintaining the 
current DRV of 30 percent of calories. As noted previously, the DRV for 
total fat was calculated based on a 2,000 reference calorie intake and 
the dietary recommendation for fat intake at the time of 30 percent or 
less of total caloric intake, amounting to 66.7 g of fat, which was 
rounded down to 65 g. Current dietary recommendations for fat intake 
provide a range of acceptable intakes (i.e., between 20 and 35 percent 
of caloric intake) and encompass the 30 percent value that formed the 
basis for the existing DRV. Therefore, we are not proposing any changes 
to the current DRV for total fat of 30 percent of calories.
2. Saturated Fat
    a. Definition--FDA regulations define ``Saturated fat'' in Sec.  
101.9(c)(2)(i) as the sum of all fatty acids containing no double 
bonds. We received a citizen petition from the American Cocoa Research 
Institute on April 3, 1996 (Docket No. FDA-1996-P-0035) requesting that 
the Agency exclude stearic acid from the definition of saturated fat 
because the petitioner claimed that stearic acid does not raise LDL-
cholesterol levels or the risk of CHD (http://www.regulations.gov/# 
!docketDetail;D=FDA-1996-P-0035). In the 2007 ANPRM, we did not seek 
comments on the definition of saturated fat, but received a few 
comments that requested excluding stearic acid from the definition of 
saturated fat or permitting a separate listing for stearic acid below 
the line for saturated fat (Ref. 47).
    We considered the comments to the 2007 ANPRM and the request by the 
American Cocoa Research Institute petition, and do not agree that 
stearic acid should be excluded from the definition of saturated fat. 
While there is evidence that there are potential differences in the 
physiological effects of different saturated fatty acids, including on 
LDL cholesterol levels, the definitions of nutrients for food labeling 
purposes have traditionally been based on chemical definitions, rather 
than on individual physiological effects. The definition for saturated 
fat in Sec.  101.9(c)(2)(i) includes all fatty acids without double 
bonds and the accepted analytical methods capture all of the saturated 
fatty acids, including stearic acid. In adopting this definition, we 
addressed the issue of inclusion/exclusion of individual saturated 
fatty acids and determined that a chemical definition (which includes 
all fatty acids containing no double bonds) was the appropriate 
approach to define saturated fat (58 FR 2079 at 2088). We further note 
that the 2010 DGA recommendation related to saturated fat intake is 
based on scientific evidence related to the intake of all saturated 
fatty acids combined, which includes stearic acid. The DGA 
recommendation to consume less than 10 percent of calories from 
saturated fatty acids makes no specific exclusion of stearic acid and, 
instead, relates to the intake of total saturated fatty acids (Ref. 6). 
There are no quantitative intake recommendations for stearic acid.
    The inclusion of stearic acid in the definition of saturated fat is 
consistent with our overall approach to rely on chemical definitions of 
nutrients as the basis for regulatory definitions for food labeling 
purposes. The American Cocoa Research Institute petition did not 
provide a basis for why we should deviate from this overall approach to 
rely on the chemical definition of nutrient as a basis for a regulatory 
definition. Thus, we are not proposing to exclude stearic acid from the 
definition of saturated fat.
    Finally, we also considered voluntary declaration of stearic acid 
on the Nutrition Facts label, as recommended by a few comments. The 
effects of stearic acid on LDL cholesterol levels appear to vary 
depending on the macronutrient component that is replaced by stearic 
acid (Ref. 30).

[[Page 11895]]

Moderate evidence indicates that when stearic acid substitutes for 
other saturated fatty acids or trans fat, plasma LDL cholesterol levels 
decrease whereas when it replaces monounsaturated or polyunsaturated 
fatty acids, LDL cholesterol levels increase (Ref. 30). Considering 
such scientific data, the 2010 DGAC concluded that the potential 
effects of changes in dietary intake of stearic acid on the risk of CVD 
remain unclear. Thus, the evidence for a role of stearic acid in human 
health (e.g., changes in plasma LDL cholesterol levels) is not well-
established. Furthermore, there is no quantitative intake 
recommendation available for stearic acid. Therefore, we tentatively 
conclude that the individual declaration of stearic acid is not 
necessary to assist consumers in maintaining health dietary practices, 
consistent with the factors we consider, discussed in section I.C., and 
therefore the declaration would not be permitted on the Nutrition Facts 
label.
    As discussed in section II.B.1., we received a citizen petition 
from Nabisco, Inc. on May 7, 1997 (Docket No. FDA-1997-P-0476) 
requesting that FDA amend the definitions of ``total fat'' and 
``saturated fat'' in its food labeling regulations to exclude acetic, 
propionic, and butyric acids (http://www.regulations.gov/# 
!docketDetail;D=FDA-19970-P-0476). With respect to saturated fat, the 
petition requested that FDA amend Sec.  101.9(c)(2) to read as follows: 
(i) ``Saturated fat,'' or ``Saturated'': A statement of the number of g 
of saturated fat in a serving defined as the sum of all fatty acids, 
excluding acetic (C:2), propionic (C:3), and butyric (C:4) acids, 
containing no double bonds.'' For the same reasons discussed in section 
II.B.1. regarding total fat, we are not proposing to exclude acetic, 
propionic, and butyric acids from the definition of saturated fat.
    b. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act 
requires the declaration of the amount of saturated fat on food labels. 
Accordingly, FDA regulations require mandatory declaration of the gram 
amount for saturated fat (Sec.  101.9(c)(2)).
    Dietary recommendations continue to recognize the well-established 
relationship between consumption of saturated fat and its effect on 
blood cholesterol levels (Refs. 6 and 49). In addition, the 2010 DGA 
provided a quantitative intake recommendation for saturated fat. We are 
unaware of evidence to support a determination that information 
relating to saturated fat on the Nutrition Facts label is no longer 
necessary to assist consumers in maintaining healthy dietary practices. 
Therefore, we are not proposing to change the requirement for mandatory 
declaration of saturated fat on the Nutrition Facts label in Sec.  
101.9(c)(2)(i).
    c. DRV--The DRV for saturated fat is 20 g, which is 10 percent of 
calories based on a 2,000 reference calorie intake level (Sec.  
101.9(c)(9)). The IOM Labeling Committee recommended that the DV for 
saturated fatty acids (along with trans fatty acids and cholesterol) 
should be set at a level that is as low as possible in keeping with an 
achievable health-promoting diet and consistent with IOM DRIs (Ref. 
25). The IOM Labeling Committee suggested that FDA use food composition 
data, menu modeling, and data from dietary surveys to estimate minimum 
intakes that are consistent with nutritionally adequate and health-
promoting diets for diverse populations. In the 2007 ANPRM, we asked 
for public comment on (1) whether the current DRV for saturated fat of 
20 g should be retained and (2) whether food composition data, menu 
modeling, and data from dietary surveys should be used to establish a 
DRV for saturated fat that is as low as possible while consuming a 
nutritionally adequate diet. We received several comments in response 
to these questions (Ref. 47).
    Current consensus reports that reviewed scientific evidence related 
to saturated fatty acid intake continue to recommend saturated fat 
intakes of no more than 10 percent of calories, based on risk of CVD. 
Specifically, the IOM DRIs recommended that intakes of these fats 
should be as low as possible while consuming a nutritionally adequate 
diet (Ref. 49). In addition, confirming the relationship between high 
intakes of saturated fatty acids and increased risk of unhealthy blood 
lipid levels and CHD, the 2010 DGA reaffirmed the recommendation to 
reduce saturated fatty acid intake to less than 10 percent of calories 
and noted that lowering the intake even more, to 7 percent of calories, 
can further reduce the risk of CVD (Ref. 6). The 2002 report from the 
National Cholesterol Education Program of the NIH National Heart, Lung, 
and Blood Institute established saturated fat intakes of no more than 
10 percent of calories as an optimal intake level for reduction of CHD 
risk while also establishing intakes of no more than 7 percent of 
calories as a therapeutic intake level for treating CHD (Ref. 55). 
Although some comments suggested reducing the DRV to 15 g and to lower 
the DRV to 7 percent of calories, we are not persuaded to do so because 
the current saturated fatty acid recommendation of less than 10 percent 
of calories is still appropriate for the general U.S. population and 
that the existing DRV of 20 g continues to conform to current dietary 
recommendations as a maximum intake level that covers the general U.S. 
population.
    We do not consider the use of food composition data, menu modeling, 
or dietary survey data as a suitable approach to determine DRVs. We 
note that the majority of comments opposed the use of such alternative 
methods to determine the DRV for saturated fat.
    We established the current DRVs based on quantitative intake 
recommendations and underlying science on the association between 
increased intakes and either reduced risk of chronic disease (e.g., 
dietary fiber and CHD) or increased risk of chronic disease (e.g., 
saturated fat and CHD). The approach to determine DRVs using food 
composition data, menu modeling, or dietary surveys has a number of 
deficiencies. Menu modeling is an approach, based on available foods in 
the marketplace, to design a set of food items for meals, which will 
meet certain nutrient or food intake pattern recommendations (Ref. 56). 
Menu modeling, by its very nature, would not permit the selection of 
DRVs that are based on scientific evidence related to actual public 
health outcomes. Furthermore, menu modeling permits the creation of 
model menus that may be able to meet certain nutrient thresholds 
through the inclusion of foods that are not representative of the type 
or quantity of foods eaten in the U.S. population or any specific 
population and, thus, may result in nutrient intake levels that do not 
reflect typical diets and, as such, may be unachievable or 
unreasonable. The use of menu modeling can be appropriate in other 
circumstances, such as the use of modeling to determine scenarios of 
highest possible nutrient intake levels or potential nutrient profiles 
of diets. Thus, food composition data and related models can help 
provide useful information about consumption trends and the general 
nutrient content of the food supply and can serve as an additional 
consideration in choosing a reference point for daily intake that is 
realistically achievable and practical in light of the current food 
supply and consumption patterns. However, these data cannot form the 
primary scientific bases for selecting DRVs. Another challenge with the 
use of the menu modeling approach is that numerous and rapid changes to 
food formulations can make it difficult for food composition databases 
to provide current and accurate estimates of nutrient intakes. Based on 
these inherent limitations of menu modeling

[[Page 11896]]

and the data sources used, we tentatively conclude that the menu 
modeling approach, as recommended in the IOM Labeling Report, is an 
unsuitable method for determining DRVs (or RDIs). Instead, we intend to 
continue using science-based recommendations to set DRVs and RDIs. In 
the case of saturated fat, as explained previously, the existing 
scientific evidence does not support a change to the current 20 g DRV. 
Therefore, we are not proposing any changes to the current DRV of 20 g 
for saturated fat as specified in Sec.  101.9(c)(9).
3. Trans Fat
    a. Definition--FDA defines ``Trans fat'' or ``Trans'' in Sec.  
101.9(c)(2)(ii) as the sum of all unsaturated fatty acids that contain 
one or more isolated (i.e., non-conjugated) double bonds in a trans 
configuration. In the 2007 ANPRM, we did not seek public comment on the 
definition of trans fat. However, we received a comment recommending 
the exclusion of a specific trans fat isomer, vaccenic acid (18:1 t11) 
from the definition of trans fat because, according to the comment, 
unlike other trans fat isomers, vaccenic acid may not have adverse 
health effects. As discussed in the preamble to the final rule 
regarding trans fat labeling (68 FR 41434 at 41461), we defined trans 
fatty acids by their chemical structure, not their physiological 
effects or functional attributes. While the comment provided us with 
some preliminary observational data suggesting that trans fat from 
ruminant sources, such as vaccenic acid, may not have the same effects 
on CHD risk as trans fat from industrial sources, such as partially 
hydrogenated oils, we do not agree that potential differences in 
physiological effects should be the basis for determining the specific 
isomers to be included in a regulatory definition of trans fat. The 
definition for trans fat is its chemical definition which captures all 
trans fat isomers that have isolated bonds and, thus, vaccenic acid 
would be measured by the analytical method used to determine trans fat 
content of foods. This chemical definition is consistent with how 
polyunsaturated fat is defined as cis, cis-methylene-interrupted (Sec.  
101.9(c)(2)(ii)). Accordingly, we are not proposing to change the 
definition of trans fat in Sec.  101.9(c)(2)(ii).
    b. Mandatory Declaration--FDA regulations require the declaration 
of trans fat on the Nutrition Facts label (Sec.  101.9(c)(2)(ii). 
Dietary recommendations continue to recognize the well-established 
relationship between consumption of trans fat and its effect on blood 
cholesterol levels (Ref. 6). Furthermore, under section 403(r)(3)(C) of 
the FD&C Act, we did not object to a 2006 Food and Drug Administration 
Modernization Act of 1997 (FDAMA) notification for the health claim 
``Diets low in saturated fat and cholesterol, and as low as possible in 
trans fat, may reduce the risk of heart disease,'' based on statements 
made in the 2005 DGA (Ref. 57). As such, because of its role in chronic 
disease, trans fat continues to be a nutrient with public health 
significance. We are unaware of evidence to support a determination 
that information relating to trans fat on the Nutrition Facts label is 
not necessary to assist consumers in maintaining healthy dietary 
practices. We tentatively conclude that information on the amount of 
trans fat in food products allows consumers to reduce their intake of 
trans fat, and thus, reduce the risk of CHD. Therefore, we are not 
proposing any changes to the requirement for mandatory declaration of 
trans fat on the Nutrition Facts label in Sec.  101.9(c)(2)(ii). 
However the Agency recently published a tentative determination that 
partially hydrogenated oils, the source of industrially produced trans 
fat, may not be generally recognized as safe (78 FR 67169; November 8, 
2013). We request comment on whether mandatory labeling of trans fat 
would still be necessary if this determination is finalized.
    Per Sec.  101.9(c)(2)(ii), if a food contains less than 0.5 g of 
trans fat per serving, the content, when declared, is to be expressed 
as zero. We received a citizen petition from an individual on January 
17, 2007 (Docket No. FDA-2007-P-0404) which requested that FDA amend 
the definition of trans fat in its food labeling regulations to express 
the value of ``zero'' for trans fat only when there are ``absolutely no 
trans fats at all'' and require the use of a symbol (e.g., ``~'') to 
indicate when there is ``more than zero but less than 0.5g of trans fat 
per tablespoon'' (http://www.regulations.gov/# !docketDetail;D=FDA-
2007-P-0404). The petition claimed that the declaration of zero trans 
fats on the label is misleading to consumers because it does not denote 
the absence of trans fat (as ``zero'' is defined in Webster's 
Dictionary) and that people will consume a food incorrectly thinking 
that it has zero amount of trans fat. The petition stated that, because 
trans fat is associated with negative effects on heart health, this 
situation could be detrimental to people's health.
    Validated analytical methodologies that provide sensitive and 
reliable estimates of trans fatty acids in all foods at levels below 
0.5 g per serving are currently not available. For most nutrients 
declared on the nutrition label, the maximum amount permitted for a 
declaration of a zero value is governed by the limitations associated 
with analytical methods available to determine the content of a 
nutrient in a food. The analytical methods used to determine nutrient 
content for purposes of compliance are discussed in more depth in 
section II.N. The petition did not provide any information on 
alternative analytical methodologies that are more sensitive and 
reliable nor did the petition provide any evidence to support the claim 
that consumers are misled by the provisions for the declaration of zero 
trans fat. Thus, we are not proposing any changes to the requirement 
for the declaration of zero when trans fat content is less than 0.5 g 
per serving.
    c. DRV--FDA regulations do not provide a DRV for trans fat. At the 
time of the issuance of the trans fat final rule, we concurrently 
issued the 2003 ANPRM in the same issue of the Federal Register (68 FR 
41507) to solicit information and data on several trans fat labeling 
issues. In the 2007 ANPRM, we again requested comments on various 
issues related to the DV for trans fat, including the use of food 
composition data, menu modeling and data from dietary surveys, and a 
potential joint percent DV for trans fat and saturated fat. We received 
several comments in response to the 2007 ANPRM. We considered the 
recommendations in the IOM Labeling Report, available scientific 
evidence, and comments (Ref. 47) received in response to both the 2003 
and 2007 ANPRMs.
    i. Use of food composition data, menu modeling, and dietary 
surveys. FDA considered the approach recommended in the IOM Labeling 
Report to use food composition data, menu modeling, and dietary survey 
data to estimate a minimum trans fat intake within a nutritionally 
adequate diet.
    As explained previously (see section II.B.2.c.), we do not consider 
food composition data, menu modeling, or dietary survey data suitable 
for determining DRVs. Furthermore, such an approach is not linked to a 
health outcome, which we have traditionally used as a basis for 
determining DRVs. As described in the IOM macronutrient DRI report 
(Ref. 49), the IOM reviewed the evidence for trans fat and was not able 
to set a UL for trans fat, which indicates that there is insufficient 
scientific evidence from which to determine a specific level of trans 
fat intake that would likely pose no risk of adverse health effects. We 
continue to

[[Page 11897]]

adhere to the approach of determining DRVs for a nutrient based on the 
nutrient's association with specific health outcomes (e.g., LDL 
cholesterol levels).
    As an additional consideration, even if we were to use the menu 
modeling approach, it would be difficult to apply such an approach for 
trans fat. Current estimates of trans fat content in food composition 
databases are not comprehensive and do not include trans fat content 
for all foods. The levels of trans fat in foods have changed since the 
publication of the 2003 trans fat final rule, in part due to 
reformulation of foods (Ref. 58). The numerous and rapid changes to 
food formulations can make it difficult for food composition databases 
to provide current and accurate estimates of the usual intake of trans 
fat.
    Therefore, we tentatively conclude that the menu modeling approach, 
as recommended in the IOM Labeling Report, is an unsuitable method for 
determining an appropriate DRV for trans fat.
    ii. Determining a DRV. The IOM did not set a UL for trans fat in 
the DRI macronutrient report. The IOM noted that any increase in trans 
fat intake increases CHD risk but because trans fats are unavoidable in 
ordinary diets, consuming zero percent of calories would require 
significant changes in dietary intake patterns that may introduce 
undesirable effects and unknown and unquantifiable health risks (Ref. 
49). The 2005 and 2010 DGA and the FDA Food Advisory Committee (Refs. 6 
and 36) likewise could not set a definitive quantitative intake 
recommendation for trans fat. Comments generally supported a single 
trans fat DRV and a single percent DV, but noted that such levels are 
not possible based on existing science. Although some comments 
supported a joint percent DV declaration for saturated and trans fat 
combined, the majority of comments opposed it due in large part to the 
chemical and physiological differences between these fats. We will 
consider determining a DRV for trans fat, if and when scientific 
evidence and relevant dietary recommendations become available. At that 
time, we will also consider whether a single DRV specific to trans fat 
or a provision for joint DV declaration for trans fat and saturated fat 
are appropriate. Thus, we tentatively conclude that there is no basis 
for setting a DRV for trans fat and, accordingly, we are not proposing 
a DRV for trans fat, a joint DRV declaration or joint percent DV 
declaration.
4. Polyunsaturated Fat
    Polyunsaturated fats represent two general categories: n-6 and n-3 
polyunsaturated fatty acids. The most common n-6 and n-3 
polyunsaturated fatty acid in food is linoleic acid and [alpha]-
linolenic acid, respectively. Other n-3 fatty acids found in foods, 
particularly in fish, are the long chain fatty acids, eicosapentaeneoic 
acid (EPA) and docosahexaenoic acid (DHA).
    a. Voluntary Declaration--FDA regulations permit, but do not 
require, the declaration of polyunsaturated fat (defined as cis, cis-
methylene-interrupted polyunsaturated fatty acids) on the Nutrition 
Facts label (Sec.  101.9(c)(2)(iii)).
    To determine whether any changes are needed to the current 
provision for voluntary declaration, we considered recommendations of 
current U.S. consensus reports as well as comments received (Ref. 47) 
in response to the 2007 ANPRM, in which we requested comment on whether 
declaration of polyunsaturated fat should continue to be voluntary or 
made mandatory. Current dietary recommendations advise consumers to 
increase intakes of polyunsaturated fatty acids to replace saturated 
fatty acids in their diets (Ref. 6). The 2010 DGA recommends limiting 
the consumption of saturated fatty acids accompanied with replacing 
them with polyunsaturated and monounsaturated fatty acids (Ref. 6). 
However, as discussed in this document, the IOM did not set DRIs for 
total polyunsaturated fatty acids, but rather provided AIs and AMDRs 
each for two specific fatty acids, linoleic acid (an n-6 
polyunsaturated fatty acid) and [alpha]-linolenic acid (an n-3 
polyunsaturated fatty acid) based on median intakes of each fatty acid 
using NHANES data (Ref. 49).
    We acknowledge that certain polyunsaturated fatty acids are 
essential and understand the interest expressed by some comments that 
there is a need to provide information on beneficial fats. However, the 
essentiality of a nutrient is not a factor considered for the mandatory 
or voluntary labeling of non-statutory nutrients, other than essential 
vitamins and minerals (see section I.C). Although certain 
polyunsaturated fatty acids are essential, an essential fatty acid 
deficiency is basically nonexistent in the United States and, 
therefore, is not of public health significance (Ref. 49).
    A quantitative intake recommendation is not available from relevant 
U.S. consensus reports (see discussion in this document), but there is 
well-established evidence to indicate that replacing saturated fatty 
acids with polyunsaturated and monounsaturated fatty acids reduces 
blood LDL cholesterol levels and, therefore, the risk of CVD (Ref. 30). 
The prevalence of CVD in the U.S. population is substantial (Ref. 30). 
We are not proposing any changes to the requirement for mandatory 
declaration of saturated fat (see section II.B.2.). Because 
polyunsaturated fat has public health significance when it replaces 
saturated fat, consistent with the factors for voluntary declaration 
discussed in section I.C., we are proposing to continue to permit 
voluntary declaration of polyunsaturated fat, as provided in Sec.  
101.9(c)(2)(iii). We request comment about whether there is an 
appropriate alternative analysis to the application of the factors in 
section I.C. regarding the voluntary declaration of polyunsaturated 
fat.
    b. DRV--FDA regulations do not provide a DRV for polyunsaturated 
fat. The IOM did not set a DRI or AMDR for polyunsaturated fat, but 
provided AIs and AMDRs for two specific essential fatty acids, linoleic 
acid (an n-6 polyunsaturated fatty acid) and [alpha]-linolenic acid (an 
n-3 polyunsaturated fatty acid) based on median intakes of each fatty 
acid using NHANES data (Ref. 49). The AIs for linoleic acid and 
[alpha]-linolenic acid are 17 and 1.6 micrograms (mcg)/d, respectively. 
The AMDRs for linoleic acid and [alpha]-linoleic acid are 5 to 10 
percent of calories and 0.6 to 1.2 percent of calories, respectively. 
In the 2007 ANPRM, we asked: (1) Whether a DRV for total 
polyunsaturated fat should be derived based upon AIs for linoleic acid 
plus [alpha]-linolenic acid; and (2) whether a DRV for total 
polyunsaturated fat should be established using the AMDRs for n-6 and 
n-3 polyunsaturated fatty acids and, if so, should a midpoint be used. 
We received comments in response to these questions (Ref. 47).
    We are not able to set an appropriate DRV for polyunsaturated fat 
at this time given the lack of established DRIs for total 
polyunsaturated fatty acids. We do not consider that the AMDRs or AIs 
for linoleic acid and [alpha]-linolenic acid provide a sufficient basis 
on which a DRV for polyunsaturated fat could be derived. The AIs for 
linoleic and [alpha]-linolenic acid were set based on U.S. median 
intake levels because there were insufficient experimental data to set 
an RDA (Ref. 49). Similarly, the AMDRs for linoleic acid and [alpha]-
linolenic acid were based on the percent of calories needed to meet the 
AI for each fatty acid (lower range) and the percent of calories 
representing the highest intake level of each fatty acid (upper range). 
As such,

[[Page 11898]]

neither of these values provides an adequate basis on which to 
determine a DRV. For these reasons, we disagree with comments that 
supported using the sum of AIs or AMDRs to establish a DRV for total 
polyunsaturated fat.
    Therefore, we tentatively conclude that there is no appropriate 
quantitative intake recommendation to form a basis for setting a DRV 
for polyunsaturated fat. Accordingly, we are not proposing a DRV for 
polyunsaturated fat.
    c. Declaration of Individual Polyunsaturated Fatty Acids--The 
declaration of individual polyunsaturated fatty acids on the Nutrition 
Facts label is not permitted. The IOM did not set DRIs for total n-6 
and n-3 polyunsaturated fatty acids, but established AIs and AMDRs for 
two specific fatty acids, linoleic acid (an n-6 polyunsaturated fatty 
acid) and [alpha]-linolenic acid (an n-3 polyunsaturated fatty acid) 
(Ref. 49). The 2007 ANPRM asked for public comment on whether separate 
DRVs for linoleic acid and [alpha]-linolenic acid should be established 
and, if so, whether the declaration of these nutrients should be 
voluntary or made mandatory. We received comments in response to these 
questions (Ref. 47).
    Linoleic and [alpha]-linolenic acids are essential fatty acids that 
differ physiologically and compete metabolically. Based on a review of 
relevant scientific research, in 2004, FDA concluded in its qualified 
health claim review that there is supportive, but not conclusive, 
research to suggest that n-3 polyunsaturated fatty acids (EPA and DHA) 
reduce the risk of CHD (Ref. 59). Results of one clinical trial on the 
effects of EPA published since 2004 fail to demonstrate a significant 
reduction in the hazard ratio for the primary prevention of major 
coronary events (Ref. 60).
    More recently, the 2010 DGAC concluded that moderate evidence shows 
that the consumption of two servings of seafood per week, which 
provides an average of 250 mg/d of long-chain n-3 polyunsaturated fatty 
acids (i.e., EPA and DHA), is associated with reduced cardiac mortality 
from CHD or sudden deaths, both in persons with and without CVD (Ref. 
30). The DGAC also concluded that the evidence for plant-derived n-3 
polyunsaturated fatty acids (i.e., [alpha]-linolenic acid) in reducing 
mortality among persons with existing CVD is limited (Ref. 30). 
Similarly, there is no conclusive evidence for an independent role of 
n-6 polyunsaturated fatty acids in reducing blood cholesterol levels 
and, consequently, the risk of CHD. Evidence suggests that the benefit 
of n-6 polyunsaturated fatty acids is observed only as a result of a 
reduction in saturated fatty acid intake (Refs. 6 and 59). The IOM 
noted that the evidence for a role of EPA and DHA in CHD risk is 
growing (Ref. 49), but set AIs and AMDRs for [alpha]-linolenic acid, 
not for EPA or DHA.
    While a ``healthy'' n-6:n-3 ratio may be important in human health, 
such a ratio has not been defined and much of the available evidence is 
based on studies conducted in animals, infants, and patients on total 
parenteral nutrition and much of the evidence in adults has come from 
observational studies (Ref. 49).
    Because of the lack of well-established evidence for a role of n-3 
or n-6 polyunsaturated fatty acids in chronic disease risk and the lack 
of a quantitative intake recommendation, and consistent with the 
factors discussed in section I.C., we tentatively conclude that the 
declarations of n-3 and n-6 polyunsaturated fatty acids are not 
necessary to assist consumers to maintain healthy dietary practices. 
Accordingly, we are not proposing to provide for the individual 
declaration of either n-3 or n-6 polyunsaturated fatty acids on the 
Nutrition Facts label. Similarly, because of the lack of well-
established evidence for a role of EPA and DHA in chronic disease risk 
and the lack of a quantitative intake recommendation, consistent with 
the factors discussed in section I.C., we tentatively conclude that the 
declarations of EPA and DHA are not necessary to assist consumers to 
maintain healthy dietary practices. Accordingly, we are not proposing 
to provide for the mandatory or voluntary declaration of EPA or DHA on 
the Nutrition Facts label. We request comment about whether there is an 
appropriate alternative analysis to the application of the factors in 
section I.C. regarding the individual declaration of n-3 or n-6 
polyunsaturated fatty acids, as well as EPA or DHA.
5. Monounsaturated Fat
    a. Voluntary Declaration--FDA regulations currently permit, but do 
not require, the declaration of monounsaturated fat (defined as cis-
monounsaturated fatty acids (e.g., oleic acid)) on the Nutrition Facts 
label (Sec.  101.9(c)(2)(iii)). To determine whether any changes are 
needed to the provision for voluntary declaration, we considered 
recommendations in current consensus reports as well as comments 
received in response to the 2007 ANPRM (Ref. 47), in which we requested 
comment on whether declaration of monounsaturated fat should remain 
voluntary or be made mandatory.
    In 2002, the IOM noted that there was no known independent role of 
monounsaturated fatty acids in preventing chronic disease (Ref. 49). 
The lack of an independent effect of monounsaturated fatty acids on 
heart disease risk was also substantiated in a 2004 FDA review of a 
qualified health claim regarding monounsaturated fatty acids from olive 
oil and CHD (Ref. 61). Upon review of data related to this qualified 
health claim, we concluded that there was no evidence to indicate that 
monounsaturated fatty acids from olive oil, independent of saturated 
fatty acid displacement, lower serum total and LDL cholesterol levels. 
Most recently, the 2010 DGAC (Ref. 30) noted that there was strong 
evidence indicating that monounsaturated fatty acids are associated 
with improved blood lipids related to CVD when they replace saturated 
fatty acids. Consequently, the 2010 DGA recommends that most fats 
should be consumed as polyunsaturated and monounsaturated fatty acids 
(Ref. 6). Current dietary recommendations advise consumers to increase 
intakes of monounsaturated fatty acids to replace saturated fatty acids 
in their diets.
    We acknowledge that monounsaturated fatty acids are not essential 
in the diet (Ref. 49). However, a lack of essentiality is not a basis 
for determining whether a nutrient should be required to be declared 
(see section I.C.). Indeed, nonessential nutrients trans fat, saturated 
fat, and cholesterol are required to be declared on the label because 
of their public health significance. Scientific evidence points to the 
positive effects of increased monounsaturated fatty acid intake as a 
result of reduced intake of saturated fatty acids.
    While a quantitative intake recommendation is not available from 
relevant U.S. consensus reports, there is well-established evidence to 
indicate that replacing saturated fatty acids with polyunsaturated and 
monounsaturated fatty acids reduces blood LDL cholesterol levels and, 
therefore, the risk of CVD, and that the prevalence of CVD is 
substantial in the United States (Ref. 30). We are not proposing any 
changes to the current requirement for mandatory declaration of 
saturated fat (see section II.B.2.). Because monounsaturated fat has 
public health significance when it replaces saturated fat, consistent 
with the factors we consider for voluntary declaration discussed in 
section I.C., we are proposing to continue to allow for voluntary 
declaration of

[[Page 11899]]

monounsaturated fat, as provided in Sec.  101.9(c)(2)(iii). We request 
comment about whether there is an appropriate alternative analysis to 
the application of the factors in section I.C. regarding the voluntary 
declaration of monounsaturated fat.
    b. DRV--FDA regulations do not provide a DRV for monounsaturated 
fat. Current consensus reports do not provide specific quantitative 
intake recommendations for monounsaturated fatty acids. The IOM did not 
set a DRI for monounsaturated fatty acids because these fatty acids are 
not essential in the diet and have no known independent role in 
preventing chronic diseases (Ref. 49). Therefore, we tentatively 
conclude that there is no scientific basis on which we can rely to set 
a DRV for monounsaturated fat and, therefore, we are not proposing to 
set a DRV for monounsaturated fat.

C. Cholesterol

1. Mandatory Declaration
    Section 403(q)(1)(D) of the FD&C Act requires the declaration of 
the amount of cholesterol on food labels, and cholesterol content must 
be declared on the Nutrition Facts label in accordance with Sec.  
101.9(c)(3). Current dietary recommendations continue to recognize the 
well-established relationship between consumption of cholesterol and 
its effect on blood cholesterol levels, which are a surrogate endpoint 
for CHD risk (Ref. 6). In addition, the 2010 DGA provided a 
quantitative intake recommendation for cholesterol (Ref. 6) (see 
discussion in this document). Furthermore, FDA authorized a health 
claim for dietary saturated fat and cholesterol and risk of CHD, for 
which we evaluated the scientific evidence on the association between 
dietary cholesterol and serum cholesterol levels (Sec.  101.75).
    We are unaware of evidence that would support a change to the 
requirement for mandatory declaration of cholesterol on the Nutrition 
Facts label in Sec.  101.9(c)(3) and, therefore, we are not proposing 
any changes to the current requirement for mandatory declaration.
2. DRV
    FDA regulations provide a DRV for cholesterol of 300 mg (Sec.  
101.9(c)(9)). The IOM Labeling Committee recommended, based on the IOM 
DRIs, that the DV for cholesterol (along with saturated fat and trans 
fat) should be set at a level that is as low as possible in keeping 
with an achievable health-promoting diet (Ref. 25). The IOM Labeling 
Committee suggested that FDA use food composition data, menu modeling, 
and data from dietary surveys to estimate minimum intakes that are 
consistent with nutritionally adequate and health-promoting diets for 
diverse populations (Ref. 25). Acknowledging these IOM recommendations, 
in the 2007 ANPRM, we asked for public comment on (1) whether the 
current DRV for cholesterol of 300 mg should be retained; and (2) 
whether food composition data, menu modeling, and data from dietary 
surveys should be used to establish a DRV for cholesterol that is as 
low as possible while consuming a nutritionally adequate diet. We 
considered recommendations in current consensus reports as well as 
comments received (Ref. 47).
    The 2010 DGA recommends consuming less than 300 mg/d of cholesterol 
to help maintain normal blood cholesterol levels and reducing intake to 
less than 200 mg/d for individuals at high risk of CVD (Ref. 6). The 
IOM also reported a relationship between increased cholesterol intake 
and increase in serum cholesterol, a surrogate endpoint for CHD risk 
(Ref. 62). The IOM macronutrient report recommended that cholesterol 
intakes should be as low as possible while consuming a nutritionally 
adequate diet, but did not set ULs for cholesterol (Ref. 62). Based on 
the reasons set forth previously, we disagree with the comments 
suggesting that a DRV of 300 mg is too low or that there is no strong 
association between cholesterol intake and CHD risk, or that current 
science justifies eliminating the percent DV declaration.
    We do not agree with the IOM recommendation that food composition 
data, menu modeling, and data from dietary surveys offer a suitable 
approach for determining DRVs. Limitations inherent to menu modeling 
and food composition and dietary survey data sources are discussed in 
sections II.B.2.c. and II.B.3.c. We established the current DRV for 
cholesterol based on quantitative intake recommendations that 
considered specific effects on health outcomes (e.g., CHD) (58 FR 2206 
at 2217). Use of menu modeling to determine a quantitative intake 
recommendation for cholesterol is inconsistent with this approach and 
may result in a reference intake level that is not based on scientific 
evidence related to actual public health outcomes.
    Although the 2010 DGA recommends that cholesterol intake levels 
should be less than 200 mg/d for individuals at high risk of CVD, we 
consider the DGA recommendation of 300 mg/d for maintaining normal 
blood cholesterol levels as an appropriate basis for setting a DRV 
because it represents the maximum intake level that covers the general 
U.S. population 4 years of age and older. Therefore, we are not 
proposing any changes to the DRV for cholesterol of 300 mg specified in 
Sec.  101.9(c)(9).

D. Carbohydrate

    In this section, we discuss our consideration of provisions related 
to definitions, declarations, DRVs, and analytical methods for total 
carbohydrate, total sugars, added sugars, dietary fiber, soluble and 
insoluble fiber, sugar alcohols, and other carbohydrates.
1. Total Carbohydrate
    a. Calculation of Total Carbohydrate--For the purposes of the 
Nutrition Facts label, total carbohydrate content is calculated by 
subtracting the sum of protein, total fat, moisture, and ash from the 
total weight of the food (Sec.  101.9(c)(6)). This calculation method 
is called ``carbohydrate by difference'' and is described in A.L. 
Merrill and B.K. Watt, ``Energy Value of Foods--Basis and Derivation,'' 
in the USDA Handbook No. 74 (Ref. 63). Total carbohydrate includes 
starch, sugars, sugar alcohols, and dietary fiber.
    On July 8, 2004, the National Starch and Chemical Company (National 
Starch) submitted a citizen petition requesting that dietary fiber 
content be excluded from the calculation of total carbohydrate that is 
declared on the Nutrition Facts label (Docket No. FDA-2004-P-0094) 
(http://www.regulations.gov/# !docketDetail;D=FDA-2004-P-0094). The 
petition noted that consumers wishing to reduce their intake of 
carbohydrate may also be inadvertently decreasing their consumption of 
high fiber foods, such as whole grains, because dietary fiber is 
included in the definition of ``Total Carbohydrate.'' National Starch, 
therefore, requested an amendment to the second sentence in Sec.  
101.9(c)(6) to read as follows: ``Total carbohydrate content shall be 
calculated by subtraction of the sum of the crude protein, total fat, 
moisture, ash, and dietary fiber from the total weight of the food.'' 
The petition noted that excluding dietary fiber from the definition 
would be consistent with the way the IOM DRI report and Codex 
guidelines refer to carbohydrates and would be a more accurate 
representation of the amount of calories contributed by carbohydrates. 
To support this request, the petition presented study findings reported 
in the New York Times in 2004 and from research conducted on the 
Internet. In

[[Page 11900]]

addition, the petition discussed the use of the term ``net carbs'' in 
labeling and discussed inconsistencies in the way different 
manufacturers define the term ``net carbs.'' According to the petition, 
some manufacturers define ``net carbs'' as the amount of total 
carbohydrate excluding the amount of dietary fiber and sugar alcohols 
while others exclude sugar alcohols and ``other carbohydrates,'' as 
specified in Sec.  101.9(c)(6)(iv), or sugar alcohols and ``certain 
other carbohydrates.'' The petition suggested that the varied 
approaches to describing carbohydrates have led to consumer confusion.
    In the 2007 ANPRM, we asked for comment on whether the approach for 
calculating total carbohydrate by difference should be retained and, if 
not, which specific components should be included or excluded from the 
calculation of total carbohydrate. In addition, acknowledging the 2005 
DGA recommendation to consume fiber-rich foods, we asked for comment on 
whether separating dietary fiber from the amount of total carbohydrate 
would affect consumer understanding and use of the information, 
particularly with respect to fiber consumption. We received several 
comments (Ref. 47).
    We reviewed scientific evidence and considered the petition's 
requests and comments received. As explained in this document, we 
decline to change to the current method for calculating total 
carbohydrate by difference.
    Under FDA regulations, compliance with certain nutrition labeling 
requirements may be achieved by the use of an FDA-approved database 
(Sec.  101.9(g)(8)). Nutrient databases include carbohydrate values 
that are determined by difference. Changing the way carbohydrate is 
calculated would either necessitate an analogous change to the way 
carbohydrate is calculated in major nutrient databases, such as the 
USDA National Nutrient Database for Standard Reference, or would 
substantially decrease the usefulness of these databases in assisting 
manufacturers in making nutrient content declarations.
    We also considered an alternative approach of calculating total 
carbohydrates by summing individual carbohydrate measurements rather 
than calculating by difference, as suggested by a comment. There is 
variability and error that are introduced with each analytical test 
that is performed (Ref. 64). When summing the values from the various 
tests, the amount of variability and error would multiply and such an 
approach is likely to result in greater variability and error. As 
discussed in the documentation for USDA's National Nutrient Database 
for Standard Reference, Release 23, when the analyses of starch, 
sugars, sugar alcohol, and dietary fiber are performed separately, the 
result reflects the analytical variability inherent to each of those 
measurement processes (Ref. 65). Thus, such an approach does not 
provide any distinct advantage over measuring carbohydrate by 
difference.
    With respect to removal of dietary fiber from the calculation of 
total carbohydrate, we agree that the IOM provided separate DRIs for 
carbohydrate (i.e., starch and sugars) and dietary fiber. However, the 
IOM DRI Report does not provide recommendations for nutrition labeling. 
Furthermore, the report defines dietary fiber as ``non-digestible 
carbohydrates and lignin that are intrinsic and intact in plants'' 
(Ref. 66). Thus, the report acknowledges that dietary fibers, with the 
exception of lignin, are carbohydrates. As discussed in section 
II.D.5., the definition of dietary fiber adopted by Codex in 2010 
specifies that dietary fibers are carbohydrate polymers (Ref. 67). The 
Codex Guidelines on Nutrition Labeling, however, indicate that the 
nutrient declaration for carbohydrate should be ``available 
carbohydrate,'' which is the amount of dietary carbohydrate, excluding 
dietary fiber (Ref. 67).
    The petition states that the inclusion of dietary fibers in the 
calculation of total carbohydrate is not fully aligned with the Codex 
Guidelines on Nutrition Labeling. Our rationale for including dietary 
fiber in the calculation of total carbohydrate is based on what is 
considered to be a carbohydrate. To the extent the petition is 
requesting the removal of dietary fiber from the total carbohydrate 
calculation due to its physiological effects, we consider in greater 
detail in this document the classification and declaration of 
carbohydrates based on their chemical definition or their physiological 
effects. As discussed in greater detail in this document, we find that 
inclusion of dietary fiber in the determination of the label 
declaration of total carbohydrate is scientifically sound based on our 
chemical definition of total carbohydrate and the analytical methods 
used to determine carbohydrate content, as well as being consistent 
with the way subcategories of other macronutrients, such as fat, are 
listed on the Nutrition Facts label. Dietary fiber is a subset of 
carbohydrates. All dietary fibers, with the exception of lignin, are 
carbohydrate polymers. Although lignin is not a carbohydrate, it is 
tightly bound to other dietary fibers and cannot be easily isolated 
using AOAC or equivalent methods. It is, therefore, included in the 
calculation of total carbohydrate.
    Further, dietary fiber is a mandatory separate listing on the 
Nutrition Facts label. Therefore, for consumers who wish to know the 
carbohydrate content of a food that excludes dietary fiber, this 
information can be deduced by subtracting the declared amount of 
dietary fiber from the declared amount of total carbohydrate on the 
Nutrition Facts label.
    In addition, a calculation based on eliminating dietary fiber 
content from the declared value of total carbohydrate would necessitate 
calculating total carbohydrate by difference using the current method 
and then subtracting from that number the amount of dietary fiber 
obtained from separate analysis. This option presents a challenge with 
respect to the use of existing databases in the United States, which 
include dietary fiber in the calculation of total carbohydrate.
    Moreover, the petition provided no references to (and we could not 
locate) the studies identified in the petition. We have no data or 
information at this time to indicate that removal of dietary fiber from 
the declaration of total carbohydrate would promote consumption of 
dietary fiber due to lower amounts of carbohydrate contents declared in 
nutrition labeling. Finally, to the extent that the petition seeks to 
define the term ``net carbs,'' such a request is outside the scope of 
this rulemaking. In this proposed rule, we are considering whether to 
propose a change in how ``total carbohydrate'' is calculated. 
Therefore, to the extent the petitioner is requesting to remove 
``dietary fiber'' from the total carbohydrate calculation to prevent 
consumer confusion from the term ``net carb,'' we decline to change the 
calculation of total carbohydrate by difference on that basis. We 
consider the calculation and declaration of ``net carbs'' and the total 
carbohydrate calculation and declaration on the label as separate and 
distinct. The declaration of total carbohydrate is required under 
section 403(q)(1)(D) of the FD&C Act.
    For these reasons, we decline to change the method for calculating 
total carbohydrate by difference and, therefore, we are not proposing 
any changes to the method for calculating total carbohydrate by 
difference specified in Sec.  101.9(c)(6).
    b. Classification of Carbohydrates Based on a Chemical Definition 
or Physiological Effect--In the 2007 ANPRM, we asked for comment on 
whether carbohydrates should be classified and declared in nutrition 
labeling based on their chemical

[[Page 11901]]

definition (current method) or on their physiological effect (e.g., 
attenuation of blood sugar or laxation if dietary fiber were to be 
included in the total carbohydrate declaration), and whether additional 
types of carbohydrates (e.g., starch) should be listed separately on 
the Nutrition Facts label. We received several comments (Ref. 47) in 
response to these questions.
    We considered this issue in light of the comments received. We 
agree with the comments that stated that classification of 
carbohydrates based on validated analytical techniques, which isolate 
and measure the individual carbohydrates based on their chemical 
structure rather than based on their physiological effects, is 
necessary for determining the accuracy of values declared on the label. 
Carbohydrates include starch, sugars, sugar alcohols, and dietary 
fibers. Different types of carbohydrates have different physiological 
effects. The effects of some carbohydrates are not fully understood and 
are the subject of debate in the scientific community. Within the 
different types of carbohydrate (i.e., starch, sugars, sugar alcohols, 
and dietary fibers), too, specific carbohydrates may have different 
physiological effects (e.g., different types of dietary fibers) making 
it difficult to apply a definition that is based on physiological 
effects across a category of carbohydrates. Furthermore, analytical 
methods for measuring different types of carbohydrates are based on 
chemical structure rather than physiological effect. Given the various 
components of total carbohydrate and different types of physiological 
effects of each, we disagree that a definition based on ``physiological 
effects'' would be a better approach than a chemical definition for 
total carbohydrate declaration. The use of a chemical definition is 
also consistent with the classification and declaration of fat on the 
Nutrition Facts label. Different types of fats identified in nutrition 
labeling are not classified based on their physiological effect but 
rather on their chemical definition.
    Therefore, we are not proposing to use physiological effects of 
carbohydrates as a basis for classifying or declaring total 
carbohydrate. Accordingly, we are not proposing to change our 
provisions for the classification or declaration of carbohydrates 
specified in Sec.  101.9(c)(6).
    c. Separate Declaration of Additional Individual Types of 
Carbohydrates--In the 2007 ANPRM, we asked whether additional types of 
carbohydrates (e.g., starch) should be listed separately on the 
Nutrition Facts label. We considered comments received (Ref. 47), 
which, taken together, did not support declaration of additional types 
of carbohydrates. Some comments stated that such additional information 
could distract consumers from information that is important, such as 
dietary fiber. A few comments that supported the declaration of starch 
provided no evidence to support their assertions regarding the benefit 
of this declaration for diabetics. Moreover, there is no strong 
scientific evidence for us to consider related to the role of starch in 
human health. Therefore, we are not proposing to require the separate 
declaration of additional types of individual carbohydrates such as 
starch on the Nutrition Facts label.
    d. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act 
requires the declaration of total carbohydrate. Correspondingly, 
regulations require the declaration of the amount of total carbohydrate 
on the Nutrition Facts label (Sec.  101.9(c)(6)). Carbohydrates are an 
essential part of the diet because they provide energy to the cells in 
the body, especially the brain, which is dependent on carbohydrate for 
proper functioning (Ref. 68). We have no basis on which to reconsider 
the requirement for mandatory declaration of the amount of total 
carbohydrate on the Nutrition Facts label and comments in response to 
the 2007 ANPRM also supported this mandatory declaration. We 
tentatively conclude that the declaration of carbohydrates on the 
Nutrition Facts label continues to be necessary to assist consumers in 
maintaining healthy dietary practices. Therefore, we are not proposing 
any changes to the current requirement for mandatory declaration of 
total carbohydrate, as specified in Sec.  101.9(c)(6).
    e. DRV--The DRV for total carbohydrate is 300 g (Sec.  
101.9(c)(9)). The IOM established an AMDR for carbohydrate intake of 45 
to 65 percent of energy for adults and an EAR of 100 g/d for adults and 
children (Ref. 69). In the IOM report, ``carbohydrate'' only included 
starch and sugars, not sugar alcohols or dietary fiber. The IOM also 
set the RDA for ``carbohydrate'' (i.e., starch and sugars) at 130 g/d 
for adults and children based on the average minimum amount of glucose 
utilized by the brain in adults, which was extrapolated to children 
ages 1 through 18 years. Subsequently, the IOM Labeling Committee 
recommended that, as in the case of protein and total fat, the AMDRs 
should be the basis for DVs for total carbohydrate (Ref. 25). 
Considering that AMDRs vary with age, the IOM Labeling Committee 
recommended a population-weighted midpoint of the AMDR. Under this 
approach, using a population-weighted mid-point of the AMDR for adults 
and children, i.e., 45 to 65 percent, the DV for total carbohydrate 
would amount to 55 percent or, based on a 2,000 calorie reference 
calorie intake, 275 g of carbohydrate.
    However, as we noted in the 2007 ANPRM, the IOM's AMDR, EAR, and 
RDA values for carbohydrate do not include sugar alcohols or dietary 
fiber. In contrast, our calculation of total carbohydrates for the 
purposes of nutrition labeling accounts for all types of carbohydrates, 
including sugar alcohols and dietary fiber. Therefore, applying the IOM 
Labeling Committee's approach, in which a DV is derived from the AMDR, 
would result in a reference value based on recommendations specifically 
for sugars and starches, whereas the absolute gram amount of 
carbohydrates declared on the label includes all carbohydrates. 
Consequently, if the midpoint of the AMDR range is used as the basis 
for the DRV, there would be a discrepancy in what carbohydrates are 
encompassed in the information provided on the label for the absolute 
gram amount versus the percent DV. We did not ask any questions about 
the DRV for total carbohydrate in the 2007 ANPRM nor did we receive any 
comments on this issue. Consistent with calculating total carbohydrate 
``by difference'' (discussed previously), we are proposing no changes 
to the approach to calculate the percent DV for carbohydrate ``by 
difference'' as well. In addition, we are not proposing to change the 
DRVs for fat or protein (see sections II.B. and II.E.), which are used 
to derive the DRV for total carbohydrate. Therefore, we are not 
proposing any changes to the DRV for total carbohydrate of 300 g/d. We 
note that the RDA for carbohydrate for men and women 19 years of age 
and older is 130 g/d. Therefore, the DRV should not be viewed as an 
intake requirement, but as a reference amount.
    f. Calculation of Calories From Carbohydrate--FDA regulations 
require that the calories from total carbohydrate be calculated by 
using the general factor of 4 calories/g of carbohydrate less the 
amount of insoluble dietary fiber (Sec.  101.9(c)(1)(i)(C)). We are 
proposing a new definition of dietary fiber (see section II.D.5.a.i.) 
that only allows for the declaration of dietary fibers that we have 
determined to have a physiological effect that is beneficial to human 
health, as ``dietary fiber'' on the Nutrition Facts label. Therefore, 
the new definition of dietary fiber would exclude both soluble and 
insoluble non-digestible carbohydrates that do not meet the proposed 
definition. For the purposes of

[[Page 11902]]

calculating calories from carbohydrate, all soluble and insoluble non-
digestible carbohydrates should be excluded from the calculation, not 
just those known to meet the definition of dietary fiber. To ensure 
that all soluble and insoluble non-digestible carbohydrates are 
excluded from the calculation of calories from carbohydrate, we are 
proposing to amend Sec.  101.9(c)(1)(i)(C) to require that calories 
from carbohydrate be calculated using a general factor of 4 calories/g 
of total carbohydrate less the amount of non-digestible carbohydrates. 
As discussed in section II.D.5.b.v., a value of 2 calories/g of soluble 
non-digestible carbohydrates is then added to the calculation.
2. Sugars
    a. Definition--Sugars are defined in Sec.  101.9(c)(6)(ii) as a 
statement of the number of g of sugars in a serving. They are the sum 
of all free mono and disaccharides (e.g., glucose, fructose, lactose, 
and sucrose). We received a citizen petition on the term ``sugars'' 
and, as explained in this document, we are not proposing any changes to 
the term or its definition for the purpose of nutrition labeling.
    b. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act 
requires the declaration of sugars. FDA regulations require the 
declaration of sugars on the Nutrition Facts label (Sec.  
101.9(c)(6)(ii)).
    The Sugar Association submitted a citizen petition on August 16, 
2005 (Docket No. FDA-2005-P-0373) requesting among other things that we 
eliminate ``sugars'' as a mandatory nutrient that is declared on the 
Nutrition Facts label or, alternatively, rename ``sugars'' as ``sugars/
syrup'' and require the mandatory declaration of polyol and artificial 
sweeteners on the Nutrition Facts label, as well as the mandatory 
labeling of each specific polyol and artificial sweetener ingredient 
and its amount on the food label (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0373). The petition asserted that consumers 
understand ``sugars'' to mean sucrose. The petition stated that an 
increasing number of manufacturers are using artificially produced 
(alternative) sweeteners, such as high fructose corn syrup, instead of 
sucrose products such as table sugar. The petition also asserted that, 
under current regulations, information on sugar content is presented in 
a manner that is misleading to consumers because it does not reflect 
the caloric content of artificially produced sweeteners and does not 
identify the specific sweeteners used in food products. The petition 
also expressed concern about the potential caloric and health effects 
of alternative sweeteners and asserted that the current labeling of 
sugar and lack of labeling for artificially produced sweeteners on the 
Nutrition Facts label did not provide consumers with relevant 
information about alternative sweeteners. However, the petitioner did 
not include any data to specifically support these assertions and 
concerns.
    In the 2007 ANPRM, we requested comment on whether ``sugars'' 
should continue to be included on the Nutrition Facts label. We 
received several comments which were in favor of continuing to require 
mandatory labeling of sugars on the Nutrition Facts label (Ref. 47).
    We considered the petition and comments received in light of 
scientific evidence. There is strong and consistent evidence based on 
valid endpoints that consumption of sugars is associated with an 
increased risk of dental caries (Refs. 6 and 68). We authorized a 
health claim for dietary non-cariogenic carbohydrate sweeteners and 
dental caries (Sec.  101.80). The IOM macronutrient report noted that 
dental caries is a condition of public health concern that is 
associated with consumption of sugars (Ref. 68). Therefore, we 
tentatively conclude that the declaration of sugars continues to be 
necessary to assist consumers in maintaining healthy dietary practices, 
and we are not proposing to change the current requirement for 
mandatory declaration of sugars.
    Moreover, we decline the petition's request to rename ``sugars'' as 
``sugars/syrups'' on the Nutrition Facts label. The petition requested 
that we rename the ``sugars'' category to prevent consumers from being 
misled with regard to the ingredients that are permitted to be 
considered sugars under the current regulation (monosaccharides plus 
disaccharides such as high fructose corn syrup). The petition, however, 
did not provide data or information to support the assertion that 
consumers are misled by the term ``sugars'' on products containing 
sweeteners that are a combination of mono and disaccharides, as defined 
in Sec.  101.9(c)(6)(ii). We are considering using the term ``total 
sugars'' in lieu of ``sugars'' on the Nutrition Facts label if ``added 
sugars' declaration is finalized, as proposed. FDA plans to conduct 
consumer testing of the terms ``total sugars'' and ``sugars'' on the 
Nutrition Facts label (FR 2013-12824) to determine if use of the term 
``total sugars'' aids consumers in understanding that added sugars are 
part of the total amount of sugars in product.
    We also decline the petition's request to require manufacturers to 
declare the specific type of artificial sweetener used on the Nutrition 
Facts label so that consumers can be made aware of the degree of 
substitution, when artificial sweeteners are substituted for sugars, 
and the overall level of the artificial sweeteners in the food. Under 
FDA regulations, artificial sweeteners that are added to a food are 
required to be declared in the ingredient statement of the label. The 
petition did not provide any justification that additional information 
about artificial sweeteners in nutrition labeling is warranted and we 
have no data to suggest that a declaration of artificial sweeteners is 
necessary to assist consumers in maintaining healthy dietary practices.
    Therefore, we are not proposing any change to the current 
requirement for mandatory declaration of sugars on the Nutrition Facts 
label, as specified in Sec.  101.9(c)(6)(ii). We are also not proposing 
to rename the ``sugars'' category as ``sugars/syrups'' or require the 
mandatory declaration of specific sugar alcohols or other artificial 
sweeteners.
    c. DRV--FDA regulations do not specify a DRV for sugars. Current 
consensus reports have not set dietary reference values based on which 
we could derive an appropriate DRV for total sugars. While the IOM 
found an association between sugar consumption and risk of dental 
caries, due to the various factors that contribute to dental caries, 
IOM could not determine an intake level of sugars that is associated 
with increased risk of dental caries and, therefore, did not have 
sufficient evidence to set a UL for sugars (Ref. 68). We did not ask 
any questions related to the DRV for sugars in the 2007 ANPRM nor did 
we receive any comments recommending the establishment of a DRV for 
total sugars. For these reasons, we are not proposing to establish a 
DRV for total sugars.
3. Added Sugars
    a. Declaration--FDA regulations neither define the term ``added 
sugars'' nor require or permit its declaration on the Nutrition Facts 
label. We are reconsidering the declaration of added sugars taking into 
account new data and information, including U.S. consensus reports and 
recommendations related to the consumption of added sugars, a citizen 
petition submitted by the CSPI, and public comments. For the purposes 
of the discussion in this document, added sugars refer to sugars and 
syrups that are added to foods during processing or preparation (Ref. 
6).

[[Page 11903]]

    i. Consensus Reports. The IOM DRI Report on Macronutrients stated 
that ``although added sugars are not chemically different from 
naturally occurring sugars, many foods and beverages that are major 
sources of added sugars have lower micronutrient densities compared to 
foods and beverages that are major sources of naturally occurring 
sugars'' (Ref. 68). Although an upper level was not set for total or 
added sugars, a maximal intake level of 25 percent or less of energy 
from added sugars was suggested based on data that demonstrated 
decreased intakes of some micronutrients among American subpopulations 
whose intake of added sugars exceeded this level.
    In addition, the 2010 DGA (Ref. 6) noted that the primary 
prevention of obesity, especially in childhood, is an important 
strategy for combating and reversing the obesity epidemic. Over the 
last few decades, the prevalence of overweight and obese individuals in 
the United States dramatically increased among children, adolescents 
and adults. Many factors contribute to weight gain and obesity but 
maintaining an appropriate calorie balance and increasing physical 
activity and reducing sedentary behaviors are key recommendations to 
help combat the problem. The 2010 Dietary Guidelines Advisory Committee 
(DGAC) concluded that strong evidence shows that children who consume 
more sugar-sweetened beverages have greater adiposity (body fat) 
compared to those with a lower intake. The sole source of calories in 
many sugar-sweetened beverages (e.g., soda) is added sugars. The 2010 
DGA specifically suggest that reducing the intake of sugar-sweetened 
beverages may help individuals control their total calorie intake and 
manage their body weight. The report stated that Americans consume too 
many calories from solid fats (fats containing a high percentage of 
saturated and trans fatty acids and are solid at room temperature) and 
added sugars and these foods replace nutrient-dense foods and beverages 
and make it difficult for people to achieve the recommended nutrient 
intake while controlling their calorie intake. Together, solid fats and 
added sugars contribute a substantial portion of Americans' calories, 
35 percent on average (16 percent total on average from added sugar) 
without contributing to the overall nutrient adequacy of the diet and 
thus have implications for weight management. Thus, to meet nutrient 
needs within an individual's calorie limits, a key recommendation of 
the 2010 DGA is to reduce the intake of calories from solid fats and 
added sugars.
    The report recognized that foods containing solid fats and added 
sugars are no more likely to contribute to weight gain than any other 
source of calories in an eating pattern that is within calorie limits. 
However, reducing the consumption of calories from solid fats and added 
sugars allows for increased intake of nutrient-dense foods without 
exceeding overall calorie needs. The report recommended several ways to 
reduce the consumption of solid fats and added sugars including eating 
the most nutrient-dense forms of foods from all food groups, limiting 
the amount of solid fats and added sugars when cooking or eating, and 
consuming fewer and smaller portions of foods and beverages that 
contain solid fats and added sugars. Specifically, the 2010 DGA noted 
that, for most people, no more than about 5 to 15 percent of calories 
from solid fats and added sugars can be reasonably accommodated in the 
USDA Food Patterns, which are designed to meet nutrient needs within 
calorie limits. The 2010 DGA also outlined common elements of healthy 
eating patterns and stated that reducing the intake of added sugars is 
one component.
    Although the subject of front-of-package labeling (FOP) is outside 
the scope of this proposed rule, we reviewed the IOM Front-of-package 
Nutrition Rating Systems and Symbols Committee's final report for their 
conclusions on scientific evidence related to the effect of added 
sugars on human health. This Committee cited the 2010 DGA 
recommendations related to added sugars and noted that while there is a 
lack of scientific agreement on the effects of added sugars on health 
outcomes independent of the effects of total sugar, there is adequate 
evidence that added sugars (whether a solid or liquid) contribute extra 
calories to a diet, which could in turn lead to weight gain and obesity 
(Ref. 28).
    ii. CSPI Petitions. We received a petition from CSPI on August 3, 
1999 (hereafter referred to as ``the 1999 CSPI petition'') requesting 
that we require the Nutrition Facts label to disclose the quantity of 
added sugars present in packaged foods and to set a DRV for refined 
sugars added to foods (Docket No. FDA-1999-P-0158) (http://www.regulations.gov/#!docketDetail;D=FDA-1999-P-0158). The petition 
stated that the DRV for added sugars should be 40 g based on USDA's 
``Food Guide Pyramid'' recommendations that Americans should limit 
their daily intake of added sugars to about ten teaspoons (40 g) for a 
2,000 calorie healthful diet. The petition cited USDA Economic Research 
Service's data that show that the per capita consumption of added 
sugars rose by 28 percent from 1983 to 1999 (Ref. 70). The petition 
also referred to evidence that added sugars may contribute to obesity 
and heart disease, and argued that it is impossible for consumers to 
determine how much sugar has been added to foods or how much added 
sugars are reasonable to consume because the Nutrition Facts label does 
not currently provide this information. Although the petition also 
requested that we amend our regulations to prescribe nutrient content 
claims and health claims related to ``added sugars,'' those requests 
are not considered within the scope of this proposed rule. We received 
another petition from CSPI on February 13, 2013 (hereafter referred to 
as ``the 2013 CSPI petition''), requesting that we revise the 
``sugars'' line of the Nutrition Facts label to address ``added 
sugars.'' (Docket No. FDA-2013-P-0217) (http://www.regulations.gov/#!docketDetail;D=FDA-2013-P-0217). CSPI described ``added sugars'' as 
``various caloric sweeteners,'' including sucrose, high-fructose corn 
syrup, corn sugar, invert sugar, corn syrup ``and others.'' We address 
CSPI's request for an ``added sugar'' declaration in this proposed 
rulemaking. The data and information provided by the 2013 CSPI petition 
in regards to added sugar declaration does not change our current 
considerations or rationale for mandating added sugars on the label 
that are addressed in this document. Although CSPI included other 
requests in its petition, which generally relate to lowering levels of 
added sugars in foods, we do not address those requests in the context 
of this proposed rule because they are outside the scope of this 
proposed rule.
    iii. Public Comments. On June 26, 2000, we published a notice of 
availability of the 1999 CSPI petition in the Federal Register and 
requested comment (65 FR 39414). We received more than 2,700 comments 
from individuals, industry, academic institutions, advocacy groups, and 
health care groups. Several comments stated that added sugar 
declaration should be voluntary and not mandatory (Ref. 47). We did not 
ask any questions on added sugars in the 2007 ANPRM. However, we 
received comments that supported and others that opposed the 
declaration of added sugars on the Nutrition Facts label (Ref. 47).
    iv. FDA's Considerations and Proposal. A key recommendation of the 
2010 DGA is to reduce the intake of

[[Page 11904]]

calories from solid fats and added sugars. A high intake of calories 
from excess solid fat and added sugars can decrease the intake of 
nutrient-rich foods in the diet and can increase the overall caloric 
intake which could lead to weight management issues. As such, this key 
recommendation feeds into two overarching concepts of the intent of the 
Dietary Guidelines of maintaining calorie balance over time to achieve 
and sustain a healthy weight as well as supporting consumption of 
nutrient-dense foods (Ref. 6). As discussed in this document, a 
declaration of added sugars on the Nutrition Facts label would assist 
consumers in maintaining healthy dietary practices by providing them 
with information necessary to meet the key recommendations to construct 
diets containing nutrient-dense foods and reduce calorie intake from 
added sugars by reducing consumption of added sugars.
    The Nutrition Facts label includes the mandatory declaration of the 
fatty acids that are contained in solid fats from the DGA 
recommendation, in that saturated fatty acids and trans fatty acids are 
required to be declared on the Nutrition Facts label. Solid fats are 
solid at room temperature and contain a mixture of saturated and 
unsaturated fatty acids but tend to contain a high percentage of 
saturated or trans fatty acids. The disclosure of saturated fat and 
trans fat on the label not only provides information to consumers for 
managing their effects on CVD (see sections II.B. and II.C.) but also 
could provide a marker for foods that contain solid fats that are 
abundant in the diets of Americans and contribute significantly to 
excess calorie intake (Ref. 6). However, similar information about 
added sugars is not currently available on the Nutrition Facts label. 
Thus, we are proposing to require the declaration of added sugars on 
the Nutrition Facts label to provide consumers with information that is 
necessary to meet the dietary recommendation to reduce caloric intake 
from solid fats and added sugars.
    Added sugars contribute an average of 16 percent of the total 
calories in American diets (Ref. 6). According to NHANES, the major 
sources of added sugars in the diet in descending order are soda, 
energy and sports drinks, grain based desserts, sugar-sweetened fruit 
drinks, dairy-based desserts and candy. Most of these foods are not 
nutrient-dense and may add calories to the diet without providing 
dietary fiber or essential vitamins and minerals (Ref. 6). The 
consumption levels of added sugars alone exceed the discretionary 
calorie recommendations of 5 to 15 percent of calories from both solid 
fats and added sugars discussed in the 2010 DGA. Although foods 
containing solid fats and added sugars do not contribute to weight gain 
any more than another calorie source, they make up a significant 
percentage of the American diet and are a source of excess calories. 
The 2010 DGAC concluded that strong evidence shows that children who 
consume sugar-sweetened beverages have increased adiposity (increased 
body fat). The 2010 DGAC also concluded that there is a moderate body 
of evidence suggesting that greater consumption of sugar-sweetened 
beverages is associated with increased body weight in adults and that 
under isocaloric controlled conditions, added sugars, including sugar-
sweetened beverages, are no more likely to cause weight gain in adults 
than any other source of energy. While the IOM FOP report did not 
review scientific data on added sugars, based on the 2010 DGA 
recommendation to reduce intake of calories from added sugars, it 
concluded that added sugars should be included in an FOP labeling 
system. In addition the IOM FOP committee recommended that the FOP 
symbol system should be integrated with the Nutrition Facts label so 
that the two are mutually reinforcing. The IOM DRI Macronutrient Report 
noted the difficulty, among some populations, of consuming adequate 
amounts of certain micronutrients when excessive amounts of added 
sugars are consumed.
    As the CSPI petition pointed out, other groups such as the American 
Heart Association (AHA), American Academy of Pediatrics, and World 
Health Organization (WHO) have recommended limiting added sugars 
consumption. None of these recommendations was based on an increased 
risk of obesity or heart disease. Both the AHA and American Academy of 
Pediatrics recommendations point out that added sugars intake is 
associated with a greater intake of calories and a lower intake of 
essential nutrients, whereas the 1990 WHO recommendation for decreasing 
added sugars is based on dental caries and that excessive consumption 
of these sugars can displace nutrient-containing foods in the diet 
(Refs. 71 to 73). While these groups are not recognized as U.S. 
consensus groups by FDA, these recommendations support our proposal to 
require the mandatory declaration of added sugars so that consumers can 
achieve a dietary pattern that is nutrient-dense and that does not 
exceed caloric needs from added sugars, consistent with the 2010 DGA 
recommendations.
    Further, we consider it necessary to require a declaration of added 
sugars for all foods for which a Nutrition Facts label is required. 
Using the current label, consumers cannot identify or compare the 
amounts of added sugars to enable them to follow the recommendation of 
the 2010 DGA. We are proposing mandatory declaration of added sugars on 
all foods because of (1) the variability in ingredients used, (2) the 
need for consumers to have a consistent basis on which to compare 
products, (3) the need for consumers to identify the presence or 
absence of added sugars, and (4) when added sugars are present, the 
need for consumers to identify the amount of added sugars added to the 
food. The mandatory declaration of added sugars may also prompt product 
reformulation of foods high in added sugars like what was seen when 
trans fat labeling was mandated (Ref. 58).
    We understand that our rationale to support an added sugars 
mandatory declaration in labeling is different from our rationale to 
support other mandatory nutrients to date which, consistent with the 
factors we describe in section I.C., generally relate to the intake of 
a nutrient and risk of chronic disease, a health-related condition, or 
a physiological endpoint. U.S. consensus reports have determined that 
inadequate evidence exists to support the direct contribution of added 
sugars to obesity or heart disease. Specifically, although it is 
recognized that sugar-sweetened beverages increase adiposity (body fat) 
in children (Ref. 30), neither the 2010 DGA nor the IOM macronutrient 
report concluded that added sugars consumption from all dietary 
sources, in itself, increases obesity. In fact, the 2010 DGA states 
that added sugars do not contribute to weight gain more than any other 
source of calories. The evidence submitted by CSPI supporting the 
contribution of added sugars to heart disease failed to show a direct 
association between added sugars consumption and heart disease risk. 
Rather, the evidence shows that the consumption of total carbohydrates 
(not added sugars, per se) is associated with an increase in serum 
triglyceride levels. Moreover, serum triglyceride level is not an 
endpoint that we recognize as a validated surrogate marker for CHD risk 
in our evidence-based review system for health claims (Ref. 74). 
Nevertheless, for the reasons explained previously that include 
providing consumers with the information necessary to follow the 2010 
DGA recommendations to reduce the intake of calories from added sugars,

[[Page 11905]]

we tentatively conclude that the declaration of added sugars is 
required to assist consumers in maintaining healthy dietary practices.
    Additionally, in the absence of uniform added sugars declaration on 
the Nutrition Facts label, consumers would not be able to compare the 
added sugars content of foods, particularly those that contain both 
naturally occurring sugars and added sugars (e.g., yogurt and dairy-
based desserts). Contrary to what one comment stated, the added sugars 
declaration in the ingredient statement of a food label may not provide 
sufficient or quantitative information for consumers to be able to 
formulate diets consistent with the dietary recommendations. Sugars may 
be added to foods in the form of various ingredients, such as fruit 
juice concentrates, fructose, maltose, sucrose, and honey, and 
consumers may not realize that these ingredients are, in fact, forms of 
added sugars and would not be able to determine the quantities added. 
Thus, as pointed out in some comments, calorie declaration and 
ingredient listing do not provide enough information for consumers to 
determine the amount of calories derived from added sugars in the food. 
We acknowledge that some products may contain only added sugars and no 
naturally occurring sugars (e.g., soda) and that the amount shown in 
the total ``sugars'' declaration on the Nutrition Facts label for such 
products would be the amount of added sugars. In this case, however, 
some consumers may still not be able to determine the amount of added 
sugars because the term would not appear on the label at all. At this 
point in time, we cannot be certain that most consumers would 
understand that, in the absence of added sugars declaration, all sugars 
in these products are added sugars. Therefore, without the added sugars 
declaration, some consumers may perceive the amount of added sugars in 
the product differently and some perceived amounts may differ from the 
actual amount in the product. Food formulations may vary and 
consistency in the mandatory declaration of added sugars is important 
so that consumers are not confused.
    We recognize that small amounts of added sugars can increase the 
palatability of nutrient-dense foods, as suggested by a comment. The 
disclosure of added sugars on the label may allow consumers to plan and 
construct their diets to include small amounts of added sugars and 
still consume adequate amounts of necessary nutrients. Consumers may 
select from a variety of such nutrient-dense foods as part of their 
overall dietary pattern in a way to reduce or minimize the caloric 
contribution of added sugars from such sources. The IOM FOP report 
noted that small amounts of added sugars would be appropriate for foods 
to earn FOP points in their recommended labeling scheme, which suggests 
that small amounts would be appropriate in a balanced diet (Ref. 29).
    We acknowledge that, if finalized, a requirement for declaration of 
added sugars on the Nutrition Facts label will need to be accompanied 
by consumer education on the role of added sugars, along with solid 
fats, and the use of the new information on the label in overall 
dietary planning. We will be conducting consumer studies that include 
questions regarding including added sugars on the Nutrition Facts 
label. We plan to use the results of these studies to help inform our 
future actions on this issue.
    We understand that there are currently no analytical methods that 
are able to distinguish between naturally occurring sugars and those 
sugars added to a food. However, we do not agree with comments that 
analytical limitations should preclude mandatory declaration of added 
sugars because there is an alternative method to assess compliance. The 
amount of added sugars declared on the label could be verified through 
means other than chemical analysis, such as through maintenance and 
review of records. The reliance on records for compliance purposes is 
not unique to added sugars as we have previously required that 
manufacturers provide records under certain circumstances to support 
statements made on food labels (for example, with respect to aeration 
to reduce fat and caloric content of foods (58 FR 2229 at 2271) and 
caloric content of new products with reduced digestibility (58 FR 2079 
at 2111)). In addition, in sections II.D.5., II.J.2., and II.J.3., we 
are proposing to use records to determine compliance with declared 
values of dietary fiber, folate, and vitamin E, under certain specified 
circumstances.
    We continue to recognize the lack of a physiological distinction 
between added and naturally occurring sugars. While comments expressed 
concerns that declaration of added sugars could significantly under-
represent the sugars content of many foods with a large quantity of 
naturally occurring sugars, we are not proposing to remove the total 
sugars declaration (see section II.D.2.) because there continues to be 
strong scientific evidence linking total sugars intake with dental 
caries. Therefore, the sugar content of foods with naturally occurring 
sugars would not be under-reported.
    We also considered the appropriateness of voluntary declaration of 
added sugars, an approach supported by several comments. However, we 
are concerned that voluntary declaration of added sugars may not ensure 
that consumers have the information that will allow them to follow the 
current dietary recommendations. Added sugars declared voluntarily by 
manufacturers on some products, but not on others, either within a 
given product category or across different product categories, could be 
confusing to consumers, and would not provide consumers with the 
information they need to plan their dietary pattern to reduce 
consumption of calories from added sugars.
    In light of current dietary recommendations that advise Americans 
to reduce their intake of calories from added sugars, we consider that 
an added sugars declaration will help individuals identify foods that 
are nutrient-dense within calorie limits and aid in reducing excess 
discretionary calorie intake from added sugars. We tentatively conclude 
that the declaration of added sugars on the Nutrition Facts label is 
necessary to assist consumers to formulate diets consistent with 
current dietary recommendations and, thus, maintain healthy dietary 
practices. Therefore, proposed Sec.  101.9(c)(6)(iii) would require the 
mandatory declaration of added sugars as an indented line item 
underneath the declaration of total sugars on the Nutrition Facts 
label. We invite comment on this issue. We also invite comment, 
including the submission of research on whether calories from added 
sugars should be declared on the Nutrition Facts label in lieu of a 
gram declaration of added sugars to aid consumers in maintaining 
healthy dietary practices.
    FDA regulations require that the statement ``Not a significant 
source of ----'' for calories from fat, saturated fat, trans fat, 
cholesterol, dietary fiber, sugars, and protein must be placed at the 
bottom of the table of nutrient values in the same type size, under the 
specific circumstances described for each nutrient in Sec.  101.9(c). 
For sugars, the phrase ``Not a significant source of sugars'' must be 
placed at the bottom of the table of nutrient values if a statement of 
the sugars content is not required and, as a result, not declared. A 
statement of sugars content is not required for products that contain 
less than 1 gram of sugars in a serving if no claims are made about 
sweeteners, sugars, or sugar alcohol content (Sec.  101.9(c)(6)(ii)). 
Similar information on added sugars could also be useful to consumers 
who are trying to limit their

[[Page 11906]]

intake of added sugars. Therefore, proposed Sec.  101.9(c)(6)(iii) 
would require that the phrase ``Not a significant source of added 
sugars'' be placed at the bottom of the table of nutrient values if a 
statement of the added sugars content is not required and, as a result, 
is not declared. We are also proposing that a statement of added sugars 
content would not be required for products that contain less than 1 
gram of added sugars in a serving if no claims are made about 
sweeteners, sugars, or sugar alcohol content (proposed Sec.  
101.9(c)(6)(iii)).
    In addition, for total carbohydrate, dietary fiber, soluble fiber, 
insoluble fiber, sugars, and sugar alcohol, when a serving of the food 
contains less than 1 gram of the nutrient, FDA regulations in Sec.  
101.9 permit the use the alternative statements ``Contains less than 1 
gram'' or ``less than 1 gram,'' and if a serving of the food contains 
less than 0.5 grams of the nutrient, the content may be expressed as 
zero. Proposed Sec.  101.9(c)(6)(iii) would provide for similar use of 
alternative statements, ``Contains less than 1 gram'' and ``less than 1 
gram'' for added sugars. In addition, if the serving contains less than 
0.5 g of added sugars, we are proposing to permit the content to be 
expressed as zero (proposed Sec.  101.9(c)(6)(iii)).
    b. Proposed Definition--The term ``added sugars'' is not defined in 
FDA regulations. Given our tentative conclusion to require mandatory 
declaration of ``added sugars'' on the Nutrition Facts label, we are 
proposing to define added sugars. In proposed Sec.  101.9(c)(6)(iii), 
we are proposing to define ``added sugars'' as sugars that are either 
added during the processing of foods, or are packaged as such, and 
include sugars (free, mono- and disaccharides), syrups, naturally 
occurring sugars that are isolated from a whole food and concentrated 
so that sugar is the primary component (e.g., fruit juice 
concentrates), and other caloric sweeteners. This would include single 
ingredient foods such as individually packaged table sugar. Sugar 
alcohols are not considered to be added sugars. Names for added sugars 
include: Brown sugar, corn sweetener, corn syrup, dextrose, fructose, 
fruit juice concentrates, glucose, high-fructose corn syrup, honey, 
invert sugar, lactose, maltose, malt sugar, molasses, raw sugar, 
turbinado, sugar, trehalose, and sucrose. This proposed definition of 
added sugars includes what CSPI described as ``added sugars'' in the 
2013 CSPI petition.
    c. Daily Value--Given our proposal to require the declaration of 
added sugars, we also considered establishing a DRV for added sugars. 
In its 1999 petition as well as in a published report (Ref. 75), CSPI 
recommended that FDA base a DV for ``added sugars'' on suggested limits 
of added sugars published in the 1992 USDA's Food Guide Pyramid (Ref. 
76). CSPI determined that a DRV for added sugars based on a 2,000 
calorie diet would be 10 teaspoons or 40 g of added sugars. Overall, 
comments submitted in response to CSPI's 1999 petition were in favor of 
this approach to setting a DRV for added sugars. Comments in response 
to the 2007 ANPRM also recommended establishing a DV for added sugars 
(Ref. 47).
    We reviewed scientific evidence and recommendations of consensus 
reports, and disagree with the petitioner and comments that there is 
currently a sound scientific basis for the establishment of a 
quantitative intake recommendation upon which a DRV could be derived. 
The IOM did not set a DRI, such as a UL, for added sugars (Ref. 68). 
The IOM suggested that no more than 25 percent of energy should be 
consumed from added sugars, but noted that a defined intake level at 
which inadequate micronutrient intakes occur could not be identified. 
The 2010 DGA did not provide a quantitative intake recommendation for 
added sugars intake but did provide a maximum intake level for solid 
fats and added sugars at 13 percent of calories for a 2,000 calorie 
diet based on food pattern modeling of the USDA Food Patterns and also 
described the ``DASH'' (Dietary Approaches to Stop Hypertension) eating 
plan which recommends 5 servings or less per week of sweets and added 
sugars for a 2,000 calorie diet (Ref. 6). The USDA Food Patterns, which 
provide recommended amounts of foods from each food group that 
individuals should consume in order to meet their nutrient needs within 
a specific calorie level, specify that the maximum amount of calories 
from solid fats and added sugars that can be consumed at the 2,000 
calorie level while staying within calorie limits is 258 calories (Ref. 
6). The solid fats and added sugars limit at each calorie level in the 
USDA Food Patterns is determined by calculation through food pattern 
modeling rather than on any biomarker of risk of disease or other 
public health endpoint. However, an exact amount of calories for added 
sugars is not detailed in either the USDA Food Patterns or ``DASH'' 
eating plans, as they represent templates that translate and integrate 
dietary recommendations, rather than specific quantitative intake 
recommendations (Ref. 6). Thus, we have no scientifically supported 
quantitative intake recommendation for added sugars on which a DRV for 
added sugars can be derived. Therefore, we are not proposing a DRV for 
added sugars. Accordingly, the proposed rule, if finalized, would 
declare added sugars on the Nutrition Facts label only in absolute 
amounts (in g), similar to the declaration of total sugars.
    d. Compliance--As expressed in the preamble to the 1993 RDI/DRV 
final rule, we are not aware of an analytical method that is capable of 
distinguishing between added and intrinsically occurring sugars in a 
food product (58 FR 2206 at 2222). Thus, it is not technologically 
feasible for us to rely on an analytical method to determine compliance 
with the declaration of added sugars in foods that contain both added 
sugars and naturally occurring sugars. We recognize that enforcement of 
the mandatory declaration of added sugars content will require an 
alternative means of verifying compliance and are proposing in Sec.  
101.9(g)(10) to include records requirements related to the added 
sugars declaration in food. Similarly, in the other cases where there 
are not reliable and appropriate analytical methods that will allow us 
to verify the amount of a given nutrient in a food (dietary fiber, 
vitamin E (tocopherol), and folate), we are also proposing to require 
manufacturers make and keep certain records necessary to verify the 
amount of these nutrients present in a food (see proposed Sec.  
101.9(g)(10)). In the case of added sugars that are not subject to 
fermentation, when a mixture of naturally occurring and added sugars is 
present in the food, we are proposing that a manufacturer must make and 
keep written records of the amount of added sugars added to the food 
during the processing of the food, and if packaged as a separate 
ingredient, as packaged (whether as part of a package containing one or 
more ingredients or packaged as a single ingredient) to verify the 
amount of added sugars present in the food (Sec.  101.9(g)(10)(iv)). 
(See section II.N for more details about this requirement.)
    i. Reactions during processing. Sugars in some foods may undergo 
chemical changes mediated by chemical reactions from non-enzymatic 
browning (i.e., Maillard reactions and caramelization) and fermentation 
during food processing. During these reactions, some sugars are 
metabolized or otherwise transformed and converted into compounds that 
are no longer recognizable or detectable as sugars through conventional 
analytical methods (Ref. 77). We expect that the

[[Page 11907]]

amount of added sugars transformed during non-enzymatic browning 
reactions is insignificant relative to the initial levels of sugars 
(Ref. 78).
    Unlike browning reactions, fermentation is a process that typically 
involves the action of desirable microorganisms (e.g., yeasts and 
lactic acid bacteria) and enzymes to convert organic compounds, 
especially sugars and other carbohydrates, to simpler compounds such as 
carbon dioxide, lactic acid, and ethyl alcohol (Refs. 52 and 79). 
Typical foods that are subject to fermentation during manufacturing are 
breads, cheese, yogurt, vinegar, vegetables, meats, beer and wine. Some 
foods, such as sweetened, yeast-leavened breads and wines that are 
processed through a fermentation step contain added sugars which will 
likely be consumed by the microorganisms during fermentation; other 
foods processed through a fermentation step contain added sugars that 
will likely not be consumed to a large extent, if at all, during 
fermentation, for example, yogurt sweetened with sucrose. In addition, 
many products processed through a fermentation step, such as cheese, do 
not contain added sugars to aid in fermentation or improve taste (Ref. 
78). Therefore, we tentatively conclude that the amount of added sugars 
present in foods prior to undergoing fermentation, with the exception 
of yeast-leavened bakery products, wines with less than 7 percent 
alcohol by volume, and beers that do not meet the definition of a 
``malt beverage'' as defined by the Federal Alcohol Administration Act 
(27 U.S.C. 211(a)(7)) with sugars added during the fermentation 
process, will not be significantly affected by virtue of the food 
having undergone fermentation. We do not have adequate information to 
assess the degradation of added sugars during fermentation for yeast-
leavened bakery products, wine with less than 7 percent alcohol by 
volume, and beers that do not meet the definition of a malt beverage 
with sugars added before or during the fermentation process. (Ref. 78).
    We request comments, including available data and information, on 
our tentative conclusions with respect to added sugars in products that 
are subjected to non-enzymatic browning reactions and fermentation. We 
specifically request data on the amount of variability that occurs 
among various types of products where added sugars are transformed into 
other compounds as a result of chemical reactions during food 
processing.
    ii. Records required to assess compliance. For yeast-leavened 
bakery products, wines with less than 7 percent alcohol by volume, and 
beers that do not meet the definition of a malt beverage with sugars 
added before and during the fermentation process, it is unclear to us 
whether, as with most fermented foods, the reduction in the amount of 
added sugars would be insignificant. In addition to the records we 
propose to require for added sugars in foods generally, under proposed 
Sec.  101.9(g)(10), we recognize that there is a need to consider other 
types of records related to added sugars content for a yeast-leavened 
bakery product, wine with less than 7 percent alcohol by volume, or a 
beer that does not meet the definition of a malt beverage when sugars 
are added to the food before or during the fermentation process (e.g. 
the added sugars are present during fermentation and the amount may be 
reduced by the fermentation process). Because of the unique issues that 
may be associated with a yeast-leavened bakery product, wine with less 
than 7 percent alcohol by volume, or a beer that does not meet the 
definition of a malt beverage when added sugars are present during the 
fermentation process (Ref. 78), we are proposing a new subparagraph 
(Sec.  101.9(g)(10)(v)) to specifically address records requirements 
for these products.
    Some manufacturers of yeast-leavened bakery products, wine with 
less than 7 percent alcohol by volume, and beers that do not meet the 
definition of a malt beverage where sugar is added before or during the 
fermentation process would likely have more detailed information about 
the reduction in added sugars from the process for the products they 
manufacture. Thus, we anticipate that manufacturers of some of these 
foods that undergo fermentation would be able to determine the amount 
of added sugars in the finished food product. For example, 
manufacturers could choose to determine through laboratory analysis the 
amount of added sugars as well as naturally occurring sugars consumed 
in their product during the fermentation process. Other manufacturers 
that are unable to conduct additional laboratory analyses of their 
product may rely on a scientific document (e.g., journal article or 
reference book) showing the amount of added sugars typically consumed 
during fermentation in a specific food product (see proposed Sec.  
101.9(g)(10)(v)(A)). Manufacturers may use information gathered through 
additional analyses or from scientific references to adjust the amount 
of sugars added in processing to achieve the desired taste and 
organoleptic properties in the finished food product.
    We also recognize that some manufacturers of these foods may not be 
able to use scientific data and information to verify the amount of 
added sugars in the finished food product. We tentatively conclude that 
it is appropriate to include, as an alternative to the use of 
scientific data and information for such verification, proposed record 
requirements for the amount of added sugars added to these products 
before and during fermentation for the verification of the declaration 
of added sugars content (see proposed Sec.  101.9(g)(10)(v)(B)). As 
with other products containing added sugars, the amount of sugars added 
before or during fermentation could be determined through information 
such as databases, recipes, formulations, or batch records.
    Therefore, we are proposing, in Sec.  101.9(g)(10)(v), to require a 
manufacturer of yeast-leavened bakery products, wines with less than 7 
percent alcohol by volume, and beers that do not meet the definition of 
a malt beverage with sugars added before and during the fermentation 
process to make and keep records of added sugars necessary to determine 
the amount of added sugars present in the finished food in one of two 
ways. The first would require the manufacturer to make and keep records 
of all relevant scientific data and information relied upon by the 
manufacturer that demonstrates the amount of added sugars in the food 
after fermentation and a narrative explaining why the data and 
information are sufficient to demonstrate the amount of added sugars 
declared in the finished food. When the manufacturer is relying upon 
scientific data and information from reference documents to determine 
the amount of added sugars in these finished food products, the 
information used must be specific to the type of fermented food 
manufactured. For example, if a manufacturer produces raisin bread, the 
reference that the manufacturer is relying upon would need to show the 
amount of sugars typically consumed in raisin bread that undergoes 
fermentation. The second would require the manufacturer to make and 
keep records of the amount of added sugars added to the food before and 
during the processing of the food, and, if packaged as a separate 
ingredient, as packaged (whether as part of a package containing one or 
more ingredients or packaged as a single ingredient). The records would 
need to be made available to FDA consistent with the proposed 
requirements in Sec.  101.9(g)(11).
    It is likely that the actual amount of added sugars remaining in 
yeast-leavened breads, wines with less than 7

[[Page 11908]]

percent alcohol by volume, and beers that do not meet the definition of 
a malt beverage after they undergo fermentation will be less than the 
amount added before processing. We are proposing in section II.N to 
allow for reasonable deficiencies of added sugars under labeled amounts 
that are acceptable within current good manufacturing practice in Sec.  
101.9(g)(6). Because the consumer is not generally harmed if the amount 
declared on the nutrition label is a reasonable overage of the actual 
amount as indicated by Sec.  101.9(g)(6), when the manufacturer 
chooses, as the declaration, the amount of sugars added to these 
specific foods before fermentation, the we consider the actual amount 
of added sugars in the finished food product to be a reasonable 
deficiency under Sec.  101.9(g)(6). In some cases of these specific 
fermented foods, when the amount of sugar added to a product before 
fermentation is declared, it will exceed the amount of total sugars in 
the finished food product determined through laboratory analysis. This 
is due to the fact that the amount of added sugars consumed during the 
fermentation process is not reflected in the declared amount. In such 
cases, the we tentatively conclude that it may be confusing to the 
consumer if the amount of added sugars declared exceeds the amount of 
total sugars declared on the Nutrition Facts label. Therefore, we are 
proposing in Sec.  101.9(g)(10)(v)(B) that the amount of added sugars 
declared shall not exceed the amount of total sugars declared on the 
label.
4. Sugar Alcohols
    FDA regulations define sugar alcohols, in part, as the sum of 
saccharide derivatives in which a hydroxyl group replaces a ketone or 
aldehyde group (e.g., mannitol or sorbitol) (Sec.  101.9(c)(6)(iii)).
    a. Voluntary Declaration--FDA regulations permit the voluntary 
declaration of sugar alcohols on the Nutrition Facts label (Sec.  
101.9(c)(6)(iii)). In 2005, we received a citizen petition from the 
Sugar Association (Docket No. 2005-P-0373) requesting, among other 
requests, mandatory declaration of sugar alcohols on the Nutrition 
Facts label (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-
0373). The petition stated that, without this information, consumers 
would be misinformed about important modifications to foods and cannot 
make informed decisions about their particular sensitivity to the 
potential effects of sugar alcohols on the body. In the 2007 ANPRM, we 
asked whether the declaration of sugar alcohols should continue to be 
voluntary or made mandatory. We considered comments received (Ref. 47) 
as well as arguments presented by the petition.
    We tentatively conclude that declaration of sugar alcohols should 
continue to be voluntary. Although a quantitative intake recommendation 
for sugar alcohols is not available from relevant U.S. consensus 
reports, sugar alcohols have positive health effects when they replace 
sugars in the diet. For example, there is well-established evidence to 
indicate that replacing sugars in the diet with sugar alcohols reduces 
the risk of dental caries, including the evidence used to support the 
health claims authorized by FDA on sugar alcohols and dental caries (72 
FR 52783 at 52785; Sec.  101.80). Therefore, we tentatively conclude 
that sugar alcohols have public health significance and, in the absence 
of a quantitative intake recommendation, voluntary declaration is 
consistent with the factors we consider for when voluntary declaration 
is appropriate (section I.C.). Accordingly, we are proposing to 
continue to provide for the voluntary declaration of sugar alcohols (in 
Sec.  101.9(c)(6)(iii) redesignated as Sec.  101.9(c)(6)(iv)).
    We disagree with the petition that mandatory declaration of sugar 
alcohols is necessary to ensure that consumers are not misinformed 
about modifications to foods. Sugar alcohols that are added to food 
must be listed in the ingredients list on food labels and, therefore, 
consumers will be informed of their use in a product. We also disagree 
with the comment that supported mandatory declaration when there is at 
least 1 gram of sugar alcohols per serving due to gastrointestinal 
problems at such a level. As warranted, FDA regulations require 
specific labeling statements to accompany the use of certain sugar 
alcohols to provide information to consumers about any gastrointestinal 
effects. For example, in the case of mannitol and sorbitol, the 
statement ``Excessive consumption may have a laxative effect,'' is 
required on the label and labeling of a food whose reasonably 
foreseeable consumption may result in a daily ingestion of 20 g for 
mannitol (21 CFR 180.25) and 50 g for sorbitol (Sec.  184.1835 (21 CFR 
184.1835)).
    b. Use of the Term ``Sugar Alcohol''--In 1995, we received a 
citizen petition submitted by the Calorie Control Council requesting 
the use of the term ``polyols'' in lieu of ``sugar alcohols'' (Docket 
No. FDA-1995-P-0142) (http://www.regulations.gov/#!docketDetail;D=FDA-
1995-P-0142). The petition stated that ``polyol'' is a regulatory term 
used in other countries, such as Canada and New Zealand. In addition, 
the petition cited a survey that showed that 78 percent of consumers 
surveyed thought that products with sugar alcohol contained some sugar 
even when labeled ``sugar free'' and 69 percent thought that the 
product contained some alcohol. We considered the petition as well as 
comments in response to the 2007 ANPRM (Ref. 80).
    We previously considered the use of ``polyol'' (a contraction of 
``polyalcohol'') and determined that it could be potentially more 
confusing to consumers than the term ``sugar alcohol.'' However, we 
acknowledge that consumers also may not be familiar with the term 
``sugar alcohol.'' Therefore, in Sec.  101.9(c)(6)(iii), we allow for 
the use of the name of the specific sugar alcohol in lieu of ``sugar 
alcohols,'' provided that only one sugar alcohol is present in the 
food, since many of the sugar alcohols are listed as ingredients (e.g., 
sorbitol, mannitol, xylitol) and hence may be more recognizable for 
consumers (58 FR 2079 at 2100).
    We continue to support the term ``sugar alcohols'' rather than 
``polyols,'' because ``sugar alcohols'' more accurately describes the 
group of substances encompassed in the definition in Sec.  
101.9(c)(6)(iii). ``Polyols'' includes non-carbohydrate polyalcohols, 
such as polyesters, whereas ``sugar alcohols,'' as defined by FDA, 
includes only carbohydrates. Accordingly, we are not proposing to 
change the term ``sugar alcohols'' when used on the Nutrition Facts 
label, as specified in Sec.  101.9(c)(6)(iii) redesignated as Sec.  
101.9(c)(6)(iv).
    c. DRV--FDA regulations do not provide a DRV for total sugar 
alcohols or for individual sugar alcohols. A quantitative reference 
intake recommendation for sugar alcohols is not available from current 
consensus reports and we have no basis on which to consider setting an 
appropriate DRV. Therefore, we are not proposing to set a DRV for sugar 
alcohols.
    d. Caloric Value--The caloric value for carbohydrates, other than 
insoluble fiber, is 4 kcal/g (Sec.  101.9(c)(1)(i)(C)). Sugar alcohols 
have been shown to have a caloric value lower than 4 kcal/g (Refs. 81 
and 82). The 2007 ANPRM asked for comment on (1) how the energy 
contribution of sugar alcohols should be represented on the label since 
energy values vary, and (2) what analytical methods could be used to 
determine the energy contribution of sugar alcohols. We considered 
comments received (Ref. 47). We also considered relevant caloric values 
recommended by the Life Sciences Research Office (LSRO) that

[[Page 11909]]

were determined by various methods, including studies conducted in 
animals and human subjects, and based on the amount of energy 
metabolized or net energy values (Refs. 81 and 82). LSRO expert panel 
reports provided the following caloric values for individual sugar 
alcohols: Isomalt (2.0 kcal/g), lactitol (2.0 kcal/g), xylitol (2.4 
kcal/g), maltitol (2.1 kcal/g), sorbitol (2.6 kcal/g), hydrogenated 
starch hydrolysates (3.0 kcal/g), and mannitol (1.6 kcal/g).
    We support the use of the LSRO caloric values for individual sugar 
alcohols. The LSRO reports used appropriate methods and study design 
criteria for measuring caloric value, and noted that human data were 
preferred and that animal data should be viewed as supplemental 
information. We do not have any data that would question the caloric 
values determined by the LSRO reports for the specified sugar alcohols. 
We did not identify any human studies published since the release of 
the LSRO reports that demonstrate that a different caloric value for 
any of these sugar alcohols would be more appropriate. Therefore, we 
are proposing to amend Sec.  101.9(c)(1)(i)(F) to establish the 
following general factors for caloric values of sugar alcohols, using 
the values recommended by LSRO: Isomalt--2.0 kcal/g, lactitol--2.0 
kcal/g, xylitol--2.4 kcal/g, maltitol--2.1 kcal/g, sorbitol--2.6 kcal/
g, hydrogenated starch hydrolysates--3.0 kcal/g, and mannitol--1.6 
kcal/g. Accordingly, we are also proposing to amend Sec.  
101.9(c)(1)(i)(C) such that the 4 kcal/g is not applied to sugar 
alcohols.
5. Dietary Fiber
a. Dietary Fiber
    i. Definition. FDA regulations do not establish a definition for 
dietary fiber. There is no specific chemical definition for dietary 
fiber. Because of the difficulties in accurately isolating the set of 
fibers relevant to health, in 2001, the IOM established a panel to 
develop a new definition of dietary fiber (IOM Panel on the Definition 
of Dietary Fiber or IOM Panel). Subsequently, the IOM then issued a 
report defining ``total fiber'' as the sum of ``dietary fiber'' and 
``added fiber,'' where ``dietary fiber'' consists of non-digestible 
carbohydrates and lignin that are intrinsic and intact in plants, and 
``added fiber'' (referred to as ``functional fiber'' in the IOM 
Macronutrient Report) consists of isolated, non-digestible 
carbohydrates that have beneficial physiological effects in humans 
(Ref. 24). The IOM's definitions of ``dietary fiber'' and ``total 
fiber'' only include those fibers that are considered to have health 
benefits. The 2007 ANPRM asked for public comment on whether the IOM 
dietary or functional fiber definitions should become the FDA 
definition for dietary fiber. We also asked whether it should develop 
criteria for identifying fibers that demonstrate a physiological 
benefit, and, if so, what those criteria should be. We received several 
comments (Ref. 47).
    We considered IOM recommendations, comments received, and relevant 
international guidelines. The Codex Alimentarius Commission adopted the 
following definition of dietary fiber in 2010 (Ref. 67):
    ``Dietary fibre means carbohydrate polymers \1\ with ten or more 
monomeric units,\2\ which are not hydrolysed by the endogenous enzymes 
in the small intestine of humans and belong to the following 
categories:
---------------------------------------------------------------------------

    \1\ ``When derived from a plant origin, dietary fibre may 
include fractions of lignin and/or other compounds associated with 
polysaccharides in the plant cell walls. These compounds also may be 
measured by certain analytical method(s) for dietary fibre. However, 
such compounds are not included in the definition of dietary fibre 
if extracted and re-introduced into a food.'' (Ref. 67).
    \2\ ``Decision on whether to include carbohydrates from 3 to 9 
monomeric units should be left to national authorities.'' (Ref. 67).
---------------------------------------------------------------------------

     Edible carbohydrate polymers naturally occurring in the 
food as consumed,
     Carbohydrate polymers, which have been obtained from food 
raw material by physical, enzymatic or chemical means and which have 
been shown to have a physiological effect of benefit to health as 
demonstrated by generally accepted scientific evidence to competent 
authorities, and
     Synthetic carbohydrate polymers which have been shown to 
have a physiological effect of benefit to health as demonstrated by 
generally accepted scientific evidence to competent authorities.
    As with the IOM definition of ``total fiber,'' the 2010 Codex 
definition for ``dietary fiber'' includes naturally occurring fibers 
and only those non-digestible carbohydrates added to food that have a 
physiological effect that is beneficial to human health.
    Dietary fiber represents a heterogeneous group of compounds that 
vary in their carbohydrate composition, linkages between carbohydrates, 
and molecular weight. As stated previously, there is no specific 
chemical definition for dietary fiber. Therefore, considering the IOM 
and Codex definitions and comments received, as well as the role of the 
dietary fiber declaration on the Nutrition Facts label, we tentatively 
conclude that a regulatory definition for dietary fiber should be one 
that emphasizes its physiological effect that is beneficial to human 
health. The declaration of dietary fiber that accurately reflects the 
amount of fiber that provides a physiological effect that is beneficial 
to human health would assist consumers in maintaining healthy dietary 
practices.
    We are proposing a single definition for dietary fiber that is 
equivalent to the IOM's definition for ``total fiber,'' rather than 
IOM's separate definitions of ``dietary fiber'' and ``functional 
fiber.'' Because both ``dietary fiber'' and ``functional fiber'' as 
defined by IOM are considered to have beneficial health effects, we 
tentatively conclude that there is little benefit for consumers in 
distinguishing between these two types of fiber on the Nutrition Facts 
label. In addition, the IOM itself recognized analytical limitations in 
distinguishing between ``dietary fiber'' and ``functional fiber'' and 
noted that the labeling of ``total fiber'' would be more practical than 
labeling ``dietary fiber'' and ``functional fiber'' separately (Ref. 
24).
    The Codex definition includes a minimum degree of polymerization 
(DP) for a carbohydrate of 10, and it also provides that the inclusion 
of non-digestible carbohydrates with 3 to 9 monomeric units should be 
left to national authorities. The IOM's definition for ``total fiber'' 
includes those non-digestible carbohydrates of 3 to 9 DP (Ref. 24).
    Because we seek to include in our definition non-digestible 
carbohydrates with physiological effects that are beneficial to human 
health, regardless of size, we are proposing to adopt a definition for 
total fiber that includes a DP of >= 3, consistent with the IOM's 
definition.
    Therefore, we are proposing to amend Sec.  101.9(c)(6)(i) to 
include the following definition for dietary fiber: (1) Non-digestible 
soluble and insoluble carbohydrates (with 3 or more monomeric units) 
and lignin that are intrinsic and intact in plants; (2) isolated and 
synthetic non-digestible carbohydrates (with 3 or more monomeric units) 
that FDA has granted be included in the definition of dietary fiber, in 
response to a petition submitted to FDA under Sec.  10.30 (21 CFR 
10.30) demonstrating that such carbohydrates have a physiological 
effect(s) that is beneficial to human health; or (3) isolated and 
synthetic non-digestible carbohydrates (with 3 or more monomeric units) 
that are the subject of an authorized health claim. We invite comment 
on the proposed definition of dietary fiber.
    As proposed, under provisions 2 and 3, manufacturers would be 
required to provide evidence to FDA to demonstrate

[[Page 11910]]

the physiological effects that are beneficial to human health, of 
isolated and synthetic non-digestible carbohydrates added to food, and 
FDA would have to grant a petition or authorize a health claim before 
they can be considered as ``dietary fiber'' for declaration on the 
Nutrition Facts label. Manufacturers would use the citizen petition 
process in Sec.  10.30 or, in case of a related health claim, the 
health claims petition process in Sec.  101.70. We intend to issue 
guidance to industry on submissions to demonstrate physiological 
effects that are beneficial to human health.
    Under these proposed provisions, both [beta]-glucan soluble fiber 
(Sec.  101.81(c)(2)(ii)(A)) and barley [beta]-fiber (Sec.  
101.81(c)(2)(ii)(A)(6)) that are added to foods would meet the 
definition of dietary fiber and, therefore, would be included in the 
amount of dietary fiber declared on the Nutrition Facts label. We are 
proposing to list isolated and synthetic non-digestible carbohydrates 
that have been determined by FDA to have a physiological effect that is 
beneficial to human health, in Sec.  101.9(c)(6)(i). Accordingly, we 
are proposing to amend Sec.  101.9(c)(6)(i) to list [beta]-glucan 
soluble fiber and barley [beta]-fiber (as these substances are 
described in Sec.  101.81(c)(2)(ii)(A) and (c)(2)(ii)(A)(6), 
respectively) as isolated and synthetic non-digestible carbohydrates 
that have been determined by FDA to have a physiological effect that is 
beneficial to human health and, therefore, must be included in the 
declaration of dietary fiber. Under this process, we would amend Sec.  
101.9(c)(6)(i) to list any additional isolated and synthetic non-
digestible carbohydrates that FDA determines have a physiological 
effect that is beneficial to human health, through either the citizen 
petition process or the health claims petition process.
    ii. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act 
specifies, in part, that for each serving size or other unit of measure 
of a food, the amount of dietary fiber must be provided. Accordingly, 
FDA regulations require the declaration of dietary fiber on the 
Nutrition Facts label, as provided in Sec.  101.9(c)(6)(i).
    We did not ask any questions about the mandatory labeling of 
dietary fiber in the 2007 ANPRM, and we received no comments on this 
subject. Dietary fiber is not an essential nutrient. However, it has 
physiological effects that are beneficial to human health, such as 
attenuation of postprandial blood glucose concentrations, attenuation 
of blood cholesterol concentrations, and improved laxation (Ref. 66). 
The IOM DRI report noted that consumption of certain dietary fibers, 
particularly those that are poorly fermented (i.e., insoluble fiber), 
improve fecal bulk and laxation and ameliorate constipation (Ref. 66). 
In addition, soluble fiber plays a beneficial role in reducing the risk 
of heart disease (Ref. 66). ``Dietary fiber'' is identified as a 
nutrient of public health concern in the 2010 DGA. The 2010 DGA also 
emphasized the consumption of whole grains, in part, because they are a 
source of dietary fiber, noting that choosing whole grains that are 
higher in dietary fiber has health benefits in addition to meeting 
nutrient needs (Ref. 6).
    Given the health benefits of dietary fiber, we have no basis to 
conclude that the declaration of dietary fiber is no longer necessary 
to assist consumers in maintaining healthy dietary practices. 
Therefore, we are not proposing to change our current requirement for 
the mandatory declaration of dietary fiber in Sec.  101.9(6)(i).
    With respect to the term used to declare dietary fiber content on 
the Nutrition Facts label, we considered comments received in response 
to the 2007 ANPRM (Ref. 47). The term ``dietary fiber'' has been listed 
on the Nutrition Facts label since 1993. One survey pointed out by 
comments suggests that both ``fiber'' and ``dietary fiber'' are 
similarly acceptable by consumers (Ref. 47). Alternative terms such as 
``natural fiber'' or ``isolated fiber'' would not be appropriate to 
declare all dietary fiber given that we are proposing a definition of 
dietary fiber that includes both natural fiber and fiber that is added 
to food. Although the IOM used the term ``total fiber,'' there is no 
evidence to suggest that this term is preferable to the term ``dietary 
fiber.'' Therefore, we are not proposing to change the current 
requirement to declare dietary fiber using the term ``dietary fiber,'' 
as specified in Sec.  101.9(f). However, we request comment on this 
issue, including consumer understanding of the term ``dietary fiber'' 
relative to other relevant terms.
    iii. Analytical methods. Per FDA regulations, compliance with the 
requirement for declaration of dietary fiber is determined using 
appropriate AOAC analytical methods (58 FR 2079 at 2113; Sec.  
101.9(g)(2)). In the 2007 ANPRM, we noted the IOM Panel's consideration 
of analytical issues related to dietary fiber, and asked whether we 
should continue to use the AOAC International methods to determine the 
amount of dietary fiber and, if not, what other or additional methods 
should be used.
    We reviewed comments (Ref. 47) received as well as current AOAC 
methods for dietary fiber and the various analytes measured by these 
methods in light of our proposed definition for dietary fiber. AOAC 
methods, such as AOAC 985.29, 991.43 and 994.13, measure soluble and 
insoluble polysaccharides, lignin, higher molecular weight non-
digestible oligosaccharides (DP > 12), and some resistant starch, 
inulin and low molecular weight non-digestible oligosaccharides (DP < 
10). These methods do not measure all non-digestible carbohydrates with 
a DP < 10. In contrast, newer methods (AOAC 2009.01 and AOAC 2011.25) 
measure all low molecular weight non-digestible carbohydrates (i.e., 
non-digestible oligosaccharides) in addition to the higher molecular 
weight non-digestible carbohydrates (Ref. 83). Thus, these newer, more 
inclusive AOAC methods would be more consistent with our proposed 
definition. However, there is no analytical method that can distinguish 
non-digestible carbohydrates that have a beneficial physiological 
effect from those that do not.
    We are proposing to amend Sec.  101.9(c)(6)(i) to indicate that 
dietary fiber content may be determined by subtracting the amount of 
non-digestible carbohydrates added during processing that do not meet 
the definition of dietary fiber (in proposed Sec.  101.9(c)(6)(i)) from 
the value obtained using AOAC 2009.01, AOAC 2011.25 or an equivalent 
AOAC method of analysis as given in the ``Official Methods of Analysis 
of the AOAC International'' 19th Edition. If a product contains only 
non-digestible carbohydrates that meet the proposed definition of 
dietary fiber, using AOAC 2009.01, AOAC 2011.25, or an equivalent 
method would be sufficient to quantify the dietary fiber content of a 
food. However, if the product contains both dietary fiber that is 
included in the proposed definition (e.g., naturally occurring fibers) 
and non-digestible carbohydrates not included in the definition (e.g., 
synthetic fibers without a physiological effect that is beneficial to 
human health), neither AOAC 2009.01 or AOAC 2011.25 nor an equivalent 
AOAC method would accurately quantify the dietary fiber that could be 
declared on the Nutrition Facts label, because the determination of 
fiber by these methods would include the non-digestible carbohydrates 
that do not meet the proposed definition of dietary fiber.
    To verify that the quantity of dietary fiber declared on the 
Nutrition Facts label includes only those fibers that

[[Page 11911]]

meet the regulatory definition of dietary fiber, when a food contains a 
mixture of non-digestible carbohydrates that meet the proposed dietary 
fiber definition and those that do not, we are proposing in Sec.  
101.9(c)(6) and (g)(10) to require manufacturers to make and keep 
written records to verify the amount of added non-digestible 
carbohydrates that do not meet the proposed definition of dietary 
fiber. See discussion in section II.N. Such records would provide 
information to verify that the amount of dietary fiber declared meets 
the proposed definition. The amount of non-digestible carbohydrate 
measured by AOAC 2009.01 or AOAC 2011.25 (or an equivalent AOAC method) 
minus the amount of added non-digestible carbohydrate that has not been 
determined by FDA to have a physiological effect that is beneficial to 
human health would reflect the amount of dietary fiber lawfully 
declared on the label.
    iv. DRV. The DRV for dietary fiber is 25g (Sec.  101.9(c)(9)). We 
did not ask specific questions in the 2007 ANPRM and received no 
comments on the DRV for dietary fiber. In 2002, the IOM set an AI of 14 
g/1,000 kcal for ``total fiber'' (Ref. 66). The AI was primarily based 
on the intake level that was associated with the greatest reduction in 
the risk of CHD. We are proposing to define dietary fiber to include 
those fibers that have a physiological effect that is beneficial to 
human health (see section II.D.5.) and, as such, the AI for ``total 
fiber'' provides an appropriate basis for setting a DRV for dietary 
fiber declared on the Nutrition Facts label.
    Therefore, we are proposing to use 14 g/1,000 kcal as the basis for 
a DRV for dietary fiber. Using a reference calorie intake of 2,000 
calories (see section II.A.3.), we are proposing to amend Sec.  
101.9(c)(9) to set a DRV of 28 g (14g/1,000 kcal x 2,000 kcal/d) for 
dietary fiber.
    b. Soluble and Insoluble Fiber--Dietary fibers can be classified as 
being soluble or insoluble. Soluble fibers, such as pectin and gums, 
dissolve in water and are digested by the bacteria in the large 
intestine. Insoluble fibers, such as cellulose and lignin, do not 
dissolve in water and are not digested by bacteria in the large 
intestine, adding bulk to the stool for improved laxation.
    i. Definition. Like dietary fiber, FDA regulations do not establish 
definitions for soluble or insoluble fiber. The 2007 ANPRM did not ask 
questions about definitions for soluble and insoluble fiber and we did 
not receive any comments about them. Because soluble and insoluble 
fibers are components of dietary fiber, we tentatively conclude that 
soluble and insoluble fibers must meet the proposed definition of 
dietary fiber. Therefore, we are proposing in Sec.  101.9(c)(6)(i)(A) 
and (c)(6)(i)(B) that soluble fiber and insoluble fiber, respectively, 
must meet the definition of dietary fiber in paragraph 101.9(c)(6)(i).
    ii. Voluntary declaration. FDA regulations permit, but do not 
require, the declaration of soluble fiber (Sec.  101.9(c)(6)(i)(A)) and 
insoluble fiber (Sec.  101.9(c)(6)(i)(B)) on the Nutrition Facts label. 
In the 2007 ANPRM, FDA asked whether the declaration of soluble and 
insoluble fiber should continue to be voluntary or made mandatory. We 
considered comments received (Ref. 47).
    While a quantitative intake recommendation is not available from 
relevant U.S. consensus reports, there is well-established evidence 
showing that soluble and insoluble fibers have distinct physiological 
effects that are beneficial to human health. For example, the IOM noted 
that the body of evidence indicates that non-fermentable fiber sources 
(often isolated as insoluble fiber) promote laxation, and improved 
laxation is an established physiological effect that is beneficial to 
human health (Ref. 66). Therefore, we tentatively conclude that soluble 
and insoluble fibers that meet the definition of dietary fiber have 
public health significance and, in the absence of quantitative intake 
recommendations, are consistent with the considerations for voluntary 
declaration explained in section I.C. Accordingly, we are proposing to 
continue to provide for the voluntary declaration of soluble and 
insoluble fibers, as specified in Sec.  101.9(c)(6)(i)(A) and (B).
    With respect to the term used to declare dietary fiber content on 
the Nutrition Facts label, in 2001, the IOM Panel recommended that the 
terms ``soluble'' and ``insoluble'' fiber be phased out and replaced 
with relevant descriptors of the physicochemical properties of 
particular fibers (e.g., ``viscous'' or ``fermentable'' fiber to 
replace ``soluble'' fiber), as the characterization of the properties 
of various fibers becomes standardized (Ref. 24). In the 2007 ANPRM, we 
noted this recommendation and asked for public comment on whether the 
terms ``soluble fiber'' and ``insoluble fiber'' should be changed to 
``viscous'' and ``nonviscous'' fiber.
    We considered the IOM recommendations as well as comments received 
(Ref. 47), and tentatively conclude that the terms ``soluble fiber'' 
and ``insoluble fiber'' are most appropriate for reasons discussed in 
this document. While the IOM recommended replacing ``soluble fiber'' 
and ``insoluble fiber'' with appropriate physicochemical terms as the 
characterization of the properties of various fibers becomes 
standardized, such standardization has not yet occurred. In addition, 
as the comments stated, viscosity does not predict fermentability (Ref. 
47), which the IOM recognized is a physicochemical property that is 
linked to health benefits, and it is not known at what level of 
viscosity a fiber begins to have a physiological effect (Ref. 66). 
Moreover, there are no currently available scientifically valid methods 
that FDA could use to measure the amount of various fibers defined by 
their physicochemical properties in various food matrices, whereas 
scientifically valid methods to measure soluble and insoluble fiber are 
currently available. Therefore, we are not proposing any changes to the 
use of terms ``soluble fiber'' and ``insoluble fiber'' in the Nutrition 
Facts label.
    iii. Analytical methods. Per FDA regulations, compliance with any 
declaration of soluble or insoluble fibers is determined using 
appropriate AOAC analytical methods (Sec.  101.9(g)(2)). While there 
are a number of traditional AOAC methods available for measuring 
soluble fiber (e.g., AOAC 991.43 and 993.19) and insoluble fiber (e.g., 
AOAC 991.42 and 991.43), as is the case with dietary fiber, these 
methods cannot measure all non-digestible carbohydrates with a DP < 10. 
A newer method, AOAC 2011.25 (Ref. 83), can measure low molecular 
weight non-digestible carbohydrates, as well as separately measure 
soluble and insoluble non-digestible carbohydrates. However, as in the 
case of AOAC 2009.01, AOAC 2011.25 (Ref. 83) cannot distinguish soluble 
and insoluble non-digestible carbohydrates that have a physiological 
effect that is beneficial to human health from those that do not.
    We are proposing to amend Sec.  101.9(c)(6)(i)(A) and (c)(6)(i)(B) 
to indicate that the soluble and insoluble non-digestible carbohydrate 
content may be calculated by first using AOAC 2011.25, or an equivalent 
AOAC method of analysis. If a food contains only non-digestible 
carbohydrates that meet the proposed definition of dietary fiber (e.g., 
contains naturally occurring fiber only), then AOAC 2011.25 or an 
equivalent AOAC method would measure the amount of soluble or insoluble 
fiber that can be declared on the Nutrition Facts label. If a food 
contains a mixture of non-digestible carbohydrates that do and do not 
meet the proposed dietary fiber definition, and the label of the food 
declares soluble or insoluble fiber content, we are proposing to amend 
Sec.  101.9(c)(6)(i)(A) and (c)(6)(i)(B) to

[[Page 11912]]

require manufacturers to make and keep records to verify the amount of 
soluble or insoluble non-digestible carbohydrates that do not meet the 
proposed definition of dietary fiber that have been added to the food 
product during processing. (See discussion in section II.N.)
    iv. DRV. FDA regulations do not establish DRVs for soluble fiber or 
insoluble fiber. No DRIs were established for soluble or insoluble 
fiber during the IOM's evaluation of a DRI for dietary fiber (Ref. 66), 
and we have no basis on which to derive an appropriate DRV. Therefore, 
we are not proposing to set a DRV for either soluble fiber or insoluble 
fiber.
    v. Caloric value. Per FDA regulations, the caloric content of a 
food may be calculated by, among other methods, using the general 
factors of 4, 4, and 9 kcal/g for protein, total carbohydrate less the 
amount of insoluble dietary fiber, and total fat, respectively (Sec.  
101.9(c)(1)(i)(C)). Accordingly, soluble fiber, which is encompassed 
within ``total carbohydrate,'' is assigned a general factor of 4 kcal/
g. We did not ask questions about the caloric value of dietary fibers 
in the 2007 ANPRM, but received a few comments on the caloric value of 
soluble fiber, including that 4 kcal/g for soluble fiber was too high 
and that we should consider 2 kcal/g, which is the caloric value 
identified by the United Nations Food and Agriculture Organization. We 
also received a citizen petition from the Calorie Control Council 
requesting that the caloric value of soluble fiber be no more than 2 
kcal/g (Docket No. FDA-1997-P-0232), based on the caloric contribution 
of energy yielding short chain fatty acids that are produced as a 
result of colonic fermentation of soluble fiber (http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0232).
    We agree with the comments and the petition supporting a caloric 
value of 2 kcal/g for soluble fiber. The anaerobic fermentation of 
soluble fibers in the colon has been shown to yield less energy than 
the 4 kcal/g obtained from aerobic metabolism of carbohydrates (Ref. 
66). In addition, the absorption of energy yielding short chain fatty 
acids that are produced as a result of colonic fermentation of soluble 
fiber can vary, and data indicate that the average energy yield from 
soluble fibers is 1.5 to 2.5 kcal/g (Ref. 66). Therefore, we 
tentatively conclude that 2 kcal/g is a reasonable estimate of the 
caloric value of soluble non-digestible carbohydrates. Accordingly, we 
are proposing to amend Sec.  101.9(c)(1)(i)(C) to establish a general 
factor of 2 kcal/g as the caloric value of soluble non-digestible 
carbohydrates. Insoluble non-digestible carbohydrates are not included 
in the caloric calculation.
    We are also proposing a corresponding change to the introductory 
text in Sec.  101.9(c)(1)(i)(C) to exclude non-digestible carbohydrate 
from total carbohydrate. FDA regulations require that the calories from 
total carbohydrate be calculated by using the general factor of 4 kcal/
g of carbohydrate less the amount of insoluble dietary fiber (Sec.  
101.9(c)(1)(i)(C)). We are proposing a new definition of dietary fiber 
(see section II.D.5.a.i.) that only allows for the declaration of 
dietary fibers that are added to foods that we have determined to have 
a physiological effect that is beneficial to human health, as ``dietary 
fiber'' on the Nutrition Facts label. Therefore, the proposed new 
definition of dietary fiber would exclude soluble and insoluble non-
digestible carbohydrates that do not meet the proposed definition of 
dietary fiber. For the purposes of calculating calories from soluble 
non-digestible carbohydrate, the proposed factor of 2 kcal/g should 
apply to those soluble non-digestible carbohydrates that both do and do 
not meet the proposed definition of dietary fiber. To ensure that 
soluble non-digestible carbohydrates that do and do not meet the 
proposed definition of dietary fiber are excluded from total 
carbohydrate, such that a general factor of 2 kcal/g is applied to 
these non-digestible carbohydrates, we are proposing to amend Sec.  
101.9(c)(1)(i)(C) to require that calories from carbohydrate be 
calculated using a general factor of 4 kcal/g of total carbohydrate 
less the amount of non-digestible carbohydrates, which includes soluble 
and insoluble non-digestible carbohydrates that do and do not meet the 
definition of dietary fiber (see also section II.D.1.f.).
6. Other Carbohydrate
    FDA regulations define ``other carbohydrate'' as the difference 
between total carbohydrate and the sum of dietary fiber, sugars, and 
sugar alcohol, except that if sugar alcohol is not declared, ``other 
carbohydrate'' is defined as the difference between total carbohydrate 
and the sum of dietary fiber and sugars (Sec.  101.9(c)(6)(iv)). 
Examples of ``other carbohydrate'' include starch and oligosaccharides. 
A statement of the amount of ``other carbohydrate'' may be voluntarily 
declared on the Nutrition Facts label (Sec.  101.9(c)(6)(iv)). We did 
not ask questions about the labeling of ``other carbohydrate'' in the 
2007 ANPRM, and we received no comments on this issue. However, we 
reconsidered the provision for voluntary declaration of ``Other 
carbohydrate'' on the Nutrition Facts label based on the factors we 
consider for the mandatory and voluntary declaration discussed in 
section I.C.
    ``Other carbohydrate'' represents different types of carbohydrate, 
and, unlike sugars and dietary fiber, carbohydrates covered under this 
heterogeneous category have no shared physiological effects. Moreover, 
there is no well-established evidence to support the role of particular 
types of carbohydrate that fall within the ``other carbohydrate'' 
category, such as starch and oligosaccharides, in human health that is 
based on reliable and valid physiological or clinical endpoints. In 
addition, a quantitative intake recommendation for ``Other 
carbohydrate'' is not available from relevant consensus reports. Given 
the lack of public health significance or a quantitative intake 
recommendation for ``other carbohydrate'' as a category, consistent 
with the factors discussed in section I.C., we tentatively conclude 
that ``Other carbohydrate'' should no longer be permitted to be 
declared on the Nutrition Facts label.
    Therefore, we are proposing to remove current Sec.  101.9(c)(6)(iv) 
to remove the provision that allows for the voluntary declaration of 
``Other carbohydrate'' on the Nutrition Facts label. We are also 
proposing to make a corresponding revision to Sec.  101.9(g)(4) and 
(g)(6) to remove references to ``Other carbohydrates.'' We invite 
comment on this issue, including any other data or factual information 
that we should consider in making a final determination.

E. Protein

1. Mandatory and Voluntary Declaration
    Section 403(q)(1)(D) of the FD&C Act requires food labeling to bear 
nutrition information about protein. FDA regulations require the 
declaration of the amount of protein by weight, and provide for 
voluntary declaration of the percent DV for protein on the Nutrition 
Facts label (Sec.  101.9(c)(7)(i)). In response to the 2007 ANPRM, one 
comment supported the current approach, whereas another comment 
recommended that FDA require the labeling of the percent DV for 
protein.
    We considered current scientific evidence and comments received 
(Ref. 47). There is strong evidence based on valid physiological and 
clinical endpoints that protein is an essential nutrient that is 
necessary for human health and growth (Refs. 6 and 84). Therefore, we 
tentatively conclude that the declaration of protein content

[[Page 11913]]

remains necessary to assist consumers in maintaining healthy dietary 
practices. In addition, because protein intake in the U.S. population 
continues to be adequate when compared to the EAR absent a mandatory 
percent DV declaration (Ref. 85), we tentatively conclude that the 
declaration of protein as a percent DV should remain voluntary. 
Accordingly, we are not proposing any changes to the requirement for 
declaration of the quantitative amount of protein and the voluntary 
declaration of this amount as a percent DV on the Nutrition Facts 
label.
2. Analytical Methods
    Under Sec.  101.9(c)(7), protein may be calculated on the basis of 
6.25 times the nitrogen content of the food determined by the 
appropriate method of analysis as given in the Official Methods of 
Analysis of AOAC International, 15th ed. (1990), except when the 
official procedure for a specific food requires another factor. On 
December 21, 2000, we received a citizen petition from Protein 
Technologies International, Inc. (FDA-2000-P-0569), requesting that FDA 
amend the reference to the method used to calculate protein content 
found in Sec.  101.9(c)(7) to read ``the appropriate method of analysis 
as given in the Official Methods of Analysis of the AOAC International, 
17th ed. (2000)'' (http://www.regulations.gov/#!docketDetail;D=FDA-
2000-P-0569). The petition explained that the only approved method for 
use in human food in the 15th edition of the AOAC Official Methods of 
Analysis was the Kjeldahl method, which the petition stated involves 
the use of a mercury catalyst and, therefore, can be potentially 
harmful to humans and the environment. The petition asserted that the 
17th edition of the AOAC Official Methods of Analysis recognized an 
alternative method, the Combustion method, also known as the Dumas 
method, to measure protein levels in some human foods and that we 
should permit its use for measuring protein content.
    We note that not all Kjeldahl methods included in the Official 
Methods of Analysis of the AOAC contain a mercury catalyst. 
Furthermore, the Kjeldahl method is a well-recognized, standard method 
for determination of protein content. In fact, it is the method cited 
for use in determination of protein digestibility in the ``Protein 
Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on 
Protein Quality Evaluation'' (Ref. 86) that is incorporated by 
reference in Sec.  101.9(c)(7)(ii).
    As discussed in section II.N.2., we see a need to update the 
version of the Official Methods of Analysis of the AOAC International 
that we use for compliance purposes because newer, and sometimes 
better, analytical methods for many nutrients are included in versions 
of the methods that have been published since the 15th edition. We are, 
therefore, proposing to amend Sec.  101.9(c)(7) to incorporate by 
reference the Official Methods of Analysis of the AOAC International, 
19th ed. (2012) by removing ``15th Ed. (1990)'' and adding in its place 
``19th Ed. (2012).'' The 19th edition is the most recent edition of the 
published AOAC methods, and includes both the Kjeldahl and the 
Combustion/Dumas methods. While the petition requested that the Agency 
amend Sec.  101.9(c)(7) to incorporate the 17th edition of the AOAC 
methods, the 19th edition includes all of the methods for protein that 
were available in the 17th edition. Thus, the proposed action is 
consistent with the petition's request. If a newer version of the 
Official Methods of Analysis of the AOAC International is published 
before publication of the final rule (assuming that this rulemaking 
does result in a final rule), we will consider, as appropriate, using 
the most recent version of the official AOAC methods in the final rule. 
To the extent that the methods for protein determination in the newer 
version differ from those provided in the 19th edition of the Official 
Methods of Analysis of the AOAC International, we will consider the 
need to seek additional public comment on the version of the AOAC 
Methods of Analysis of the AOAC International that is incorporated by 
reference in Sec.  101.9(c)(7).
3. DRV
    The DRV for protein is 50 g (Sec.  101.9(c)(9)) and represents 10 
percent of the 2,000 reference calorie intake level. The IOM Labeling 
Committee considered the IOM's AMDR for protein (10 to 35 percent of 
energy intake for adults) and the AMDRs for fat and carbohydrates, and 
recommended setting the DV for protein based on the difference between 
total energy intake and the combined DVs for fat and carbohydrate 
(i.e., 100 percent of energy - (DVfat + 
DVcarbohydrate). The 2007 ANPRM requested comment on whether 
the DV for protein should be based on (1) the approach recommended in 
the IOM Labeling Report; (2) the midpoint of the AMDR for protein 
(i.e., 22.5 percent); or (3) the EAR or RDA for protein. We received 
comments on each of these approaches (Ref. 47). Overall, comments 
supported the approach recommended in the IOM Labeling Report and 
maintaining the DV of 50 g/d.
    We considered current scientific recommendations and agree with the 
comments that supported the continued use of the current approach. 
First, as explained in sections II.B. and II.D., we are not proposing 
to change the DRVs for fat (30 percent of calories from fat or 65 g) or 
carbohydrate (60 percent of calories from carbohydrate or 300 g). 
Applying the IOM Labeling Committee's recommended approach, given our 
tentative conclusions on DRVs for fat and carbohydrates, that approach 
would result in no change to the DRV for protein, i.e., 10 percent (100 
- (60 + 30)) of calories from protein.
    Second, at 10 percent of caloric intake and using a reference 
energy intake of 2,000 calories, the DRV for protein is set at 50 g, 
which is relatively close to the IOM's RDAs for men and women. The 
RDAs, which represent values that meet the needs of almost all (97 to 
98 percent) individuals in a group, are set at 0.80 g/kg for men and 
women who are 19 years and older, 0.85 g/kg for boys and girls 14 to 18 
years of age, and 0.95 g/kg for boys and girls 4 to 13 years of age. 
Using reference weights established for age and gender groups, the 
resulting values are 56 g/d for males and 46 g/d for females who are 19 
years of age or older (not including pregnant and lactating women), 52 
g/d for males and 46 g/d for females between the ages of 14 through 18 
years of age, 34 g/d for males and females between the ages of 9 and 13 
years, and 19 g/d for males and females between the ages of 4 through 8 
years. Thus, the DRV of 50 g for protein falls within the range of the 
RDAs calculated using reference weights.
    We do not consider the midpoint of the AMDR of 22.5 percent of 
energy intake to provide the most appropriate basis for a DRV for 
protein. We have no data to show that protein intakes are inadequate or 
that setting a higher DRV that is based on the midpoint of the AMDR is 
needed to prevent chronic diseases such as cardiovascular disease, 
obesity, and sarcopenia, as asserted by some comments (Ref. 47). The 
AMDR is a range of intakes for a particular energy source that is 
associated with reduced risk of chronic diseases while providing 
adequate intakes of essential nutrients (Ref. 20). The DRV of 10 
percent of calories from protein falls within the AMDR. Thus, the DRV 
for protein falls within a range of protein consumption that is 
associated with a reduced risk of chronic disease while providing 
essential nutrients.

[[Page 11914]]

    Finally, we consider the use of the population-weighted EAR to be 
inappropriate. First, as the comments pointed out (Ref. 47), using the 
population-weighted EAR could lead to inadequate consumption in some 
subpopulations, such as males 19 years and older. In addition, the EARs 
for protein are expressed in terms of g/kg of body weight and based on 
consumption of good quality or ``complete'' protein. In order to 
calculate a DRV from the population-weighted EAR for the purposes of 
nutrition labeling, a reference body weight would have to be selected. 
Although we could use the EER predictive equations included in the 
IOM's DRI macronutrient report (Ref. 50) to determine a reference body 
weight, these values may be inappropriate for the general U.S. 
population, which has a high percentage of overweight individuals. The 
IOM Labeling Report stated that deriving a label reference value for 
protein based on values from the EER predictive equations may not be 
appropriate for large segments of the North American population for the 
same reason (Ref. 25).
    Therefore, we tentatively conclude that the DRV for protein should 
continue to be based on 10 percent of calories. Accordingly, we are not 
proposing to change the DRV of 50 g for protein.

F. Sodium

1. Mandatory Declaration
    FDA regulations require the declaration of sodium content on the 
Nutrition Facts label (Sec.  101.9(c)(4)). The 2007 ANPRM did not ask 
any questions about the mandatory declaration of sodium, but one 
comment that recommended the declaration of sodium should remain 
mandatory because the information can help consumers who are concerned 
about sodium and salt make appropriate food choices.
    Americans 4 years and older consume an average of approximately 
3,650 mg sodium/d (NHANES 2003-2006), which is more than twice the 
amount required to meet their adequate intake (1,500 mg/day for 
individuals 9 to 50 years old). Evidence continues to support the 
association between increased sodium consumption and increased blood 
pressure. In 2005, the IOM noted the direct relationship between sodium 
intake and increased blood pressure (Ref. 10). The 2010 DGAC and the 
2013 IOM committee on Sodium Intake in Populations (Ref. 87) concluded 
that a strong body of evidence has been documented in adults that as 
sodium intake decreases, so does blood pressure (Ref. 30). We agree 
with the comment that information about sodium content on the food 
label can help consumers make appropriate food choices.
    Therefore, we tentatively conclude that declaration of sodium 
should remain mandatory so consumers are provided information necessary 
to assist them in maintaining healthy dietary practices. Accordingly, 
we are not proposing to amend the current requirement for declaration 
of sodium in Sec.  101.9(c)(4).
2. DRV
    a. Need to update the DRV--The DRV for sodium is 2,400 mg (Sec.  
101.9(c)(9)). New scientific data and consensus reports on sodium 
published since the 1993 final rule (58 FR 2206 at 2224) highlight the 
need to reconsider the DRV. Recent key consensus reports and 
recommendations that FDA reviewed in reconsidering the DRV are as 
follows:
    i. IOM DRI Electrolytes Report. In 2005, the IOM established AIs 
and ULs for sodium (Ref. 10). The IOM found that data from dose-
response trials for determining the daily requirement for sodium were 
insufficient to establish an EAR for sodium and, thus, an RDA could not 
be determined and an AI was set. The AIs for sodium are intake levels 
that meet or exceed the daily nutrient requirement, i.e., the 
recommended daily average intake levels that are needed to meet the 
sodium needs of most healthy and moderately active individuals, are 
1,500 mg/d for individuals 9 to 50 years, 1,300 mg/d for individuals 51 
to 70 years, and 1,200 mg/d for individuals older than 70 years and for 
children 4 to 8 years of age. AIs meet or exceed the intake levels 
required to meet nutrient needs and there is no benefit in consuming a 
nutrient in excess of its AI.
    Data available to the IOM showed that; (1) a carefully planned diet 
that provided an average of approximately 1,500 mg/d of sodium can meet 
recommended intakes of other nutrients; (2) 1,500 mg/d exceeds the 
levels of sodium intake that have been associated with effects of 
inadequacy, such as adverse effects on blood lipid concentrations and 
insulin resistance; and (3) 1,500 mg/d allows for sodium sweat losses 
in acclimatized individuals who are exposed to high temperatures or who 
become physically active. The AI does not apply to individuals who are 
highly active and workers who are exposed to heat stress that lose 
large volumes of sodium in sweat (Ref. 10).
    ULs are the highest level of daily nutrient intake that is likely 
to pose no risk of adverse health effects to almost all individuals in 
the general population (Ref. 10). The major adverse and dose-dependent 
effect of increased sodium intake is elevated blood pressure and the 
IOM noted that the relationship between sodium intake and blood 
pressure is continuous, making it difficult to set a precise UL because 
other environmental factors (weight, exercise, potassium intake, 
dietary pattern, and alcohol intake) and genetic factors also affect 
blood pressure. The ULs for sodium are 2,300 mg/d for all individuals 
ages 14 years and older, 1,900 mg/d for children 4 to 8 years old, and 
2,200 mg/d for adolescents 9 to 13 years old. The UL is not intended to 
be a recommended intake level to encourage, but rather a level not to 
exceed.
    The IOM stated that the UL may be lower than 2,300 mg/d among 
certain groups who are at increased risk of the blood pressure-raising 
effects of increased sodium intake (e.g., older individuals, African 
Americans, and individuals with hypertension, chronic kidney disease, 
or diabetes), but insufficient data prevented IOM from defining a 
specific UL for these groups. Instead, the IOM set the same UL for 
these population groups as the one for the general population (i.e., 
2,300 mg/d), with the acknowledgment that the actual UL for this group 
may be lower.
    ii. IOM Report on the Strategies to Reduce Sodium Intake in the 
United States (IOM Sodium Strategies Report). After considering current 
trends in hypertension, sodium consumption, sodium content of the food 
supply, and existing strategies for sodium reduction, the IOM developed 
various strategies for reducing dietary sodium intake to levels 
recommended by the 2005 DGA. Among various recommendations to 
Government Agencies, food manufacturers, consumers, and other 
stakeholders, the IOM recommended that FDA adopt 1,500 mg as the DV for 
sodium, given that sodium is an essential nutrient and that, unlike in 
1993 (58 FR 2206 at 2224), a reference value of adequacy is now 
available (i.e., the AI of 1,500 mg/d).
    iii. 2010 DGA. The 2005 DGA made a key recommendation for the 
general U.S. population to consume less than 2,300 mg/d of sodium and 
that individuals with hypertension, African-Americans, and middle-aged 
and older adults should aim to consume no more than 1,500 mg/d of 
sodium (Ref. 36). In 2010, the DGAC evaluated evidence considered in 
the 2005 DGAC report in addition to new research on the relationship 
between sodium intake and blood pressure, focusing on the strength of 
the scientific evidence (Ref. 30). The 2010 DGAC report noted that 
1,500 mg/d should be the intake goal for the

[[Page 11915]]

general U.S. population. Further, the DGAC noted that, given the 
current U.S. marketplace and the resulting excessively high sodium 
intake, it will be challenging to achieve the lower level. The 2010 
DGA, considering the 2010 DGAC conclusions, recommended a reduction in 
sodium intake to less than 2,300 mg/d and a further reduction to 1,500 
mg/d among African Americans, individuals with hypertension, diabetes, 
or chronic kidney disease, and individuals ages 51 years or older.
    iv. IOM Report on Sodium Intake in Populations, Assessment of 
Evidence, 2013 (Ref. 87). The charge to the committee focused on 
literature published since 2003, therefore they reviewed literature 
between 2003 and 2012. The committee assessed the benefits and adverse 
outcomes (if any) of reducing sodium intake, particularly in the range 
of 1,500 to 2,300 mg/d, with an emphasis on the subgroups known to be 
at increased risk of the blood pressure-raising effects of increased 
sodium intake. Based on the review of studies that assessed 
cardiovascular events and mortality, the committee found that evidence 
from studies on direct health outcomes is inconsistent and insufficient 
to conclude that lowering sodium intakes below 2,300 mg/d will increase 
or decrease the risk of CVD outcomes or all-cause mortality in the 
general U.S. population. The committee also concluded that the evidence 
from direct health outcomes does not support recommendations for 
subgroups (people with diabetes, chronic kidney disease and pre-CVD) to 
lower their sodium intake to or even below 1,500 mg/d. No relevant 
evidence was found on health outcomes for the other population 
subgroups considered (i.e., African Americans and persons 51 years of 
age and older).
    b. CSPI petition--In 2005, we received a citizen petition from CSPI 
(2005 CSPI petition) requesting, among other sodium related issues, 
that FDA initiate rulemaking to reduce the DRV for sodium from 2,400 to 
1,500 mg (Docket No. FDA-2005-P-0196 (formerly Docket No. 2005P-0450)) 
(http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0196). Citing 
the 2005 DGA, the petition requested that FDA adopt a DV of 1,500 mg 
because that is the recommended maximum intake for roughly one-half of 
the adult population (i.e., people with hypertension, African-
Americans, and middle-aged and older people). According to the 
petition, when recommended intake levels vary among population groups, 
FDA has typically been conservative, choosing a DV that is most 
protective. In this proposed rule, we are responding to the petition's 
request to reduce the DRV for sodium from 2,400 mg to 1,500 mg. The 
petition's other requests are outside the scope of this rulemaking.
    c. Comments to 2007 ANPRM--In the 2007 ANPRM, we asked whether a 
new DV for sodium should be based on the UL or on the AI. We also asked 
whether the UL, were it to be used, should reflect the same approach 
(population-weighted or population-coverage) as the other DRIs. While a 
few comments supported retaining the current DRV of 2,400 mg, the 
majority of comments supported using the UL of 2,300 mg/d. Some other 
comments recommended setting a DV for sodium based on the AI of 1,500 
mg/d. One comment urged that we adopt a tiered two-phase, step-down 
approach establishing an interim DRV of 2,000 mg in 2013 and a final 
revised DRV of 1,500 mg by 2020. See also (Ref. 47).
    d. Options Considered--When the Nutrition Facts label was developed 
in the early 1990s, no RDA or Estimated Safe and Adequate Daily Dietary 
Intake (ESADDI) levels were available for consideration. While the 
National Academy of Sciences established 500 mg/d as an estimated 
minimum requirement for healthy adults in 1989, the Agency relied on 
the recommendation from 1989 National Research Council Report Diet and 
Health: Implications for Reducing Chronic Disease Risk (Ref. 88) that 
provided a quantitative intake recommendation for salt, based on blood 
pressure, that was equivalent to 2,400 mg/d as a value that consumers 
should not exceed (58 FR 2206 at 2223, 2224). There is debate in the 
scientific community about the appropriate DV for sodium, taking into 
account its essentiality in relatively small amounts as well as its 
association with increased blood pressure at greater but varying levels 
of intake.
    Current recommendations recognize the benefits of reduced sodium 
intake in the general population, despite the heterogeneity among 
individuals in blood pressure responses to changes in sodium intake. 
Although several factors influence inter-individual variability in 
blood pressure responses to changes in dietary sodium, certain 
population groups have been reported to have a higher prevalence of 
salt sensitivity and are considered to be most at risk of sodium-
related chronic disease. Salt sensitivity is the extent of change in 
blood pressure in response to a change in salt intake (Ref. 10). Salt 
sensitivity differs among subgroups of the population as well as among 
individuals within a subgroup. Subgroups that have been reported to 
have a high prevalence of salt sensitivity include individuals 51 years 
of age and older, African Americans, and individuals with hypertension, 
diabetes or chronic kidney disease. The 2010 DGA recommended that 
Americans reduce sodium intakes and also noted that these population 
subgroups, representing nearly half of the U.S. population, would 
benefit from even greater reductions in sodium intake than the general 
population. We have considered the challenges related to lowering the 
DV for sodium. For example, lowering the value on which the percent DV 
declaration is based would likely require efforts to ensure consumer 
understanding of the new percent DV declaration of sodium on the 
Nutrition Facts label. Based on recent dietary recommendations from 
consensus reports, currently available scientific evidence, comments in 
response to the 2007 ANPRM, and the 2005 CSPI petition, we considered 
the following options for updating the DV for sodium:
    (1) A DRV of 2,300 mg which reflects the UL for individuals aged 14 
years and older;
    (2) An RDI of 1,500 mg which reflects the AI for individuals 9 to 
50 years of age; and
    (3) Alternative approaches such as retaining a DRV of 2,400 mg, 
using a tiered approach or setting a DRV of 1,900 mg based on the UL 
for children 4 to 9 years of age.
    i. DRV of 2,300 mg/d. A DRV of 2,300 mg, which represents the UL 
for the majority of the population (persons 14 years of age and older), 
would be consistent with both the 2005 and 2010 DGA recommendations for 
sodium intake for the general population, as well as the 2013 IOM 
report on Sodium Intake in Populations. However, while a DRV of 2,300 
mg would reflect the UL that is applicable to 88 percent of the U.S. 
population, including those who are susceptible to the blood pressure-
raising effects of sodium, it would exceed the UL for children 4 to 13 
years of age which is 1,900mg/day for children 4-8 years of age and 
2,000mg/day for children 9-13 years of age.
    Setting the DV at 2,300 mg would classify the level as a DRV 
(rather than an RDI) and represent a reference intake level not to 
exceed. As such, it would be consistent with our current and proposed 
approach to using DRVs for other nutrients that should be limited in 
the diet and for which there are concerns of excess intake and risk of 
chronic disease or health-related conditions, for example, saturated 
fat

[[Page 11916]]

and cholesterol. The current and proposed DRVs for saturated fat and 
cholesterol are based on quantitative intake recommendations and 
underlying science that links the excess intake of these nutrients to 
specific adverse health effects (Ref. 6) (see sections II.B.2 and 
II.C.). We do note, however, that unlike saturated fat and cholesterol, 
sodium is an essential nutrient and, in the DRI Electrolytes report, 
the IOM established an AI for sodium.
    Results from the FDA Health and Diet Surveys have shown that 
consumers are aware that too much sodium is unhealthy (Refs. 39 to 41) 
and this awareness would suggest consumer acceptance of a DV based on a 
level not to exceed would be consistent with a DRV of 2,300 mg. 
Changing the DRV from 2,400 mg to 2,300 mg would likely result in less 
consumer confusion than changing the DRV to an RDI (a level to achieve) 
of 1,500 mg. Moreover, we have no data to suggest that lowering the 
reference value for the percent DV could result in consumer confusion, 
as claimed by a commenter (Ref. 47).
    ii. RDI of 1,500 mg. An RDI of 1,500 mg, based on the highest AI 
(i.e., among adults aged 19 to 50 years), would provide a daily average 
intake level that would reflect a low prevalence of inadequate sodium 
intakes of healthy and moderately active individuals while allowing for 
adequate intakes of other essential nutrients. As opposed to 2,300 mg, 
a DV of 1,500 mg would classify the level as an RDI representing a 
reference intake level to achieve. The 2005 IOM electrolytes report 
reviewed the evidence on low sodium intake and blood lipid 
concentrations and insulin resistance and noted that the AI of 1,500 
mg/d exceeds the levels of sodium intake (typically less than 700 mg/d) 
that have been associated in some studies with adverse effects of blood 
lipid concentrations and insulin resistance (Ref. 10). The 2005 IOM 
electrolytes report reviewed the evidence for plasma renin and 
concluded that, in contrast to blood pressure, there is no consensus on 
the interpretation of plasma renin activity and its role in guiding 
therapy for high blood pressure (Ref. 10). Similar to plasma renin 
activity, the evidence for the role of sympathetic nerve activity and 
aldosterone is limited, and therefore neither is recognized as 
surrogate endpoints for CVD risk. Therefore, the AI of 1,500 mg/d 
exceeds the levels associated with low sodium intake and the previously 
discussed adverse effects.
    Using the population-coverage AI to set the RDI for sodium would be 
consistent with the proposed RDIs for other essential vitamins and 
minerals for which AIs are established (e.g., vitamin K and choline) 
(see section II.I.). AIs are similar to RDAs in that they meet the 
needs of essentially all members of the population. Thus, using an AI 
as a quantitative intake recommendation for setting an RDI would be 
consistent with the proposed RDIs for other essential minerals that 
have AIs or RDAs, such as potassium and calcium. Traditionally, we have 
based the RDI for essential nutrients on quantitative intake 
recommendations that reflect the intake level necessary to meet the 
daily physiological needs for that nutrient. However, unlike the 
consumption of other vitamins and minerals, the majority of the 
population consumes sodium at levels that exceed the AI and the UL. 
This makes sodium unique in comparison to other vitamins and minerals 
for which people generally must strive to meet their daily needs.
    In addition, an RDI of 1,500 mg would be consistent with the 2010 
IOM Sodium Strategies Report (Ref. 89). The IOM recommended that FDA 
base the DV for sodium on the AI of 1,500 mg/d. First, the IOM stated 
that using the AI is consistent with the approach used for all other 
essential nutrients, where the DV is based on a reference value of 
adequacy rather than a reference value of safety. Second, although 
consumer data were not provided, the IOM strategies report argued that 
the use of the AI could better inform consumers of the actual 
contribution of sodium content to total sodium needs as an essential 
nutrient. Third, the IOM stated that adopting the AI would avoid 
misleading consumers into thinking that the sodium content of foods is 
more favorable than is actually the case. As such, from a public health 
perspective, the AI would provide a truer picture for the consumer of 
the contribution of the particular foods in assembling a healthful diet 
and is preferable for this purpose over the UL. Finally, the IOM opined 
that lowering the DV might act as an incentive for companies to reduce 
the sodium content of their foods because reducing the DV would result 
in a higher value of percent DV declared on the label if sodium content 
remained unchanged.
    The 2013 IOM Sodium Intake in Populations Committee concluded that 
the evidence was insufficient and inconsistent to recommend sodium 
intake levels below 2,300 mg/d for the general U.S. population based on 
the direct outcomes of CVD or all-cause mortality. While this 
recommendation does not address blood pressure or essentiality, it 
provides a level that the general population should seek to reduce 
their consumption to and therefore is a consideration in our proposal.
    ANPRM comments pointed out challenges related to the feasibility of 
achieving a DV of 1,500 mg given the current marketplace and patterns 
of sodium consumption as well as changes in our nutrient content 
claims. If we were to adopt a DV of 1,500 mg, we anticipate that 
consumer education efforts would be needed to help consumers understand 
that the updated DV for sodium is a level to achieve rather than a 
level to consume less than and also that consuming in excess of this 
level would not be helpful. Additionally, the IOM set the AI, in part, 
at a level that would allow individuals to meet the recommended intakes 
of other nutrients if they adopted a carefully planned diet (Ref. 10) 
and consumer education efforts would need to communicate that 1,500 mg/
d is a level that consumers should achieve rather than not exceed. 
While the Agency is considering ways to support the reduction of sodium 
in the food supply (76 FR 57050), significant changes in the food 
supply would be needed to achieve this goal.
    An updated DV for sodium based on 1,500 mg/d would perhaps 
necessitate revising other relevant regulatory requirements such as 
nutrient content claims, however such revisions would be less likely if 
the DV was updated to 2,300 mg. Previously, our decision to retain the 
sodium level for a ``healthy'' claim (Sec.  101.65) at 480 mg/reference 
amount customarily consumed (RACC) was based, in part, on technological 
barriers and product acceptance issues by consumers with the more 
restrictive level of 360 mg/RACC (70 FR 56828; September 29, 2005). We 
acknowledge concerns from comments that consumers may find it difficult 
to reduce dietary sodium levels to 1,500 mg/d.
    iii. Alternative approaches.
    A few comments suggested retaining 2,400 mg as the DRV for sodium. 
Retaining the DRV of 2,400 mg would exceed the UL for sodium for the 
entire population and there is no scientific evidence to support this 
level. Therefore, we do not consider 2,400 mg an appropriate DRV for 
sodium going forward. Also, based on ANPRM comments, we considered 
setting an interim DRV of 2,300 mg that would be further lowered to an 
RDI of 1,500 mg over time, providing companies a longer time to 
manufacture new foods or reformulate existing products to lower the 
sodium content. This approach would address concerns regarding the 
feasibility of individuals being able to meet an RDI of 1,500 mg given 
taste

[[Page 11917]]

preferences and sodium content of foods in the current marketplace. A 
tiered approach would help to gradually achieve the adequate intake 
level of 1,500 mg/d and would give manufacturers time to develop lower 
sodium products and for consumers to adjust their taste preferences. In 
addition, this approach would be consistent with the 2010 DGAC 
recommendations which suggested that reduction in sodium intakes to 
1,500 mg/d among Americans should occur gradually over time to allow 
for adjustments in taste perceptions and to accompany changes in the 
sodium content of foods in the marketplace.
    We tentatively conclude that there is inadequate justification in 
consensus reports or arguments presented by comments (Ref. 47) to 
propose a tiered option. While levels of sodium intake may need to 
decrease gradually due to time needed for modifications to the sodium 
content of the food supply and consumer taste preferences, the DV for 
sodium should reflect an amount that will assist consumers in 
maintaining healthy dietary practices and in understanding the relative 
significance of the percent DV for a particular food in the context of 
the total daily diet. Moreover, DVs are based on scientific data 
supporting healthy dietary practices, not on the levels of a nutrient 
present in the food supply.
    We also considered using 1,900 mg/d, the UL for children 4 to 8 
years of age, to set the DRV for sodium. Using the lowest UL for a 
population above 4 years of age is consistent with the population-
coverage approach discussed in section II.1.5. In this case, it is a 
population-coverage approach that is protective for the age and gender 
subpopulation with the lowest relative UL, providing an intake level 
that is likely to pose no risk for any age or gender subpopulations. 
This is in contrast to the population-coverage approach, using the RDA 
or AI for other essential vitamins and minerals, to ensure that all age 
and gender subpopulations consume adequate amounts. However, a DRV of 
1,900 mg is not aligned with any recommendations from consensus reports 
including the 2010 IOM Sodium Intake in Populations and was not 
suggested by any comments.
    e. Proposed DV--After considering the options discussed previously, 
we are proposing to set a DRV of 2,300 mg for sodium based on the UL 
for individuals ages 4 years of age and older (proposed Sec.  
101.9(c)(8)(iv)). First, a DRV of 2,300 mg would be consistent with the 
current sodium intake recommendations from consensus reports. Second, a 
DRV of 2,300 mg would be consistent with our current and proposed 
approach for other nutrients that should be limited in the diet and for 
which there are concerns of excess intake and risk of chronic disease 
and health-related conditions. Third, consumers are generally aware 
that too much sodium is not healthy and therefore the current consumer 
education messaging is consistent with a DRV of 2,300 mg.
    For the reasons explained previously, we tentatively conclude that 
a DRV of 2,300 mg for sodium is the most appropriate DV to assist 
consumers in maintaining healthy dietary practices and in understanding 
the relative significance of the sodium content within the context of a 
total daily diet. We invite comment on our consideration of various 
options and tentative conclusions presented in this section. In 
particular, we invite comment on: (1) The rationale for the proposed 
DRV of 2,300 mg of sodium; (2) whether an RDI of 1,500 mg would be more 
appropriate and why; and (3) whether any alternative approaches for 
selecting a DV for sodium and their public health bases for these 
approaches could be more appropriate and why. We are also interested in 
data and factual information on consumer understanding, interpretation, 
and use of the percent DV of sodium declared on food labels, including 
the understanding and potential influences of a DV that reflects an RDI 
based on an AI (an intake level to not consume less of), instead of a 
DRV based on a UL (an intake level not to exceed).

G. Fluoride

1. Voluntary Declaration
    FDA regulations do not require or permit the declaration of 
fluoride on the Nutrition Facts label. In 1993, no U.S. consensus 
report had set a quantitative intake recommendation for fluoride. The 
2007 ANPRM did not ask questions regarding the declaration of fluoride, 
but several comments supported the voluntary declaration of fluoride in 
mg or mcg amounts (Ref. 47). We are considering in this proposed rule 
whether fluoride should be required or permitted to be declared or 
whether the lack of provisions should be maintained.
    Fluoride is a nonessential nutrient, but there is well established 
evidence for the role of fluoride in reducing the risk of dental caries 
(Ref. 90). The IOM set a quantitative intake recommendation for 
fluoride based on its role in the reduction of risk of dental caries. 
Additionally, in 2006, a FDAMA notification for a health claim for 
fluoride in bottled water and dental caries was submitted to us under 
section 403(r)(2)(G) of the FD&C Act (Ref. 91). We did not object to 
the notification, indicating that we considered the evidence submitted 
to be sufficient for bottled water that meets the standards of identity 
and quality set forth in Sec.  165.110 and the general requirements for 
health claims in Sec.  101.14 to bear the claim (Ref. 91). Given that 
the positive health effects of fluoride are well-established, we 
tentatively conclude that declaration of fluoride content of a food can 
provide consumers with information to assist them in maintaining 
healthy dietary practices. However, as discussed in section II.G.2., a 
DRV cannot be established based on available quantitative intake 
recommendations. Thus, while fluoride is a nutrient with public health 
significance, an appropriate quantitative intake recommendation is not 
available for setting a DRV.
    Therefore, consistent with the factors we consider for declaration 
of non-statutory nutrients discussed in section I.C., we are proposing 
to amend Sec.  101.9(c)(5) to provide for voluntary declaration of 
fluoride. In addition, consistent with existing provisions for 
voluntary declaration of other nutrients, we are proposing that the 
declaration of fluoride would be mandatory when a claim about fluoride 
is made on the label or in labeling of foods. We are also proposing 
that when fluoride content is declared, it must be expressed as zero 
when a serving contains less than 0.1 mg of fluoride, to the nearest 
0.1 mg increment when a serving contains less than or equal to 0.8 mg 
of fluoride, and the nearest 0.2 mg when a serving contains more than 
0.8 mg of fluoride, consistent with how we have approached incremental 
values for other nutrients that are present in food in small amounts.
2. DRV
    FDA regulations do not provide an RDI or DRV for fluoride. The 2007 
ANRPM discussed the DRIs for fluoride and asked whether we should 
establish a DV, given the availability of an AI. We considered current 
recommendations and scientific evidence as well as comments received 
(Ref. 47).
    In 1997, the IOM established DRIs (AIs and ULs) for fluoride (Ref. 
90). The AI was set at 3 mg/d for women 19 years and older and 4 mg/d 
for men 19 years or older, to represent the intake value that reduces 
the occurrence of dental caries maximally in a group of individuals 
without causing unwanted side effects. AIs for children are 0.7 mg/d (1 
through 3 years), 1 mg/d (4 through

[[Page 11918]]

8 years), and 2 mg/d (9 through 13 years). In addition, the IOM set a 
UL for fluoride at 10 mg/d (0.1 mg/kg/d) for individuals older than 8 
years, based on data that suggest that increased risk of developing 
early signs of skeletal fluorosis is associated with fluoride intakes 
greater than 10 mg/d. The UL for children 4 through 8 years is 2.2 mg/d 
based on risk of developing moderate enamel fluorosis.
    A recent report highlighted the potential adverse impact of excess 
fluoride intake (Ref. 92). These adverse impacts include moderate 
enamel fluorosis in children up to 8 years and skeletal fluorosis for 
individuals older than 8 years. In 2010, the Environmental Protection 
Agency (EPA) published a report on exposure of fluoride from various 
sources. This report provided a benchmark of no more than 0.08 mg/kg/d 
of total fluoride intake to protect 99.5 percent of the population from 
severe dental fluorosis (Ref. 92). These benchmark levels (e.g., 1.68 
mg/d for 4 to 7 years; 2.56 mg/d for 7 to 11 years; 4.08 mg/d for 11 to 
14 years of age; and 5.6 mg/d for adults) are considerably lower than 
the ULs set by IOM in 1997.
    Thus, although the IOM set AIs for fluoride based on its role in 
reducing the risk of dental caries, more recent conclusions have 
highlighted concern about dental fluorosis associated with excess 
intakes. Because an RDI of 4 mg, using the population-coverage AI of 4 
mg/d, exceeds or is equivalent to EPA's benchmark values for children 4 
to 14 years of age (1.68 to 4.08 mg/d), we are not proposing to set a 
DRV for fluoride.
    We considered concerns expressed by comments that a DRV should not 
be established because fluoride is not an essential nutrient. That 
fluoride is not essential is not, in itself, a justification for not 
establishing a DV for fluoride, because there is evidence demonstrating 
that dietary fluoride exposure is beneficial to public health owing to 
its ability to inhibit the development of dental caries in both 
children and adults (Ref. 90). However, we are not proposing to set a 
DRV for fluoride for other reasons as explained previously. We also do 
not consider that the DRV for fluoride should be set at zero because of 
concerns with adverse health effects and toxicity, as suggested by a 
comment. The IOM established an AI for fluoride based on risk reduction 
of dental caries. In addition, the ULs for children and adults that are 
set based on dental and skeletal fluorosis are greater than zero. 
Moreover, FDA regulations other than those related to nutrition 
labeling are intended to prevent excessive addition of fluoride in 
foods (Sec. Sec.  165.110 and 170.45).

H. Essential Vitamins and Minerals of Public Health Significance

    In addition to sodium, a statutorily required nutrient, FDA 
regulations require the declaration of four essential vitamins and 
minerals, namely, vitamin A, vitamin C, calcium, and iron (Sec.  
101.9(c)(8)(ii)). Vitamins and minerals that may be declared 
voluntarily are vitamin D, vitamin E, vitamin K, vitamin B6, 
vitamin B12, thiamin, riboflavin, niacin, folate, biotin, 
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, 
copper, manganese, chromium, molybdenum, chloride, and potassium. In 
1993, we identified vitamins A and C, calcium, and iron for mandatory 
declaration because we considered them to be nutrients of public health 
significance based on their inadequate dietary intakes among specific 
segments of the U.S. population and because they were identified as 
nutrients of potential public health significance in consensus reports 
(Refs. 88, 93 to 95) (58 FR 2079 at 2106). We continue to consider, 
consistent with the rationale put forth in 1993, that a vitamin or 
mineral's public health significance should be the key factor in 
mandatory labeling (58 FR 2079 at 2106).
    In this section of the proposed rule, we discuss essential vitamins 
and minerals that are not expressly required to be declared by statute 
(referred to as ``non-statutory''). We are using our discretion, as 
described in this document, to propose mandatory declaration of certain 
non-statutory essential vitamins and minerals and voluntary declaration 
of others. Our tentative conclusions are based on an assessment of 
scientific data available for these nutrients, and consideration of the 
factors discussed in section I.C. (explained in this document). The 
RDIs that we are proposing for the declaration of vitamins and minerals 
are discussed in section II.I.
    We conducted an analysis of available data to determine the public 
health significance of non-statutory essential vitamins and minerals. 
The 2010 DGA identified nutrients of public health concern for the 
general U.S. population using criteria that are similar to factors that 
FDA considered in its own analysis (Ref. 6). The factors and the 
evaluation process used in our analysis, discussed in greater detail in 
Ref. 48, incorporate whether a DRI (i.e., RDA or AI) is based on a 
chronic disease risk (e.g., osteoporosis), a health-related condition 
(e.g., high blood pressure), or a nutrient deficiency with clinical 
significance (e.g., low iron storage leading to iron deficiency anemia) 
and whether national survey data on nutrient intake, and/or, when 
available, biomarkers of nutrient status, provide evidence of 
inadequate intakes in the general healthy U.S. population (4 years of 
age and older). Furthermore, we consider whether a substantial 
prevalence exists in the general population of a chronic disease, 
health-related condition, or nutrient deficiency with clinical 
significance that was linked to the particular nutrient (e.g., 
potassium and risk of high blood pressure).
    To estimate the prevalence of nutrient adequacy or inadequacy in 
the U.S. population, we compared dietary intake data with the EAR or AI 
(whichever is established by the IOM for a particular nutrient) (Ref. 
96) and, when reliable biomarkers of nutritional status were available, 
we compared the biomarker survey data with the data on adequacy of 
nutrient intake. The use of reliable status biomarker data provides 
assessments of nutrient status, independent of subjective factors 
associated with assessing nutrient intake, such as underreporting of 
food intake (Ref. 97 pp. 373, 513, 534, 602, and 606). In the 2007 
ANPRM, we sought input on whether vitamin A, vitamin C, calcium, and 
iron are still considered to be of public health significance; and (2) 
whether there are other micronutrients of public health significance. 
We received several comments in response to these questions (Ref. 47).
    Based on our analysis of data, and considering the factors for 
mandatory and voluntary declaration discussed in section I.C. and the 
comments received, as discussed in this document, we are proposing to: 
(1) With respect to essential vitamins and minerals that are currently 
required to be declared, retain mandatory declaration of calcium and 
iron and provide for voluntary declaration of vitamins A and C; and (2) 
with respect to essential vitamins and minerals that are permitted to 
be declared, require the declaration of potassium and vitamin D and 
retain voluntary declaration of others. We discuss these proposed 
changes in this document.
1. Essential Vitamins and Minerals That Are Mandatory
    a. Calcium--Calcium content must be declared as a percent DV on the 
Nutrition Facts label (Sec.  101.9(c)(8)(ii)). In 1993, we required the 
declaration of calcium in nutrition labeling because: (1) There were a 
limited number of calcium-rich foods in the food supply; (2) calcium 
intakes in the United States were generally marginal; (3) adequate 
calcium intakes are needed to allow for

[[Page 11919]]

optimal bone mass development during childhood and young adulthood (55 
FR 29487 at 29501); and (4) calcium was identified as a nutrient of 
public health significance in the 1990 IOM report (Ref. 95) and in 
other consensus reports (Refs. 88,93,94) (58 FR 2079 at 2106). In 
response to the 2007 ANPRM, many comments maintained that calcium is 
still considered a nutrient of public health significance, especially 
in bone development, and therefore should be retained as a mandatory 
nutrient on the Nutrition Facts label.
    Our analysis of NHANES (2003-2006) data shows that usual calcium 
intakes among the U.S. population continue to be low. About 49 percent 
of individuals ages 4 years and older have usual calcium intakes from 
conventional foods below the EAR, and 37 percent have intakes from both 
conventional foods plus supplements below the EAR (table 1). The 2010 
DGA, too, recognized that low intakes of calcium are a public health 
concern for the general U.S. population (Ref. 6). We are unable to 
consider biomarker data because sensitive biochemical indicators 
reflecting calcium nutritional status are lacking.
    In setting DRIs for calcium, the IOM reviewed various endpoints 
(e.g., bone health, cancer, cardiovascular disease and diabetes), and 
bone health was the only endpoint with sufficient evidence to set a DRI 
(Ref. 22). Therefore, the IOM set age- and gender-specific DRIs based 
on the level of calcium intake consistent with bone accretion, 
achieving and maintaining bone calcium balance, minimizing the degree 
of bone loss, and reducing the risk of fracture in later stages of life 
(Ref. 22). The DRIs for calcium assume adequate intakes of vitamin D, a 
nutrient which is essential for promoting calcium absorption in the gut 
and for maintaining adequate calcium levels in the blood (Ref. 22). 
Building strong bones during childhood and adolescence can help prevent 
osteoporosis (the most common bone disease) later in life. Adequate 
calcium intakes are needed to allow for optimal bone mass development 
during childhood and young adulthood and to decrease rate of bone loss 
in adults (Ref. 22). An estimated 10 million Americans over 50 years of 
age have osteoporosis, while another 34 million are at risk and an 
estimated 1.5 million people suffer an osteoporotic-related fracture 
each year (Ref. 98). Furthermore, based on 2005-2006 NHANES data, about 
5.3 million older men and women in the United States have osteoporosis 
at the femur neck, and 34.5 million more have osteopenia (low bone 
mass) in the femur neck (Ref. 99).
    In addition, we independently reviewed data related to calcium 
intake and risk reduction of osteoporosis (Sec.  101.72) and authorized 
two health claims for this association, signifying calcium's critical 
role in the reduction of risk of this chronic disease in the general 
healthy population.
    In view of the benefits of adequate calcium intake on bone health, 
reflected in the IOM's DRIs, relatively low intakes of calcium, and the 
high prevalence of osteoporosis and osteopenia among the U.S. 
population, we tentatively conclude that calcium is a nutrient of 
public health significance and its declaration continues to be 
necessary to assist consumers in maintaining healthy dietary practices. 
Therefore, consistent with the factors we consider for mandatory 
declaration of non-statutory nutrients (see section I.C.), we are not 
proposing any changes to the current requirement for declaration of 
calcium on the Nutrition Facts label, as specified in Sec.  
101.9(c)(8)(ii).
    b. Iron--Iron must be declared as a percent DV on the Nutrition 
Facts label (Sec.  101.9(c)(8)(ii)). In 1993, we required the 
declaration of iron because (1) iron was identified as a nutrient of 
public health significance in a 1990 IOM report (Ref. 95) and in other 
consensus reports (Refs. 88,93,94); and (2) iron deficiency was a risk 
for certain segments of the U.S. population (i.e., young children, 
adolescents and women of childbearing age and pregnant women, 
especially those with low incomes) (58 FR 2079 at 2106). In response to 
the 2007 ANPRM, comments suggested retaining the mandatory declaration 
of iron because it is a nutrient of concern for women of childbearing 
age identified by the 2005 DGA (Ref. 36) and substantial numbers of 
adolescent females and women of childbearing age are iron deficient.
    Our analysis of NHANES (2003-2006) intake data shows that about 3.5 
percent of the population ages 4 years and older (excluding pregnant 
and lactating women) have inadequate iron intakes from conventional 
foods (i.e., an intake below the EAR), and about 3.3 percent have 
inadequate iron intakes from conventional foods and dietary supplements 
(table 1). Subpopulation analyses of these NHANES 2003-2006 data shows 
that about 11.2 percent of women of childbearing age (12 to 49 years of 
age) continue to have intakes below the EAR, from conventional foods 
only and 10.4 percent continue to have intakes below the EAR from 
conventional foods plus dietary supplements (table 1).
    We also considered data for several status biomarkers related to 
iron nutrition, in addition to intake data. Serum ferritin is the major 
iron-storage compound and its concentration declines in the early 
stages of the development of iron deficiency (Refs. 100 and 101). 
Although low serum ferritin concentration is an indicator of early iron 
deficiency, it does not necessarily reflect the severity of iron 
depletion as it progresses (Ref. 101). In addition to determining serum 
ferritin, when relevant NHANES data were available, we also considered 
iron deficiency based on estimating stored body iron using the ferritin 
model and the body iron model (Ref. 102). Compared to the ferritin 
model, the body iron model is reported to produce lower estimates of 
prevalence of iron deficiency, better predict anemia, and be less 
affected by inflammation, although this model has some limitations 
(Ref. 103). Data from NHANES 1999-2002 for the general U.S. population 
showed a prevalence of iron deficiency, based on serum ferritin 
concentration (less than 15 nanograms (ng)/mL), body iron stores (based 
on the ferritin model), and iron deficiency anemia (defined as having 
iron deficiency and a low hemoglobin value) of 8.3, 6.5 and 1.9 
percent, respectively (table 1). The IOM set age and gender specific 
DRIs (EARs and RDAs) based on factorial modeling, which included basal 
iron losses, menstrual losses, fetal requirements in pregnancy, 
increased requirements during growth for the expansion of blood volume, 
and/or increased tissue and storage iron (Ref. 100). Although the DRIs 
were not based directly on a chronic disease risk, iron deficiency and 
low iron stores over time will lead to iron deficiency anemia, an 
advanced stage of iron deficiency (Ref. 100). Anemia is associated with 
poor cognitive function, lower work performance, and low endurance in 
the general population; delayed psychomotor development in infants; and 
adverse pregnancy outcome (Ref. 100).
    Relevant biomarker data were available from NHANES 2003-2006 for 
certain subpopulations such as women of childbearing age (12 to 49 
years old). Analyses of these data showed that about 14 percent of 
women of childbearing age (12 to 49 years) had serum ferritin 
concentration less than 15 ng/mL, while 10 and 14.5 percent of women 
had inadequate stores of body iron based on the body iron model or 
ferritin model, respectively (table 1). In addition, about 4.7 percent 
of these women had iron deficiency anemia. Based on these prevalence 
rates, the absolute numbers of individuals with iron deficiency in 
women of

[[Page 11920]]

childbearing age using 2010 projected U.S. Census data translate into 
7.2 or 11.6 million women of childbearing age (12 to 49 years of age) 
with inadequate iron stores based on body iron model or ferritin model, 
respectively. About 3.76 million of these women are considered to have 
iron deficiency anemia. Thus, iron continues to be of public health 
significance among women of childbearing age and pregnant women, who 
account for 26 percent of the general U.S. population.
    Iron is also identified as a nutrient of public health significance 
in consensus reports. For example, Healthy People 2020 identified iron 
as a nutrient of public health significance among young children (1 to 
4 years of age), women of childbearing age (12 to 49 years of age), and 
pregnant women, and announced an objective of a ten percent reduction 
in iron deficiency (using the body iron model) by the year 2020 (Ref. 
104). Similarly, the 2010 DGA identified iron as a nutrient of concern 
among women capable of becoming pregnant and recommends choosing foods 
that supply heme iron, which is more readily absorbed by the body, 
additional iron sources, and enhancers of iron absorption such as 
vitamin C-rich foods (Ref. 6).
    Given the importance of the role of iron in public health and 
continued significance of inadequate intakes and deficiency among women 
of childbearing age, a significant portion of the general healthy 
population, we tentatively conclude that iron is a nutrient of public 
health significance and its declaration continues to be necessary to 
assist consumers in maintaining healthy dietary practices. Therefore, 
consistent with the factors used for mandatory declaration of non-
statutory nutrients (see section I.C.), we are not proposing any 
changes to the current requirement for declaration of iron on the 
Nutrition Facts label, as specified in Sec.  101.9(c)(8)(ii).
    c. Vitamin A--Vitamin A must be declared as a percent DV on the 
Nutrition Facts label (Sec.  101.9(c)(8)(ii)). In 1993, we required the 
declaration of vitamin A in nutrition labeling because (1) it was found 
in a limited number of foods within the food supply, and (2) a 1990 IOM 
labeling report (Ref. 95) identified vitamin A as a nutrient of 
potential public health significance and stated that certain 
subpopulations (children under 5 years of age) were still at risk of 
deficiency for this vitamin (58 FR 2079 at 2106). In response to the 
2007 ANPRM, several comments recommended retaining the mandatory 
declaration of vitamin A, with some noting that the 2005 DGA identified 
it as a nutrient of concern (Ref. 36). Our analysis of intake data from 
NHANES 2003-2006 estimated that about 45 percent of the general U.S. 
population has usual vitamin A intakes from conventional foods below 
the EAR, and 34 percent have intakes from conventional foods plus 
dietary supplements below the EAR (table 1). However, the prevalence of 
vitamin A deficiency is not apparent. Only about 0.3 percent of those 
ages 6 years and older (excluding pregnant and lactating women) have a 
serum retinol concentration (a biomarker of vitamin A status) below 20 
mcg/dL, a cutoff level that is used as an indicator of vitamin A 
deficiency (table 1) (Refs. 6 and 105). Because serum retinol levels 
are tightly regulated (homeostatically controlled) and do not always 
reflect total body status, using serum vitamin A for assessment of 
vitamin A status of individuals may not be useful (Ref. 101). However, 
the distribution of serum retinol levels in a population plus the 
prevalence of individuals with serum retinol levels below a given 
cutoff point may offer a better picture of the vitamin A status of a 
population (Ref. 101). Based on the analysis of distribution of serum 
retinol (NHANES 2003-2006), and the prevalence of those below the 
cutoff of 20 mcg/dL (0.3 percent), we estimated that the prevalence of 
vitamin A deficiency in the general U.S. population is not apparent.
    The IOM recognized that vitamin A deficiency is rarely seen in the 
healthy U.S. population (Ref. 105). Furthermore, the specific age and 
gender DRIs (EAR and RDA) set by the IOM were based on the amount of 
dietary vitamin A required to maintain adequate liver stores in well-
nourished subjects, rather than on a specific adverse public health 
endpoint (Ref. 105). The DRIs represent an amount that will assure 
vitamin A reserves to cover periods of increased needs such as stress 
and low vitamin A intake (Ref. 105). In addition, the 2010 DGA does not 
include vitamin A among the list of nutrients of public health concern 
for the general U.S. population (Ref. 6).
    We also considered whether any changes are necessary to the 
provision for voluntary declaration of the portion of vitamin A 
activity derived from [beta]-carotene, including whether its mandatory 
declaration is appropriate, as suggested by a comment. One comment 
noted that [beta]-carotene intake, in particular, needs to be 
increased, but the comment provided no further explanation. The IOM did 
not set DRIs for [beta]-carotene and other carotenoids due to limited 
scientific data (Ref. 18). The only known function of provitamin A 
carotenoids (i.e., [alpha]-carotene, [beta]-carotene, and [beta]-
cryptoxanthin, which can be converted into vitamin A (retinol) in the 
body) in humans is to act as a source of vitamin A in the diet (Ref. 
18). Furthermore, there is no clear evidence that suggests a protective 
association between dietary vitamin A or [beta]-carotene and risk 
reduction of chronic diseases, such as cardiovascular disease and 
cancers (Ref. 105). In addition, evidence from large clinical trials 
suggests that [beta]-carotene supplementation increases the incidence 
of lung cancer in a high-risk population (e.g., current or former 
smokers, asbestos workers) (Refs. 106 and 107). Further, the IOM 
introduced mcg of RAEs (retinol activity equivalents) as a new unit for 
expressing vitamin A activity to account for the reduced absorption for 
provitamin A carotenoids, including [beta]-carotene (Ref. 105). This 
new unit, which would be the appropriate unit for declaring vitamin A 
on the Nutrition Facts label, takes into consideration vitamin A from 
all sources as well as the bioavailability of [beta]-carotene and other 
provitamin A carotenoids (see section II.J.3.).
    Our analysis demonstrates that, even though vitamin A intakes 
appear to be low, vitamin A deficiency based on an assessment of 
vitamin A status is rare in the U.S. population. The IOM did not set a 
quantitative intake recommendation for vitamin A based on a public 
health endpoint. Thus, we tentatively conclude that vitamin A is no 
longer a nutrient of public health significance for the general U.S. 
population. Therefore, consistent with the factors for declaration of 
non-statutory nutrients (see section I.C.), we are proposing to amend 
101.9(c)(8)(ii) to no longer require, but to permit voluntary 
declaration of vitamin A on the Nutrition Facts label. However, vitamin 
A declaration would remain mandatory when vitamin A is added as a 
nutrient supplement or claims are made about it on the label or in 
labeling of foods. We are also not proposing to change the current 
provision for voluntary declaration of the percent of vitamin A that is 
present as [beta]-carotene, as specified in Sec.  101.9(c)(8)(vi). We 
request comment about whether there is an appropriate alternative 
analysis to application of the factors in section I.C. regarding the 
mandatory declaration of vitamin A.
    d. Vitamin C--Vitamin C must be declared as a percent DV on the 
Nutrition Facts label (Sec.  101.9(c)(8)(ii)). In 1993, we required the 
declaration of vitamin C because (1) a 1990 IOM labeling report (Ref. 
95) identified vitamin C as a nutrient of potential

[[Page 11921]]

public health significance and stated that certain subpopulations were 
considered at risk of deficiency (such as elderly individuals on 
inadequate diets and infants fed cow's milk exclusively) (58 FR 2079 at 
2106), and (2) vitamin C was thought to play a role in promoting the 
intestinal absorption of non-heme iron, meaning that vitamin C in the 
same food as iron was considered to help prevent iron deficiency 
anemia, while excess vitamin C was considered to increase the risk of 
excessive iron absorption (55 FR 29487 at 29501, July 19, 1990). In 
response to the 2007 ANPRM about whether vitamin C is still a nutrient 
of public health significance, several comments recommended retaining 
the mandatory declaration of vitamin C, with some stating that vitamin 
C should be retained because it is a nutrient of concern identified by 
the 2005 DGA (Ref. 36), and is an enhancer of iron absorption for women 
of childbearing age.
    Our analysis of NHANES 2003-2006 estimated that about 35 percent of 
the general U.S. population has usual vitamin C intakes below the EAR, 
from conventional foods only and 27.5 percent have intakes below the 
EAR from conventional foods and supplements (table 1). While the 
prevalence of inadequate intake is high, prevalence of vitamin C 
deficiency is not apparent in the U.S. population. Only about 6 percent 
of the general population had serum vitamin C concentrations below 11.4 
micromoles ([mu]mol)/L, a cutoff level that is used as an indicator of 
vitamin C deficiency (Ref. 97 p.534; Ref. 101). The EAR for vitamin C 
is based on estimates of body pool or tissue levels of vitamin C that 
are required for antioxidant protection with minimal urinary loss, not 
on a public health endpoint (Ref. 18).
    The effects of vitamin C on risk of chronic diseases, such as 
cardiovascular disease or cancer, are not conclusive at this time (Ref. 
18). We issued a letter of enforcement discretion on qualified health 
claims for vitamin C supplement intake and reduced risk of cancers, in 
which we concluded that there was no credible evidence on the risk 
reduction from vitamin C for most cancers (squamous cell cancer of the 
esophagus, colorectal, laryngeal, lung, oral cavity, pancreatic, 
pharyngeal, renal cell, and salivary gland cancers), and very limited 
evidence for an association between vitamin C supplement intake and 
gastric cancer (Ref. 108).
    The 2010 DGA does not include vitamin C among the list of nutrients 
of public health concern for the general U.S. population (Ref. 6). 
However, the 2010 DGA recommends that women capable of becoming 
pregnant choose foods that are enhancers of iron absorption, such as 
vitamin C-rich foods (Ref. 6). While we agree that vitamin C enhances 
iron absorption, the prevalence of vitamin C deficiency in this 
subpopulation is not apparent. Only about 6 percent of this subgroup 
had serum vitamin C concentrations below 11.4 [mu]mol/L (table 1).
    Based on the previous analysis and information, we tentatively 
conclude that while vitamin C intakes are low, vitamin C deficiency is 
uncommon and vitamin C is no longer a nutrient of public health 
significance for the general U.S. population. Therefore, consistent 
with the factors we consider for declaration of non-statutory nutrients 
(see section I.C.), we are proposing to amend Sec.  101.9(c)(8)(ii) to 
no longer require, but to permit voluntary declaration of vitamin C on 
the Nutrition Facts label. However, vitamin C declaration would remain 
mandatory when vitamin C is added as a nutrient supplement or claims 
are made about it on the label or in labeling of foods. We request 
comment about whether there is an appropriate alternative analysis to 
the application of the factors in section I.C. regarding the mandatory 
declaration of vitamin C.
2. Essential Vitamins and Minerals That Are Voluntary
    a. Vitamin D--The declaration of vitamin D content in nutrition 
labeling is voluntary, unless vitamin D is added as a nutrient 
supplement or claims are made about it (Sec.  101.9(c)(8)(ii)). In 
1993, we determined that vitamin D is not of particular public health 
significance in the United States because the human requirement for 
vitamin D could be met with sufficient exposure to sunlight and milk 
and other foods that were fortified with vitamin D. As a result, 
deficiencies in this vitamin were very rare (58 FR 2079 at 2107). In 
response to the 2007 ANPRM about what, if any, other micronutrients are 
of public health significance, several comments recommended vitamin D 
for mandatory declaration citing vitamin D inadequacy; relationship of 
vitamin D to chronic disease risk (e.g., rheumatoid arthritis, multiple 
sclerosis, and cancers, such as prostate, breast, lung, colon, and 
colorectal cancers); and the 2005 DGA, which identified vitamin D as a 
nutrient of concern for certain subpopulations (e.g., older adults, 
people with dark skin, and those exposed to insufficient ultraviolet 
band radiation) (Ref. 36).
    The IOM set age and gender specific DRIs (EAR and RDA) for vitamin 
D at a level that would achieve and maintain serum 25-hydroxy vitamin D 
(25(OH)D) concentrations above a defined level (40 to 50 nanomoles 
(nmol)/L) in order to maintain bone health (Ref. 22). Vitamin D has a 
role in bone health through calcium absorption and uptake by bones 
(Ref. 22). In addition, in 2008, we authorized a health claim for 
calcium and vitamin D intake and reduced risk of osteoporosis (Sec.  
101.72), signifying vitamin D's critical role in the risk reduction of 
this chronic disease.
    Vitamin D can be obtained through dietary sources, such as fish 
(e.g., salmon, rockfish, and tuna) and shellfish, which are the primary 
natural food sources of vitamin D. FDA affirmed certain uses of vitamin 
D food ingredients as Generally Recognized as Safe (GRAS) with specific 
limitations as listed in Sec.  184.1950. Under Sec.  184.1(b)(2), an 
ingredient affirmed as GRAS with specific limitations may be used in 
food only within such limitations, including the category of food, 
functional use, and level of use. Any addition of the ingredient to 
food beyond the limitations set out in Sec.  184.1950 requires either a 
food additive regulation or an amendment of Sec.  184.1950. In this 
way, FDA can ensure that the vitamin D ingredients are added to food at 
safe levels. For detail on estimating dietary intake of substances in 
food, see FDA's Guidance for Industry: Estimating Dietary Intake of 
Substances in Food (Ref. 109). Under FDA regulations (Sec. Sec.  
172.380 (21 CFR 172.380) and 184.1950), vitamin D can be added in 
specific amounts to foods such as breakfast cereals, grain products and 
pastas, fluid milks and milk products, and calcium-fortified juices. As 
for any vitamin or mineral, when vitamin D is added to a food, the 
total amount per serving must be declared in the Nutrition Facts label. 
In addition to dietary sources of vitamin D from conventional foods and 
dietary supplements, vitamin D is synthesized in the skin following 
direct exposure to the sun. Therefore, sunlight exposure is an 
important source of vitamin D.
    Serum concentration of 25(OH)D is widely considered as a biomarker 
of total vitamin D nutritional status and is recommended to be used for 
assessing vitamin D total exposure from all sources, including 
conventional foods, dietary supplements, synthesis from sun, and 
conversion of vitamin D from adipose stores in liver (Ref. 22). Our 
analysis of NHANES 2003-2006 data showed that about 18 percent of the 
U.S. population 4 years and older (excluding pregnant and lactating 
women) have serum 25(OH)D levels below the 40 nmol/L (a level set by 
IOM as equivalent to EAR), which indicates an increased risk of 
inadequate vitamin D exposure.

[[Page 11922]]

NHANES data collection normally does not include serum levels in the 
northern regions of the United States in the winter months, when one 
would expect a lower serum vitamin D level. Therefore, analysis of 
NHANES data may underestimate the prevalence of low serum vitamin D 
levels in the Unites States population. Analysis of NHANES 2005-2008 
dietary data showed that, about 94 percent of the U.S. population have 
usual vitamin D intakes below the EAR from conventional foods only and 
62 percent have intakes below the EAR from conventional foods and 
supplements (table 1). The IOM set the DRIs (e.g., EAR) assuming 
minimal sun exposure (Ref. 22).
    Furthermore, approximately 24 percent of the U.S. population ages 4 
years and older have serum 25(OH)D concentrations between 30 and 50 
nmol/L, levels that indicate risk for inadequacy according to the IOM 
and CDC (Refs. 22 and 101). Approximately 32 percent of the U.S. 
population have serum 25(OH)D levels below 50 nmol/L (a level set by 
IOM as equivalent to RDA and associated with optimal benefit for nearly 
all the population) (Ref. 22). Also, about 8 percent have serum 25(OH)D 
levels below IOM's cutoff of 30 nmol/L and may be at increased risk of 
vitamin D deficiency. Vitamin D deficiency results in inadequate bone 
mineralization or demineralization of the skeleton including rickets, 
osteomalacia, and osteoporosis (Ref. 22). The 2010 DGA, too, 
highlighted vitamin D as a nutrient of concern for the U.S. population, 
in general, rather than for specific population groups alone (Ref. 6).
    We do not agree with some comments that suggested that vitamin D 
intake should be mandatory on the label because of its relationship to 
disease risk reduction, generally. The IOM did not set DRIs for vitamin 
D based on its protective effect against diseases, such as cancers, 
cardiovascular disease, and diabetes, because the scientific evidence 
does not support a role other than that associated with bone health 
(Ref. 22).
    In view of the benefits of adequate vitamin D intakes on bone 
health, reflected in the IOM's DRIs, data indicating inadequate 
intakes, poor vitamin D status, and high prevalence of osteoporosis and 
osteopenia (discussed previously in the calcium section, (Refs. 98 and 
99) among the general U.S. population, we tentatively conclude that 
vitamin D is a nutrient of ``public health significance,'' as described 
in section I.C., and its mandatory declaration is necessary to assist 
consumers in maintaining healthy dietary practices. Therefore, 
consistent with the factors we consider for mandatory declaration of 
non-statutory nutrients (see section I.C.), we are proposing to amend 
Sec.  101.9(c)(8)(ii) to require the mandatory declaration of vitamin D 
on the Nutrition Facts label. We request comment about whether there is 
an appropriate alternative analysis to the application of the factors 
in section I.C. regarding the mandatory declaration of vitamin D.
    b. Potassium--The declaration of potassium content is voluntary, 
except when a claim is made about it (Sec.  101.9(c)(5)). In 1993, 
potassium did not meet our considerations for inclusion as a mandatory 
element of nutrition labeling because no quantitative intake 
recommendations were available in national consensus reports (58 FR 
2079 at 2095). In response to our question in the 2007 ANPRM about 
what, if any, other micronutrients are of public health significance, 
several comments supported mandatory declaration of potassium on the 
Nutrition Facts label because the 2005 DGA identified it as a nutrient 
of concern (Ref. 36). One comment also pointed out that scientific 
evidence from three meta-analyses of over 30 clinical trials shows that 
high potassium intake is associated with reduced blood pressure in non-
hypertensive and hypertensive individuals (Refs. 110 to 112).
    Our analysis of data from NHANES 2003-2006 shows that the usual 
mean intakes of potassium from conventional foods only (2,644 mg/d) and 
from conventional foods plus dietary supplements (2,651 mg/d) are below 
the population-weighted AI of 4,622 mg/d. Where the mean usual intake 
is at or above the AI, we consider that there is probably a low 
prevalence of nutrient inadequacy in the population assessed. However, 
where the mean usual intake is below the AI, the population's 
prevalence of inadequacy cannot be estimated (Ref. 96). Therefore, the 
likelihood of nutrient inadequacy cannot be estimated. Only about 1.9 
percent of the general population has usual potassium intakes above the 
AI from conventional foods only and 2.4 percent has intakes above the 
AI from conventional foods plus dietary supplements (table 1), 
indicating that the adequacy of intakes is very low. In the absence of 
a sensitive biochemical indicator of potassium nutritional status, we 
could not consider biomarker data to inform the determination of 
prevalence of potassium deficiency. However, the IOM set age- and 
gender-specific AIs for potassium based on risk of chronic disease. The 
AI was set at a level that would maintain blood pressure, reduce the 
adverse effects of sodium chloride intake on blood pressure, and reduce 
the risk of recurrent kidney stones (Ref. 21). According to the CDC, 
about one out of three U.S. adults has high blood pressure (Ref. 113).
    In 2000, a FDAMA notification for a health claim about potassium, 
blood pressure, and stroke was submitted to us under section 
403(r)(2)(g) of the FD&C Act (Ref. 114). We did not object to the 
notification and this meant that manufacturers could include the 
following claim ``Diets containing foods that are good sources of 
potassium and low in sodium may reduce the risk of high blood pressure 
and stroke,'' on the label or labeling of any food that meets the 
eligibility criteria described in the notification and meets the 
general requirements for health claims (Sec.  101.14(e)(6)). Thus, we 
recognize the importance of potassium in the risk reduction of these 
chronic diseases. The 2010 DGA also concluded that potassium is a 
nutrient of concern for the general U.S. population (Ref. 6).
    In view of the benefits of adequate potassium intake in lowering 
blood pressure, reflected in IOM's DRIs, and data indicating low 
likelihood of potassium adequacy and high prevalence of hypertension 
among the general population, we tentatively conclude that potassium is 
a nutrient of public health significance for the general U.S. 
population and its declaration is necessary to assist consumers in 
maintaining healthy dietary practices. Therefore, consistent with the 
factors we consider for mandatory declaration of non-statutory 
nutrients (see section I.C.), we are proposing to amend Sec.  
101.9(c)(8)(ii) to require the mandatory declaration of potassium.
3. Other Essential Vitamins and Minerals
    Several other essential vitamins and minerals, in addition to 
vitamin D and potassium, may be declared on the Nutrition Facts label, 
i.e., vitamin E, vitamin K, vitamin B6, vitamin 
B12, thiamin, riboflavin, niacin, folate, biotin, 
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, 
copper, manganese, chromium, molybdenum, and chloride. In response to 
the 2007 ANPRM about what, if any, other micronutrients are of public 
health significance, several comments recommended mandatory declaration 
of these voluntarily declared essential vitamins and minerals: Vitamin 
E, folate, vitamin B12, magnesium, and phosphorus. The 
reasons cited in

[[Page 11923]]

comments included: (1) The 2005 DGA identification of these nutrients 
as nutrients of concern (Ref. 36); (2) the need to provide information 
to patients; (3) the need to heighten consumer awareness; and (4) the 
intakes of these nutrients are inadequate in the U.S. population or 
subpopulations (Ref. 47).
    Based on FDA's analysis of available data using the factors we 
consider for mandatory and voluntary declaration of non-statutory 
nutrients (see section I.C.) and comments received on essential 
vitamins and minerals that are currently voluntarily declared, we are 
not proposing any changes to the current provisions for voluntary 
declaration (for detailed information and the analysis of each of the 
vitamins and minerals see Ref. 115). We reviewed data related to the 
intake and status of nutrients where available standards allow for such 
calculations (table 1). Consistent with the factors (see section I.C.), 
essential vitamins and minerals (with the exception of potassium and 
vitamin D discussed previously) that are voluntarily declared should 
continue to be permitted to be voluntarily declared (Ref. 115). 
Therefore, we are not proposing any changes to the provisions for 
voluntary declaration of vitamin E, vitamin K, vitamin B6, 
vitamin B12, thiamin, riboflavin, niacin, folate, biotin, 
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, 
copper, manganese, chromium, molybdenum, and chloride.
    In addition, several comments recommended mandatory declaration of 
choline, which is currently not permitted to be declared on the 
Nutrition Facts label. Based on the factors we consider (see section 
1.C.) and comments that asked us to provide for its declaration on the 
Nutrition Facts label (Ref. 115), we tentatively conclude that the 
voluntary declaration of choline is consistent with the factors we 
consider for voluntary declaration (table 1) and, therefore, we are 
proposing to permit the voluntary declaration of choline on the 
Nutrition Facts label.
4. Summary
    In summary, based on an analysis of the factors FDA considered (as 
described in section I.C.), comments received, and other data and 
information set forth previously, FDA tentatively concludes that 
calcium, iron, vitamin D and potassium are nutrients of public health 
significance and their declarations on the Nutrition Facts label are 
necessary to assist consumers in maintaining healthy dietary practices. 
Calcium is considered a nutrient of public health significance due to 
the benefits of adequate calcium intake on bone health, and the 
relatively low intakes of calcium and the high prevalence of 
osteoporosis and osteopenia among the U.S. population. Iron is 
considered a nutrient of public health significance due to the 
continued inadequate intakes and deficiency (using relevant biomarker 
data) among women of childbearing age, who comprise a significant 
portion of the general healthy U.S. population. Although the DRIs for 
iron were not based on a chronic disease risk, iron deficiency and low 
iron stores over time will lead to iron deficiency anemia, an advanced 
stage of iron deficiency. Anemia is associated with poor cognitive 
function, lower work performance, and low endurance in the general 
population; delayed psychomotor development in infants; and adverse 
pregnancy outcome. Vitamin D is considered a nutrient of public health 
significance due to the benefits of adequate vitamin D intake on bone 
health, data indicating inadequate intakes and status (both from total 
exposure (serum data) and dietary intake data), and the high prevalence 
of osteoporosis and osteopenia among the U.S. population. Adequate 
intake of vitamin D is essential for promoting calcium absorption in 
the gut and for maintaining adequate calcium levels in the blood and 
thus promoting bone health. Potassium is considered a nutrient of 
public health significance due to the benefit of adequate intake of 
potassium in lowering blood pressure, reducing the adverse effects of 
sodium chloride intake on blood pressure and reducing the risk of 
recurrent kidney stones, and due to data indicating a low likelihood of 
potassium adequacy and a high prevalence of hypertension among the 
general U.S. population.
    Although we continue to consider, consistent with our rationale put 
forth in 1993, that a vitamin or mineral's public health significance 
should be the key factor in mandatory labeling (58 FR 2079 at 2106), 
the proposed vitamins and minerals of public health significance (i.e., 
potassium, calcium, vitamin D, and iron) and dietary fiber (listed on 
the label as a nutrient to increase) do represent various food groups. 
For example, potassium is found in most food groups, especially 
vegetables, fruits, and milk and milk products. Milk and milk products 
contribute substantially to calcium intake. Sources of heme iron 
include lean meat, poultry and seafood, while the non-heme sources of 
iron come from plants foods, such as beans, lentils and spinach. 
Although vitamin D is mostly found in fortified foods in the United 
States, such as fluid milk and some milk products (e.g., yogurt), its 
natural sources include seafood. Dietary fiber is generally found in 
most fruits and vegetables, whole grains and beans.
    The 2010 DGA recommends increasing the amount and variety of 
seafood in place of some meat and poultry (Ref. 6). As mentioned, fish/
seafood is the primary source of naturally occurring vitamin D (Ref. 
6). Data shows that fish/seafood only provides 9 percent of the total 
vitamin D intake in the United States (Ref. 116). Therefore, we 
tentatively conclude that the proposed mandatory declaration of vitamin 
D on the label would allow consumers to understand the relative 
significance of the contribution of vitamin D from natural food 
sources, in addition to fortified foods, in the context of the total 
daily diet and also is necessary to assist consumers in maintaining 
healthy dietary practices.
    We are not aware of any unintended consequences of mandatory 
listing, in general, of vitamins and minerals. We invite comment, 
including the submission of data and information on whether the 
mandatory listing of vitamins and minerals somehow impacts food 
fortification practices. We invite comment on the proposed mandatory 
declaration of vitamin D, potassium, calcium and iron on the label, 
including how we consider the public health significance of each. We 
also invite comment on whether the presence of these nutrients presents 
concerns related to label space or the need for consumer education.

[[Page 11924]]



   Table 1--Prevalence of Adequacy and Inadequacy (From Conventional Foods and Water) and Total Intake (Conventional Foods, Water, and Supplement) and
                         Status Biomarkers for Essential Vitamins and Minerals Among the U.S. Population, Ages 4 Years and Older
                                                      [Excluding pregnant and lactating women] \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Usual nutrient intake \2\                                Status biomarkers
                                                --------------------------------------------------------------------------------------------------------
                                                      % Below weighted EAR \4\         % above weighted AI \5\ (mean
          Nutrients             Weighted EAR/AI ------------------------------------              intake)
                                      \3\                                           -----------------------------------    Biomarker      % Below cutoff
                                                       Food            Food plus                          Food plus          cutoff
                                                                      supplement           Food           supplement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Vitamins
--------------------------------------------------------------------------------------------------------------------------------------------------------
Choline (NHANES 2005-2008)...  460 mg (AI).....  ................  ................  10 (mean = 311    10 (mean = 312   NA.............  NA
                                                                                      mg).              mg).
Folate.......................  304 mcg DFE.....  8.7.............  7.3.............  ................  ...............  Serum folate <   0
                                                                                                                         2 ng/mL.
                                                                                                                        RBC folate < 95  0.26
                                                                                                                         ng/mL
                                                                                                                        Women 12-49 yrs
                                                                                                                        Serum folate <   0
                                                                                                                         2 ng/mL
                                                                                                                        RBC folate < 95  0.36
                                                                                                                         ng/mL
Niacin 6 7...................  11 mg NE........  2.1.............  1.7.............  ................  ...............  NA.............  NA
Riboflavin 6 7...............  0.9 mg..........  1.5.............  1.3.............  ................  ...............  NA.............  NA
Thiamin 6 7..................  0.9 mg..........  5.6.............  3.8.............  ................  ...............  NA.............  NA
Vitamin A....................  531 mcg RAE.....  45..............  34..............  ................  ...............  Serum A < 20     0.3 \8\
                                                                                                                         mcg/dL.
Vitamin B6 6 7...............  1.1 mg..........  9.4.............  7.3.............  ................  ...............  NHANES 2005-     10
                                                                                                                         2006 < 20 nmol/
                                                                                                                         L.
Vitamin B12..................  1.9 mcg.........  2.3.............  2.2.............  ................  ...............  Serum B12 < 200  2.0
                                                                                                                         picograms (pg)/
                                                                                                                         mL.
                                                                                                                        19-50 yrs......  0.7-2.5
                               2 mcg (51 yrs     Women 51 yrs and                                                       51 yrs and       3.3-5.2
                                and older).       older.                                                                 older.
                                                 6.4-7.5
                                                 Men 51 yrs and
                                                  older
                                                 0.6-0.7.........
Vitamin C....................  61 mg...........  35..............  27.5............  ................  ...............  Serum C < 11.4   6.1 \8\
                                                                                                                         [micro]mol/L.
                                                 Women 12-49 yrs.  Women 12-49 yrs.  ................  ...............  Women 12-49 yrs  6.00
                                                 41..............  30..............
Vitamin D....................  10 mcg..........  93.7 (NHANES      62 (NAHNES 2005-  ................  ...............  Serum 25 (OH)D:  17.6
                                                  2005-2008).       2008).                                               <40 nmol/L.
                                                                                                                        30-50 nmol/L...  24
                                                                                                                        < 30 nmol/L....  8.3
Vitamin E....................  11 mg [alpha]-    92..............  64..............  ................  ...............  Serum E < 11.6   0.9 \8\
                                tocopherol.                                                                              [micro]mol/L.
Vitamin K 6 7................  95 mcg (AI).....  ................  ................  27.2 (mean =      30.9 (mean = 88  NA.............  NA
                                                                                      82.9 mcg).        mcg).
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Minerals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Calcium......................  885 mg..........  49..............  37..............  ................  ...............  NA.............  NA
Copper 6 7...................  0.7 mg..........  5.2.............  4.9.............  ................  ...............  NA.............  NA
Iron (probability approach     See footnote 3..  3.5.............  3.3.............  ................  ...............  NHANES 1999-
 method) \9\.                                                                                                            2002 \10\.
                                                                                                                        Serum ferritin   8.3
                                                                                                                         < 15 mcg/L.
                                                                                                                        Ferritin model.  6.5
                                                                                                                        Anemia.........  1.9
                                                                                                                        Women, 12-49
                                                                                                                         yrs
                                                                                                                        NHANES 2003-
                                                                                                                         2006:.
                                                 Women 12-49 yrs.  Women 12-49 yrs.                                     Serum Ferritin   14
                                                 11.2............  10.4............                                      < 15 mcg/L      10
                                                                                                                        Body Iron model  14.5
                                                                                                                        Ferritin Model   4.7
                                                                                                                         Anemia.
Iodine 6 7...................  91 mcg..........  2.3 \11\........  2.3.............  ................  ...............  Urinary iodine
                                                                                                                        NHANES 2007-
                                                                                                                         2008:.

[[Page 11925]]

 
                                                                                                                        <50 ng/mL \12\.  8.7 \8\.
                                                                                                                        <100 ng/mL \13\  Median =
                                                                                                                                         165 ng/mL.
Magnesium....................  283 mg..........  56..............  53..............  ................  ...............  NA.............  NA.
Phosphorus...................  640 mg..........  3...............  2.6.............  ................  ...............  NA.............  NA.
Potassium....................  4,622 mg (AI)...  ................  ................  1.9 (mean =       2.4 (mean =      NA.............  NA.
                                                                                      2,644 mg).        2,654 mg).
Selenium 6 7.................  43 mcg..........  1.4.............  1.1.............  ................  ...............  NA.............  NA.
Zinc 6 7.....................  7.7 mg..........  13.4............  9.1.............  ................  ...............  NA.............  NA.
--------------------------------------------------------------------------------------------------------------------------------------------------------
NA = Data is not available in NHANES; mg = milligrams; mcg = micrograms; DFE = Dietary folate equivalents; NE = Niacin equivalents; RAE = Retinol
  activity equivalents.
\1\ All prevalence of nutrient adequacy or inadequacy and status biomarker data is based on NHANES 2003-2006 unless otherwise is reported. All data
  analysis are based on ages 4 years and older (excluding pregnant and lactating women), unless reported otherwise.
\2\ Usual nutrient intake distributions from conventional foods or conventional foods plus supplements are determined using the National Cancer
  Institute statistical method for all nutrients except iron (see footnote 9 to this table and Ref. 48).
\3\ Weighted Estimated Average Requirement (EAR) and Adequate Intake (AI) for all nutrients (except iron) are based on the U.S. population ages 4 years
  and older using U.S. Census Bureau, Population Projection for 2005, Middle Series Data (NP-D1-A) (Ref. 48,117). For iron, the published IOM tables
  (tables I-6 and I-7) of probability of iron requirement distribution were used (Ref. 100).
\4\ EAR cut-point method used to compare usual nutrient intakes to the EAR to determine the prevalence of nutrient inadequacy.
\5\ For nutrients with an AI, prevalence of nutrient adequacy was determined when mean usual nutrient intakes are at or above the AI or based on the
  percent of those above the AI.
\6\ The Agency did not receive any comments for these nutrients (which voluntary declaration is permitted) in response to the 2007 ANPRM. In addition,
  dietary intake or status biomarker data were not provided in the NHANES database for chromium, biotin, pantothenic acid, molybdenum, manganese and
  chloride and, therefore, these nutrients are not listed in this table.
\7\ The DRIs for these nutrients were not based on a public health endpoint (e.g., chronic disease).
\8\ Ages 6 years and older.
\9\ Probability approach method was used to determine the prevalence of nutrient inadequacy for iron. The PC-SIDE software developed by the Iowa State
  University was used to determine the usual intake distribution for iron.
\10\ Iron deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables (transferrin saturation, serum
  ferritin, and erythrocyte protoporphyrin). Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to
  ferritin. Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. NHANES 1999-2002 did not measure transferrin
  receptor, therefore body iron model could not be analyzed for the general population (ages 4 years and older). NHANES 2003-2006 did not measure all
  iron biomarkers for all ages (4 years and older), thus serum ferritin, body iron model or ferritin model could not be analyzed for all ages during
  this time period.
\11\ Iodine nutrient intake data are calculated from the Total Diet Study 2003-2008 and intake data are calculated from NHANES 2003-2008 (http://www.nutrientdataconf.org/PastConf/NDBC36/7-3_Juan_NNDC2012.pdf).
\12\ One criterion for iodine adequacy is that not more than 20 percent be below the urinary iodine cutoff of 50 ng/mL (indicator of moderate
  deficiency) (Ref. 118).
\13\ WHO categories for median urinary iodine concentrations are widely used to define iodine intake (Ref. 118). Median intake levels below 100 ng/mL
  may indicate mild iodine deficiency.


I. Reference Daily Intakes for Vitamins and Minerals

1. Need To Update RDIs
    RDIs used to calculate the percent DVs for vitamins and minerals 
that are required or permitted to be declared on the Nutrition Facts 
label are codified in Sec.  101.9(c)(8)(iv). We established the RDIs in 
1993 and in 1995, and explained our rationale and relevant 
considerations during those rulemakings (58 FR 2079; 60 FR 67164; see 
also Ref. 1). We noted specifically that the purpose of establishing 
RDIs for vitamins and minerals was to provide ``label reference 
values'' intended to help consumers to understand nutrient levels in 
the context of the total daily diet, to compare foods, and to plan 
general diets (58 FR 2206 at 2213). We recognized that nutritional 
needs vary considerably among consumers, but noted that no other viable 
option existed other than a single reference value (58 FR 2206 at 
2213). Thus, RDIs are intended as general food labeling reference 
values and are not intended to represent dietary allowances for 
individuals (55 FR 29476 at 29478). While RDIs are not precise values 
for certain age and sex groups, they function as an overall population 
reference to help consumers judge a food's usefulness in meeting 
overall daily nutrient requirements or recommended consumption levels 
and to compare nutrient contributions of different foods (55 FR 29476).
    IOM reports published since 1997 provide new information for our 
use in reconsidering the RDIs. The DRIs revised many of the previously 
set RDAs for vitamins and minerals. Four types of DRIs are relevant to 
the discussion on RDIs for vitamins and minerals: EAR, RDA, AI, and UL. 
We describe each of these DRIs in section I.B.2. According to the new 
DRI reports, some nutrients that had RDAs now have an AI because it was 
determined that data were not sufficient to set a new RDA (e.g., 
vitamin K), whereas others that had ESADDIs now have either an RDA 
(copper and molybdenum) or an AI (manganese, fluoride, and chromium).
    The IOM Labeling Report (Ref. 25) recommended that FDA use a 
population-weighted EAR or, in its absence, a population-weighted AI as 
the basis for establishing DVs for vitamins and minerals. In developing 
these recommendations, the IOM

[[Page 11926]]

indicated that the reference values on food labeling are to enable 
consumers to compare the nutrient content of different food products 
and to determine the relative contributions of a food to an overall 
health promoting diet. The IOM Labeling Committee did not consider that 
the information in nutrition labeling is used to plan individual diets. 
The IOM recommended that the DVs should be based on a population-
weighted value of the EAR for the different life stage and gender 
groups so that the DVs are representative of the various population 
groups in proportion to their contribution to the overall population. A 
DV defined this way would represent a central value of the requirements 
of the population, with individual requirements varying around this 
value. The IOM Labeling Committee further stated that the EAR 
represents the most accurate representation of the true contribution of 
food to total nutrient needs of the general population, whereas the RDA 
provides an exaggerated impression of Americans' daily needs and, thus, 
would systematically under-represent the true contribution of an 
individual food to many consumers' needs. The IOM Labeling Committee 
concluded that the EAR is the best estimate of any given individual's 
requirements, because the EAR is the median of the estimated 
distribution of requirements for a particular life stage and gender 
group. Therefore, the IOM Labeling Committee stated that setting the DV 
at the EAR is most likely to help individuals understand nutrition 
information about vitamins and minerals on the Nutrition Facts label in 
the context of their total daily diet. The IOM Labeling Committee 
further recommended that, in the absence of an available EAR, a 
population-weighted AI should be used as the basis for a DV.
    The IOM Dietary Planning Report noted that intake goals (i.e., 
RDAs) should be translated into dietary plans to help individuals 
choose foods that will make up a healthful diet. The IOM Dietary 
Planning Report gave several examples of dietary plans such as the 
Nutrition Facts label, United States Food Guide Pyramid and the Dietary 
Guidelines for Americans that are intended to help consumers choose 
foods that are part of a healthful diet (Ref. 26). This report noted 
that when food guides such as those mentioned previously are used, 
reference standards for nutrients, such as RDAs, are implicitly used in 
planning individual diets (Ref. 26). The recommendations in the IOM 
Labeling Report and the IOM Dietary Planning Report have been the 
subject of much debate in the scientific community, and several review 
articles about the basis for selecting the DRI values that are most 
appropriate for setting DVs (i.e., RDIs) have been published in 
scientific journals (Refs. 119 to 126).
    The 2007 ANPRM asked for public comment on whether the DV should be 
based on an EAR or RDA; how AIs should be used for determining DVs for 
vitamins and minerals without an EAR or RDA; and whether DVs should be 
based on a population-coverage or population-weighted approach. We 
received several comments both on the overall approach for setting the 
RDIs and on the DRIs for specific vitamins and minerals (Ref. 47).
    We tentatively conclude that the existing RDIs for vitamins and 
minerals should be revised based on the DRIs set by the IOM that 
reflect the most current science regarding nutrient requirements. Our 
consideration of the DRIs, relevant recommendations, and comments 
received in updating the RDIs is presented in this document.
2. Approach to Setting RDIs: EAR Versus RDA
    The percent DV advises the consumer how much of the recommended 
intake of that nutrient is provided by the food (58 FR 2206 at 2213). 
The DV for the nutrient, on which the percent DV declaration is based, 
is not to be interpreted as a precise recommended intake level for an 
individual; it is for use as a general guide or reference value that 
can help the consumer judge a food's usefulness in meeting overall 
daily nutrient requirements or recommended consumption levels and to 
compare nutrient contributions of different foods (55 FR 29476). We 
established the RDIs for vitamins and minerals based primarily on RDAs, 
and using other available recommendations for those vitamins and 
minerals for which an RDA was not established (55 FR 29476; 58 FR 2206; 
60 FR 67164). Overall, comments to the 2007 ANPRM supported continuing 
to use the RDA as the basis for the DVs for vitamins and minerals, 
whereas some other comments supported using the EAR instead (Ref. 47).
    Considering the purpose of the DV, and for the reasons explained in 
this document, we tentatively conclude that RDAs, when available, 
continue to provide the most appropriate basis for establishing RDIs. 
RDAs are available for calcium, copper, folate, iodine, iron, 
magnesium, molybdenum, niacin, phosphorus, riboflavin, selenium, 
thiamin, vitamins A B6, B12, C, D, and E, and 
zinc (Refs. 16 to 19,22).
    The EAR, by definition, is the median requirement that is most 
likely to be close to an individual's actual needs within a particular 
life stage and gender group, with the needs of half of the individuals 
within that group falling above or below the EAR. The EAR is a 
quantitative intake recommendation that is used to derive target 
nutrient intake goals for the planning of diets for groups, but is not 
used as a target intake goal for individuals. Examples of planning for 
groups include planning diets in an assisted living facility for senior 
citizens or planning menus for a school nutrition program (Ref. 26). 
However, the EAR is not intended to be a target intake level for 
individuals because an individual does not know how their needs relate 
to the EAR. While the RDA may not be the best estimate of any given 
individual's nutrient requirement, which is usually unknown, the RDA 
was developed as a target intake level for individuals and is designed 
to meet the nutrient needs of practically all (97 to 98 percent) 
individuals within a life stage and gender group. Therefore, if the RDI 
were to be based on the EAR, the RDI would not meet the daily nutrient 
requirements for some consumers and understate target intake levels. In 
contrast, an RDI that is based on a RDA would meet the daily nutrient 
requirements for the majority of all individuals 4 years of age and 
older. As we explained during the NLEA rulemaking, while RDIs are not 
precise values for specific age and sex groups, they function as an 
overall population reference to help consumers judge a food's 
usefulness in meeting overall daily nutrient requirements or 
recommended consumption levels and to compare nutrient contributions of 
different foods (55 FR 29476). An RDI based on the RDA would mean that 
a product with 100 percent of the DV would have a higher probability of 
meeting an individual's nutrient needs than if the RDI was based on the 
EAR.
    In addition, consumers have indicated that they use the label, 
among other things, to make dietary judgments about a food and to plan 
meals. Our 2008 Diet and Health Survey reported that, among consumers 
who use the label when they buy a product for the first time, 62 
percent often or sometimes use the label to help in meal planning; 85 
percent often or sometimes use the label to get a general idea of the 
nutritional content of the food; and 90 percent often or sometimes use 
the label to see how high or low the food is in things like calories, 
salt, vitamins, or fat (Ref. 41). A series of surveys conducted by the

[[Page 11927]]

International Food Information Council over the past several years also 
showed that approximately 65 percent of respondents used the Nutrition 
Facts label to decide whether to purchase or consume a food, and 
different individuals focus on different aspects of the label (e.g., 
calories, fat, or sodium) (Refs. 127 to 130).
    We recognize that the recommendations of the 2003 IOM Labeling 
Report (Ref. 25) differ from the conclusions of the 2003 IOM Planning 
Report (Ref. 26). The IOM Labeling Report recommends using the EAR as 
the basis for developing DVs, whereas the IOM Planning Report indicated 
that the RDAs are appropriate targets for nutrient intakes for 
individuals. Inadequate intakes of some nutrients continue to be of 
public health significance, as noted by the 2010 DGA, which identified 
potassium, calcium, and vitamin D as nutrients of public health concern 
for general U.S. population and iron, folic acid, and vitamin 
B12 for certain segments of the population (Ref. 6). Based 
on these concerns of inadequate nutrient intakes, we find that the IOM 
Dietary Planning Report discussion supports the use of RDAs as the 
basis for establishing reference values for the purposes of food 
labeling. We continue to believe that given the greater coverage 
provided by the RDAs compared to the EARs, more individuals who use the 
percent DV information to select foods, compare foods, or plan diets 
will have greater assurance that their nutrient needs are being met (58 
FR 2206 at 2213). RDAs and AIs, not EARs, are also cited in both the 
2010 DGA and the USDA's Food Patterns, which were formerly known as the 
MyPyramid Food Patterns (Refs. 6 and 131). It is important to 
reiterate, however, that the RDIs are not the same as RDAs. The RDAs 
are recommended intake levels set for different age and gender groups, 
whereas the RDIs are intended to provide an overall population 
reference value for use in calculating the percent DV for the food 
label that can help consumers understand the nutritional content of 
foods in the context of the total daily diet (55 FR 29476 at 29481 and 
58 FR 2206 at 2213).
    Finally, we considered the potential for the RDIs to influence the 
vitamin or mineral content of foods, as suggested by several comments 
(Ref. 47). We are not persuaded that using an EAR will promote rational 
fortification and that using the RDA as the basis for the RDI will lead 
to overconsumption of vitamins and minerals, as was suggested by a 
comment (Ref. 47). FDA's principles of rational fortification are 
expressed in our fortification policy (Sec.  104.20). The addition of 
nutrients to foods is also governed by the requirements established in 
food standards of identity (21 CFR parts 130 to 169), nutrition quality 
guidelines (21 CFR part 104), substitute food regulations (Sec.  
101.3(e)), and relevant specifications in food additive and food 
substance regulations (for example, folic acid (Sec.  172.345) and 
vitamin D (Sec. Sec.  184.1950 and 172.380)). Consistent with our 
previous position (58 FR 2206 at 2210), we acknowledge that some 
manufacturers may fortify products to a specific percentage of the DV 
(e.g., 25 percent) and, to the extent this practice continues, nutrient 
levels in these foods would be affected by updated RDI values. Changing 
the basis from the current RDA approach to EARs would lower RDIs for 
many important nutrients. Regardless of whether the basis for the RDI 
is the RDA or EAR, manufacturers must comply with relevant regulations, 
and we urge them to follow the principles stated in our fortification 
policy. With respect to the concern for risk of excessive intakes of 
vitamins and minerals, we conducted a thorough analysis of available 
data to determine whether intakes of vitamins and minerals from both 
foods and dietary supplements exceed established ULs. An analysis of 
NHANES (2003-2006) data showed that usual total nutrient intakes (from 
both conventional foods and dietary supplements) at the 90th percentile 
do not exceed the ULs for most vitamins and minerals at any age group, 
except for zinc intake, vitamin A (preformed), iodine intake and folic 
acid intake among children 4 to 8 years (Ref. 132).
    While there were a few exceptions, we have determined that such 
intakes are not of public health significance, and for some nutrients, 
are not a result of discretionary fortification. Therefore, we do not 
consider that the existing approach of using RDAs as the basis for RDIs 
leads to widespread overconsumption of vitamins and minerals. Moreover, 
about half of the proposed RDIs decrease when compared to the current 
RDIs (table 2) because many of the new RDAs and AIs established by the 
IOM are now lower than previously set RDAs or ESADDIs. Most of the RDIs 
proposed in this rulemaking that would increase (i.e., calcium, vitamin 
D, dietary fiber, and potassium) have also been proposed by FDA to be 
nutrients of public health significance for the general U.S. population 
(see section II.H.). Furthermore, none of the RDIs proposed in this 
rulemaking exceed the ULs for children 4 to 8 years of age (see tables 
11a and 11b of the 2007 ANPRM).
    Therefore, we tentatively conclude that RDAs, when available, 
provide the most appropriate basis for establishing RDIs. Using 
corresponding RDAs, proposed Sec.  101.9(c)(8)(iv) would update the 
RDIs for calcium, copper, folate, iodine, iron, magnesium, molybdenum, 
niacin, phosphorus, riboflavin, selenium, thiamin, vitamins A, 
B6, B12, C, D, and E, and zinc, as shown in table 
2. We request comment on our analysis and request data and factual 
information, including any additional data on what role, if any, the 
basis of the DV (EAR or RDA) has in consumption of nutrients above the 
UL and in discretionary fortification of foods.
3. Approach to Setting RDIs: Adequate Intake
    We consider that, in the absence of RDAs, AIs represent the best 
estimate of adequate daily nutrient intake level based on available 
science and, as such, they provide an appropriate basis for selecting 
RDIs for those vitamins and minerals where available data are 
insufficient to determine RDAs. While the prevalence of inadequacy of a 
nutrient with an AI cannot be determined, AIs, like RDAs, are goals for 
nutrient intakes and AIs are expected to meet the nutrient needs of 
most healthy people. The IOM noted that usual individual intakes for a 
nutrient that are equal to or above the AI can be assumed adequate 
(Ref. 25). We acknowledge that there is more uncertainty with an AI 
than an EAR or RDA. However, in the case of nutrients without 
established RDAs, AIs reflect the most current scientific 
recommendations for intake (Ref. 25).
    Moreover, using the AIs (where RDAs are not available) would ensure 
consistency in the basis of setting RDIs. We agree with comments to the 
ANPRM that RDIs for vitamins and minerals and consequently, percent DVs 
declared on the label, should have comparable meanings in order to 
enable consistent use. RDIs should not be based on average requirements 
(i.e., EAR) for some nutrients, but goals for intakes (i.e., RDAs) for 
others. AIs, in the absence of RDAs, would provide uniformity in 
setting RDIs for vitamins and minerals based on goals for their 
intakes. Most of the comments in response to the 2007 ANPRM supported 
the AI as the basis for the DV for those nutrients for which no EARs or 
RDAs have been established (i.e., biotin, chloride, choline, chromium, 
manganese, pantothenic acid, potassium, and vitamin K) (Ref. 47).

[[Page 11928]]

    Therefore, we tentatively conclude that AIs provide an appropriate 
basis for selecting RDIs for those vitamins and minerals where 
available data are insufficient to determine RDAs. Accordingly, we are 
proposing to use AIs to set the RDIs for biotin, chloride, choline, 
chromium, manganese, pantothenic acid, potassium, and vitamin K.
4. Approach to Setting RDIs: Tolerable Upper Intake Level
    The UL is the highest average daily intake level likely to pose no 
risk of adverse health effects for nearly all people in a particular 
group. As intake increases above the UL, potential risk of adverse 
effects may increase (Ref. 96). The UL can be used to estimate the 
percentage of the population at potential risk of adverse effects from 
excess nutrient intake (Ref. 25). However, the UL is not intended to be 
a recommended level of intake for vitamins and minerals where excess 
intake is not a concern, as there is generally (with the exception of 
folate in the prevention of neural tube defects) no established benefit 
for consuming amounts of nutrients above the RDA or AI (Ref. 96). 
Therefore, we do not consider the UL to be an appropriate basis for 
setting RDIs. However, as the IOM noted, ULs can be used to plan diets 
to ensure usual intakes of vitamins and minerals are below the UL for 
individuals or to plan diets for groups to minimize the proportion of 
the population at risk of excess nutrient intake (Ref. 25).
    Therefore, we tentatively conclude that the UL does not provide an 
appropriate basis for establishing RDIs for vitamins and minerals. As 
noted previously (sections II.I.2. and II.I.3.), we tentatively 
conclude that the RDAs and, for nutrients where an RDA has not been 
established, AIs are the most appropriate quantitative intake 
recommendations for setting RDIs that can help consumers to plan 
general diets and understand the nutritional content of the foods they 
buy in the context of the total daily diet.
5. Approach to Setting RDIs: Population-Weighted Versus Population-
Coverage
    As discussed in the 2007 ANPRM, we set the RDIs based on a 
population-coverage approach, after concluding that this approach was 
more appropriate than a population-weighted approach, in part, so that 
vulnerable or at-risk groups would be sufficiently covered by the DV 
(72 FR 62149 at 62150). In determining an approach for setting RDIs in 
this proposed rule, we considered recommendations of current consensus 
reports, scientific review articles, and comments to the 2007 ANPRM. We 
presented a comparison of potential RDIs based on the various 
established DRIs and applying the population-coverage versus 
population-weighted approaches (see tables 11A and 11B of the 2007 
ANPRM). As discussed in this document, we tentatively conclude that 
RDIs for vitamins and minerals should continue to be based on a 
population-coverage approach, using the highest RDA and, where an RDA 
has not been established, the highest AI.
    We continue to agree with the rationale we set forth in 1993 that 
the population-coverage approach would sufficiently cover the 
vulnerable or at-risk groups (58 FR 2206 at 2211). Using the highest 
age and gender group RDA/AI value (i.e., a population-coverage 
approach) would avoid a higher risk of nutrient inadequacy among 
certain segments of the population because such a value is not derived 
from averaging the requirements for populations with lower needs 
(children and elderly) and those with greater needs (adolescents or 
adults). While incidences of deficiency diseases, such as pellagra, are 
now rare, intakes and status biomarkers of certain nutrients continue 
to be inadequate and of public health significance (see section II.H.). 
Although, for some nutrients, the population-coverage RDA approach 
would result in RDIs that are higher than the nutrient requirements for 
some consumers, RDA, by definition, is the target intake goal for 
nutrient intakes for individuals. In addition, as noted by one comment, 
unlike the population-weighted approach, the population-coverage 
approach would not be susceptible to changes in age demographics of the 
population. Therefore, any future revisions to RDIs would be based 
primarily on new scientific data related to nutrition or new dietary 
recommendations, and we would not need to revise RDIs solely based on 
the availability of new census data.
    We also considered concerns that the population-coverage approach 
may lead to excessive intakes of nutrients. As in the case of the RDA 
approach (discussed previously), we find such concerns unfounded. 
Intakes of vitamins and minerals generally do not exceed the ULs under 
current RDIs that are based on a population-coverage RDA approach. In a 
few instances where total usual intakes of vitamins and minerals by 
children 4 to 8 years exceed corresponding ULs, we have determined that 
such intakes are not of public health significance, and for some 
nutrients, are not as a result of fortification (see accompanying Ref. 
115). Furthermore, because many of the new RDAs and AIs established by 
the IOM are now lower than previously set RDAs or ESADDIs, the RDIs 
based on a population-coverage RDA for many nutrients will decrease 
(see table 2). We consider that, from a public health perspective, it 
is more important for the DV of vitamins and minerals to cover the 
intake needs of most consumers than it is for certain age and gender 
groups to be covered by the DV based on their proportion of the overall 
population. We are also not aware of any data indicating that use of a 
population-coverage approach versus a population-weighted approach 
results in increases in nutrient consumption. Therefore, we tentatively 
conclude that the population-coverage approach using the highest RDA 
or, in its absence, the highest AI continues to provide an appropriate 
basis for setting RDIs for vitamins and minerals. We are proposing to 
amend Sec.  101.9(c)(8)(iv) to update RDIs as presented in table 2.
6. Declaration of Absolute Amounts of Vitamins and Minerals
    Currently, mandatory nutrients and, when declared, voluntary 
nutrients must be declared by their absolute amounts in weight on the 
Nutrition Facts label, except for vitamins and minerals (other than 
sodium and potassium) (see Sec.  101.9(d)(7)(i)). Thus, except when the 
linear label format is used (Sec.  101.9(j)(13)(ii)(A)(2)), listings 
for sodium and potassium (when declared) appear above the third bar and 
include both weight amounts and percent DVs, while vitamins A and C, 
calcium, and iron appear below the third bar and include percent DVs 
only. In the case of dietary supplements, both the quantitative amount 
by weight and percent DV (if available) are required to be declared on 
the Supplement Facts label (Sec.  101.36(b)(2)(ii) and (iii)). The 2007 
ANPRM invited comment on whether the absolute amounts (e.g., grams or 
milligrams) of mandatory and voluntary vitamins and minerals should be 
included on the Nutrition Facts and Supplement Facts labels (72 FR 
62149 at 62170). Most comments supported including the absolute amounts 
of these nutrients in addition to the requirement of listing percent 
DVs.
    Research suggests that consumers, in general, and physicians who 
prescribe nutrient supplements for specific medical reasons have 
difficulty understanding how percent DVs relate to the absolute amounts 
of nutrients listed on the Nutrition Facts label (Ref.

[[Page 11929]]

133). More recently, in a report on labeling and fortification, the IOM 
recommended listing both absolute amounts (e.g., mg/serving) and 
percent DVs to assist consumers who have difficulty understanding how 
to interpret the percent DV declaration (Ref. 25). This IOM report also 
stated that absolute amounts declaration for all micronutrients would 
maintain consistency in how nutrients are declared on the Nutrition 
Facts label.
    Based on the IOM's recommendation, research findings, and comments 
received, we are proposing to require that, similar to the requirement 
for dietary supplements (Sec.  101.36(b)(2)(i)(A)), all vitamins and 
minerals declared on the Nutrition Facts label must include their 
quantitative amounts (in addition to the requirement for corresponding 
percent DV declaration) (proposed Sec.  101.9(c)(8)). We request 
comments on this tentative conclusion, and seek input on the 
appropriate placement of the quantitative amounts of nutrients on the 
Nutrition Facts label.
    Further, with the proposed requirement for declaration of absolute 
amounts of vitamins and minerals, it is necessary to establish when a 
vitamin or mineral is present in an insignificant amount as well as 
increments for declaration of the quantitative amounts of vitamins and 
minerals on the Nutrition Facts label. In determining requirements for 
vitamins and minerals present in insignificant quantities, as well as 
increments for declared vitamins and minerals, we looked to 
requirements that have already been established for declaration of 
quantitative amounts of sodium and potassium, vitamins and minerals 
declared on the Supplement Facts label, and percent DVs.
    Quantitative amounts in milligrams may currently be listed on the 
Nutrition Facts label for only two minerals: Sodium, a mandatory 
nutrient (Sec.  101.9(c)(4)) and potassium (Sec.  101.9(c)(5)), which 
may be voluntarily declared on the Nutrition Facts label. We require in 
Sec.  101.9(c)(4) and (c)(5) that when a serving contains less than 5 
mg of sodium or potassium, the value shall be declared as zero; when a 
serving contains 5 to 140 mg of sodium or potassium, the declared value 
shall be rounded to the nearest 5 milligram increment; and when a 
serving contains greater than 140 mg of sodium or potassium, the 
declared value shall be rounded to the nearest 10 mg increment. We are 
now proposing to establish an RDI for potassium. Since potassium will 
now have an RDI, rather than a DRV, we are proposing to remove the 
specific requirements for the declaration of potassium in Sec.  
101.9(c)(5), and replace the section with requirements for the 
declaration of fluoride. Requirements for the declaration of 
quantitative amounts of other nutrients with an established RDI 
discussed in this document will apply to potassium, if finalized.
    The quantitative amounts by weight per serving of vitamins and 
minerals are also required to be declared on the Supplement Facts label 
(Sec.  101.36(b)(2)(ii)). The amounts of vitamins and minerals, 
excluding sodium and potassium, that are declared on the Supplement 
Facts label are the amount of the vitamin or mineral included in one 
serving of the product, using the units of measurement and levels of 
significance given in Sec.  101.9(c)(8)(iv). Section 
101.36(b)(2)(ii)(B) also specifies that for declaration of vitamins and 
minerals on the Supplement Facts label, zeros following decimal points 
may be dropped, and additional levels of significance may be used when 
the number of decimal places indicated is not sufficient to express 
lower amounts (e.g., the RDI for zinc is given in whole mg, but the 
quantitative amount may be declared in tenths of a mg).
    For conventional foods, FDA specifies in Sec.  101.9(c)(8)(iii) 
that the percent DV declaration for vitamins and minerals present at 
less than 2 percent of the RDI is not required for nutrition labeling, 
but may be declared as zero or by the use of an asterisk (or other 
symbol) that refers to another asterisk (or symbol) that is placed at 
the bottom of the table and that is followed by the statement 
``Contains less than 2 percent of the Daily Value of this (these) 
nutrient (nutrients).'' Alternatively, the statement ``Not a 
significant source of (listing the vitamins or minerals omitted)'' may 
be placed at the bottom of the table of nutrient values.
    For the purpose of determining when a vitamin or mineral is present 
in an insignificant amount, we tentatively conclude that the cutoff 
used for declaration of percent DV of less than 2 percent of the RDI 
(Sec.  101.9(c)(8)(iii)) can reasonably be applied to the declaration 
of quantitative amounts of vitamins and minerals on the Nutrition Facts 
label. We find that, if a product contains less than 2 percent of the 
RDI per serving, it is appropriate to express the declared vitamin or 
mineral quantitative amount as zero. The manufacturer may choose to use 
an asterisk (or other symbol), instead of a declaration of zero, that 
refers to another asterisk (or symbol) placed at the bottom of the 
table and that is followed by the statement ``Contains less than 2 
percent of the Daily Value of this (these) nutrient (nutrients).'' 
Alternatively, the statement ``Not a significant source of (listing the 
vitamins or minerals omitted)'' (``not a significant source'' 
statement) may be placed at the bottom of the table of nutrient values.
    As previously discussed, manufacturers have the option of using an 
asterisk (or symbol), instead of a declaration of zero, that directs 
the consumer to a statement indicating that the product is not a 
significant source of certain vitamins or minerals found at the bottom 
of the table of nutrient values when the calculated percent DV is less 
than 2 percent. We are concerned that it may be confusing to consumers 
if the manufacturer chooses to declare the quantitative amount of a 
vitamin or mineral as zero, and also chooses to use an asterisk 
referring the reader to a statement at the bottom of the label instead 
of in the percent DV column on the Nutrition Facts label. Therefore, we 
are proposing to require that, when a product contains less than 2 
percent of the RDI for a vitamin or mineral, the manufacturer must 
declare the quantitative amount of the vitamin or mineral and the 
percent DV in the same manner. For example, if a serving of the product 
contains less than 2 percent of the RDI for calcium, both the 
quantitative amount and the percent DV for calcium may be listed as 
zero or an asterisk (or symbol) directing the consumer to a statement 
at the bottom of the label may be used in place of both the 
quantitative amount and the percent DV declaration for calcium.
    We see no reason to provide different declaration increments for 
the Nutrition Facts label than those that have already been established 
for the declaration of quantitative amounts of vitamins and minerals on 
the Supplement Facts label in Sec.  101.36(b)(2)(ii). Therefore, we 
tentatively conclude that, as with the declaration of quantitative 
amounts of vitamins and minerals on the Supplement Facts label, the 
levels of significance given in Sec.  101.9(c)(8)(iv) should be used. 
Zeros following decimal points may be dropped, and additional levels of 
significance may be used when the number of decimal places indicated is 
not sufficient to express lower amounts (e.g., the RDI for zinc is 
given in whole mg, but the quantitative amount may be declared in 
tenths of a mg).
    We acknowledge that for some vitamins and minerals with RDIs that 
contain three or four digits (e.g., phosphorous has a proposed RDI of 
1,250 mg), a difference of 1 mg per serving may not be meaningful in 
terms

[[Page 11930]]

of health impacts. We request comment on whether quantitative amounts 
for nutrients with RDI values that contain three or four digits should 
be rounded, what the rounding increments should be, and data to support 
suggested rounding increments for such vitamins and minerals.
7. Issues Concerning Specific Vitamins and Minerals
    In this section, we address issues related to RDIs for specific 
vitamins and minerals, including those received in comments to the 2007 
ANPRM. We discussed the declaration of these vitamins and minerals in 
section II.H. (and in accompanying Ref. 115).
    a. Vitamin K--There are three general forms of vitamin K: 
Phylloquinone (vitamin K1), menaquinone (vitamin 
K2), and menadione (vitamin K3). For labeling 
purposes, there is no specific definition for vitamin K. The AIs for 
vitamin K are based on median intakes from NHANES data, which 
specifically represents the intake of phylloquinone, the major form of 
vitamin K in the diet (Ref. 134). The AI for vitamin K does not account 
for the intake of menaquinone or menadione because (1) NHANES data only 
includes phylloquinone content of foods, (2) the contribution of 
menaquinones, which can be produced by bacteria in the gut, to the 
maintenance of vitamin K status has not been established, and (3) 
menadione is a synthetic form of vitamin K that can be converted to a 
form of menaquinone in animal tissues. Because the AI for vitamin K is 
specific to phylloquinone, our proposed RDI for vitamin K, 120 mcg in 
proposed Sec.  101.9(c)(8)(iv), that is based on the AI pertains only 
to phylloquinone.
    b. Chloride--The RDI for chloride of 3,400 mg/d (Sec.  
101.9(c)(8)(iv)) was established in 1995 and is based on the midpoint 
of the range (1,700 to 5,100 mg/d) of the ESADDI set in the 1980 RDA 
report (Ref. 135; 59 FR 427). The RDI for chloride is proportional to 
the DRV for sodium, considering that chloride losses tend to parallel 
losses of sodium and almost all dietary chloride comes from sodium 
chloride (60 FR 67164). The IOM set AIs and ULs for chloride on an 
equimolar basis to the AI and UL for sodium (Ref. 10). The 2007 ANPRM 
requested comment on whether (1) the DV for chloride should continue to 
be an RDI, or should be a DRV like the current DV for sodium and (2) 
the DV for chloride should be based on the same DRI (AI versus UL) as 
used to set a DV for sodium.
    A few comments supported setting a DRV for chloride on an equimolar 
basis to the UL for sodium. We disagree because the UL for chloride was 
not based on adverse effects associated with excess intake of chloride. 
Furthermore, the UL was not based on a public health endpoint specific 
to chloride intake, which is a basis for setting a DRV. Because 
chloride is an essential mineral and has age- and gender-specific AIs, 
we tentatively conclude that chloride should remain a RDI and be based 
on population-coverage AI (see section II.I.5.). Therefore, we are 
proposing to set an RDI for chloride using the population-coverage AI 
of 2,300 mg/d (proposed Sec.  101.9(c)(8)(iv)).
    c. Potassium--The DRV of 3,500 mg/d for potassium was established 
based on its beneficial health effects (e.g., reduction in blood 
pressure) (55 FR 29487 at 29500). We established a DRV rather than an 
RDI because an RDA for specific age and gender groups was not 
established at that time. In 2005, the IOM established age- and gender-
specific AIs for potassium based on data showing that potassium lowers 
blood pressure, blunts the adverse effects of sodium chloride intake on 
blood pressure, reduces the risk of recurrent kidney stones, and 
possibly decreases bone loss (Ref. 136). Because potassium is an 
essential mineral and age- and gender-specific AIs are available, we 
tentatively conclude that an RDI should be established in place of the 
DRV. Therefore, using the population-coverage AI, we are proposing to 
establish an RDI for potassium of 4,700 mg/d (proposed Sec.  
101.9(c)(8)(iv)).
    d. Choline--FDA regulations do not establish a reference value for 
choline. In 1998, the IOM established age- and gender-specific AIs for 
choline based on intakes necessary to maintain liver function (Ref. 
137). In 2001, we received a FDAMA notification under section 
403(r)(2)(G) of the FD&C Act for the use of certain nutrient content 
claims for choline (Ref. 138). The FDAMA notification identified the DV 
for choline as 550 mg, which was based on the population-coverage AI 
for choline. Because the IOM established age- and gender-specific AIs 
for choline, we tentatively conclude that an RDI should be established. 
Thus, we are proposing in Sec.  101.9(c)(8)(iv) to set an RDI of 550 mg 
for choline based on the population-coverage AI.
    e. Vitamin B12--We are proposing to lower the RDI for 
Vitamin B12 from 6 to 2.4 [mu]g/day which reflects the 
population-coverage RDA for Vitamin B12. The RDAs for 
Vitamin B12 were established by the IOM in 2000. The IOM 
noted that 10 to 30 percent of individuals older than 50 years of age 
are estimated to have atrophic gastritis with low stomach acid 
secretion which can decrease the bioavailability of naturally occurring 
vitamin B12 in food (Ref. 17). The bioavailability of 
crystalline vitamin B12 that is added to food is not altered 
in people with this condition. While the IOM set an RDA of 2.4 [mu]g/d 
that can be met by consuming natural and crystalline forms of vitamin 
B12 and is for all adults, it was noted that it is advisable 
that individuals older than 50 years of age meet their RDA mainly by 
consuming foods fortified with crystalline vitamin B12 or 
vitamin B12-containing supplements. If the RDI is lowered 
from 6 to 2.4 [mu]g, it is possible that the fortification level in 
foods, such as ready-to-eat breakfast cereals, may be lowered, 
decreasing the overall amount of crystalline vitamin B12 in 
the food supply. Given the current level of fortification in food, less 
than 1 percent of men and 6.4 to 7.5 percent of women older than 50 
years of age consume below the EAR for vitamin B12, while 
only 3 to 5 percent of men and women in this age group have serum 
vitamin B12 levels that are considered to be inadequate 
(2003-2006 NHANES) (table 1). Reflecting the current food supply and 
regulations, data from NHANES (2003-2006) indicate that ready-to-eat 
cereal is the primary source of crystalline B12 added to 
food, providing approximately 14.6 percent of the total vitamin 
B12 consumed by individuals 51 years of age and older (Ref. 
139). Dietary supplements appear to be an important contributor of 
vitamin B12 for this age group because the mean increase in 
vitamin B12 intake ranged between 2.5 and 4.7 [mu]g/d when 
comparing intake from food only compared to food plus dietary 
supplements (NHANES 2003-2006) (table 1). We request comment and data 
on lowering the RDI for vitamin B12 to 2.4 [mu]g.

[[Page 11931]]



                            Table 2--Current and Proposed RDIs for Nutrition Labeling
                [Based on a 2,000 calorie intake for adults and children 4 or more years of age]
----------------------------------------------------------------------------------------------------------------
               Nutrient                          Current RDIs                         Proposed RDIs
----------------------------------------------------------------------------------------------------------------
Vitamins:
    Biotin............................  300 micrograms................  30 micrograms.
    Choline...........................  550 \1\ milligrams............  550 milligrams.
    Folate............................  400 micrograms................  400 micrograms DFE.
    Niacin............................  20 milligrams.................  16 milligrams NE.
    Pantothenic acid..................  10 milligrams.................  5 milligrams.
    Riboflavin........................  1.7 milligrams................  1.3 milligrams.
    Thiamin...........................  1.5 milligrams................  1.2 milligrams.
    Vitamin A.........................  5,000 International Units.....  900 micrograms RAE.
    Vitamin B6........................  2.0 milligrams................  1.7 milligrams.
    Vitamin B12.......................  6 micrograms..................  2.4 micrograms.
    Vitamin C.........................  60 milligrams.................  90 milligrams.
    Vitamin D.........................  400 International Units.......  20 micrograms.
    Vitamin E.........................  30 International Units........  15 milligrams.
    Vitamin K.........................  80 micrograms.................  120 micrograms.
Minerals:
    Calcium...........................  1,000 milligrams..............  1,300 milligrams.
    Chloride..........................  3,400 milligrams..............  2,300 milligrams.
    Chromium..........................  120 micrograms................  35 micrograms.
    Copper............................  2.0 milligrams................  0.9 milligrams.
    Iodine............................  150 micrograms................  150 micrograms.
    Iron..............................  18 milligrams.................  18 milligrams.
    Magnesium.........................  400 milligrams................  420 milligrams.
    Manganese.........................  2.0 milligrams................  2.3 milligrams.
    Molybdenum........................  75 micrograms.................  45 micrograms.
    Phosphorus........................  1,000 milligrams..............  1,250 milligrams.
    Potassium \2\.....................  3,500 milligrams..............  4,700 milligrams.
    Selenium..........................  70 micrograms.................  55 micrograms.
    Zinc..............................  15 milligrams.................  11 milligrams.
----------------------------------------------------------------------------------------------------------------
RAE = Retinol activity equivalents; 1 RAE = 1 mcg retinol, 12 mcg [beta]-carotene, or 24 mcg [alpha]- carotene,
  or 24 mcg [beta]-cryptoxanthin.
NE = Niacin equivalents, 1 mg niacin = 60 mg of tryptophan.
DFE = Dietary folate equivalents; 1 DFE = 1 mcg food folate = 0.6 mcg of folic acid from fortified food or as a
  supplement consumed with food.
\1\ A notification was submitted under section 403(r)(2)(G) of the FD&C Act in 2001 for the use of certain
  nutrient content claims for choline. These statements identify the daily value for choline as 550 mg. This
  value is based on the AI set by the IOM of the NAS in 1998 (Refs. 138 and 137).
\2\ These minerals currently have a DRV and we are proposing to establish an RDI.

J. Units of Measure, Analytical Methods, and Terms for Vitamins and 
Minerals

    As discussed in this document, the IOM set DRIs using new units of 
measure for vitamin A, vitamin E, and folate, as well as provided 
recommendations on the use of International Units (IUs), and expression 
of weight amounts for sodium, potassium, copper, and chloride (Refs. 17 
to 19,25). The new units of measure for vitamin A, vitamin E, and 
folate affect how total amount of each nutrient is measured. The 2007 
ANPRM asked several questions about these issues. We discuss our 
reconsideration of the units of measure, analytical methods, and terms 
used in declaration of specific vitamins and minerals in this section.
1. Sodium, Potassium, Copper, and Chloride
    The absolute amount declaration for sodium, potassium, copper, and 
chloride must be expressed in mg (Sec.  101.9(c)(8)(iv) and (c)(9)). 
However, in the DRI reports for these nutrients, these nutrients are 
expressed as grams (sodium, potassium, chloride) or micrograms (copper) 
(Refs. 21,140). The IOM Labeling Committee recommended that the current 
requirement for units of measurement used in the declaration of these 
nutrients should be changed to be consistent with the units used in the 
new DRI reports. In response to the 2007 ANPRM that asked about whether 
the units of measure should be changed for these nutrients, we received 
comments that generally supported maintaining the current units of 
measure.
    We considered the IOM Labeling Committee recommendations and 
comments received. When expressed as ``g'' units, rather than in ``mg'' 
units, significant differences in the amounts of sodium or potassium 
could appear inconsequential or less significant. For example, amounts 
declared as 0.2 g and 0.5 g may not seem as significantly different as 
200 mg and 500 mg. Furthermore, units of measure for these nutrients 
have been in use since 1993 and consumers may be already familiar with 
the units used on the label. In addition, the use of milligrams for 
sodium and potassium is consistent with the 2010 DGA, which provides 
recommendations for sodium and potassium in milligram units (Ref. 6). 
We tentatively conclude that there is no advantage to change the units 
of measure for sodium, potassium, copper, or chloride from those 
currently in use. Thus, we are not proposing any changes to the units 
used for declaring these nutrients on the Nutrition Facts label.
2. Folate and Folic Acid
    a. Units of Measure--The RDI for ``folate'' is listed in 
``micrograms'' (Sec.  101.9(c)(8)(iv)). Folate represents the sum of 
naturally occurring folate and synthetic folic acid that has been added 
to foods. In 1998, the IOM set the RDA for folate expressed as mcg 
Dietary Folate Equivalents (DFE) (Ref. 141). The IOM Labeling Committee 
recommended that the units used for folate (mcg) in nutrition labeling 
should be consistent with the units in the new DRI report (mcg DFE) 
(Ref. 25). In response to the 2007 ANPRM, in which we asked for comment 
on this issue, a few comments supported retaining the current units 
(mcg) for folate and one comment noted

[[Page 11932]]

that the use of the term DFE on the label would be unfamiliar to 
consumers and could be confusing (Ref. 47). The IOM developed the new 
term, DFE, to account for the greater bioavailability of synthetic 
folic acid that is added to fortified foods or dietary supplements than 
folate that occurs naturally in foods (food folate). As defined by the 
IOM, mcg DFE is equivalent to mcg food folate + (1.7 x mcg synthetic 
folic acid) (Ref. 141). The current unit of measure (mcg) does not take 
into account the difference in the bioavailability of folate and folic 
acid. In addition, mcg DFE declaration would provide a more accurate 
representation of the amount of folate in foods that contain both 
naturally occurring folate and added folic acid. For example, the 
standards of identity for certain enriched foods require the addition 
of folic acid (21 CFR parts 136, 137, and 139) and, these foods contain 
both food folate and synthetic folic acid.
    Therefore, we are proposing to amend Sec.  101.9(c)(8)(iv) such 
that mcg DFE would be used to declare the amount of total folate (food 
folate and synthetic folic acid) on the Nutrition Facts label. Section 
101.36(b)(2)(ii)(B) for the labeling of dietary supplements includes a 
reference to Sec.  101.9(c)(8)(iv), which, as proposed, designates the 
units of measure for declaration of folic acid as mcg DFE units (see 
section II.L.).
    We are aware that education efforts should be provided to assist 
with consumer understanding of the new ``equivalent'' units of 
measurement for folic acid. For example, using the new units, a dietary 
supplement that now declares 400 mcg of folic acid would declare the 
same amount as 680 mcg DFE or 170 percent of the proposed RDI. One 
option to help ensure consumer understanding would be to allow the 
declaration of the amount of folic acid in parenthesis similar to that 
permitted for the percent of vitamin A as [beta]-carotene (Sec.  
101.9(c)(8)(vi)). For example, for a conventional food that contains 
both folic acid and folate, the total mcg DFE could be declared and in 
parenthesis indicate how much is from folic acid. We invite comment on 
this approach.
    b. Analytical Methods--Because we are proposing to amend the units 
used for declaring the sum of folate and folic acid, we considered the 
availability and limitations of analytical methods necessary to measure 
each nutrient separately for calculating mcg DFE. Available analytical 
methods (e.g., AOAC 960.46, 944.12, and 2004.05) cannot distinguish 
between naturally occurring folate in conventional food and folic acid 
that is added to conventional food products. There is a difference in 
folate activity between naturally occurring folate and synthetic folic 
acid that is added to fortify foods. When a conventional food product 
contains a mixture of naturally occurring folate and synthetic folic 
acid that has been added, available analytical methods do not allow for 
verification of the declared amount of mcg DFEs on the Nutrition Facts 
label. To calculate DFEs, it is necessary to know both the amount of 
folate and folic acid in the food product. Therefore, proposed Sec.  
101.9(g)(10) would require manufacturers to make and keep records to 
verify the amount of folic acid added to the food and folate in the 
finished food, when a mixture of both naturally occurring folate and 
added folic acid are present in the food. (See section II.N.) We invite 
comment on available scientifically valid methods that are capable of 
measuring folic acid and folate separately.
    c. Terms to Declare Folate--''Folic acid'' or ``folacin'' are 
identified as synonyms of folate and can be added in parentheses after 
folate or can be listed without parentheses in lieu of ``folate'' on 
the Nutrition Facts label (Sec.  101.9(c)(8)(v)) or in the Supplement 
Facts label (Sec.  101.36(b)(2)(B)(2)).
    Consistent with the proposed amendments related to the units of 
measure for folate that take into account the differences between 
folate and folic acid, we are reconsidering appropriate terms for 
declaration of folate content in foods and dietary supplements. We are 
proposing to (1) eliminate the synonym ``folacin'' specified in 
Sec. Sec.  101.9(c)(8)(v) and 101.36(b)(2)(B)(2); (2) require, in 
proposed Sec.  101.9(c)(8)(vii), that the term ``folate'' be used in 
the labeling of conventional foods that contain either folate only or a 
mixture of folate and folic acid; and (3) require that the term ``folic 
acid'' be used in the labeling of dietary supplements only. As 
proposed, conventional foods would not be permitted to use the term 
``folic acid.''
3. Vitamins A, D, and E
    International Units (IUs) are used for the labeling of vitamins A, 
D, and E on the Nutrition and Supplements Facts labels (Sec. Sec.  
101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B)). The IOM Labeling Committee 
recommended that the units for these nutrients should be changed to be 
consistent with the units in the new DRI reports, i.e., [mu]g Retinol 
Activity Equivalents for vitamin A, [mu]g for vitamin D, and mg 
[alpha]-tocopherol for vitamin E (Refs. 18,22,25,140). In response to 
the 2007 ANPRM, several comments supported replacing IUs with mcg RAE 
for vitamin A, [mu]g for vitamin D, and mg [alpha]-tocopherol for 
vitamin E. We agree that IUs should be replaced with units that are 
consistent with the DRIs. In addition, because DRIs form the basis for 
the proposed RDIs for these vitamins (see section II.I.), using the new 
units would also correspond with the proposed RDIs for vitamins A, D, 
and E. We discuss issues relevant to vitamin A and vitamin E units of 
activity in this document.
    a. Units of Vitamin A Activity--The RDI for vitamin A is 5,000 IU 
(Sec.  101.9(c)(8)(iv)). Because the vitamin A activity of provitamin A 
carotenoids (e.g., [beta]-carotene) is less than pre-formed vitamin A 
(retinol), the following conversions were developed: One mcg retinol = 
3.33 IU vitamin A activity from retinol (Ref. 105) and 10 IU [beta]-
carotene = 3.33 IU retinol (Ref. 105). Because the vitamin A activity 
of [beta]-carotene in dietary supplements is greater than [beta]-
carotene in food, ten IU of [beta]-carotene is based on 3.33 IU of 
vitamin A activity x 3 (the relative vitamin A activity of [beta]-
carotene in supplements versus diets). The RDA in mcg Retinol 
Equivalents (RE) for vitamin A is equivalent to 1 mcg retinol or 6 mcg 
of [beta]-carotene (i.e., carotene:retinol equivalency ratio of 6:1) 
and considers 3 mcg of dietary [beta]-carotene to be equivalent to 1 
mcg of purified [beta]-carotene in supplements (i.e., a 
carotene:retinol equivalency ratio of 3:1).
    A comment to the 2007 ANPRM noted that the IU for vitamin A does 
not take into account the recent information on the bioavailability of 
dietary provitamin A carotenoids that was used to define retinol 
activity equivalents (RAEs) for these carotenoids (Ref. 105). The unit 
of measure associated with the RDA for vitamin A is mcg RE. We agree 
that the IU for vitamin A does not reflect the carotene:retinol 
equivalency ratio. RAEs consider 6 mcg of dietary [beta]-carotene to be 
equivalent to 1 mcg of purified [beta]-carotene in supplements (i.e., a 
carotene:retinol equivalency ratio of 6:1) because more recent evidence 
suggests that the bioavailability of [beta]-carotene is approximately 
half of what was previously considered for setting mcg RE. A change in 
units does not present any challenges to AOAC methods used for 
measuring provitamin A carotenoids and vitamin A in foods or dietary 
supplements.
    Therefore, proposed Sec.  101.9(c)(8)(iv) would change the units of 
measure for vitamin A to replace ``IU'' with ``mcg,'' representing mcg 
RAE. In addition, because the difference in the bioconversion of 
[beta]-carotene to vitamin A will be accounted for with the proposed 
declaration of vitamin A content as ``mcg'' (representing mcg

[[Page 11933]]

RAE), we are not proposing to preclude the declaration of [beta]-
carotene in conventional foods as vitamin A. A corresponding change for 
dietary supplements is made in proposed Sec.  101.36(b)(2)(i)(B)(3).
    b. Units of Vitamin E Activity--The RDI for vitamin E is 30 IU 
(Sec.  101.9(c)(8)(iv)). Before 1980, one IU of vitamin E activity was 
defined as 1 mg of dl-[alpha]-tocopherol acetate by the U.S. 
Pharmacopeia (USP) (Ref. 142). After 1980, the IU was changed to the 
USP unit where one USP unit of vitamin E was still defined as having 1 
mg of all rac-[alpha]-tocopherol acetate. Therefore there is no longer 
an IU for vitamin E (Ref. 142). One comment to the 2007 ANPRM said that 
the current RDI of 30 IU underestimates the amount of vitamin E 
naturally present in foods. We agree. The RDA for vitamin E is 15 mg/d 
of [alpha]-tocopherol (Ref. 143). [alpha]-Tocopherol is the only form 
of vitamin E that is maintained in blood and has biological activity. 
There are eight stereoisomers of [alpha]-tocopherol (RRR, RSR, RRS, 
RSS, SRR, SSR, SRS, SSS). Of the eight, only RRR [alpha]-tocopherol 
occurs naturally in foods. Commercially available vitamin E that is 
used to fortify foods and used in dietary supplements contains esters 
of either the natural RRR- or, more commonly, mixtures of the 8 
stereoisomers (all rac [alpha]-tocopherol acetate). Four of the eight 
stereoisomers of [alpha]-tocopherol are not maintained in human plasma 
or tissues (SRR, SSR, SRS, and SSS). Thus, the new RDA for vitamin E is 
limited to the four 2R stereoisomeric forms (RRR, RSR, RRS and RSS) of 
[alpha]-tocopherol (Ref. 143). These four forms of [alpha]-tocopherol 
are found in nonfortified and fortified conventional foods and dietary 
supplements. The all rac-[alpha]-tocopherol acetate in fortified foods 
or dietary supplements has one-half the activity of RRR-[alpha]-
tocopherol naturally found in foods or the 2R stereoisomeric forms of 
[alpha]-tocopherol. Unlike the IU, the new IOM measure of vitamin E 
activity, mg [alpha]-tocopherol accounts for this difference in 
activity between naturally occurring and synthetic vitamin E. 
Therefore, proposed Sec.  101.9(c)(8)(iv) would change the units of 
measure for vitamin E to replace ``IU'' with ``mg,'' representing mg of 
[alpha]-tocopherol. Section 101.36(b)(2)(ii)(B) for the labeling of 
dietary supplements includes a reference to Sec.  101.9(c)(8)(iv), 
which, as proposed, designates the units of measure for declaration of 
vitamin E as ``mg.''
    Because of the difference in vitamin E activity between all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol, AOAC methods or 
other validated analytical methods would be needed for individually 
measuring naturally occurring vitamin E (RRR-[alpha]-tocopherol) and 
all rac-[alpha]-tocopherol acetate in food products. Current AOAC 
methods cannot individually measure these two forms of vitamin E. In 
addition, it is necessary to know the amount of both RRR-[alpha]-
tocopherol and all rac-[alpha]-tocopherol acetate in a food product to 
calculate vitamin E equivalents for declaration as mg [alpha]-
tocopherol. It is not possible to determine the amount of RRR-[alpha]-
tocopherol in a food product by subtracting the amount of all rac-
[alpha]-tocopherol acetate from the total amount of vitamin E declared. 
Therefore, when a conventional food contains a mixture of all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol, we are proposing 
to require manufacturers to verify the declared amount of both all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol in the finished 
food product (proposed Sec.  101. 9(g)(10)). (See section II.N.) We 
invite comment on available validated methods that are capable of 
individually measuring all rac-[alpha]-tocopherol acetate and RRR-
[alpha]-tocopherol.
    For the reasons stated previously, we are proposing to amend Sec.  
101.9(c)(8)(iv) to replace IUs for the RDIs for vitamin A, vitamin D, 
and vitamin E with mcg RAE for vitamin A, [mu]g for vitamin D, and mg 
[alpha]-tocopherol for vitamin E.

K. Labeling of Foods for Infants, Young Children, and Pregnant or 
Lactating Women

    The general labeling requirements for foods in Sec.  101.9(c) apply 
to foods for infants, young children, and pregnant and lactating women 
with certain exceptions. For example, foods, other than infant formula, 
represented or purported to be specifically for infants and children 
less than 4 years of age are not permitted to include declarations of 
percent DV for the following nutrients: Total fat, saturated fat, 
cholesterol, sodium, potassium, total carbohydrate and dietary fiber 
(Sec.  101.9(j)(5)(ii)(A)). There are additional exceptions to labeling 
for foods, other than infant formula, represented or purported to be 
specifically for infants and children less than 2 years of age. For 
example, these foods are also not permitted to declare calories from 
fat, calories from saturated fat, saturated fat, polyunsaturated fat, 
monounsaturated fat and cholesterol on the Nutrition Facts label (Sec.  
101.9(j)(5)(i)).
    FDA regulations do not include DRVs or RDIs for nutrients, 
generally, for infants, children under 4 years of age, or pregnant and 
lactating women. However, there are requirements for a DRV for protein 
for children 4 or more years of age, and an RDI for protein for each of 
the following subpopulations: (1) Children less than 4 years of age; 
(2) infants; (3) pregnant women; and (4) lactating women (Sec.  
101.9(c)(7)(iii)). In the preamble to the 1993 DRV/RDI final rule, we 
included a table listing RDIs for various nutrients for these 
subpopulations, based on the 1968 NAS RDAs (58 FR 2206 at 2213). These 
RDIs also appear in FDA's Food Labeling Guide (Ref. 144) and we are 
aware that some manufacturers use these RDIs in labeling foods 
represented or purported to be specifically for these subpopulations.
    We are reconsidering the requirements for the labeling of foods, 
other than infant formula, represented or purported to be specifically 
for infants, children under 4 years of age, and pregnant and lactating 
women, in light of current recommendations in consensus reports and 
proposed changes to the Nutrition Facts label discussed in sections 
II.A. to II.J., and comments to the 2007 ANPRM. We are proposing 
various changes, which we discuss in this document.
1. Age Range for Infants and Young Children
    FDA regulations use the age ranges ``less than 2 years of age'' and 
``less than 4 years of age'' to establish labeling requirements for 
foods represented or purported to be specifically for infants and young 
children (Sec.  101.9(j)(5)). The 2007 ANPRM did not ask for comments 
on this issue, but several comments (Ref. 47) recommended that we 
change the current age categories to infants 7 to 12 months and young 
children 1 through 3 years (13 through 48 months), consistent with the 
age ranges used in the IOM's age-specific DRI recommendations.
    In general, we consider it appropriate to adopt the same age 
categories as those used in the IOM DRIs for infants and children 
because our proposed DVs are based on these age-specific DRIs. With 
respect to the infant category, the nutritional requirements of infants 
0 to 6 months should be met almost exclusively by breast milk or infant 
formula (Refs. 145 and 146). Therefore, regulations for the labeling of 
foods, other than infant formula, represented or purported to be 
specifically for infants 0 to 6 months of age are not necessary or 
appropriate. However, infants are transitioning to eating solid foods 
by 7 through 12 months. There are a number of foods in the marketplace 
identified for this age group. Therefore, we are proposing a separate 
category of foods represented or purported to be

[[Page 11934]]

specifically for infants 7 through 12 months.
    With respect to children 1 through 3 years of age, using the DRI 
age range would result in infants no longer being the lower end of the 
age range in the category of infants and children less than 2 years and 
less than 4 years of age as specified in Sec.  101.9(j)(5). Young 
children who are 1 year of age would be the lower end of the age range. 
Assigning DVs for children 1 through 3 years of age would ensure 
consistency with the 1 through 3 year toddler age category established 
for RACCs specified in Sec.  101.12(a)(2). Moreover, because the growth 
velocity in height is most similar for children 1 through 3 years of 
age, we consider it appropriate to revise the age range to include 
children of these ages into a single category for food labeling 
purposes (Ref. 15).
    Therefore, we are proposing to revise the exceptions for 
requirements for nutrition labeling provided in Sec.  101.9(j)(5)(i) 
and the exception to the requirement for the format used for nutrient 
information on food labeling in Sec.  101.9(d)(1) for foods represented 
or purported to be specifically for infants and children less than 4 
years of age. Specifically, we are proposing to replace the current 
category of infants and children less than 4 years with infants 7 
through 12 months and children 1 through 3 years of age.
2. Mandatory Declaration of Calories and Statutorily Required Nutrients
    Currently, foods, other than infant formula, represented or 
purported to be specifically for infants and children less than 4 years 
must declare statutorily required nutrients, including calories, 
calories from fat, total fat, saturated fat, cholesterol, sodium, total 
carbohydrate, sugars, dietary fiber, and protein. For foods, other than 
infant formula, represented or purported to be for infants and children 
less than 2 years, the declaration of certain statutorily required 
nutrients, which include calories from fat, saturated fat, and 
cholesterol, is not required or permitted (Sec.  101.9(j)(5)(i)).
    a. Declaration of Saturated Fat and Cholesterol--One comment to the 
2007 ANPRM noted that the diet of U.S. infants is nutritionally 
adequate with negligible risk of nutrient deficiency and recommended 
continuing to require the declaration of calories and the amount of 
total fat, total carbohydrate, dietary fiber, sugars, and total protein 
on the Nutrition Facts label of foods for infants. Another comment 
supported mandatory declaration of saturated fat on food products for 
children less than 2 years of age.
    As discussed in section II.K.1., we are proposing new categories of 
infants 7 through 12 months and children 1 through 3 years of age. We 
are considering, in this proposed rule, whether there is a need to 
require or permit the declaration of calories from fat, saturated fat, 
and cholesterol in the labeling for foods represented or purported to 
be specifically for these subpopulations. In section II.A.1., we 
discuss our intent to revise Sec.  101.9(c)(1)(ii) to no longer require 
and not permit the declaration of calories from fat on the Nutrition 
Fact label. Therefore, if these proposed changes are finalized, the 
exceptions in Sec.  101.9(j)(5)(i) would no longer be needed.
    With respect to saturated fat and cholesterol, we did not require 
or permit the labeling of any fat or fatty acid on foods represented or 
purported to be specifically for children less than 2 years because 
consensus reports noted the need for the higher percentage of calories 
from fat for this subpopulation and that nutrient guidelines on fats, 
cholesterol and calories for children less than 2 years of age is 
inappropriate (58 FR 2079 at 2150). A recent consensus report continues 
to recommend that fat intake in infants less than 12 months of age 
should not be restricted; however, there is no discussion or 
recommendation about not providing nutrient guidelines for fat and 
cholesterol to children under the age of 2 years (Ref. 146). While fat 
is still considered to be an important source of calories for infants 
and young children, recent evidence suggests that a diet with saturated 
fat less than 10 percent of calories and cholesterol intake less than 
300 mg/d can safely and effectively reduce the levels of total and LDL 
cholesterol in healthy children (Ref. 146). This type of diet may have 
similar effects when started in infancy and sustained throughout 
childhood into adolescence (Ref. 146). Furthermore, the 2010 DGA 
recommended that Americans 2 years of age and older consume less 
saturated fatty acids and less than 300 mg/d of cholesterol (Ref. 6).
    We tentatively conclude that, except for the declaration of 
calories from fat, the declaration of statutorily required nutrients 
that include saturated fat and cholesterol on the label of foods 
represented or purported to be specifically for infants 7 through 12 
months and children 1 through 3 years of age should be mandatory 
because: (1) The declaration of calories and these nutrients is 
mandated by section 403(q) of the FD&C Act and we have no basis on 
which to not require or permit their declaration as discussed 
previously; and (2) these nutrients are essential in fostering growth 
and maintaining good health during a critical stage of human 
development and physiology (Ref. 147 p. 71) and, therefore, their 
mandatory declaration can assist in maintaining healthy dietary 
practices. Therefore, we are proposing to remove current Sec.  
101.9(j)(5)(i) and revise and re-designate current Sec.  
101.9(j)(5)(ii) as Sec.  101.9(j)(5)(i).
    We request comment on our tentative conclusions and any available 
relevant empirical research as to whether the proposed declaration of 
saturated fat and cholesterol for these subpopulations is likely to be 
confusing to consumers or otherwise result in restriction of fat 
intakes among infants 7 through 12 months or children 1 through 3 years 
of age.
    Currently, foods consumed by pregnant and lactating women must 
declare statutorily required nutrients, including calories, calories 
from fat, total fat, saturated fat, cholesterol, sodium, total 
carbohydrate, sugars, dietary fiber, and protein. Women of reproductive 
age consume the same foods as the general population and, in general, 
continue consuming similar foods during pregnancy and lactation. We 
tentatively conclude that, except for the declaration of calories from 
fat, the declaration of statutorily required nutrients should be 
mandatory because the declaration of calories and these nutrients is 
mandated by section 403(q) of the FD&C Act and we have no basis on 
which to not require or permit their declaration as discussed 
previously.
    Accordingly, we are proposing to require the mandatory declaration 
of calories, and the amount of total fat, saturated fat, trans fat, 
cholesterol, sodium, total carbohydrate, dietary fiber, sugars, and 
protein on foods represented or purported to be specifically for 
infants 7 through 12 months of age, children 1 through 3 years of age, 
and pregnant and lactating women, and permit the declaration of 
calories from saturated fat such that these nutrients would be subject 
to the same requirements applicable to foods for the general 
population.
    A comment to the 2007 ANPRM requested that we permit the use of a 
footnote statement about not limiting fat intake on foods represented 
or purported to be specifically for infants and children less than 2 
years to enable consumers to make informed choices, should the Agency 
decide to propose the mandatory declaration of saturated fat for 
infants and children less than 2

[[Page 11935]]

years. The comment noted that saturated fat should not be limited in 
the diets of children less than 2 years of age. The comment provided no 
consumer data about such a footnote statement. At this time, we are not 
proposing to require a footnote stating that total fat and other types 
of fat should not be limited in infants and children less than 2 years 
in response to this comment. However, we request comments and 
information on how consumers would understand and use the amount of 
saturated fat and cholesterol declared on the Nutrition Facts label, as 
well as on the need for an explanatory footnote to accompany the 
declaration of saturated fat and cholesterol, on foods represented or 
purported to be specifically for infants 7 through 12 months or 
children 1 through 3 years.
    b. Percent DV Declaration--Currently, the percent DV declaration is 
not permitted on the food label for foods, other than infant formula, 
represented or purported to be specifically for infants and children 
less than 4 years (which includes infants and children less than 2 
years) for total fat, saturated fat, cholesterol, sodium, potassium, 
total carbohydrate, and dietary fiber (Sec.  101.9(j)(5)(ii)). Percent 
DV is required for protein and vitamins and other minerals. We 
tentatively conclude that it is appropriate to require declarations of 
percent DV for those nutrients for which we are establishing a DRV or 
RDI for infants 7 to 12 months, for children 1 through 3 years of age, 
and for pregnant and lactating women (see the discussion in this 
document for the nutrients in each subpopulation for which FDA is 
establishing a DRV or RDI). This change is reflected in re-designated 
Sec.  101.9(j)(5)(i). The percent DV, as discussed in section II.B.3., 
provides information in a manner which enables consumers to understand 
the relative significance of nutrition information in the context of a 
total daily diet.
    One comment to the 2007 ANPRM suggested that the percent DV 
declaration for protein should be voluntary for all infant products, 
unless a claim is made for protein because protein intake and quality 
appear to be adequate for infants (Refs. 148 and 149). As we previously 
stated, protein is of critical importance in maintaining good health 
because it supplies essential amino acids and is a principal source of 
calories along with fat and carbohydrate (55 FR 29487 at 29499). 
Current evidence suggests that protein intake is adequate in infants 
and young children and the majority of protein sources in their diets 
constitute high quality protein sources (Ref. 150). However, the level 
and quality of protein present in a food remain an important 
consideration in food selection for infants because infant diets are 
derived from a limited number of foods (55 FR 29487 at 29499). For 
example, at 6 to 11 months of age, approximately 46 percent of the 
total protein intake comes from sources other than breast milk, 
formula, and cow's milk (e.g., baby foods and meats) (Ref. 149). The 
percentage increases at ages 12 to 24 months to 63 percent (Ref. 149). 
Calculating the percent DV for protein incorporates a measure of 
protein quality (e.g., a corrected protein amount obtained from the 
protein digestibility-corrected amino acid score) (Sec.  101.9 
(c)(7)(i)). Thus, the percent DV declaration is a useful tool to 
indicate protein quality to the consumer. As such, we disagree that the 
percent DV declaration for protein should be voluntary. Because of the 
importance of adequate high quality protein in the diets of infants and 
young children, we tentatively conclude that the percent DV declaration 
for protein is necessary to assist consumers in maintaining healthy 
dietary practices among infants and young children 1 through 3 years of 
age.
3. Declaration of Non-Statutory Nutrients Other Than Essential Vitamins 
and Minerals
    Foods, other than infant formula, represented or purported to be 
specifically for infants and children less than 2 years of age are not 
permitted to declare calories from saturated fat and the amount of 
polyunsaturated fat and monounsaturated fat (Sec.  101.9(j)(5)(i)), 
whereas soluble fiber, insoluble fiber, and sugar alcohols can be 
voluntarily declared. Polyunsaturated fat, monounsaturated fat, soluble 
fiber, insoluble fiber, and sugar alcohols can be voluntarily declared 
on the label of foods represented or purported to be specifically for 
children 2 through 4 years of age, and pregnant and lactating women.
    Section I.C. includes a discussion of the factors that we consider 
in proposing the requirements for declaration of non-statutorily 
required nutrients on the Nutrition Facts label of foods (e.g., 
polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble 
fiber, and sugar alcohols). These factors include the availability of 
information from consensus reports, including evidence for the public 
health significance of a nutrient. Consensus reports that provide 
information about the relationship between nutrients and chronic 
diseases, heath-related conditions, or health-related physiological 
endpoints are generally not available for infants 7 to 12 months. 
Therefore, for foods represented or purported to be for these infants, 
we are not considering consensus reports in the way described in 
section I.C., but, rather, we are considering other types of 
information that are available from consensus reports applicable to 
this subpopulation. With respect to certain nutrition declaration 
requirements, we determined there was not sufficient evidence to 
propose a change to the regulations. In addition, we determined that, 
in some cases, there is not sufficient evidence to propose different 
requirements for foods represented or purported to be specifically for 
infants 7 through 12 months than for foods represented or purported to 
be specifically for children 1 through 3 years of age.
    For foods represented or purported to be specifically for children 
1 through 3 years of age and pregnant and lactating women, we 
considered the factors in section I.C. to determine whether to propose 
the mandatory or voluntary declaration of non-statutory nutrients. Most 
advisory consensus and policy reports on which we rely for the general 
population apply to children 2 years of age and older and pregnant and 
lactating women, unless noted otherwise (e.g., 2010 DGAC and health 
claims (Sec.  101.14(e)(5)). While the recommendations in these reports 
are for 2 years of age and older, we are using the information in these 
consensus reports for considering the factors in section I.C. for 
children 1 through 3 years of age because it is not expected that the 
role of these nutrients in health would be markedly different between 1 
and 2 year olds. Moreover, the IOM has established the DRI ranges for 1 
to 3 year olds.
    a. Voluntary Declaration of Calories From Saturated Fat, and the 
Amount of Polyunsaturated and Monounsaturated Fat--For infants 7 to 12 
months, there are no specific recommendations provided about calories 
from saturated or polyunsaturated or monounsaturated fat. However, as 
discussed previously, there is some evidence to suggest that reduction 
of total and LDL cholesterol levels can occur with reducing saturated 
fat intake to less than 10 percent of calories, beginning in infancy 
and sustained throughout childhood into adolescence (Ref. 146). 
Furthermore, consensus reports provide no discussion or recommendation 
about not providing nutrient guidelines for fatty acids to children 
under the age of 2 years and there is no evidence to suggest that 
infants 7 through 12 months of age would be different than children 1

[[Page 11936]]

through 3 years of age. Therefore, we tentatively conclude that there 
is no basis to continue to provide an exception that does not permit 
the declaration of calories from saturated fat, or polyunsaturated and 
monounsaturated fats on foods represented or purported to be 
specifically for infants and children less than 2 years of age.
    Quantitative intake recommendations are not available from relevant 
U.S. consensus reports for monounsaturated and polyunsaturated fats for 
children 1 through 3 years of age or pregnant and lactating women. 
There is well-established evidence to indicate that replacing saturated 
fatty acids with polyunsaturated and monounsaturated fatty acids 
reduces blood LDL cholesterol levels and, therefore, the risk of CVD 
(Ref. 6). Because monounsaturated and polyunsaturated fats have public 
health significance when they replace saturated fat, consistent with 
the factors we consider for voluntary declaration discussed in section 
I.C., we tentatively conclude that not permitting the declaration of 
polyunsaturated and monounsaturated fat on foods represented or 
purported to be specifically for children less than 2 years of age in 
Sec.  101.9(j)(5)(i) is no longer necessary.
    Therefore, we are proposing to revise Sec.  101.9(j)(5)(i) to 
remove the exceptions for the declaration of calories from saturated 
fat, and the amount of polyunsaturated fat and monounsaturated fat on 
foods represented or purported to be specifically for children less 
than 2 years of age. If finalized, these declarations would be the same 
as the proposed voluntary declarations for foods for the general 
population (see sections II.A.2, II.B.4, and II.B.5., respectively).
    b. Voluntary Declaration of Soluble Fiber, Insoluble Fiber, and 
Sugar Alcohols--As discussed in section II.D., while quantitative 
intake recommendations are lacking for soluble fiber, insoluble fiber, 
and sugar alcohols, there is well established evidence for the role of 
these nutrients in chronic disease risk, risk of a health-related or a 
physiological endpoint (i.e., CHD, laxation or dental caries) (Ref. 66 
and Sec. Sec.  101.76, 101.77, 101.80, and 101.81). There is no 
evidence to suggest that the role of these nutrients would be different 
among infants 7 through 12 months, children 1 through 3 years of age, 
or pregnant and lactating women compared to the general population.
    Accordingly, we are not proposing any changes to the provisions for 
the voluntary declaration of soluble fiber, insoluble fiber, and sugar 
alcohols on the label of foods represented or purported to be 
specifically for infants 7 to 12 months, children 1 through 3 years of 
age, or pregnant and lactating women.
    c. Mandatory Declaration of Trans Fat--Trans fat is required to be 
declared on the Nutrition Facts label and regulations do not provide 
exceptions for foods represented or purported to be specifically for 
infants, young children, or pregnant and lactating women. One comment 
to the 2007 ANPRM recommended eliminating mandatory trans fat labeling 
when total fat is declared as 0 g in the Nutrition Facts label of foods 
for infants.
    As explained in section II.B.3., we are not proposing any changes 
to the mandatory declaration of trans fat in the labeling of foods 
intended for the general population. The relationship between the 
consumption of trans fat and risk of CHD is well established (Refs. 6 
and 49). Cardiovascular disease is also known to begin in childhood 
(Refs. 146 and 151). Thus, we tentatively conclude that declaration of 
trans fat continues to be necessary to assist consumers in maintaining 
health dietary practices, including among infants, young children, and 
pregnant and lactating women.
    Trans fat declaration is voluntary when the total fat content of a 
food is less than 0.5 g (Sec.  101.9(c)(2)(ii)). In addition, if a 
manufacturer does not declare the trans fat content because total fat 
amount is less than 0.5 g, then the statement ``Not a significant 
source of trans fat'' must be placed at the bottom of the table of 
nutrient values. This statement indicates why information that is 
required to be declared is omitted and provides necessary information 
to assist in making healthy dietary choices (55 FR 29487 at 29502). The 
statement is also helpful in minimizing space requirements for labels 
that do not meet the simplified label format requirements (58 FR 2079 
at 2084).
    Therefore, we are not proposing any changes to the mandatory 
declaration of trans fat on the label of foods represented or purported 
to be specifically for infants, children 1 through 3 years of age, or 
pregnant and lactating women.
    d. Mandatory Declaration of Added Sugars--Whereas FDA regulations 
do not provide for the declaration of added sugars on the Nutrition 
Facts label, as explained in section II.D.3., we are proposing to 
require the mandatory declaration of added sugars on the Nutrition 
Facts label. The 2010 DGA provides recommendations for consumption of 
added sugars for the U.S. population 2 years of age and older, but not 
for infants and children under age two. However, we would not expect 
the recommendations for added sugars for a 2 year old to be different 
from that of a 1 year old because we do not expect the role of added 
sugars in health to be markedly different between children 1 and 2 year 
olds. Moreover, the IOM has established DRI ranges for 1 through 3 year 
olds because growth velocity is most similar during this age range 
(Ref. 15). Further, mandatory declaration of added sugars would be 
important for foods for infants 7 through 12 months, as it is for the 
general population, to assist consumers in choosing nutrient-dense 
foods for infants 7 through 12 months during this phase of accelerated 
growth and development. Moreover, we do not have any information that 
providing added sugars information on the Nutrition Facts label of 
foods marketed to the subpopulations of infants 7 through 12 months and 
children 1 to 3 years of age would not assist in maintaining healthy 
dietary practices.
    Therefore, we are proposing the mandatory declaration of added 
sugars on the Nutrition Facts label of foods represented or purported 
to be specifically for infants 7 through 12 months, children 1 through 
3 years of age, and pregnant and lactating women. We request comment on 
our tentative conclusion.
    e. Voluntary Declaration of Fluoride--FDA regulations do not 
provide for the declaration of fluoride on the Nutrition Facts label of 
any foods. For the reasons discussed in section II.G., we are proposing 
to permit voluntary declaration of fluoride on the labeling of foods 
for the general population based on the factors we consider in section 
I.C. and fluoride's role in reducing the risk of dental caries. Because 
fluoride provides protection against dental caries by strengthening the 
tooth enamel before and after teeth appear (Ref. 90) and because 
excessive fluoride intake can cause dental fluorosis in young children 
(Ref. 92), we tentatively conclude that the declaration of fluoride on 
foods represented or purported to be specifically for children 1 
through 3 years of age, and pregnant and lactating women can assist in 
maintaining healthy dietary practices. While evidence on dental caries 
is lacking for infants 7 through 12 months of age, there is no reason 
to expect the role of fluoride in the protection against dental caries 
to be different from other age groups. Therefore, proposed Sec.  
101.9(c)(5) would permit the voluntary declaration of fluoride on foods

[[Page 11937]]

represented or purported to be specifically for infants 7 through 12 
months of age, children 1 through 3 years of age, and pregnant and 
lactating women.
4. Declaration of Essential Vitamins and Minerals
    The declarations of vitamin A, vitamin C, calcium, and iron are 
required on the Nutrition Facts label, and there are no specific 
exceptions to this requirement for foods represented or purported to be 
specifically for infants and children less than 2 years and children 
less than 4 years of age, and pregnant and lactating women. We 
considered the factors for mandatory and voluntary declaration of 
nutrients discussed in section I.C., as applicable, to determine 
whether to propose to require or permit certain vitamins and minerals 
in the labeling of foods for infants, children, and pregnant and 
lactating women.
    The AIs for essential vitamins and minerals (and RDAs for iron and 
zinc) for infants 7 to 12 months of age are based on the average intake 
of nutrients that infants consumed from breast milk, complementary 
foods, and/or supplements with the understanding that these sources 
provided sufficient amounts of the nutrients to meet the infant's daily 
needs (Refs. 18, 22, and 23). Therefore, the AIs (as well as the RDAs 
for iron and zinc) for infants were not based on endpoints related to 
chronic disease risk, or a health-related conditions or health-related 
physiology. Furthermore, because the AI represents intakes that are 
considered adequate and are based on average nutrient intakes from 
breast milk, foods, and/or supplements, the presence of an AI indicates 
that there is not a public health concern about adequate intake of that 
nutrient. Therefore, we could not determine public health significance 
for a nutrient during infancy based on an AI for infants. Instead, we 
considered the importance of the nutrient in establishing healthy 
dietary practices during infancy for later in life, as well as the 
relevant available information for children 1 through 3 months of age 
that may also be applicable to infants. For nutrients with an RDA for 
infants 7 through 12 months of age (i.e., iron and zinc), we considered 
the factors for mandatory and voluntary labeling described in section 
I.C. to determine whether to propose mandatory or voluntary labeling 
for the nutrient.
    For the declaration of essential vitamins and minerals for children 
1 through 3 years of age and pregnant and lactating women, we propose 
the same considerations based on the same rationale as we set forth and 
proposed for the general population because scientific and policy 
considerations are generally the same and the DGA recommendations apply 
to Americans 2 years of age and older. While NHANES data were collected 
in lactating women, these data are not included in our analysis in this 
document because the sample size of lactating women was small and, 
thus, we could not reliably estimate mean intake and status of this 
population. However, the conclusions made about nutrient inadequacy 
during pregnancy are applied to lactating women since the needs of 
essential vitamin and minerals are increased for both pregnant and 
lactating women. Therefore, we are proposing the requirements related 
to essential vitamins and minerals in the labeling of foods for 
pregnant women and those for foods for lactating women should be the 
same. Accordingly, we are proposing to remove the provision in Sec.  
101.9(c)(8)(i) that requires separate declaration of percent DVs based 
on both RDI values for pregnant women and for lactating women in the 
labeling of foods represented or purported to be for use by both 
pregnant and lactating women.
    We did not ask questions related to this issue in the 2007 ANPRM, 
but received some comments which we considered in reaching our 
tentative conclusions discussed in this document.
    a. Mandatory Declaration of Calcium and Iron--We are not proposing 
any changes to the mandatory declaration of calcium on foods for the 
general population (see section II.H.1.). The AI for calcium for 
infants 7 through 12 months of age is based on average calcium 
consumption of these nutrients, rather than chronic disease risk, 
health related-condition, or physiological endpoints (Ref. 152). For 
children 1 through 3 years of age, and pregnant and lactating women, 
the RDAs for calcium are based, in part, on bone health (Ref. 22). One 
comment to the 2007 ANPRM recommended mandatory declaration of calcium 
and iron for labeling of foods for young children.
    Our analysis of NHANES 2003-2006 data estimated that infants ages 7 
to 12 months have usual calcium intakes above the AI (table 3). Our 
analysis of NHANES 2003-2006 estimated that about 12 percent of 
children 1 through 3 years of age had usual intakes of calcium below 
the EAR, based on intakes from conventional foods only (table 4). The 
percentage did not change when supplements were included. We are unable 
to consider biomarker data because sensitive biochemical indicators 
reflecting calcium nutritional status are lacking. Promoting the 
development of eating patterns that are associated with adequate 
calcium intake later in life is important (Ref. 153) given that calcium 
intakes are inadequate for the majority of the population (see table 
1). Intakes of calcium, which is necessary for growth and bone 
development, are inadequate among children. Similar to the general 
population, approximately 20 percent of pregnant women consumed less 
than the EAR for calcium from conventional foods as well as from 
conventional foods and supplements (table 5).
    Consistent with the factors we consider for essential vitamins and 
minerals (see section I.C.), we tentatively conclude that calcium is a 
nutrient of public health significance for children 1 through 3 years 
of age, and pregnant and lactating women. Because calcium is important 
for growth and development, we tentatively conclude that calcium is of 
public health significance for infants 7 through 12 months of age. As 
such, we agree with the comment that recommended mandatory declaration 
of calcium for foods purported to be specifically for young children.
    We are not proposing any changes to the mandatory declaration of 
iron on foods for the general population (see section II.H.1.). 
Although the EAR and RDA are based on daily iron requirements and not 
directly on chronic disease risk, iron deficiency is associated with 
delayed normal infant motor function (i.e., normal activity and 
movement) and mental function (i.e., normal thinking and processing 
skills) (Ref. 100). Our analysis of NHANES 2003-2006 data estimated 
that about 18 percent of infants ages 7 to 12 months have usual iron 
intakes below the EAR, based on intakes from conventional foods only 
and 4 percent of infants ages 7 to 12 months have usual iron intakes 
below the EAR based on intakes from conventional foods and supplements 
(table 3).
    For children 1 through 3 years of age, about 1 percent of children 
have usual iron intakes below the EAR, based on intakes from 
conventional foods only and 0.4 percent of children have usual iron 
intakes below the EAR based on intakes from conventional foods and 
supplements (table 4). The IOM set the EAR by modeling components of 
iron requirements. While total iron intakes appear adequate, the 
prevalence of iron deficiency in children ages 1 to 2 years has been 
reported to be 14.4 percent and the prevalence of iron deficiency 
anemia in children younger than 5 years has been reported to be 14.9 
percent (Refs. 74 and 154). Therefore, we agree with the comment that 
recommended

[[Page 11938]]

mandatory declaration of iron in the labeling of foods for young 
children.
    Inadequate iron intakes during pregnancy are also of public health 
significance because of the adverse effects for both the mother and the 
fetus (such as maternal anemia, premature delivery, low birth weight, 
and increased perinatal infant mortality) (Ref. 15). Our analysis of 
data collected by NHANES 2003-2006 estimated that 5 percent of pregnant 
women 14 to 50 years of age had usual iron intakes below the EAR based 
on intakes from conventional foods and 4 percent of pregnant women 14 
to 50 years of age had usual iron intakes below the EAR based on 
intakes from conventional foods and supplements (table 5). The EAR for 
iron for pregnant women was based on estimates of iron stores needed 
during the first trimester (Ref. 100). Our analysis of 2003-2006 NHANES 
data indicate that among pregnant women aged 12 to 49 years, 25 percent 
were iron deficient and 13 percent had iron deficiency anemia. For the 
purpose of this analysis, iron deficiency was based on two out of three 
cutoffs of iron deficiency variables (transferrin saturation, serum 
ferritin, and erythrocyte protoporphyrin) (Ref. 155). While intakes 
appear adequate for most individuals, the prevalence of iron deficiency 
and iron deficiency anemia indicates that iron deficiency is of public 
health significance for pregnant women. As discussed in section 
II.H.1., iron is of public health significance for women of 
childbearing age. Therefore, we tentatively conclude that iron is a 
nutrient of public health significance for lactating women as well.
    Because calcium and iron have quantitative intake recommendations 
and are considered to have public health significance for infants 7 
through 12 months, children 1 through 3 years of age, and pregnant and 
lactating women, we tentatively conclude that the declaration of 
calcium and iron is necessary to assist consumers in maintaining 
healthy dietary practices. Accordingly, proposed Sec.  101.9(c)(8)(ii) 
would require the mandatory declaration of calcium and iron on foods 
represented or purported to be specifically for infants 7 to 12 months, 
children 1 through 3 years of age, or pregnant and lactating women; we 
are not providing for any exceptions for these subpopulations from the 
requirement for declaration of calcium and iron applicable to foods for 
the general population.
    b. Mandatory Declaration of Vitamin D and Potassium--We are 
proposing to require the declaration of vitamin D on foods for the 
general population (see section II.H.1.). The AI for vitamin D for 
infants was based on maintenance of serum 25(OH)D concentrations at a 
level to achieve and maintain serum 25(OH)D concentrations above a 
defined level (30 to 50 nmol/L) in order to meet the needs of the 
majority of the infants and support bone accretion (Ref. 22). DRIs (EAR 
and RDA) for vitamin D were established at a level to achieve and 
maintain serum 25(OH)D concentrations above a defined level (40 to 50 
nmol/L) in order to maintain bone health for children 1 through 3 years 
of age and pregnant women (Ref. 22).
    Serum 25(OH)D data were not available in NHANES 2003-2006 for 
infants ages 7 to 12 months. Our analysis of NHANES 2003-2006 dietary 
data shows that 28.7 and 33.6 percent of infants ages 7 to 12 months 
have usual vitamin D intakes above the AI from conventional foods and 
conventional foods plus supplements, respectively (table 3).
    Our analysis of NHANES 2003-2006 data shows that about 3 percent of 
children 1 through 3 years of age had serum 25(OH)D levels below 40 
nmol/L (a level set by IOM as equivalent to EAR, see section II.H.2.a). 
Analysis of NHANES 2005-2008 dietary data shows that, assuming minimal 
sun exposure, about 82 percent of these children had usual vitamin D 
intakes below the EAR from conventional foods only and 66 percent had 
usual intakes below the EAR from conventional foods and supplements 
(table 4). For pregnant women, 15 percent had serum 25(OH)D levels 
below 40 nmol/L, while about 88 percent of pregnant women had usual 
vitamin D intakes below the EAR from conventional foods only and 48 
percent had usual intakes below the EAR from conventional foods and 
supplements (table 5). In addition to data on vitamin D status and 
intake, we considered other scientific and policy considerations, such 
as the importance of the nutrient in establishing healthy dietary 
practices for later life for children 1 through 3 years of age and 
pregnant and lactating women. Vitamin D has a role in bone health 
through calcium absorption and uptake by bones (Ref. 22). Deficiency 
results in inadequate bone mineralization or demineralization of the 
skeleton including rickets, osteomalacia, and osteoporosis (Ref. 22). 
Therefore, we tentatively conclude that vitamin D has public health 
significance in children 1 through 3 years of age and pregnant women 
based on the high prevalence of inadequate intakes of vitamin D and its 
important role in bone development and health (Ref. 22). In addition, 
in 2008, we authorized a health claim for calcium and vitamin D intake 
and reduced risk of osteoporosis (Sec.  101.72), signifying vitamin D's 
critical role in the risk reduction of this chronic disease for 
individuals 2 years of age and older. We also tentatively conclude that 
vitamin D is of public health significance for infants 7 through 12 
months of age based on its importance for growth and development during 
infancy.
    We are proposing to require the declaration of potassium on foods 
for the general population (see proposed Sec.  101.9(c)(8)(ii) and 
section II.H.1.). The AI for infants is based on average potassium 
intake from breast milk and/or complementary foods. The AI for the 
other life-stage and gender groups is set at a level to maintain blood 
pressure, reduce the adverse effects of sodium chloride intake on blood 
pressure, and reduce the risk of recurrent kidney stones (Ref. 21).
    Our analysis of NHANES 2003-2006 shows that 99 percent of infants 
ages 7 to 12 months have usual potassium intakes above the AI (table 
3). Only 7 percent of children 1 through 3 years of age (table 4) and 4 
percent of pregnant women (table 5) had usual potassium intakes above 
the AI from conventional foods or conventional foods plus dietary 
supplements, indicating that the adequacy of intakes is very low. In 
the absence of a sensitive biochemical indicator of potassium 
nutritional status, we could not consider biomarker data to inform the 
determination of prevalence of potassium deficiency. In 2000, a FDAMA 
notification for a health claim about potassium, blood pressure, and 
stroke was submitted to us under section 403(r)(2)(g) of the FD&C Act 
(Ref. 114). Foods may bear the following claim ``Diets containing foods 
that are good sources of potassium and low in sodium may reduce the 
risk of high blood pressure and stroke,'' on the label or labeling of 
any food product that meets the eligibility criteria described in the 
notification and meets the general requirements for a health claim 
(Sec.  101.14(e)(6)). This health claim pertains to the general 
population 2 years of age and older. Thus, we recognize the importance 
of potassium in the risk reduction of these chronic diseases for 
children 2 years of age and older. Therefore, we tentatively conclude 
that potassium is of public health significance to children 1 through 3 
years of age, and pregnant and lactating women. We have no basis to 
conclude that the public health significance of potassium among infants 
7 through 12 months of age would be different than the science-based 
evidence for children 1 through 3 years of age and consider it 
important to

[[Page 11939]]

establish healthy dietary practices for later life. Because of the 
benefits of adequate potassium intake in lowering blood pressure, data 
indicating low likelihood of potassium adequacy, and importance of 
establishing healthy dietary practices for later life, we tentatively 
conclude that potassium is a nutrient of public health significance for 
infants 7 through 12 months of age, children 1 through 3 years of age, 
and pregnant and lactating women.
    We are proposing to require the labeling of vitamin D and potassium 
on foods represented or purported to be specifically for infants 7 
through 12 months of age, children 1 through 3 years of age, or 
pregnant and lactating women based on the quantitative intake 
recommendations for vitamin D and potassium and the public health 
significance of these nutrients. Consequently, we are not providing for 
any exceptions for these subpopulations from the general requirement 
for declaration of vitamin D and potassium in proposed Sec.  
101.9(c)(8)(ii).
    c. Voluntary Declaration of Vitamin A and Vitamin C--We are 
proposing to no longer require the declaration of vitamin A and vitamin 
C on foods for the general population (see section II.H.1.). None of 
the DRIs (AIs or RDAs) for vitamin A were based on chronic disease 
risk, a health related-condition, or health-related physiological 
endpoints. One comment to the 2007 ANPRM stated that intakes of 
vitamins A and C among young children appear to be adequate (Ref. 148) 
and supported voluntary declaration of these nutrients in the labeling 
of foods for this subpopulation.
    Our analysis of data from NHANES 2003-2006 shows that less than 2 
percent of children had usual vitamin A intakes below the EAR from 
conventional foods or conventional foods plus dietary supplements 
(table 4). While 36 percent of pregnant women had usual intakes below 
the EAR from conventional foods and 22 percent had usual intakes below 
the EAR for conventional foods plus dietary supplements, only 1 percent 
of these women had serum vitamin A levels that were considered to be 
indicative of a vitamin A deficiency (table 5).
    While quantitative intake recommendations are available for 
vitamins A and C, neither of these vitamins is considered to have 
public health significance for children 1 through 3 years of age and 
pregnant women. There is a very low prevalence of inadequate intakes of 
vitamins A and C or inadequate status among children 1 through 3 years 
of age or pregnant women, and we have no evidence to indicate that this 
would be different for infants or lactating women. Therefore, we 
tentatively conclude that vitamin A and vitamin C are not of public 
health significance among infants 7 through 12 months of age, children 
1 through 3 years of age, and pregnant and lactating women. Thus, we 
agree with a comment that supported voluntary declaration of vitamins A 
and C in the labeling of foods for young children. An AI for older 
infants was provided by the IOM with the assumption that vitamin A and 
vitamin C intakes are adequate during infancy. Accordingly, similar to 
our proposal for voluntary declaration of vitamins A and C in the 
labeling of foods for the general population, we are proposing to 
permit, but not require, the declaration of vitamin A and vitamin C on 
foods represented and purported to be specifically for infants 7 
through 12 months, children 1 through 3 years of age, or pregnant and 
lactating women. As for other voluntary nutrients, the declaration of 
these nutrients would be required when these nutrients are added as 
nutrient supplements or claims are made about them (proposed Sec.  
101.9(c)(8)(ii)).
    d. Voluntary Declaration of Other Vitamins and Minerals--As 
discussed in section II.H.3., for the general population, we are 
proposing to permit the voluntary declaration of vitamin E, vitamin K, 
vitamin B6, vitamin B12, thiamin, riboflavin, 
niacin, folate, biotin, pantothenic acid, phosphorus, iodine, 
magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, 
chloride, and choline (proposed Sec.  101.9(c)(8)(ii)). Vitamins and 
minerals other than iron, calcium, vitamin D and potassium for infants 
either have DRIs that are not based on chronic disease risk, heath-
related conditions, or health-related physiological endpoints or are 
not shown to have public health significance due to the prevalence of a 
clinically relevant nutrient deficiency. For infants 7 to 12 months, 
children 1 through 3 years of age, and pregnant and lactating women, we 
tentatively conclude that the essential vitamins and minerals, other 
than iron, calcium, vitamin D and potassium, do not have public health 
significance and there is no basis for the declaration of these 
nutrients to be different from that proposed for the general 
population. Accordingly, proposed Sec.  101.9(c)(8)(ii) would allow the 
voluntary declaration of vitamin E, vitamin K, vitamin B6, 
vitamin B12, thiamin, riboflavin, niacin, folate, biotin, 
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, 
copper, manganese, chromium, molybdenum, chloride, and choline on foods 
represented or purported to be specifically for infants 7 to 12 months, 
children 1 through 3 years of age, or pregnant and lactating women, 
under the requirements of this section, unless they are added to foods 
as a nutrient supplement or if the label or labeling makes a claim 
about them, in which case the nutrients would have to be declared.
5. DRVs and RDIs for Infants 7 Through 12 Months of Age
    FDA regulations do not include DRVs or RDIs for nutrients for 
infants 7 through 12 months of age, except an RDI for protein of 14 g 
for infants. We reviewed scientific evidence and recommendations, as 
well as comments in response to the 2007 ANPRM to consider establishing 
DRVs and RDIs for nutrients for infants 7 through 12 months of age and 
to consider revisions to the current RDI for protein.
    a. Calories--We have not established a reference calorie intake 
level for infants and children less than 2 years of age. For the 
general population, a reference calorie intake level is necessary when 
using a percent of calories approach to calculating the DRV for 
nutrients, such as total fat and carbohydrate. There is no quantitative 
intake recommendation for calories for infants and we are not aware of 
other scientific data and information on which we could rely to 
establish that level. Therefore, we are not proposing to establish a 
reference calorie intake level for infants 7 to 12 months.
    b. Total Fat--The IOM set an AI of 30 g/d for fat for infants 7 
through 12 months of age based on the average intake of human milk and 
complementary foods (Ref. 49). There was no AI available in 1993. The 
current AI provides a basis on which we can determine an appropriate 
DRV for total fat for this subpopulation that can assist consumers in 
maintaining healthy dietary practices among this subpopulation. 
Therefore, we are proposing to amend Sec.  101.9(c)(9) to include a DRV 
of 30 g for fat for infants 7 through 12 months of age.
    c. Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber and 
Sugars--There are no quantitative intake recommendations from U.S. 
consensus reports available for saturated fat, trans fat, cholesterol, 
dietary fiber, and sugars for infants. We are not aware of other 
scientific data and information on which we could rely to establish 
DRVs for these nutrients for infants 7 through 12 months of age. 
Accordingly, we are not proposing to establish DRVs for these nutrients 
for infants 7 through 12 months of age.

[[Page 11940]]

    d. Polyunsaturated Fat, Monounsaturated Fat, Insoluble Fiber, 
Soluble Fiber, Insoluble Fiber, Added Sugars, and Sugar Alcohols--
Quantitative intake recommendations from U.S. consensus reports are not 
available for polyunsaturated fat, monounsaturated fat, insoluble 
fiber, soluble fiber, added sugars, or sugar alcohols for infants. We 
are not aware of other scientific data and information on which we 
could rely to establish DRVs for these nutrients for this 
subpopulation. Accordingly, we are not proposing to establish DRVs for 
these nutrients for infants 7 through 12 months of age.
    e. Total Carbohydrate--The IOM has set an AI of 95 g/d for 
carbohydrates for infants 7 through 12 months of age based on the 
average intake of human milk and complementary foods (Ref. 68). There 
was no AI available in 1993. The current AI provides a basis on which 
we can determine an appropriate DRV for total carbohydrate for this 
subpopulation that can assist consumers in maintaining healthy dietary 
practices among this subpopulation. Therefore, we are proposing to 
amend Sec.  101.9(c)(9) to establish a DRV of 95 g for total 
carbohydrate for infants 7 through 12 months of age.
    f. Protein--The DV for protein for infants is an RDI, rather than a 
DRV. Before 1993, we established the RDIs for protein for all age 
groups based on the 1989 RDA. In 1993, we changed the RDI for protein 
for the general population to a DRV in response to comments that 
suggested the DV for protein should be consistent with the ``percent of 
calories'' approach used for the other energy-yielding macronutrients, 
total fat and total carbohydrate (58 FR 2206 at 2216). However, we 
retained the RDI for infants, and based it on the highest 1968 RDA 
value (14 g/d for infants), to be consistent with a population-coverage 
approach (58 FR 2206 at 2216).
    We find no reason to change the approach of using the RDI for 
infants 7 through 12 months. However, we consider it appropriate to 
revise the RDI to rely on current quantitative intake recommendations. 
In 2002, the IOM established an RDA for infants 7 through 12 months of 
1.2 g/kg/d based on nitrogen balance studies and using a reference body 
weight of 9 kg (Ref. 84). This reference body weight is also consistent 
with current growth charts for infants (Ref. 156). The value 1.2g/kg/
gx9 kg equals 10.8 g/d or a rounded value of 11 g/d. In addition, 
protein intakes are well above the current and proposed RDI. Mean 
protein intake for infants 6 to 11 months of age was 22 g/d (Ref. 150), 
well above the RDA of 11 g/d. Accordingly, we are proposing to revise 
Sec.  101.9(c)(9) to establish an RDI of 11 g for protein for infants 7 
through 12 months of age.
    g. Sodium--For the general population, we are proposing to 
establish a DRV for sodium based on the IOM's UL (section II.F.). The 
IOM did not set a UL for sodium for infants 7 through 12 months of age 
due to insufficient data on adverse effects of chronic overconsumption 
in this age group (Ref. 10). We are not aware of other scientific data 
and information on which we could rely to establish a DRV for sodium 
for this subpopulation. Therefore, we are not proposing a DRV for 
sodium for infants 7 through 12 months of age.
    h. Fluoride--As discussed in section II.G., although the IOM set an 
AI for fluoride, the AIs for infants 7 through 12 months and children 1 
through 3 years are close to the EPA benchmarks for total fluoride 
intake (Ref. 92). We are not proposing a DRV for fluoride for use in 
the labeling of foods for the general population because of a concern 
about excess intakes associated with dental fluorosis (section II.G.). 
Therefore, we tentatively conclude that a DRV for fluoride is not 
warranted for infants 7 through 12 months. The use of such a DRV to 
calculate percent DV may have the unintended effect of consumers 
selecting foods with higher fluoride amounts, which are not necessary 
or advised. Accordingly, we are not proposing to establish a DRV for 
fluoride for infants 7 through 12 months of age.
    i. Vitamins and Minerals--As noted previously in the introduction 
to section II.K., while not included in current regulations, the 
preamble to the 1993 DRV/RDI final rule provides a table listing RDIs 
for infants (58 FR 2206 at 2213), which is also provided in FDA's Food 
Labeling Guide (Ref. 144). We reviewed current quantitative intake 
recommendations for vitamins and minerals for infants and considered 
comments received in response to the 2007 ANPRM (Ref. 47) to determine 
appropriate RDIs for vitamins and minerals to be established in 
regulations for infants 7 through 12 months of age.
    We consider it important to establish RDIs for infants 7 through 12 
months of age because infants in this age range transition from a diet 
of mostly breast milk and infant formula to infant cereal and baby 
foods (Ref. 147 p. 71) and labeling foods for this subpopulation with 
percent DV declarations can assist parents in making nutritious food 
choices. The DRIs (AIs and RDAs) provide a basis on which to determine 
RDIs for vitamins and minerals for this subpopulation. We consider it 
appropriate to use RDAs and, in the absence of RDAs, AIs to determine 
appropriate micronutrient RDIs for infants. While there is more 
certainty with RDAs than AIs, both RDAs and AIs are sufficient for 
setting RDIs, because they both represent intake levels that are 
expected to meet or exceed the nutrient needs of the majority of 
infants (Ref. 157).
    We also considered and rejected an approach, as suggested by a 
comment, where the highest reference value available would be used for 
each nutrient, irrespective of whether it is an RDI based on the 1968 
RDAs, a current RDA, or a current AI. The IOM established DRIs based on 
scientific knowledge that update and supersede previous RDA 
recommendations. Because DRIs are available for infants 7 through 12 
months of age, we are proposing to use these current quantitative 
intake recommendations (i.e., AIs and RDAs) for setting RDIs for 
infants.
    Accordingly, we are proposing to amend Sec.  101.9(c)(8)(iv) to 
include a listing of RDIs for vitamin A, vitamin C, vitamin D, vitamin 
E, vitamin K, vitamin B12, folate, choline, riboflavin, 
niacin, vitamin B6, calcium, iron, thiamin, biotin, 
pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium, 
copper, manganese, chromium, molybdenum, chloride, and potassium for 
infants 7 months through 12 months of age.
    We invite comment on the adequacy of the proposed RDIs for vitamins 
and minerals for older infants.
6. DRVs and RDIs for Children 1 Through 3 Years of Age
    FDA regulations do not include DRVs or RDIs for nutrients for 
children 1 through 3 years of age, except an RDI for protein of 16 g 
for children less than 4 years of age. We reviewed scientific evidence 
and current recommendations, as well as comments in response to the 
2007 ANPRM to consider establishing DRVs and RDIs for nutrients for 
this subpopulation and to consider revisions to the current RDI for 
protein.
    a. Calories--We have not established a reference calorie intake 
level for nutrition labeling for children ages 1 through 3 years. 
Several comments to the 2007 ANPRM supported establishing a DV for 
calories specifically for young children 1 through 3 years of age. 
Citing the IOM and AAP/AHA caloric intake recommendations (Refs. 50 and 
71), one comment recommended 1,050 calories as the DV for calories and 
supported

[[Page 11941]]

rounding it down to 1,000 calories to facilitate use by consumers.
    We consider it appropriate to establish a reference calorie intake 
level for children 1 through 3 years of age because, as discussed in 
this document, we are proposing to set DRVs using quantitative intake 
recommendations that are based on calories (e.g., total fat, saturated 
fat, and dietary fiber). Current recommendations from the IOM, AHA, 
AAP, and the 2010 DGA for caloric intake range from 800 to 900 
calories/d for children 1 year old, approximately 1,000 calories/d for 
children 2 years of age, and from 1,000 to 1,200 calories/d for 
children 3 years of age (Refs. 6, 50, and 71) . We consider that an 
average of the range of these caloric intake recommendations (800 to 
1,200 calories/d), i.e., 1,000 calories/d, provides a reasonable 
reference calorie intake level. Therefore, we are proposing to amend 
Sec.  101.9(c)(9) to provide a reference calorie intake level of 1,000 
calories/d for children 1 through 3 years of age.
    b. Total Fat--There is no DRV for total fat for children ages 1 
through 3 years. One comment to the 2007 ANPRM recommended that 35 
percent of the recommended 1,050 calories or 41 g/d of fat be used to 
as the DRV for fat because it is the midpoint of the AAP/AHA 
recommendation and the IOM Acceptable Macronutrient Distribution Range 
(AMDR) for 1 through 3 year olds. We agree that 35 percent of calories 
from fat for children 1 through 3 years of age, the midpoint of the IOM 
AMDR of 30 to 40 percent, serves as an appropriate basis on which to 
set the DRV for total fat. This approach to calculating the DRV for 
total fat is consistent with our proposed approach to setting the DRV 
for total fat for the general population. Thirty-five percent is also 
consistent with AHA and AAP recommendations that 30 to 40 percent of 
calories consumed by children 12 through 24 months of age and 30 to 35 
percent of calories consumed by children 24 through 48 months of age 
should come from fat (Ref. 71). Therefore, we tentatively conclude that 
35 percent of total calories from fat (i.e., 39 g using the proposed 
reference calorie intake level of 1,000 calories/d) is an appropriate 
DRV for total fat for children 1 through 3 years of age. Accordingly, 
we are proposing to amend Sec.  101.9(c)(9) to establish a DRV of 39 g 
for fat for children 1 through 3 years of age.
    c. Saturated Fat, Trans Fat, and Cholesterol--There are no DRVs for 
saturated fat, trans fat, or cholesterol for children 1 through 3 years 
of age. Once comment to the 2007 ANPRM suggested using the midpoint of 
10 to 15 percent of calories for saturated fat, 2 percent of calories 
for trans fat based on estimates of mean trans fat intake for the U.S. 
population 3 years of age and older, and less than or equal to 300 mg/d 
for cholesterol based on the 2005 DGA recommendation.
    Cardiovascular disease is known to begin in childhood (Refs. 146 
and 151). The 2010 DGA recommends that Americans 2 years of age and 
older consume less than 10 percent of calories from saturated fat and 
less than 300 mg/d of cholesterol (Ref. 6). Based on these 
recommendations, we tentatively conclude that it is appropriate to set 
a DRV of 10 g for saturated fat, based on 10 percent of total calories 
from saturated fat and using the proposed reference calorie intake 
level of 1,000 calories/d which equals 11 g, rounded down to 10 g, and 
a DRV of 300 mg for cholesterol for children 1 through 3 years of age. 
The comment provided no rationale for using an upper range of 15 
percent of calories from saturated fat. We have no information to 
indicate that applying the level of 10 percent of calories from 
saturated fat to this subpopulation is restrictive, as the comment 
asserted. Accordingly, we are proposing to amend Sec.  101.9(c)(9) to 
establish a DRV of 10 g for saturated fat and a DRV of 300 mg for 
cholesterol for children 1 through 3 years of age.
    Current recommendations from the IOM (Ref. 49) and 2010 DGA (Ref. 
6) recommend keeping trans fat intake as low as possible but do not 
provide any specific appropriate levels of intake. Thus, consistent 
with our discussion in section II.B.3., we disagree with the comment 
that suggested setting a DRV for trans fat and, therefore, we are not 
proposing to establish a DRV for trans fat in response to this comment.
    d. Polyunsaturated Fat, Monounsaturated Fat, Sugars, Added Sugars, 
Insoluble Fiber, Soluble Fiber, and Sugar Alcohols--There are no DRVs 
for polyunsaturated fat, monounsaturated fat, sugars, added sugars, 
insoluble fiber, soluble fiber, or sugar alcohol for children 1 through 
3 years of age. One comment to the 2007 ANPRM recommended establishing 
a DV for n-3 polyunsaturated fatty acids ([alpha]-linolenic acid) of 
700 mg/d because [alpha]- linolenic acid is essential to the human diet 
and children 1 through 3 years of age are below recommended intake 
levels. We disagree that a DRV should be set for n-3 polyunsaturated 
fatty acids for children 1 through 3 years of age for the same reasons 
that we are not proposing a DRV for these fatty acids for the general 
population (see section II.B.). We recognize the essential nature of 
[alpha]-linolenic acid in the diet. The IOM based AIs for n-6 linoleic 
and n-3 [alpha]-linolenic acid on U.S. median intake levels because of 
the lack of linoleic and [alpha]- linolenic acid deficiency in non-
institutionalized populations in the United States (Ref. 49).
    For children 1 through 3 years of age, DRIs or other data and 
information are not available on which we could rely to establish DRVs 
for polyunsaturated fat, monounsaturated fat, sugars, added sugars, 
insoluble fiber, soluble fiber, and sugar alcohols. Therefore, we 
tentatively conclude that there is no basis for setting DRVs for these 
nutrients. Accordingly, we are not proposing DRVs for polyunsaturated 
fat, including n-3 or n-6 polyunsaturated fatty acids, monounsaturated 
fat, sugars, added sugars, soluble fiber, insoluble fiber, or sugar 
alcohols for children 1 through 3 years of age.
    e. Total Carbohydrate--There is not a DRV for total carbohydrate 
for children 1 through 3 years of age. One comment to the 2007 ANPRM 
suggested that we establish a DV for carbohydrates using 59 percent of 
calories from carbohydrates, or 154 g using the method of calculation 
by difference.
    As discussed in section II.D.1., we are proposing a DRV for total 
carbohydrate for the general population based on the percentage of 
calories in a 2,000 calorie diet remaining after the sum of the DRV for 
fat (30 percent) plus the DRV for protein (10 percent) have been 
subtracted. We also consider this method to be appropriate for setting 
a DRV for total carbohydrate for children 1 through 3 years of age. 
Total calories (100 percent) minus the proposed DRV for total fat (35 
percent of calories) and the proposed DRV for protein (5 percent of 
calories) equals 60 percent of calories from total carbohydrate. A 
value of 60 percent of total calories from total carbohydrates also 
falls within the IOM AMDR recommendation of 45 to 65 percent of 
calories from carbohydrates for children 1 through 3 years of age. 
Therefore, we tentatively conclude that an appropriate DRV for total 
carbohydrate is 60 percent of calories (i.e., 150 g using the proposed 
reference calorie intake level of 1,000 calories/d). Accordingly, we 
are proposing to amend Sec.  101.9(c)(9) to set a DRV of 150 g for 
total carbohydrate for children 1 through 3 years of age.
    f. Dietary Fiber--There is not a DRV for dietary fiber for children 
1 through 3 years of age. One comment to the 2007 ANPRM recommended 
using 15 g/d as the basis of the DRV for dietary fiber, based on the AI 
of 14 g/1,000 calories and a 1,050 calorie diet. We agree that the AI 
of 14 g/1,000 calories for dietary fiber for children 1 through 3 years 
of

[[Page 11942]]

age (Ref. 66) should be used to set a DRV for dietary fiber to be 
consistent with how other proposed DRVs are being set. Given that we 
are proposing a reference calorie intake level of 1,000 calories/d for 
this subpopulation, we are proposing to amend Sec.  101.9(c)(9) to 
establish a DRV of 14 g for dietary fiber for children 1 through 3 
years of age.
    g. Protein--The RDI for protein for children less than 4 years of 
age was based on the 1989 RDA for protein of 16 g/d (Sec.  
101.9(c)(7)(iii)). One comment to the 2007 ANPRM recommended 
maintaining the DV of 16 g for protein because the RDA for protein of 
13 g/d for toddlers 1 through 3 years of age appears low relative to 
the amount of protein from a diet pattern consistent with dietary 
guidance from AAP/AHA.
    We consider it appropriate to determine whether changes are 
necessary to the current RDI taking into account current 
recommendations and protein intakes. Protein intakes are well above the 
current RDI. Mean protein intake for children 12 to 23 months of age 
was 44 g/d (Ref. 150), well above the RDA of 13 g/d and the midpoint of 
the AMDR of 5 to 20 percent calories from protein (i.e., 12.5 percent 
of calories from protein or 31 g/d) (Ref. 84). The protein AMDR for 
children 1 through 3 years of age is 5 to 20 percent of calories and 
the RDA is approximately 5 percent of calories (Ref. 84). While the RDA 
is lower than the amount of protein consistent with guidance from AAP/
AHA, we explain in section II.B.2.c. that we do not consider the menu 
modeling approach used to develop this guidance appropriate to 
determine DRVs because it does not permit the selection of DRVs that 
are based on scientific evidence related to actual public health 
outcomes. In light of the proposed reference calorie intake level and 
the approaches used for the proposed DRVs for fat and carbohydrate that 
are based on percent of calories, we tentatively conclude that, as with 
the general population, the DV for protein for children 1 through 3 
years of age should be a DRV, rather than an RDI (using the RDA). 
Therefore, we tentatively conclude that a DRV for protein should be 
based on 5 percent of 1,000 calories or 50 calories which equals 12.5 g 
or, when rounded up, is 13 g. Accordingly, we are proposing to amend 
Sec.  101.9(c)(7)(iii) to establish a DRV for protein of 13 g for 
children 1 through 3 years of age.
    h. Sodium--For the general population, we are proposing to 
establish a DRV based on the UL for sodium (section II.F.). There is no 
DRV for sodium for children 1 through 3 years of age. Two comments to 
the 2007 ANPRM recommended basing the DRV for sodium on the IOM's UL of 
1,500 mg/d for children 1 through 3 years of age to be consistent with 
recommendations from AAP and AHA (Ref. 71).
    The IOM derived the UL for children 1 through 3 years of age by 
extrapolation from the adult UL of 2,300 mg/d based on observational 
studies showing that blood pressure increases with age into adulthood 
and the recognition that risk factors for CVD, such as high blood 
pressure and atherosclerosis, occur in childhood (Ref. 10). We agree 
with the comments noting that 1,500 mg is an appropriate DRV for sodium 
for children 1 through 3 years of age. Consistent with the proposed 
approach for the general population, we are proposing to amend Sec.  
101.9(c)(8)(iv) to establish a DRV of 1,500 mg for sodium for children 
1 through 3 years of age.
    i. Fluoride--There is not a DV for fluoride for children 1 through 
3 years of age. One comment to the 2007 ANPRM suggested that fluoride 
should not have a DV because it is not found abundantly in food. We 
disagree with this comment. Whether a nutrient is found abundantly in 
food is not a consideration for FDA in setting DVs. The IOM recognized 
fluoride as a trace mineral that is important for public health by 
setting an AI based on evidence of its role in reducing the risk of 
dental caries.
    However, we tentatively conclude that a DRV should not be 
established for fluoride. Although the IOM set an AI for fluoride, the 
AI for children 1 through 3 years of age is close to the EPA benchmarks 
for maximum total fluoride intake (Ref. 92). In addition, we are not 
proposing a DRV for the general population because of concern about 
excess intakes associated with dental fluorosis (see section II.G.). 
The use of such a DRV to calculate percent DV may have the untoward 
effect of consumers selecting foods with higher fluoride amounts, which 
are not necessary or advised. Therefore, we tentatively conclude that a 
DRV for fluoride is not warranted for children 1 through 3 years of 
age. Accordingly, we are not proposing a DRV for fluoride for children 
1 through 3 years of age.
    j. Vitamins and Minerals--As explained earlier, while not included 
in our regulations, the preamble to the 1993 DRV/RDI final rule 
provides a table listing RDIs for children less than 4 years of age (58 
FR 2206 at 2213), which is also provided in FDA's Food Labeling Guide 
(Ref. 144). We reviewed current quantitative intake recommendations for 
vitamins and minerals for infants and considered comments received in 
response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for 
vitamins and minerals for children 1 through 3 years of age.
    The IOM's quantitative intake recommendations (AIs and RDAs) 
provide a basis on which to determine RDIs for vitamins and minerals 
for this subpopulation. In addition, where data on functional 
indicators of nutritional status were available, the IOM relied on such 
data and determined that available evidence was sufficient to establish 
appropriate RDAs and AIs for vitamins and minerals for this 
subpopulation. Therefore, we disagree with a comment to the 2007 ANPRM 
that suggested that more population-specific data based on functional 
indicators of nutritional status are needed before establishing the 
RDIs for vitamins and minerals.
    We consider it appropriate to use RDAs and, in the absence of RDAs, 
AIs to determine appropriate micronutrient RDIs for children 1 through 
3 years of age. As such, we agree with comments that suggested using 
RDAs to determine the RDIs for selenium and vitamin E and AIs to 
determine the RDIs for choline, vitamin K, and manganese, which do not 
have established RDAs. The RDA, when available, is the best estimate of 
an intake level that will meet the nutrient goals of practically all 
consumers who would use the Nutrition Facts label. AIs have less 
certainty than RDAs, but they represent goals for nutrient intake for 
individuals and provide the best estimate based on current science for 
use in setting RDIs for such nutrients.
    Finally, we disagree with comments suggesting we use 1,800 or 2,000 
mg/d potassium as the basis for the RDI for potassium because it is 
inconsistent with the proposed approach for the general population. The 
comments did not explain why data collection on mean potassium intake 
should be the basis for the DV in lieu of the AIs and RDAs. In 
addition, promoting the development of eating patterns that will be 
associated with adequate potassium intake later in life is important 
because chronic conditions such as elevated blood pressure, bone 
demineralization, and kidney stones likely result from inadequate 
potassium intakes over an extended period of time, including childhood 
(Ref. 136). The AI for potassium is 3,000 mg/d and we consider it an 
appropriate basis for establishing a RDI for potassium for children 1 
through 3 years of age.
    Therefore, using the RDAs and AIs, we are proposing to amend Sec.  
101.9(c)(8)(iv) to establish RDIs as set forth previously for vitamin 
A, vitamin

[[Page 11943]]

C, vitamin D, vitamin E, vitamin K, vitamin B12, folate, 
choline, riboflavin, niacin, vitamin B6, calcium, iron, 
thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, 
zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and 
potassium for children 1 through 3 years of age.
    We invite comment on the adequacy of the proposed RDIs for vitamins 
and minerals for children 1 through 3 years of age.
7. DRVs and RDIs for Pregnant and Lactating Women
    a. Calories--The reference calorie intake of 2,000 used for the 
general population applies to pregnant and lactating women (Sec.  
101.9(c)(9)). The calorie needs for pregnant and lactating women are 
similar to the general population and few products are purported for 
pregnant and lactating women. Therefore, we tentatively conclude that 
it is appropriate to establish a reference calorie intake level for 
setting DRVs for pregnant and lactating women that is the same as for 
the general population. Accordingly, we are proposing to use the 2,000 
reference calorie intake level for setting DRVs for pregnant and 
lactating women (Sec.  101.9(c)(9)).
    b. Total Fat, Saturated Fat, Cholesterol, Total Carbohydrate, 
Sodium, and Dietary Fiber--FDA regulations do not provide DRVs for 
total fat, saturated fat, cholesterol, total carbohydrate, sodium, and 
dietary fiber for pregnant and lactating women. Quantitative intake 
recommendations for total fat, saturated fat, cholesterol, total 
carbohydrate, sodium, and dietary fiber for pregnant and lactating 
women are generally similar to the general population (Refs. 6 and 23). 
Therefore, we tentatively conclude that the DRVs for total fat, 
saturated fat, cholesterol, total carbohydrate, sodium, and dietary 
fiber for pregnant and lactating women should remain the same as for 
the general population. Accordingly, we are proposing to amend Sec.  
101.9(c)(9) to establish DRVs for pregnant and lactating women using 
the proposed DRVs for the general population for total fat, saturated 
fat, cholesterol, total carbohydrate, sodium, and dietary fiber.
    c. Trans Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble 
Fiber, Insoluble Fiber, Sugars, Added Sugars, and Sugar Alcohols--There 
are no DRVs for trans fat, polyunsaturated fat, monounsaturated fat, 
soluble fiber, insoluble fiber, sugars, added sugars, or sugar alcohol 
for pregnant and lactating women. As discussed in sections II.B. and 
II.D., we are not proposing DRVs for these nutrients for the general 
population because of a lack of quantitative intake recommendations. 
Similarly, quantitative intake recommendations are lacking for these 
nutrients for pregnant and lactating women. Therefore, we are not 
proposing to establish DRVs for trans fat, polyunsaturated and 
monounsaturated fat, soluble fiber, insoluble fiber, sugars, added 
sugars, or sugar alcohols for pregnant and lactating women.
    d. Protein--FDA established RDIs of 60 g protein for pregnant women 
and 65 g protein for lactating women (Sec.  101.9(c)(7)(iii)) based on 
the highest 1989 RDAs for pregnant and lactating women (58 FR 2206 at 
2216). The IOM established 71 g/d protein as the RDA for pregnant and 
lactating women based on the needs for maternal and fetal development 
and human milk production. Because the RDA for protein during both 
pregnancy and lactation is the same (Ref. 84) and given that most foods 
represented or purported to be specifically for pregnant women are also 
represented or purported to be specifically for lactating women, we 
tentatively conclude that it is appropriate to establish a single RDI 
of 71 g applicable to both pregnant and lactating women. We tentatively 
conclude that the DV for protein for pregnant and lactating women 
should remain an RDI (using the RDA) instead of a DRV because the DRV 
approach used to calculate protein for the general population based on 
10 percent of 2,000 calories, which equals 50 g of protein/d, falls 
short of the recommended protein needs of pregnant and lactating women 
of 71 g/d. Therefore, we are proposing to amend Sec.  101.9(c)(7)(iii) 
to establish an RDI of 71 g for protein for pregnant and lactating 
women.
    e. Fluoride--There is no DRV for fluoride for the general 
population or for pregnant and lactating women. While an AI has been 
established for fluoride, we are not proposing to establish a DRV for 
fluoride for the general population for the reasons discussed in 
section II.G. Similarly, because the AI for fluoride for pregnant and 
lactating women is not different from the general population (Ref. 90), 
we are not proposing a DRV for fluoride for pregnant and lactating 
women.
    f. Vitamins and Minerals--While not included in FDA regulations, 
the preamble to the 1993 DRV/RDI final rule provides a table listing 
RDIs for pregnant and lactating women (58 FR 2206 at 2213), which is 
also provided in FDA's food labeling guide (Ref. 144). We reviewed 
current quantitative intake recommendations for vitamins and minerals 
for pregnant and lactating women and considered comments received in 
response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for 
vitamins and minerals for pregnant and lactating women.
    For the same reasons stated for the general population (see section 
II.I.), we consider it appropriate to establish RDIs for pregnant and 
lactating women for vitamins and minerals that have DRIs, using 
population-coverage RDAs and AIs, instead of population-weighted EARs. 
In addition, we are proposing to establish a single set of RDIs 
intended for both pregnant women and lactating women because nutrient 
needs during pregnancy and lactation are similar (Refs. 16, 17, 21, 22, 
140). Moreover, most foods represented or purported to be specifically 
for pregnant women are, at the same time, represented or purported to 
be specifically for lactating women and, as such, using one set of RDIs 
would address practical concerns related to limited space on food 
labels.
    Therefore, we are proposing to amend Sec.  101.9(c)(8)(iv) to 
establish RDIs as set forth previously for vitamin A, vitamin C, 
vitamin D, vitamin E, vitamin K, vitamin B12, folate, 
choline, riboflavin, niacin, vitamin B6, calcium, iron, 
thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, 
zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and 
potassium for pregnant and lactating women.

[[Page 11944]]



   Table 3--Prevalence of Nutrient Inadequacy and Adequacy (From Conventional Foods and Water) and From Total
       Intake (Conventional Foods, Water, and Supplements) of U.S. Infants 7 Through 12 Months of Age \1\
----------------------------------------------------------------------------------------------------------------
                                                                                       Usual nutrient intake \2\
                                                                                     ---------------------------
                    Nutrients                                   EAR \3\                   % Below the EAR \4\
                                                                                     ---------------------------
                                                                                          Food      Total intake
----------------------------------------------------------------------------------------------------------------
Iron............................................  6.9 mg............................          17.8           3.7
Zinc............................................  2.5 mg............................           0.1           0.1
                                                                                     ---------------------------
                                                  AI \3\............................        % Above AI \5\
                                                                                     ---------------------------
Choline.........................................  150 mg............................          23.5          23.5
Folate..........................................  80 mcg............................         100           100
Niacin..........................................  4 mg..............................          99.9          99.9
Riboflavin......................................  0.4 mg............................         100           100
Thiamin.........................................  0.3 mg............................          99.9          99.9
Vitamin A.......................................  500 mcg...........................          86.9          87.5
Vitamin B6......................................  0.3 mg............................          99.9          99.9
Vitamin B12.....................................  0.5 mg............................          99.8          99.8
Vitamin C.......................................  50 mg.............................          90.1          94
Vitamin D.......................................  10 mcg............................          28.7          33.6
Vitamin E.......................................  5 mcg.............................          67            70.6
Vitamin K.......................................  2.5 mcg...........................         100           100
Calcium.........................................  260 mg............................          99.6          99.6
Copper..........................................  220 mcg...........................         100           100
Magnesium.......................................  75 mg.............................          97.6          97.6
Phosphorus......................................  275 mg............................          98.9          98.9
Potassium.......................................  700 mg............................          98.8          98.8
Selenium \6\....................................  20 mcg............................           9.9           9.9
----------------------------------------------------------------------------------------------------------------
\1\ All prevalence of nutrient inadequacy or adequacy and status biomarker data is based on NHANES 2003-2006
  except for vitamin D and choline (NHANES 05-08).
\2\ Usual nutrient intake distributions from conventional foods are determined using the National Cancer
  Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48).
\3\ The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for infants ages 7-12 months are
  established by the Institute of Medicine http://www.iom.edu/Activities/Nutrition/SummaryDRIs/~/media/Files/
  Activity%20Files/Nutrition/DRIs/New%20Material/2--%20RDA%20and%20AI%20Values--Vitamin%20and%20Elements.pdf.
\4\ The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence
  of nutrient inadequacy for iron and zinc. For iron, refer to Table I-5 Probability of inadequate iron intakes
  (Refs. 100 and 158).
\5\ For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at
  or above the AI.
\6\ We did not receive any comments for this nutrient (for which voluntary declaration is permitted) in response
  to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database for
  chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these nutrients
  are not listed in this table.


   Table 4--Prevalence of Nutrient Inadequacy and Adequacy (From Conventional Foods and Water and Total Intake
(Conventional Foods, Water, and Supplement) and Status Biomarkers of the U.S. Population of Children 1 Through 3
                                                Years of Age \1\
----------------------------------------------------------------------------------------------------------------
                                                                      Usual nutrient intake \2\
                                --------------------------------------------------------------------------------
                                                         % below EAR \4\               Status biomarker
            Nutrient                                ------------------------------------------------------------
                                       EAR \3\                      Total                               % Below
                                                        Food       intake        Biomarker cutoff       cutoff
----------------------------------------------------------------------------------------------------------------
Folate.........................  120 mcg...........         0.1         0.1  Serum folate < 2 ng/mL         0.01
                                                                              RBC folate < 95 ng/mL.        0.17
Niacin.........................  5 mg..............         0.6         0.6  N/A....................         N/A
Riboflavin.....................  0.4 mg............           0           0  N/A....................         N/A
Thiamin........................  0.4 mg............           0           0  N/A....................         N/A
Vitamin A......................  210 mcg...........         1.9         1.5  N/A....................         N/A
Vitamin B6.....................  0.4 mg............         1.5         1.1  Serum B6 (pyridoxal 5'         2.57
                                                                              phosphate) < 20 nmol/L.
Vitamin B12....................  0.7 mcg...........           0           0  Serum B12 < 200 pg/mL..         0.2
Vitamin C......................  13 mg.............         1.9         1.3  N/A....................         N/A
Vitamin D......................  10 mcg............        82.0        66.5  Serum 25(OH)D..........         8.2
                                                                                                             2.9
                                                                             < 50 nmol/L............         0.8
                                                                             < 40 nmol/L............
                                                                             < 30 nmol/L............
Vitamin E......................  5 mg..............        84.6        61.6  Serum E < 516 mcg/dL...         1.3
Calcium........................  500 mg............        11.7        11.7  N/A....................         N/A
Copper.........................  260 mcg...........         0.2         0.2  N/A....................         N/A
Iron...........................  3 mg..............         1.0        0.42  Serum ferritin < 12 mcg/       17.7
                                                                              L (99-02) \5\.
                                                                             Iron deficiency                 7.9
                                                                              (Ferritin model, 99-
                                                                              02).

[[Page 11945]]

 
                                                                             Anemia (99-02).........         1.8
                                                                             Serum ferritin < 12 mcg/       23.3
                                                                              L (03-06).
                                                                             Iron deficiency (Body           9.5
                                                                              iron model, 03-06).
Magnesium......................  65 mg.............           0           0  N/A....................         N/A
Phosphorus.....................  380 mg............         0.2         0.2  N/A....................         N/A
Selenium \6\...................  17 mcg............           0           0  N/A....................         N/A
Zinc...........................  2.5 mg............         1.4         1.2  N/A....................         N/A
                                                    ------------------------
                                 AI \3\............      % Above AI \7\
                                                    ------------------------
Choline........................  200 mg............        46.4        48.5  N/A....................         N/A
Potassium......................  3000 mg...........         6.5         6.5  N/A....................         N/A
Vitamin K......................  30 mcg............        50.9        51.2  N/A....................         N/A
----------------------------------------------------------------------------------------------------------------
N/A = Data is not available in NHANES; mg = milligrams; mcg = micrograms.
\1\ All prevalence of nutrient adequacy or inadequacy and status biomarker data is based on NHANES 2003-2006
  except for vitamin D and choline intakes (2005-2008); serum pyridoxal-5'-phosphate (2005-2006); serum
  tocopherol for age 3 years (1999-2002), and serum ferritin (1999-2002).
\2\ Usual nutrient intake distributions from conventional foods are determined using the National Cancer
  Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48).
\3\ The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for children 1-3 years of age
  are established by the Institute of Medicine. Units are in mg/d or mcg/d http://www.iom.edu/Activities/
  Nutrition/SummaryDRIs/~/media/Files/Activity%20Files/Nutrition/DRIs/New%20Material/2--
  %20RDA%20and%20AI%20Values--Vitamin%20and%20Elements.pdf.
\4\ The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence
  of nutrient inadequacy. For iron, refer to Table I-5 Probability of inadequate iron intakes (Ref. 100).
\5\ Serum ferritin analysis changed from the Biorad assay to the Roche assay in 2003. Serum ferritin for 2003-
  2006 using the Biorad assay was adjusted to be comparable to those 2004-2006 data using the Roche assay. Iron
  deficiency based on the ferritin model is calculated using 2 out of 3 cutoffs of iron deficiency variables
  (transferrin saturation, serum ferritin, and erythrocyte protoporphyrin, NHANES 1999-2002) (Refs. 155 and
  159). Anemia was based upon iron deficiency criteria (ferritin model) and a low hemoglobin level. Iron
  deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to ferritin
  using NHANES 2003-2006 data. NHANES 1999-2002 did not measure transferrin receptor; therefore body iron model
  could not be analyzed for this time frame. NHANES 2003-2006 did not measure all iron biomarkers for all ages,
  thus serum ferritin, body iron model or ferritin model could not be analyzed for all ages during this time
  period.
\6\ We did not receive any comments for this nutrient (for which voluntary declaration is permitted) in response
  to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database for
  chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these nutrients
  are not listed in this table.
\7\ For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at
  or above the AI.


  Table 5--Prevalence of Nutrient Inadequacy and Adequacy (From Conventional Foods and Water) and Total Intake
(Conventional Foods, Water, and Supplement) and Status Biomarkers of the U.S. Population of Pregnant Women 14-50
                                                Years of Age \1\
----------------------------------------------------------------------------------------------------------------
                                                                       Usual nutrient intake \2\
                                                      ----------------------------------------------------------
                                                          % below EAR \4\              Status biomarker
            Nutrient                Weighted EAR \3\  ----------------------------------------------------------
                                                                    Total                               % below
                                                          Food      intake       Biomarker cutoff        cutoff
----------------------------------------------------------------------------------------------------------------
Folate..........................  520 mcg............       39.6       27.5  Serum folate < 2 ng/mL..       0.28
                                                                             RBC folate < 95 ng/mL...          0
Niacin..........................  14 mg..............        3.7        2.6  N/A.....................        N/A
Riboflavin......................  1.2 mg.............        3.6        3.1  N/A.....................        N/A
Thiamin.........................  1.2 mg.............       10.4        6.1  N/A.....................        N/A
Vitamin A.......................  549 mcg............       36.4         22  Serum A < 20 mcg/mL.....        1.0
Vitamin B6......................  1.6 mg.............       28.3       15.7  Serum B6 (Pyridoxal 5'            0
                                                                              phosphate) < 20 nmol/L.
Vitamin B12.....................  2.2 mcg............        1.6        1.1  Serum B12 < 200 pg/mL...        4.1
Vitamin C.......................  70 mg..............       21.7       11.2  Serum C < 11.4                  0.4
                                                                              [micro]mol/L.
Vitamin D.......................  10 mcg.............       87.6       47.6  Serum 25(OH)D
                                                                             < 50 nmol/L.............       16.9
                                                                             < 40 nmol/L.............        6.4
                                                                             < 30 nmol/L.............        3.7
Vitamin E.......................  12 mg..............       94.8         51  Serum E < 516 mcg/dL....        0.6
Calcium.........................  835 mg.............       20.7       18.9  N/A.....................        N/A
Copper..........................  0.79 mcg...........        4.4        4.1  N/A.....................        N/A
Iron............................  22 mg..............        5.3       3.71  Serum ferritin < 15 mcg/       26.1
                                                                              L.
                                                                             \5\ Iron deficiency
                                                                                --Body iron model....       16.4
                                                                                --Ferritin model            25.1
                                                                                 Anemia.

[[Page 11946]]

 
                                                                                                            12.8
Magnesium.......................  295 mg.............       57.2       55.0  N/A.....................        N/A
Phosphorus......................  583 mg.............        0.3        0.3  N/A.....................        N/A
Selenium \6\....................  49 mcg.............        0.7        0.7  N/A.....................        N/A
Zinc............................  9.5 mg.............       15.9       12.8  N/A.....................        N/A
                                 -------------------------------------------
                                  Weighted AI \3\         % Above AI \7\
                                 -------------------------------------------
Choline.........................  450 mg.............       13.5       13.6  N/A.....................        N/A
Potassium.......................  4700 mg............        3.9        3.9  N/A.....................        N/A
Vitamin K \6\...................  89 mcg.............       34.5       36.1  N/A.....................        N/A
----------------------------------------------------------------------------------------------------------------
N/A = Data is not available in NHANES; mg = milligrams; mcg = micrograms.
\1\ All prevalence of nutrient adequacy or inadequacy and biomarker data is based on NHANES 2003-2006 except for
  vitamin D and choline intakes (2005-2008); serum pyridoxal-5'-phosphate (2005-2006); serum tocopherol (1999-
  2002), and serum ferritin (1999-2002). Biomarker data are for pregnant women 12 through 49 years of age.
\2\ Usual nutrient intake distributions from conventional foods are determined using the National Cancer
  Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48).
\3\ The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for pregnant women 14-50 years
  of age are established by the Institute of Medicine. Units are in mg/d or mcg/d http://www.iom.edu/Activities/
  Nutrition/SummaryDRIs/~/media/Files/Activity%20Files/Nutrition/DRIs/New%20Material/2--
  %20RDA%20and%20AI%20Values--Vitamin%20and%20Elements.pdf.
\4\ The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence
  of nutrient inadequacy. For iron, refer to Table I-5 Probability of inadequate iron intakes (Ref. 100).
\5\ Iron deficiency based on the iron body model is calculated from the log ratio of transferrin receptor to
  ferritin using NHANES 2003-2006 data. Iron deficiency based on the ferritin model is calculated using 2 out of
  3 cutoffs of iron deficiency variables (transferrin saturation, serum ferritin, and erythrocyte
  protoporphyrin, NHANES 1999-2002) (Refs. 155 and 159). Anemia was based upon iron deficiency criteria
  (ferritin model) and a low hemoglobin level.
\6\ We did not receive any comments for these nutrients (for which voluntary declaration is permitted) in
  response to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database
  for chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these
  nutrients are not listed in this table.
\7\ For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at
  or above the AI.

L. Dietary Supplements

    FDA regulations specific to dietary supplement nutrition labeling 
appear in Sec.  101.36. Many requirements in Sec.  101.36 are 
consistent with the requirements for the nutrition labeling of 
conventional foods in Sec.  101.9 and there are references throughout 
Sec.  101.36 to requirements established in Sec.  101.9. As discussed 
previously, we are proposing several amendments to Sec.  101.9 that, if 
finalized, would result in significant changes to the content and 
format of the Nutrition Facts label. For consistency, we are proposing 
to amend Sec.  101.36 so that the content and format of the Supplement 
Facts label corresponds with that of the Nutrition Facts label. The IOM 
Labeling Report included a recommendation that the Supplement Facts 
label should use the same DVs as the Nutrition Facts label. In light of 
the IOM recommendation, we requested comment in the 2007 ANPRM on 
whether the Supplement Facts label should use the same DVs as the 
Nutrition Facts label, as suggested in the IOM labeling report. We 
received no comments in response to this question. We also did not 
receive any other comments to the 2007 ANPRM that are relevant to the 
Supplement Facts label.
    We expect that the proposed DVs for infants 6 through 12 months, 
children 1 through 3 years, pregnant and lactating women, and 
individuals 4 years of age and older may result in reformulation of 
dietary supplement products. Reformulations could impact intakes of 
vitamins and minerals for all age groups. We invite comment, including 
the submission of data and other factual information, on the 
reformulation of dietary supplement products that may result from 
proposed changes to the DVs, as well as information on the potential 
consequences of such reformulations.
    Our proposed changes to the Supplement Facts label in light of 
proposed changes to the Nutrition Facts label are described in this 
document.
1. Mandatory Dietary Ingredients
    In Sec.  101.36(b)(2), we established a list of dietary ingredients 
that have an RDI or a DRV as established in Sec.  101.9(c)(8)(ii) that 
are referred to as the ``(b)(2)-dietary ingredients.'' These 15 
nutrients must be listed in the Supplements Facts label for a dietary 
supplement when they are present in amounts that exceed the amount that 
can be declared as zero in the nutrition labeling of foods in 
accordance with Sec.  101.9(c).
    Section Sec.  101.9(c)(8)(ii) requires vitamin A, vitamin C, 
calcium, and iron to be declared on food labels. As discussed in 
section II.H., we are proposing to amend Sec.  101.9(c)(8)(ii) to allow 
for voluntary declaration of vitamins A and C and to require mandatory 
declaration of calcium, vitamin D, potassium, and iron. In addition, we 
are proposing to eliminate the mandatory declaration of ``Calories from 
fat'' on the Nutrition Facts label (see section II.A.1.).
    We are proposing to update the list of (b)(2)-dietary ingredients 
to maintain consistency with the proposed requirements for nutrition 
labeling of foods in Sec.  101.9. Therefore, proposed Sec.  
101.36(b)(2)(i) would: (1) No longer require declaration of vitamin A, 
vitamin C, or Calories from fat; (2) require vitamin D and potassium; 
(3) require the declaration of added sugars; and (4) retain the other 
(b)(2)-dietary ingredients as mandatory declarations. We are also 
proposing to amend

[[Page 11947]]

Sec.  101.36(b)(2)(i), (b)(2)(i)(B)(1), and (b)(2)(iii)(G) to remove 
the requirement for declaration of ``Calories from fat.''
2. Folate and Folic Acid
    We are proposing to only allow the use of the term ``folic acid'' 
for the labeling of dietary supplements. Folate is a nutrient found in 
conventional foods, whereas folic acid is the synthetic form of folate 
that is added to fortified conventional foods and dietary supplements. 
As discussed in section II.J.2., ``folic acid'' or ``folacin'' are 
identified as synonyms of folate and can be used on the Nutrition Facts 
label (Sec.  101.9(c)(8)(v)) or in the Supplement Facts label (Sec.  
101.36(b)(2)(i)(B)(2)). However, because of the difference in 
bioavailability between naturally occurring folate, and synthetic folic 
acid, we are proposing to amend Sec.  101.9(c)(8)(v) such that the term 
``folate'' would be used in the labeling of conventional foods that 
contain either folate alone or a mixture of folate and folic acid. As 
discussed in section II.J.2.c., we consider only the term ``folic 
acid'' to be appropriate for use in the labeling of dietary 
supplements. Therefore, we are proposing to amend Sec. Sec.  
101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to specify that ``folic acid'' 
is the term used to declare folic acid content of dietary supplements; 
and to remove ``folate'' and ``folacin'' from the list of synonyms that 
may be used to declare folic acid on the Supplement Facts label.
3. Units of Measure
    In section II.J.3., we are proposing to amend Sec.  101.9(c)(8)(iv) 
to replace ``IU'' for the RDIs for vitamin A, vitamin D, and vitamin E 
with mcg RAE for vitamin A, mcg for vitamin D, and mg [alpha]-
tocopherol for vitamin E. In addition, in section II.J.2., we are 
proposing to quantify and declare folate and folic acid in ``mcg DFE'' 
instead of ``mcg.'' In the interest of maintaining consistency in 
nutrition labeling of foods and dietary supplements, we are proposing 
to amend Sec.  101.36(b)(2)(i)(B)(3) to require that when [beta]-
carotene is included in parentheses following the percent statement for 
vitamin A, it should be declared using ``mcg'' (representing mcg RAE) 
as the unit of measure. In addition, under Sec.  101.36(b)(2)(ii)(B), 
the proposed units of measure for vitamin D, vitamin E, and folate in 
Sec.  101.9(c)(8)(iv) would be used in the declaration of vitamin D, 
vitamin E, and folic acid in the Supplement Facts label.
    In 2005, we received a citizen petition (Docket No. FDA-2005-P-0126 
(formerly Docket No. 2005P-0293)) requesting us to preclude the 
declaration of [beta]-carotene in supplements as vitamin A (http://www.regulations.gov/# !docketDetail;D=FDA-2005-P-0126). The petition 
maintained that the declaration of vitamin A on dietary supplement 
labels is misleading when the supplement contains mostly [beta]-
carotene because only a small amount of [beta]-carotene is converted by 
the liver into vitamin A. We do not see a need to preclude the 
declaration of [beta]-carotene as vitamin A, because the difference in 
the bioconversion of [beta]-carotene to vitamin A will be accounted for 
with the proposed declaration of vitamin A content as ``mcg'' 
(representing mcg RAE) (see section II.J.3.). Therefore, we are not 
proposing to preclude the declaration of [beta]-carotene in dietary 
supplements as vitamin A.
4. Order of Nutrients Declared on the Label
    For dietary supplements, Sec.  101.36(b)(2)(i)(B) specifies that 
vitamins and minerals must be declared in a specific order on the 
Supplement Facts label. We are now proposing to establish an RDI for 
choline in section I.7. Therefore, it is necessary to add choline to 
the list of ordered nutrients in Sec.  101.36(b)(2)(i)(B). We are 
proposing to require that, when declared, choline shall follow 
potassium on the label.
5. Subpopulations
    We discussed several changes in section II.K. that will affect 
dietary supplement labeling currently required for infants, children 
under 4 years of age, and pregnant and lactating women. To maintain 
consistency with the proposed requirements for nutrition labeling of 
foods in Sec.  101.9, we tentatively conclude that it is appropriate to 
revise the appropriate sections of Sec.  101.36 that pertain to 
labeling requirements for foods, other than infant formula, that are 
represented or purported to be specifically for infants 7 through 12 
months, children 1 through 3 years, and pregnant and lactating women. 
Therefore, we are proposing to amend Sec.  101.36(b)(2)(iii) to read as 
follows: ``The percent of the Daily Value of all dietary ingredients 
declared under paragraph (b)(2)(i) of this section shall be listed, 
except that the percent DV for protein may be omitted as provided in 
Sec.  101.9(c)(7); no percent DV shall be given for subcomponents for 
which DRVs have not been established (e.g., sugars).''
    When the percent DV is declared for total fat, saturated fat, total 
carbohydrate, dietary fiber, or protein, we require that a symbol be 
placed next to the percent DV declaration for these nutrients that 
refers the consumer to a statement at the bottom of the label that says 
``Percent Daily Values are based on a 2,000 calorie diet.'' This 
statement is only accurate for products meant for children and adults 
that are 4 years of age and older. The proposed DRVs for total fat, 
total carbohydrate, dietary fiber, and protein for children 1 through 3 
years of age are based on a 1,000 calorie diet. Therefore, when a 
product that is represented or purported to be for children 1 through 3 
years of age contains a percent DV declaration for total fat, total 
carbohydrate, dietary fiber, or protein, we are proposing to require in 
Sec.  101.36(b)(2)(iii)(D) that a symbol be placed next to the percent 
DV declaration that refers the consumer to a statement at the bottom of 
the label that says ``Percent Daily Values are based on a 1,000 calorie 
diet.''
    In addition, we are proposing to amend Sec.  101.36(b)(2)(iii)(E) 
to change the categories of infants and children less than 4 years of 
age to infants 7 through 12 months of age and children 1 through 3 
years of age.
    Finally, because we are proposing DRVs for various nutrients for 
infants 7 through 12 months, children 1 through 3 years, and pregnant 
and lactating women (see section II.K.), we are proposing to amend 
Sec.  101.36(b)(2)(iii)(F) such that the requirement for an asterisk 
noting that a DV has not been established would be applicable to foods 
for these subpopulations only when a DRV has not been established for a 
nutrient (i.e., for saturated fat, cholesterol, or dietary fiber for 
dietary supplements that are represented or purported to be for use by 
infants 7 through 12 months). Proposed Sec.  101.36(b)(2)(iii)(F) 
states: ``For declared subcomponents that have no DRVs, a symbol (e.g., 
an asterisk) shall be placed in the ``Percent Daily Value'' column that 
shall refer to the same symbol that is placed at the bottom of the 
nutrition label, below the last heavy bar and inside the box, and 
followed by the statement ``Daily Value not established.''
6. Footnote
    As discussed in section II.M, we are proposing to modify the 
footnote on the Nutrition Facts label. We are planning to conduct 
consumer studies related to the footnote on the Nutrition Facts label. 
The current footnote statement required for the Supplement Facts label 
differs from that which is currently required on the Nutrition Facts 
label. We expect that consumers that purchase dietary supplements would 
be more interested in information about the amount of specific 
micronutrients contained in dietary supplements and would be less

[[Page 11948]]

focused on the caloric reference value used in determining the percent 
DV for macronutrients. Based on the results of the consumer study, we 
will consider whether it is necessary to make corresponding changes to 
the footnote used on the Supplement Facts label when certain 
macronutrients are declared. We invite comment on whether we should 
consider changes to the footnote statement on the Supplement Facts 
label to be consistent with any changes to the footnote statement in 
the Nutrition Facts label.

M. Format

    Nutrition information must be presented on food labels in a 
specific format (see e.g., Sec.  101.9(d)-(f) and (j)). The elements of 
format related to the Nutrition Facts label include such features and 
graphic design principles as the type style (i.e., font) and size of 
the type (i.e., point); use of boldface, lines, and bars; arrangement 
of information in one or more columns; column headings; presence of a 
footnote and use of a symbol (such as an asterisk) to designate a 
footnote; and whether nutrition information is listed as a percentage 
or in absolute (i.e., quantitative) amounts. The elements of format 
also include the alignment of information; whether indentations are 
used in listing nutrient data; and the use of white space (or negative 
space) where no image or text exists. White space helps to isolate an 
element of the label that demands attention and provides a hierarchy 
and pacing of information for the reader (Ref. 160). The format may 
differ from package to package according to the amount of space on the 
package that is available for labeling, as described and detailed in 
the relevant sections in this document.
    The format of the Nutrition Facts label was informed by a number of 
factors, including consumer research conducted by FDA (Refs. 161 to 
163); consideration of the environment in which consumers typically use 
the label (i.e., grocery stores); the diversity of consumers for whom 
the label is intended (i.e., with respect to education, age, 
socioeconomic status, etc.); and comments and data received on this 
issue in response to a 1990 proposed rule, as discussed in the 1993 
final rule entitled Food Labeling: Mandatory Status of Nutrition 
Labeling and Nutrient Content Revision, Format for Nutrition Label (58 
FR 2079 at 2114-2144) (the format rule). Research studies consistently 
confirmed that simple formats are easier to comprehend and require less 
consumer effort than complex information formats. A simple format is 
one that minimizes clutter and best meets the NLEA requirements that 
nutrition information should enable the public to readily observe and 
comprehend such information. In addition, a simple format allows 
consumers to search for accurate nutrition information with minimum 
effort, and provides information in a succinct manner that maximizes 
understanding.
    Although the original intent of the format rule to meet the 
requirements and objectives of the NLEA for format has not changed, FDA 
is proposing certain changes to the format because of new information 
that has become available to us since 1993. The new information 
includes results of consumer research including studies that we 
conducted (Ref. 164), trends in health conditions (especially obesity), 
comments received in response to the 2005 and 2007 ANPRMs, and 
recommendations from FDA's Obesity Working Group (OWG) (Ref. 165). We 
are using this notice of proposed rulemaking to re-examine aspects of 
the current label format to determine which, if any, design changes may 
facilitate how information is conveyed to consumers.
    We are not proposing an extensive reformatting of the Nutrition 
Facts label. The original design, which took into account fundamental 
design principles for communicating complex ideas with clarity, 
precision, and efficiency, are largely being retained (Ref. 166). 
Rather, our tentative views, tentative conclusions, and proposed 
changes include our consideration of graphic design principles such as 
alignment, consistency, repetition, and contrast, and place an emphasis 
on highlighting key nutrients and key information and removing or 
modifying parts of the label to assist consumers in maintaining healthy 
dietary practices (Ref. 167). We consider our proposed changes to the 
Nutrition Facts label to be visually appealing and inviting. In 
general, the goal is to continue to display the information in a simple 
manner that is legible, readable, and follows a logical hierarchy. This 
presentation should serve as a visual guide to the reader that allows 
the eye to easily scan the label while the actual effort of reading is 
reduced.
    Toward that end, we are proposing the following changes to the 
format of the Nutrition Facts label: (1) Increasing the prominence of 
calories and serving size; (2) reversing the order of the ``Serving 
Size'' declaration and the ``Servings Per Container'' declaration and 
increasing the prominence of ``Servings Per Container''; (3) right-
justifying the quantitative amounts of the serving size information; 
(4) changing the phrase ``Amount Per Serving'' to ``Amount Per ----'' 
with the blank filled in with the serving size; (5) removing the 
declaration of ``Calories from fat''; (6) modifying the presentation of 
the ``% DV'' information by changing its position to the left of the 
name of the nutrient on certain labels, and separating it from the list 
of nutrients with a vertical line; (7) declaring ``Added Sugars'' as an 
indented listing directly beneath the listing for ``Sugars''; (8) 
declaring the quantitative amounts (in addition to percent DVs) of 
mandatory vitamins and minerals and, when declared, voluntary vitamins 
and minerals; (9) requiring dual column labeling under certain 
conditions; (10) modifying the footnote; (11) requiring that all 
nutrients not currently highlighted in bold or extra bold type be 
highlighted in a type that is intermediate between bold or extra bold 
and regular (i.e., semi-bold) type; (12) adding a horizontal line 
directly beneath the ``Nutrition Facts'' heading; and (13) replacing 
the listing of ``Total Carbohydrate'' with ``Total Carbs.'' We discuss 
each of these proposed amendments in this document. In addition, we are 
requesting comments on other issues related to the Nutrition Facts 
label format, including the use of an alternative format design or 
requiring the use of a specific font.
    Although the discussion in this document focuses primarily on the 
format of the standard Nutrition Facts label illustrated in Sec.  
101.9(d)(12), we also discuss certain modifications that we are 
proposing to be applied to other label formats to maintain consistency 
with the new format of the standard Nutrition Facts label. These other 
modifications pertain to formats for packages of products that contain 
two or more separately packaged foods that are intended to be eaten 
individually (e.g., variety packs of cereals and snacks) or that are 
used interchangeably for the same type of foods (e.g., round ice cream 
containers (Sec.  101.9(d)(13)); formats that apply to subpopulations 
(Sec.  101.9(e) and Sec.  101.9(j)(5)); the simplified format (Sec.  
101.9(f)); the tabular display on packages that do not have sufficient 
continuous vertical space (Sec.  101.9(d)(11)(iii)); and the tabular 
display (Sec.  101.9(j)(13)(ii)(A)(1)) and linear display (Sec.  
101.9(j)(13)(ii)(A)(2)) for small packages.
1. Increasing the Prominence of Calories and Serving Size
    The ability to determine the caloric content of packaged foods is 
important for all consumers, especially those who are trying to control 
their total caloric

[[Page 11949]]

intake and manage their weight. Inasmuch as overweight and obesity are 
major public health problems in the United States and are fundamentally 
a direct result of calorie consumption exceeding energy expenditure, we 
are interested in increasing consumer attention to the calorie content 
of packaged foods.
    Current FDA regulations require ``Calories'' to be declared in a 
type size no smaller than 8 point (Sec.  101.9(d)(1)(iii)) and 
highlighted in bold or extra bold type or other highlighting (Sec.  
101.9(d)(1)(iv)). While calorie information is mandatory on the 
Nutrition Facts label, it is possible that modifying the Nutrition 
Facts label to give more prominence to calories may benefit consumers 
in weight control and maintenance, as noted by the OWG in its final 
report entitled ``Calories Count'' (Ref. 165).
    The OWG recommended, in part, that FDA issue an ANPRM to solicit 
comments on how to give more prominence to calories on the food label. 
The OWG suggested possible changes to the Nutrition Facts label, such 
as increasing the prominence of ``Calories'' and ``Serving Size,'' 
providing a percent DV for calories, and eliminating the ``Calories 
from fat'' declaration, which may detract from the emphasis on total 
calories. The OWG recommended that we obtain information on the 
effectiveness of these options on consumer understanding and behavior 
related to calorie intake (Ref. 165). After issuing the 2005 ANPRM, in 
which we solicited comment on the OWG recommendations, we received 
several comments that generally supported increasing the prominence of 
calories on the Nutrition Facts label. These comments suggested various 
approaches for doing so, and pointed out the need for additional 
research to fully understand the effects of potential label changes on 
consumer understanding and behavior (Ref. 47).
    We considered available data from consumer research and comments 
received in response to the ANPRMs. Research conducted for warning 
labels and drug label formats has consistently demonstrated that 
increasing type size, among other things, increases attention to, and 
improves understanding of warning information, especially for older 
consumers and those with limited vision (Refs. 168 to 170). Also, our 
research on food labels with two servings per container found that 
labeling changes that highlighted the number of servings per container 
(via text or a dual column) served as cues to consumers that the 
product contained more than one serving and helped them more accurately 
determine the number of calories per container (Ref. 164).
    We tentatively conclude that the proposed changes to the number of 
calories per serving and the number of servings per container would 
result in these declarations serving as an anchor to the Nutrition 
Facts label by focusing the reader's attention to this information and 
therefore would assist consumers to effectively use this information in 
the Nutrition Facts label (Ref. 171). Accordingly, we are proposing to 
revise Sec.  101.9(d) to increase the type size for ``Calories'' and 
the numeric value for ``Calories.'' We are also proposing that the 
numeric value for calories be highlighted in bold or extra bold type in 
order to draw attention to this information, emphasize the importance 
of calories on the label, and maintain consistency with the bolded 
declaration for ``Calories.'' We invite comment on these tentative 
conclusions.
    We also consider it appropriate to make corresponding changes to 
the prominence of calories on the Supplement Facts label, when 
``Calories'' is declared. Although the majority of dietary supplement 
products contain a negligible amount of calories, and therefore 
calories are not declared on most Supplement Facts labels, we note that 
some dietary supplement products may contain a significant amount of 
calories and macronutrients. We are concerned that a small number of 
dietary supplement products, especially those in liquid form, could 
contribute a significant amount of calories and other macronutrients to 
the diet when consumed regularly. For such products, our tentative view 
is that it may be necessary for the Supplement Facts label to have a 
format similar to the format being proposed for the Nutrition Facts 
label with respect to increasing the prominence of information for 
calories. We invite comment on whether any of the changes that are 
being proposed to the Nutrition Facts label in the following sections 
should also be required for certain products with Supplement Facts 
labels that list calories and/or other macronutrients, and if so, under 
what conditions and for which dietary supplement products should such 
labeling be required.
2. Changing the Order of the ``Serving Size'' and ``Servings Per 
Container'' Declarations and Increasing the Prominence of ``Servings 
Per Container''
    Current regulations specify that information on serving size, 
consisting of a statement of the serving size (Sec.  101.9(d)(3)(i)) 
and the number of servings per container (Sec.  101.9(d)(3)(ii)), shall 
immediately follow the identifying heading of ``Nutrition Facts.'' In 
addition, ``Serving Size'' and ``Servings Per Container'' must be in a 
type size no smaller than 8 point (Sec.  101.9(d)(1)(iii)). As 
mentioned previously, we are interested in taking steps to increase 
consumer attention to the calorie content in packaged foods, such as by 
increasing the prominence of this information as suggested by the OWG. 
Consumer research on information displays suggests that accuracy of 
judgments and quality of decisions are improved when information 
displays closely match the judgment and decision needs of consumers 
(Refs. 172 and 173). With respect to the Nutrition Facts label, an 
important consumer need is to identify the number of servings per 
container of a packaged food. Therefore, placing ``Servings Per 
Container'' above ``Serving Size'' would be expected to help consumers 
find the number of servings per container with less effort than is now 
needed. Listing ``---- servings per container'' with the blank filled 
in with the actual number of servings directly beneath the ``Nutrition 
Facts'' heading, and highlighting it in bold or extra bold type would 
also help increase awareness that the information presented in the 
Nutrition Facts label does not refer to the contents of the entire 
package when the label indicates that there is more than one serving 
per container. Further, listing ``Serving size'' in the same proximity 
to where the actual nutrient information is located on the label would 
help consumers understand that this nutrient information pertains to 
the particular serving size that is declared. Proximity is a graphic 
design principle that asserts that items closer together are perceived 
to be more related (Ref. 167). This, in turn, would help consumers 
grasp the relative significance of a particular food product in the 
context of their daily diet.
    Therefore, based on the available data and information discussed 
previously, including graphic design principle, of proximity we 
tentatively conclude that reversing the order of the declarations of 
``Servings Per Container'' and ``Serving Size'' would help consumers 
more readily observe and comprehend the nutrition information appearing 
in the Nutrition Facts label, allow consumers to search for information 
with a minimum of effort, and assist consumers in their food purchasing 
decisions and in maintaining healthy dietary practices. Accordingly, we 
are proposing to re-designate Sec.  101.9(d)(3)(i) as Sec.  
101.9(d)(3)(ii), re-designate Sec.  101.9(d)(3)(ii) as Sec.  
101.9(d)(3)(i), and

[[Page 11950]]

make changes in how the serving size information is capitalized on the 
label so that no capital letters are used, except for the first letter 
in ``Serving size.'' (Current Sec.  101.9(d)(3)(i) and (d)(3)(ii) 
specify that information on serving size be capitalized and listed as 
``Serving Size'' and ``Servings Per Container.'') We also are proposing 
to require that the declaration of ``---- servings per container'' 
(with the blank filled in with the actual number of servings) be 
highlighted in bold or extra bold type, and be in a type size no 
smaller than 11 point (except for the tabular and linear displays for 
small packages) (proposed Sec.  101.9(d)(3)(i)) and that the serving 
size information must be in a type size no smaller than 8 point (except 
for the linear display for small packages) (proposed Sec.  
101.9(d)(3)(ii)). We tentatively conclude that these proposed changes 
would lessen the effort of consumers to locate this information, and 
assist them in accurately identifying the calorie amounts and nutrient 
contents of packaged food products.
    Current regulations regarding serving size information for dietary 
supplements is described in Sec.  101.36(b)(1). When taking dietary 
supplements, consumers need to know how much of the product to take 
(e.g., 1 capsule, 2 tablets, 1 packet). This information, which is 
currently provided in the ``Serving Size'' line of the Supplement Facts 
label, is more important for the consumer to know than the number of 
servings (e.g., 100 tablets) contained in the package. We received no 
comments recommending that the serving size or servings per container 
information on the Supplement Facts label should be made more prominent 
or noticeable. Therefore, our tentative conclusion is that there is no 
need to propose changing the order of how serving size and servings per 
container are listed on the Supplement Facts label, or to make 
amendments in the type size or capitalization corresponding to our 
proposed changes for this information on the Nutrition Facts labels. We 
invite comment on these tentative conclusions.
3. Right-Justifying the Quantitative Amounts Declared in the ``Serving 
size'' Statement
    We have also tentatively concluded, based on design considerations, 
that the label statement for ``Serving size'' in both household unit 
(Sec.  101.9(b)(5), refers to a common household measure such as a cup, 
tablespoon, piece or slice) and gram amounts must be right-justified on 
the same line that ``Serving size'' is listed. Currently, this 
numerical information is stated immediately adjacent to the ``Serving 
Size'' declaration, as seen in current Sec.  101.9(d)(12). By keeping 
the proposed ``Serving size'' declaration left-justified while right-
justifying the corresponding numerical values, the proposed change 
would create white space on the Nutrition Facts label that would result 
in a less cluttered appearance, heightened focus and emphasis, and 
improved readability (Ref. 160). This design feature would provide 
enhanced emphasis to the information about serving size, allowing this 
information to be more noticeable and thereby facilitating its access 
and use by consumers. We invite comment on this tentative conclusion.
4. Changing the ``Amount Per Serving'' Statement
    Current regulations specify that the Nutrition Facts label shall 
include a subheading designated as ``Amount Per Serving'' and that this 
subheading shall be separated from the serving size information by a 
bar (Sec.  101.9(d)(4)) and be highlighted in bold or extra bold type 
or other highlighting (Sec.  109(d)(1)(iv)). We are proposing, based in 
part on the consumer research previously cited (Refs. 172 and 173), to 
change the ``Amount Per Serving'' declaration to ``Amount per ----'' 
with the blank filled in with the actual serving size expressed in 
household units, and to increase the type size. These changes would 
make it easier for label users to judge the amounts of nutrients per 
serving because it removes the need for label users to refer back to 
the unit of the serving size which is currently declared just below the 
Nutrition Facts heading and which would be declared under the number of 
servings per container in the proposed label formats.
    Other studies suggest that consumers are often confused by serving 
size information as it is currently presented on the Nutrition Facts 
label (Refs. 174 and 175). Therefore, specifying the actual serving 
size in the listing of ``Amount per ----'' declaration would be 
expected to help consumers more readily observe and comprehend the 
nutrition information appearing in the label. Based on the reasons 
provided, we tentatively conclude that changing the ``Amount Per 
Serving'' statement to ``Amount per ----'' with the blank filled in 
with the actual serving size and increasing the type size would assist 
consumers in using the information and may lessen the time and effort 
needed to locate the target information. Accordingly, we are proposing 
to amend Sec.  101.9(d)(4) by requiring that the Nutrition Facts label 
specify what the serving size actually is by declaring ``Amount per --
--'' with the blank filled in with the actual serving size in household 
units as indicated in the ``Serving size'' declaration. To further 
facilitate use of the Nutrition Facts label, as mentioned in section 2, 
we are proposing to move the ``Serving size'' declaration closer to the 
proposed ``Amount per ----'' listing. We also are proposing to require 
that the ``Amount per ----'' information be highlighted in semi-bold, 
rather than in bold or extra bold, in order not to detract from the 
calories information. In addition, we are proposing that the type size 
of the ``Amount per ----'' declaration be no smaller than 8 point 
(except for the linear display for small packages). We invite comment 
on our tentative conclusions.
5. Declaration of ``Calories from Fat''
    We have tentatively concluded that a declaration of calories from 
fat on the Nutrition Facts label is not necessary to assist consumers 
in maintaining healthy dietary practices and, consequently, we are 
proposing to remove the current requirement for declaration of 
``Calories from fat'' (see section II.A.1.). Our Consumer research 
(Ref. 164), which evaluated a label format that did not contain the 
``Calories from fat'' statement, found that the lack of this 
information had no effect on consumers' judgments of product 
healthfulness, accuracy in identifying nutrient contents of products, 
or perceptions of the label. These findings support our proposal to 
remove the ``Calories from fat'' declaration from the Nutrition Facts 
label.
6. Presentation of Percent DVs
    The format for listing nutrients with DRVs on the Nutrition Facts 
label, including the quantitative amount by weight and percent DVs, is 
described in Sec.  101.9(d)(7). In establishing the requirements for 
percent DV declaration, we considered that this information would help 
consumers evaluate the nutrient characteristics of a single product 
(e.g., how high or low a particular product is in certain nutrients or 
the extent to which it contributes toward daily nutritional goals) and 
assist them in making choices between products (58 FR 2079 at 2121). 
Consumer research at that time of rulemaking for the Nutrition Facts 
label (Ref. 162) indicated that the percent DV information improved 
consumers' abilities to make correct dietary judgments about a food in 
the context of a total daily diet. Research also indicated that percent 
DV information helped consumers to verify the accuracy

[[Page 11951]]

of front-panel claims (Ref. 163). We received comments on the format of 
the Nutrition Facts label in response to the 2007 ANPRM (Ref. 47) that 
suggested modifying the way percent DV is presented to facilitate 
greater use of this information, although one comment suggested that 
the percent DV should not be used on the label. Other comments noted 
the need for additional consumer research and a comprehensive consumer 
education program.
    We continue to believe that the percent DV information on the 
Nutrition Facts label can serve a number of useful purposes, including 
helping consumers to compare foods; determine if a serving of food is 
high or low in a particular nutrient; and make dietary trade-offs among 
food choices throughout the day. As such, we do not agree that the 
percent DV declarations should be eliminated from the Nutrition Facts 
label. We are proposing to switch using the ``% Daily Value'' to the 
``% DV'' in the column that is above the nutrient listings. The ``% 
DV'' is used on some of nutrition facts labels for smaller packages and 
we think this will help with maintaining consistency among the labels. 
In addition we are adding a hairline rule (see discussion in this 
document) to differentiate the DVs from the nutrients and using ``% 
DV'' as the header which maintains the alignment of the heading over 
the DV column. Therefore based on the graphic design principle of 
alignment (Ref. 167) and in order to promote consistency of the labels 
we tentatively conclude to use ``% DV'' as the column header over the 
numerical listing of the nutrients DVs (proposed Sec.  101.9(d)(7)(ii)) 
.
    We have considered alternative terms that may be more readily 
understandable than Daily Value, such as Daily Guide or Daily Need, and 
invite comment on these or other terms. The issue of using an 
appropriate single term to refer to all of the reference values in the 
nutrition label was previously discussed in the format rule (58 FR 2079 
at 2124), in which we explained our rationale for deciding upon the 
single term ``Daily Value.'' We also request comment on whether the 
word ``percent'' (or the % symbol) should precede whatever term is used 
in the column heading where the percent DVs are listed, as specified in 
current Sec.  101.9(d)(6). Since the % symbol is currently included 
next to the numerical values that are listed in this column, including 
the word ``percent'' or the % symbol in the column heading may be 
redundant and, after considering comments, we may remove that 
requirement in a final rule. For the reasons explained previously, we 
are not proposing to change the requirements for the declaration of 
percent DV for all nutrients, as specified in Sec.  101.9(c)(8) and 
Sec.  101.9(d)(7).
    As discussed previously, percent DV is intended to help consumers 
make dietary decisions. Therefore, we tentatively conclude that making 
the percent DV more prominent may make the information even more useful 
to consumers than it is now. One potential approach to making the 
percent DV more prominent is to rearrange the positions of the columns 
listing the percent DV information. As currently described in Sec.  
101.9(d)(6), and Sec.  101.9(d)(7) the percent should be arranged on 
the right of certain Nutrition Facts label formats. For labels 
displaying the tabular format (proposed Sec.  101.9(d)(11)(iii)), the 
standard format (proposed Sec.  101.9(d)(12)), the format for infants 7 
to 12 months of age (proposed Sec.  101.9(j)(5)(i)), the tabular format 
for small packages, (proposed Sec.  101.9(j)(13)(ii)(A)(1)), the linear 
display (proposed Sec.  101.9(j)(13)(ii)(A)(2)), and the simplified 
format (as described in current Sec.  101.9(f)), we propose to list 
percent DVs in a column to the left of the names of the nutrients and 
their quantitative amounts, with a thin vertical line separating the 
``% DV'' column from the list of nutrients.
    The rearrangement is based on the graphic design principles of 
primacy (which asserts that initial items in a list are stored more 
efficiently in memory than items listed later), proximity (which 
asserts that elements positioned close together are perceived as a 
single group), and the importance of white space (which, among other 
things, is used by designers to isolate an element that demands 
attention) (Ref. 160 and 167), and the fact that English text is read 
from left to right. The addition of a vertical hairline rule to the 
right of the ``% DV'' column assists in chunking this information, 
thereby accentuating it and further distinguishing it from the nutrient 
name and the quantitative weight information. Chunking is a technique 
for combining multiple units of information into a limited number of 
units or chunks so that the information is easier to process and 
remember) (Ref. 167). Based on these design principles, positioning the 
% DV to the left of the label should increase consumers focus on the % 
DV. Displaying the % DV in this manner would assist consumers in 
understanding the relevant contribution of a nutrient in a food to the 
diet by highlighting the % DV information on the label more than on the 
current label format (where % DV is listed on the right of the label).
    We tentatively conclude that the proposed rearrangement would 
assist consumers by helping them to understand the nutrition 
information on the label in the context of a total daily diet. We are 
unaware of any consumer survey data concerning this particular proposed 
change related to consumer understanding and use of the information. 
Although, we are aware that the prevalence of inadequate numeracy 
(defined as ``the ability to comprehend, use, and attach meaning to 
numbers'' (Ref. 176) and low literacy in the population have been 
persistent concerns regarding the ability of consumers to comprehend 
health-related information, it is unclear to what extent the changes we 
are proposing to the positioning of the % DV from its current placement 
would have on overall consumer use or understanding. We are also aware 
that the prominence of the percent DV first could potentially make the 
Nutrition Facts label appear less user-friendly particularly to 
frequent users of Nutrition Facts labels, who have grown accustomed to 
the format and organization of the existing Nutrition Facts label. In 
addition, we acknowledge that moving the % DVs to the left could 
potentially draw consumer attention from nutrients that do not have a 
DV. We invite comment and data on the tentative conclusion to shift the 
``% DV'' to the left of the Nutrition Facts label.
    On all dual column labels, including those (1) for two or more 
forms of the same food (proposed Sec.  101.9(e)(5)); (2) displaying 
nutrition information per container and per unit, in addition to 
nutrition information per serving (proposed Sec.  101.9(e)(6)(i); (3) 
using the tabular display (proposed Sec.  101.9(e)(6)(ii)), and; (4) 
that provide the aggregate display (proposed Sec.  101.9(d)(13)(ii)), 
we propose to list the names of nutrients on the right side of the % DV 
column, followed by the quantitative (weight) amounts of each nutrient. 
In each of these labels, we propose to use thin vertical lines to 
separate the information in the ``% DV'' column from the information in 
the column containing the quantitative weights. Further, we propose to 
use the same style of thin vertical lines to separate each of the dual 
columns and aggregate display columns from each other. The use of these 
vertical lines helps to differentiate the columns and make the 
information easier for consumers to read and identify (Ref. 167). We 
invite comment on this tentative conclusion.
    As described in the Dietary Supplement Health and Education Act of 
1994, dietary supplements are

[[Page 11952]]

products taken by mouth containing ``dietary ingredients'' that are 
intended to supplement the diet. They may contain not only vitamins and 
minerals, but also herbs or other botanicals and amino acids, as well 
as concentrates, metabolites, constituents, and extracts of these 
dietary ingredients (section 201(ff) of the FD&C Act). Thus, many 
dietary supplement products contain few or no dietary ingredients with 
DRVs or RDIs, and therefore would not list any percent DVs on the 
Supplement Facts label. Further, consumers taking dietary supplements 
may find information about the quantitative amounts of dietary 
ingredients in the product to be of equal or greater importance than a 
percent DV listing, even if a DV existed for an ingredient contained in 
the dietary supplement. Therefore, we are not proposing any changes in 
the position of the percent DV listing on the Supplement Facts label 
relative to the position of the nutrient and dietary ingredient 
information. As mentioned previously, we are proposing to require that 
the Nutrition Facts labels that include dual columns contain vertical 
lines separating the percent DV information from the quantitative 
amounts per weight listings in each of the dual columns, and to 
separate the dual columns from each other. We invite comment on whether 
there is a need to include vertical lines that are similarly placed on 
Supplement Facts labels for multiple vitamins in packets (Sec.  
101.36(e)(11)(iii)) and for dietary supplements that list ``per 
serving'' and ``per day'' information (Sec.  101.36(e)(11)(viii)).
    Current Sec.  101.9(j)(5)(ii)(A), (j)(5)(ii)(C), and (j)(5)(ii)(D) 
include certain provisions for the presentation of percent DV for 
nutrients on the Nutrition Facts label of foods represented or 
purported to be specifically for infants and children less than 4 years 
of age. In particular, the percent DVs for protein, vitamins, and 
minerals are listed in a separate section of the Nutrition Facts label 
below the quantitative information by weight for protein. As discussed 
in section II.K., we are proposing changes to the nutrition labeling of 
foods represented or purported to be specifically for infants 7 through 
12 months, children 1 through 3 years of age, and pregnant and 
lactating women. These include, among other things: (1) Establishing 
RDIs and DRVs that are used in determining the percent DVs declared on 
the label; and (2) allowing for certain percent DV declarations that 
are currently excluded in Sec.  101.9(j)(5)(ii)(A). Given these 
proposed amendments that would require percent DV declarations for 
macronutrients, we invite comment on the appropriate placement of 
percent DVs in the labeling of foods for infants 7 through 12 months, 
children 1 through 3 years of age, and pregnant and lactating women. We 
are considering listing the percent DV to the left of the name of any 
nutrient that has a DV, as shown in proposed Sec.  101.9(j)(5)(i), 
similar to the placement of the declaration of percent DVs in the 
labeling of foods for the general population. Therefore, we are 
proposing that the percent DV for protein would no longer be listed 
with the vitamins and minerals at the bottom of the label as currently 
required.
7. Placement of ``Added Sugars''
    As discussed in section II.D.3., we are proposing to require the 
declaration of added sugars as an indented line item underneath the 
declaration of total sugars on the Nutrition Facts label. If finalized, 
added sugars would be the first mandatory nutrient required to be 
listed in a double indentation format on the Nutrition Facts label. FDA 
regulations permit the voluntary declaration of ``soluble fiber'' and 
``insoluble fiber'' as double indented listings under ``dietary fiber'' 
(Sec.  101.9(c)(6)(i)). We are planning to conduct a consumer study (78 
FR 32394, May 30, 2013) that will include, among other things, 
questions regarding the declaration of added sugars on the Nutrition 
Facts label. The results of this study will help enhance our 
understanding of how consumers would comprehend and use this new 
information. We will publish the results of the study when they become 
available. We are interested in receiving, as part of any comment, 
other available research data and other factual information relevant to 
this issue, including the proposed double indented placement of added 
sugars below total sugars.
8. Declaration of Absolute Amounts of Vitamins and Minerals
    A declaration of the quantitative amount by weight is required for 
both mandatory and voluntary nutrients that are declared on the 
Nutrition Facts label, except for vitamins and minerals (other than 
sodium and potassium) which must be declared only as percent DVs. As 
discussed in section II.I.6., we are proposing to require the 
declaration of the absolute amounts for all mandatory and voluntary 
vitamins and minerals, in addition to the requirement for percent DV 
declaration. An exception to this proposed requirement would be 
Nutrition Facts labels for foods in small packages that have a total 
surface area available to bear labeling of 40 or less square inches. 
Because of space limitations, we are not proposing any changes to the 
tabular display (Sec.  101.9(j)(13)(ii)(A)(1)) and the linear display 
(Sec.  101.9(j)(13)(ii)(A)(2)) on packages that have a total surface 
area available to bear labeling of 40 or less square inches, where 
vitamins and minerals (other than sodium) would have to be declared 
only as percent DVs.
9. Single and Dual Column Labeling
    There are currently multiple provisions for voluntary dual column 
labeling. For example, there is dual column labeling that presents 
nutrition information per serving size and per 100 g or 100 mL, or per 
1 oz. or 1 fl oz. of the food as packaged or purchased (Sec.  
101.9(b)(10)(i)). Dual column labeling is mandatory for products that 
are promoted on the label, or in advertising, for a use that differs in 
quantity by twofold or greater from the use upon which the reference 
amount was based (e.g., liquid cream substitutes promoted for use with 
breakfast cereals) (Sec.  101.9(b)(11)). We are also proposing for 
foods that are commonly combined with other ingredients or that are 
cooked otherwise prepared before eating to present the percent DVs and 
the quantitative amounts for both the food in the ``as purchased'' form 
and for the ``as prepared'' form in Sec.  101.9(h)(4).
    We are proposing under certain conditions (i.e., when the package 
contains at least 200 percent and up to and including 400 percent of 
the applicable reference amount customarily consumed) to require dual 
column labeling where nutrition information would be presented based 
both on the serving size and on the entire package or unit of food. 
This is described in a proposed rule entitled ``Food Labeling: Serving 
Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; 
Dual Column Labeling; Updating, Modifying, and Establishing Certain 
Reference Amounts Customarily Consumed; Serving Size for Breath Mints; 
and Technical Amendments'' (serving size proposed rule) that is 
published elsewhere in this issue of the Federal Register.
    In addition to proposing dual-column labeling per serving and per 
container (or unit, as applicable) for all nutrition information on the 
label, we are considering two additional options that would require 
nutrition information per serving and per container for only certain 
declarations but not all label declarations for containers of food or 
units of food, as applicable, containing

[[Page 11953]]

at least 200 percent and up to and including 400 percent of the 
applicable RACC. The first option is for a label that includes calorie 
information per serving and per container (or unit, as applicable) 
following the serving size information in the Nutrition Facts label. 
With this option, the remaining nutrition information would be listed 
on a per serving basis only and in a single column below the calorie 
information per serving and per container. The second option is to 
provide nutrition information per serving and per container (or unit, 
as applicable) for calories, saturated fat and sodium following the 
serving size information in the Nutrition Facts label and the remaining 
nutrition information would be listed on a per serving basis in a 
single column below the dual column provided for calories, saturated 
fat and sodium declarations. These options may specifically highlight 
the calorie content alone, and the calorie content, saturated fat 
content, and sodium content, respectively, for both the serving size 
and the entire container of food (or unit, as applicable). These 
options would focus on a smaller number of nutrients presented per 
serving and per container of food (or unit, applicable) that the U.S. 
population should limit for those foods with at least 200 percent and 
up to and including 400 percent of the RACC. We question whether 
consumers would be more inclined to use dual column labeling for a 
smaller set of nutrients. We invite comment and data on dual column 
labeling as proposed in this rule as well as the options presented for 
providing nutrition information per serving and per container (or unit, 
as applicable) for only certain declarations.
    We will consider whether to require one of these options in the 
serving size final rule after considering comments on the serving size 
proposed rule.
10. The Footnote
    The Nutrition Facts label requires an asterisk following the ``% 
Daily Value'' declaration that refers to a footnote statement that 
reads: ``*Percent Daily Values are based on a 2,000 calorie diet. Your 
Daily Values may be higher or lower depending on your calorie needs'' 
(Sec.  101.9(d)(9)(i)). Below this footnote, a table that lists DRVs 
for total fat, saturated fat, cholesterol, sodium, total carbohydrate, 
and dietary fiber based on 2,000 and 2,500 calorie diets must be 
provided (Sec.  101.9(d)(9)(i)). This table was originally included in 
the Nutrition Facts label to assist consumers in estimating their own 
quantitative dietary needs relative to the reference DVs (58 FR 2079 at 
2127). It was also intended to communicate that some DVs vary with 
caloric intake whereas others do not. Specifically, only the DRVs for 
the macronutrients (i.e., total fat, saturated fat, total carbohydrate, 
dietary fiber, and protein) differ according to calorie needs while the 
current DRVs for cholesterol, sodium, and potassium, as well as the 
RDIs for essential vitamins and minerals, do not vary according to 
caloric intake, and therefore are the same for both the 2,000 and 2,500 
calorie levels listed in the footnote. Finally, a statement indicating 
that the kcal/g for fat, carbohydrate, and protein are 9, 4, and 4, 
respectively, is permitted to be declared below the DRVs table (Sec.  
101.9(d)(10)).
    Several comments to the 2007 ANPRM suggested deleting either the 
entire footnote or the DRVs table from the footnote, and stated that 
the footnote information is not readily useable or understood by 
consumers and may be potentially confusing. Other comments recommended 
replacing the footnote with a short, simple statement that directs 
consumers to the USDA's MyPyramid Web site (which has now been replaced 
with ChooseMyPlate.gov) for further information. We do not agree with 
these latter comments, as information on the Nutrition Facts label 
should be available to the consumer at the time of product purchase or 
consumption.
    The percent DV is not described in the footnote or anywhere else on 
the Nutrition Facts label and we are interested in whether such a 
description would help improve consumer understanding of the percent DV 
information. In addition, as one comment pointed out, a recent study by 
the International Food Information Council Foundation entitled ``Food 
Label and Consumer Research Project'' showed that some consumers did 
not understand what was being conveyed in the percent DV explanatory 
footnote and others thought that the DRVs table changed according to 
the content of each food and beverage product. Therefore, although data 
indicate that the DRVs table is not well understood by consumers, it 
also appears unlikely that consumers would understand this information 
any better if calorie values were lowered or if a separate listing for 
men and women were provided, as was suggested by some comments. 
Therefore, we are proposing to remove the requirement for the footnote 
table listing the DRVs for total fat, saturated fat, cholesterol, 
sodium, total carbohydrate, and dietary fiber for 2,000 and 2,500 
calorie diets that is specified in Sec.  101.9(d)(9)(i).
    We also note that consumers are better able to discriminate between 
more and less healthful products when they are given an explanation 
about percent DVs than when they are not (Ref. 177). Therefore, it is 
our tentative view that a new footnote statement containing 
informational text to help consumers interpret the meaning of the 
percent DV and use the DVs is needed. Such information may include a 
definition of the percent DV, a succinct statement regarding calorie 
intake, and/or an explanation of when the percent DV signifies a 
relatively high or low level of a nutrient, such as the ``5/20 rule,'' 
which we describe in this document. In addition, it is our tentative 
view that such a footnote statement should be simple and easy to 
understand, as simplified information is more useful and accessible to 
consumers than complex information (Ref. 178).
    We also recognize that the footnote appearing in small type size at 
the bottom of the label may have made it less noticeable to consumers 
and therefore of less use than if it had been larger and otherwise more 
noticeable. Therefore, it is our tentative view that increasing the 
type size, bolding key elements of the footnote (space permitting), and 
adding a bar clearly separating it from the micronutrient information 
directly above will assist consumers in using the information. Again, 
we request comment on the impact such changes would have on enhancing 
consumers' use of the percent DV. We will consider comments we receive 
and whether to include such changes in the final rule.
    We also consider that a succinct statement about daily calorie 
intake (2,000 calories) is a necessary part of the footnote because 
2,000 calories is consistent with widely used food plans (76 FR 19192 
at 19209), the percent DV of certain nutrients (e.g., total fat, total 
carbohydrate, and dietary fiber) is based on 2,000 calories, and 2,000 
calories approximates the estimated energy need for adults who are 
sedentary to moderately active. However, we recognize that a succinct 
statement about daily calorie intake should not suggest that the 
percent DV of all nutrients is linked to a 2,000 calorie diet.
    As previously discussed in section II.M.7, we are planning to 
conduct consumer research on various format issues, including percent 
DV information in the footnote area. We agree that consumer education 
programs are important, and have offered such programs on our Web site 
to a variety of audiences, including young individuals (Ref. 179). We 
will consider additional efforts, as appropriate. In an

[[Page 11954]]

effort to provide consumers with a general approach for using the 
percent DV to evaluate the nutrient content in foods, we have explained 
on our Web site that, as a general frame of reference, a 5 percent DV 
or less is low and a 20 percent DV or more is high (often called the 
``5/20 rule'') (Ref. 180). Even though this general frame of reference 
has been publicized and advocated by the 2010 DGA (Ref. 6) and various 
Web sites (Ref. 181), it is unclear whether consumers are aware of the 
``5/20 rule,'' and to what extent it can improve consumer judgments 
about what constitutes high or low levels of nutrients in foods since 
quantitative information about food constituents is difficult for 
consumer to interpret (Ref. 180). The ``5/20 rule'' also closely 
approximates FDA regulations for nutrient content claims that provide 
criteria for the terms ``low'' (Sec. Sec.  101.61 and 101.62) and the 
terms ``rich in'' and ``excellent source'' (Sec.  101.54). Thus, the 
``5/20 rule'' could assist consumers in choosing foods that are high in 
specific nutrients they want to consume more of (e.g., calcium) and/or 
low in nutrients they want to eat less of (e.g., saturated fat). To 
inform our decision on how best to construct the new footnote, 
including its content and format, we plan to conduct consumer research 
during this rulemaking that will test consumer reactions to a 
definition of percent DV, a succinct statement on calories, and several 
statements related to the ``5/20 rule'' (77 FR 32120, May 31, 2012, and 
78 FR 32394). We will make the results of this study available for 
public review and comment. We request comments, including available 
data and information (such as experimental evidence) related to this 
issue.
    We are not aware of data gathered since the NLEA's implementation 
on whether listing information about converting gram amounts of fat, 
carbohydrate, and protein to calories has been useful to consumers. We 
are not proposing changes to this aspect of the footnote specified in 
Sec.  101.9(d)(10). However, we request comments and supporting data on 
whether or not this calorie conversion information should continue to 
be optional on the Nutrition Facts label, and whether there are any 
data suggesting that consumers do or do not use this information. We 
may consider deleting this optional requirement in the final rule if we 
determine the information is not useful. We will consider corresponding 
changes to the footnote requirements for the Supplement Facts label 
consistent with any changes to the footnote on the Nutrition Facts 
label.
11. Use of Highlighting With a Type Intermediate Between Bold or Extra 
Bold and Regular Type
    Currently, only nutrients that are not indented (i.e., 
``Calories,'' ``Total Fat,'' ``Cholesterol,'' ``Sodium,'' ``Total 
Carbohydrate,'' and ``Protein'') on the Nutrition Facts label are 
required to be highlighted in bold or extra bold type or other 
highlighting (Sec.  101.9(d)(1)(iv)). We have tentatively concluded, 
based on design considerations of highlighting information in Bold type 
(Ref. 167) would help differentiate the name of the nutrient from its 
absolute amount, that all of the other nutrients listed on the 
Nutrition Facts label, including those that are indented and the 
vitamins and minerals, should also be highlighted in order to set them 
apart from other information that appears in the Nutrition Facts label. 
The key nutrients that are not indented above would still be 
highlighted in a font that is bolder than the indented nutrients, so 
the overall style of the Nutrition Facts label will not change. 
Accordingly, we are proposing to amend Sec.  101.9(d)(1)(iv) to remove 
the restriction that prohibits any other information on the label to be 
highlighted, and to require that all voluntary nutrients specified in 
Sec.  101.9(c), including the vitamins and minerals listed in Sec.  
101.9(c)(8)(iv), appear in a type intermediate between bold and regular 
type (if bold type is used) or between extra bold and regular type (if 
extra bold type is used) on the Nutrition Facts label.
12. Addition of a Horizontal Line Beneath the Nutrition Facts Heading
    The current label requires that the Nutrition Facts heading be set 
in a type size larger than all other print size in the nutrition label 
(Sec.  101.9(d)(2)) but does not require that this heading be set apart 
from the rest of the label with a horizontal hairline rule, which is a 
thin line. Horizontal lines are used throughout the Nutrition Facts 
label as a key graphic element to divide space, direct the eye, and 
give the label a unique and identifiable look. The repeated use of 
horizontal lines helps develop the organization of the label, 
strengthens the label's unity, accentuates width, and promotes 
stability (Ref. 182). The addition of a hairline rule immediately below 
the Nutrition Facts heading directs the reader's eye to the serving 
size information, further emphasizes the information about servings, 
and helps break the information into small chunks, thus making it 
easier to process and remember the information (Ref. 167). Accordingly, 
we have tentatively concluded that a 0.25 point hairline rule shall be 
inserted directly beneath the Nutrition Fact heading on all label 
formats, with the exception of the linear display for small packages. 
We invite comment on this tentative conclusion.
13. Replacing ``Total Carbohydrate'' With ``Total Carbs''
    Nutrition information declared on the Nutrition Facts label must be 
presented using the nutrient names specified in Sec.  101.9(c) or Sec.  
101.9(j)(13)(ii)(B). According to Sec.  101.9(c)(6), the nutrient name 
used for listing information about the carbohydrate content of a 
product is ``Total Carbohydrate.'' Certain abbreviations, as specified 
in Sec.  101.9(j)(13)(ii)(B), may be used on the Nutrition Facts label 
on packages that have a total surface area available to bear labeling 
of 40 or less square inches. In addition, the term ``carb'' is commonly 
used as a shortened term or acronym for ``carbohydrate'' (Ref. 183). 
Although the current abbreviation for ``Total carbohydrate'' is ``Total 
carb,'' we found that ``total carbs'' was extensively preferred over 
``total carb'' as a Google search term during the past 15 years, 
suggesting that ``carbs'' is the more commonly used term by the general 
public (Ref. 184). As previously discussed, we are interested in 
maximizing the amount of white space on the Nutrition Facts label and 
in maintaining a simple format that minimizes clutter and enables the 
public to readily observe and comprehend the nutrition information that 
is presented. For the reasons set forth previously, we tentatively 
conclude that using the term ``Total Carbs'' instead of ``Total 
Carbohydrate'' would help achieve these objectives. Accordingly, we are 
proposing to amend Sec.  101.9(c)(6) and Sec.  101.9(j)(13)(ii)(B) by 
requiring that the total carbohydrate content in a serving be listed as 
``Total Carbs'' instead of ``Total Carbohydrate'' or ``Total Carb'' and 
that this listing be used on all label formats. We invite comment on 
this tentative conclusion.
14. Alternative Visual Formats/Fonts
    We considered the utility of alternative visual presentation 
formats, in response to some comments that suggested using charts or 
graphs to facilitate consumer understanding (Ref. 47). During the 
development of the current label format, we examined alternative 
graphic designs, including graphs, and determined that the current 
format was optimal (Ref. 185). Since 1993, we reviewed two published 
studies that explored alternative graphical formats (Refs. 172 and 
186). These studies provided limited and

[[Page 11955]]

mixed evidence in support of the tested formats. For example, one study 
(Ref. 186) did not investigate how graphical formats would perform when 
individuals have to compare the healthfulness of more than one product 
simultaneously. The other study (Ref. 172) demonstrated that when 
participants used the test labels to compare two products, the 
alternative graphical format was not unequivocally superior to a format 
resembling the standard Nutrition Facts format, and indeed the 
graphical display appeared to be inferior to the Nutrition Facts-type 
format in supporting consumers' ability to calculate the number of 
servings of a food that would provide the daily value of particular 
nutrients. Therefore, in the absence of conclusive evidence to support 
alternative graphical layouts, we are not proposing any changes to the 
basic format of the Nutrition Facts label as specified in Sec.  
101.9(d)(12). However, we invite comment on an alternative concept for 
the Nutrition Facts label format that indicates ``quick facts'' (e.g., 
amount of total carbohydrate, fat and protein) about a product's 
nutrient content first, and then explicitly points out nutrients to 
``avoid too much'' of as well as nutrients to ``get enough'' of as a 
way to categorize the nutrient declarations in the Nutrition Facts 
label. We previously considered this concept of separating nutrients 
out on the label and would like to reconsider it (Ref. 163). We request 
comment on how this display may or may not convey the information in a 
manner which enables the public to readily observe and comprehend such 
information and whether separating and placing nutrients such as `` 
``Total Fat and ``Saturated Fat'' under different headings would help 
or hinder consumer's understanding of the Nutrition Facts label. We are 
also interested in comments on what headings could be used and how to 
categorize all of the nutrients.
    Additionally, we are seeking comment on whether a specific type 
style should be required for the Nutrition Facts label. Currently, we 
specify in Sec.  101.9(d)(1)(ii)(A) that the type style should be a 
``single easy-to-read type style'' but no specific type style is 
required. However, in Sec.  101.9(d)(1) we urge that certain type 
styles (i.e., Helvetica Black, Helvetica Regular, Franklin Gothic 
Heavy) and other graphic design features be used, as described in 
appendix B to title 21, part 101, of the Code of Federal Regulations. 
We request comment on whether a specific font should be required to 
ensure the readability of the Nutrition Facts label. 
[GRAPHIC] [TIFF OMITTED] TP03MR14.002

N. Compliance

    Section 101.9(g) provides information about how we determine 
compliance with our nutrition labeling requirements, including the 
methods of analysis used to determine compliance, reasonable excesses 
and deficiencies of nutrients, and acceptable levels of variance from 
declared values. Based on the proposed changes to other sections of 
Sec.  101.9 (discussed in sections II.A. to II.M.) and taking into 
account comments in response to the 2007 ANPRM, we are proposing 
several changes to Sec.  101.9(g), which we discuss in this document.
1. Level of Variance Allowed for the Label Declaration of Specific 
Nutrients
    Section 101.9(g)(5) establishes that a food with a label 
declaration of calories, sugars, total fat, saturated fat, trans fat, 
cholesterol, or sodium shall be deemed to be misbranded under section 
403(a) of the FD&C Act if the nutrient content of the composite is 
greater than 20 percent in excess of the value for that nutrient 
declared on the label. In addition, no regulatory action will be based 
on a determination of a nutrient value that falls above this level by a 
factor less than the variability generally recognized for the 
analytical method used in that food at the level involved.
    One comment to the 2007 ANPRM asked us to reevaluate the level of 
variance permitted for nutrient content declarations, particularly for 
added nutrients of concern such as sodium, sugar, and fat. Expressing 
concern that the current practice could result in the provision of 
inaccurate and misleading information to consumers, the comment 
recommended that if we are unable to reduce the amount of permitted 
variability, we should, at a minimum, require food processors to 
include a disclosure on the food label.
    In determining the allowances for variability in Sec.  101.9(g), we 
considered variability in the nutrient content of foods, analytical 
variability inherent to test methods used to determine compliance, and 
statistical probability (38 FR 2125 at 2128, January 19, 1973). In 
addition, we evaluated compliance procedures and found them to be 
statistically sound and adequate. The comment provided no information 
to support a change to the current level of variance or the use of a 
disclosure statement in this context.
    Therefore, we are not proposing to change the level of variance 
allowed in Sec.  101.9(g)(5) in response to the comment.
2. Methods Used To Determine Compliance
    Under Sec.  101.9(g)(2), a composite of 12 subsamples, each taken 
from 12 different randomly chosen shipping cases are analyzed by 
appropriate methods as given in the ``Official Methods of Analysis of 
the AOAC International,'' 15th Ed. (1990) to determine compliance with 
the requirements in Sec.  101.9, unless a particular method of analysis 
is specified in Sec.  101.9(c). If no AOAC method is available or 
appropriate, we use other reliable and appropriate analytical 
procedures (see Sec.  101.9(g)(2)). The current edition (19th Ed.) of 
the ``Official Methods of Analysis of the AOAC International'' includes 
many updates to the 15th Edition.
    When we issued Sec.  101.9(g) related to compliance with nutrition 
labeling requirements, the most current version of the AOAC methods was 
its 15th edition and, therefore, we identified the 15th edition in our 
regulation. Newer and better methods of analysis have

[[Page 11956]]

been subsequently validated and recognized as ``official'' methods in 
the current 19th edition (2012) of the Official Methods of Analysis of 
the AOAC International. Accordingly, we are proposing to amend Sec.  
101.9(g)(2) by removing ``15th Ed. (1990)'' and adding in its place 
``19th Ed. (2012)'' to specify that we will analyze composites ``by 
appropriate methods as given in the ``Official Methods of Analysis of 
the AOAC International,'' 19th Ed. (2012).'' If a newer edition of the 
Official Methods of the AOAC International is published before issuance 
of a final rule, and assuming that we issue a final rule, we intend to 
finalize this rule with the newer edition, as appropriate, provided 
there are no substantive changes in the newer edition requiring 
additional comment.
3. Records Requirements
    Current Sec.  101.9(g)(2) sets forth requirements for composite 
sampling and analysis to determine compliance with labeling 
declarations. Specifically, unless a specific analytical method is 
identified by regulation, composites are analyzed by the appropriate 
AOAC method (15th Edition) or, if no AOAC method is available or 
appropriate, by other reliable and appropriate analytical procedures. 
For certain nutrients subject to this proposed rule, however, there is 
no AOAC official method of analysis or other reliable or appropriate 
analytical procedure that is available for us to verify the amount of 
the declared nutrient on the Nutrition Facts label and ensure that the 
declared nutrient amount is truthful, accurate and complies with all 
applicable labeling requirements, including the requirements in Sec.  
101.9(g). Specifically, there is no suitable analytical procedure 
available to measure the quantity of: (1) Added sugars (when a food 
product contains both naturally occurring sugars and added sugars and 
for specific foods containing added sugars, alone or in combination 
with naturally occurring sugars, where the added sugars are subject to 
fermentation); (2) dietary fiber (when a food product contains both 
non-digestible carbohydrate(s) that meets the proposed definition of 
dietary fiber and non-digestible carbohydrate(s) that does not meet the 
definition of dietary fiber); (3) soluble fiber (when a mixture of 
soluble fiber and added non-digestible carbohydrate(s) that does not 
meet the definition of dietary fiber are present in a food); (4) 
insoluble fiber (when a mixture of insoluble fiber and non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber are 
present in a food); (5) vitamin E (when a food product contains both 
RRR-[alpha]-tocopherol and all rac-[alpha]-tocopherol acetate); and (6) 
folate (when a food product contains both folate and folic acid). As 
discussed in sections II.D.3. (added sugars), II.D.5.a. (dietary 
fiber), II.D.5.b. (soluble and insoluble fiber), II.J.2. (folate), and 
II.J.3. (vitamin E)
    Under current Sec.  101.9(g)(9), FDA may permit the use of an 
alternative means of compliance or additional exemptions when it is not 
technologically feasible, or some other circumstance makes it 
impracticable, for firms to comply with the requirements of Sec.  
101.9. In such a case, under Sec.  101.9(g)(9), firms must submit a 
request in writing to FDA for the use of an alternative means of 
compliance or for a labeling exemption. We are proposing an alternative 
approach for assessing compliance of the declared amount of each of the 
nutrients identified previously under the circumstances we describe, 
given the nature of the information necessary to determine compliance 
and the number of foods potentially affected, because there is no 
suitable analytical method available to measure the quantity of each 
such nutrient as declared on the label or in labeling. We are proposing 
to require the manufacturer to make and keep records, identified in 
proposed Sec.  101.9(g)(10), that are necessary to verify the declared 
amount of each of these nutrients on the Nutrition Facts label. In 
proposed Sec.  101.9(g)(10) and (g)(11), we are proposing that 
manufacturers must make and keep written records, as specified for each 
of the nutrients and under the circumstances described in proposed 
Sec.  101.9(g)(10)(i-vii), that are necessary to verify the declared 
amount. We tentatively conclude that the records will provide the 
manufacturer and FDA with the necessary means to determine compliance 
with Sec.  101.9(g) requirements related to nutrient declaration.
    The manufacturer is in the best position to know which of its 
records provide the documentation required under the circumstances 
described previously for us to determine compliance. Some of the 
required records may appropriately include one or more of the 
following: Analyses of databases, recipes or formulations, or batch 
records. We recognize that the nutrient profile of processed foods that 
have added sugars, dietary fiber, soluble fiber, insoluble fiber, 
vitamin E, or folate/folic acid can vary depending on the recipe or 
formulation, the suppliers of ingredients, etc. Therefore, the amount 
of nutrients in a food may change if a manufacturer changes ingredient 
suppliers or changes a recipe. In order to verify the nutrient 
composition of a packaged food, the manufacturer would need to ensure 
that the records it provides to us to verify the declared amount of 
each of these nutrients, under the circumstances described, 
substantiate the nutrient composition of the specific food and, as 
appropriate, can distinguish among the same or similar product the 
manufacturer has in the marketplace that may contain differing amounts 
of the declared nutrient. For example, the manufacturer may have to 
distinguish among different fruit juice products with different amounts 
of added sugars or the same fruit juice product with different 
formulations. Most manufacturers should already have the type of 
records needed to validate the declared amount of each of these 
nutrients. The records requirements provide flexibility in what records 
the manufacturer makes available to us to verify the declared amount of 
these nutrients for a particular marketed product. In the absence of an 
accurate and reliable analytical method for quantifying the amount of 
these nutrients for nutrition labeling under the circumstances 
described, only the manufacturer will have the information required to 
determine the accuracy of the declared amount. The information 
contained in manufacturers' records is an accurate and practical method 
for assuring that the nutrient declarations comply with section 403(q) 
of the FD&C Act. Under section 403(q) of the FD&C Act, a food must 
bear, in its label or labeling, the amount of the nutrient the food 
contains. The purpose of providing the nutritional value of the food is 
to assist consumers in maintaining health dietary practices. Moreover, 
the nutrient declaration must be truthful and not misleading under 
sections 403(a)(1) and 201(n) of the FD&C Act.
    Under section 701(a) of the FD&C Act, we may issue regulations for 
the efficient enforcement of the FD&C Act in order to ``effectuate a 
congressional objective expressed elsewhere in the Act'' (Association 
of American Physicians and Surgeons, Inc. v FDA, 226 F. Supp. 2d 204 
(D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v FDA, 484 F. Supp. 1179, 
1183 (D. Del. 1980). The proposed record requirements for these 
nutrients, under the circumstances described, are designed to ensure 
that the nutrient declarations are accurate, truthful and not 
misleading, based on information known only to the manufacturer, and to 
facilitate efficient and effective action to enforce the requirements 
when necessary. Our authority to establish records

[[Page 11957]]

requirements has been upheld under other provisions of the FD&C Act 
where we have found such records to be necessary (National 
Confectioners Assoc. v. Califano, 569 F.2d 690, 693-94 (D.C. Cir. 
1978). The records we propose to require are only for foods for which 
an AOAC or other reliable and appropriate analytical method is not 
available. They allow us to verify the declared amount of each of these 
nutrients and that such amount is truthful and not misleading. Thus, 
the proposed records requirements assist in the efficient enforcement 
of the FD&C Act.
    The authority granted to us under sections 701(a), 403(q), 
403(a)(1) and 201(n) of the FD&C Act not only includes authority to 
establish records requirements, but also includes access to such 
records. Without such authority, the nutrient declarations for these 
specific nutrients that we have determined are necessary to assist 
consumers in maintaining healthy dietary practices under section 
403(q)(2)(A) of the FD&C Act are, practically speaking, not 
enforceable. Without access to such records, we would not know whether 
the amount declared on the label or in the labeling of each of these 
nutrients, under the circumstances described, is truthful and not 
misleading under sections 403(a)(1) and 201(n). The introduction or 
delivery for introduction into interstate commerce of a misbranded food 
is a prohibited act under section 301(a) of the FD&C Act. Thus, in 
order for us to determine whether the food is misbranded and the 
manufacturer has committed a prohibited act, we must have access to the 
manufacturer's records that we are requiring be kept under sections 
403(q), 403(a) and 201(n) of the FD&C Act.
    We anticipate that manufacturers may have concerns about the 
confidentiality of the information inspected by us under this proposal. 
We would protect confidential information from disclosure, consistent 
with applicable statutes and regulations, including 5 U.S.C. 552(b)(4), 
18 U.S.C. 1905, and 21 CFR part 20.
    Finally, it is necessary for the aforementioned records to be made 
available for review and copying while the product is available for 
purchase in the marketplace. The shelf life of packaged foods varies by 
product. Due to the significant number of packaged food products in the 
marketplace, there could be a wide variety of shelf lives among 
packaged foods. Some foods are subject to specific records 
requirements, such as dietary supplements (Sec.  111.605 (21 CFR 
111.605)), low acid canned foods (21 CFR 113.100), acidified foods (21 
CFR 114.100), fruit juice (Sec.  111.120), and seafood (Sec.  111.123). 
Therefore, the record retention period we propose to require to verify 
certain nutrient declarations may include records that manufacturers 
are required to make and keep for the same or longer periods under 
other requirements. The proposed record requirements for purposes of 
verifying nutrient declarations of such nutrients are separate and 
distinct from other record requirements. Generally, manufacturers are 
required to make and keep records for a minimum of 2 years (21 CFR 
1.360(d)), which the Agency considers a reasonable period of time for 
most foods to be available for purchase in the marketplace.
    Thus, we are proposing to require that manufacturers must make and 
keep written records to verify the declaration of: (1) The amount of 
added sugars when both naturally occurring and added sugars are present 
in a food (in Sec.  101.9(c)(6)(iii)); (2) the amount of added non-
digestible carbohydrate(s) that does not meet the proposed definition 
of dietary fiber when the dietary fiber present in a food is a mixture 
of non-digestible carbohydrates that do and that do not meet the 
definition of dietary fiber (in Sec.  101.9(c)(6)(i)); (3) the amount 
of added soluble non-digestible carbohydrate(s) that does not meet the 
proposed definition of dietary fiber when the soluble dietary fiber 
present in a food is a mixture of soluble non-digestible carbohydrates 
that do and that do not meet the definition of dietary fiber (in Sec.  
101.9(c)(6)(i)(A)); (4) the amount of added insoluble non-digestible 
carbohydrate(s) that do not meet the proposed definition of dietary 
fiber when the insoluble dietary fiber present in a food is a mixture 
of insoluble non-digestible carbohydrates that do and that do not meet 
the definition of dietary fiber (in Sec.  101.9(c)(6)(i)(B)); (5) the 
amount of all rac-[alpha]-tocopherol acetate added to the food and RRR-
[alpha]-tocopherol in the finished food when a mixture of both forms of 
vitamin E are present in a food (in Sec.  101.9(g)(10)(i)); and (6) and 
the amount of folic acid added to the food and the amount of folate in 
the finished food when a mixture of both forms are present in a food 
(in Sec.  101.9(g)(10)(ii)). We are also proposing, in Sec.  
101.9(g)(11), that such records must be kept for a period of 2 years 
after introduction or delivery for introduction of the food into 
interstate commerce. In addition, we are proposing to require that such 
records must be provided upon request, during an inspection, for 
official review and photocopying or other means of reproduction, and 
that records required may be retained either as original records, true 
copies (such as photocopies, pictures scanned copies, microfilm, 
microfiche, or other accurate reproductions of the original records) or 
electronic records. Where reduction techniques, such as microfilming 
are used, suitable reader and photocopying equipment would need to be 
readily available. All electronic records maintained under Sec.  101.9 
would need to comply with part 11 of this chapter (Sec.  101.9(g)(11)). 
We note that Part 11 would apply to any electronic records that are 
maintained to comply with the proposed requirements. We advise that the 
use of electronic records is voluntary and thus, a paper record system 
could be used to comply with these proposed recordkeeping requirements. 
The proposed requirements for electronic records extend to electronic 
signatures. We issued final guidance for industry on this topic. The 
guidance, entitled ``Part 11, Electronic Records; Electronic Signatures 
Scope and Application,'' sets out the Agency's enforcement policies 
with respect to certain aspects of part 11. The guidance is available 
at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm. 
This guidance would apply to any electronic record, including 
electronic signatures, established or maintained to meet a proposed 
requirement in this rule, if finalized as proposed. We request comment 
on the proposed requirements for the types of records that must be made 
and kept and the length of time that the records must be kept.
4. Inclusion of Potassium as a Mineral
    Potassium is specified as a Class I and Class II nutrient in Sec.  
101.9(g)(4)(i) and (g)(4)(ii), respectively. This nutrient is the only 
vitamin or mineral that is specifically listed under the description of 
both Class I and Class II nutrients. Potassium is a mineral for which 
an RDI is being proposed (Sec.  101.9(c)(8)(iv)) and the absolute 
amount would be required to be declared along with a percent DV on the 
Nutrition Facts label. We tentatively conclude that there is no need to 
separately list potassium under the description of Class I and Class II 
nutrients because it is encompassed within the category, mineral. 
Therefore, we are proposing to remove specific inclusion of the term 
``potassium'' within Sec.  101.9(g)(4), (g)(4)(i), (g)(4)(ii), and 
(g)(6) such that it would be covered under ``mineral'' and any listing 
of potassium on the Nutrition Facts label would have to meet the 
specific compliance requirements for minerals

[[Page 11958]]

under Sec.  101.9(g)(4), (g)(4)(i), (g)(4)(ii), and (g)(6).
5. Requirements for Other Carbohydrate, Soluble and Insoluble Fiber, 
Added Sugars, and Sugar Alcohols
    The labeling requirements for Class I and Class II nutrients are 
provided in section Sec.  101.9(g)(4). For the reasons discussed in 
section II.D.6., we are proposing to revise Sec.  101.9(c)(6)(iv) to 
remove the provision for voluntary declaration of ``Other 
carbohydrate.'' Accordingly, we are proposing to remove compliance 
requirements related to ``Other carbohydrate'' in Sec.  101.9(g)(4) and 
(g)(6).
    Dietary fiber is included as both a Class I and Class II nutrient 
because food products may contain only non-digestible carbohydrates 
that meet the definition of dietary fiber and that may be naturally 
occurring or that may be added to fortified or fabricated foods. The 
same is true for soluble and insoluble fiber, yet these nutrients are 
not specifically listed as Class I or Class II nutrients. Therefore, we 
are proposing to include soluble and insoluble fiber in Sec.  
101.9(g)(4) as both Class I and Class II nutrients.
    Section Sec.  101.9(g)(5) specifies that a food with a label 
declaration of calories, sugars, total fat, saturated fat, trans fat, 
cholesterol or sodium shall be deemed to be misbranded under section 
403(a) of the FD&C Act if the nutrient content of the composite is 
greater than 20 percent in excess of the value for that nutrient 
declared on the label. The nutrients listed in this section can have a 
negative impact on health in the general U.S. population if consumed in 
excess and/or there are current dietary recommendations to reduce the 
consumption of these nutrients. Therefore, we are ensuring in Sec.  
101.9(g)(5) that foods do not contain excessive amounts of these 
nutrients of which the consumer is not aware. Current dietary 
recommendations acknowledge that Americans consume excess amounts of 
added sugars and encourage reducing intake of calories from added 
sugars. As discussed in section II.D.3., added sugars, like naturally 
occurring sugars, can contribute to dental caries. As with the other 
nutrients listed in Sec.  101.9(g)(5), we have an interest in ensuring 
that foods do not contain excessive amounts of added sugars that are 
not declared on the label. Therefore, we are proposing to include added 
sugars in Sec.  101.9(g)(5). In some food products, the only source of 
sugars may be added sugars. In such cases, an analytical method could 
be used to determine the amount of added sugars in the food product and 
the permitted analytical variability would be applicable. Accordingly, 
we are proposing to amend Sec.  101.9(g)(5) to include ``added sugars 
(when the only source of sugars in the food is added sugars)'' among 
the list of nutrients.
    In Sec.  101.9(g)(6), reasonable excesses of certain nutrients over 
labeled amounts are acceptable within current good manufacturing 
practice. In addition, reasonable deficiencies of certain other 
nutrients under labeled amounts are acceptable within current good 
manufacturing practice. Consistent with this approach, we are proposing 
to allow, in Sec.  101.9(g)(6), reasonable excesses over the labeled 
amount of soluble and insoluble fiber and sugar alcohols when they are 
acceptable within current good manufacturing practice, and reasonable 
deficiencies under labeled amounts of added sugars when they are 
acceptable within current good manufacturing practice. As with other 
nutrients added to fortified or fabricated foods, we expect that when a 
food product contains added sugars, when all of the dietary fiber (both 
soluble and insoluble) is added non-digestible carbohydrate that meets 
the definition of dietary fiber, when all of the vitamin E is all rac-
[alpha]-tocopherol acetate, and when only folic acid is present in a 
food, the declared amount must be a least equal to the amount of the 
nutrient added to the food.
    In summary, we are proposing the following changes related to 
compliance: (1) Amend Sec.  101.9(g)(2) to cite the 19th edition of the 
Official Methods of Analysis of the AOAC International as the reference 
for appropriate methods used to determine compliance with amounts of 
nutrients declared on the Nutrition Facts label; (2) amend Sec.  
101.9(c)(6)(i), (c)(6)(iii), (g)(10), (g)(10)(i), and (g)(10)(ii) to 
establish general recordkeeping requirements when records are necessary 
to verify information related to dietary fiber, added sugars, folate, 
and vitamin E provided on the label; (3) remove specific inclusion of 
the term ``potassium'' within Sec.  101.9(g)(4), (g)(4)(i), (g)(4)(ii), 
and (g)(6) such that potassium would covered under ``mineral'' and any 
listing of potassium on the Nutrition Facts label would meet the 
specific compliance requirements for minerals under Sec.  101.9(g)(4), 
(g)(4)(i), (g)(4)(ii), and (g)(6); (4) when all of dietary fiber in a 
food product meets the proposed definition of dietary fiber, include 
soluble and insoluble fiber as both Class I and Class II nutrients 
under Sec.  101.9(g)(4); (5) include added sugars within Sec.  
101.9(g)(5) such that the label declaration of added sugars will be 
deemed misbranded under section 403(a) of the FD&C Act if the nutrient 
composite is greater than 20 percent in excess of the added sugars 
value declared on the label, and within Sec.  101.9(g)(6) such that 
reasonable deficiencies of added sugars would be permitted; (6) include 
soluble and insoluble fiber and sugar alcohols within Sec.  101.9(g)(6) 
such that reasonable excesses of these nutrients would be permitted; 
and (7) consistent with the tentative conclusion in section II.D.6., 
remove references to ``Other carbohydrates'' in Sec.  101.9(g).

O. Technical Amendments

1. Changing the Name of the Program Office
    Since publication of the regulations for nutrition labeling, the 
name of the office at the Center for Food Safety and Applied Nutrition 
that is responsible for developing regulations and answering questions 
related to nutrition labeling as well as for maintaining some of the 
references discussed throughout Sec.  101.9 has changed. The Office of 
Nutritional Products, Labeling and Dietary Supplements is now called 
the Office of Nutrition, Labeling and Dietary Supplements. We are 
proposing to update the name of the office throughout Sec.  101.9.
2. Changing the Publication Date of Report Incorporated by Reference
    Section Sec.  101.9(c)(7)(ii) provides that the protein 
digestibility-corrected amino acid score ``shall be determined by 
methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein Quality 
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation,'' Rome, 1990, except that when official AOAC 
procedures described in section (c)(7) of this paragraph require a 
specific food factor other than 6.25, that specific factor shall be 
used.'' We incorporated the ``Report of the Joint FAO/WHO Expert 
Consultation on Protein Quality Evaluation'' by reference in Sec.  
101.9(c)(7)(ii). Although the referenced report was written in 1989, it 
was published in 1991. We are, therefore, proposing to change the 
publication date of the report that is incorporated by reference from 
1990 to 1991.
3. Plain Language Edits
    On October 13, 2010, the President signed the Plain Writing Act of 
2010 requiring that Federal Agencies use ``clear Government 
communication that the public can understand and use.'' On January 18, 
2011, the President issued an Executive Order (E.O. 13563 (75 FR 
3821)--Improving Regulation and

[[Page 11959]]

Regulatory Review) that requires that the government must ensure that 
regulations are accessible, consistent, written in plain language, and 
easy to understand. In an effort to make the requirements of Sec.  
101.9 easier to understand, we are proposing to make editorial changes 
that do not change the meaning or intent of the language in Sec.  
101.9(g)(3)(ii); (g)(4)(i); (g)(4)(ii); and (g)(5).
    In Sec.  101.9(g)(3)(ii), we are revising the current language to 
clarify that when a nutrient or nutrients are not naturally occurring 
(exogenous) in an ingredient that is added to a food, the total amount 
of such nutrient(s) in the final food product is subject to Class I 
requirements rather than Class II requirements. It is not explicitly 
stated in the current regulation that such a nutrient would be subject 
to Class I requirements.
    In Sec.  101.9(g)(4)(i) and (g)(4)(ii), the definitions include a 
list of vitamins and minerals that are being defined as Class I or 
Class II vitamins and minerals followed by compliance requirements for 
those nutrients. This differs from the definition provided in Sec.  
101.9(g)(3)(i) and (g)(3)(ii) in that the definitions provided in Sec.  
101.9(g)(3)(i) and (g)(3)(ii) are about whether a nutrient is added or 
naturally occurring. We are proposing to remove ``Class I'' and ``Class 
II'' from the beginning of sections Sec.  101.9(g)(4)(i) and (g)(4)(ii) 
and to state instead that when the list of nutrients provided in those 
sections meets the definition of a Class I or Class II nutrient 
provided for in Sec.  101.9(g)(3)(i) and (g)(3)(ii), the declaration of 
those nutrients must meet certain requirements. The proposed change is 
being made to prevent confusion by having two different definitions of 
a ``Class I'' and ``Class II'' nutrient for compliance with nutrition 
labeling requirements.
    In Sec.  101.9(g)(5), we are proposing to remove the words 
``Provided, That''. These words do not provide further clarification 
and they add additional complexity to the section that is not 
necessary.

III. Proposed Effective and Compliance Dates

    We intend that any final rule resulting from this rulemaking, as 
well as any final rule resulting from the proposed rule entitled ``Food 
Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At 
One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and 
Establishing Certain Reference Amounts Customarily Consumed; Serving 
Size for Breath Mints; and Technical Amendments'' become effective 60 
days after the date of the final rule's publication in the Federal 
Register with a compliance date 2 years after the effective date. We 
recognize that it may take industry time to analyze products for which 
there may be new mandatory nutrient declarations, make any required 
changes to the Nutrition Facts label (which may be coordinated with 
other planned label changes), review and update their records of 
product labels, and print new labels. A compliance date that is 2 years 
after the effective date is intended to provide industry time to revise 
labeling to come into compliance with the new labeling requirements 
while balancing the need for consumers to have the information in a 
timely manner. We invite comment on the proposed compliance date.

IV. Analysis of Impacts

    We have examined the impacts of this proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) and the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
Executive Orders 12866 and 13563 direct us 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 are 
publishing two proposed rules on nutrition labeling in the Federal 
Register. We have developed one comprehensive Preliminary Regulatory 
Impact Analysis (PRIA) (Ref. 187) that presents the benefits and costs 
of the two proposed nutrition labeling rules taken together; the PRIA 
is available at http://www.regulations.gov (Docket No. FDA-2012-N-
1210). 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 on this site. We believe that 
the cumulative impact of the proposed rules on nutrition labeling, 
taken as a whole, represent a significant regulatory action as defined 
by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Additional costs per entity of the proposed rule are 
small, but not negligible, and as a result we conclude that the 
proposed rules on nutrition labeling, taken as a whole, would have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that we 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 (2012) Implicit 
Price Deflator for the Gross Domestic Product. We have determined that 
the proposed rules on nutrition labeling, taken as a whole, meet this 
threshold.
    The analysis that we have performed to examine the impacts of the 
proposed rules under Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the PRA (see section V.) are included 
in the PRIA (Ref. 187) and are available at http://www.regulations.gov 
(Docket No. FDA-2012-N-1210). We invite comment on the PRIA.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the PRA. A description of these provisions is given in the PRIA 
(Ref. 187) available at http://www.regulations.gov (Docket No. FDA-
2012-N-1210) with an estimate of the annual reporting, recordkeeping, 
and third-party disclosure burden. Included in the 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.
    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.
    To ensure that comments on information collection are received,

[[Page 11960]]

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 title ``Record Retention, Reporting, and 
Third-Party Disclosure Requirements for the Declaration of Added 
Sugars, Dietary Fiber, Soluble Fiber, Insoluble Fiber, Vitamin E, and 
Folate/Folic Acid.''
    In compliance with the PRA, we have submitted the information 
collection provisions of this proposed rule to OMB for review. These 
requirements will not be effective until we obtain OMB approval. We 
will publish a notice concerning OMB approval of these requirements in 
the Federal Register.

VI. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of 
this action. We have concluded that the action will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required (Refs. 188 and 189). Our finding of no 
significant impact and the evidence supporting that finding, contained 
in an environmental assessment, may be seen in the Division of Dockets 
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday.

VII. Federalism

    We have analyzed this proposed 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.''
    Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express 
preemption provision. Section 403A(a) of the FD&C Act provides that: 
``* * * no State or political subdivision of a State may directly or 
indirectly establish under any authority or continue in effect as to 
any food in interstate commerce--(4) any requirement for nutrition 
labeling of food that is not identical to the requirement of section 
403(q) * * *.''
    The express preemption provision of section 403A(a) of the FD&C Act 
does 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 (section 6(c)(2) of the 
Nutrition Labeling and Education Act of 1990, Pub. L. 101-535, 104 
Stat. 2353, 2364 (1990)). If this proposed rule is made final, the 
final rule would create requirements that fall within the scope of 
section 403A(a) of the FD&C Act.

VIII. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    We invite comment on all aspects of the proposed rule, including 
the need for, and appropriateness of, the various provisions proposed 
in this rule and our accompanying rationale. Specifically:
    (1) We invite comment on our use of the most recent consensus 
reports and whether the information and data on which FDA relies from 
such reports for proposed changes is consistent with current scientific 
information, the factors for considering mandatory and voluntary 
declaration of non-statutory nutrients, and whether there is an 
appropriate alternative analysis to application of these factors 
regarding (a) no longer permitting mandatory declaration (i.e., 
vitamins A and C); (b) requiring the declaration of a nutrient that is 
currently voluntary (e.g., vitamin D), and; (c) continuing the 
voluntary labeling of macronutrients (e.g., monounsaturated and 
polyunsaturated fats);
    (2) We invite comment on the tentative conclusion to no longer 
permit the declaration of ``Calories from fat'' on the Nutrition Facts 
label and on the tentative conclusion not to establish a DRV for 
calories and include a percent DV for the declaration of calories, 
which are discussed in section II.A;
    (3) In section II.B., we addressed various issues related to the 
declaration of total fat and related nutrients. We invite comment on 
the proposed definition of fatty acids, as well as on our tentative 
conclusion that acetic, propionic, and butyric acids should not be 
excluded from the definition of total fat;
    (4) We invite comment on various issues related to the declaration 
of carbohydrates and related nutrients, which are discussed in section 
II.D.: (a) With respect to added sugars, we request comments on our 
tentative conclusions and proposed provisions for mandatory declaration 
of added sugars, the placement of this information as double indented 
line below total sugars, and means to verify compliance. We also invite 
comment, including the submission of available research, on whether 
calories from added sugars should be declared on the Nutrition Facts 
label in lieu of a gram declaration of added sugars to aid consumers in 
maintaining healthy dietary practices. We also invite comment on 
products that are subjected to non-enzymatic browning reactions and 
fermentation, and the amount of variability that occurs among various 
types of products where added sugars are transformed into other 
compounds as a result of chemical reactions during food processing; (b) 
with respect to dietary fiber, we invite comment on the proposed 
definition of dietary fiber and retaining the term ``dietary fiber.'' 
We invite comment, including the submission of information on consumer 
understanding of the term ``dietary fiber'' relative to other relevant 
terms; and (c) we are proposing to eliminate the provision for 
voluntary declaration of ``Other carbohydrate'' on the Nutrition Facts 
label, and tentatively conclude that the proposed amendment is unlikely 
to have a significant impact on industry or consumers. We invite 
comment on this issue, including the submission of any other data or 
factual information that we should consider in making a final 
determination.
    (5) We invite comment on our tentative conclusions related to 
sodium discussed in section II.G., including the proposed DRV. In 
particular, we invite comment on: (a) The rationale for the proposed 
DRV of 2,300 for sodium; (b) whether a RDI of 1,500j mg would be more 
appropriate and why, and; (c) alternative approaches for selecting a DV 
for sodium and their public health basis for these approaches. We are 
also interested in comment, including data and factual information on 
consumer understanding, interpretation, and use of the percent DV of 
sodium declared on food labels, and the understanding and potential 
influences of a DV that reflects an RDI based on an AI (an intake level 
to not consume less of), instead of a DRV based on a UL (an intake 
level not to exceed);
    (6) In section II.H., we are proposing to: (a) Retain mandatory 
declaration of calcium and iron; (b) provide for voluntary declaration 
of vitamins A and C; (c) require the declaration of potassium and 
vitamin D; and (d) retain voluntary declaration of several other

[[Page 11961]]

vitamins and minerals. We are also proposing to require that all 
vitamins and minerals declared on the Nutrition Facts label must 
include their quantitative amounts (in addition to the requirements for 
corresponding percent DV declaration). We invite comment on these 
tentative conclusions, including the appropriate placement of the 
quantitative amounts of nutrients on the Nutrition Facts label, 
including data and other available information on the impact of 
mandatory labeling of vitamins and minerals on food fortification. We 
invite comment on the proposed mandatory declaration of vitamin D, 
potassium, calcium and iron on the label, including how we consider the 
public health significance of each. We also invite comment on whether 
the presence of these nutrients presents concerns related to label 
space or the need for consumer education. We also invite comment on 
whether the presence of these nutrients presents concerns related to 
label space or the need for consumer education.
    (7) In section II.I., we are proposing to use population-coverage 
RDAs, when available, or AIs as the basis for establishing RDIs. We 
invite comment on our analysis and rationale, including available data 
and information related to our analysis, and any available data on what 
role, if any, the basis of the DV (EAR or RDA) has on consumption of 
nutrients above the UL and in discretionary fortification of foods; we 
request comment on lowering the RDI of B12 to 2.4 [mu]g.
    (8) In section II.I.6, whether quantitative amounts for nutrients 
with RDI values that contain three or four digits should be rounded, 
what the rounding increments should be, and data to support suggested 
rounding increments for such vitamins and minerals.
    (9) We invite comment on issues related to units of measure, 
nomenclature, and analytical methods, which are discussed in section 
II.J.;
    (10) We invite comment on issues related to nutrition labeling for 
foods represented or purported to be specifically for infants 7 through 
12 months of age, children 1 through 3 years of age, and pregnant and 
lactating women, which are addressed in section II.K., including (a) 
any available relevant empirical research as to whether the proposed 
declaration of saturated fat and cholesterol for infants and children 1 
through 3 years of age is likely to be confusing to consumers or 
otherwise result in restriction of fat intakes among these 
subpopulations; (b) how consumers would understand and use the 
information on amounts of saturated fat and cholesterol in the 
nutrition labeling of foods for infants and young children and whether 
there is a need for an explanatory footnote to accompany such proposed 
mandatory declaration; (c) our tentative conclusion that declaration of 
added sugars should be mandatory on foods represented or purported to 
be specifically for infants 7 through 12 months of age, children 1 
through 3 years of age, and pregnant and lactating women; and (d) 
adequacy of the proposed RDIs for vitamins and minerals for older 
infants and children 1 through 3 years of age.
    (11) We invite comment, including available data and other 
information on the reformulation of dietary supplement products that 
may result from proposed changes to the DVs, as well as information on 
the potential consequences of such reformulations;
    (12) We invite comment on whether we should consider changes to the 
footnote statement ``Percent Daily Values are based on a 2,000 calorie 
diet'' used on dietary supplement labels to be consistent with any 
changes to the footnote statement in the Nutrition Facts label.
    (13) We invite comment on (a) including the use of an alternative 
format design or requiring the use of a specific font; (b) our 
tentative conclusion that emphasizing both the number of calories per 
serving and the number of servings per container will serve as an 
anchor to highlight this information and grab the reader's attention, 
and therefore will assist consumers to effectively use this information 
in the Nutrition Facts label; (c) whether any of the changes that are 
being proposed to the Nutrition Facts label should also be required for 
certain products with Supplement Facts labels that list calories and/or 
other macronutrients, and if so, under what conditions and for which 
dietary supplement products should such labeling be required; (d) our 
tentative view that there is no need to propose changing the order of 
how serving size and servings per container are listed on the 
Supplement Facts label, or to make amendments in the type size or 
capitalization corresponding to our proposed changes for this 
information on the Nutrition Facts labels; (e) our tentative conclusion 
that, based on design considerations, the label statement for ``Serving 
size'' in both household units and gram amounts should be right-
justified on the same line that ``Serving size'' is listed; (f) our 
tentative conclusion that changing the ``Amount Per Serving'' statement 
to ``Amount per------'' with the blank filled in with the actual 
serving size would assist consumers in using the information and may 
lessen the time and effort needed to locate the target information and 
improve the accuracy of judgments about the calorie amounts and 
nutrient contents of packaged food products; (g) the double indented 
placement of added sugars below total sugars and invite available 
research data formation; (h) our tentative view that increasing the 
type size, bolding key elements of the footnote (space permitting), and 
adding a bar clearly separating it from the micronutrient information 
directly above will assist consumers in using the information; (i) our 
tentative view on the need for a footnote statement for enhancing 
consumers' use and understanding of the percent DV; (j) using data 
provided consumer research we plan to conduct during this rulemaking 
that will test consumer reactions to a definition of percent DV, a 
succinct statement on calories, and several statements related to the 
``5/20 rule''; (k) whether or not this calorie conversion information 
should continue to be optional on the Nutrition Facts label, and 
whether there are any data suggesting that consumers do or do not use 
this information; (l) alternative terms that may be more readily 
understandable than Daily Value, such as Daily Guide or Daily Need; (m) 
whether the word ``percent'' (or the % symbol) needs to precede 
whatever term is used in the column heading where the percent DVs are 
listed; (n) whether there is a need to include vertical lines that are 
similarly placed on Supplement Facts labels for multiple vitamins in 
packets (Sec.  101.36(e)(11)(iii)) and for dietary supplements that 
list ``per serving'' and ``per day'' information (Sec.  
101.36(e)(11)(viii)); (o) the appropriate placement of percent DVs in 
the labeling of foods for infants 7 through 12 months, children 1 
through 3 years of age, and pregnant and lactating women; (p) our 
tentative conclusion to insert a 0.25 point hairline rule directly 
beneath the Nutrition Fact heading on all label formats, with the 
exception of the linear display for small packages; (q) listing the 
total carbohydrate content in a serving as ``Total Carbs'' instead of 
``Total Carbohydrate'' or ``Total Carb'' and its listing used on all 
label formats; (r) an alternative concept for the Nutrition Facts label 
format that indicates ``quick facts'' about a product's nutrient 
content and explicitly points out nutrients to ``avoid too much'' of as 
well as nutrients to ``get enough'' of, and; (s) whether a specific 
font should be required for the Nutrition

[[Page 11962]]

Facts label. We request comment on how this display may or may not 
convey the information in a manner which enables the public to readily 
observe and comprehend such information and whether separating and 
placing nutrients such as ``Total Fat'' and ``Saturated Fat'' under 
different headings would help or hinder consumer's understanding of the 
Nutrition Facts label. We also are interested in comments on what 
headings could be used and how to categorize all of the nutrients.

IX. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) 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 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

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List of Subjects in 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, it is 
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

0
1. The authority 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
2. In Sec.  101.9:
0
a. Revise paragraphs (c) introductory text, (c)(1)(i)(A), (c)(1)(i)(C) 
through (E) (c)(2) introductory text, (c)(5), (c)(6)(i), (c)(6)(iii) 
and (iv), (c)(7), (c)(8) introductory text, (c)(8)(i), (c)(8)(ii) 
introductory text, (c)(8)(iii) through (v), (c)(9), (d)(1) introductory 
text, (d)(1)(ii)(C), (d)(1)(iii) through (v), (d)(2), (d)(3)(i) and 
(ii), (d)(4) through (8), (d)(10) through (12), (d)(13)(ii), (e), (f) 
introductory text, (f)(2)(ii), (f)(4) and (5), (g) introductory text, 
(g)(2), (g)(3)(ii), (g)(4) through (8), (h)(3)(iv), (h)(4) introductory 
text, (j)(5)(i), (j)(5)(ii) introductory text, (j)(5)(ii)(A), 
(j)(13)(ii)(A)(1) and (2), (j)(13)(ii)(B) and (C), and (j)(18)(iv) 
introductory text.
0
b. Remove paragraph (c)(1)(ii), redesignate paragraph (c)(1)(iii) as 
(c)(1)(ii), and revise newly designated paragraph (c)(1)(ii);
0
c. Remove paragraph (c)(6)(iv), redesignate paragraph (c)(6)(iii) as 
(c)(6)(iv), and add new paragraph (c)(6)(iii);
0
d. Add paragraphs (c)(1)(i)(F), (c)(8)(vii), (g)(10), and (g)(11);
0
e. Remove and reserve paragraph (d)(9);
0
f. Remove paragraphs (e)(3)(i) and (e)(3)(ii); and
0
j. Remove paragraphs (j)(5)(ii)(B) through (j)(5)(ii)(D), and 
redesignate paragraph (j)(5)(ii)(E) as (j)(5)(ii)(B).
    The revisions read as follows:


Sec.  101.9  Nutrition labeling of food.

* * * * *
    (c) The declaration of nutrition information on the label and in 
labeling of food for adults and children over the age of 4 years, and 
on foods (other than infant formula) purported to be specifically for 
infants 7 through 12 months, children 1 through 3 years of age, and 
pregnant and lactating women, shall contain information about the level 
of the following nutrients, except for those nutrients whose inclusion, 
and the declaration of the amounts, is voluntary as set forth in this 
paragraph. No nutrients or food components other than those listed in 
this paragraph as either mandatory or voluntary may be included within 
the nutrition label. Except as provided for in paragraphs (f) or (j) of 
this section, nutrient information shall be presented using the 
nutrient names specified and in the following order in the formats 
specified in paragraphs (d) or (e) of this section.
    (1) * * *
    (i) * * *
    (A) Using specific Atwater factors (i.e., the Atwater method) given 
in table 13, ``Energy Value of Foods--Basis and Derivation,'' by A. L. 
Merrill and B. K. Watt, United States Department of Agriculture (USDA) 
Handbook No. 74 (slightly revised, 1973), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is 
available from the Office of Nutrition, Labeling, and Dietary 
Supplements (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or may be inspected at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.;
* * * * *
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate (less the amount of non-digestible 
carbohydrates and sugar alcohols), and total fat, respectively, as 
described in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11, 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51 (the availability of this incorporation by reference 
is given in paragraph (c)(1)(i)(A) of this section). A general factor 
of 2 calories per gram for soluble non-digestible carbohydrates shall 
be used. The general factors for caloric value of sugar alcohols 
provided in paragraph (c)(1)(i)(F) of this section shall be used;
    (D) Using data for specific food factors for particular foods or 
ingredients approved by the Food and Drug Administration (FDA) and 
provided in parts 172 or 184 of this chapter, or by other means, as 
appropriate;

[[Page 11968]]

    (E) Using bomb calorimetry data subtracting 1.25 calories per gram 
protein to correct for incomplete digestibility, as described in USDA 
Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the 
availability of this incorporation by reference is given in paragraph 
(c)(1)(i)(A) of this section);


or

    (F) Using the following general factors for caloric value of sugar 
alcohols: Isomalt--2.0 calories per gram, lactitol--2.0 calories per 
gram, xylitol--2.4 calories per gram, maltitol--2.1 calories per gram, 
sorbitol--2.6 calories per gram, hydrogenated starch hydrolysates--3.0 
calories per gram, and mannitol--1.6 calories per gram.
    (ii) ``Calories from saturated fat'' or ``Calories from saturated'' 
(VOLUNTARY): A statement of the caloric content derived from saturated 
fat as defined in paragraph (c)(2)(i) of this section in a serving may 
be declared voluntarily, expressed to the nearest 5-calorie increment, 
up to and including 50 calories, and the nearest 10-calorie increment 
above 50 calories, except that amounts less than 5 calories may be 
expressed as zero. This statement shall be indented under the statement 
of calories as provided in paragraph (d)(5) of this section.
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat in a serving defined as total lipid fatty acids and 
expressed as triglycerides where fatty acids are aliphatic carboxylic 
acids consisting of a chain of alkyl groups and characterized by a 
terminal carboxyl group. Amounts shall be expressed to the nearest 0.5 
(1/2) gram increment below 5 grams and to the nearest gram increment 
above 5 grams. If the serving contains less than 0.5 gram, the content 
shall be expressed as zero.
* * * * *
    (5) ``Fluoride'' (VOLUNTARY): A statement of the number of 
milligrams of fluoride in a specified serving of food may be declared 
voluntarily, except that when a claim is made about fluoride content, 
label declaration shall be required. Fluoride content shall be 
expressed as zero when the serving contains less than 0.1 milligrams of 
fluoride, to the nearest 0.1-milligram increment when the serving 
contains less than or equal to 0.8 milligrams of fluoride, and the 
nearest 0.2 milligram-increment when a serving contains more than 0.8 
milligrams of fluoride.
    (6) * * *
    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber in a serving, indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, declaration of 
dietary fiber is not required or, alternatively, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and 
if the serving contains less than 0.5 gram, the content may be 
expressed as zero. Dietary fiber is defined as non-digestible soluble 
and insoluble carbohydrates (with 3 or more monomeric units) and lignin 
that are intrinsic and intact in plants; isolated and synthetic non-
digestible carbohydrates (with 3 or more monomeric units) that FDA has 
granted be included in the definition of dietary fiber, in response to 
a petition submitted to FDA under Sec.  10.30 (21 CFR 10.30) 
demonstrating that such carbohydrates have a physiological effect(s) 
that is beneficial to human health; or isolated and synthetic non-
digestible carbohydrates (with 3 or more monomeric units) that are the 
subject of an authorized health claim. Except as provided for in 
paragraph (f) of this section, if dietary fiber content is not 
required, and as a result not declared, the statement ``Not a 
significant source of dietary fiber'' shall be placed at the bottom of 
the table of nutrient values in the same type size. Dietary fiber 
content may be determined by subtracting the amount of non-digestible 
carbohydrates added during processing that do not meet the definition 
of dietary fiber from the value obtained using AOAC 2009.01, AOAC 
2011.25, or an equivalent method of analysis as given in the ``Official 
Methods of Analysis of the AOAC International,'' 19th Ed. (2012), which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51 in paragraph (g)(2). The following isolated and synthetic 
non-digestible carbohydrate(s) have been determined by FDA to have 
physiological effects that are beneficial to human health and, 
therefore, shall be included in the calculation of the amount of 
dietary fiber: [beta]-glucan soluble fiber (as described in Sec.  
101.81(c)(2)(ii)(A)) and barley [beta]-fiber (as described in Sec.  
101.81(c)(2)(ii)(A)(6)). Manufacturers may submit a citizen petition in 
accordance with the requirements of Sec.  10.30 to request that FDA 
allow for the declaration of the gram amount of an isolated and 
synthetic non-digestible carbohydrate or a health claim petition in 
accordance with the requirements of Sec.  101.70 for an isolated and 
synthetic non-digestible carbohydrate. The manufacturer must make and 
keep records in accordance with paragraphs (g)(10) and (g)(11) of this 
section to verify the declared amount of dietary fiber in the label and 
labeling of food when a mixture of dietary fiber, and added non-
digestible carbohydrate(s) that does not meet the definition of dietary 
fiber, is present in the food.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber in a serving may be declared voluntarily 
except that when a claim is made on the label or in labeling about 
soluble fiber, label declaration shall be required. Soluble fiber must 
meet the definition of dietary fiber in this paragraph (c)(6)(i). 
Soluble fiber may be determined using AOAC 2011.25 or an equivalent 
method of analysis as given in the ``Official Methods of Analysis of 
the AOAC International,'' 19th Ed. (2012), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 in 
paragraph (g)(2). The manufacturer must make and keep records in 
accordance with paragraphs (g)(10) and (g)(11) of this section to 
verify the declared amount of soluble fiber in the label and labeling 
of food when a mixture of soluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food. Soluble fiber content shall be indented under 
dietary fiber and expressed to the nearest gram, except that if a 
serving contains less than 1 gram, the statement ``Contains less than 1 
gram'' or ``less than 1 gram'' may be used as an alternative, and if 
the serving contains less than 0.5 gram, the content may be expressed 
as zero.''
    (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of 
grams of insoluble dietary fiber in a serving may be declared 
voluntarily except that when a claim is made on the label or in 
labeling about insoluble fiber, label declaration shall be required. 
Insoluble fiber must meet the definition of dietary fiber in this 
paragraph (c)(6)(i). Insoluble fiber may be determined using AOAC 
2011.25 or an equivalent method of analysis as given in the ``Official 
Methods of Analysis of the AOAC International,'' 19th Ed. (2012), which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51 in paragraph (g)(2) of this section. The manufacturer must 
make and keep records in accordance with paragraphs (g)(10) and (g)(11) 
of this section to verify the declared amount of insoluble fiber in the 
label and labeling of food when a mixture of insoluble and added non-
digestible carbohydrate(s) that does not meet the definition of dietary 
fiber is present in the food. Insoluble fiber content shall be indented 
under dietary

[[Page 11969]]

fiber and expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero.''
* * * * *
    (iii) ``Added Sugars'': A statement of the number of grams of added 
sugars in a serving, except that label declaration of added sugars 
content is not required for products that contain less than 1 gram of 
added sugars in a serving if no claims are made about sweeteners, 
sugars, added sugars, or sugar alcohol content. If a statement of the 
added sugars content is not required and, as a result, not declared, 
the statement ``Not a significant source of added sugars'' shall be 
placed at the bottom of the table of nutrient values in the same type 
size. Added sugars shall be defined as sugars that are either added 
during the processing of foods, or are packaged as such, and include 
sugars (free, mono- and disaccharides), syrups, naturally occurring 
sugars that are isolated from a whole food and concentrated so that 
sugar is the primary component (e.g., fruit juice concentrates), and 
other caloric sweeteners. Added sugars content shall be indented under 
sugars and expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero. When a mixture of naturally occurring and added sugars is present 
in the food, and for specific foods containing added sugars, alone or 
in combination with naturally occurring sugars, where the added sugars 
are subject to fermentation, the manufacturer must make and keep 
records in accordance with paragraphs (g)(10) and (g)(11) of this 
section to verify the declared amount of added sugars in the label and 
labeling of food.
    (iv) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols in a serving may be declared voluntarily on the 
label, except that when a claim is made on the label or in labeling 
about sugar alcohol or sugars when sugar alcohols are present in the 
food, sugar alcohol content shall be declared. For nutrition labeling 
purposes, sugar alcohols are defined as the sum of saccharide 
derivatives in which a hydroxyl group replaces a ketone or aldehyde 
group and whose use in the food is listed by FDA (e.g., mannitol or 
xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu 
of the term ``sugar alcohol,'' the name of the specific sugar alcohol 
(e.g., ``xylitol'') present in the food may be used in the nutrition 
label provided that only one sugar alcohol is present in the food. 
Sugar alcohol content shall be indented and expressed to the nearest 
gram, except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the 
content may be expressed as zero.
    (7) ``Protein'': A statement of the number of grams of protein in a 
serving, expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero. When the protein in foods represented or purported to be for 
adults and children 4 or more years of age has a protein quality value 
that is a protein digestibility-corrected amino acid score of less than 
20 expressed as a percent, or when the protein in a food represented or 
purported to be for children greater than 1 but less than 4 years of 
age has a protein quality value that is a protein digestibility-
corrected amino acid score of less than 40 expressed as a percent, 
either of the following shall be placed adjacent to the declaration of 
protein content by weight: The statement ``not a significant source of 
protein,'' or a listing aligned under the column headed ``Percent Daily 
Value'' of the corrected amount of protein per serving, as determined 
in paragraph (c)(7)(ii) of this section, calculated as a percentage of 
the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as 
appropriate, for protein and expressed as a Percent of Daily Value. 
When the protein quality in a food as measured by the Protein 
Efficiency Ratio (PER) is less than 40 percent of the reference 
standard (casein) for a food represented or purported to be 
specifically for infants 7 through 12 months, the statement ``not a 
significant source of protein'' shall be placed adjacent to the 
declaration of protein content. Protein content may be calculated on 
the basis of the factor 6.25 times the nitrogen content of the food as 
determined by the appropriate method of analysis as given in the 
``Official Methods of Analysis of the AOAC International,'' 19th Ed. 
(2012), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51, except when the official procedure for a 
specific food requires another factor. Copies may be obtained from AOAC 
INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877, or may be inspected at the National Archives and Records 
Administration (NARA). For more information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (i) A statement of the corrected amount of protein per serving, as 
determined in paragraph (c)(7)(ii) of this section, calculated as a 
percentage of the RDI or DRV for protein, as appropriate, and expressed 
as Percent of Daily Value, may be placed on the label, except that such 
a statement shall be given if a protein claim is made for the product, 
or if the product is represented or purported to be specifically for 
infants 7 through 12 months or children 1 through 3 years of age. When 
such a declaration is provided, it should be placed on the label 
adjacent to the statement of grams of protein and aligned under the 
column headed ``Percent Daily Value,'' and expressed to the nearest 
whole percent. However, the percentage of the RDI for protein shall not 
be declared if the food is represented or purported to be specifically 
for infants 7 through 12 months and the protein quality value is less 
than 40 percent of the reference standard.
    (ii) The ``corrected amount of protein (gram) per serving'' for 
foods represented or purported for adults and children 1 or more years 
of age is equal to the actual amount of protein (gram) per serving 
multiplied by the amino acid score corrected for protein digestibility. 
If the corrected score is above 1.00, then it shall be set at 1.00. The 
protein digestibility-corrected amino acid score shall be determined by 
methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein Quality 
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation,'' Rome, 1991, except that when official AOAC 
procedures described in this paragraph (c)(7) require a specific food 
factor other than 6.25, that specific factor shall be used. The 
``Report of the Joint FAO/WHO Expert Consultation on Protein Quality 
Evaluation'' as published by the Food and Agriculture Organization of 
the United Nations/World Health Organization is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is 
available from the Office of Nutrition, Labeling, and Dietary 
Supplements (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug

[[Page 11970]]

Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may 
be inspected at the National Archives and Records Administration 
(NARA). For more information on the availability of this material at 
NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. For foods 
represented or purported to be specifically for infants 7 through 12 
months, the corrected amount of protein (grams) per serving is equal to 
the actual amount of protein (grams) per serving multiplied by the 
relative protein quality value. The relative protein quality value 
shall be determined by dividing the subject food protein PER value by 
the PER value for casein. If the relative protein value is above 1.00, 
it shall be set at 1.00.
    (iii) For the purpose of labeling with a percent of the DRV or RDI, 
a value of 50 grams of protein shall be the DRV for adults and children 
4 or more years of age, a value of 11 grams of protein shall be the RDI 
for infants 7 through 12 months, a value of 13 grams shall be the DRV 
for children 1 through 3 years of age, and a value of 71 grams of 
protein shall be the RDI for pregnant and lactating women.
    (8) Vitamins and minerals: A statement of the amount per serving of 
the vitamins and minerals as described in this paragraph, expressed as 
a quantitative amount by weight using the appropriate unit of measure 
provided in paragraph (c)(8)(iv) of this section and as a percent of 
Daily Value calculated as a percent of the RDI provided in paragraph 
(c)(8)(iv) of this section.
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d), (e), and (f) of this section, foods 
represented or purported to be specifically for infants 7 through 12 
months, children 1 through 3 years, and pregnant and lactating women 
shall use the RDIs that are specified for the intended group. For foods 
represented or purported to be specifically for both infants 7 through 
12 months and children 1 through 3 years of age, the percent of Daily 
Value shall be presented by separate declarations according to 
paragraph (e) of this section based on the RDI values for infants 7 
through 12 months and children 1 through 3 years of age. When such dual 
declaration is used on any label, it shall be included in all labeling, 
and equal prominence shall be given to both values in all such 
labeling. The percent Daily Value based on the RDI values for pregnant 
and lactating women shall be declared on food represented or purported 
to be specifically for pregnant and lactating women. All other foods 
shall use the RDI for adults and children 4 or more years of age.
    (ii) The declaration of vitamins and minerals as a quantitative 
amount by weight and percent of the RDI shall include vitamin D, 
calcium, iron, and potassium in that order, for infants 7 through 12 
months, children 1 through 3 years of age, pregnant and lactating 
women, and adults and children 4 or more years of age. The declaration 
of vitamins and minerals as a quantitative amount by weight and percent 
of the RDI shall include any of the other vitamins and minerals listed 
in paragraph (c)(8)(iv) of this section when they are added as a 
nutrient supplement, or when a claim is made about them. Other vitamins 
and minerals need not be declared if neither the nutrient nor the 
component is otherwise referred to on the label or the labeling or 
advertising and the vitamins and minerals are:
* * * * *
    (iii) The percentages for vitamins and minerals shall be expressed 
to the nearest 2-percent increment above 10 percent and up to and 
including the 50-percent level. Quantitative amounts and percentages of 
vitamins and minerals present at less than 2 percent of the RDI are not 
required to be declared in nutrition labeling but may be declared by a 
zero or by the use of an asterisk (or other symbol) that refers to 
another asterisk (or symbol) that is placed at the bottom of the table 
and that is followed by the statement ``Contains less than 2 percent of 
the Daily Value of this (these) nutrient (nutrients)'' or ``Contains < 
2 percent of the Daily Value of this (these) nutrient (nutrients).'' 
Alternatively, except as provided for in paragraph (f) of this section, 
if vitamin D, calcium, iron, or potassium is present in amounts less 
than 2 percent of the RDI, label declaration of the nutrient(s) is not 
required if the statement ``Not a significant source of ---- (listing 
the vitamins or minerals omitted)'' is placed at the bottom of the 
table of nutrient values. Either statement shall be in the same type 
size as nutrients that are indented. The quantitative amounts of 
vitamins and minerals, excluding sodium, shall be the amount of the 
vitamin or mineral included in one serving of the product, using the 
units of measurement and the levels of significance given in paragraph 
(c)(8)(iv) of this section, except that zeros following decimal points 
may be dropped, and additional levels of significance may be used when 
the number of decimal places indicated is not sufficient to express 
lower amounts (e.g., the RDI for zinc is given in whole milligrams, but 
the quantitative amount may be declared in tenths of a milligram).
    (iv) The following RDIs, nomenclature, and units of measure are 
established for the following vitamins and minerals which are essential 
in human nutrition:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      RDI
                                                                                     -------------------------------------------------------------------
                    Nutrient                                Unit of measure              Adults and       Infants 7
                                                                                       children >= 4      through 12       Children 1      Pregnant and
                                                                                           years            months      through 3 years  lactating women
--------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin A.......................................  Micrograms RAE \1\ (mcg)..........            900              500              300            1,300
Vitamin C.......................................  Milligrams (mg)...................             90               50               15              120
Calcium.........................................  Milligrams (mg)...................          1,300              260              700            1,300
Iron............................................  Milligrams (mg)...................             18               11                7               27
Vitamin D.......................................  Micrograms (mcg)..................             20               10               15               15
Vitamin E.......................................  Milligrams (mg)...................             15                5                6               19
Vitamin K.......................................  Micrograms (mcg)..................            120                2.5             30               90
Thiamin.........................................  Milligrams (mg)...................              1.2              0.3              0.5              1.4
Riboflavin......................................  Milligrams (mg)...................              1.3              0.4              0.5              1.6
Niacin..........................................  Milligrams NE \2\ (mg)............             16                4                6               18
Vitamin B6......................................  Milligrams (mg)...................              1.7              0.3              0.5              2.0
Folate \3\......................................  Micrograms DFE \4\ (mcg)..........            400               80              150              600
Vitamin B12.....................................  Micrograms (mcg)..................              2.4              0.5              0.9              2.8
Biotin..........................................  Micrograms (mcg)..................             30                6                8               35
Pantothenic acid................................  Milligrams (mg)...................              5                1.8              2                7

[[Page 11971]]

 
Phosphorous.....................................  Milligrams (mg)...................          1,250              275              460            1,250
Iodine..........................................  Micrograms (mcg)..................            150              130               90              290
Magnesium.......................................  Milligrams (mg)...................            420               75               80              400
Zinc............................................  Milligrams (mg)...................             11                3                3               13
Selenium........................................  Micrograms (mcg)..................             55               20               20               70
Copper..........................................  Milligrams (mg)...................              0.9              0.2              0.3              1.3
Manganese.......................................  Milligrams (mg)...................              2.3              0.6              1.2              2.6
Chromium........................................  Micrograms (mcg)..................             35                5.5             11               45
Molybdenum......................................  Micrograms (mcg)..................             45                3               17               50
Chloride........................................  Milligrams (mg)...................          2,300              570             1500             2300
Potassium.......................................  Milligrams (mg)...................          4,700              700             3000             5100
Choline.........................................  Milligrams (mg)...................            550              150              200              550
Protein.........................................  Grams (g).........................            N/A               11              N/A           \5\ 71
--------------------------------------------------------------------------------------------------------------------------------------------------------
A percent daily value must be declared on the label for bolded nutrients.
\1\ RAE = Retinol activity equivalents; 1 RAE = 1 microgram retinol, 12 micrograms [beta]-carotene, or 24 micrograms [alpha]-carotene, or 24 micrograms
  [beta]-cryptoxanthin.
\2\ NE = Niacin equivalents, 1 milligram niacin = 60 milligrams of tryptophan.
\3\ ``Folic Acid'' must be used for purposes of declaration in the labeling of dietary supplements. It must also be declared in mcg DFE.
\4\ DFE = Dietary folate equivalents; 1 DFE = 1 microgram food folate = 0.6 micrograms folic acid from fortified food or as a supplement consumed with
  food = 0.5 micrograms of a supplement.
\5\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant and lactating women.

    (v) The following synonyms may be added in parentheses immediately 
following the name of the nutrient or dietary component:

Calories--Energy
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
* * * * *
    (vii) When the amount of folate is declared in the labeling of a 
conventional food, the nutrient name ``folate'' shall be listed for 
products containing either folate alone or a mixture of folate and 
folic acid. The name of the synthetic form of the nutrient, ``folic 
acid'' shall be used when the nutrient is declared in the labeling of 
dietary supplements.
    (9) The following DRVs, nomenclature, and units of measure are 
established for the following food components:

----------------------------------------------------------------------------------------------------------------
                                                                                DRV
                                                 ---------------------------------------------------------------
        Food component               Unit of        Adults and       Infants 7      Children 1     Pregnant and
                                   measurement     children >= 4    through 12       through 3       lactating
                                                       years          months           years           women
----------------------------------------------------------------------------------------------------------------
Fat...........................  Grams (g).......          \1\ 65              30          \2\ 39          \1\ 65
Saturated fatty acids.........  Grams (g).......          \1\ 20             N/A          \2\ 10          \1\ 20
Cholesterol...................  Milligrams (mg).             300             N/A             300             300
Total carbohydrate............  Grams (g).......         \1\ 300              95         \2\ 150         \1\ 300
Sodium........................  Milligrams (mg).           2,300             N/A           1,500           2,300
Dietary fiber.................  Grams (g).......          \1\ 28             N/A          \2\ 14          \1\ 28
Protein.......................  Grams (g).......          \1\ 50             N/A          \2\ 13             N/A
----------------------------------------------------------------------------------------------------------------
\1\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  for pregnant and lactating women
\2\ Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on foods in the following format, as shown 
in paragraph (d)(12) of this section, except on foods where the tabular 
display is permitted as provided for in paragraph (d)(11) of this 
section, on which dual columns of nutrition information are declared as 
provided for in paragraph (e) of this section, on those food products 
on which the simplified format is required to be used as provided for 
in paragraph (f) of this section, on foods for infants 7 months to 12 
months of age and children 1 through 3 years of age as provided for in 
paragraph (j)(5) of this section, and on foods in small or 
intermediate-sized packages as provided for in paragraph (j)(13) of 
this section. In the interest of uniformity of presentation, FDA 
strongly recommends that the nutrition information be presented using 
the graphic specifications set forth in appendix B to part 101.
* * * * *
    (ii) * * *
    (C) At least nine points leading (i.e., space between two lines of 
text) except that at least 12 points leading shall be utilized for the 
information required by paragraphs (d)(7) and (d)(8) of this section as 
shown in paragraph (d)(12), and
* * * * *
    (iii) Information required in paragraphs (d)(7) and (d)(8) of this 
section shall be in type size no smaller than 8 point, except the type 
size for this information required in the linear display for small 
packages as shown in paragraph (j)(13)(ii)(A)(2) of this section shall 
be no smaller than 7 point. Information required in the footnote 
statement shall be no smaller than 7 point, except the type size for 
this information required in the tabular display for small packages as 
shown in paragraph (j)(13)(ii)(A)(1) of this section, for the linear 
display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of 
this section, and for the simplified format as shown in paragraph 
(f)(5) of

[[Page 11972]]

this section shall be no smaller than 6 point. Information required in 
paragraph (d)(5) of this section for the ``Calories'' declaration shall 
be highlighted in bold or extra bold and shall be in a type size no 
smaller than 16 point except the type size for this information 
required in the tabular display for small packages as shown in 
paragraph (j)(13)(ii)(A)(1) of this section, the linear display for 
small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, 
and the required information shown in paragraphs (d)(11)(iii) and 
(e)(6)(ii) of this section shall be in a type size no smaller than 12 
point. The numeric amount for the information required in paragraph 
(d)(5) of this section shall also be highlighted in bold or extra bold 
type and shall be in a type size no smaller than 24 point, except the 
type size for this information required in the tabular display for 
small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section, 
the linear display for small packages as shown in paragraph 
(j)(13)(ii)(A)(2) of this section, and for the required information 
shown in paragraph (e)(6)(ii) of this section shall be in a type size 
no smaller than 20 point. The information required in paragraph (d)(6) 
of this section shall be in a type size no smaller than 7 point. When 
provided, the information described in paragraph (d)(10) of this 
section shall be in a type size no smaller than 6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(3)(i), and 
(d)(6) of this section (i.e., ``Nutrition Facts,'' ``----servings per 
container,'' and ``% DV*''), the calorie information, and the names of 
all nutrients that are not indented according to requirements of 
paragraph (c) of this section (i.e., ``Calories,'' ``Total Fat,'' 
``Cholesterol,'' ``Sodium,'' ``Total Carbs'' and ``Protein''), and the 
percentage amounts required by paragraph (d)(7)(ii) of this section 
shall be highlighted in bold or extra bold type or other highlighting 
(reverse printing is not permitted as a form of highlighting) that 
prominently distinguishes it from other information. The names of all 
nutrients that are indented according to the requirements of paragraph 
(c) of this section (i.e., ``Saturated Fat,'' ``Trans Fat,'' ``Dietary 
Fiber,'' ``Sugars,'' and ``Added Sugars'') and the mandatory and any 
voluntary vitamins and minerals (except sodium), shall be highlighted 
in a type that is intermediate between bold or extra bold type and the 
type for all other information.
    (v) A hairline rule that is centered between the lines of text 
shall separate ``Nutrition Facts'' from the servings per container 
statement required in paragraph (d)(3)(i) of this section and shall 
separate each nutrient and its corresponding percent Daily Value 
required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from 
the nutrient and percent Daily Value above and below it, as shown in 
paragraph (d)(12) of this section.
    (2) The information shall be presented under the identifying 
heading of ``Nutrition Facts'' in the nutrition label and, except for 
labels presented according to the format provided for in paragraphs 
(d)(11)(iii), (d)(13)(ii), (e)(6)(ii), (j)(13)(ii)(A)(1), and 
(j)(13)(ii)(A)(2) of this section, unless impractical, shall be set the 
full width of the information provided under paragraph (d)(7) of this 
section, as shown in paragraph (d)(12) of this section.
    (3) * * *
    (i) ``----servings per container'': The number of servings per 
container, except that this statement is not required on single serving 
containers as defined in paragraph (b)(6) of this section or on other 
food containers when this information is stated in the net quantity of 
contents declaration. The information required in this paragraph shall 
be highlighted in bold or extra bold and be in a type size no smaller 
than 11 point except the type size shall be no smaller than 10 point 
for this information as shown in paragraph (j)(13)(ii)(A)(1) and no 
smaller than 7 point as shown in paragraph (j)(13)(ii)(A)(2) of this 
section. This information shall be set the full width of the label as 
shown in paragraph (d)(12) of this section.
    (ii) ``Serving size'': A statement of the serving size as specified 
in paragraph (b)(7) of this section. The serving size as specified in 
paragraph (b)(7) of this section must be right justified as shown in 
paragraph (d)(12) of this section. The information required in this 
paragraph shall be in a type size no smaller than 8 point except the 
type size shall be no smaller than 7 point for this information as 
shown in paragraph (j)(13)(ii)(A)(2) of this section.
    (4) A subheading ``Amount per'' followed by the serving size shall 
be separated from the serving size information by a bar as shown in 
paragraph (d)(12) of this section and shall be highlighted in a type 
that is intermediate between bold or extra bold type and the type for 
all other information, and be in a type size no smaller than 8 point, 
except the type size for this information required in the linear 
display for small packages as shown in paragraph (j)(13)(ii)(A)(2) and 
the tabular display for small packages as shown in paragraph 
(j)(13)(ii)(A)(1) of this section shall be no smaller than 6 point, and 
there shall be no bar separating this information from the serving size 
information in both of these displays for small packages.
    (5) Information on calories shall immediately follow the heading 
``Amount per'' followed by the serving size and shall be declared in 
one line. If ``Calories from saturated fat'' is declared, it shall be 
indented under ``Calories'' and shall be in a type size no smaller than 
8 point.
    (6) The column heading ``% DV,'' followed by an asterisk (e.g., ``% 
DV*''), shall be separated from information on calories by a bar as 
shown in paragraph (d)(12) of this section. The position of this column 
heading shall allow for a list of nutrient names and amounts as 
described in paragraph (d)(7) of this section to be to the right of, 
and below, this column heading, except for labels with a dual or 
multiple column format as shown in paragraphs (d)(13)(ii), (e)(5), 
(e)(6)(i), and (e)(6)(ii) the ``% DV'' column will appear to the right 
of the list of nutrient names. The column heading described in this 
paragraph shall not appear on the linear display for small packages as 
shown in paragraph (j)(13)(ii)(A)(2) of this section.
    (7) Except as provided for in paragraphs (d)(13)(ii), (e)(5), 
(e)(6)(i), (e)(6)(ii), and (j)(13) of this section, nutrient 
information for both mandatory and any voluntary nutrients listed in 
paragraph (c) of this section that are to be declared in the nutrition 
label shall be declared as follows:
    (i) The name of each nutrient, as specified in paragraph (c) of 
this section, shall be given in a column and followed immediately by 
the quantitative amount by weight for that nutrient appended with a 
``g'' for grams, ``mg'' for milligrams, or ``mcg'' for micrograms as 
shown in paragraph (d)(12) of this section. The symbol ``>'' may be 
used in place of ``less than.''
    (ii) A listing of the percent of the DRV as established in 
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a 
column aligned under the heading ``% DV'' established in paragraph 
(d)(6) of this section with the percent expressed to the nearest whole 
percent for each nutrient declared in the column described in paragraph 
(d)(7)(i) of this section for which a DRV has been established, except 
that the percent for protein may be omitted as provided in paragraph 
(c)(7) of this section. The percent shall be calculated by dividing 
either the amount declared on the label for each nutrient or the actual 
amount of each nutrient (i.e., before rounding) by the DRV for the 
nutrient, except that the percent for protein shall be

[[Page 11973]]

calculated as specified in paragraph (c)(7)(ii) of this section. The 
numerical value shall be followed by the symbol for percent (i.e., %).
    (8) Nutrient information for vitamins and minerals (except sodium) 
shall be separated from information on other nutrients by a bar and may 
be arrayed vertically as shown in paragraph (d)(12) of this section 
(e.g., Vitamin D 2mcg (10%), Calcium 260mg (20%), Iron 8mg (45%), 
Potassium 235mg (5%)) or may be listed in two columns. When listed 
horizontally in two columns, vitamin D and calcium should be listed on 
the first line and iron and potassium should be listed on the second 
line.
    (9) [Reserved]
    (10) Caloric conversion information on a per gram basis for fat, 
carbohydrate, and protein may be presented beneath the information 
required in the footnote statement, separated from that information by 
a hairline. This information may be presented horizontally as shown in 
paragraph (d)(12) of this section (i.e. ``Calories per gram: fat 9, 
carbohydrate 4, protein 4'') or vertically in columns.
    (11)(i) If the space beneath the information on vitamins and 
minerals is not adequate to accommodate the information required in the 
footnote statement, the information required in the footnote statement 
may be moved to the right of the column required in paragraph 
(d)(7)(ii) of this section and set off by a line that distinguishes it 
and sets it apart from the percent Daily Value information. The caloric 
conversion information provided for in paragraph (d)(10) of this 
section may be presented beneath either side or along the full length 
of the nutrition label.
    (ii) If the space beneath the mandatory declaration of potassium is 
not adequate to accommodate any remaining vitamins and minerals to be 
declared or the information required in the footnote statement, the 
remaining information may be moved to the right and set off by a line 
that distinguishes it and sets it apart from the nutrients and the 
percent DV information given to the left. The caloric conversion 
information provided for in paragraph (d)(10) of this section may be 
presented beneath either side or along the full length of the nutrition 
label.
    (iii) If there is not sufficient continuous vertical space (i.e., 
approximately 3 in) to accommodate the required components of the 
nutrition label up to and including the mandatory declaration of 
potassium, the nutrition label may be presented in a tabular display as 
shown in the following sample label.
[GRAPHIC] [TIFF OMITTED] TP03MR14.003

    (12) The following sample labels illustrate the mandatory 
provisions and mandatory plus voluntary provisions of paragraph (d) of 
this section.

[[Page 11974]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.004

    (13) * * *
    (ii) Aggregate displays shall comply with the format requirements 
of paragraph (d) of this section to the maximum extent possible, except 
that the identity of each food shall be specified immediately to the 
right of the ``Nutrition Facts'' heading, and both the quantitative 
amount by weight (i.e., g/mg/mcg amounts) and the percent Daily Value 
for each nutrient shall be listed in separate columns under the name of 
each food. The following sample label illustrates an aggregate display.

[[Page 11975]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.005

* * * * *
    (e) Nutrition information may be presented for two or more forms of 
the same food (e.g., both ``as purchased'' and ``as prepared'') or for 
common combinations of food as provided for in paragraph (h)(4) of this 
section, for different units (e.g., slices of bread or per 100 grams) 
as provided for in paragraph (b) of this section, or for two or more 
groups for which RDIs are established (e.g., both infants 7 through 12 
months and children 1 through 3 years of age) as shown in paragraph 
(e)(5) of this section. When such dual labeling is provided, equal 
prominence shall be given to both sets of values. Information shall be 
presented in a format consistent with paragraph (d) of this section, 
except that:
    (1) Following the serving size information there shall be two or 
more column headings accurately describing the amount per serving size 
of the form of the same food (e.g., ``Per \1/4\ cup mix'' and ``Per 
prepared portion''), the combinations of food, the units, or the RDI 
groups that are being declared as shown in paragraph (e)(5) of this 
section.
    (2) The information required in paragraph (d)(7)(ii) and the 
quantitative information by weight as required in paragraph (d)(7)(i) 
of this section shall be presented for the form of the product as 
packaged and for any other form of the product (e.g., ``as prepared'' 
or combined with another ingredient as shown in paragraph (e)(5) of 
this section).
    (3) When the dual labeling is presented for two or more forms of 
the same food, for combinations of food, for different units, or for 
two or more groups for which RDIs are established, the percent DV and 
quantitative information shall be separated by vertical lines as shown 
in paragraph (e)(5) of this section.
    (4) Nutrient information for vitamins and minerals (except sodium) 
shall be separated from information on other nutrients by a bar and 
shall be arrayed vertically in the following order: Vitamin D, calcium, 
iron, potassium as shown in paragraph (e)(5) of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:
[GRAPHIC] [TIFF OMITTED] TP03MR14.006

    (6) When dual labeling is presented for a food on a per serving 
basis and per container basis as required in paragraph (b)(12)(i) of 
this section or on a per serving basis and per unit basis as required 
in paragraph (b)(2)(i)(D) of this section, the percent Daily Value as 
required in paragraph (d)(7)(ii) and the quantitative information by 
weight shall be presented in two columns, and the percent DV and 
quantitative information shall be separated by vertical lines as

[[Page 11976]]

shown in the displays in paragraph (e)(6)(i) of this section.
    (i) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed vertically in the following order: Vitamin D, calcium, iron, 
and potassium as shown in the following sample labels.
[GRAPHIC] [TIFF OMITTED] TP03MR14.007

    (ii) The following sample label illustrates the provisions of 
paragraphs (b)(2)(i)(D) and (b)(12)(i) of this section for labels that 
use the tabular display.
[GRAPHIC] [TIFF OMITTED] TP03MR14.008

    (f) The declaration of nutrition information may be presented in 
the simplified format set forth herein when a food product contains 
insignificant amounts of eight or more of the following: Calories, 
total fat, saturated fat, trans fat, cholesterol, sodium, total 
carbohydrate, dietary fiber, sugars, added sugars, protein, vitamin D, 
calcium, iron, and potassium; except that for foods intended for 
infants 7 months to 12 months of age and children 1 through 3 years of 
age to which paragraph (j)(5)(i) of this section applies, nutrition 
information may be presented in the simplified format when a food 
product contains insignificant amounts of six or more of the following: 
Calories, total fat, sodium, total carbohydrate, dietary fiber, sugars, 
added sugars, protein, vitamin D, calcium, iron, and potassium.
* * * * *
    (2) * * *
    (ii) Any other nutrients identified in paragraph (f) of this 
section that are present in the food in more than insignificant 
amounts; and
* * * * *
    (4) If any nutrients are declared as provided in paragraphs 
(f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the 
simplified format or if any nutrition claims are made on the label or 
in labeling, the statement ``Not a significant source of ------'' (with 
the blank filled in with the name(s) of any nutrient(s) identified in 
paragraph (f) of this section that are present in insignificant 
amounts) shall be included at the bottom of the nutrition label.

[[Page 11977]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.009

    (5) Except as provided for in paragraphs (j)(5) and (j)(13) of this 
section, nutrient information declared in the simplified format shall 
be presented in the same manner as specified in paragraphs (d) or (e) 
of this section.
    (g) Compliance with this section shall be determined as follows:
* * * * *
    (2) The sample for nutrient analysis shall consist of a composite 
of 12 subsamples (consumer units), taken 1 from each of 12 different 
randomly chosen shipping cases, to be representative of a lot. Unless a 
particular method of analysis is specified in paragraph (c) of this 
section, composites shall be analyzed by appropriate methods as given 
in the ``Official Methods of Analysis of the AOAC International,'' 19th 
Ed. (2012), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) or 1 CFR part 51 or, if no AOAC method is available or 
appropriate, by other reliable and appropriate analytical procedures. 
The availability of this incorporation by reference is given in 
paragraph (c)(7) of this section.
    (3) * * *
    (ii) Class II. Naturally occurring (indigenous) nutrients. When a 
nutrient or nutrients are naturally occurring (indigenous) in an 
ingredient that is added to a food, the total amount of such 
nutrient(s) in the final food product is subject to class II 
requirements, except that when a nutrient or nutrients are not 
naturally occurring (exogenous) in an ingredient that is added to a 
food, the total amount of such nutrient(s) in the final food product is 
subject to class I requirements.
    (4) A food with a label declaration of a vitamin, mineral, protein, 
total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, 
polyunsaturated or monounsaturated fat shall be deemed to be misbranded 
under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) unless it meets the following requirements:
    (i) When a vitamin, mineral, protein, or non-digestible 
carbohydrate(s) (when the food contains only non-digestible 
carbohydrates (soluble or insoluble) that meet the definition of 
dietary fiber) meets the definition of a Class I nutrient, the nutrient 
content of the composite must be formulated to be at least equal to the 
value for that nutrient declared on the label.
    (ii) When a vitamin, mineral, protein, total carbohydrate, 
polyunsaturated or monounsaturated fat, or non-digestible 
carbohydrate(s) (when the food contains only non-digestible 
carbohydrates (soluble or insoluble) that meet the definition of 
dietary fiber) meets the definition of a Class II nutrient, the 
nutrient content of the composite must be at least equal to 80 percent 
of the value for that nutrient declared on the label. No regulatory 
action will be based on a determination of a nutrient value that falls 
below this level by a factor less than the variability generally 
recognized for the analytical method used in that food at the level 
involved.
    (5) A food with a label declaration of calories, sugars, added 
sugars (when the only source of sugars in the food is added sugars), 
total fat, saturated fat, trans fat, cholesterol, or sodium shall be 
deemed to be misbranded under section 403(a) of the act if the nutrient 
content of the composite is greater than 20 percent in excess of the 
value for that nutrient declared on the label. No regulatory action 
will be based on a determination of a nutrient value that falls above 
this level by a factor less than the variability generally recognized 
for the analytical method used in that food at the level involved.
    (6) Reasonable excesses of vitamins, minerals, protein, total 
carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugar 
alcohols, polyunsaturated or monounsaturated fat over labeled amounts 
are acceptable within current good manufacturing practice. Reasonable 
deficiencies of calories, sugars, added sugars, total fat, saturated 
fat, trans fat, cholesterol, or sodium under labeled amounts are 
acceptable within current good manufacturing practice.
    (7) Compliance will be based on the metric measure specified in the 
label statement of the serving size.
    (8) Alternatively, compliance with the provisions set forth in 
paragraphs (g)(1) through (g)(6) of this section may be provided by use 
of an FDA approved database that has been computed following FDA 
guideline procedures and where food samples have been handled in 
accordance with current good manufacturing practice to prevent 
nutrition loss. FDA approval of a database shall not be considered 
granted until the Center for Food Safety and Applied Nutrition has 
agreed to all aspects of the database in writing. The approval will be 
granted where a clear need is presented (e.g., raw produce and 
seafood). Approvals will be in effect for a limited time, e.g., 10 
years, and will be eligible for renewal in the absence of significant 
changes in agricultural or industry practices. Approval requests shall 
be submitted in accordance with the provisions of Sec.  10.30 of this 
chapter. Guidance in the use of databases may be found in the ``FDA 
Nutrition Labeling Manual--A Guide for Developing and Using Data 
Bases,'' available from the Office of Nutrition, Labeling, and Dietary 
Supplements (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740 or by going to http://www.fda.gov.
* * * * *
    (10) The manufacturer must make and keep written records (e.g., 
analyses of databases, recipes, formulations, or batch records) to 
verify the declared amount of that nutrient on the Nutrition Facts 
label as follows:
    (i) When a mixture of dietary fiber, and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber, is 
present in the food, a manufacturer must make and keep written records 
of the amount of non-digestible carbohydrate(s) added to the food that 
does not meet the definition of dietary fiber.
    (ii) When a mixture of soluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food, a manufacturer must make and keep written records 
necessary to verify the amount of the non-digestible carbohydrate(s) 
added to the food that does not meet the definition of dietary fiber.
    (iii) When a mixture of insoluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food, a manufacturer must make and keep written records 
necessary to verify the amount of the non-digestible carbohydrate(s) 
added to the food that does not meet the definition of dietary fiber.
    (iv) When a mixture of naturally occurring and added sugars is 
present in

[[Page 11978]]

the food, a manufacturer must make and keep written records of the 
amount of added sugars added to the food during the processing of the 
food, and if packaged as a separate ingredient, as packaged (whether as 
part of a package containing one or more ingredients or packaged as a 
single ingredient).
    (v) When the amount of added sugars added to yeast-leavened bakery 
products, wines with less than 7 percent alcohol by volume, or beer 
that does not meet the definition of a ``malt beverage,'' as defined by 
the Federal Alcohol Administration Act (27 U.S.C. 211(a)(7)), is 
reduced through the process of fermentation, manufacturers must:
    (A) Make and keep records of all relevant scientific data and 
information relied upon by the manufacturer that demonstrates the 
amount of added sugars in the food after fermentation and a narrative 
explaining why the data and information are sufficient to demonstrate 
the amount of added sugars declared in the finished food, provided the 
data and information used is specific to the type of fermented food 
manufactured; or
    (B) Make and keep records of the amount of added sugars added to 
the food before and during the processing of the food, and if packaged 
as a separate ingredient, as packaged (whether as part of a package 
containing one or more ingredients or packaged as a single ingredient) 
and in no event shall the amount of added sugars declared exceed the 
amount of total sugars on the label.
    (vi) When a mixture of all rac-[alpha]-tocopherol acetate and RRR-
[alpha]-tocopherol is present in a food, manufacturers must make and 
keep written records of the amount of all rac-[alpha]-tocopherol 
acetate added to the food and RRR-[alpha]-tocopherol in the finished 
food.
    (vii) When a mixture of folate and folic acid is present in a food, 
manufacturers must make and keep written records of the amount of folic 
acid added to the food and folate in the finished food.
    (11) Records necessary to verify certain nutrient declarations that 
are specified in paragraph (g)(10) of this section must be kept for a 
period of at least 2 years after introduction or delivery for 
introduction of the food into interstate commerce. Such records must be 
provided to FDA upon request, during an inspection, for official review 
and photocopying or other means of reproduction. Records required to 
verify information on the label may be kept either as original records, 
true copies (such as photocopies, pictures, scanned copies, microfilm, 
microfiche, or other accurate reproductions of the original records), 
or electronic records which must be kept in accordance with part 11 of 
this chapter. These records must be accurate, indelible, and legible. 
Failure to make and keep the records or provide the records to 
appropriate regulatory authorities, as required by this subparagraph, 
would result in the food being misbranded under section 403(a)(1) of 
the act.
    (h) * * *
    (3) * * *
    (iv) Nutrition information may be provided per serving for 
individual foods in the package, or, alternatively, as a composite per 
serving for reasonable categories of foods in the package having 
similar dietary uses and similar significant nutritional 
characteristics. Reasonable categories of foods may be used only if 
accepted by FDA. In determining whether a proposed category is 
reasonable, FDA will consider whether the values of the characterizing 
nutrients in the foods proposed to be in the category meet the 
compliance criteria set forth in paragraphs (g)(3) through (g)(6) of 
this section. Proposals for such categories may be submitted in writing 
to the Office of Nutrition, Labeling and Dietary Supplements (HFS-800), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
* * * * *
    (4) If a food is commonly combined with other ingredients or is 
cooked or otherwise prepared before eating, and directions for such 
combination or preparations are provided, another column of figures may 
be used to declare nutrition information on the basis of the food as 
consumed in the format required in paragraph (e) of this section; e.g., 
a dry ready-to-eat cereal may be described with the percent Daily Value 
and the quantitative amounts for the cereal as sold (e.g., per ounce), 
and the percent Daily Value and the quantitative amounts for the cereal 
and milk as suggested in the label (e.g., per ounce of cereal and \1/2\ 
cup of vitamin D fortified skim milk); and a cake mix may be labeled 
with the percent Daily Value and the quantitative amounts for the dry 
mix (per serving) and the percent Daily Value and the quantitative 
amounts for the serving of the final cake when prepared, as shown in 
paragraph (e)(5): Provided, that, the type and quantity of the other 
ingredients to be added to the product by the user and the specific 
method of cooking and other preparation shall be specified prominently 
on the label.
* * * * *
    (j) * * *
    (5)(i) Foods, other than infant formula, represented or purported 
to be specifically for infants 7 through 12 months and children 1 
through 3 years of age shall bear nutrition labeling. The nutrients 
declared for infants 7 through 12 months and children 1 through 3 years 
of age shall include calories, total fat, saturated fat, trans fat, 
cholesterol, sodium, total carbohydrates, dietary fiber, sugars, added 
sugars, protein, and the following vitamins and minerals: Vitamin D, 
calcium, iron, and potassium.
[GRAPHIC] [TIFF OMITTED] TP03MR14.010

    (ii) Foods other than infant formula, represented or purported to 
be specifically for infants 7 through 12 months of age shall bear 
nutrition labeling, except that:
    (A) Such labeling shall not declare a percent Daily Value for 
saturated fat, trans fat, cholesterol, sodium, dietary fiber, sugars, 
or added sugars.
* * * * *
    (13) * * *
    (ii) * * *
    (A) * * *.
    (1) The following sample label illustrates the tabular display for 
small packages.

[[Page 11979]]

[GRAPHIC] [TIFF OMITTED] TP03MR14.011

    (2) The following sample label illustrates the linear display.
    [GRAPHIC] [TIFF OMITTED] TP03MR14.012
    
    (B) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carbs
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc

    (C) Omitting the footnote statement and placing another asterisk at 
the bottom of the label followed by the statement ``Percent Daily 
Values are based on a 2,000 calorie diet.''
* * * * *
    (18) * * *
    (iv) A notice shall be filed with the Office of Nutrition, 
Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740 and contain the following information, 
except that if the person is not an importer and has fewer than 10 
full-time equivalent employees, that person does not have to file a 
notice for any food product with annual sales of fewer than 10,000 
total units:
* * * * *
0
3. In Sec.  101.36:
0
a. Revise paragraphs (b)(1)(i), (b)(2)(i) introductory text, 
(b)(2)(i)(B), (b)(2)(ii)(A), (b)(2)(iii) introductory text, 
(b)(2)(iii)(D) through (G), (b)(3)(ii)(A), (c)(4), (e) introductory 
text, (e)(8), (e)(11)(i) through (viii), (e)(12), (f)(2), and (i)(1); 
and
0
b. Remove paragraph (i) introductory text.
    The revisions read as follows:


Sec.  101.36  Nutrition labeling of dietary supplements.

* * * * *
    (b) * * *
    (1) Serving size. (i) The subheading ``Serving Size'' shall be 
placed under the heading ``Supplement Facts'' and aligned on the left 
side of the nutrition label. The subheading ``Servings Per Container'' 
and the actual number of servings shall be highlighted in bold or extra 
bold type. The serving size shall be determined in accordance with 
Sec. Sec.  101.9(b) and 101.12(b), table 2. Serving size for dietary 
supplements shall be expressed using a term that is appropriate for the 
form of the supplement, such as ``tablets,'' ``capsules,'' ``packets,'' 
or ``teaspoonfuls.''
* * * * *
    (2) * * * (i) The (b)(2)-dietary ingredients to be declared, that 
is, total calories, total fat, saturated fat, trans fat, cholesterol, 
sodium, total carbohydrate, dietary fiber, sugars, added sugars, 
protein, vitamin D, calcium, iron, and potassium, shall be declared 
when they are present in a dietary supplement in quantitative amounts 
by weight that exceed the amount that can be declared as zero in 
nutrition labeling of foods in accordance with Sec.  101.9(c). Calories 
from saturated fat, polyunsaturated fat, monounsaturated fat, soluble 
fiber, insoluble fiber, and sugar alcohol may be declared, but they 
shall be declared when a claim is made about them. Any (b)(2)-dietary 
ingredients that are not present, or that are present in amounts that 
can be declared as zero in Sec.  101.9(c), shall not be declared (e.g., 
amounts corresponding to less than 2 percent of the RDI for vitamins 
and minerals). Protein shall not be declared on labels of products 
that, other than ingredients added solely for technological reasons, 
contain only individual amino acids.
* * * * *
    (B) The names of dietary ingredients that are declared under 
paragraph (b)(2)(i) of this section shall be presented in a column 
aligned on the left side of the nutritional label in the order and 
manner of indentation specified in Sec.  101.9(c), except that calcium 
and iron shall follow pantothenic acid, and sodium and potassium shall 
follow chloride. This results in the following order for vitamins and 
minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, 
thiamin, riboflavin, niacin, vitamin B6, folic acid, vitamin 
B12, biotin, pantothenic acid, calcium, iron, phosphorous, 
iodine, magnesium, zinc, selenium, copper, manganese, chromium, 
molybdenum, chloride, sodium, potassium, and choline. The (b)(2)-
dietary ingredients shall be listed according to the nomenclature 
specified in Sec.  101.9 or in paragraph (b)(2)(i)(B)(2) of this 
section.
    (1) When ``Calories'' are declared, they shall be listed first in 
the column of names, beneath a light bar separating the heading 
``Amount Per Serving'' from the list of names. When ``Calories from 
saturated fat'' are declared, they shall be indented under 
``Calories.''
    (2) The following synonyms may be added in parentheses immediately 
following the name of these (b)(2)-dietary ingredients: Vitamin C 
(ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin 
B2), and calories (energy). Energy content per serving may 
be expressed in kilojoule units, added in parentheses immediately 
following the statement of caloric content.
    (3) Beta-carotene may be declared as the percent of vitamin A that 
is present as beta-carotene, except that the

[[Page 11980]]

declaration is required when a claim is made about beta-carotene. When 
declared, the percent shall be declared to the nearest whole percent, 
immediately adjacent to or beneath the name vitamin A (e.g., ``Vitamin 
A (90% as beta-carotene)''). The amount of beta-carotene in terms of 
micrograms (mcg) may be included in the parentheses following the 
percent statement (e.g., ``Vitamin A (90% (810 mcg) as beta-
carotene)'').
    (ii) * * *
    (A) The amounts shall be expressed in the increments specified in 
Sec.  101.9(c)(1) through (c)(7), which includes increments for sodium.
* * * * *
    (iii) The percent of the Daily Value of all dietary ingredients 
declared under paragraph (b)(2)(i) of this section shall be listed, 
except that the percent of the Daily Value for protein may be omitted 
as provided in Sec.  101.9(c)(7); no percent of the Daily Value shall 
be given for subcomponents for which DRVs or RDIs have not been 
established (e.g., sugars).
* * * * *
    (D) If the percent of Daily Value is declared for total fat, 
saturated fat, total carbohydrate, dietary fiber, or protein, a symbol 
shall follow the value listed for those nutrients that refers to the 
same symbol that is placed at the bottom of the nutrition label, below 
the bar required under paragraph (e)(6) of this section and inside the 
box, that is followed by the statement ``Percent Daily Values are based 
on a 2,000 calorie diet.'' If the product is represented or purported 
to be for use by children 1 through 3 years of age, and if the percent 
of Daily Value is declared for total fat, total carbohydrate, dietary 
fiber, or protein, a symbol shall follow the value listed for those 
nutrients that refers to the same symbol that is placed at the bottom 
of the nutrition label, below the bar required under paragraph (e)(6) 
of this section and inside the box, that is followed by the statement 
``Percent Daily Values are based on a 1,000 calorie diet.''
    (E) The percent of Daily Value shall be based on RDI or DRV values 
for adults and children 4 or more years of age, unless the product is 
represented or purported to be specifically for infants 7 through 12 
months of age, children 1 through 3 years of age, or pregnant and 
lactating women, in which case the column heading shall clearly state 
the intended group. If the product is for persons within more than one 
group, the percent of Daily Value for each group shall be presented in 
separate columns as shown in paragraph (e)(11)(ii) of this section.
    (F) For declared subcomponents that have no DRVs or RDIs, a symbol 
(e.g., an asterisk) shall be placed in the ``Percent Daily Value'' 
column that shall refer to the same symbol that is placed at the bottom 
of the nutrition label, below the last heavy bar and inside the box, 
and followed by a statement ``Daily Value not established.''
    (G) When calories or calories from saturated fat are declared, the 
space under the ``% DV'' column shall be left blank for these items. 
When there are no other (b)(2)-dietary ingredients listed for which a 
value must be declared in the ``% DV'' column, the column may be 
omitted as shown in paragraph (e)(11)(vii) of this section. When the 
``% DV'' column is not required, but the dietary ingredients listed are 
subject to paragraph (b)(2)(iii)(F) of this section, the symbol 
required in that paragraph shall immediately follow the quantitative 
amount by weight for each dietary ingredient listed under ``Amount Per 
Serving.''
    (3) * * *
    (ii) * * *
    (A) These amounts shall be expressed using metric measures in 
appropriate units.
* * * * *
    (c) * * *
    (4) The sample label shown in paragraph (e)(11)(v) of this section 
illustrates one method of nutrition labeling a proprietary blend of 
dietary ingredients.
* * * * *
    (e) Except as provided for small and intermediate sized packages 
under paragraph (i)(2) of this section, information other than the 
title, headings, and footnotes shall be in uniform type size no smaller 
than 8 point. A font size at least two points greater shall be used for 
``Calories'' and the heading ``Calories'' and the actual number of 
calories per serving shall be highlighted in bold or extra bold type. 
Type size no smaller than 6 point may be used for column headings 
(e.g., ``Amount Per Serving'' and ``% Daily Value'') and for footnotes 
(e.g., ``Percent Daily Values are based on a 2,000 calorie diet).
* * * * *
    (8) If the product contains two or more separately packaged dietary 
supplements that differ from each other (e.g., the product has a packet 
of supplements to be taken in the morning and a different packet to be 
taken in the afternoon), the quantitative amounts and percent of Daily 
Value may be presented as specified in this paragraph in individual 
nutrition labels or in one aggregate nutrition label as illustrated in 
paragraph (e)(11)(iii) of this section.
* * * * *
    (11) * * *
BILLING CODE 4160-01-P
    (l) Multiple vitamins

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    (12) If space is not adequate to list the required information as 
shown in the sample labels in paragraph (e)(11) of this section, the 
list may be split and continued to the right as long as the headings 
are repeated. The list to the right must be set off by a line that 
distinguishes it and sets it apart from the dietary ingredients and 
percent of Daily Value information given to the left. The following 
sample label illustrates this display:

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BILLING CODE 4160-01-C
    (f) * * *
    (2) When it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of this section, FDA may permit alternative means of 
compliance or additional exemptions to deal with the situation in 
accordance with Sec.  101.9(g)(9). Firms in need of such special 
allowances shall make their request in writing to the Office of 
Nutrition, Labeling and Dietary Supplements (HFS-800), Food and Drug

[[Page 11987]]

Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
* * * * *
    (i)(1) Dietary supplements are subject to the special labeling 
provisions specified in Sec.  101.9(j)(5)(i) for foods other than 
infant formula, represented or purported to be specifically for infants 
and children less than 2 years of age.
* * * * *

    Dated: February 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04387 Filed 2-27-14; 8:45 am]
BILLING CODE 4160-01-C


