
[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Notices]               
[Page 52425-52427]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au10-129]                         


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Part III





Department of Health and Human Services





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Food and Drug Administration



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Guidance for Industry; Section 4205 of the Patient Protection and 
Affordable Care Act of 2010; Availability; Notices


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0370]

 
Draft Guidance for Industry: Questions and Answers Regarding 
Implementation of the Menu Labeling Provisions of Section 4205 of the 
Patient Protection and Affordable Care Act of 2010; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Guidance for Industry: 
Questions and Answers Regarding Implementation of the Menu Labeling 
Provisions of Section 4205 of the Patient Protection and Affordable 
Care Act of 2010.'' Section 4205 of the Patient Protection and 
Affordable Care Act (Affordable Care Act) requires certain chain 
restaurants and similar retail food establishments with 20 or more 
locations (hereinafter ``chain retail food establishments'') to provide 
calorie information, and other nutrition information, for standard menu 
items, food on display, and self-service food. Section 4205 also 
requires vending machine operators who own or operate 20 or more 
machines (hereinafter ``chain vending machine operators'') to disclose 
calories for articles of food. Restaurants and similar retail food 
establishments with fewer than 20 locations and vending machine 
operators with fewer than 20 machines may elect to be subject to these 
Federal requirements by registering every other year with the FDA.
    Section 4205 of the Affordable Care Act became effective on the 
date the law was signed, March 23, 2010; however, some provisions 
specifically require FDA to issue rules before FDA implements them. 
Other provisions became requirements immediately upon enactment of the 
law. The draft guidance, when finalized, will explain how those 
provisions should be implemented.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on the 
draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 
by October 12, 2010.

ADDRESSES: Submit electronic comments on the draft guidance to http://
www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies of the draft guidance to the 
Office of Nutrition, Labeling, and Dietary Supplements, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Geraldine A. June, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Guidance for Industry: Questions and Answers Regarding Implementation 
of the Menu Labeling Provisions of Section 4205 of the Patient 
Protection and Affordable Care Act of 2010.''
    The availability of nutrition information through menu and vending 
machine labeling would provide Americans with additional information to 
make informed choices about their diets. Studies show that providing 
nutrition information at restaurants can help people make healthier 
choices (Refs. 1 and 2). Responding to this demand for information, 
several States and localities have initiated a variety of legislative 
or regulatory efforts for menu labeling, which has resulted in 
differing requirements across jurisdictions. These differing 
requirements have created logistical challenges for restaurant chains 
that have locations in more than one jurisdiction (Ref. 3).
    On March 23, 2010, the President signed into law the Affordable 
Care Act (Public Law 111-148), which sets up a uniform nationwide 
approach to menu and vending machine labeling. Section 4205 of the 
Affordable Care Act (hereinafter ``section 4205'') creates a new 
subparagraph (H) within section 403(q)(5) of the Federal Food, Drug, 
and Cosmetic Act (the act), to be codified at 21 U.S.C. 343(q)(5)(H), 
which requires certain chain retail food establishments to provide 
calorie information and other nutrition information for menu items, 
food on display, and self-service food. Section 4205 also requires 
chain vending machine operators to disclose calories for articles of 
food. Chain retail food establishments with fewer than 20 locations (or 
other restaurants or similar retail food establishments not covered by 
section 4205) and vending machine operators with fewer than 20 machines 
may elect to be subject to these Federal requirements by registering 
every other year with the FDA.
    Section 4205 became effective on the date the law was signed, March 
23, 2010; however, some provisions require FDA to issue rules before 
FDA implements them. Other provisions must be implemented immediately 
upon enactment of the law. FDA is required to issue a proposed rule 
implementing section 4205 by March 23, 2011.
    For chain retail food establishments, the provisions that became 
requirements immediately upon enactment of the law include:
    (1) Disclosing the number of calories in each standard menu item on 
menus and menu boards,
    (2) Making additional written nutrition information available to 
consumers upon request,
    (3) Providing a statement on menus and menu boards about the 
availability of the additional nutrition information, and
    (4) Providing calorie information (per serving or per food item) 
for most self-service items and food on display, on a sign adjacent to 
each food item.
    In addition, the provision requiring chain vending machine 
operators to disclose, in a clear and conspicuous manner, calories of 
any article of food that does not permit a prospective purchaser to 
examine its Nutrition Facts panel before purchasing, or does not 
otherwise provide visible nutrition information at the point of 
purchase, became an immediate requirement upon enactment of the law.
    FDA is issuing this draft guidance as Level 1 draft guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent the 
agency's current thinking on the provisions in section 4205 related to 
chain retail food establishments that became requirements immediately 
upon enactment of the law. It does not create or confer any rights for 
or on any person and does not operate to bind FDA or the public. An 
alternate approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations. FDA is 
soliciting comments from interested parties on the entire document to 
better inform the agency as it develops further guidance.

[[Page 52427]]

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in section 4205 of the Affordable Care Act 
have been approved under OMB Control No. 0910-0665 (menu labeling third 
party disclosures and recordkeeping) and OMB Control No. 0910-0664 
(voluntary registration program).

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
draft guidance. It is only necessary to send one set of comments. It is 
no longer necessary to send two sets of mailed 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://www.fda.gov/FoodGuidances.

V. References

    FDA has placed the following references on display in the Division 
of Dockets Management (see ADDRESSES), and they may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequesnt changes to the Web sites after this document 
publishes in the Federal Register.)
    1. Howlett, E.A., S. Burton, K. Bates, and K. Huggins, ``Coming 
to a Restaurant Near You? Potential Consumer Responses to Nutrition 
Information Disclosure on Menus,'' Journal of Consumer Research 
36(3): 494-503, 2009. Available at http://www.journals.uchicago.edu/
doi/pdf/10.1086/598799.
    2. Tandon, P.S., J.Wright, C. Zhou, C.B. Rogers, D.A. 
Christakis, ``Nutrition Menu Labeling May Lead to Lower-Calorie 
Restaurant Meal Choices for Children,'' Pediatrics 125(2): 244-248, 
2010.
    3. Center for Science in the Public Interest, ``Comparison of 
Menu Labeling Policies,'' Available at http://cspinet.org/new/pdf/
comparison_of_ml_policies_6-9.pdf.

    Dated: August 18, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21065 Filed 8-24-10; 8:45 am]
BILLING CODE 4160-01-S

