[Federal Register Volume 75, Number 164 (Wednesday, August 25, 2010)]
[Notices]
[Pages 52426-52427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21065]
[[Page 52425]]
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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
Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 /
Notices
[[Page 52426]]
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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Draft Guidance for Industry: Questions and Answers Regarding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availability of the draft guidance entitled ``Guidance for Industry: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 The draft guidance, when finalized, will explain how those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