[Federal Register Volume 75, Number 129 (Wednesday, July 7, 2010)]
[Notices]
[Pages 39026-39028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES>
Food and Drug Administration
[Docket No. FDA-2010-N-0298]
Disclosure of Nutrient Content Information for Standard Menu
Items Offered for Sale at Chain Restaurants or Similar Retail Food
Establishments and for Articles of Food Sold From Vending Machines
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of docket; request for comments, data,
and information.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a docket to solicit comments, data, and other information
helpful to the implementation of section 4205 of the Patient Protection
and Affordable Care Act of 2010, which was enacted on March 23, 2010.
That section, principally amending sections 403 and 403A of the Federal
Food, Drug, and Cosmetic Act (the act), requires chain restaurants and
similar retail food establishments with 20 or more locations doing
business under the same name and offering for sale substantially the
same menu items to disclose nutrient content information for standard
menu items appearing on restaurant menus and menu boards, and requires
vending machine operators that own or operate 20 or more vending
machines to disclose nutrient content information for certain articles
of food sold from vending machines. Section 4205 also amended the act
to allow restaurants or similar retail food establishments and
operators of vending machines not subject to the requirements of
section 4205 to elect to be subject to the requirements through
biannual registration. FDA is establishing this docket to provide an
opportunity for interested parties to submit data and other information
relevant to the implementation of section 4205.
DATES: Submit either electronic or written comments by September 7,
2010.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
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
The availability of nutritional information through menu labeling
would provide Americans the opportunity to exercise personal
responsibility and make informed choices about their diets. Studies
show that providing nutrition information at restaurants can help
people make healthier choices (e.g., Refs. 1 and 2). Responding to this
demand for information, several states and localities have initiated
legislative or regulatory efforts on restaurant menu labeling, creating
a patchwork of ideas and logistical challenges for many restaurant
chains (Ref. 3). While various approaches to menu labeling in chain
restaurants have been tried, several stakeholders ultimately sought a
national approach that would ensure nationwide uniformity, better
protections, and flexibility in how additional nutrition information is
provided.
On March 23, 2010, the President signed into law the Patient
Protection and Affordable Care Act (Affordable Care Act) (Public Law
111-148). 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 chain restaurants
and similar retail food establishments with 20 or more locations doing
business under the same name and offering for sale substantially
[[Page 39027]]
the same menu items (hereinafter ``chain retail food establishments'')
to disclose specific nutrition information on certain food items
offered for sale. The new provision also requires vending machine
operators that own or operate 20 or more vending machines (hereinafter
``chain vending machine operators'') to disclose nutrient content
information for certain food articles sold from vending machines.
A. Chain Restaurants or Similar Retail Establishments
Specifically, section 4205 provides that chain retail food
establishments must:
Display on menus and menu boards, including drive-through
menu boards, the number of calories next to the listing for each
``standard menu item, as usually prepared and offered for sale.''
Include on the menu or menu board, ``posted prominently,''
``a succinct statement concerning suggested daily caloric intake.''
This statement, which is to be specified by the Secretary of the
Department of Health and Human Services (the Secretary) by regulation,
must be ``designed to enable the public to understand, in the context
of a total daily diet, the significance'' of the required information.
Provide in a written form, available to the customer upon
request, the nutrition information required under section 403(q)(1)(C)
and (D) of the act (i.e., per-serving information with respect to the
amount of calories, total fat, saturated fat, cholesterol, sodium,
total carbohydrates, complex carbohydrates, sugars, fiber, and total
protein).
Make a ``prominent, clear, and conspicuous statement'' on
the menu or menu board about the availability of the written nutrition
information under section 403(q)(1)(C) and (D).
In the case of self-service food and food on display
(e.g., food sold at a salad bar, buffet line, cafeteria line, or
similar self-service facility), include a sign adjacent to each food
item that lists the calories per displayed food item or per serving.
Base its nutrient content disclosures on sources described
in 21 CFR 101.10 or related FDA guidance.
Under section 4205, the Secretary must establish standards, by
regulation, for determining and disclosing the nutrient content for
standard menu items that come in different flavors, varieties, or
combinations, but that are listed as a single menu item (e.g., soft
drinks, ice cream, pizza, doughnuts, children's combination meals),
through means including ranges, averages, or other methods.
Certain food items sold in chain retail food establishments are not
subject to the nutrition content disclosure requirements. These items
include:
Items not listed on a menu or menu board (such as
condiments or items placed on the table or counter for general use).
Daily specials, temporary menu items appearing on the menu
for fewer than 60 days per calendar year, or custom orders.
Food that is part of a customary market test and appearing
on the menu for fewer than 90 days, under terms and conditions
established by the Secretary.
B. Vending Machines
Section 4205 provides that chain vending machine operators must
provide a sign ``in close proximity to'' each article of food or to the
selection button that includes ``a clear and conspicuous statement
disclosing the number of calories contained in the article,'' unless
the vending machine permits a prospective purchaser to examine the
Nutrition Facts panel before buying the food article, or otherwise
provides ``visible nutrition information at the point of purchase.''
C. Proposed Rule
Section 4205 requires FDA to issue proposed regulations to carry
out the provisions of section 4205 no later than March 23, 2011. In
issuing these regulations, FDA must: (1) Consider ``standardization of
recipes and methods of preparation, reasonable variation in serving
size and formulation of menu items, space on menus and menu boards,
inadvertent human error, training of food service workers, variations
in ingredients, and other factors, as the Secretary determines'' and
(2) ``specify the format and manner of the nutrient content disclosure
requirements'' under section 4205.
D. Voluntary Provision of Nutrition Information
Under the Affordable Care Act, persons or firms not subject to the
disclosure of nutrition information required by section 4205, such as
retail food establishments with fewer than 20 locations or vending
machine operators with fewer than 20 vending machines, may elect to be
subject to the requirements by registering biannually with FDA. FDA
must publish a notice in the Federal Register within 120 days of the
date of enactment of the Affordable Care Act (i.e., by July 21,
2010),''specifying the terms and conditions for implementation'' of the
voluntary registration provision.
II. Request for Data and Other Information
FDA is establishing a docket to provide an opportunity for
interested parties to submit data and other information and share views
that will inform us in the implementation of the new legislative
requirements for mandatory or voluntary menu, menu board, and vending
machine labeling. In particular, we welcome input on any of the matters
listed below:
A. Chain Retail Food Establishments
The types of restaurants or similar retail food
establishments and the nature of their food service activities.
Current practices within the restaurant or similar retail
food establishment industry with respect to standard and non-standard
menu items and the use of menus or menu boards.
Current practices with respect to the format and manner of
nutrient content disclosures concerning food items that appear on
retail food service menus or menu boards.
Considerations in the disclosure of calorie content
information for food sold at a salad bar, buffet line, cafeteria line,
or similar self-service facility, and for self-service beverages or
food that is on display.
Issues to be considered in developing a succinct statement
about a suggested daily caloric intake that is required to appear on
menus and menu boards.
Methods related to presentation of nutrient content
(ranges, averages, or other methods) for standard menu items that come
in different flavors, varieties, or combinations but which are listed
as a single menu item, such as soft drinks, ice cream, pizza, etc., or
combination meals such as children's combination meals.
Factors to consider with respect to determining what foods
or categories of foods might be exempt from the menu labeling
requirements because, e.g., they are condiments and other items placed
on tables or counters for general use; daily specials, temporary menu
items, or custom orders; or other food that is part of a customary
market test.
Information about the size of chain retail food
establishments (e.g., based on annual revenue or on number of
locations).
Information about the number of chain retail food
establishments that are or could be affected by section 4205.
Information about the number of retail food establishments
that may
[[Page 39028]]
choose voluntarily to be subject to section 4205.
Factors to consider with respect to availability and use
of space on menus and menu boards.
B. Determination of Calorie Content of Foods Offered by Chain Retail
Food Establishments
Information about standardization of recipes and methods
of preparation.
Information about variation in serving size and
formulation of menu items.
The role of inadvertent human error.
Information about training of food service workers.
Information about variations in ingredients.
Any other relevant factors.
C. Vending Machine Operations
Current practices within the vending machine industry with
respect to the availability to prospective purchasers of Nutrition
Facts panel information or otherwise providing visible nutrition
information at the point of purchase.
Possible mechanisms for displaying products' Nutrition
Facts panels or otherwise providing visible nutrition information at
the point of purchase.
Factors to consider with respect to availability and use
of space on vending machines.
Considerations in requiring caloric content disclosure
about food items sold from vending machines.
Information about the size of chain vending machine
operators (e.g., based on annual revenue or on number of locations).
Information about the number of chain vending machine
operators that are or could be affected by section 4205.
Information about vending machine operators not covered by
section 4205 of the Affordable Care Act that might elect to be subject
to the requirements of section 4205.
D. Implementation and Enforcement
Information about implementation, including information
about options for inspection and enforcement.
Information about inspection and enforcement mechanisms in
state and local nutrition labeling programs.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies 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. References
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,'' Available at http://www.journals.uchicago.edu/doi/pdf/10.1086/598799 Journal of Consumer
Research36(3): 494-503, 2009.
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: June 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16303 Filed 7-6-10; 8:45 am]
BILLING CODE 4160-01-S