[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