Food and Drug Administration, HHS.
Notice; establishment of docket; request for comments, data, and information.
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.
Submit either electronic or written comments by September 7, 2010.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 39027the 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 Start Printed Page 39028choose 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.
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.
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 Research 36(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.Start Signature
Dated: June 29, 2010.
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16303 Filed 7-6-10; 8:45 am]
BILLING CODE 4160-01-S