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4205 - Nutrition Labeling of Standard Menu Items at Chain Restaurants

 
Implementation Status 
Statutory Text 

Summary

Specifies new requirements of restaurants, retail food establishments, and vending machines.  With certain limited exceptions, stipulates that restaurants or similar retail food establishments that are part of a 20+ location chain doing business under the same name (regardless of differences in ownership at the locations) disclose certain nutrient content information (e.g., number of calories) for each standard menu item.  Delineates the information that these entities must make available to consumers and the manner in which it must be disclosed (e.g., in written form available on the premises and prominently displayed on the menu or menu board).

These requirements generally apply to self-service food (e.g., buffets and salad bars) and food on display to such entities.  Directs the Secretary to develop regulations pertaining to the disclosure of nutrient content with respect to menu variability and combination meals, and authorizes the Secretary to require, by regulation, additional nutrient disclosure information as appropriate.  With respect to vending machines owned or operated by individuals with 20 or more vending machines, requires that vending machine operators prominently display a sign in close proximity to each food item the respective caloric information.  Provides a process whereby other retail food establishments or vending machines (to which the requirements would normally not apply) may voluntarily elect to provide such nutrition information, with details about such process to be determined by the Secretary via notice in the Federal Register by July 23, 2010.  Directs the Secretary to issue proposed regulations to carry out these requirements by March 23, 2011. Also stipulates quarterly reporting requirements of the Secretary to select Congressional committees regarding the Administration’s progress toward issuing final regulations in this vein.

#Prevention, #Wellness

Implementation Status

 
Summary 
Statutory Text 

2011

The FDA issued a proposed rule in the spring of 2011 to implement these new requirements.  However, to date, the agency has not yet implemented a final rule, though per the OMB/OIRA website, a final rule is targeted in April 2013.  For the most up-to-date information on this forthcoming final rulemaking, including the FDA’s activities to date (e.g., draft guidance and so forth), see here.

2013

On July 23, 2013, HHS posted its updated semiannual regulatory agenda.  Per the updated agenda, consistent with the ACA requirement at section 4205, the FDA provided updated target promulgation dates for two regulations (both tentatively due in September 2013) to implement this provision of the law pertaining to caloric labeling of food sold in vending machines as well as nutrition labeling of standard menu items in restaurants and similar establishments (regulatory IDs 0910–AG56 and 0910–AG57, respectively).  More general information about the FDA’s efforts in fulfilling this provision of the law is available here.

2014

On July 10, 2014, the CDC’s Morbidity and Mortality Weekly Report (available in full here) included an article delineating state-specific restaurant menu–labeling use (in 2012) among adults across 17 states – namely: Delaware; Georgia; Hawaii; Iowa; Kansas; Maryland; Minnesota; Mississippi; Montana; Nebraska; Nevada; New Hampshire; New Jersey; New York; Oklahoma; South Dakota; and Tennessee.

On Nov. 25, the FDA published a pair of final regulations – available here and here – codifying ACA-mandated menu and vending machine nutritional/caloric labeling requirements, respectively. A FDA blog post highlights these changes, which will be applicable to restaurants or similar retail food establishments that are part of a 20+ location chain, as well as vending machines that are owned or operated by individuals with 20+ vending machines. More detailed information about these new requirements is also available here and here.

2015

On Mar. 12, the FDA issued a notice announcing the availability of industry guidance intended to assist small entities comply with the agency’s Dec. 2014 final rule titled, “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.” Also, on Mar. 30, FDA published an information collection indicating that OMB approved a data undertaking titled, “Food Labeling; Calorie Labeling of Articles of Food in Vending Machines.”

On Apr. 3, FDA indicated that OMB approved an information collection titled, “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.”

On May 15, a group of bipartisan senators wrote to the FDA calling for a one-year implementation delay (to Dec. 2016) of the agency’s Dec. 2014 final rule titled, “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.” The lawmakers indicate that “outstanding guidance from the agency…is necessary to provide much needed clarity for small and large businesses impacted by the new requirements.”

On July 23, FDA issued a final rule extending the compliance date for the ACA required disclosure of certain nutrition information for standard menu items in chain restaurants and retail food establishments to Dec. 1, 2016 (as opposed to Dec. 1, 2015).

The FY 2016 omnibus spending measure (omnibus text; section-by-section summary), passed in December 2015, included a provision at sec. 747 delaying implementation of the ACA’s menu labeling requirements until the later of Dec. 1, 2016 or the date that is one year following HHS’ publication of Level 1 menu labeling guidance. 

2017

In early July, the FDA announced it would extend the comment period for the interim final rule that extended the menu labeling compliance date. Previously set to close on July 3, the comment period was extended until Aug. 2.

On July 14, Republican Energy and Commerce Committee leaders sent a letter to the FDA regarding localities like New York City ignoring the agency’s compliance delays, and instituting the rules by pervious compliance dates.

On Aug. 25, FDA Commissioner Scott Gottlieb issued a statement articulating the agency’s commitment to enacting the menu labeling regulations promulgated under the previous administration, and indicating that the FDA plans to provide additional guidance to industry by the end of the year.

On Nov. 9, 2017, the FDA released updated draft guidance (details) for the restaurant industry on how to comply with the ACA’s menu labeling requirements. The guidance addresses concerns raised by stakeholders in response to the interim final rule issued in May 2017, and includes “expanded and new interpretations of policy,” and “additional options” for complying with the labeling requirements.

2018

On May 7, the FDA released final guidance tiled, “Menu Labeling: Supplemental Guidance for Industry.” The guidance is meant to inform implementation of FDA’s rulemaking on nutrition labeling of menu items in restaurants and retail food establishments. Those underlying regulatory requirements are set to take effect on May 7, 2018.  The guidance finalizes a draft that was published on Nov. 9, 2017. Comments on the final guidance will be accepted at any time. A blog post authored by FDA Commissioner Gottlieb is available here.

2019

In August, the FDA announced its path forward for continued implementation of requiring restaurants to provide caloric and other nutritional information in food products. Details.

 

Statutory Text

 
Implementation Status 
Summary 

SEC. 4205. NUTRITION LABELING OF STANDARD MENU ITEMS AT CHAIN RESTAURANTS. (a) TECHNICAL AMENDMENTS.

—Section 403(q)(5)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(A)) is amended— (1) in sub-item (i), by inserting at the beginning ‘‘except as provided in clause (H)(ii)(III),’’; and (2) in subitem (ii), by inserting at the beginning ‘‘except as provided in clause (H)(ii)(III),’’. (b) LABELING REQUIREMENTS.—Section 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)) is amended by adding at the end the following: ‘‘(H) RESTAURANTS, RETAIL FOOD ESTABLISHMENTS, AND VEND- ING MACHINES.— ‘‘(i) GENERAL REQUIREMENTS FOR RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS.—Except for food described in subclause (vii), in the case of food that is a standard menu item that is offered for sale in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items, the restaurant or similar retail food establishment shall disclose the information described in subclauses (ii) and (iii). ‘‘(ii) INFORMATION REQUIRED TO BE DISCLOSED BY RES- TAURANTS AND RETAIL FOOD ESTABLISHMENTS.—Except as provided in subclause (vii), the restaurant or similar retail food establishment shall disclose in a clear and conspicuous manner— ‘‘(I)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu listing the item for sale, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and ‘‘(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu and designed to enable the public to understand, in the context of a total daily diet, the significance of the caloric information that is provided on the menu; ‘‘(II)(aa) in a nutrient content disclosure statement adjacent to the name of the standard menu item, so as to be clearly associated with the standard menu item, on the menu board, including a drive-through menu board, the number of calories contained in the standard menu item, as usually prepared and offered for sale; and ‘‘(bb) a succinct statement concerning suggested daily caloric intake, as specified by the Secretary by regulation and posted prominently on the menu board, designed to enable the public to understand, in the context of a total daily diet, the significance of the nutrition information that is provided on the menu board; ‘‘(III) in a written form, available on the premises of the restaurant or similar retail establishment and to the consumer upon request, the nutrition information required under clauses (C) and (D) of subparagraph (1); and ‘‘(IV) on the menu or menu board, a prominent, clear, and conspicuous statement regarding the availability of the information described in item (III). ‘‘(iii) SELF-SERVICE FOOD AND FOOD ON DISPLAY.—Except as provided in subclause (vii), in the case of 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 and that is visible to customers, a restaurant or similar retail food establishment shall place adjacent to each food offered a sign that lists calories per displayed food item or per serving. ‘‘(iv) REASONABLE BASIS.—For the purposes of this clause, a restaurant or similar retail food establishment shall have a reasonable basis for its nutrient content disclosures, including nutrient databases, cookbooks, laboratory analyses, and other reasonable means, as described in section 101.10 of title 21, Code of Federal Regulations (or any successor regulation) or in a related guidance of the Food and Drug Administration. ‘‘(v) MENU VARIABILITY AND COMBINATION MEALS.—The Secretary shall establish by regulation standards for determining and disclosing the nutrient content 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, doughnuts, or children’s combination meals, through means determined by the Secretary, including ranges, averages, or other methods. ‘‘(vi) ADDITIONAL INFORMATION.—If the Secretary determines that a nutrient, other than a nutrient required under subclause (ii)(III), should be disclosed for the purpose of providing information to assist consumers in maintaining healthy dietary practices, the Secretary may require, by regulation, disclosure of such nutrient in the written form required under subclause (ii)(III). ‘‘(vii) NON-APPLICABILITY TO CERTAIN FOOD.— ‘‘(I) IN GENERAL.—Subclauses (i) through (vi) do not apply to— ‘‘(aa) items that are not listed on a menu or menu board (such as condiments and other items placed on the table or counter for general use); ‘‘(bb) daily specials, temporary menu items appearing on the menu for less than 60 days per calendar year, or custom orders; or ‘‘(cc) such other food that is part of a customary market test appearing on the menu for less than 90 days, under terms and conditions established by the Secretary. ‘‘(II) WRITTEN FORMS.—Subparagraph (5)(C) shall apply to any regulations promulgated under sub-clauses (ii)(III) and (vi). ‘‘(viii) VENDING MACHINES.— ‘‘(I) IN GENERAL.—In the case of an article of food sold from a vending machine that— ‘‘(aa) does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article or does not otherwise provide visible nutrition information at the point of purchase; and ‘‘(bb) is operated by a person who is engaged in the business of owning or operating 20 or more vending machines, the vending machine operator shall provide a sign in close proximity to each article of food or the selection button that includes a clear and conspicuous statement disclosing the number of calories contained in the article. ‘‘(ix) VOLUNTARY PROVISION OF NUTRITION INFORMATION.— ‘‘(I) IN GENERAL.—An authorized official of any restaurant or similar retail food establishment or vending machine operator not subject to the requirements of this clause may elect to be subject to the requirements of such clause, by registering biannually the name and address of such restaurant or similar retail food establishment or vending machine operator with the Secretary, as specified by the Secretary by regulation. ‘‘(II) REGISTRATION.—Within 120 days of enactment of this clause, the Secretary shall publish a notice in the Federal Register specifying the terms and conditions for implementation of item (I), pending promulgation of regulations. ‘‘(III) RULE OF CONSTRUCTION.—Nothing in this sub-clause shall be construed to authorize the Secretary to require an application, review, or licensing process for any entity to register with the Secretary, as described in such item. ‘‘(x) REGULATIONS.— ‘‘(I) PROPOSED REGULATION.—Not later than 1 year after the date of enactment of this clause, the Secretary shall promulgate proposed regulations to carry out this clause. ‘‘(II) CONTENTS.—In promulgating regulations, the Secretary shall— ‘‘(aa) 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 ‘‘(bb) specify the format and manner of the nutrient content disclosure requirements under this sub-clause. ‘‘(III) REPORTING.—The Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a quarterly report that describes the Secretary’s progress toward promulgating final regulations under this subparagraph. ‘‘(xi) DEFINITION.—In this clause, the term ‘menu’ or ‘menu board’ means the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection.’’ (c) NATIONAL UNIFORMITY.—Section 403A(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–1(a)(4)) is amended by striking ‘‘except a requirement for nutrition labeling of food which is exempt under sub-clause (i) or (ii) of section 403(q)(5)(A)’’ and inserting ‘‘except that this paragraph does not apply to food that is offered for sale in a restaurant or similar retail food establishment that is not part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items unless such restaurant or similar retail food establishment complies with the voluntary provision of nutrition information requirements under section 403(q)(5)(H)(ix)’’. (d) RULE OF CONSTRUCTION.—Nothing in the amendments made by this section shall be construed— (1) to preempt any provision of State or local law, unless such provision establishes or continues into effect nutrient content disclosures of the type required under section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b)) and is expressly preempted under subsection (a)(4) of such section; (2) to apply to any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food; or (3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b)), to apply to any restaurant or similar retail food establishment other than a restaurant or similar retail food establishment described in section 403(q)(5)(H)(i) of such Act.

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