The FDA is providing final guidance designed to help restaurants and retail food establishments that are part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items, to comply with the menu labeling requirements contained in section 4205 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) and the menu-labeling Final rule (79 FR 71156) (see Finally final: FDA releases ACA-mandated menu labeling requirements, December 3, 2014). Specifically, this ACA provision and the menu-labeling Final rule require calorie and other nutrition information for standard menu items, including food on display and self-service food. In addition to the final guidance, the FDA is announcing that enforcement of the menu-labeling Final rule will begin on May 5, 2017, one year after the date of publication of this final guidance notice in the Federal Register (Notice, 81 FR 27067, May 5, 2016).
Restaurants previously exempted. Section 403(q) of the federal Food, Drug & Cosmetic Act (FDC Act) requires that food offered for sale must adhere to labeling requirements and include a variety of information such as serving size and calories. Section 403(q), however, previously exempted the following items from these labeling requirements:
- food served in restaurants for immediate consumption;
- food processed and prepared in a retail establishment and ready for human consumption; and
- food that was offered for sale in restaurants to consumers that was not for immediate consumption, but not offered for sale outside of the establishment.
Exemptions removed. ACA section 4205 removed this exemption for restaurants, retail food establishments, and vending machine chains with 20 or more locations. The ACA modified the FDC Act’s exemptions and required these establishments to disclose in a clear and conspicuous manner, for each standard menu item on menus and menu boards, the calories for the items prepared and the suggested daily caloric intake specified by HHS. The ACA required restaurant and retail establishments offering food for sale in salad bars, buffet lines, cafeteria lines, other self-service facilities, self-service beverage lines, and displays visible to customers, to place signs adjacent to each food offering noting calories per displayed item or serving. Furthermore, establishments must specify nutrition information of food items available in written form on the premises.
Delay of menu-labeling Final rule enforcement. On December 18, 2015, the Consolidated Appropriations Act, 2016 (H.R. 2029) delayed enforcement of the menu-labeling Final rule until the later of December 1, 2016, or the date that is one year after the date on which the FDA publishes a final guidance on the subject (see Changes to ACA requirements, COOL, cybersecurity, and more in Appropriations Act, December 23, 2015).
Previous FDA proposals and guidance. Prior to the menu-labeling Final rule, the FDA issued a Proposed rule on April 6, 2011 (76 FR 19192). In addition, the agency published a notice in July 2010 assisting restaurants and similar retail food establishments that are not subject to the menu labeling requirements, but who choose to register to become subject to the requirements, pending promulgation of the regulations by the FDA (75 FR 43182).
Next, on August 25, 2010, the FDA issued a draft guidance (75 FR 52426) to clarify the effects of section 4205 of the ACA, titled "Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010." However, based on industry comments, on January 21, 2011 (76 FR 4360), the FDA decided to withdraw the draft guidance and instead fully complete the notice and comment rulemaking process for section 4205 before initiating enforcement activities and issuing a final guidance.
Final guidance. On September 16, 2015, the FDA announced the availability of the draft version of this final guidance (see FDA serves up some guidance on restaurant menu labeling requirements, September 23, 2015). The draft version contained definitions of key terms and provided information in a question and answer format on covered establishments, nutrition labeling, nutrient values, alcoholic beverages, and voluntary registration. The FDA reportedly received many comments on the draft guidance and modified the guidance by revising several questions and answers and adding new questions and answers.
The final guidance is titled "A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11)." It describes nutrition labeling that is required for foods sold in covered establishments, how this information (calorie and nutrition labeling) may be presented, and when exempt foods must provide nutrition labeling. The guidance also describes the means (reasonable basis) by which nutrient values may be derived.
New questions and answers that did not appear in the draft version are located in sections 5.5, 5.7, 5.11, 5.17, 5.35, 7.11, and 7.12 of the final guidance. The final guidance also includes additional examples and explanations to clarify how the provisions of the menu-labeling Final rule would apply to various situations.
The final guidance is intended as a companion to "A Food Labeling Guide," published by the FDA in January 2013.
MainStory: TopStory NewsFeed FoodNews GeneralNews
Interested in submitting an article?
Submit your information to us today!Learn More