Written By Katharine Richter
On September 11, 2015, the Food and Drug Administration (FDA) released a draft guidance titled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR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).”
According to the draft guidance document, “section 4205 of the Patient Protection and Affordable Care Act amended 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343 (q)(5)(H)) to require that restaurants and similar retail food establishments . . . provide calorie information for standard menu items.”
The guide was issued to assist restaurants in complying with the final rule published by the FDA December 1, 2014, which requires standard menu items to have the nutrition content labeled. According to the guidance document, “the rule is codified at Title 21 of the Code of Federal Regulations at § 101.11 (21 CFR § 101.11).” The rule applies to restaurants and similar retail establishments that have 20 or more locations operating under the same name with similar menu items. This includes bakeries but will not include food trucks, schools, prisons, trains, and a few other exceptions mentioned in the draft guidance.
The guidance document describes what is defined as a ‘covered establishment’ under the act and the expected nutritional labeling requirements and how to implement the changes. The draft offers nonbinding recommendations and the FDA is accepting comments to better clarify sections that may still contain ambiguities and questions.