Docket Number: FDA-2011-F-0172 Issued by: Guidance Issuing Office Center for Food Safety and Applied Nutrition

On December 1, 2014, FDA (we) published a final rule entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments” (“the rule”) in the Federal Register to implement the nutrition labeling provisions in section 4205 of the Patient Protection and Affordable Care Act of 2010 (“section 4205”).2 The rule is effective on December 1, 2015. Section 4205 amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), among other things, to require restaurants and similar 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 provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under section 4205, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to the Federal requirements by registering every other year with FDA. Providing accurate, clear, and consistent nutrition information, including the calorie content of foods, in restaurants and similar retail food establishments will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the requirements set forth in 21 CFR 101.11 concerning nutrition labeling of standard menu items in establishments covered by the rule. We have organized this guidance in a question/answer format and also identify the relevant regulation in parentheses after each answer. The rule is binding and has the full force and effect of law.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in our guidances means that something is suggested or recommended, but not required.

In the remainder of this guidance, “you” and “I” refer to establishments that are subject to the rule.

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