Guidance for Industry: 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)


How to Comment

Submit electronic comments on to docket number FDA-2011-F-0172.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
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All comments should be identified with the docket number FDA-2011-F-0172.

Contains Nonbinding Recommendations

April 2016

“A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods – Part II” is intended to help restaurants and similar retail food establishments understand nutrition labeling requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations that may apply to them. Broadly, these requirements include the menu labeling provisions of section 403(q)(5)(H) of the (FD&C Act) [21 U.S.C. 343(q)(5)(H)] and the final rule on nutrition labeling of standard menu items in restaurants and similar retail food establishments we published on December 1, 2014 (79 FR 71156) (menu labeling final rule).

Throughout this guidance the terms “you” and “I” refer to persons or establishments that are subject to these labeling requirements.

Please see “A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods – Part I” for guidance on other nutrition-related information that must be provided to customers of restaurants or similar establishments that are not covered by this guidance but that choose to make certain types of claims about nutrients in the food it serves or about beneficial health effects that can be obtained from the food it serves.

We will continue to update and issue additional editions of guidance as resources permit. We will collect questions from correspondence and other inquiries that we receive and consider including them in future editions of this guidance. Submit your questions concerning the interpretation of the requirements of the food labeling regulations to the Office of Nutrition and Food Labeling (HFS-800), Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740.

Our guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents 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 FDA guidance documents means that something is suggested or recommended, but not required. 

Download the Guidance for Industry (PDF: 362KB) 

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