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This guidance is being distributed for comment purposes only.
This guidance document addresses concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments*, including expanded and new interpretations of policy. It also clarifies that there are additional options for complying with the labeling requirements and identifies places where FDA intends to be more flexible in its approach. The guidance reflects input from stakeholders, including the public and industry, in response to an interim final rule (IFR) (82 FR 20825, May 4, 2017). The IFR also extended the compliance date for menu labeling, and invited comments to the docket.
In addition, given extensive further analysis by the FDA, we are withdrawing Questions and Answers 5.17 and 5.18 in our previous guidance entitled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance With FDA’s Food Labeling Regulations) effective November 7, 2017. We address the issue of distinguishing between menus and other information presented to the consumer in this draft guidance, and once finalized, this will represent our current thinking on this topic. This guidance also includes many graphical depictions in order to convey our thinking on various topics. The draft guidance covers several topic areas outlined in the IFR, including: calorie disclosure signage for self-service food, including buffets and grab-and-go food; various methods for providing calorie disclosure information, including those for pizza; criteria for distinguishing between menus and marketing material; compliance and enforcement; reasonable basis, including the criteria for considering the natural variation of foods; criteria for covered establishments; and standard menu items.
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 FDA guidances means that something is suggested or recommended, but not required.
This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.
Download the Draft Guidance for Industry (PDF: 219KB)
This guidance has been prepared by the Nutrition Programs Staff in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.
* 21 CFR 101.11(a) defines “covered establishment” as a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, e.g., individual franchises) and offering for sale substantially the same menu items, as well as a restaurant or similar retail food establishment that voluntarily registers with FDA to be covered by the federal menu labeling requirements.
Page Last Updated: 11/07/2017
U.S. Food and Drug Administration