- Docket Number:
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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
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 examples of alternatives to aid in compliance. 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industry, in response to an interim final rule (IFR) (82 FR 20825, May 4, 2017), as well as comments received on the draft guidance document. The IFR also extended the compliance date for menu labeling, and invited comments to the docket.
In addition, given extensive further analysis by FDA, Questions and Answers 5.17 and 5.18 have been withdrawn from our previous April 2016 guidance entitled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu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): Guidance for Industry.”
In this guidance, we address the issue of distinguishing between menus and other information presented to the consumer, which represents our current thinking on this topic. This guidance also includes many graphical depictions in order to convey our thinking on various topics. The guidance covers several topic areas 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, when determining nutrition labeling; criteria for covered establishments; and standard menu items.
Finally, as a result of our further analysis of the menu labeling requirements and, in particular, the nutrient declaration requirements for the additional written nutrition information in 21 CFR 101.11(b)(2)(ii)(A) that requires “calories from fat” be declared for standard menu items, and to align with the final rule, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels,” 81 FR 33742 et seq, we are advising covered establishments of our intent to exercise enforcement discretion regarding the “calories from fat” declaration requirement. This means that, during this period, we do not intend to enforce this regulatory provision as it currently applies to “calories from fat” declarations. We are taking this position because the current science supports a view that the type of fat is more relevant with respect to the risk of chronic disease than the overall caloric fat intake. Therefore, if a covered establishment meets all of the provisions of the menu labeling requirements for the additional written nutrition information in 21 CFR 101.11(b)(2)(ii)(A), except that “calories from fat” is not declared, we do not intend to pursue actions against the covered establishment. We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 CFR 10.115). With respect to our enforcement discretion policy pertaining to “calories from fat” declarations, this part of the guidance is immediately effective because we have determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).
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.
* 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. See generally 21 U.S.C. 343(q)(5)(H)(i).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-F-0172.