FDA Issues Menu Labeling Guidance, Utilizing Q&A Format and Graphics to Address Concerns, Offer Solutions, and Provide Flexibility

Constituent Update

November 7, 2017

The U.S. Food and Drug Administration today released the draft guidance Menu Labeling: Supplemental Guidance for Industry. It addresses comments the agency received on the May 2017 interim final rule (IFR) extending the compliance date for the Menu Labeling Final Rule from May 5, 2017, to May 7, 2018. The FDA has been working hard to address industry and other concerns through the least burdensome route and believe that is through guidance.

The question-and-answer style draft guidance features approximately 20 different graphics to illustrate the agency’s new and expanded interpretations of the menu labeling provisions and practical ways for industry to comply with these provisions. It addresses concerns some stakeholders have raised including: calorie disclosure for self-service foods, such as buffets and grab-and-go foods; accounting for the natural variation of foods; compliance and enforcement of the rule; criteria for covered establishments; determining standard menu items; criteria for distinguishing between menus and other information presented to the consumer, like marketing materials; various methods for providing calorie disclosure information on foods such as pizza.

For example, the sample graphic below (Figure 16 in the draft guidance) illustrates how a pizza chain can structure a build-your-own pizza menu board. This graphic demonstrates a flexible solution to address industry’s concern about how to provide calorie counts for the complex permutations of a build-your-own pizza order.

The Menu Labeling Final Rule, when applied to marketing materials, is intended to be flexible and not prescriptive. As an example, the draft guidance explains that marketing materials (e.g., pizza coupons, posters in store windows, signs on gas pumps, or paper inserts) generally would not be considered a menu or menu board and would not require calorie declarations. The agency is withdrawing two questions from the previous Menu Labeling Guidance that pertained to marketing materials. When finalized, this guidance will provide clarity on the FDA’s flexible approach to distinguishing between a menu/menu board and marketing materials.

The agency will accept comments on this draft guidance from November 9, 2017 to January 8, 2018, after which it will move to finalize it to ensure industry has adequate time to implement the requirements. Consumers can expect to see menu labeling in covered establishments nationwide by May 7, 2018. We are fully committed to keeping this deadline.

Submit electronic comments to http://www.regulations.gov.

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852. All comments should be identified with Docket No. FDA-2011-F-0172 for “Menu Labeling: Supplemental Guidance for Industry.”

For Additional Information

• Federal Register Notice - Menu Labeling: Supplemental Guidance for Industry
• Menu Labeling: Supplemental Guidance for Industry (Draft)
• Statement from FDA Commissioner Scott Gottlieb, M.D. on the practical approach to ensuring timely implementation of FDA’s menu labeling rule
• Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (April 2016 Menu Labeling Guidance)
• Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date and Request for Comments
• Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Final Rule