Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act. Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items. The menu labeling requirements originally were scheduled to take effect on December 1, 2015. The compliance date has since been delayed until May 7, 2018. And on August 25, 2017, FDA Commissioner Scott Gottlieb issued a statement in support of the menu labeling rule and announced that additional guidance would be issued by the end of 2017 to provide further clarity on regulatory compliance obligations under the new requirements.

On November 7, 2017, FDA released “draft” guidance, entitled “Menu Labeling: Supplemental Guidance for Industry.” The draft guidance addresses: calorie disclosure for self-service foods, such as buffets and grab-and-go foods; accounting for the natural variation of foods; compliance and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.

The draft guidance document specifically hones in on marketing materials, explaining that marketing materials — like pizza coupons, posters in store windows, signs on gas pumps, or paper inserts – are not menu or menu board items within the meaning of the final rule and, as such, would not require calorie declarations. Of note, the Agency is withdrawing two questions from the previous Menu Labeling Guidance that pertained to marketing materials. The Agency intends for this latest guidance to provide clarity on the FDA’s “flexible approach” to distinguishing between a menu/menu board and marketing material.

In a statement announcing the roll out of this new guidance, FDA Commissioner Scott Gottlieb noted that “over the next several months, [FDA] will continue to partner with restaurants and similar retail food establishments through each step in the implementation process and look forward to May, when consumers will have access to clear, consistent calorie information on the menus in their favorite chain restaurants and food establishments.”

Early reaction to the draft guidance was decidedly mixed – Lyle Beckwith, spokesman for the National Association of Convenience Stores, commented that the guidance “didn’t give flexibility or clear guidance on what you could do in any number of situations” and that “retailers remain concerned about potential consumer lawsuits.”

FDA will be accepting comments on the draft guidance for 60 days following its imminent publication in the Federal Register.