On November 7, 2017, the U.S. Food and Drug Administration (FDA or the Agency) released the much-anticipated draft supplemental guidance, “Menu Labeling: Supplemental Guidance for Industry” (Draft Guidance). The Draft Guidance provides further details on the Menu Labeling Final Rule (Menu Labeling Rule) and responds to comments the Agency received on the interim final rule, which was released in May 2017.

The Agency’s Menu Labeling Rule has had a long history. The rule requires restaurants and “similar retail food establishments”, such as grocery stores and convenience stores that are part of a chain of 20 or more locations, doing business under the same name, and offering similar food menu items from a menu or menu board to provide: (1) calorie information; (2) a statement on suggested daily caloric intake; and (3) a statement with written nutrition information (which must be provided if requested).

After release of the interim rule in May 2017, which was originally presented in 2015, a number of restaurants and stores in New York City filed suit seeking to prevent New York City from enforcing its substantially similar rule against nutritional information (read here). The City agreed to delay enforcing the rule until March 7, 2018, and the parties reached a settlement agreement contingent upon implementation of the rule by this date. Following the settlement, Scott Gottleib, FDA Commissioner, announced that the Agency planned to release a practical guide on the rule before the end of 2017. The November 7 Draft Guidance seeks to fulfill this promise of a “practical guide”, and appears to continue to suggest that the Menu Labeling Rule will be implemented in May 2018.

While many support the overall goal of the Menu Labeling Rule, many organizations such as the National Restaurant Association are concerned about the patchwork of state and local menu requirements, and the burden created by different store formats attempting to comply with varied rules and regulations. The newly issued Draft Guidance attempts to address these issues has been met with mixed reactions.

As an example of the concerns over this rule, a big issue for many pizza chains is the burden of addressing the thousands of topping combinations people may want on their pizza in calorie counts posted on menu boards in the store. Many pizza chains have been pushing for FDA to allow calorie information to be posted on their website instead of in the store location, with the rationale that the majority of customers order their pizza online rather than in-store. The Agency has rejected this approach in the Draft Guidance, noting that calorie count information may appear online but, if they have in-store menu boards, the calorie information must also appear on the board.

The Agency has indicated that it is willing to continue considering feedback and questions concerning the Draft Guidance. Comments on the proposal are due January 8, 2018.