On April 29, 2016, the U.S. Food and Drug Administration (FDA or the Agency) announced the publication of its final guidance for industry, "A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II (Menu Labeling Requirements in accordance with 21 CFR 101.11" (Guidance). As some readers will recall, the Agency released the draft version of this Guidance in September 2015. For more information on the draft guidance, please see our previous alert analyzing that document here.
By way of background, on December 1, 2014, FDA published the Menu Labeling Rule (Rule) requiring covered establishments to disclose calorie and certain nutrition information for standard menu items. As we reported in July, FDA extended the Menu Labeling Rule compliance date to December 1, 2016. The Agency will begin enforcing the menu labeling rule one year from publication of the Notice of Availability (NOA) in the Federal Register. The Agency currently anticipates publishing the NOA for the Guidance early this month.
The Guidance responds to many frequently asked questions (FAQs) received by FDA. Some notable differences between the draft and final versions of the Guidance are that the final version provides additional examples as well as new or revised questions and answers on myriad topics, such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and recordkeeping requirements.
More specifically, the final version contains answers to the following questions:
- What establishments are not “covered establishments” and not covered by the requirements of 21 C.F.R. § 101.11?
- Does a catered event have to provide calorie declarations to its guests?
- Within stadiums and arenas, are the mobile vendors that are walking through the stands and selling food and beverages from a tray or bag required to declare calories?
- Does a covered establishment need to include calorie information for suggested alcohol pairings?
- Are establishments that sell only beer, such as concession stands within a stadium, covered by the menu labeling requirements?
- What records will covered establishments need to keep to verify that a menu item meets the definition of a temporary menu item or a food that is part of a customary market test if the establishment changes its recipe or method of preparation?
Importantly, while the Guidance contains FAQs on a wide variety of topics, it is equally notable for what it does not include. The controversial elements of the Rule still remain (e.g., uniform application to grocery stores and restaurants alike, high costs of compliance, etc.). In addition, the examples provided may be limited in their usefulness to those businesses that can identify with the hypotheticals provided.
If you have questions regarding the issues raised in this alert, or would like to submit comments to the Agency regarding the Guidance, please contact one of the authors.