The FDA today released a final version of a November 2017 guidance document that promises a flexible approach to enforcement of agency regulations prescribing calorie declarations at restaurants and similar retail food establishments.  The release of the final guidance coincides with the effective date of the regulations.  Covered establishments are now expected to comply with the rule, following multiple extensions including one mandated by Congress conditioning enforcement on the agency’s publication of guidance.

As we previously discussed here and here, the rule requires covered food establishments to include three separate disclosures on all menus and menu boards: (1) calorie information for standard menu items and other specified items, (2) the statement that “2,000 calories a day is used for general nutrition advice, but calorie needs vary,” or a substitute statement for children’s menus and menu boards, and (3) a statement that written nutrition information is available upon request.  Establishments are only covered if they are part of a chain with 20 or more locations doing business under the same name and offering substantially the same menu items.

FDA Commissioner Scott Gottlieb explained in a statement last week that the guidance was intended to “make it easy for manufacturers and restaurants to provide this information in cost effective ways already found in many chains” and in a manner that “won’t require costly changes to existing infrastructure.”  Notable takeaways from the guidance include:

  • FDA intends to exercise enforcement discretion regarding the “calories from fat” declaration requirement in recognition of “current science support[ing] the view that the type of fat is more relevant with respect to the risk of chronic disease than the overall caloric fat intake.”
  • Covered establishments have some flexibility in determining how best to display required calorie information.  For example, an establishment with a self-service buffet could display calories next to each item, on the sneeze guard over an item, or on a single sign near the buffet.  The guidance offers images of displays that FDA considers compliant.  Similarly, the guidance explains that an establishment need not create menu boards in addition to paper menus or online menus to meet the requirements, but could add the information to paper menus or use an electronic kiosk to disclose calorie information in lieu of having a menu board.
  • FDA plans to take a “flexible and not prescriptive” approach to evaluating whether marketing materials constitute a “menu” or “menu board” that would be required to bear calorie information.  If the primary purpose of a sign is to entice customers into purchasing a particular item or items, then it would not generally require a calorie declaration.  Provided examples of materials that would not require calorie declarations include coupons, posters in store windows, and flyers.
  • Establishments are only counted towards the threshold number of 20 if they meet each of the following criteria: (1) they do business under the same name; (2) they sell substantially the same menu items; and (3) they sell restaurant-type foods (e., food that is usually eaten on the premises, while walking away, or soon after arriving at another location).  For example, if a store had 30 locations operating under the same name but only ten locations sold substantially the same menu items, then the establishments would not be covered under the rule.

The guidance also explains that FDA plans to “work cooperatively with covered establishments to come into compliance with the menu labeling requirements” and “continue with education and outreach, especially in the first year.”  Nonetheless, covered establishments should take notice and evaluate whether current labeling practices comply with now effective menu labeling requirements.