By Victoria Moran, J.D.
The FDA has issued draft guidance addressing stakeholder concerns regarding the implementation of nutrition labeling requirements entitled "Menu Labeling: Supplemental Guidance for Industry." In the draft guidance, written in question-and-answer format, the FDA responds to stakeholder comments on the Interim Final rule (82 FR 20825, May 4, 2017)), provides interpretations of policies, and identifies areas where flexibility will be afforded. Graphical depictions are also provided. Comments on the draft guidance must be submitted by January 8, 2018 (Notice, 82 FR 52036, November 9, 2017).
Background. On December 1, 2014, the FDA published a Final rule (79 FR 71156) implementing the nutrition labeling requirements of section 403(q)(5)(H) of the federal Food, Drug, and Cosmetic Act (FDC Act) for standard menu items in restaurants and retail food establishments in accordance with section 4205 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148).The compliance date, which was originally scheduled for December, 1, 2015, was extended multiple times. Most recently, an Interim Final rule (82 FR 20825) published on May 4, 2017, extended the compliance date to May 7, 2018 (see FDA turns page on restaurant menu labeling back another year, May 2, 2017).
Guidance. The draft guidance is meant to address concerns raised by stakeholders, including:
- calorie disclosure signage for self-service foods (including buffet and grab-and-go food);
- criteria for distinguishing between menus and marketing materials;
- methods for providing calorie disclosure information;
- compliance and enforcement;
- determining nutrient content for standard menu items;
- covered establishments;
- standard menu items; and
Self-service foods. Covered establishments are not required to have individual signs next to each buffet item. Compliance can be achieved by placing a sign next to each item or on the sneeze guard over the item, but it is also acceptable to place a single sign listing the information for multiple food items. The customer must be able to view the name, calorie declaration, and serving of the food item. Illustrations are provided in the draft guidance and also address grab-and-go food.
Menus versus marketing materials. Marketing materials are not considered menus or menu boards and do not require calorie declarations. If the primary purpose of the material is to lure the customers into the establishment, then the material is not considered a "primary writing" and does not require calorie declarations.
Methods for providing calorie disclosure information. The draft guidance provides graphical examples for disclosing calorie information, including examples for pizza parlors.
Determining nutrient content. The draft guidance addresses how to determine nutrient content when there is multiple vendors of one item. It also provides examples of a "reasonable basis" to derive the nutritional content, and clarification on storage of information and required frequency of recalculating information.
Covered establishments and standard menu items. Establishments that do not sell substantially the same menu items are not a "covered establishment" and, therefore, are not covered by the rule. Food items that are routinely offered at a covered establishment can still be a standard menu item triggering labeling requirements even if other covered chains do not offer the same item.
Alcohol. The draft guidance distinguishes between beers listed on menus or menu boards, unlisted beers, and temporary menu items (beers listed on a menu for 60 total days per year). It also discusses determining nutrient content declarations.
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