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From Health Law Daily, September 16, 2015

FDA serves up some guidance on restaurant menu labeling requirements

By Mary Damitio, J.D.

The FDA is providing guidance to assist restaurants and food establishments in complying with new menu labeling requirements implemented by the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). The FDA’s draft guidance, which is presented in a questions-and-answers format, details menu labeling requirements and describes calorie and other nutrition information that must be provided for standard menu items and self-service food (Notice, 80 FR 55564, September 16, 2015).

ACA. Section 4205 of the ACA amended the Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 343(q)(5)(H) to require restaurants that are part of a chain of 20 or more locations doing business under the same name and offering substantially the same menu items, to provide calorie information for standard menu items. Additionally, such establishments are required to provide written nutrition information for all standard menu items.

Final rule. The FDA subsequently issued a Final rule to update restaurant menu labeling requirements in accordance with the ACA (21 C.F.R. Sec. 101.11) (see Finally final: FDA releases ACA-mandated menu labeling requirements, December 1, 2014).

Overview. The draft guidance provides information on the type of nutrition labeling that is required for food sold in covered establishments and describes how the information may be presented and when nutrition labeling is required for certain exempt food. Additionally, the draft guidance is intended to clarify other issues and serve as a companion to the FDA’s A Food Labeling Guide.

General requirements. The draft guidance provides various definitions such as what constitutes a “standard menu item,” or a “combination meal,” and provides general labeling requirements. Any covered establishment that makes nutrient content claims must provide nutrition information relating to those claims. For example, an establishment that makes a claim that a particular menu item is “high in Vitamin C,” must provide information as to the nutrient amounts as set forth in the draft guidance.

Nutrition labeling. The number of calories in each standard menu item “as usually prepared and offered for sale,” must be listed on either the menu or menu board, and a succinct statement must be included that allows consumers to understand the calorie information in the context of a total daily diet of 2,000 calories per day. The menus must also contain a statement that additional nutrition information is available upon request.

The draft guidance also details the manner in which calories must be broken down on menus, including for items that contain multiple servings, and states that calories must be listed adjacent to the name or price of menu items and calories must be rounded. The draft guidance also provides information on complying with the labeling requirements for home delivery items, self-service bars, such as salad bars, and individual food components such as pizza toppings.

Content determinations. The FDA also describes how establishments may determine the nutrient contents of their menu items and emphasizes that such establishments must have a reasonable basis for determining calorie and nutrient information that is provided for standard menu items. Nutrient calculations may be based on nutrient databases, values contained in cookbooks, laboratory analyses of food items, and other reasonable means such as packaged food labels that comply with FDC Act requirements. Additionally, the draft guidance provides instructions for determining and listing nutrient contents for alcoholic beverages.

Voluntary registration. Establishments that are not covered by the menu labeling requirements may voluntarily register to be covered and, in doing so, will not be subject to state or local labeling restrictions that are not identical to federal requirements.

MainStory: TopStory FDAGuidanceNotices FDCActNews FoodNews LabelingNews

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