United States: Menu Labeling: The FDA's Final Rules And Guidance

The FDA recently published a final rule entitled " Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments" (the rule). The rule mandates that, among other things, certain restaurants and food establishments must provide consumers with calorie and other nutrition information for standard menu items. A brief discussion of the rule, its requirements and an accompanying, recommended, but non-binding, FDA Guidance follows:

Who Must Comply?

  • Restaurants and similar retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu items.

For example, a franchise restaurant chain with 20 or more locations— regardless of the type of ownership (e.g. individual franchises)—would be subject to the rule.

When is the Deadline for Compliance?

  • The rule is effective December 1, 2015, and all establishments subject to the rule must comply by that date.

What items are covered?

  • "Standard menu items," i.e. any "restaurant-type food routinely included on a menu or menu board or routinely offered as a self-service food or food on display."

Covered items include items offered on a salad bar, buffet line or cafeteria line; self-service beverages; and food offered on breakfast, lunch, dinner, dessert, children's or beverage menus.

Items not subject to the rule include condiments for general use, daily specials not routinely listed on the menu, temporary items appearing on the menu for less than 60 total days, custom orders requiring deviation from the standard menu and food being offered for less than 90 consecutive days as part of a customary market test.

What are the Labeling Requirements?

  • The rule establishes requirements for:

The information that must be displayed on menus and menu boards including: (a) number of calories; (b) a "succinct statement" that enables consumers to understand the significance of the calorie information in the context of a total daily diet; and (c) a statement on menus and menu boards about the availability of additional written nutrition information.

Nutrition information that must be available in written form on the premises of the covered establishment and provided to the customer upon request; and

        Labeling requirements for standard menu items that are self-service or on display.

Additional and very specific information about the labeling requirements is set forth in the Guidance.

What are the accuracy requirements of the rule?

  • The rule requires that there be a reasonable basis for nutrient declarations. The rule further provides that nutrient values may be determined by using: (a) nutrient databases, (b) cookbooks, (c) laboratory analysis, or (d) other reasonable means such as Nutrition Facts on packaged food labels, FDA nutrient values for raw fruits, vegetables and cooked fish. Reasonableness will likely be determined based on accuracy and consistency and steps taken to ensure that the method of preparation and amount of a standard menu item offered for sale adhere to the factors on which the nutrient values were determined.

For example, when a restaurant offers a turkey sandwich for sale as a standard menu item and determines the nutrition information for the sandwich based on a recipe along with nutrition information provided in a cookbook, if the recipe specifies using one tablespoon of mayonnaise, the restaurant must take reasonable steps to ensure its employees use one tablespoon of mayonnaise when preparing the sandwich.

How will the FDA enforce the accuracy of nutrient information?

  • The FDA requires that a restaurant or food establishment provide upon request information substantiating nutrient values including the method and data used to derive these nutrient values. The information must be provided within a reasonable period of time. The specific information required varies depending on the method used to determine nutrient values.

If, for example, a restaurant uses a cookbook to determine nutrient values, upon request, the restaurant will be required to provide the FDA with: (a) "the name, author, and publisher of the cookbook used;" (b) "if available, information provided by the cookbook or from the author or publisher about how the nutrition information for the recipes was obtained;" (c) "a copy of the recipe used to prepare the standard menu item and a copy of the nutrition information for that standard menu item as provided by the cookbook;" and (d) "a statement signed and dated by a responsible individual employed at the covered establishment certifying that the covered establishment has taken reasonable steps to ensure that the method of preparation (e.g. types and amounts of ingredients in the recipe, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined.

What penalties apply if the labeling does not comply with the rule?

  • Violations of the rule may result in enforcement action consistent with the penalties established in the Federal Food, Drug, and Cosmetic Act (FDCA).

For example, introducing a misbranded food in interstate commerce is a prohibited act under Section 301 of the FDCA ( 21 U.S.C. 331), carrying criminal penalties under Section 303 of the FDCA ( 21 U.S.C. 333). In addition, under Section 302 of the FDCA ( 21 U.S.C. 332), the United States can bring a civil action in federal court to enjoin a person who commits a prohibited action. Under Section 304(a)(1) of the FDCA ( 21 U.S.C. 334(a)(1)), the food item may be seized by order of a Federal court.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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