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FDA Draft Guidance on Menu Labeling

This article was last updated on September 16 at 11 AM.

The U.S. Food and Drug Administration (FDA) has issued a draft guidance document on its menu labeling rule.  Draft Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with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).

While comments on guidance documents may be submitted at any time, comments on this draft guidance must be submitted by November 2, 2015 to be considered by FDA before it prepares a final guidance document.

If you’re wondering if you missed Part I of the guidance document, don’t worry.  FDA explains that Part I is still in the works and will contain “guidance on other nutrition-related information that must be provided to customers of restaurants or similar establishments that are not covered by this guidance but that choose to make certain types of claims about nutrients in the food it serves or about beneficial health effects that can be obtained from the food it serves.”

The menu labeling final rule was issued on December 1, 2014.  In July, FDA published a notice delaying the compliance date from December 1, 2015 to December 1, 2016.

The draft guidance document clarifies a few aspects of the menu labeling rule, including:

  • Menu/menu board versus advertising/marketing materials

The menu labeling rule defines a “menu or menu board” as “the primary writing of the covered establishment from which a customer makes an order selection.”  In the preamble to the final rule, FDA explained that it would consider a writing to be a menu or menu board if it included the name (or image) and price of at least one standard menu item and it could be used by a customer to place an order while viewing the writing.  FDA also said that marketing materials, such as coupons and advertising circulars, would not be considered menus or menu boards. 

The draft guidance strictly applies FDA’s preamble definition of “menu or menu board.”  It says that a coupon for a pizza that includes the name and price of the pizza and a phone number to call to place an order is a menu or menu board and must include calorie information.  FDA does not say whether it must also include the succinct statement (“2,000 calories a day is used for general nutrition advice, but calorie needs vary”) and the statement of availability (“Additional nutrition information available upon request”), but that would appear to follow from FDA’s logic.  A “take out” or delivery menu also meets the definition of a “menu or menu board” and must provide calorie information, the succinct statement, and the statement of availability of written nutrition information.

FDA appears to take the position that any writing that includes the name and price of at least one standard menu item and that can be used to place an order is a “menu or menu board.”  

  • Menu boards with multiple panels

FDA says that, in general, it considers a multi-paneled menu board to be a single menu board “if the entire multi-paneled menu board is visible to consumers when consumers are placing order selections for the standard menu items listed on such menu board.”  This means, for example, that the succinct statement and the statement of availability need appear only once on one of panels.  However, in the case of an electronic menu board with multiple panels that rotate, the succinct statement and statement of availability must appear on all rotating displays that list standard menu items.    

  • Grab-and-go foods

Under the menu labeling rule, grab-and-go foods (e.g., a pre-packaged sandwich, wrap, or salad that consumers can select) are considered “self-service foods” requiring calorie information using one of three options: (1) on a sign or placard adjacent to and clearly associated with the food; (2) on a sign attached to a sneeze guard above the food; or (3) on a single sign or placard listing the names and calories of several menu items, as long as the sign is located where consumers can view the name, calories, and serving or unit of food while selecting the item.   The draft guidance states that grab-and-go packaged foods may instead provide a calorie declaration on the package itself, which FDA will consider equivalent to a sign adjacent to and clearly associated with the food.

  • Salad dressing is not an exempt food

The menu labeling rule provides that certain foods offered for sale in covered establishments, including items such as condiments offered for general use, are exempt from menu labeling.  The draft guidance makes clear that salad dressings in a salad bar do not fall within this exemption.

  • 4-6 weeks is a reasonable time to respond to FDA requests for substantiation

The rule requires that a covered establishment must provide FDA with information substantiating its calorie and nutrient declarations “within a reasonable period of time upon request.”  According to the draft guidance, FDA considers a reasonable period of time to be about 4-6 weeks after an FDA request.

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If you have any questions about the menu labeling rule that were not addressed in the draft guidance document, be sure to get them to FDA soon.  FDA says it will “collect questions from correspondence and other inquiries that we receive and consider including them in future editions of this guidance.”

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