FDA Sets Enforcement Date for Restaurant Menu (and Coupon!) Labeling

By Etan J. Yeshua –

Today, FDA officially announced the availability of a final guidance document that answers questions about the Agency’s menu labeling rule. In doing so, FDA also set May 5, 2017 as the rule’s enforcement date. Although there are only a few differences between the final guidance document and the draft that was published last September (which we reported on here), one difference that caught our eye appears to expand the Agency’s understanding of what constitutes a “menu” by including coupons and other materials that provide a web address where customers can place an order.

The final guidance is available here and is titled “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): Guidance for Industry” (hereinafter “final guidance document”).

The Countdown to Enforcement

As we’ve previously reported, the Affordable Care Act amended the Federal Food, Drug, and Cosmetic Act (FDC Act) in 2010 to require that certain chain restaurants and other covered establishments include calorie and other nutrition information on menus, menu boards, and elsewhere in the restaurant. FDA issued final regulations implementing those “menu labeling” requirements in 2014, and set a compliance date of December 1, 2015. Amid requests from industry, FDA extended the compliance date to December 2016. Then, Congress delayed the implementation date even further (in the omnibus appropriations bill for 2016) by postponing implementation until one year after FDA issues a final guidance on the menu labeling requirements. FDA released the final guidance document last Friday, and formally announced its availability (in the Federal Register) today, with enforcement to begin in one year.

The Definition of “Menu”

The final guidance document is largely identical to the draft that was published in September 2015. However, one seemingly minor addition in the final guidance document may result in restaurants and other covered establishments having to provide calorie information on many more marketing materials than previously thought.

FDA’s final regulations state that an establishment must provide calorie counts on “menus” and “menu boards,” and that certain materials may require calorie counts if they are “part of” the establishment’s menu or menu board: “Determining whether a writing . . . is part of the [menu or menu board] depends on a number of factors, including whether the writing lists the name of a standard menu item (or an image depicting the standard menu item) and the price of the standard menu item, and whether the writing can be used by a customer to make an order selection at the time the customer is viewing the writing.” Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments, 79 Fed. Reg. 71,156, 71,254 (Dec. 1, 2014) (to be codified at 21 C.F.R. § 101.11(a)) (emphasis added). In today’s final guidance document, FDA seems to take a more expansive view of this last factor than it previously did.

In the preamble to the final rule, FDA provided the following as examples of writings that “can be used by a consumer to make an order selection at the time the consumer is viewing the writing (e.g., the writing is posted at the cash register in a covered establishment, or the writing lists the phone number or email address of a covered establishment for purposes of placing an order).” 79 Fed. Reg. at 71,177 (emphasis added). The September 2015 draft guidance document similarly stated that “a pizza coupon that includes a phone number to place the order” is considered to provide a means to make an order selection. See FDA Draft Guidance: 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) at 19 (Sept. 2015) (emphasis added).

The final guidance document, however, states that even a “web address” can turn a coupon into a menu (provided, of course, that the coupon includes the name, or picture, and price of a standard menu item):

[I]n the example of a pizza coupon that includes a . . . web address where the customer can place an order and that states “1 large pepperoni and sausage pizza $9.99,” the “coupon” can be used by a consumer to make an order selection at the time a consumer is viewing the coupon (i.e., the coupon includes the name of the standard menu item, price of the standard menu item and a . . . web address where an order can be placed).

Final guidance document at 19-20.

It is not clear whether a “web address where the customer can place an order” (emphasis added) includes an establishment’s homepage (e.g., www.CafeEtan.com), or only the specific webpage from which customers can place an order (e.g., www.CafeEtan.com/order). It is also not clear whether a street address would similarly turn a coupon or other marketing material into a menu.

The Agency continues to accept comments to the final guidance document’s docket at www.regulations.gov, and questions about menu labeling at CalorieLabeling@fda.hhs.gov.