September 14, 2015

FDA Releases Much-Anticipated Menu Labeling Rule Draft Guidance

3 min

Covered Restaurants and Retail Food Establishments Receive Needed Direction; Many Questions Remain Unanswered

Late last week, the U.S. Food and Drug Administration (FDA) issued its Draft "Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods—Part II" (Draft Guidance). The Draft Guidance will help industry better understand the nutrition labeling requirements in the Agency's "Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments" Final Rule (Menu Labeling Rule or the Rule). As we reported in July, FDA previously extended the Menu Labeling Rule compliance date until December 1, 2016.

On December 1, 2014, FDA published the Menu Labeling Rule requiring covered establishments to disclose calorie and certain nutrition information for standard menu items. The Rule defines "covered establishment" as a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, e.g., individual franchises) and offering for sale substantially the same menu items. Covered establishments also include restaurants or similar retail food establishments that voluntarily registered to be covered.

Per the statement of Dr. Susan Mayne, Director of FDA's Center for Food Safety and Applied Nutrition (CFSAN), the Draft Guidance contains answers to many of the most frequently asked questions posed by industry that have been received by the Agency. What the document does not address are the controversial elements of the Rule, such as its uniform application to grocery stores and restaurants alike, and the high costs of compliance that covered establishments face related to, among other things, determining calorie and nutrition information for menu items. Moreover, it remains to be seen how the Rule will be enforced. It is unlikely that FDA will primarily enforce the Rule's requirements because of the Agency's limited resources. While state and local health inspectors could enforce the Rule on FDA's behalf, it is more likely that private litigants will "enforce" the rule through suits alleging that, for example, covered entities' calorie counts are inaccurate.

The Draft Guidance largely tracks the Rule, although it goes into additional detail on a few items, such as:

  • Whether marketing material is required to bear calorie information (e.g., a pizza coupon that includes a phone number to place the order states, "1 large pepperoni and sausage pizza $9.99");
  • How to declare calorie information for combination meals (e.g., whether a combination meal that is pictured along with its name on the menu, and another section of the menu that includes the name, description, and price of that item, are both required to have calories listed); and
  • How to declare calorie information for items such as party platters.

Because of the heavy reliance on examples in the Draft Guidance, it may be limited in its helpfulness to those covered entities that cannot identify with the hypotheticals provided.

If you have questions regarding the issues raised in this alert, or would like to submit comments to the Agency regarding the Draft Guidance, please contact one of the authors.