FDA Postpones and Reconsiders Menu Labeling Regulation; Comments Due July 3, 2017

May 2, 2017By Etan J. Yeshua

FDA has again decided to delay the compliance date for its regulations governing calorie labeling for menus and menu boards at restaurants and similar retail food establishments. In an unpublished Interim Final Rule (IFR) released on May 1 (and scheduled to be published in the Federal Register on May 4), FDA states that it will delay the compliance date for menu labeling from May 5, 2017 to May 7, 2018. The Agency is reconsidering certain aspects of the menu labeling regulations and requesting comments from industry and other stakeholders. FDA says it is “taking this action to enable [FDA] to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration’s policies.”

The delay in the compliance date will be effective immediately upon formal publication of the IFR in the Federal Register. FDA cites the good cause exception of the Administrative Procedure Act (5 U.S.C. 553(b)(B)) as its basis for not following notice and comment rulemaking before issuing the delay. Specifically, the Agency says that because “a number of regulated establishments continue to raise numerous, complex questions about applicability of the menu labeling requirements and about how to implement them, we have decided that providing an opportunity for public comment would be impracticable and contrary to the public interest.”

As we reported here, the deadline for compliance with FDA’s final menu labeling regulations has been delayed a number of times. Back in 2010, the Affordable Care Act required 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. In response to requests from industry, FDA extended the compliance date to December 1, 2016. Then, in the omnibus appropriations bill for 2016, Congress prohibited FDA from using appropriated funds to implement the rule until one year after FDA would issue a final guidance on the menu labeling requirements. FDA issued the final guidance document in May 2016 and later formally extended the compliance date to May 5, 2017.

FDA has received five requests for an extension of the compliance date and a Citizen Petition that asked FDA to delay and reconsider the final menu labeling rule. (In the IFR, the Agency states that it intends to add the five requests to the docket on Regulations.gov).

Although this week’s announcement of the delay has not been framed as a response to any one of the various requests from industry, the Agency states that “continued, fundamental questions and concerns with the final rule suggest that critical implementation issues, including some related to scope, may not have been fully understood and the agency does not want to proceed if we do not have all of the relevant facts on these matters.” In its request for comments, FDA is particularly interested in “approaches to reduce the regulatory burden or increase flexibility with respect to:

(1) Calorie disclosure signage for self-service foods, including buffets and grab-and-go foods;

(2) methods for providing calorie disclosure information other than on the menu itself, including how different kinds of retailers might use different methods; and

(3) criteria for distinguishing between menus and other information presented to the consumer.”

Issue (3) is one that has caused considerable confusion and that we have blogged about before.

FDA is requesting that comments be submitted within 60 days after the IFR is published, i.e., by July 3, 2017.