Continuing the pattern of delays in the implementation of a compliance date for the menu labeling final rule requirements (previously covered in our posts, FDA Delaying Enforcement (Again) for Menu Labeling Final Rule (March 2016) and LawFlash: FDA Issues Menu Labeling Final Guidance (May 2016)), FDA has issued an interim final rule (to be published on May 4, 2017) again extending the compliance date for menu labeling requirements by one year—from May 5, 2017 to May 7, 2018.
The rationale for FDA’s extension includes the agency’s continued concern about the fundamental questions of implementation as well as concerns related to the scope of establishments that must comply. FDA states that these concerns may not have been fully understood, and it does not want to proceed with implementation without the relevant facts on key matters at hand.
Thus, in addition to extending the implementation of the compliance date, FDA is requesting comments for 60 days on the implementation of the requirements—such as approaches to reduce regulatory burden or increase flexibility related to
- calorie disclosure signage for self-service foods, including buffets and “grab-and-go” foods;
- methods for providing calorie disclosure information other than on the menu itself; and
- criteria for distinguishing between menus and other information presented to the consumer.
Effective Date and Comment Period
The extension will be effective on May 4, 2017, when the Federal Register publishes the extension in advance of the May 5 compliance date. The 60-day comment period also will begin on that date.
Electronic comments should be submitted to http://www.regulations.gov and identified by Docket No. FDA-2011-F-0172 for “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date and Request for Comments.” Paper comments also must include the docket number and can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Impact of Potential ACA Repeal
Importantly, the menu labeling final rule is a statutory mandate under Section 4205 of the Patient Protection and Affordable Care Act of 2010 (ACA). Thus, if Congress repeals the ACA between now and May 2018, the requirements of the rule may be eliminated entirely. However, if the ACA stays in place but FDA significantly alters the scope of the rule (e.g., reducing establishment types required to comply or required nutritional information), the potential exists for states to undertake separate and distinct legislation requiring companies to implement multiple regulatory frameworks to accommodate differing state laws.