Lawyer Commentary JD Supra United States FDA’s Delay of the Menu Labeling Rule Challenged

FDA’s Delay of the Menu Labeling Rule Challenged

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Two consumer advocacy groups recently sued the Food and Drug Administration (FDA) for delaying the compliance deadline for the agency’s 2014 menu labeling rule for a fourth time. The menu labeling rule requires menu items offered for sale in restaurants with 20 or more locations to disclose nutritional information and the number of calories in each standard menu item. FDA and Congress previously extended or delayed compliance with the menu labeling rule three times in 2015 and 2016. Before the latest delay, the most recent “compliance date” for the menu labeling rule was May 5, 2017.

FDA’s Justification of the Delay

The day before the compliance date, FDA delayed the compliance date for an additional year by issuing an interim final rule. This interim final rule stated the extension of the compliance date was (1) consistent with three executive orders and (2) done in response to questions raised by stakeholders affected by the menu labeling rule and its implementation. Two of the executive orders cited were issued by President Trump and address regulatory reform and regulatory costs. President Obama issued the third executive order, which discusses retrospective analyses of existing regulations. Since the menu labeling rule took effect in 2015, it would be considered an existing regulation, though FDA has delayed compliance with the rule. FDA also stated its desire to reconsider the menu labeling rule and indicated that the rule’s requirements may change as a result. FDA announced it would accept comments regarding the agency’s extension of the compliance date and implementation of the already-effective final rule.

Today, FDA announced an extension of the comment period. FDA will now accept comments until August 2, 2017, a few weeks prior to the next step in the litigation on the interim final rule, as discussed below. It is possible that the agency could use the additional comments on the extension of the compliance date to further justify the delay of the compliance date.

Alleged Administrative Procedure Act Violations

In Center for Science in the Public Interest v. Price, the consumer groups challenged the interim final rule and the agency’s delay of compliance with the 2014 menu labeling rule on Administrative Procedure Act (APA) grounds. The consumer groups argued the interim final rule was arbitrary, capricious, an abuse of discretion and issued in violation of the APA’s procedural requirements, discussed below. The lawsuit asks the US District Court for the District of Columbia to vacate the FDA’s interim final rule and to declare that compliance with the menu labeling rule is required no less than 15 days after the court’s ruling...

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