FDA Law Blog: FDA Sued Over its Delay of the Menu Labeling Compliance Date and Reconsideration of the Regulations

FDA Law Blog: FDA Sued Over its Delay of the Menu Labeling Compliance Date and Reconsideration of the Regulations

FDA Sued Over its Delay of the Menu Labeling Compliance Date and Reconsideration of the Regulations Posted: 12 Jun 2017 04:34 PM PDT By Riëtte van Laack & Etan Yeshua – As we previously reported, FDA recently extended the compliance date for its restaurant menu labeling regulations to May 8, 2018. Just one day before the previous (May 5, 2017) compliance date, FDA published an interim final rule (IFR) that delayed compliance for one year and solicited comments on how the Agency can “further reduce the regulatory burden or increase flexibility.” On June 7, two consumer advocacy organizations sued FDA to have the IFR vacated and a more immediate compliance date instated. The Center for Science in the Public Interest and the National Consumer League (the plaintiffs) claim that FDA’s delay of the menu labeling rule was illegal because it did not “rationally explain[] why it was changing its interpretation of” the federal requirements, and because it did not provide an opportunity for public notice and comment before the delay took effect. First, the plaintiffs allege that FDA’s decision to delay the compliance date violated the Administrative Procedure Act (APA) by “departing from its prior interpretation of the [Affordable Care Act] and its prior conclusions about the importance of nutrition labeling without providing a rational explanation.” (The Affordable Care Act was the statutory basis for the menu labeling requirements.) They point to FDA’s own Regulatory Impact Analysis for the IFR – where the Agency assesses the costs and benefits of delaying the compliance date – to support the claim that FDA did not provide a rational explanation for the delay: the Agency’s analysis concludes that the costs of the delay in terms of reduction in benefits to the consumer ($5 million to $19 million) outweigh the benefits to industry ($2 million to $8 million). The plaintiffs also quote a spokesperson for the National Restaurant Association as opposing the delay. Second, the plaintiffs allege that FDA was not permitted to issue the IFR without providing an opportunity for public comment. Under the APA, an agency may forego notice and comment rulemaking and issue an IFR with an immediate effective date only when it has “good cause,” i.e., when it determines that it would be “impracticable, unnecessary, or contrary to the public interest” to follow the notice and comment procedures. The plaintiffs assert that FDA did not have the required good cause: they cite FDA’s preamble to the final menu labeling regulations, which states that the rule “provides flexibility where appropriate” by “accommodat[ing] different types of menus and menu boards and the various ways that standard menu items may be listed on menus and menu boards.” The plaintiffs request that the court declare the IFR “arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law, and to have been published without observance of legally required procedure, in violation of the APA.” They further request that the court issue an order vacating the IFR and set a compliance date for the final menu labeling rule that is within 15 days of the court’s order.