On January 16, a federal judge in the Eastern District of Kentucky dismissed a case brought by a vapor trade organization and one of its members, leaving in place the court-mandated May 12, 2020 deadline for premarket review submissions for suppliers of “deemed” tobacco products, such as electronic nicotine delivery systems (ENDS), cigars, pipe tobacco and hookah tobacco.
The lawsuit stems from an opinion issued by a federal judge in the District of Maryland, which overruled the then-existing FDA deadline and required that new deemed tobacco products on the market as of August 8, 2016 be subject to FDA enforcement actions beginning May 12, 2020 unless a request for FDA marketing authorization is filed by then. Plaintiffs filed the Kentucky lawsuit, arguing that the FDA’s suggestion of a ten-month deadline in its briefing to the Maryland court was “a transparent attempt at regulation by litigation” that “circumvented the proper notice-and- comment procedure” required by federal law. Accordingly, plaintiffs asked the court for injunctive relief, preventing the FDA from enforcing the May 12 deadline, and a declaratory judgment stating that enforcement of that deadline violated federal statutory and constitutional law.
FDA moved to dismiss the complaint, arguing, among other things, that the court lacked jurisdiction because plaintiffs did not have standing to bring the lawsuit. The court accepted this argument, reasoning that the plaintiffs’ predicament was not caused by the FDA, but “entirely a function of a judicial ruling.” The court rejected the plaintiffs’ argument that the FDA’s suggested 10-month deadline was a motivating factor in the Maryland court’s decision and noted that the FDA was not the cause of the injury simply because the agency would be imposing the regulatory deadline. Rather, the court stated that the FDA, as a party to the litigation, must obey the Maryland court’s order.
Please feel free to contact us with questions you may have regarding this judgment or FDA’s May 12 deadline.