Tuesday, May 5, 2020 (Washington, DC)—Yesterday, the U.S. Court of Appeals for the Fourth Circuit issued a ruling on the appeals of the U.S. District Court of Maryland’s decisions in the American Academy of Pediatrics (AAP) case. In sum, the court dismissed the appeal on procedural grounds, claiming that January 2, 2020, FDA guidance mooted the case for e-cigarettes and that the cigar industry should have sought to intervene sooner.
The Fourth Circuit case was about a very limited issue: Whether the FDA acted through proper procedures when it extended deadlines for submitting marketing applications for ”new tobacco products” in the “deemed” categories of products that FDA began regulating in August of 2016, including e-cigarettes. Importantly, the deadlines at issue apply only to “deemed” products and only to those that qualify as “new tobacco products,” that were on the U.S. market when FDA began regulating these categories of products (i.e., August 8, 2016), and that do not already have marketing authorizations issued by the FDA. The case focused almost exclusively on e-cigarettes, and the only thing at issue for cigars and pipe tobacco was the FDA’s authority to adjust the timing—to extend the deadline until August 2021 for submitting marketing applications. The case had nothing to do with the substance of the application review process itself or whether it is lawful.
That the district court in this case has extended the May 12 deadline to September 9 due to the impacts of the COVID-19 pandemic mitigates the impacts of yesterday’s decision to an extent. FDA sought this extension after PCA and other industry members and groups petitioned the agency to extend the deadline.
Although this appeal regarding the limited issue of the deadlines was not successful, the cigar associations have been fighting against the legality of the FDA’s review process for “new tobacco products,” and our claims will be heard by the United States District Court for the District of Columbia on June 24, to allow a decision on whether that process is legal when applied to premium cigars before the September 9 deadline. This has always been the primary path to achieve lasting relief for premium cigars from this unfair scheme.
Michael Edney, Chair of the Regulatory Litigation Practice at Steptoe & Johnson and lead counsel for the cigar associations, says he remains optimistic the premium cigar industry will ultimately be granted some relief. “We are evaluating the opinion regarding the limited issue of the FDA’s ability to extend deadlines and next steps. The premium cigar industry, however, continues to press ahead on its long-standing challenge to the legality of the substantial equivalence requirements as applied to our unique products. Notably, the deadline already has been extended to September 9 and we are confident our challenge will prevail before then.”