The premium cigar industry suffered another defeat in court when 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. The appeal had been focused on moving the deadline for Substantial Equivalence filings for non-grandfathered products to August 8, 2021.

The cigar industry was teamed with two very unlikely partners as plaintiffs in the case – the U.S. Food and Drug Administration (FDA) and the Vaping industry. The court dismissed the appeal on numerous procedural grounds, but upheld a District Court’s ruling that the cigar industry should have interceded sooner, and the new guidance issued on January 2, 2020, mooted the vaping industry’s case.

When the Deeming Regulations were announced in May 2016, the plan was that product approval, which includes Substantial Equivalence, would be implemented beginning August 8, 2018. Shortly after U.S. President Donald Trump named Dr. Scott Gottlieb FDA Commissioner, Gottlieb announced a delay that pushed FDA approval out nearly three years to August 8, 2021. This triggered a lawsuit filed by the American Academy of Pediatrics in the U.S. District Court of Maryland against the FDA claiming the FDA did not have the authority to delay the implementation. It created an interesting scenario where the cigar industry and FDA were on the same page as far as the 2021 deadline. In May 2019 Judge Paul Grimm of the Maryland Court ruled against the FDA, restoring the original August 8, 2018 deadline. Since that time had passed, Grimm implemented a new date of May 12, 2020. Since then the district court extended the May 12 deadline to September 9th due to the impacts of the COVID-19 pandemic.

The Premium Cigar Association (PCA) issued a statement stating that “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, commented on the PCA’s statement. “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.”

Essentially this means, unless something comes from the June 24th hearing in District Court, the cigar industry will have the September 9th date as the deadline to file for substantial equivalence to keep non-grandfathered products on the market.