On Wednesday, August 19, 2020, the U.S. District Court for the District of Columbia issued an order enjoining FDA from enforcing the premarket review requirement contained in the agency’s “Deeming Rule” against “premium cigars” (as defined in the order) until the agency completes a review of the question of “whether a streamlined substantial equivalence process is appropriate for premium cigars.” The opinion does not throw out the Deeming Rule in its entirety but only remands it to the agency for further consideration of this question.
The DC Court’s order defines a “premium cigar” as a cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar); (4) is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling); (5) has no filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weighs more than 6 pounds per 1,000 units. This definition was taken from FDA’s own proposed guidance.
The issuance of this opinion comes two weeks after the FDA filed a remarkable Notice of Filing of Request for Clarification of Scope of Remedy Order with the Maryland District Court in the American Academy of Pediatrics vs. FDA case advising that FDA intends to issue new guidance describing “how manufacturers and importers of premium cigars may, on a case-by-case basis, request deferral of enforcement of the premarket authorization requirement for products meeting the definition of premium cigars set forth in the guidance,” and “out of an abundance of caution and because plaintiffs have indicated their contrary view” requesting authorization from the Maryland Court to issue this guidance.
The DC District Court’s order seems to have given premium cigars another reprieve of unspecified time from the September 9, 2020 premarket authorization filing date. It appears that FDA may intend to apply a different enforcement mechanism to this product segment. What is unclear is how long the delay will last. FDA’s task from the DC District Court is to assess the “appropriateness” of a “streamlined” substantial equivalence premarket authorization process. The FDA may take the form of the guidance that is pending approval from the Maryland Court, or FDA conceivably could consider an entirely different regulatory regime.