Earlier this afternoon, Judge Mehta of US District Court of Washington has issued a ruling that gives the cigar industry a temporary win.
Judge Mehta issued his decision on the remaining claims in the industry litigation, CAA et al v. FDA et al.
Among other things, Judge Mehta ruled for the industry, holding that FDA “arbitrarily failed to consider a streamlined substantial equivalence process for premium cigars.” Judge Mehta specifically pointed to CAA’s comments on the Proposed Deeming Rule as an example of a possible streamlined process FDA should have considered for “premium” cigars. As to all other issues raised by the industry, including the failure to have a final substantial equivalence rule out before SE Reports are due, Judge Mehta ruled that FDA’s “actions were lawful, reasonable, and adequately explained.”
Judge Mehta adopted the definition of “premium” cigar FDA provided in the August 5, 2020 notice filed in the American Academy of Pediatrics v. FDA case before Judge Grimm. That definition of “premium” cigar is as follows:
“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.”
Cigars meeting this definition do not have to comply with the upcoming September 9, 2020 SE Report deadline, and do not need to request a deferral, as FDA had suggested previously. Currently, based on this ruling, all other cigars and pipe tobacco do need to comply with the September 9, 2020 deadline.
CAA and legal counsel are continuing to evaluate all legal options open to the industry.
