The cigar industry suffered another defeat in court when Judge Amit P Mehta of the U.S. District Court of the District of Columbia ruled against Motion for Partial Summary Judgment filed by the cigar industry trade associations (Cigar Association of America, Cigar Rights of America, and the International Premium Cigar and Pipe Retailers Association) to delay the implementation of substantial equivalence which is scheduled to be enforced on May 12, 2020.

Substantial Equivalence marks a pathway where many cigar companies can keep product on the market introduced after February 15th, 2007 without going through a more costly pre-market approval process. It involves demonstrating a product is substantially equivalent to a product commercially marketed before February 15th, 2007. Products commercially marketed before that date are exempt from FDA regulation.

The argument by the cigar industry has been the specifics of what this process entails has not been defined. were

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.

The cigar industry trade associations turned back to the District of Columbia Court asking them to throw out the Maryland decision. In Judge Mehta’s decision denying the request by the cigar industry trade associations, he commented “Such an order would be tantamount to permitting a collateral attack on the AAP court’s order, which this court cannot do. See McNeil v. Brown, No. 17-CV- 2602, 2018 WL 4623057, at *7 (D.D.C. Sept. 26, 2018) (observing that ‘federal district courts lack the power to void or otherwise alter other federal courts’ orders through a collateral attack’). Because AAP vacated the FDA’s guidance wholesale, and the FDA remains bound by the AAP court’s decision unless an appeal overturns the decision, this court cannot issue a declaration in this case altering that reality.”

Draft guidance for Substantial Equivalence recently went through an open comment period as mandated by the FDA.