The FDA is helping the cigar industry in the fight against the agency itself. Yes, it’s happening as today the U.S. Food and Drug Administration (FDA) has filed an appeal on the decision of Judge Paul Grimm of the United States District Court for the District of Maryland which moved to accelerate the timetable where Substantial Equivalence filings would take place from August 8, 2021 to May 12, 2020. That case was filed by the American Academy of Pediatrics who argued the FDA did not have the authority to delay the implementation of the Deeming Regulations to August 2, 2021.
The FDA’s motivation for this appeal is that the rulemaking process for implementation of Substantial Equivalence has not yet been completed.
The CRA, CRA, and IPCPR (now PCA) have been fighting the FDA in regards to the Deeming Regulations the FDA issued which impact premium cigars. There is ongoing litigation between the trade associations and the FDA in the U.S. District Court of the District of Columbia. The cigar trade associations tried for a motion of summary judgement to have the District of Columbia court thrown out the Maryland court ruling. Last week, Judge Amit Mehta of that court denied that motion.
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.
Cigar Rights of America stated that, “The original Guidance was issued during our litigation against the agency and allowed Premium Cigar manufacturers to hold off the expansive and outrageous requirements of preparation, fining and prosecution of SE Reports. While Judge Mehta denied our Motion to overrule Judge Grimm’s Order with respect to CRA, PCA and CAA Members on strictly procedural grounds, we are proceeding to vigorously contest the application of the SE Rules to Premium Cigars and towards that end, endorsed and filed an Amended Complaint this week with Judge Mehta including new and clarified claims with respect to SE Reports.”