Premium cigar manufacturers no longer have to worry about the upcoming September 9 deadline for some FDA premarket applications as a judge handed them victory in court today, striking down the process and granting them welcome regulatory relief.
In his decision in the case of Cigar Association of America, et al. v. U.S. Food and Drug Administration, et al., Judge Amit P. Mehta of the U.S. District Court for the District of Columbia wrote that the agency that oversees all tobacco products violated the American Procedure Act in its handling of the Substantial Equivalence approval process. As a result, Judge Mehta has sent that part of the FDA’s Final Deeming Rule back to the agency for further review.
Substantial Equivalence is one of the three pathways to product approval that the FDA established when it published its Final Deeming Rule in May 2016. According to the FDA, a cigar manufacturer must file an SE report to show that a new tobacco product has similar characteristics to a grandfathered (predicate) tobacco product, or has different characteristics, but doesn't raise any new questions of public health. A predicate tobacco product is one that was on the market on February 15, 2007.
Out of the three pathways to approval, Substantial Equivalence is the most costly and burdensome.
Today’s decision means that the Substantial Equivalence approval process is delayed until the agency figures out how it pertains to premium cigars. According to some manufacturers, this could take years.
“I think it’s a giant burden and weight off our backs,” Rocky Patel, owner of Rocky Patel Premium Cigars, told Cigar Aficionado. “This has been a well-thought out and hard-fought battle for saving the premium cigar industry and finally we can focus on what we do best.”
Robert Levin, owner of Ashton Distributors Inc. and retailer Holt’s Cigar in Pennsylvania, agreed with Patel.
“It was a long and very expensive court case, but the premium cigar industry should celebrate. The Cigar Rights of America and the Premium Cigar Association financed the lawsuit, and we picked the right attorney to represent us. Not having to submit premarket approval and Substantial Equivalence filings for all our products will allow our small industry to not only survive but prosper and grow.”