As an important product approval deadline looms, the cigar industry asked a trio of circuit court judges this morning for relief.
Last July, Judge Paul Grimm of the U.S. District Court for the District of Maryland ruled against the FDA’s decision to extend the Substantial Equivalence deadline to 2021, shortening it instead to May 12, 2020.
Substantial Equivalence is one of the three pathways to product approval that the FDA outlined in its Final Deeming Rule of 2016. It allows a cigar manufacturer to file a report showing that a new tobacco product has similar characteristics to a grandfathered (or 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.
In response to Judge Grimm’s ruling, the three main cigar lobbying groups—Cigar Association of America, Cigar Rights of America and the Premium Cigar Association—filed a motion to intervene, hoping to push the date back to 2021.
This morning, attorney Mark Raffman argued for the cigar industry in front of Judges G. Steven Agee, Stephanie D. Thacker and Allison J. Rushing, of the U.S. Court of Appeals for the Fourth Circuit. The oral arguments were given via video conference due to the Coronavirus outbreak.
The crux of the cigar industry’s case is that when Judge Grimm offered his decision last July, he believed that he was primarily trying to help put an end to the youth vaping epidemic. At one point, the judges asked about a series of regulations the FDA is considering applying to flavored cigars.
“Flavored cigars are not 50 percent of the market, and two of our associations don’t make those cigars,” argued Raffman, “and those two associations are the ones who are going to bear the great burden of this order because they make the largest number stock-keeping units (SKUs), they’re FDA’s lowest priority and yet they’re the ones who are going to have to spend millions of dollars for the May 2020 deadline that the agency doesn’t even think is appropriate for those cigars.”
In his final remarks, Judge Agee said that he understood that the case was time sensitive and hoped to have a decision as soon as possible.