Cigar Industry Fights to Delay FDA Product Approval Deadline
- July 3, 2019 |
- By Andrew Nagy
The fight between the cigar industry and the FDA continued yesterday when the three major cigar industry associations filed a motion asking a Washington D.C. court to maintain the compliance deadlines that had been previously been set for handmade cigars.
Filed in front of Judge Amit P. Mehta of United States District Court for the District of Columbia, the motion seeks to keep the August 2021 deadline, arguing that any Substantial Equivalence reports for handmade cigars that were on the market as of August 2016 should be allowed to submit applications at that point, two years from now.
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 files 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.
Back in July 2017, then-FDA commissioner Dr. Scott Gottlieb extended the SE report deadline to August 2021, and this deadline was recognized by Judge Mehta.
Earlier this year, in May, a Maryland judge ruled in favor of a coalition of public health groups that had sued the FDA and ordered the agency to speed up its approval process for deemed tobacco products.
The motion was filed on behalf of the Cigar Rights of America, Cigar Association of America and Premium Cigar Association, formerly known as IPCPR.