Government Will Appeal FDA Premium Cigar Lawsuit Decision

The FDA premium cigar lawsuit is not over just yet.

Multiple sources have informed halfwheel that the Department of Justice will appeal last month’s decision in Cigar Association of America et al. v. United States Food and Drug Administration et al. In August, Judge Amit P. Mehta made a sweeping, albeit expected, ruling that granted relief to the plaintiffs in the case, three cigar industry trade groups that sued FDA in 2016 on behalf of the premium cigar industry.

Mehta’s August 2023 ruling determined the form of remedy; the judge had already decided in July 2022 that the U.S. Food & Drug Administration erred when considering how to regulate premium cigars. Specifically, he found the agency ignored comments that showed that premium cigars—larger, unflavored cigars—were not used in the same way as their smaller and oftentimes flavored counterparts. After more than seven years, Mehta opted to vacate the rule for cigars that met a definition of “premium cigars,” meaning those cigars were no longer subject to FDA’s deeming regulations, meaning those cigars would not be required to submit to testing requirements, companies would not have to pay user fees for those cigars and companies could once again give away those cigars for retail promotions or charitable donations.

Just a couple of weeks ago, FDA acknowledged that decision and one of its impacts, telling cigar companies that it did not plan to assess user fees for “premium cigars” sold during Q4 FY23.

The Department of Justice, which represents FDA on legal matters, had 60 days to appeal the ruling. It’s unclear whether the agency will ask a court for a stay, which could reenact the deeming regulations for “premium cigars” as the appeal process works itself out.

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.