Hearing for FDA Premium Cigar Lawsuit Appeal Scheduled for Sept. 13 (Update)

Oral arguments in Cigar Association of America et al. v. United States Food and Drug Administration et al., the eight-year-old lawsuit over the FDA’s regulation of premium cigars, will take place Friday, Sept. 13, 2024, at 9:30 a.m. at the U.S. Court of Appeals for the District of Columbia.

The appeal is being made by the government, which lost the case last year. In August, Judge Amit P. Mehta ruled in favor of the three cigar trade groups that filed the case, finding that the FDA failed to properly evaluate comments submitted to the agency prior to the enacting of the 2016 deeming regulation. This meant that cigars that meet the definition of “premium cigars”—large handmade cigars that are not flavored—were no longer subject to FDA’s deeming regulations, such as testing requirements, user fees and a ban on giving away those cigars for retail promotions or charitable donations.

Update (Aug. 14, 2024) — The judges have been assigned, they are:

• Patricia Millett — an Obama appointee 
• Florence Y. Pan — a Biden appointee
• A. Raymond Randolph — a George H.W. Bush appointee

Update (Sept. 6, 2024) — Due to the recent passing and funeral of John J. Byron, who worked for the cigar trade groups on the case, the appeal’s start time has been moved from 9:30 a.m. to 9:00 a.m.

In the time since, the Department of Justice filed an appeal and the two sides have submitted written arguments to the appeals court. So far, these briefs have not been all that novel, largely rehasing many of the arguments that were made to Mehta. September’s hearing will allow the three judges to ask questions to the two sides.

Last month, the Supreme Court overturned Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., a landmark ruling that deals directly with how courts should handle regulations from executive agencies like the FDA. While Chevron was repeatedly mentioned throughout the lawsuit, it will be curious to see how much either side and the judges wade into the matter given that this case was decided and argued while the Chevron deference was still in place.

Update (Aug. 14, 2024) — The judges have been assigned. This story was originally published on July 15.

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.