Court Vacates FDA Deeming Regulations for Premium Cigars

Last week, Judge Amit Mehta of the U.S. District Court for the District of Columbia issued a ruling that vacates the U.S. Food and Drug Administration’s deeming regulations which pertain to premium cigars. When a court “vacates” a regulation, the regulation is cancelled or declared null and void. This decision was issued in a seven-year long lawsuit filed by the Cigar Association of America, the Premium Cigar Association, and the Cigar Rights of America against the FDA challenging the inclusion of premium cigars in the deeming regulations.

This ruling means that those cigars which meet the definition of a “premium cigar” would not be regulated by the FDA. In this lawsuit, the federal district court relied on a definition of “premium cigar” which requires that a cigar meet all of the following eight criteria:

1. Is wrapped in whole tobacco leaf;
2. Contains a 100 percent leaf tobacco binder;
3. Contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);
4. Is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);
5. Has no filter, nontobacco tip, or nontobacco mouthpiece;
6. Does not have a characterizing flavor other than tobacco;
7. Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and
8. Weighs more than 6 pounds per 1,000 units.

In July of 2022, Judge Mehta issued a ruling that the FDA’s decision to include premium cigars in the deeming regulations to exert regulatory authority over these products was arbitrary and capricious because the agency failed to consider data submitted to it concerning the use of premium cigars and the health effects of such use. Based on that decision, Judge Mehta needed to decide whether to vacate those portions of the deeming regulation that regulated premium cigars or remand, or send the issue back to the FDA to correct the deficiencies in the provisions of the deeming regulations related to premium cigars.

The decision issued by Judge Mehta on August 10 vacated those portions of the rule related to premium cigars in their entirety and did not provide the FDA an opportunity to correct the deeming regulations. The FDA has the right to appeal this latest court decision to the U.S. Circuit Court of Appeals. A copy of the court decision issued yesterday is here.