Judge Tosses FDA's Rule Over Premium Cigars
WASHINGTON, D.C. — The Food and Drug Administration's (FDA) attempt to regulate premium cigars under its 2016 deeming rule has gone up in smoke.
On Aug. 9, Judge Amit Mehta of the U.S. District Court for the District of Columbia issued a ruling that vacates the agency's deeming regulations which pertain to premium cigars. As a result of the ruling, according to the National Association of Tobacco Outlets (NATO), the regulation is cancelled or declared null and void.
Mehta's issued the decision in a lawsuit filed by the Cigar Association of America (CAA), the Premium Cigar Association and the Cigar Rights of America, bringing an end to a seven-year legal battle. Following the ruling cigars which meet the definition of a "premium cigar" would not be regulated by the FDA.
[Read more: Cigar Associations File Suit Against FDA's 'Unlawful' Deeming Rule]
According to NATO, in the lawsuit, the federal district court relied on a definition of "premium cigar" which requires that a cigar meet all of the following eight criteria:
- Is wrapped in whole tobacco leaf;
- Contains a 100 percent leaf tobacco binder;
- Contains at least 50 percent (of the filler by weight) long filler tobacco;
- Is handmade or hand rolled;
- Has no filter, nontobacco tip or nontobacco mouthpiece;
- Does not have a characterizing flavor other than tobacco;
- Contains only tobacco, water and vegetable gum with no other ingredients or additives; and
- Weighs more than 6 pounds per 1,000 units.
"This is a big victory for cigar enthusiasts across America. The evidence clearly showed the public would receive little benefit resulting from FDA regulation of premium cigars. Moreover, regulation would add burdensome costs to all premium cigar manufacturers which cannot be justified," said CAA President David Ozgo.
The decision comes one year after Mehta issued a ruling that the agency's decision to include premium cigars in the deeming regulations to exert regulatory authority over these products was arbitrary and capricious. In July 2022, the judge said the FDA failed to consider data submitted to it concerning the use of premium cigars and the health effects of such use, NATO said.
Based on that decision, Mehta needed to decide whether to vacate those portions of the deeming regulation that regulated premium cigars or send the issue back to the FDA to correct the deficiencies in the provisions of the deeming regulations related to premium cigars.
As a result of the decision to vacate those portions of the rule related to premium cigars, the FDA does not have an opportunity to correct the deeming regulations. The agency has 60 days to appeal the decision to the U.S. Circuit Court of Appeals, NATO added.