Yesterday, a federal judge made it clear that the FDA must scrap its present plan to regulate premium cigars under the Deeming Rule, a 2016 regulation that gave the agency control over nicotine products that Congress did not specifically designate in the Tobacco Control Act.
After a protracted legal battle between three cigar industry associations and the FDA, U.S. District Court Judge Amit P. Mehta of the D.C. District rendered a decision that implies premium cigars will not be subject to premarket review or FDA enforcement proceedings.
Although the verdict won't immediately impact FDA regulation of vaping goods, it represents the agency's most humiliating and significant judicial setback since it increased its jurisdiction in 2016.
During the comment period, the FDA disregarded evidence.
According to Halfwheel, a cigar must be unflavored, wrapped in whole tobacco leaves, have a 100% leaf tobacco binder and at least 50% long filler tobacco, be handmade or hand rolled (simple tools are the only machinery used), and satisfy a few other requirements in order to qualify as a premium cigar under the FDA's definition.
The FDA was found to have disregarded public feedback on the proposed Deeming Rule, which addressed some of the agency's concerns over health risks and the potential threat that expensive cigars posed to public health. Judge Mehta rendered a decision against the FDA in this case last year.
"Where an agency speaks in absolute terms that there is no evidence, as it does here, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it," Mehta said in that ruling.
Last year, Judge Mehta requested arguments from the plaintiffs and the FDA before delaying a ruling on the remedy. The judge clarified that he might either revoke the regulation or send it back to the FDA for revision.
Mehta invalidated the regulation in his ruling yesterday, which means the FDA will have to start over if it wishes to continue regulating premium cigars. First, it must publish a proposed rule, gather feedback from the public, and then draft a final rule. It's unclear if the FDA will decide to take that action, file an appeal with a federal circuit court, or give up on regulating premium cigars entirely.
No immediate impact on court rulings regarding vaping
Other items covered by the Deeming Rule, including as nicotine pouches, little cigars, and vaping and heated tobacco products, will not be directly impacted by the decision. Despite the vaping industry's repeated legal challenges to the Deeming Rule, the FDA is committed to enacting a rule prohibiting flavored mass-market cigars anytime soon.
However, the result might make judges reconsidering their rulings in vaping cases in the future about the FDA's regulatory procedures and scientific claims.
According to Gregory Conley of the American Vapor Manufacturers Association, "premium cigar connoisseurs, cigar businesses, and their interest groups no doubt have much to celebrate today,"vaporboss. "Just as it has destroyed vaping companies, the FDA's one-size-fits-all approach to regulation would have destroyed small cigar manufacturers."
"Although the court's ruling is a damning critique of the FDA's scientific credibility, the judge's decision was extremely fact-specific on the distinctive qualities of cigars. Unfortunately, this decision won't have a significant impact on the vaping sector right away, but we think more judges will be standing up to FDA orders in the future.
