A federal judge ruled yesterday that the FDA will have to abandon its current plan to regulate premium cigars under the Deeming Rule, the 2016 regulation in which the agency granted itself authority over nicotine products not specifically named by Congress in the Tobacco Control Act.
The decision from U.S. District Court Judge Amit P. Mehta of the D.C. District, is the culmination of a long court fight between three cigar industry associations and the FDA, and means that premium cigars will not be subject to premarket review or FDA enforcement actions.
The ruling will have no immediate effect on FDA regulation of vaping products, but is the most embarrassing and consequential legal defeat suffered by the agency since it expanded its authority in 2016.
To meet the FDA’s definition of premium cigars, according to Halfwheel, a cigar must be unflavored, wrapped in whole tobacco leaf, contain a 100 percent leaf tobacco binder and at least 50 percent long filler tobacco, be handmade or hand rolled (no machinery used except simple tools), and meet some other requirements.
Judge Mehta ruled against the FDA last year in the case, noting that the agency ignored public comment on the draft Deeming Rule that answered some of the agency’s questions about health risks and the public health threat of premium cigars.
“Where, as here,” wrote Mehta in that decision, “an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it.”
Judge Mehta last year postponed a decision on the remedy, asking for arguments from the plaintiffs and the FDA. The judge explained he could either vacate the rule or remand it to the FDA to repair.
In his decision yesterday, Mehta vacated the rule, meaning the FDA, if it still wants to regulate premium cigars, will have to begin the process again from scratch—issuing a proposed rule, accepting public comment, then creating a final rule. It isn’t known if the FDA will choose to do that, or appeal the case to a federal circuit court, or abandon regulation of premium cigars altogether.
The ruling won’t have a direct effect on other products subject to the Deeming Rule, including vaping and heated tobacco products, nicotine pouches, and small cigars. All of the vaping industry’s attempts to challenge the Deeming Rule in court have failed so far, and the FDA still intends to issue a rule banning flavored mass-market cigars soon.
But the decision could encourage judges ruling on future vaping cases to think twice about the FDA’s scientific claims and its regulatory processes.
“Premium cigar connoisseurs, cigar businesses, and their interest groups no doubt have much to celebrate today,” the American Vapor Manufacturers Association’s Gregory Conley told Vaping360. “FDA’s one-size-fits-all approach to regulation would have decimated small cigar manufacturers in much the same way it has vaping companies.”
“While the court’s opinion is a scorching indictment of the FDA’s scientific integrity, the judge’s holding was very fact-specific to the unique characteristics of cigars. Regrettably, this case will not lead to major changes for the vaping industry in the short-term, but we are optimistic that the number of judges pushing back on FDA edicts will continue to grow.”