FDA Appeals Premium Cigar Ruling

The U.S. Food and Drug Administration on Jan. 31 appealed an August 2023 court ruling vacating the agency’s decision to regulate premium cigars, reports Halfwheel.

The court ruling stemmed from a lawsuit filed by the Cigar Association of America, the Cigar Rights of America and the Premium Cigar Association (PCA).

In 2022, Judge Amit Mehta issued an opinion examining the rulemaking record and detailing the FDA’s failure to address evidence in the record showing that premium cigars have different usage patterns, with different resulting health effects, than other cigars. Mehta later ruled that the FDA’s mishandling of significant questions that the FDA itself asked in its proposed rule merited vacating it, as the FDA never made a nonarbitrary decision to regulate premium cigars.

In its appeal, the FDA urges the court to elevate deference to the agency’s “scientific judgment” over its duty of explanation under the Administrative Procedure Act. The FDA also argues that Mehta should have sent the flawed rule back to the agency to fix it while allowing the FDA to continue regulating premium cigar retailers and manufacturers under the arbitrary rule in the meantime.

In a statement, the PCA said it would be responding to the FDA’s arguments and defending Mehta’s opinion in a forthcoming filing with the D.C. Circuit Court. A hearing before three judges of the appellate court is likely to follow.