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FDA Appeals Decision To Spare Cigar Industry From Regulation

Sep 29, 2023 | By David Savona
FDA Appeals Decision To Spare Cigar Industry From Regulation

In a move that surprised some of the American handmade cigar industry, the U.S. Food and Drug istration has appealed the Deeming Rule, which sought to severely limit how fine cigars are made, marketed and enjoyed. 

Back on August 9, Judge Amit Mehta ruled in the case known as Cigar Association of America et al, v. the U.S. Food and Drug istration that the FDA acted in “an arbitrary and capricious manner” in its actions against the makers of handmade cigars. In an opinion written prior to the ruling, he referred to one of the FDA’s arguments as “exactly the sort of nonresponsive, circular reasoning the court faulted previously… Instead of addressing the relevant data before it, the agency resorted to a common refrain to obscure the issue.” The FDA statement “was not accurate then, and despite litigation counsel’s efforts it is not accurate now,” he wrote.

“I think the judge was very clear the FDA didn’t provide relevant data,” says Rocky Patel. “The amount of money spent on appealing this case makes no sense at all—we make up 0.01 percent of all tobacco products. It’s very clear and evident they are not reasonable and not rational.” 

The appeal process will not be a quick one, and nothing is expected to happen for quite some time. “It will likely take a year for the U.S. Court of Appeals for the D.C. Circuit to consider this appeal and issue its decision,” says Drew Newman, one of the owners of J.C. Newman in Tampa, Florida. “In 30 pages of clear, unequivocal text, Judge Mehta explained why the FDA’s decision to regulate cigars was ‘arbitrary and capricious’ and not ed by substantial evidence. The burden will now be on the federal government to demonstrate that Judge Mehta’s conclusions were wrong. In recent years, federal courts have become increasingly skeptical of overreaching agency action like this. The science and the law are on our side.”

“This is disappointing but not entirely surprising. We will be as diligent and vigilant in fighting this appeal as we have been over the past seven years of litigation efforts,” says Scott Pearce, executive director of the Cigar Association (PCA). 

Cigarmakers and advocates expressed some level of optimism. “We remain confident that the facts of this case are on our side and that we will prevail on appeal,” wrote the Cigar Rights of America in an email. “Although this one will take longer than expected, I am confident that will ultimately prevail,” says Newman. 

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