FDA Makes Opening Arguments In Appeal to Regulate Premium Cigars
The FDA attempted to make its case to three justices in hopes of overturning the ruling that frees the premium cigar industry from overregulation
It seemed to be a good day in court for the cigar industry this morning, or rather a difficult one for the FDA. The Food & Drug Administration made opening arguments earlier today in the United States Court of Appeals for the DC Circuit. The organization still hopes to overturn a previous judgment that voided its authority over the premium cigar industry. But the court didn’t appear to find much of the FDA’s argument compelling.
Last year, Judge Amit P. Mehta struck down the FDA’s decision to regulate premium cigars. The FDA appealed and made its opening remarks today before Judges Randolph, Millet and Pan.
Lindsey Powell, who represents the FDA, found herself struggling to convince the judges that premium cigars, despite low frequency of use, still pose material health risks high enough to warrant FDA regulation.
Powell testified: “If they’re not regulated people get the message that they are relatively safe. Patterns of use will change . . . If premium cigars are carved out from regulation, they are not subject to any of these FDA authorities . . . You can then have people handing out free samples and putting them in vending machines. And the federal minimum age of sales rules don’t apply. It’s a fundamental question about regulation.”
The judges weren’t so easily convinced of Powell’s assertions, citing an absence of data to support the claim.
“It just seems to me that the things you are saying we should be worried about probably are not really worrisome,” said Judge Pan. “They’re not selling premium cigars in a vending machine . . . They’re luxury products. Some of these cigars are very expensive.”
Powell argued that infrequent use does not negate danger, and that the risks were properly explained by the FDA in its regulatory proposal. “These are incredibly dangerous products,” she insisted.
“Wasn’t that the question you were supposed to answer?” responded Judge Pan, accusing Powel of having a circular argument. “Are these dangerous products? Maybe they’re not because of their patterns of use . . . If, based on the patterns of use, people use them very, very infrequently, they don’t have the same dangers. And that was the whole question that has not been answered. So, I don’t think you can rely on that answer to assume that it’s true.”
The premium cigar industry was represented by Michael Edney, who stated in his rebuttal: “Judge Mehta correctly held that the FDA’s decision to regulate premium cigars was arbitrary and capricious. The issue here is a finding regarding the specific differences between premium cigars and other cigars and that’s something that’s entirely absent from the final rule, and to the extent it was made, it was made erroneously.”
Drew Newman, who is a fourth-generation owner of J.C. Newman Cigar Co., also serves as the company’s legal counsel, and is optimistic about today’s showing in court.
“After hearing today’s oral argument, I am very optimistic that the court will rule in favor and affirm Judge Mehta’s decision to exempt premium cigars from FDA regulation,” Newman says. “All three judges demonstrated an excellent command of the case. They understood that premium cigars are different than other tobacco products and have different health effects.”
There is no deadline for the court to issue a decision in this case, Newman added. “If the court follows its typical timelines, we should expect a written decision early next year.”
Regardless of the outcome, either side can ask the Supreme Court to review the decision made by the DC Circuit.