FDA ordered to reconsider denial of approval for vape products

By Brendan Pierson

Jan 3 (Reuters) - A federal appeals court on Wednesday ordered the U.S. Food and Drug Administration to reconsider its decision barring two makers of flavored liquid for e-cigarettes from marketing their products, saying the agency had been arbitrary and capricious in refusing to consider the companies' marketing plans.

The 9-5 decision by the New Orleans-based 5th U.S. Circuit Court of Appeals reversed a July 2022 decision by a three-judge panel of that court.

Circuit Judge Andrew Oldham, who was appointed to the court by Republican former president Donald Trump, wrote for the majority that the FDA had first asked e-cigarette companies for detailed plans about how they would market their products to prevent abuse by youth, saying those plans were crucial, but then denied their applications without looking at them. He said that fell short of the agency's obligation to "turn square corners," or deal straightforwardly with companies.

"No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people," he wrote, apparently likening executive branch agencies such as the FDA to a separate branch of government. "And FDA's regulatory switcheroos in this case bear no resemblance to square corners."

Eric Heyer, a lawyer for liquid makers Triton Distribution and Vapetasia LLC, said he was pleased with the ruling and hoped it would lead the FDA to make "a significant course correction by communicating with specificity" what companies must do to get approval.

The FDA declined to comment.

The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act, and said manufacturers of the products would need to apply for approval to continue selling them.

It initially considered e-cigarettes as having some promise in helping adult smokers transition from conventional cigarettes, but faced pressure from anti-smoking groups to restrict flavored e-cigarettes amid a rise in youth vaping.

Triton and Vapetasia had applied to market products with flavors such as sour grape, pink lemonade, crème brulee and milk and cookies and names including "Jimmy The Juice Man Strawberry Astronaut" and "Suicide Bunny Bunny Season."

In a series of decisions beginning in 2021, the agency has rejected more than a million applications, including Triton's and Vapetasia's, finding no studies show the products have any benefit for adult smokers. As of November, the FDA had approved only 23 e-cigarette products, all tobacco flavored.

In a dissent on Wednesday, Circuit Judge Catharina Haynes wrote that the FDA's decision was reasonable, since "even the most promising plans" for marketing were "irrelevant" if the products had no benefit for adults. (Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and Daniel Wallis)