US Supreme Court to hear fight over FDA denial of flavored vape products

By John Kruzel

WASHINGTON (Reuters) - The U.S. Supreme Court agreed on Tuesday to hear the U.S. Food and Drug Administration's defense of the agency's rejection of applications by two companies to sell flavored vape products that it has determined pose health risks for young consumers.

The justices took up the FDA's appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

The Supreme Court is due to hear the case in its next term, which begins in October.

Two e-cigarette liquid makers, Triton Distribution and Vapetasia LLC, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade and crème brulee, and names including "Jimmy The Juice Man Strawberry Astronaut" and "Suicide Bunny Bunny Season."

An FDA rule that took effect in 2016 deemed e-cigarettes to be tobacco products, like traditional cigarettes, subject to agency review under a 2009 federal law called the Tobacco Control Act, and said manufacturers of the products would need to apply for approval to continue selling them.

Although the agency maintains that it has not categorically banned flavored e-cigarette products, companies seeking the agency's approval must clear a high legal bar since such products pose a "known and substantial risk to youth," the FDA said in a court filing.

For regulatory approval, companies must show, among other things, that their marketing would be "appropriate for the protection of the public health."

The FDA rejected the applications by the two companies, along with more than one million other products, according to court records. The FDA has approved only 27 e-cigarette products, all tobacco or menthol flavored.

Triton and Vapetasia in 2021 asked the New Orleans-based 5th U.S. Circuit Court of Appeals to review the FDA's denial of their applications.

In January, the full slate of 5th Circuit judges ruled 10-6 that the FDA had been arbitrary and capricious, in violation of a federal law called the Administrative Procedure Act, by denying the applications without considering plans by the companies to prevent underage access and use.

Judge Andrew Oldham, an appointee of Republican former President Donald Trump, wrote in the ruling 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.

Oldham said that fell short of the agency's obligation to "turn square corners," or deal straightforwardly with companies.

Eric Heyer, an attorney for Triton, said the company "looks forward to having the Supreme Court review FDA's surprise, after-the-fact imposition of new study requirements and failure to follow its own guidance for applicants."

The 5th Circuit ruling created a split with other federal appellate courts that have reached conflicting conclusions on the issue, and prompted the FDA's appeal to the Supreme Court.

(Reporting by John Kruzel; Editing by Will Dunham)