SCOTUS to Hear Vaping PMTA Suit FDA v. Triton

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 two companies’ premarket tobacco product applications (PMTAs) 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, according to Reuters.

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 such as “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. The rule said manufacturers of the products would need to apply for approval to continue selling them.

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.