• July 12, 2024

Second Circuit Appeals Court Rules for FDA

 Second Circuit Appeals Court Rules for FDA

Credit: Andrey Popov

Credit: Andrey Popov

The U.S. Food and Drug Administration acted reasonably in denying vapor maker Magellan Technology’s request for a marketing order for its flavored vaping products, the U.S. Court of Appeals for the 2nd Circuit ruled May 16.

The court upheld the FDA’s finding that Magellan failed to show the product would provide a benefit to adult users that would outweigh the risks to youth.

The agency found Magellan’s evidence—four nonclinical studies—was insufficient to establish that the flavored pods would be more effective than tobacco-flavored electronic nicotine-delivery systems in helping smokers switch to e-cigarettes to stop smoking altogether, according to Bloomberg Law.

The manufacturer of Hyde and Juno brand e-cigarettes sued the FDA and the U.S. Department of Health and Human Services, claiming the agencies violated the Administrative Procedure Act.

New York-based Magellan Technology accused the agencies of refusing to review the company’s premarket tobacco product applications (PMTAs) for 12 products, a process that cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications.

“Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

Texas-based retailer Vapor Train 2 is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order that the FDA issued to Magellan, according to the lawsuit filed Thursday.

The companies are expected to appeal the ruling. Magellan could now seek an en banc review of the case (a rehearing by the full 2nd Circuit) or could appeal to the Supreme Court of the United States.