FDA rejects Magellan flavored e-cigarettes
Time： 2023-06-20
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The U.S. Court of Appeals for the Second Circuit ruled on May 16 that the U.S. Food and Drug Administration was justified in denying e-cigarette maker Magellan Technology's request for a marketing order for its flavored vaping products.
The U.S. Court of Appeals for the Second Circuit ruled on May 16 that the U.S. Food and Drug Administration was justified in denying e-cigarette maker Magellan Technology's request for a marketing order for its flavored vaping products.
The court upheld the FDA's finding that Magellan failed to demonstrate that the product's benefits to adult users outweighed the risks to teens.
According to Bloomberg Law, the agency found Magellan's evidence -- four nonclinical studies -- insufficient to show that flavored pods were more effective than tobacco-flavored electronic nicotine delivery systems in helping smokers switch to e-cigarettes to quit smoking altogether.
The makers of Hyde and Juno brand e-cigarettes are suing 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 premarket tobacco product applications (PMTAs) for 12 of its products, a process that cost the company $1 million. Magellan claims the FDA rejected the applications "arbitrarily" and "capriciously."
"At the time of issuing the RTA order, Magellan had spent more than $1 million on the PMTA and planned to spend a total of more than $10 million on the PMTA," the lawsuit states.
Texas-based retailer Vapor Train 2 is also a plaintiff in the lawsuit. According to the lawsuit filed Thursday, the companies asked a Texas federal court to temporarily stay the FDA's RTA order to Magellan.
The companies are expected to appeal the ruling. Magellan can now seek a full review of the case (reviewed by the Second Circuit), or it can appeal to the U.S. Supreme Court.
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