Magellan Technology, Inc. v. FDA (U.S. Court of Appeals, 2nd Cir., June 16, 2023) In Magellan Technologies v. FDA, the United States Court of Appeals for the Second Circuit upheld the FDA’s denial of a marketing order that would have allowed Magellan to sell flavored vape products. Read the full Opinion here.
The FDA may only permit vape products on the market if doing so is appropriate for the protection of the public health. Magellan submitted an application for approval of its pod-based, flavored vape products; that application did not include long-term studies revealing the public health basis for approval, though the application did contain some scientific evidence in support. Magellan alleged that the FDA applied a new standard requiring long-term scientific studies without following required processes when rejecting the company’s application. The Court found that the FDA’s application of the public health standard and the value the Agency places on long-term studies was not arbitrary or capricious. The Ninth Circuit reached the same outcome in a similar case, Lotus Vaping Technologies v. FDA. The FDA is continuing to work through applications for more than 26 million vape products. Read the full Magellan Opinion here.