FDA Denial of Pre-Approval of Flavored Vape Pods Upheld (Correct)

The Food and Drug Administration acted reasonably in denying e-cigarette company Magellan Technology Inc.'s request for authorization to market flavored vape cartridges, a federal appeals court ruled Friday.

The US Court of Appeals for the Second Circuit 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 non-clinical 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.

The FDA’s denial of ...