Today the U.S. Court of Appeals for the D.C. Circuit concluded the Food & Drug Administration failed to conduct the proper analyses before rejecting some vaping product applications. The court's unanimous decision in Fontem US v. FDA upheld the FDA's denial of Fontem's application to market flavored vaping products, in line with prior D.C. Circuit precedent, but rejected the FDA's denial of Fontem's applications for unflavored products, and became the second circuit court of appeals to accuse the FDA of a "surprise switcheroo" when reviewing vaping product applications. This is all further evidence that the FDA has a vaping problem.
The FDA regulates vaping products—also known as ENDS or "electronic nicotine delivery systems"—because it "deemed" them to be tobacco products in 2016, subjecting them to regulation under the federal Tobacco Act. As a consequence, all such products that were not on the market by 2007 must obtain the FDA's approval in order to be sold legally. Because of how narrowly the FDA defines individual products, this has meant the FDA has had to process applications for thousands and thousands of products, and in its rush to process these applications, the FDA appears to have cut some corners.
