Since 2020, when the Food and Drug Administration (FDA) began considering millions of applications from companies seeking permission to keep selling their nicotine vaping products, it has rejected almost all of them. All of the products it has approved are tobacco-flavored, reflecting the agency's conviction that other flavors, which are the ones that former smokers overwhelmingly prefer, are dangerously appealing to teenagers. Yesterday a federal appeals court said that pattern and the shifting regulatory criteria underlying it amount to an unacknowledged and probably illegal policy change: The FDA moved the goal posts for applicants without admitting it was doing that, let alone justifying its decision.
The U.S. Court of Appeals for the 5th Circuit was responding to a lawsuit by R.J. Reynolds Vapor Company (RJRV), which challenged the FDA's decision to reject an application for the company's menthol-flavored e-cigarettes while allowing tobacco-flavored versions to remain on the market. The court granted RJRV's request for a stay that bars the FDA from enforcing a "marketing denial order" it issued in January until the case is resolved. Explaining its reasoning, a unanimous 5th Circuit panel said the company was likely to prevail in arguing that the FDA had violated the Administrative Procedure Act (APA) in several ways.
