FDA lets vape sales proceed without approval, sparking lawsuit and safety concerns

The Food and Drug Administration issued guidance that lets companies sell vaping and tobacco products while their pre-market applications are still under review, a practice that conflicts with the Tobacco Control Act’s requirement for FDA authorization before market entry. A coalition of public-health organizations has filed a federal lawsuit claiming the agency is ignoring Congress’s 180-day review deadline and exposing consumers to unsafe, often illicit, products—many imported from China.

The backlog of applications, which has ballooned to nearly 1,000 days since the Biden administration, was inherited by the Trump administration, which now seeks to address it. Enforcement operations such as “Operation Red Mist” have confiscated tens of millions of dollars in unauthorized e-cigarettes, yet the illegal market, estimated in the billions, persists. Former FDA commissioner Marty Makary estimates over half of vapes on shelves lack authorization, with some experts suggesting the figure could be as high as 90 percent. The article urges the FDA to abandon the risky shortcut, adhere to congressional timelines, and focus on promptly reviewing and approving safe products, warning that the current approach creates consumer confusion, invites litigation, and undermines public-health protections.