FDA policy lets some flavored vapes stay on shelves without full approval, raising expert concerns

The Food and Drug Administration announced a new guidance that allows certain flavored e-cigarettes and nicotine pouches to remain on the market even though they have not received full authorization.

Under the guidance, a product can stay available if the manufacturer has filed an application that the FDA has accepted and, for flavored vapes, has supplied data the agency considers sufficient to judge whether the product protects public health, weighing youth-use risk against any benefit.

Public health experts warned that the policy acts like a "get-out-of-jail-free card" for companies selling products illegally, and they expressed concern that the FDA’s large backlog of applications may delay proper review.