FDA Issues New Guidance on Unauthorized E-Cigarettes and Nicotine Pouches

U.S. shelves while under scientific review. The guidance grants enforcement discretion, meaning regulators will not remove the products during the review period. The memo marks a departure from prior FDA policy that required products to demonstrate health benefits before reaching the market.

Enforcement focus will now target devices designed to appeal to children rather than flavored products broadly.

Senior officials in the FDA's tobacco center were not consulted during development of the policy and learned of it the night before publication. The guidance also bypassed the federally required public comment period. Mitch Zeller, former FDA tobacco director, told The Associated Press that the process raises questions about whether subject matter experts may have opposed the policy and were overruled.

Large tobacco companies such as Reynolds American and Altria, which have resources to advance applications through scientific review, are positioned to benefit under the new approach. U.S. sales, may not qualify and could face continued enforcement pressure.

The market already contains unauthorized flavored vapes in flavors such as mango, gummy bear, and strawberry. The FDA has struggled to police that market for more than a decade.