US FDA sued over unauthorized vaping sales as experts question Zyn nicotine pouch approval

A coalition of public‑health groups, pediatricians and parents filed a lawsuit in the U.S. District Court in Maryland challenging a May 2024 FDA guidance that would not prioritize enforcement against certain unauthorized e‑cigarettes and nicotine‑pouch products. The plaintiffs argue the policy violates the Tobacco Control Act by allowing flavored vaping products and nicotine pouches to remain on the market without required marketing authorization, potentially letting thousands of such products be sold indefinitely. They also contend the FDA bypassed required public notice and comment procedures.

Separately, former FDA toxicologist Christy Leppanen has accused the agency of authorizing Zyn nicotine pouches without knowing what the pouch material is made of. Leppanen says she conducted informal tests that suggested the pouches might release micro‑plastic particles, yet the FDA proceeded with approval, stating no new concerns about ingredients. Former FDA officials have echoed concerns that the agency failed to fully evaluate the product’s material, raising questions about compliance with legal and public‑health obligations.