FDA Sued Over Policy Allowing Unauthorized Vaping Products to Remain on Sale

A coalition of public health organizations, pediatricians and parents filed suit against the U.S. Food and Drug Administration on Tuesday, challenging a policy they say allows vape manufacturers to sell products without the marketing authorization required under federal law.

The lawsuit, filed in U.S. District Court in Maryland, takes aim at FDA guidance issued in May stating that the agency would not prioritize enforcement action against certain unauthorized e-cigarettes and nicotine pouch products where companies have marketing applications pending review. Plaintiffs argue the policy effectively permits thousands of unauthorized products — including flavored e-cigarettes and nicotine pouches popular among young people — to remain on store shelves indefinitely.

The plaintiffs include the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Truth Initiative and Parents Against Vaping, as well as a pediatrician and a parent whose children became addicted to nicotine after using flavored e-cigarettes.

The groups contend the guidance violates the Tobacco Control Act, which requires products to obtain marketing authorization before they can be sold. They further argue the FDA bypassed mandatory public notice and comment procedures under the Administrative Procedure Act and failed to adequately justify the policy change. The lawsuit also challenges the agency's stated plan to publish a list of products it does not intend to prioritize for enforcement, arguing that doing so would actively facilitate sales of unauthorized products.

The case will be heard in the same Maryland court that in 2017 struck down an earlier FDA policy that had similarly allowed e-cigarettes to remain on the market without authorization.

The FDA did not immediately respond to a request for comment.