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FDA faces lawsuit over policy that delays enforcement on some vapes
The lawsuit filed in Maryland on July 14 challenges May guidance that would deprioritize enforcement for certain unauthorized e-cigarettes and nicotine pouches while marketing applications are still under review.
Insurance Journal reports a coalition of public health organizations, pediatricians, and parents filed a lawsuit against the U.S. Food and Drug Administration on July 14, challenging FDA guidance issued in May that would not prioritize enforcement against some unauthorized vaping and nicotine pouch products. The plaintiffs say the policy permits certain manufacturers to keep products on the market without the marketing authorization required under the Tobacco Control Act, arguing it could allow thousands of unauthorized items, including flavored e-cigarettes and nicotine pouches popular with young people, to be sold indefinitely while applications are under review. The suit, filed in U.S. District Court in Maryland, also contends the FDA bypassed required public notice and comment procedures under the Administrative Procedure Act, and failed to justify a policy shift. Plaintiffs further challenge the FDA plan to publish a list of products it does not intend to prioritize for enforcement, saying that could facilitate sales of unauthorized products. The case is set to be heard in the same Maryland court that struck down an earlier FDA policy in 2017 that had allowed many e-cigarettes to remain on the market without authorization, according to Insurance Journal.