FDA Eases Enforcement on Some Unauthorized Vapes and Pouches, Not All
Photo: The U.S. Food and Drug Administration / Wikimedia Commons (Public domain)
The FDA has changed how it enforces the premarket rules that govern vapes and nicotine pouches. The shift is one of enforcement priority, not authorization.
In May 2026 the agency issued a final guidance, "Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization," that took effect immediately and superseded its prior enforcement-discretion policy. The guidance describes when FDA generally does not intend to prioritize enforcement against an unauthorized electronic nicotine delivery system or nicotine pouch product. The determining factor is the status of the product's premarket tobacco application. A product whose PMTA has been accepted and filed and is under scientific review, or that has a qualifying supplemental PMTA pending more than 180 days, falls into the lower-priority category. A product whose application was only submitted does not.
Two categories are excluded regardless of application status. The first is youth-appealing products, such as those resembling a toy, a phone, a gaming device, or a cartoon character, or otherwise disguising what they are. The second is products that raise heightened safety concerns, including high nicotine content, a lack of child-resistant packaging required under the Child Nicotine Poisoning Prevention Act of 2015, serious or unexpected adverse-event signals, or a fire hazard. The agency also reaffirmed that it will coordinate with the Department of Justice and Customs and Border Protection to seize and destroy unauthorized products at the border.
The guidance does not authorize any product. FDA continues to state that any new tobacco product on the market without authorization is illegally marketed, and that a pending application is not a marketing authorization. As of mid-2026 the agency has authorized 45 e-cigarette products, which remain the only ones lawfully marketed, and no non-tobacco nicotine product has been authorized. Enforcement discretion describes how the agency intends to allocate its resources during review, not the legal status of the products themselves.
FDA has said it will publish and maintain a public list identifying the manufacturers and products it does not intend to prioritize against, and has directed manufacturers who want to be listed to contact the reviewer for their pending application. That list has not yet been published, and it is separate from the agency's existing roster of authorized products.
The guidance also leaves state authority untouched. State attorneys general and the product-directory states, which condition retail legality on FDA application status, can continue to act independently of the federal enforcement posture.