The guidance on ENDS and nicotine pouches emphasizes when FDA will not prioritize enforcement. 

May 11, 2026

The U.S. Food and Drug Administration (FDA) on Friday issued guidance on enforcement priorities for unauthorized electronic nicotine delivery systems (ENDS) and nicotine pouch products.

The full guidance is scheduled to be published May 12; an unpublished version is available to download.

In a statement, the FDA announced that it “continues to implement an aggressive strategy to stop illegal imports of unlawful tobacco products by focusing on the most deceptive and dangerous products, worst actors and egregious conduct related to illicit ENDS and nicotine pouch products that fail to comply with basic premarket authorization requirements (e.g., failure to submit Premarket Tobacco Application, commonly known as a PMTA), including counterfeit products and misdeclared products.”

“FDA will prioritize these efforts and continue working hand-in-hand with other federal agencies, including the U.S. Department of Justice, Customs and Border Protection and others to seize and destroy illegal products at our borders to prevent these products from ending up on shelves or in the hands of underage users in the United States,” the statement continued.

The press release announcing the new guidance stated that the FDA does not intend to prioritize enforcement:

• “If a product has a pending application that has been accepted and filed, or when a manufacturer has a pending and accepted Supplemental PMTA, and if FDA has determined the application includes data necessary to evaluate whether the product is appropriate for the protection of public health in the case of non-tobacco flavored ENDS products. Enforcement against products falling within the categories set forth above, unless they have certain presumptively underage-appealing elements such as depicting a cartoon-like fictional character; disguising its nature as a vaping product; or resembling a children’s toy, phone or gaming platform.”

The FDA said it would also consider whether a tobacco product presents a significant public health or safety concern that is greater than generally presented by e-cigarette or nicotine pouch products or other tobacco products, such as a product that:

• Has high nicotine content
• Has serious adverse experiences or a larger number of unexpected associated adverse experiences compared with authorized e-cigarettes or nicotine pouch products
• Lacks child-resistant packaging in accordance with Child Nicotine Poisoning Prevention Act of 2015
• Is a potential fire hazard

The FDA said it will also create and maintain a publicly available list of products that the FDA does not intend to prioritize enforcement against under this policy.

This guidance comes on the heels of last week’s FDA authorizations of new nicotine vapor products, including its first authorization of fruit-flavored vapor products intended for adult customers through the PMTA pathway.