The U.S. Food and Drug Administration (FDA) issued guidance on May 8, 2026, outlining enforcement priorities for unauthorized electronic nicotine delivery systems (ENDS) and nicotine pouch products marketed without premarket authorization. The guidance supports the FDA’s broader strategy to combat illicit tobacco products and strengthen enforcement against unlawful imports, counterfeit products, and products that fail to comply with Premarket Tobacco Product Application (PMTA) requirements. Under the policy, the FDA stated that it generally does not intend to prioritize enforcement against certain unauthorized ENDS and nicotine pouch products if they have pending and accepted PMTA submissions or Supplemental PMTAs containing sufficient scientific data for public health evaluation. However, products with features considered appealing to minors, including cartoon imagery, toy-like designs, or concealed vaping appearances, may still face enforcement action. The agency also identified additional risk factors such as high nicotine content, lack of child-resistant packaging, fire hazards, and significant adverse health events. The FDA further announced plans to establish a publicly available list of manufacturers and products subject to the agency’s enforcement discretion policy. The guidance emphasizes that inclusion under the policy does not indicate that a product is likely to receive marketing authorization.
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