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FDA is committed to combating illicit tobacco products in this country. The illicit market undermines the regulatory framework and puts consumers at risk from products that haven't undergone any scientific review. FDA 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.
In support of this priority, on May 8, FDA issued a guidance, “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” This document describes enforcement policies with regard to the marketing of certain ENDS products and nicotine pouch products that do not have premarket authorization.
More specifically, for ENDS and nicotine pouch products marketed without FDA authorization, the policy describes when FDA does not intend to prioritize enforcement.
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