May 8, 2026

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.

FDA does not intend to prioritize 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. FDA does not intend to prioritize 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 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 (CRP) in accordance with Child Nicotine Poisoning Prevention Act of 2015

Is a potential fire hazard

To promote transparency for consumers and retailers, FDA also will create and maintain a publicly available list of products identifying manufacturers and their products that FDA does not intend to prioritize enforcement against under this policy. The policy recommends those manufacturers whose products are marketed under this policy and who wish to be listed on this publicly available webpage should reach out to the regulatory health project manager (RHPM) for their pending application or may wish to contact CTP_enforcementpriorities@fda.hhs.gov. Manufacturers using this email address will receive an automated reply and can expect more details regarding the webpage soon.

Moreover, the fact that an e-cigarette or nicotine pouch product falls within any of the enforcement policies under this policy in no way has a bearing on whether the tobacco product is likely to receive premarket authorization.