Today, FDA and the Department of the Treasury are announcing a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number (STN) of Electronic Nicotine Delivery System (ENDS) products into the electronic imports system operated by U.S. Customs and Border Protection. This new requirement will help streamline the process of reviewing the admissibility of ENDS products into the United States.

After an applicant submits a marketing application for a new tobacco product, FDA assigns a unique identifier called an STN. Under the proposed rule, if finalized, any ENDS product, including e-cigarettes, for which the STN is not submitted may be denied entry into the U.S. An FDA-issued STN is one data element that is important to FDA’s admissibility review and determination, which also includes review of other information about the product as well as possible sampling and examination of the product.

By requiring the STN to be entered into the electronic imports system and automating its review, the FDA expects to conserve the agency’s limited resources needed for reviewing ENDS products to determine if they are in compliance with FDA laws and regulations. More specifically, this rule would result in a more effective and efficient import admissibility review process and allow FDA to more quickly identify ENDS products that may be associated with a greater public health risk.

Beginning tomorrow, the docket for the proposed rule, titled “Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products,” will be open for public comment through October 15, 2024. 

This proposed rule is part of FDA’s ongoing commitment to address unauthorized e-cigarettes as part of a coordinated all-of-government approach. FDA will continue to collaborate across the federal government as part of the recently announced multi-agency task force to address the illegal distribution and sale of e-cigarettes.