FDA Tobacco Submission Tracking Number Import Requirement

New FDA and Treasury Rule Proposes Streamlined Import Process for E-Cigarettes

In an important step toward regulating the import of Electronic Nicotine Delivery System (ENDS) products, the Food and Drug Administration (FDA) and the Department of the Treasury have announced a proposed rule that could significantly impact how these products enter the United States. This rule would require importers to submit the FDA-issued Submission Tracking Number (STN) for ENDS products into the electronic imports system managed by U.S. Customs and Border Protection. The aim is to streamline the review process for determining the admissibility of these products.

When a new tobacco product is submitted for marketing approval, the FDA assigns it a unique identifier known as a Submission Tracking Number (STN). Under the proposed rule, any ENDS product—such as e-cigarettes—lacking this STN may be refused entry into the U.S. The STN plays a crucial role in the FDA’s admissibility review process, which also considers additional product information and may involve sampling and examining the products themselves.

The inclusion of the STN in the electronic imports system is expected to automate and expedite the review process. By doing so, the FDA hopes to conserve its limited resources and focus on ensuring that ENDS products comply with existing laws and regulations. This rule aims to make the import admissibility review process more efficient and effective, enabling the FDA to quickly identify products that may pose significant public health risks.

Starting tomorrow, 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. Interested parties can submit their feedback until October 15, 2024, through the rulemaking docket at regulations.gov.