On August 15th, the United States FDA (FDA) and the Department of the Treasury announced a proposed rule that would require importers to submit a Submission Tracking Number (STN) issued by the FDA for electronic nicotine delivery systems (ENDS) products through the electronic import system operated by U.S. Customs and Border Protection (CBP). This new requirement aims to streamline the process for ENDS products entering the United States for regulatory review.
After an applicant submits a marketing application for a new tobacco product, the FDA will assign a unique identifier called an STN. If the proposed rule is ultimately adopted, any ENDS product (e-cigarette) that has not submitted an STN may be denied entry into the United States.
The FDA-issued STN is one of the key data elements that the FDA can accept for review and determination of eligibility. The FDA also reviews other information about the product and may conduct sampling and inspections of the product.
By requiring STN input into the electronic import system and automating its review, the FDA expects to save limited resources used for reviewing ENDS products to determine their compliance with FDA laws and regulations.
Furthermore, the FDA announced that starting on the 16th, a public comment period for the proposed rule titled "Submission of FDA Import Data for Certain Tobacco Products in an Automated Commercial Environment" will be open to the public, with a deadline of October 15, 2024.
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