
On August 15, 2024, the U.S. Food and Drug Administration (FDA) and the Department of the Treasury announced a proposed rule that could significantly impact the importation of e-cigarette products. The new rule would require importers to submit an FDA-issued Submission Tracking Number (STN) into the U.S. Customs and Border Protection's (CBP) electronic imports system for all Electronic Nicotine Delivery System (ENDS) products.
The STN is a unique identifier assigned by FDA when an applicant submits a marketing application for a new tobacco product. Under the proposed rule, any ENDS product without an associated STN may be denied entry into the country. By requiring the STN to be entered into the electronic system, FDA hopes to expedite the identification of products that may pose a public health risk. This change is part of the agency's broader efforts to combat unauthorized e-cigarettes and protect consumers from potentially harmful products.
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. Those interested in learning more or contributing their views can visit the rulemaking docket at regulations.gov.
This proposed rule aligns with FDA's ongoing work with federal partners, including a multi-agency task force focused on curbing the illegal distribution and sale of e-cigarettes.
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