New Requirements for E-Cigarette Imports
Today, the FDA and the Department of the Treasury announced a proposed rule that would require importers to submit the FDA-issued Submission Tracking Number (STN) for Electronic Nicotine Delivery System (ENDS) products into the electronic imports system operated by U.S. Customs and Border Protection. This new rule is designed to streamline the review process for the admissibility of ENDS products entering the United States.
What is a Submission Tracking Number (STN)?
When an applicant submits a marketing application for a new tobacco product, the FDA assigns a unique identifier known as the Submission Tracking Number (STN). Under the proposed rule, if the STN is not provided for any ENDS product, including e-cigarettes, the product may be denied entry into the U.S.
The STN is a critical data element in the FDA’s admissibility review and determination process. This review process includes not only the STN but also an examination of other product information, potential sampling, and testing.
Benefits of the Proposed Rule
By requiring the STN to be entered into the electronic imports system, the FDA anticipates a more efficient and effective review process for ENDS product imports. This automation will help the FDA conserve resources and focus on identifying products that pose a greater public health risk. The rule would enhance the FDA’s ability to quickly assess whether ENDS products comply with FDA laws and regulations.
Public Comment Period
Starting 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 until October 15, 2024. Stakeholders are encouraged to visit the rulemaking docket at regulations.gov to learn more and provide feedback on the proposed rule.
Part of a Larger Government Effort
This proposed rule is part of the FDA’s broader commitment to addressing unauthorized e-cigarettes. The FDA is working in coordination with other federal agencies as part of a recently announced multi-agency task force dedicated to tackling the illegal distribution and sale of e-cigarettes.
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Read the full FDA article here.