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.
Notice
1. This article is provided exclusively for professional research purposes related to industry, technology and policy. Any reference to brands or products is made solely for the purpose of objective description and does not constitute an endorsement, recommendation, or promotion of any brand or product.
2. The use of nicotine products, including but not limited to cigarettes, e-cigarettes, and heated tobacco products, is associated with significant health risks. Users are required to comply with all relevant laws and regulations in their respective jurisdictions.
3. This article is strictly restricted from being accessed or viewed by individuals under the legal age.
Copyright
This article is either an original work by 2Firsts or a reproduction from third-party sources with the original source clearly indicated. The copyright and usage rights of this article belong to 2Firsts or the original source. Unauthorized reproduction, distribution, or any other unauthorized use of this article by any entity or individual is strictly prohibited. Violators will be held legally responsible. For copyright-related matters, please contact: info@2firsts.com
AI Assistance Disclaimer
This article may have utilized AI to enhance translation and editing efficiency. However, due to technical limitations, errors may occur. Readers are advised to refer to the sources provided for more accurate information.
This article should not be used as a basis for any investment decisions or advice, and 2Firsts assumes no direct or indirect liability for any errors in the content.
