The U.S. FDA and the Treasury Department have drafted new regulations: E-cigarette products that do not submit tracking numbers may be refused entry into the U.S.

The U.S. FDA and the Treasury Department have drafted new regulations: E-cigarette products that do not submit tracking numbers may be refused entry into the U.S.

The U.S. FDA and the Treasury Department proposed a new rule requiring importers to submit the submission tracking number (STN) of electronic cigarette products in the electronic import system of the U.S. Customs and Border Protection (CBP). If the rule is finalized, any electronic cigarette products that do not submit the STN may be refused entry into the United States. This requirement is intended to simplify and strengthen the entry review of electronic cigarette products.

On August 15, the U.S. Food and Drug Administration (FDA) and the Treasury Department announced a proposed rule that would require importers to submit the submission tracking number (STN) of electronic nicotine delivery system (ENDS) products issued by the FDA in the electronic import system operated by the U.S. Customs and Border Protection (CBP). This new requirement is intended to simplify the admissibility review process for ENDS products entering the United States.

When an applicant submits a marketing application for a new tobacco product, the FDA will assign a unique identifier called STN. If the proposed rule is finalized, any ENDS product (electronic cigarette) that does not submit the STN may be refused entry into the United States.

The STN issued by the FDA is one of the important data elements for the FDA's admissibility review and determination. The FDA will also review other information about the product and may sample and inspect the product.

By requiring STNs to be entered into the electronic import system and automating its review, the FDA expects to save limited resources used to review ENDS products to determine whether they comply with FDA laws and regulations.

In addition, the FDA said that starting on the 16th, the comment process for the proposed rule titled "Submission of FDA Import Data for Use in an Automated Commercial Environment for Certain Tobacco Products" will be open to the public and will end on October 15, 2024.