The Food and Drug Administration and the U.S. Department of the Treasury are proposing new requirements for an importer to submit the FDA-issued submission tracking number (STN) of ENDS (Electronic Nicotine Delivery System) products into the electronic imports system operated by U.S. Customs and Border Protection (CBP). The changes would help streamline the process of reviewing the “admissibility” of ENDS products into the United States, the agency said.
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 beginning Friday through Oct. 15.
“Under the proposed rule, if finalized, any ENDS product, including e-cigarettes, for which the STN is not submitted may be denied entry into the U.S.,” the FDA said.
An FDA-issued STN also includes review of other information about the product as well as possible sampling and examination of the product, the agency said. After an applicant submits a marketing application for a new tobacco product, the FDA assigns a unique identifier called an STN.
By requiring the STN to be entered into the electronic imports system and automating its review, the FDA said it expects to conserve the agency’s “limited resources” needed for reviewing ENDS products to determine if they comply with FDA laws and regulations.
“This rule would result in a more effective and efficient import admissibility review process and allow FDA to more quickly identify ENDS products that may be associated with a greater public health risk,” the agency said.
In June the FDA and U.S. Department of Justice (DOJ) created a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes.
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