The Food and Drug Administration is accepting comments through Oct. 15 on a proposed rule that would require the submission tracking number for imported electronic nicotine delivery system tobacco products to be submitted in the Automated Commercial Environment at the time of entry.
The FDA believes this requirement would result in a more effective and efficient import admissibility review process by reducing instances of manual review. The FDA explains that an automated review would compare the STN submitted by the ACE filer to information in the agency’s internal databases to determine if a “may proceed” message is appropriate. However, an automated “may proceed” would not constitute an FDA determination about the article’s compliance status and would not preclude FDA action at a later time.
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