Review & Evaluation
What are the steps of the review process for Substantial Equivalence Reports?
The following steps outline the review process that FDA’s Center for Tobacco Products has been following:
- CTP Document Control Center receives Substantial Equivalence Reports. These reports are entered into a database, given a Submission Tracking Number (STN), and assigned to CTP’s Office of Science.
- CTP performs an administrative review to make a preliminary determination that the product is currently subject to regulation as a tobacco product. After jurisdiction is confirmed, an acknowledgement letter is sent stating that the report was received. Each acknowledgement letter provides the STN and the name and contact information of the Regulatory Health Project Manager who is the point-of-contact for that report.
- The Substantial Equivalence Reports are then reviewed for administrative completeness. If any items are missing, a letter is sent to the applicant requesting additional information to be provided within 30 days.
- At the same time, the Substantial Equivalence Report is assigned for an in-depth scientific and compliance review. For the compliance review, FDA determines whether the predicate is either a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or if the product has previously been found to be substantially equivalent to an appropriate predicate product. For the scientific review, there are certain disciplines that have been routinely assigned to each report. These disciplines include chemistry, engineering, toxicology, and environmental science. Depending on the contents of the report and any additional data submitted, other scientific disciplines may be added to the review.
- During their review, scientists compare the product to the predicate to see if the report contains information supporting a scientific finding of substantial equivalence. If additional information is needed, a scientific advice or information request letter is sent. This letter requests specific information from the applicant within 30 days. Should additional clarification be needed, the regulatory health project manager’s name and direct number is listed at the bottom of the letter.
- Based on these reviews, we determine whether the tobacco product is substantially equivalent and in compliance with the Act.
- We then communicate our decision to the applicant in writing.
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