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Tobacco Product Applications: Metrics & Reporting


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FDA regularly updates this page with reporting and progress of FDA intermediate and final actions taken on premarket applications – PMTA, SE Report and EX REQ – across the application review process.

FDA intends to provide these metrics and data on a regular and reliable basis and in an easy-to-understand format, typically within a month of the closing of the reporting period.

FY 21- 24 Products Accepted for Review

 

Note: Information on this page is current as of March 31, 2024.

FDA may periodically reassess and change the categories or amount of data provided on this website. This data is produced on an ongoing basis and is subject to change due to updates, corrections, or other reasons. Some metrics can also change as FDA is processing an extremely large number of applications that move through many steps during the review process. The data reported here is generally accurate to within 10%.

Most of the metrics reported reflect the number of tobacco products that are at each stage. Descriptions of each of the metrics are provided within the Tobacco Product Applications Metrics Glossary.


Premarket Tobacco Product Applications (PMTA)

View the complete set of PMTA Metrics* for Acceptance, Filing and Review/Action Phases

FY 21-24 Tobacco Product Application Progress

*The information in this report does not differentiate tobacco products by nicotine source.


Substantial Equivalence (SE) Reports

View the complete set of SE Report Metrics for Acceptance and Review/Action Phases

FY 21-24 Substantial Equivalence Progress

Exemption from Substantial Equivalence Requests (EX REQ)

View the complete set of EX REQ Metrics for Acceptance and Review/Action Phases

FY 21-24 Exemption Request Progress

Additional Resources



 
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