• Deanna Clark-Esposito

FDA Publishes Progress on Tobacco Product Application Review



Following the release of the Premarket Tobacco Product Application (PMTA) List on May 20,

2021, the U.S. Food and Drug Administration (FDA) continues to review timely premarket

applications for tobacco products received through all three pathways. This includes the PMTA, the Substantial Equivalence Report, and Exemption to a Substantial Equivalence pathways. Applications must have been received by the September 9, 2020 deadline to be considered timely. The FDA will continue to provide updates on its tobacco product application review via their Tobacco Product Applications: Metric And Reporting Webpage. Any actions, both intermediate and final, taken on premarket tobacco product applications will be made available during the course of the application review process.


On May 20, 2021 the FDA posted new PDF charts illustrating order letters, decision summaries, and other documents related to FDA authorized tobacco products. The charts have been created in response to the need for clarity regarding the contents of the Tobacco Product Marketing Orders Webpage. In addition to the previously available monthly aggregate numbers taken from the webpage, the new PDF charts include additional data, categories, and review process milestones. It is the Agency’s intent to regularly update this webpage to reflect the most recent available metrics and data on their application review process. The timeframe for updates will typically fall within a month of the reporting period’s close. The new PDF charts currently include available metrics and data as of April 1, 2021.


As explained by the FDA, an unprecedented number of timely applications were received by the September 9, 2020 deadline. Constant changes to available month-to-month data will occur over time as applications continue to funnel through the review process pipeline. FDA noted that it is common for retroactive corrections and adjustments to become necessary as time passes and the review process progresses. For example, a complete set of data from one month may not have been available at the time the published data was exported from the data tracking systems. So, the FDA may need to retroactively update the available data during the following month once a full data set becomes available for the previous month’s period. Significant updates to available metrics and data may need to occur over time, as many applicants submitted large bundles of products for FDA review.


Due to the Agency’s expectation of such changes, FDA will publish cumulative fiscal year-to-date information every other month. These reports can be expected about one month after the close of each reporting period and will reportedly be accurate within 10 percent.


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