How is the FDA Processing PMTAs?

The U.S. Food and Drug Administration (FDA) continues to process, review, and take action on as many timely Premarket Tobacco Product Applications (PMTA) as possible before September 9, 2021. The FDA usually sends a Deficiency Letter prior to reaching a final decision on a PMTA.

Through Deficiency Letters PMTA applicants may provide additional information required of them by the FDA in order to conduct a thorough scientific review. Recently, the FDA has updated the language in Deficiency Letters related to PMTAs.

The Clark-Esposito Law Firm, P.C. monitors FDA actions across the field of tobacco and vapor regulation. Click the button below to view this article, and to monitor our frequent updates on FDA's review of timely submitted PMTAs and many other rapidly developing areas of tobacco product regulation.

Click the button below to read our full article on FDA's review process for PMTA, what to expect as FDA conducts review on pending PMTA, and FDA's review outlook.

We can be reached at for additional questions related to Deficiency Letters, PMTAs, or tobacco product compliance in general.

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