PMTA Timetable Updated, FDA to Complete Reviewing by Year End
The US Food and Drug Administration (FDA) provided updates on the status of pending Premarket Tobacco Product Applications (PMTAs) due to a federal court order in Maryland.
With a large influx of PMTAs, the FDA was unable to complete reviews of applications submitted before September 9, 2020, by the deadline of September 9, 2021. The court established the final review period.
The FDA's fifth status report submitted on April 21st indicates that the agency has met its estimated review time for pending PMTAs of "covered applications."
The National Association of Tobacco Outlets explained that "covered applications" refer to new tobacco products on the market as of August 8, 2016, which submitted PMTAs to the FDA before September 9, 2020. These brands include JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin, and Puff Bar.
The FDA report states that as of March 31, 2023, 52% of the "covered applications" have been reviewed and acted upon.
This number will reach 53% by June 30th, 55% by September 30th, and 100% by December 31, 2023.
Also read:
FDA Introduces New E-cigarette TPMP Regulations
FDA Published New Tobacco Product Petition Webpage
FDA Public Hearing on E-cigarette Manufacturing Reveals Diverse Concerns
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