FDA On Track to Complete Review of E-cigarette PMTAs by End of 2022
According to CSP, the U.S. Food and Drug Administration (FDA) has announced that it is making progress in reviewing premarket tobacco product applications (PMTAs) for the most popular e-cigarette brands. The FDA aims to complete its reviews by the end of 2022.
As of March 31, the FDA has reviewed 52 percent of the covered applications. Covered applications are those for new tobacco products that entered the market on or before August 8, 2016, and have a PMTA filed by September 9, 2020, and are sold under the brands Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin, or Puff Bar. These brands account for two percent or more of total retail sales volume per NielsenIQ reports.
The FDA has provided a status report indicating that it aims to have 53 percent of covered applications reviewed by June 30, 55 percent reviewed by September 30, and 100 percent reviewed by December 31.
The FDA was expected to complete the PMTA review process by September 9, 2021, as per a court order. However, it missed the deadline, and now it must provide regular status reports on its progress. The next status report is due on July 24.
The FDA’s PMTA process has been closely watched by the e-cigarette industry, as it determines whether these products can remain on the market or not. The FDA will evaluate whether the benefits of e-cigarettes, including their potential to help adult smokers quit smoking, outweigh the risks posed to youth and non-smokers.
Furthermore, the PMTA process requires manufacturers to provide evidence that their products are safe for the public to use and that they meet the necessary regulatory standards. The FDA’s PMTA review process is critical to ensuring that tobacco products, including e-cigarettes, are safe for public consumption.
In conclusion, the FDA is making significant progress in reviewing PMTAs for popular e-cigarette brands, with the aim of completing the process by the end of 2022. The PMTA process is critical to ensuring the safety of tobacco products, and the FDA’s thorough review is an essential step in protecting the public’s health.
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