AVM: FDA Misreports PMTA Acceptance Numbers


The FDA announced Thursday it has rejected 800,000 of the approximately one million synthetic nicotine product marketing applications submitted by the May 14 filing deadline.

Of the 800,000 receiving Refuse to Accept (RTA) letters, the FDA says more than 700,000 were rejected in the last month.

The agency now says 85 percent of submitted synthetic nicotine premarket tobacco applications (PMTAs) have been reviewed for basic filing requirements, which means about 150,000 PMTAs have yet to receive a determination of any kind.

The FDA also reported it has accepted “over 350” applications for further review—the same vague number it used in its Aug. 3 update. But the leading vaping industry group says “over 350” is deceptive and a gross understatement of the real number. That group also says the agency altered required PMTA forms close to the submission deadline to disqualify already-submitted applications.

Is the FDA misreporting PMTA review results?

Read full article here.

Jim McDonald – Vaping360.com – 2022-09-08.

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