FDA Underestimated Pre-market Tobacco Product Applications for Synthetic Nicotine

According to reports, the US Food and Drug Administration (FDA) underestimated the number of pre-market tobacco product applications (PMTAs) related to synthetic nicotine (NTN) that it has reviewed to avoid criticism from tobacco control organizations seeking to ban all electronic cigarette products. Vaping360 cites Amanda Wheeler, the president of the American Vapor Manufacturers Association (AVM).

Translation: Amanda Wheeler (source: AVM)

On September 8th, the FDA announced that it has accepted over 350 PMTA applications for NTN products, totaling nearly one million submissions. Wheeler asserts that AVM member companies alone have received over 4,700 accepted PMTA notifications.

Wheeler stated in a press release, "The FDA and its Center for Tobacco Products are once again misleading the public and emphasizing key data and methods in their approval process for electronic cigarette products." "The data in today's press release regarding the synthetic nicotine application is clearly inconsistent with the letter sent to our own members by the FDA, which indicated a much greater number of successfully submitted applications than what the FDA is now claiming.

AVM has also stated that the FDA changed the required PMTA form close to the submission deadline, resulting in disqualification of applications that had already been submitted. According to Wheeler, the application form was suddenly altered without any public notice and "clearly intended to disqualify a large number of already submitted applications.

In March, US President Joe Biden signed legislation authorizing the FDA to regulate synthetic nicotine products. Manufacturers must submit a PMTA by May 14th and have an additional two months to continue selling products with pending PMTAs. When the grace period ends on July 13th, all synthetic nicotine-based products will be subject to FDA enforcement.

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