FDA Updates Progress on Synthetic Nicotine Applications
Time： 2022-09-09
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FDA updates synthetic nicotine application progress: 1 million received, 800,000 rejected
Since President Joe Biden signed legislation authorizing the FDA to regulate tobacco products containing nicotine, the FDA has issued more than 44 warning letters to manufacturers and more than 300 to retailers regarding the use of non-tobacco nicotine (NTN) product related violations.
Additionally, the FDA has issued new warning letters to 102 retailers for illegally selling NTN products to underage buyers.
In the update, the agency detailed its significant progress in processing and reviewing applications for synthetic nicotine products from premarket tobacco products.
On March 15, 2022, a new federal law gave the FDA the authority to regulate tobacco products containing nicotine from any source. The law goes into effect on April 14, 2022, and after July 13, 2022, any new NTN products that have not received FDA premarket authorization cannot legally be marketed.
The FDA said it received nearly 1 million NTN applications from more than 200 companies.
To date, all applications submitted before May 14 have been processed, and more than 85 percent have been reviewed to determine whether they meet the minimum requirements for further review, according to the agency.
In total, FDA has issued Rejection of Acceptance (RTA) letters for more than 800,000 NTN products that did not meet acceptance criteria.
In total, the FDA accepted more than 350 applications for NTN products, the vast majority of which were e-cigarette or e-liquid products.
The agency emphasizes that acceptance is not a determination of product authorization status. "Accepted applications will proceed to further review to ensure that the application meets certain criteria for further review," the FDA wrote in its update.
For more information on the FDA's premarket review progress and compliance and enforcement actions, please visit the agency's NTN Products webpage.
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