The FDA has rejected 800,000 NTN product applications and accepted over 350.
Synthetic nicotine vaping products, had until recently been exempt from FDA regulations because they contain nicotine made in a lab, rather than extracted from a tobacco leaf. However, following a legislation enacted on March 15th, the FDA has been granted the authority to regulate tobacco products containing nicotine from any source, which has led to an alleged ban on synthetic nicotine.

The March legislation required synthetic nicotine manufacturers to submit premarket applications by May 14, 2022, and any brand which had not submitted these documents would be considered illegal. However this was not enforced, leading to the FDA being on the receiving end of endless criticism.

Finally, on July 13th the FDA announced that it had sent two warning letters to manufacturers marketing non-authorized synthetic nicotine products or non-tobacco nicotine (NTN) and over 100 warning letters to retailers who sold synthetic nicotine products to minors.

85% of synthetic nicotine applications have been reviewed

The FDA has now reported it has issued new warning letters to 102 retailers for illegally selling NTN products to underage buyers. The agency also revealed it has received nearly 1 million NTN applications from over 200 companies, with all applications submitted by May 14 having been processed, and over 85% reviewed.

The FDA said that it has rejected 800,000 NTN product applications and accepted over 350. “Accepted applications will enter further review, which ensures certain criteria are met for applications to proceed with further review,” wrote the FDA.

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