All applications to date that have been submitted to the Food and Drug Administration (FDA) by May 14 for non-tobacco nicotine (NTN) products have been processed, and 95% have been assessed to determine if they meet the minimum requirements to be accepted for further review.
As of Oct. 7, 2022, the FDA has issued Refuse to Accept (RTA) letters for more than 889,000 out of the 1 million applications for products containing non-tobacco derived nicotine or synthetic nicotine, according to the National Association of Tobacco Outlets (NATO).
However, FDA has accepted over 1,600 applications, with the vast majority being for e-cigarette or e-liquid products.
Additionally, warning letters to manufacturers and retailers have been distributed, according to FDA.
FDA has not yet authorized any NTN products. Therefore, according to the agency, all NTN products on the market are marketed unlawfully and risk FDA enforcement action. This includes those products covered by the 1,600 applications accepted for further agency review, said NATO.