FDA Completes Initial Review of 95% of Non-Tobacco Nicotine Product Applications; Agency Has Issued Over 60 Warning Letters to Manufacturers, Including for Products with a Submitted Application and Negative Action
October 14, 2022
On April 14, 2022, a new federal law went into effect clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source, including non-tobacco nicotine (NTN) or synthetic nicotine. Nearly one million applications for NTN products were submitted to FDA from more than 200 separate companies by May 14, 2022. To date, all applications submitted by May 14 have been processed, and 95 percent have been assessed to determine if they meet the minimum requirements to be accepted for further review. As of Oct. 7, FDA has issued Refuse to Accept (RTA) letters for more than 889,000 products in applications that do not meet the criteria for acceptance. FDA has also accepted over 1,600 applications, with the vast majority being for e-cigarette or e-liquid products.
While the application review is ongoing, FDA remains vigilant in overseeing the market and will continue to use our compliance and enforcement resources to curb the unlawful marketing of NTN products. To date, FDA has issued a total of over 60 warning letters to manufacturers, including brands popular among youth such as Puff Bar. The manufacturer warning letters include those for products for which an application had been submitted but where the agency has taken a negative action, such as a Refuse to Accept Letter. FDA has also issued over 300 warning letters to retailers for violations in relation to their sale of NTN products to underage purchasers, and imposed civil money penalties against two retailers for sales of NTN products to underage purchasers.
To date, the FDA has not authorized any NTN products. Therefore, all NTN products on the market are marketed unlawfully and risk FDA enforcement action. It is illegal for a retailer or distributor to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty. All authorized e-cigarettes are posted on FDA’s Tobacco Product Marketing Orders page. The agency encourages the public to submit potential violations to us through our online form.