FDA Has Reviewed 95% of Synthetic Nicotine Production Applications

The agency has issued over 60 warning letters to manufacturers and hasn’t yet authorized any products.

October 17, 2022

WASHINGTON—The U.S. Food and Drug Administration said it has completed its initial review of 95% of the nearly one million non-tobacco nicotine (NTN) product applications submitted by more than 200 separate companies by May 14.

The FDA said as of October 7, it has issued Refuse to Accept (RTA) letters for more than 889,000 products in applications that do not meet the acceptance criteria. The agency has accepted over 1,600 applications, mostly for e-cigarette or e-liquid products. 

In March, Congress gave the FDA authority to regulate synthetic nicotine products and required any manufacturers that wanted to market their synthetic nicotine products to submit a premarket tobacco application (PMTA) by May 14, and obtain FDA authorization to stay on the market after July 13. This law took effect April 14, and after July 13, any new NTN product that has not received premarket authorization from the FDA can’t be legally marketed.

“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,” the FDA said in a press statement.

To date, the agency has issued more than 60 warning letters to manufacturers, including 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. The FDA has also issued over 300 warning letters to retailers for violations related 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. That means, all NTN products on the market are marketed unlawfully and risk FDA enforcement action, the agency said. 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.