FDA Denies Nearly 95% of Synthetic Nicotine PMTAs

The U.S. Food and Drug Administartion today announced that, as of Oct. 7, the agency has issued refuse to accept (RTA) letters for more than 889,000 products in premarket tobacco product applications (PMTAs) that do not meet the criteria for acceptance.

The agency also announced it FDA has 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 [non-tobacco nicotine] 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 FDA stated in a release. “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 [RTA].”

The 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,” the FDA stated. “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.