FDA Processing 1 Million Applications for Synthetic Nicotine Products

Agency issues warning letters to non-tobacco nicotine product companies
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) is cracking down on unauthorized synthetic nicotine products.

The agency is processing applications for about 1 million non-tobacco nicotine products submitted by more than 200 manufactures by May 14, 2022. It is preparing to issue refuse-to-accept (RTA) letters soon for those applications that do not meet the criteria for acceptance, it said in a July 13 notice. Any new non-tobacco nicotine product that has not received premarket authorization from the FDA cannot be legally marketed.

“FDA is working diligently to process the substantial number of applications submitted and, as always, will make marketing decisions based on the best available science and will pursue compliance and enforcement actions when warranted,” said Center for Tobacco Products Director Brian King. “We remain fully committed to taking whatever steps are necessary to protect the public health and to provide timely updates on our ongoing progress regulating non-tobacco nicotine products.”

Two companies—AZ Swagg Sauce LLC and Electric Smoke Vapor House—have already been issued warning letters by the FDA for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization. Neither company submitted a premarket applications by the May 14 deadline, the FDA said.

New legislation enacted on March 15 clarified that the FDA could regulate tobacco products containing nicotine from any source. The law took effect on April 14. The legislation followed a growing number of companies—including manufacturers of some of the e-cigarette brands most popular with children—began using synthetic nicotine to make their products to avoid FDA regulation, the agency said.

“FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions,” King said. “In the coming weeks, we will continue to investigate companies that may be marketing, selling or distributing non-tobacco nicotine products illegally and will pursue action, as appropriate.”

In addition, the FDA issued 107 warning letters to retailers, including some convenience stores, in the last two weeks for illegally selling non-tobacco nicotine products to underage purchasers.

When companies are found to be illegally marketing non-tobacco nicotine products, the FDA will typically first issue warning letters to achieve voluntary compliance, it said, before following up with enforcement like civil money penalties, no-tobacco sale orders and more.

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