FDA Has Sent More Than 340 Warning Letters for Non-Tobacco Nicotine Violations

Agency continues crackdown on synthetic nicotine as it reviews applications
FDA sign
Photograph: Shutterstock

SILVER SPRING, Md. — The number of warning letters the U.S. Food and Drug Administration has issued to manufacturers and retailers for violations related to non-tobacco nicotine products is growing.

The agency said on Thursday it issued 25 new warning letters since Aug. 3 to manufacturers of non-tobacco nicotine products for marketing their products without the required premarket authorization. It also issued new warning letters to 102 retailers for illegally selling non-tobacco nicotine products to underage purchasers.

That brings the total number of warning letters to more than 340, including 44 to manufacturers and more than 300 to retailers, the FDA said.

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.

As of July 13, a non-tobacco nicotine product can only be legally marketed in the United States if it has received premarket authorization from the FDA. And while the FDA has received applications for about 1 million non-tobacco nicotine products submitted by more than 200 manufacturers, none have received authorization from the agency yet. About 350 applications, mostly for e-liquid or e-cigarette products, have been accepted for further review.

Details on the companies that received warning letters and more information on non-tobacco nicotine products can be found on the FDA’s website.

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