Synthetic Nicotine, FDA Issues Over 100 Warnings

In recent days, the U.S. Food and Drug Administration (FDA) said it has issued warnings to two manufacturers for marketing vaping products containing synthetic nicotine without authorization. The agency has sent 107 other warning letters to retailers for illegally selling such products to minors.[1].

While the FDA’s initial focus was limited to tobacco-derived nicotine products and excluded lab-made nicotine, synthetic nicotine from the latter modality has grown. But a new law passed in March 2022 makes clear that the FDA can regulate nicotine-containing products regardless of the source.

Vaping products marketed without authorization

The FDA has issued two initial warning letters to manufacturers for illegally marketing e-liquids containing synthetic nicotine without the required authorization. Collectively, these two companies, AZ Swagg Sauce LLC and Electric Smoke Vapor House, have collectively notified approximately 10,000 products to the FDA. However, neither company submitted a premarket application for their products by the May 14, 2022 deadline, as required by the new law.

As of July 13, 2022, any new synthetic nicotine product that has not received FDA premarket approval can no longer be placed on the market. The FDA is currently processing applications for one million synthetic nicotine products submitted by more than 200 manufacturers by the May 14, 2022, deadline. The agency is expected to issue denials for applications that do not meet the established criteria in the near future.

Products sold to minors under 21 years of age

In addition, the FDA also announced that it has issued 107 warning letters to retailers in recent weeks for illegally selling synthetic nicotine products to minors. Under the law, anyone who makes or sells synthetic nicotine must comply with the agency's regulations, which include not selling to anyone under the age of 21 and not giving out samples. In addition, it prohibits any claims that the products are less harmful than cigarettes, since the FDA has not stated otherwise.

These efforts are consistent with the FDA’s commitment to protect youth from initiation of nicotine products, including e-cigarettes. In addition to regulatory oversight of all electronic nicotine delivery systems (ENDS), the agency launched a massive multimedia campaign to educate U.S. youth (ages 12-17) about vaping products. Nearly 11 million youth have used these products or are willing to try them. The campaign focuses on the potential risks of e-cigarette use.

Keywords: FDA, United States, synthetic nicotine, vaping, electronic cigarette, youth

AE

[1] Press release, FDA Continues to Implement Law, Regulate Non-Tobacco Nicotine Products, Warns Retailers and Manufacturers Against Illegal Sales, FDA website, published July 13, 2022, accessed July 19, 2022