July 13, 2022
Recently, a growing number of companies–including manufacturers of some of the e-cigarette brands most popular with kids–began using synthetic nicotine to make their products in an attempt to evade the U.S. Food and Drug Administration’s regulation. An important new federal law went into effect in April clarifying FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine, and the agency continues to implement the law.
Today, FDA issued its first two warning letters to manufacturers for unlawfully marketing non-tobacco nicotine e-liquid products without the required authorization. Collectively, these two companies, AZ Swagg Sauce LLC and Electric Smoke Vapor House, have listed a combined total of approximately 10,000 products with FDA. Neither company submitted a premarket application for its non-tobacco nicotine products by the May 14, 2022 deadline as required by the new law.
In addition, FDA announced today that it has issued 107 warning letters to retailers in the last two weeks for illegally selling non-tobacco nicotine products, including certain e-cigarette or e-liquid products, to underage purchasers. The law makes it clear that tobacco products, including non-tobacco derived nicotine products, cannot be sold legally to customers under age 21 following passage of the new law.
“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” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “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.”
After today, July 13, 2022, any new non-tobacco nicotine product that has not received premarket authorization from FDA cannot be legally marketed. FDA is currently processing applications for approximately one million non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14, 2022, deadline. FDA is preparing to issue refuse-to-accept (RTA) letters soon for those applications that do not meet the criteria for acceptance.
FDA is engaged in the necessary work to pursue enforcement action as swiftly as possible. When companies are found to be illegally marketing non-tobacco nicotine products, the agency will typically first issue warning letters to achieve voluntary compliance and will pursue enforcement actions, as needed, including civil money penalties, no-tobacco sale orders, seizure, or injunction. In addition, any unauthorized non-tobacco nicotine products detected for import into the United States can be detained or refused admission.
“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 Dr. 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.”
These efforts align with FDA's commitment to protecting youth from initiating tobacco use, including e-cigarettes. In addition to FDA’s regulatory oversight of all e-cigarettes and electronic nicotine delivery systems (ENDS), including the review of applications of millions of products, the agency has made a significant investment in a multimedia e-cigarette public education campaign aimed at the nearly 10.7 million youth age 12-17 who have ever used e-cigarettes or are open to trying them highlighting information about the potential risks of e-cigarette use.