Recently, an increasing number of companies — including the makers of some of the most popular e-cigarette brands for kids — have started using synthetic nicotine in their products in an attempt to evade FDA regulation, the FDA said. .

A major new federal law that took effect in April clarifying the FDA's authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine, will continue to enforce the law.

Today, the FDA issued its first two warning letters to manufacturers for illegally selling non-tobacco nicotine vaping products without authorization. Together, the two companies, AZ Swagg Sauce LLC and Electric Smoke Vapor House, have about 10,000 products listed with the FDA.

Neither company has submitted a premarket application for its non-tobacco nicotine product by the May 14, 2022 deadline, as required by the new law.

Additionally, the FDA announced today that it has issued 107 warning letters to retailers over the past two weeks for illegally selling non-tobacco nicotine products, including certain e-cigarettes or e-liquid products, to underage buyers.

The law makes clear that after the passage of the new law, tobacco products, including non-tobacco-derived nicotine products, cannot be legally sold to customers under the age of 21.

"Since the passage of this regulation, FDA has been committed to aggressively enforcing this important new law regulating non-tobacco nicotine products, and today's announcement of the warning letter is just the beginning of our compliance and enforcement actions." Director of FDA's Center for Tobacco Products, "Over the next few weeks, we will continue to investigate companies that may be illegally marketing, selling or distributing non-tobacco nicotine products and will take action as appropriate," said Dr. Brian King, MPH.

After today, July 13, 2022, any new non-tobacco nicotine products that have not received FDA premarket authorization cannot be legally marketed.

The FDA is currently processing approximately one million applications for non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14, 2022 deadline.

FDA is preparing to issue Rejection Acceptance (RTA) letters as soon as possible for those applications that do not meet acceptance criteria.

FDA is doing the necessary work to take enforcement action as quickly as possible. When companies are found to be illegally selling non-tobacco nicotine products, the agency typically first issues a warning letter to achieve voluntary compliance and takes enforcement action as needed, including civil fines, injunctions, seizures or injunctions.

Additionally, any unauthorized non-tobacco nicotine products detected for import into the United States may be detained or denied entry.

“The FDA is working hard to process the high volume of submissions and will, as always, make marketing decisions based on the best available science, taking compliance and enforcement action as necessary,” said Dr. King. "We remain fully committed to taking all necessary steps to protect public health and to provide timely information on our ongoing progress in regulating non-tobacco nicotine products."

These efforts are consistent with the FDA's commitment to protecting teens from initiating tobacco use, including e-cigarettes.

In addition to FDA oversight of all e-cigarettes and electronic nicotine delivery systems (ENDS), including the review of millions of product applications, the agency has made significant investments in multimedia e-cigarette public education campaigns aimed at nearly 10.7 million 12 to 12 17-year-olds who have used or are willing to try e-cigarettes highlighted information about the potential risks of using e-cigarettes.