U.S. FDA Sends Warning Letters to Makers of Synthetic Nicotine Products
On July 13, the U.S. Food and Drug Administration issued its first warning letters to manufacturers for illegally selling non-tobacco nicotine e-liquid products without authorization. In March, President Joe Biden signed a spending bill granting the FDA a
On July 13, the U.S. Food and Drug Administration sent its first warning letter to manufacturers for illegally selling non-tobacco nicotine e-liquid products without authorization.
In March, President Joe Biden signed a spending bill granting the FDA authority over synthetic nicotine. This regulation took effect in April and allowed manufacturers to submit marketing applications to the FDA before May 14, 2022.
Products that did not receive marketing authorization by July 13, 2022, are considered illegal and must be removed from the market.
The recipients of the FDA's first warning letter, AZ Swagg Sauce and Electric Smoke Vapor House, have listed a total of about 10,000 products with the FDA. According to the FDA, neither company submitted their premarket applications for their non-tobacco nicotine products by the deadline.
Additionally, the FDA has sent 107 warning letters to retailers in the past two weeks for illegally selling non-tobacco nicotine products to underage purchasers, including certain e-cigarettes or e-liquid products.
“Since the passage of this regulation, the FDA has been actively implementing this important new law regulating non-tobacco nicotine products, and the warning letters announced today are just the beginning of our compliance and enforcement actions,” said Brian King, director of the FDA's Center for Tobacco Products, in a statement. “In the coming 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.”
The FDA stated that it is currently processing approximately 1 million applications for non-tobacco nicotine products submitted by over 200 manufacturers before the May 14, 2022 deadline.
“The FDA is working to process the large volume of submitted applications and will continue to make marketing decisions based on the best available science and take compliance and enforcement actions as necessary,” King said. “We remain fully committed to taking all necessary measures to protect public health and to provide timely updates on our progress in regulating non-tobacco nicotine products.”
