In a press release, Mitch Zeller, J.D., the director of the FDA’s Center for Tobacco Products, issued the following statement:
“Today, the FDA issued a warning letter to a company with over 15 million tobacco products listed with the FDA, including many flavored e-liquids, for illegally marketing electronic nicotine delivery system (ENDS) products without authorization. This action demonstrates the agency’s ongoing commitment toward ensuring that marketed tobacco products are in compliance with the law to better protect youth and the public health.
“The warning letter is the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. The FDA wants all tobacco product manufacturers and retailers to know that we continue to watch the marketplace very closely and will hold companies accountable for breaking the law.
“The FDA will continue to prioritize enforcement against companies that market ENDS without the required authorization and that haven’t submitted a premarket application to the agency – especially those products with a likelihood of youth use or initiation.”
To date, the FDA has issued a total of 131 companies selling or distributing more than 1,470,000 unauthorized ENDS products. Many of these letters were sent following the failure of these companies to submit the necessary PMTAs by the Sept. 9, 2020, deadline.
