On Friday, the U.S. Food and Drug Administration issued warning letters to 10 companies who manufacture electronic nicotine delivery systems, operate websites selling them and e-liquids, and did not submit pre-market application forms.
The FDA advised the companies that the companies are selling the products illegally without pre-market authorization. According to the FDA, the companies had until Sept. 9, 2020, to submit those premarket tobacco product applications, but did not.
According to the FDA, this is the first set of warning letters issued to firms who have not submitted premarket applications to the FDA and continue to sell their productions after the deadline.
“The premarket application process ensures that new tobacco products, including many already on the market, will undergo a robust scientific evaluation by the FDA,” said FDA Commissioner Stephen M. Hahn. “Scientific review of new products is a critical part of how we carry out our mission to protect the public—especially kids—from the harms associated with tobacco use. In addition to the important premarket scientific review, prioritizing enforcement against those who violate the law by selling unauthorized products is how we help protect public health.”
The 10 firms receiving warning letters are Little House Vapes LLC; Castle Rock Vapor LLC; Dropsmoke Inc.; Perfection Vapes Inc.; CLS Trading LLC d/b/a Vape Dudes HQ; Session Supply Co.; Coastal E-Liquid Laboratory/GC Vapors LLC; Dr. Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid; CMM Capital LLC d/b/a ETX Vape; and E-Cig Barn LLC.
“These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products. “The FDA will continue to prioritize enforcement against companies that market electronic nicotine delivery systems (ENDS), including e-cigarettes, without the required authorization but haven’t submitted a premarket application to the agency, including those products with a likelihood of youth use or initiation.”