In a press release on Monday, the Food and Drug Administration (FDA) announced that it has issued warning letters to 10 different companies which both manufacture and sell electronic nicotine delivery system (ENDS) products, like e-cigarettes. The letters said that the firms had not received pre-market authorization to sell e-liquid products and so they are currently being sold and distributed illegally.
The FDA said these letters are the first set to be sent to companies who missed the September 9, 2020 deadline for submitting a premarket tobacco product application (PMTA) but are continuing sales regardless. A court previously ruled that manufacturers of new tobacco and e-liquid products developed since August 2016 needed to submit a PMTA before the 2020 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, M.D. in the press release. “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.”
According to the press release, the FDA “intends to continue to defer enforcement” for any companies who did submit their applications by the deadline and prioritize enforcement for companies that have not submitted a PMTA. The department also reported that it plans to publish a list of products that have been addressed in applications and is working to verify the information before publication.
The warning letters cite specific products that need to be placed on a PMTA. According to the press release, the 10 companies have a total of over 100,000 products, all of which need to be addressed in a premarket review.
The 10 firms which received FDA warning letters include 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. The FDA asked each of these companies to respond within 15 days to let the FDA know when and how it will address the violations.
“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.
