SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) is cracking down on companies selling electronic nicotine delivery systems (ENDS) without the proper authorization.
The FDA sent warning letters to 10 firms that manufacture and operate websites selling e-liquids and told them selling those products is illegal because they did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020, deadline.
These warning letters were the first set the FDA issued to firms who have not submitted PMTAs and are continuing to sell or distribute unauthorized ENDS.
The companies that received letters are Little House Vapes LLC; Castle Rock Vapor LLC; Dropsmoke Inc.; Perfection Vapes Inc.; CLS Trading LLC doing business as Vape Dudes HQ; Session Supply Co.; Coastal E-Liquid Laboratory/GC Vapors LLC; Dr. Crimmy LLC dba Dr. Crimmy’s V-Liquid; CMM Capital LLC dba ETX Vape; and E-Cig Barn LLC, according to the administration. Collectively, they have listed more than 100,000 products with the FDA.
“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 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 warning letters are the result of surveillance and internet monitoring for violations of tobacco laws and regulations, said Mitch Zeller, director of the FDA’s Center for Tobacco Products. The FDA found the firms listed above were all distributing unauthorized new tobacco products, and the FDA requested the letter recipients respond within 15 working days detailing how they intend to address the agency’s concerns. Failure to do so could result in a civil money penalty complaint, seizure or injunction, the FDA said.
Premarket review for deemed new tobacco products on the market after Aug. 8, 2016, were required to be submitted by the Sept. 9 deadline, according to a court order. Companies that submitted applications by the deadline are generally allowed to continue selling those products for up to a year, pending a negative action taken by the FDA on the application.
The FDA is in the process of making a public list of which products the agency received applications for.