SILVER SPRING, Maryland – The United States Food and Drug Administration (FDA) is targeting companies that sell electronic nicotine delivery systems (ENDS) without proper authorization.
The FDA sent warning letters to 10 companies that make and operate websites selling e-liquids and told them that the sale of these products was illegal because they had not submitted a tobacco product application before. marketing (PMTA) before the deadline of September 9, 2020.
These warning letters were the first to be sent by the FDA to companies that have not submitted PMTAs and continue to sell or distribute unauthorized ENDS.
The companies that have received letters are Little House Vapes LLC; Chateau Rock Vapeur LLC; Dropsmoke Inc .; Perfection Vapes Inc .; CLS Trading LLC doing business as Vape Dudes HQ; Session supply company; Coastal E-Liquids 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 over 100,000 products with the FDA.
“The pre-market application process ensures that new tobacco products, many of which are already on the market, will undergo a strong scientific assessment 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 children, from the harms associated with tobacco use. In addition to the important scientific pre-market review, prioritizing law enforcement against those who break the law by selling unauthorized products is how we help protect public health. “
The warning letters are the result of monitoring and surveillance on the Internet for violations of tobacco laws and regulations, said Mitch Zeller, director of the Center for Tobacco Products at the FDA. The FDA discovered that the companies listed above were all distributing new, unauthorized tobacco products, and the FDA asked recipients of the letter to respond within 15 business days explaining how they intended to address the agency’s concerns. . Failure to do so could result in a civil lawsuit, foreclosure or injunction, the FDA said.
The pre-market review of new tobacco products on the market after August 8, 2016 was to be submitted by the September 9 deadline, according to a court order. Companies that submitted applications before the deadline are generally allowed to continue to sell these products for up to one year, pending negative FDA action on the application.
The FDA is in the process of making a public list of products for which the agency has received applications.
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