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01/19/2021

FDA Tells Firms That Didn't Submit PMTA Applications to Stop Selling Product

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SILVER SPRING, Md. — The Food and Drug Administration (FDA) sent warning letters to 10 companies for selling electronic nicotine delivery systems (ENDS) — specifically e-liquids — even though they did not file premarket tobacco applications (PMTAs) by the Sept. 9, 2020 deadline.

The letters are the first the agency issued since to companies that continue to sell or distribute unauthorized ENDS passed the deadline.

Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016, including e-liquids, were required to be submitted to the FDA by Sept. 9, the agency explained.

Companies that submitted PMTAs are generally allowed to continue to sell or distribute their products for one year until the FDA completes its review, unless there is a negative action taken by the FDA on the application. 

The FDA plans to post a list of products for which the agency has received applications; however, before making such a list available, the FDA is verifying certain information about these products so that publication of a list complies with federal disclosure laws.

"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, director of FDA's Center for Tobacco Products.

"The FDA will continue to prioritize enforcement against companies that market [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," he added.

The letters issued on Jan. 15 cite specific products as examples, but according to the agency, collectively these companies have listed a combined total of more than 100,000 products with the FDA. The companies have 15 working days from receiving the warning letters to detail how they intend to address the agency's concerns.