FDA Starts Enforcement Against Unauthorized ENDS

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The U.S. Food and Drug Administration (FDA) has sent its first set of warnings letters to manufacturers of electronic nicotine delivery devices (ENDS) that did not submit premarket tobacco product applications (PMTA) by the Sept. 9 deadline.

On Jan. 15, the agency issued warning letters to 10 firms who manufacture and operate websites selling ENDS products, specifically e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.

Per 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, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending FDA 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.

Stephen Hahn

“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 in a statement. “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; Castle Rock Vapor; Dropsmoke; Perfection Vapes; CLS Trading; Session Supply Co.; Coastal E-Liquid Laboratory/GC Vapors; Dr. Crimmy; CMM Capital LLC; and E-Cig Barn.

Mitch Zeller

“These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations,” said Mitch Zeller, director of FDA’s Center for Tobacco Products. “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.”

The FDA has requested responses from each firm within 15 working days of receiving the letter detailing how each company intends to address the agency’s concerns.