FDA Warns U.S. Manufacturer Against Illegally Marketing ENDS

Agency vows continued monitoring of the tobacco marketplace.

July 29, 2021

E-Cigarette Smoking

WASHINGTON—The U.S. Food and Drug Administration has issued a warning letter to Visible Vapors LLC, a Philadelphia-based company that manufactures and operates a website selling electronic nicotine delivery system (ENDS) products, including e-cigarettes and e-liquids, the agency reports.

The letter advised the company that marketing new tobacco products, which lack premarket authorization, is illegal, and that the offerings cannot be sold or distributed in the United States. The firm did not submit any premarket tobacco product applications (PMTAs) for the products by the previously announced Sept. 9, 2020, deadline.

“This action demonstrates the agency’s ongoing commitment toward ensuring that marketed tobacco products are in compliance with the law to better protect youth and the public health,” said Mitch Zeller, J.D., director of the FDA Center for Tobacco Products. “The warning letter is the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations.”

Zeller added that the FDA regularly scrutinizes the marketplace and will hold companies accountable for breaking the law.

“The FDA will continue to prioritize enforcement against companies that market ENDS without the required authorization and that haven’t submitted a premarket application to the agency—especially those products with a likelihood of youth use or initiation,” he said.

While the warning letter cites specific products as examples, Visible Vapors LLC has more than 15 million products listed with the FDA and must ensure all products comply with federal rules and regulations, including the mandatory premarket review.

From January through June 2021, the FDA issued a total of 131 warning letters to firms that have sold or distributed more than 1,470,000 unauthorized ENDS and did not submit premarket applications for those products by the deadline. Retailers can check the list of warning letters sent on the FDA’s Warning Letters page to ensure they not are stocking products that are illegal to sell.

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