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August 12, 2019

FDA warns companies to stop illegally marketing vape products

By Arman Azad | CNN

The FDA began to crack down on illegally marketed tobacco products Thursday, issuing warning letters to four companies for allegedly selling e-liquids and hookah tobacco without legal authorization.

The products, according to the FDA, lack the necessary marketing authorization to be sold in the United States. No e-cigarette currently has that approval, but many are allowed to stay on the market temporarily because they were introduced before the FDA assumed authority over vapes in August 2016.

Under the agency's rules, companies now have to apply to the FDA before selling new products. The FDA said Friday that the four companies -- Mighty Vapors, Liquid Labs, V8P Juice International and Hookah Imports -- failed to do so.

Together, they sold 44 flavored e-liquid and hookah products that lacked necessary authorization, the FDA said. Three companies did not immediately respond to CNN's requests for comment. The man listed by the FDA as the owner of V8P Juice International, Alex De La Espriella, declined to comment.

The FDA has given each company 15 working days to address the agency's concerns and warned that "failure to correct violations may result in further action such as seizure or injunction." The agency said Thursday that it has several tools to ensure compliance, including fines and the courts.

"Today's actions make clear that we will continue to keep a close watch on whether companies are breaking the law and will take swift steps when violations are found," said Acting FDA Commissioner Dr. Ned Sharpless. "Our work in this area has already resulted in a number of companies removing products from the market."

The warnings come as the FDA faces scrutiny over its response to the youth vaping epidemic. A coalition of health groups, including the American Academy of Pediatrics, sued the agency last year for delaying a review of the safety and health impacts of e-cigarettes.

A federal judge ruled in May that the FDA acted illegally by allowing e-cigarettes to remain on the market until 2022 before companies applied for FDA authorization. In July, the judge moved up that deadline, giving companies just 10 months to apply.

"The FDA stands ready to accelerate the review of e-cigarettes and other new tobacco products," Sharpless said at the time.

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