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FDA issues warning for some flavored e-liquid, hookah tobacco products
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The FDA announced that it issued warning letters to four companies notifying them that 44 flavored e-liquid and hookah tobacco products are not authorized to be marketed and cannot be sold in the United States.
“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,” Ned Sharpless, MD, acting FDA commissioner, said in a press release.
“The marketing of illegal tobacco products is particularly concerning given the epidemic of youth vaping that we’re facing, which we know has resulted in part from irresponsible practices of manufacturers, importers and retailers who have targeted kids in their marketing of these products,” he continued.
The tobacco products listed in the warning were from Mighty Vapors LLC (Ovo Manufacturing & Distribution), Liquid Labs USA LLC (Likido Labs USA), V8P Juice International LLC and Hookah Imports Inc.
The products were either introduced or modified after August 8, 2016, the date the FDA’s authority over all tobacco products went into effect. According to the release, products that do not meet the premarket requirements of the Federal Food, Drug, and Cosmetic Act are considered adulterated and misbranded and cannot be marketed legally in the U.S. without FDA approval.
Each company was asked to respond to the FDA within 15 working days to explain how it plans to address the agency’s warning, including the date they discontinued sales and distribution of the now illegal products. In addition, the companies must explain how they intend to remain in compliance with the Federal Food, Drug, and Cosmetic Act.
If the companies do not correct the violations they may be subjected to fines, seizures or injunctions. The products may also be detained or refused admission if they are imported into the United States.
“We are committed to tackling the troubling trend of youth e-cigarette use by continuing to use all available regulatory tools to ensure these products aren’t being marketed to, sold to, or used by kids,” Sharpless said. “It is critical that we remain vigilant in our efforts to stem the increase in use and nicotine addiction in children driven by e-cigarettes, which threatens to erase the years of progress we’ve made combatting tobacco use among kids.”– by Erin Michael
Disclosures: Sharpless is acting FDA commissioner.