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US FDA bans 44 flavored vape, hookah products over lack of approval

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US FDA bans 44 flavored vape, hookah products over lack of approval

The U.S. Food and Drug Administration is banning the sale of 44 flavored e-liquid and hookah tobacco products for not having the required marketing authorization, according to an Aug. 8 release.

The federal agency said it issued warning letters to four companies that sell these products as part of its ongoing efforts to look into and take action against illegally marketed tobacco products amid growing e-cigarette use among the youth. The companies are Mighty Vapors LLC, doing business as Ovo Manufacturing & Distribution; Liquid Labs USA LLC, doing business as Likido Labs USA; V8P Juice International LLC; and Hookah Imports Inc.

The FDA said that any new tobacco product that does not comply with the Federal Food, Drug, and Cosmetic Act's premarket requirements is adulterated and/or misbranded and may not be legally sold without the agency's approval. Misbranded or adulterated products imported into the U.S. may be held or refused entry, the agency said.

"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," Acting FDA Commissioner Ned Sharpless said in a statement.

He added: "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 combating tobacco use among kids."

The four companies were given 15 days to respond on how they will resolve the concerns raised by the agency, including the dates on which they discontinued any violative sale and/or distribution of their products, as well as their plans for maintaining compliance with the FD&C Act. Failure to do so may lead to further action such as seizure and injunction, the FDA said.