Federal regulators said they put four vape companies on notice for illegally selling dozens of flavored e-liquid products that were not cleared with the required market authorization.
On Aug. 8, the U.S. Food and Drug Administration (FDA) sent warning letters to the companies concerning 44 e-liquid (also called e-juice) products they are selling without approval or are misbranded. The e-liquids come in a variety of fruity and sweet and are formulated with nicotine salts that make them mellower and more palatable to children and teens while being more readily absorbed by the body.
The four companies that sell these products 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 vape vendors introduced or modified the e-juice products after Aug. 8, 2016 – the day the FDA’s authority to regulate vape products and all other tobacco-derived nicotine products became effective.
The agency considers any new tobacco products that fail to meet the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket requirements to be adulterated and/or misbranded. Companies that fail to comply with the FDA’s orders to cease selling a product are subject to fines, seizure of property, injunctions, and other court-ordered actions.
The day after the FDA issued its warning letters, specific e-juice products named by the FDA were listed as “out of stock.” The website for Liquid Labs USA was “expired,” and V8P Juice International appeared to continue selling the illegal “salt based nicotine” vape products. Hookah Imports, a Phoenix, Arizona-based operation, makes and sells flavored shisha tobacco for use in hookahs under the ROR brand but is not taking orders online.
“With no clue about the process of obtaining a license to manufacture tobacco! This nightmare of getting a federal license took two and a half years of pain and suffering,” Hookah Imports states on its website.
Acting FDA Commissioner Ned Sharpless said the FDA will continue to “keep a close watch on whether companies are breaking the law.”
“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,” Dr. Sharpless said.
The agency largely blames the epidemic of youth vaping on JUUL, the San Francisco-based vape maker that took advantage of the unregulated vape market and made products that aggressively targeted kids and teens.
Although the FDA requires vape companies to submit applications for all new products prior to selling them, it still permits the manufacture and sales of vape products introduced before the agency gained regulatory oversight of the industry. This means that for now at least, the companies can still legally sell e-juice in flavors the FDA considers to be attractive to kids.
Beasley Allen lawyers Joseph VanZandt and Sydney Everett are handling cases involving injuries related to vaping. We are looking at cases involving adolescent addiction and injuries including seizures, strokes, lung problems, and cardiovascular problems related to the use of JUUL vaping devices. If you have these type cases, we would like to work with you.