Federal regulators said they have put four vape companies on notice. They state the companies lacked the required market clearance to sell dozens of flavored e-liquid products. Without proper clearance, the vendors were selling the products illegally.
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 were selling without approval. The e-liquids come in a mix of fruity and sweet flavors. Also, their formula includes nicotine salts that make them more mellow and flavorful to children and teens. Further, nicotine salts promote absorption of nicotine in the body.
The Named Companies
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 began selling or altered 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 went into effect.
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 or misbranded. Companies that fail to comply with the FDA’s orders to cease sales are subject to civil penalties. These penalties can include fines, seizure of property, injunctions, and other court-ordered actions.
After the FDA issued warning letters, vendor websites listed certain e-juice products named by the FDA as out of stock. The website for Liquid Labs USA was no longer in service. V8P Juice International appeared to continue selling the illegal “salt based nicotine” vape products. Hookah Imports makes and sells flavored shisha tobacco for use in hookahs under the ROR brand. It is not taking orders online.
The FDA is Watching
Acting FDA Commissioner Ned Sharpless states:
“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.”
“Today’s action makes clear that we will continue to keep a close watch on companies and take swift steps when violations are found.”
— Dr. Ned Sharpless, Acting FDA Commissioner
The agency largely blames the epidemic of youth vaping on JUUL. The San Francisco-based vape maker took advantage of the unregulated vape market and made products that aggressively targeted kids and teens.
The FDA requires vape companies to submit applications for all new products prior to selling them. However, it still permits the production and sales of vape products sold before the agency gained authority over the industry. This means that the companies can still legally sell e-juice in flavors the FDA considers to be attractive to kids.
JUUL Vape Lawyers
Beasley Allen lawyers Joseph VanZandt and Sydney Everett are handling cases involving injuries related to vaping. We are looking at cases involving teen addiction and injuries including seizures, strokes, lung problems, and heart problems related to the use of JUUL vaping devices. If you have these types of cases, we would like to work with you.