FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Makers
The U.S. Food and Drug Administration and the U.S. Department of Justice or DOJ are seeking permanent injunctions against six e-cigarette manufacturers for continuing to illegally manufacture and distribute their products despite warnings.
The DOJ on behalf of the FDA filed complaints in defendants’ respective federal district courts, as DOJ institutes judicial enforcement actions under the FD&C Act in court.
The affected companies include Minnesota -based Morin Enterprises Inc. doing business as E-Cig Crib, West Virginia -based Soul Vapor LLC, Washington -based Super Vape’z LLC, Georgia -based Vapor Craft LLC, Kansas -based Lucky’s Convenience & Tobacco LLC doing business as Lucky’s Vape & Smoke Shop, and Arizona-based Seditious Vapours LLC doing business as Butt Out.
In a statement, the health agency noted that these cases represent the first time it has initiated injunction proceedings relating to tobacco products.
According to the agency, these companies failed to submit premarket applications for their e-cigarettes and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA.
Brian King, director of the FDA’s Center for Tobacco Products, said, “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
The injunctions would require the companies and named individuals to stop manufacturing, selling, and distributing their e-cigarettes. The defendants are also required to obtain marketing authorization from the FDA before marketing such products, as required by law.
Earlier this month, the FDA issued a warning letter to EVO Brands LLC and PVG2 LLC, doing business as Puff Bar, for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order.
Between January 2021 through September 9, 2022, the FDA issued nearly 300 warning letters, to firms that collectively have more than 17 million e-cigarettes listed with the agency, for failure to submit a timely premarket application. A majority of these companies have complied and removed their products from the market.
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