SILVER SPRING, Md. — The U.S. Food and Drug Administration has sent warning letters to tobacco companies illegally selling vapor products—but now it’s taking enforcement a step further.
The U.S. Department of Justice, on behalf of the FDA, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufactures, which the agency said failed to submit premarket tobacco product applications (PMTAs) for their e-cigarettes and continued to illegally sell the products despite previous warning.
This is the first time the FDA initiated injunction proceedings to enforce the federal Food, Drug and Cosmetic Act’s premarket review requirements for new tobacco products, the agency said.
The defendants are:
- Morin Enterprises Inc., doing business as E-Cig Crib in Coon Rapids, Minn.
- Soul Vapor LLC in Princeton, W.Va.
- Super Vape’z LLC in Puyallup, Wash.
- Vapor Craft LLC in Columbus, Ga.
- Lucky’s Convenience & Tobacco LLC, doing business as Lucky’s Vape & Smoke Shop, in Wichita, Kan.
- Seditious Vapours LLC, doing business as Butt Out, in Phoenix, Ariz.
“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Center for Tobacco Products Director Brian King. “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 to stop manufacturing, selling and distributing their e-cigarettes, and would require the defendants to obtain marketing authorization from the FDA before marketing such products.
“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian Boynton. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”
Between January 2020 through the start of September 2022, the FDA issued nearly 300 warning letters to companies that collectively have more than 17 million e-cigarettes listed with the agency, for failure to submit a timely premarket application. Most companies complied and removed their products from the market after receiving a warning, the FDA said.
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