This is the first time the FDA has taken legal action to compel companies to comply with requirements that new tobacco products must be approved before they are sold.
WASHINGTON – The Food and Drug Administration has hardened its fight with e-cigarette companies as the Justice Department files permanent injunctions against six manufacturers, accusing them of skipping the required approval process for their products and ignoring multiple follow-up requests from the FDA to do so.
The series of complaints on behalf of the FDA is the first time the agency has taken legal action to force e-cigarette companies to follow the agency’s premarket review requirements for new tobacco products. , according to a press release.
“Today’s enforcement actions represent an important step for the FDA in preventing tobacco product manufacturers from breaking the law,” said Brian King, director of the FDA’s Center for Tobacco Products. “We will not sit idly by as manufacturers repeatedly break the law, especially after they have had multiple opportunities to comply.”
A lawsuit arose after the six companies failed to submit the required premarket application for e-cigarette products, which must be approved before the manufacturer begins selling the products.
Permanent injunctions against e-cigarette makers would force them to stop manufacturing, selling and distributing their products. The agency also said e-cigarette companies “continued to illegally manufacture, sell, and distribute their products, despite the FDA’s previous warning that they were violating the law.”
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Nearly 300 warning letters were issued by federal regulators to manufacturing companies between January 2021 and September 9, 2022, according to the FDA. The majority complied and withdrew their products from the market.
The six companies against which the FDA has filed a legal complaint are:
- Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota
- Soul Vapor LLC in the Southern District of West Virginia
- Super Vape’z LLC in the Western District of Washington
- Vapor Craft LLC in the Central District of Georgia
- Lucky’s Convenience & Tobacco LLC doing business as Lucky’s Vape & Smoke Shop in the District of Kansas
- Seditious Vapors LLC doing business as Butt Out in the District of Arizona
“Today’s enforcement actions represent an important step for the FDA in preventing tobacco product manufacturers from breaking the law,” said Brian King, director of the FDA’s Center for Tobacco Products.
This is the latest action by the FDA as it steps up its efforts against e-cigarette companies, especially companies that heavily target young people.
In June, the FDA ordered popular brand Juul to remove its e-cigarettes from the U.S. market, part of a major effort by the agency to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays. A federal judge temporarily blocked the government order.
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