This is the first time the FDA has taken legal action to force companies to comply with requirements that new tobacco products be approved before they’re sold.
WASHINGTON — The Food and Drug Administration toughened its fight with e-cigarette companies as the Justice Department filed 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 are 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 a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King, director of the FDA’s Center for Tobacco Products. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
Legal action came 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 the e-cigarette companies would require them to stop manufacturing, selling and distributing their products. The agency also said the e-cigarette companies “have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law.”
Nearly 300 warning letters were issued by federal regulators to manufacturing companies between January 2021 and Sept. 9, 2022, according to the FDA. The majority complied and pulled their products from the market.
The six companies the FDA filed a legal complaint against are:
“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King, director of the FDA’s Center for Tobacco Products.
This is the latest action from the FDA as it ramps up its push against e-cigarette businesses, especially companies that heavily target youth.
In June, the FDA ordered popular brand Juul to pull its electronic cigarettes from the U.S. market, part of a sweeping 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’s order.