The U.S. Department of Justice (DOJ), on behalf of the Food and Drug Administration (FDA), filed a complaint for a permanent injunction against West Virginia-based Soul Vapor LLC and owner Aurelius Jeffrey for manufacturing, selling and distributing unauthorized e-cigarette products, the FDA said.
This marks the eighth time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products, the agency said.
“FDA vigorously enforces the law and will continue to work with the U.S. Department of Justice to take enforcement actions, such as pursuing permanent injunctions, against those who defy the law,” said John Verbeten, director of the FDA’s Center for Tobacco Products’ office of compliance and enforcement. “This injunction is another reminder that FDA will use the full scope of its enforcement tools to protect public health.”
The FDA previously warned Soul Vapor LLC that it was in violation of the act. The complaint also alleged that Soul Vapor LLC submitted materially false information to the FDA.
“The court’s order is yet another example of how FDA—in coordination with federal partners—is successfully ramping up enforcement to combat unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products. “We will continue to work with our federal partners to identify and bring enforcement actions against bad actors, while continuing to educate stakeholders about the need for additional resources to best support these efforts.”
The FDA has taken steps to crack down on the increase of unauthorized e-cigarettes. On May 23, the FDA updated its import alert, which includes a “red list” of manufacturers, distributors and brands of vapor products that may be detained “without physical examination," the agency said.
To date, the FDA has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices.
In June, the DOJ and FDA created a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. The interagency task force will include various agencies, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), U.S. Marshals Service, U.S. Postal Inspection Service and Federal Trade Commission (FTC).
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