According to the U.S. Food and Drug Administration (FDA), on July 2, 2024, the United States District Court for the Southern District of West Virginia enjoined Soul Vapor LLC, a West Virginia-based company, and the company’s owner, Aurelius Jeffrey, from directly or indirectly manufacturing, distributing, selling and/or offering for sale any new tobacco product that has not received marketing authorization from FDA. The court also ordered Soul Vapor and Jeffrey to destroy e-cigarette products that were manufactured by Soul Vapor and are in their custody, control or possession.
“FDA … 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 (CTP) 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.”
According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, the defendants were previously warned they were in violation of the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling and distributing new tobacco products by failing to first obtain marketing authorization from FDA. The complaint also alleged that the defendants submitted materially false information to 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 CTP. “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.”
According to the FDA, the injunction against Soul Vapor highlights the successful cooperation between FDA and the DOJ to enjoin bad actors from manufacturing, selling and distributing unauthorized e-cigarette products. On June 10, 2024, FDA and DOJ announced the creation of an interagency task force focused on combating the illegal distribution and sale of unauthorized e-cigarettes in the United States through using an all-government approach.