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Office of Public Affairs | Court Orders West Virginia E-Cigarette Maker to Stop Selling Unauthorized Nicotine Vaping Products
On July 2, a federal court enjoined a West Virginia company and its owner from manufacturing, distributing or selling unauthorized nicotine vaping products.
In a complaint filed in the United States District Court for the Southern District of West Virginia, the government alleged that Soul Vapor LLC and the company’s owner, Aurelius Jeffrey, violated the Federal Food, Drug, and Cosmetic Act (FDCA) by causing tobacco products to be adulterated or counterfeit while they were held for sale after one or more of their components were shipped into interstate commerce. According to the complaint, the defendants manufactured and sold finished electronic nicotine delivery systems (ENDS) or e-cigarette products, including products under the Soul Vapor brand. The complaint alleged that the Food and Drug Administration (FDA) warned the defendants that their ENDS products were adulterated and counterfeit.
The complaint also alleged that the defendants submitted materially false information to the FDA. Under the FDCA, entities that manufacture tobacco products must register annually with the FDA. The government’s complaint alleged that the defendants falsely represented to the FDA in their registration form that the company was inactive and bankrupt while it continued to manufacture ENDS products. The complaint also alleged that Jeffrey represented to the FDA that he would cease manufacturing and selling Soul Vapor brand ENDS products that had not received FDA approval, while the products remained for sale.
The court previously granted the government’s motion for summary judgment against the defendants, finding that the defendants violated the FDCA and submitted materially false information to the FDA. The court’s order permanently enjoins the defendants from manufacturing, distributing, selling, and/or offering for sale, directly or indirectly, any new tobacco product that has not received marketing authorization from the FDA. The court also ordered the defendants to destroy any ENDS products manufactured by the defendants that are in their custody, control, or possession.
The injunction against Soul Vapor is the latest enforcement action finalized since the Justice Department and FDA announced the creation of a multi-agency federal task force to combat the illegal distribution and sale of e-cigarettes. To date, the FDA has authorized the sale of 27 specific products and devices for tobacco and menthol flavored electronic cigarettesThese are the only e-cigarette products that can currently be legally marketed and sold in the United States.
The manufacture and sale of unauthorized vaping products is illegal and threatens public health, said Principal Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. The Justice Department will continue to work closely with the task force to pursue enforcement actions against those who illegally manufacture, distribute, or sell these dangerous products.
“The FDA has clearly outlined what manufacturers must do to comply with the law, and we are committed to holding accountable those who fail to do so,” said Brian King, Ph.D., MPH, director of the FDA’s Center for Tobacco Products. The FDA will continue to work with its federal partners to identify and take enforcement action against these bad actors.
Attorney Michael J. Murali of the Consumer Protection Branch of the Civil Divisions handled the case, with assistance from Deputy Chief Counsel William Thanhauser of the FDA's Office of Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts is available at www.justice.gov/civil/consumer-protection-branch.
The allegations made in a complaint are allegations that, if a case were to go to trial, the government would be required to prove by a preponderance of the evidence.
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