A federal court on July 2 enjoined a West Virginia company and its owner from manufacturing, distributing or selling unauthorised nicotine vaping products.
In a complaint filed in the U.S. 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 become adulterated or misbranded while they were held for sale after shipment of one or more of their components in interstate commerce.
According to the complaint, the defendants manufactured and sold finished electronic nicotine delivery systems (ENDS) products 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 misbranded.
The complaint also alleged that the defendants submitted materially false information to FDA. Under the FDCA, entities that manufacture tobacco products must annually register with the FDA. The government’s complaint alleged that the defendants falsely told the FDA in their registration form that the company was “inactive” and “out of business” even while it continued to manufacture ENDS products.
The complaint also alleged that Jeffrey told the FDA that he would discontinue manufacturing and selling Soul Vapor-brand ENDS products that lacked FDA authorization, yet 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 order entered by the court permanently enjoins the defendants from directly or indirectly manufacturing, distributing, selling and offering for sale any new tobacco product that has not received marketing authorization from the FDA.
The court also ordered the defendants to destroy ENDS products manufactured by the defendants in their custody, control or possession.
The injunction against Soul Vapor is the most recent judicial enforcement action finalized since the Justice Department and FDA announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. To date, the FDA has authorized the sale of 27 specific tobacco- and menthol-flavored e-cigarette products and devices. These are the only e-cigarette products that may be lawfully marketed and sold in the United States.
“Manufacturing and selling unauthorized vaping products is illegal and threatens public health,” said Principal Deputy 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 bring enforcement actions against those who illegally manufacture, distribute or sell these dangerous products.”
“FDA has clearly outlined what manufacturers need to do to comply with the law, and we are committed to holding those who fail to do so accountable,” said Director Brian King, Ph.D., M.P.H. of the FDA’s Center for Tobacco Products. “FDA will continue to work with our federal partners to identify and bring enforcement actions against these bad actors.”
