A federal court has issued an injunction against West Virginia-based Soul Vapor LLC and its owner, Aurelius Jeffrey, prohibiting them from manufacturing, distributing, or selling unauthorized nicotine vaping products.
The U.S. District Court for the Southern District of West Virginia filed a complaint alleging that Soul Vapor LLC and Jeffrey violated the Federal Food, Drug, and Cosmetic Act (FDCA). The government accused them of selling adulterated or misbranded tobacco products after components were shipped in interstate commerce.
According to the complaint, the defendants produced and sold electronic nicotine delivery systems (ENDS) or e-cigarette products under the Soul Vapor brand. The Food and Drug Administration (FDA) had previously warned the defendants that their products were adulterated and misbranded.
Further allegations stated that the defendants submitted false information to the FDA. Companies manufacturing tobacco products must annually register with the FDA, but the defendants falsely claimed their company was “inactive” and “out of business” while continuing production. Jeffrey also assured the FDA he would cease manufacturing and selling unauthorized Soul Vapor products, yet the products remained on sale.
The court granted the government’s motion for summary judgment, finding the defendants in violation of the FDCA and guilty of submitting false information to the FDA. The court’s order permanently enjoins Soul Vapor LLC and Jeffrey from directly or indirectly engaging in the manufacture, distribution, or sale of any new tobacco product lacking FDA marketing authorization.
Additionally, the court ordered the defendants to destroy all ENDS products in their possession, custody, or control.
This injunction marks the latest enforcement action since the Justice Department and FDA established a federal multi-agency task force to tackle the illegal distribution and sale of e-cigarettes. To date, the FDA has authorized the sale of only 27 specific tobacco- and menthol-flavored e-cigarette products and devices, which are the only ones legally marketable in the U.S.
