The accusation further claimed that the defendants provided FDA with misleading information. According to the FDCA, companies producing tobacco products are required to register with FDA on a yearly basis. The government's claim stated that the defendants falsely indicated on their registration form that their company was not operational and had ceased operations, despite continuing to manufacture ENDS products
The U.S. District Court for the Southern District of West Virginia issued an injunction on July 2, prohibiting a West Virginia company and its owner from producing, distributing, or selling unauthorized nicotine vaping products.
According to the complaint filed, Soul Vapor LLC and its owner, Aurelius Jeffrey, were accused of violating the Federal Food, Drug, and Cosmetic Act (FDCA) by allowing tobacco products to become adulterated or misbranded while in interstate commerce. The defendants were alleged to have manufactured and sold electronic nicotine delivery systems (ENDS) products, including e-cigarette products under the Soul Vapor brand. The Food and Drug Administration (FDA) had reportedly warned the defendants about the adulterated and misbranded nature of their products.
“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 accusation further claimed that the defendants provided FDA with misleading information. According to the FDCA, companies producing tobacco products are required to register with FDA on a yearly basis. The government's claim stated that the defendants falsely indicated on their registration form that their company was not operational and had ceased operations, despite continuing to manufacture ENDS products.
Additionally, it was alleged that Jeffrey assured FDA that he would stop producing and selling Soul Vapor-brand ENDS products without FDA approval, yet these products were still being sold.
The government's motion for summary judgment against the defendants was approved by the court, which found that they violated the FDCA and provided false information to the FDA. As a result, the court issued an order permanently prohibiting the defendants from producing, distributing, or selling any new tobacco product without FDA authorization. Additionally, the defendants were instructed to dispose of any ENDS products in their possession.
“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.
The latest court order against Soul Vapor marks the most recent crackdown by the Justice Department and FDA, following the establishment of a federal multi-agency task force to tackle the illicit distribution and sale of e-cigarettes. Currently, the FDA has given the green light for the sale of 27 specific tobacco- and menthol-flavored e-cigarette products and devices, which are the only ones permitted for lawful marketing and sale in the United States.
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