The U.S. Department of Justice, on behalf of the Food and Drug Administration, filed a complaint Monday for a permanent injunction against Vape Junkie Ejuice for manufacturing, selling and distributing unauthorized e-cigarette products, the FDA said.
This marks the seventh time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug and Cosmetic Act’s premarket review requirements for new tobacco products.
The FDA previously warned Vape Junkie Ejuice that it was in violation of the act; however, Vape Junkie Ejuice continued to manufacture, sell and distribute unauthorized e-cigarette products to consumers, the FDA said.
“FDA has been abundantly clear that we will not stand by as bad actors choose to blatantly disregard the law, especially after being duly warned,” said Brian King, director of the FDA’s Center for Tobacco Products. “This manufacturer continued to break the law, and that behavior has consequences.”
The DOJ filed the injunction complaint on behalf of the FDA against Jessica M. Fitzgerald and Michelle L. Allen, doing business as Vape Junkie Ejuice, in the Middle District of Florida—the manufacturer’s respective U.S. District Court, the FDA said.
The injunction seeks to require Vape Junkie Ejuice to stop making and selling their e-liquids, and it would require the manufacturer to obtain marketing authorization from the FDA before marketing such products. Vape Junkie Ejuice could settle, or the U.S. government can request the relevant courts enter injunctions preventing the defendant from directly or indirectly manufacturing, selling or distributing any unauthorized tobacco products.
This is part of the FDA’s comprehensive approach to enforce the law, the agency said. The FDA has issued about 640 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and devices, issued more than 400 warning letters to retailers selling unauthorized e-cigarettes and filed civil money penalty complaints against 36 e-cigarette manufacturers and 42 retailers.
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