On December 4, 2023, the U.S. Department of Justice (DOJ), on behalf of FDA, filed a complaint for a permanent injunction against Jessica M. Fitzgerald and Michelle L. Allen doing business as Vape Junkie Ejuice (Vape Junkie Ejuice) for manufacturing, selling, and distributing unauthorized e-cigarette products. This case represents the seventh time FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for new tobacco products.

Vape Junkie Ejuice was previously warned by FDA that they were in violation of the FD&C Act’s premarket review requirements for new tobacco products by manufacturing, selling, and distributing new tobacco products without first obtaining marketing authorization from FDA. FDA’s warning noted that continued violations could lead to further action, including injunction. However, Vape Junkie Ejuice continued to manufacture, sell, and distribute unauthorized e-cigarette products to consumers.

“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, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products (CTP). “This manufacturer continued to break the law, and that behavior has consequences.”

DOJ institutes judicial enforcement actions under the FD&C Act in court. Accordingly, DOJ filed the injunction complaint on behalf of FDA against Vape Junkie Ejuice in the Middle District of Florida, the manufacturer’s respective U.S. District Court. The injunction sought would require Vape Junkie Ejuice to stop manufacturing, selling, and distributing their e-liquids. The injunction would also require the manufacturer to obtain marketing authorization from FDA before marketing such products, as required by law.

In these types of cases, defendants can agree to settle and agree not to manufacture, sell, or distribute any new tobacco products until certain requirements are met. These requirements include that the tobacco products receive FDA marketing authorization, that the agency inspect the defendants’ facilities to determine compliance with the law, and that FDA notify defendants in writing that they appear to be in compliance with the law. For those defendants who do not agree to settle, the U.S. government can request the relevant courts to enter injunctions preventing those defendants from directly or indirectly manufacturing, selling, or distributing any unauthorized tobacco products.

“Today’s injunction action should be a clear reminder to all manufacturers: If you continue to sell illegal products, we are equipped to use the full force of the law,” said Ann Simoneau, director of CTP’s Office of Compliance and Enforcement. “FDA is committed to working with federal partners, including the Department of Justice, to enforce the law.”

Today’s action is part of FDA’s comprehensive approach to enforcing the law. Within the past year, FDA has taken actions against manufacturers, distributors, importers, and retailers of illegal e-cigarette products. As of November 2023, FDA has issued approximately 640 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and devices, issued more than 400 warning letters to retailers for the sale of unauthorized e-cigarettes, filed civil money penalty complaints against 36 e-cigarette manufacturers and 42 retailers for manufacture and/or sale of unauthorized products.