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FDA and DOJ Action Leads to Entry of Consent Decree of Permanent Injunction Against Manufacturer of Unauthorized E-Cigarettes

Manufacturer continued to sell unauthorized products despite previous warnings it was breaking the law

June 14, 2024

On June 11, 2024, the United States District Court for the District of Colorado entered a consent decree of permanent injunction against Boosted LLC (who also does business as Boosted E-Juice, Boosted, and Live Boosted) and Cory Vigil, owner of Boosted LLC. The consent decree prohibits Boosted LLC and Mr. Vigil from manufacturing, selling, or distributing any new tobacco products until they meet certain requirements. 

According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, defendants were previously warned they were in violation of the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling, and distributing new tobacco products by failing to first obtain marketing authorization from FDA. The agency’s warnings noted that continued violations could lead to further action, including an injunction. 

“FDA remains steadfast in our work to enforce the law, especially after we’ve given a crystal-clear warning and explanation of what firms need to do to comply,” said Brian King, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products (CTP). “Those who flout the law are responsible for the consequences, and we are committed to using the full force of our authorities to hold them accountable.” 

In this case, to avoid litigation, the defendants signed a consent decree, which is a written agreement signed by a federal judge and entered as a court order. Under the consent decree, the defendants have agreed not to manufacture, sell, or distribute any new tobacco products until they meet certain requirements. These requirements include that the new tobacco products receive FDA marketing authorization, that FDA 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. 

This case represents the ongoing collaboration among federal partners—which will continue and expand under FDA and DOJ’s newly announced task force—to address unauthorized e-cigarettes in the United States. This is the eighth time FDA and DOJ have initiated injunction proceedings, the first of which occurred in October 2022, to enforce the FD&C Act’s premarket review requirements for new tobacco products. DOJ institutes judicial enforcement actions under the FD&C Act in court. Accordingly, DOJ, on behalf of FDA, filed the consent decree of permanent injunction against the defendants in the District of Colorado, the manufacturer’s respective U.S. District Court.

“FDA has made clear it is committed to working with our federal partners, including the U.S. Department of Justice, to take enforcement actions, like seeking permanent injunctions, against those who violate the law,” said Jill Atencio, J.D., acting director of CTP’s Office of Compliance and Enforcement. “A coordinated, all government approach that brings together collective federal resources and experiences is critical to the success of these enforcement actions.”

The action announced today is part of FDA’s comprehensive approach to enforcing the law in coordination with federal partners. Last year, FDA coordinated with U.S. Customs and Border Protection to seize more than $18 million in unauthorized e-cigarettes during a joint operation at LAX airport. This spring, FDA announced that it coordinated with the DOJ and the U.S. Marshals Service to seize over $700,000 worth of unauthorized cigarettes from a warehouse in California. Additionally, to date, FDA has issued 678 warning letters to firms for manufacturing, selling, and/or distributing illegal unauthorized new tobacco products, issued more than 550 warning letters to retailers for the sale of unauthorized tobacco products, and filed civil money penalty complaints against 57 manufacturers and 140 retailers for distribution and/or sale of unauthorized tobacco products. 

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