FDA Bans Boosted From Doing Vape Business in US
The United States District Court for the District of Colorado entered a consent decree of permanent injunction against Boosted (who also does business as Boosted E-Juice, Boosted and Live Boosted) and Cory Vigil, owner of Boosted LLC.
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.
According to the complaint filed by the U.S. Department of Justice (DOJ) on FDA’s behalf, defendants were previously warned that failing to obtain marketing authorization from FDA violated the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket review requirements for manufacturing, selling, and distributing new tobacco products.
The agency’s warnings noted that continued violations could lead to further action, including an injunction, according to a release.
“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, 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.”
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, 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 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.
