Tobacco

FDA, DOJ Enter Consent Decree of Permanent Injunction Against Boosted LLC

E-cigarette manufacturer continued to sell unauthorized products despite previous warnings it was breaking the law
vape products
Photograph: Shutterstock

The U.S. District Court for the District of Colorado has entered a consent decree of permanent injunction  against Boosted LLC, which also does business as Boosted E-Juice, Boosted, and Live Boosted, and its owner Cory Vigil, the Food and Drug Administration (FDA) said on Friday. The consent decree, which is a written agreement signed by a federal judge and entered as a court order, forbids Boosted LLC and 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 the 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 by failing to first obtain marketing authorization from FDA.

This marks the eighth time the FDA has initiated injunction proceedings to enforce the FD&C Act premarket review requirements for new tobacco products.

The 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 the FDA’s Center for Tobacco Products (CTP) Director Brian King. “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.” 

Jill Atencio, acting director of CTP’s Office of Compliance and Enforcement, said that “a coordinated, all government approach that brings together collective federal resources and experiences is critical to the success of these enforcement actions.”

Friday’s action comes just days after the creation of a federal multi-agency task force by the FDA and DOJ to combat the illegal distribution and sale of e-cigarettes.

To date, the 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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