Court Halts E-Cigarette Company’s Operations Over FDA Violations

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WASHINGTON, D.C. — The United States District Court for the District of Colorado has issued a permanent injunction against Boosted LLC and its owner, Cory Vigil. This legal action, issued June 12, 2024, prohibits the company from manufacturing, selling, or distributing any new tobacco products until specific requirements are met.

Boosted LLC, which operates under names like Boosted E-Juice, Boosted, and Live Boosted, was found in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The U.S. Department of Justice, on behalf of the FDA, filed a complaint stating that the company failed to obtain necessary marketing authorization before introducing new tobacco products to the market.

The court’s decision follows warnings issued by the FDA to Boosted LLC. According to the FDA, the company continued its operations despite clear instructions to comply with premarket review requirements.

“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.”

To avoid litigation, Boosted LLC and Vigil agreed to a consent decree. A consent decree is a written agreement signed by a federal judge and entered as a court order. The defendants have agreed to halt the manufacturing, sale, and distribution of new tobacco products until they meet several conditions. These include obtaining FDA marketing authorization, passing an FDA inspection of their facilities, and receiving written notification from the FDA confirming compliance with the law.

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“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.”

This ruling aims to reinforce the importance of regulatory compliance within the tobacco industry. The premarket review process is designed to ensure that new tobacco products meet safety standards before reaching consumers. By bypassing this process, companies risk introducing potentially harmful products to the market.

The broader implication of this case is a reminder to all e-cigarette and tobacco companies about the necessity of adhering to federal regulations. The FDA’s actions signal a strong commitment to protecting public health by ensuring that all tobacco products undergo rigorous evaluation before entering the market.

For consumers, this enforcement action underscores the reliability of regulatory oversight in safeguarding public health. It also highlights the potential risks associated with unapproved tobacco products, which may not have been thoroughly tested for safety.

In summary, the court’s injunction against Boosted LLC and its owner reflects the ongoing efforts of the FDA and DOJ to uphold the law and protect consumers. This case serves as a significant reminder to the tobacco industry about the critical importance of regulatory compliance.

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