The U.S. Food and Drug Administration (FDA) announced on its official website on June 14th that the Federal District Court of Colorado has issued a permanent injunction against Boosted LLC (dba Boosted E-Juice, Boosted, Live Boosted) and its owner Cory Vigil. The ruling prohibits them from manufacturing, selling, or distributing any new tobacco products unless they meet certain requirements.
According to a lawsuit filed by the US Department of Justice (DOJ) on behalf of the FDA, the defendant has been warned for serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding pre-market review requirements for new tobacco products, as they did not obtain market authorization from the FDA before selling them. The FDA has warned that continued violations may lead to further legal action, including injunctions.
In order to avoid litigation, the defendant signed a consent judgment, which is a written agreement signed by a federal judge and issued as a court order. According to the consent judgment, the defendant agreed not to manufacture, sell, or distribute any new tobacco products until certain requirements are met. These requirements include obtaining FDA marketing authorization for the new tobacco products, FDA inspecting the defendant's facilities to determine compliance with the law, and FDA notifying the defendant in writing that they appear to be in compliance with the law.
The FDA and the Department of Justice have initiated an injunction for the eighth time, beginning in October 2022, in order to enforce pre-market review requirements for new tobacco products. The Department of Justice has taken legal action in court under the Federal Food, Drug, and Cosmetic Act. Therefore, on behalf of the FDA, the Department of Justice filed consent decrees for permanent injunction against defendants in the district of Colorado (each manufacturer's respective U.S. District Court).
FDA Center for Tobacco Products (CTP) Director Brian King stated:
The FDA consistently and resolutely enforces the law, especially after issuing clear warnings and explaining what companies need to do to comply. Those who disregard the law will be held accountable, and we are committed to using all our powers to hold them responsible.
The FDA has made it clear that it will work together with federal partners, including the Department of Justice, to take enforcement actions and seek permanent injunctions against illegal behavior.
This action is part of a comprehensive approach to coordinated enforcement by the FDA and other federal agencies. Last year, in a joint operation at Los Angeles International Airport, the U.S. Customs and Border Protection seized over $18 million worth of illegal e-cigarettes. In addition, the FDA has issued 678 warning letters to companies suspected of manufacturing, selling, and/or distributing unauthorized novel tobacco products, issued over 550 warning letters to retailers, filed civil penalty complaints against 57 manufacturers and 140 retailers for selling unauthorized tobacco products.
The eight manufacturers who received permanent injunctions are as follows:
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