Last week, the Food and Drug Administration (FDA) announced that it had teamed up with the Department of Justice (DOJ) to launch a multi-agency task force aimed at combatting the distribution and sale of unauthorized e-cigarettes.
The task force includes efforts for multiple law enforcement agencies, including Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); the U.S. Marshals Service (USMS); the U.S. Postal Inspection Service (USPIS); and the Federal Trade Commission (FTC).
The FDA noted that the task force hopes to “coordinate and streamline efforts to bring all available criminal and civil tools to bear against the illegal distribution and sale of e-cigarettes responsible for nicotine addiction among American youth.”
Now, the newly-formed entity has taken action for the first time since its creation.
Swift Action
The FDA announced that the U.S. District Court for the District of Colorado has entered a consent decree of permanent injunction against Boosted (which also does business as Boosted E-Juice, Boosted and Live Boosted) and Cory Vigil, owner of the company.
The consent decree prohibits Boosted and Vigil from manufacturing, selling or distributing any new tobacco products until the company has “(met) certain requirements,” FDA wrote in a statement.
According to the complaint filed by the DOJ on the FDA’s behalf, Vigil was previously warned that the company was 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 the FDA.
The FDA’s warnings noted that continued violations could lead to further action, including an injunction, the agency’s statement continued.
“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.”
Legal Implications
In this case, to avoid litigation, Boosted 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 company has 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 the FDA inspect the defendants’ facilities to determine compliance with the law and that the 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 U.S.,” the FDA’s statement read.
This is the eighth time the 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.
“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.”
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.
