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FDA Takes Additional Actions Against Unauthorized Vapor Products

The agency issued warning letters to six online retailers and entered into a consent degree with another company.
A judge's gavel standing in front of a row of law books

WASHINGTON D.C. — The U.S. Food and Drug Administration (FDA) recently took several actions of varying degrees of severity against distributors illegally selling unauthorized tobacco products, including e-cigarettes.

The agency issued warning letters to six online retailers for selling unauthorized flavored, disposable e-cigarettes, including those under the brand names Funky Republic and HQD, and which have tended to have a widespread appeal to young smokers. 

The retailers will have 15 working days to respond with the steps they will take to correct any violations and to prevent future violations. 

[Read more: FDA Steps Back From JUUL MDOs]

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In an example of what can happen if retail operators or distributors fail to adjust or respond to an FDA warning, the United States District Court for the District of Colorado this past week entered a consent decree of permanent injunction against Boosted LLC and its owner, Cory Vigil. The decree will prohibit Boosted 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, the defendants were previously warned they were in violation of the Federal Food, Drug and Cosmetic Act's (FD&C Act) premarket review requirements for new tobacco products by failing to first obtain marketing authorization from FDA. 

"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 the FDA's Center for Tobacco Products. "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."

In this case, to avoid litigation, the defendants signed the consent decree to meet certain requirements, which now include that:

  • New tobacco products receive FDA marketing authorization; 

  • The FDA inspect the defendants' facilities to determine compliance with the law; and 

  • The FDA notify defendants in writing that they appear to be in compliance with the law. 

The case represents the ongoing collaboration among federal partners and is the eighth time the FDA and DOJ have initiated injunction proceedings to enforce the FD&C Act's premarket review requirements. 

The agencies recently expanded the scope of their work into a full federal task force to help coordinate and streamline investigations.

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