DOJ and FDA File Lawsuit against Six E-Cigarette Manufacturers

On October 18th, the US Department of Justice (DOJ), on behalf of the Food and Drug Administration (FDA), filed appeals with federal district courts to seek permanent injunctions against six electronic cigarette manufacturers. These cases mark the first time that the FDA has initiated injunction proceedings to enforce the pre-market review requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act for new tobacco products.

The FDA has stated that despite warning them earlier about violating the law.

The ban will require these companies and designated individuals to stop manufacturing, selling, and distributing their e-cigarettes. "Today's enforcement action is an important step by the FDA in preventing tobacco product manufacturers from breaking the law," said Brian King, director of the FDA's Center for Tobacco Products. "We will not stand idly by as manufacturers repeatedly violate the law, especially after being given multiple opportunities to comply.

The Department of Justice has taken legal action in court under the FD&C Act. As a result, DOJ representatives are filing injunctions on behalf of the FDA in their respective U.S. district courts against the following defendants:

Morin Enterprises Inc. operates an electronic cigarette shop in Minnesota.

Soul Vapor LLC is located in Southern West Virginia.

Super Vape'z LLC in the west district of Washington.

Georgia-based Steam Craft LLC.

Lucky's Convenience & Tobacco LLC, doing business as Lucky's Vape & Smoke Shop located in Kansas.

Seditious Vapors LLC d/b/a Butt Out, located in the state of Arizona.

The FDA has stated that the defendant continued to manufacture, sell, and distribute unauthorized electronic cigarettes to consumers even after receiving a warning letter from the agency. The FDA's prior warning indicated that further non-compliance could result in enforcement actions, including a ban.

These cases are an important step in preventing the illegal sale of unauthorized electronic nicotine delivery system products," said Brian M. Boynton, head of the Civil Division of the Department of Justice and Chief Deputy Assistant Attorney General. "The Department of Justice will continue to closely collaborate with the FDA in order to prevent the distribution of illegal and unauthorized tobacco products.

When a company produces and distributes unauthorized tobacco products, the FDA typically issues a warning letter first to achieve voluntary compliance with the law. If the FDA records continued violations, the agency may request DOJ to take enforcement actions, such as a ban or seizure.

The FDA has the authority to impose administrative and civil penalties for violations of the FD&C Act related to tobacco products.

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