DOJ Files Injunctions Against 6 Vapor Manufacturers
The U.S. Department of Justice (DOJ) today filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the U.S. Food and Drug Administration. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
The FDA states that each of the defendants failed to submit premarket tobacco product applications (PMTAs) for their e-cigarettes and have continued to illegally manufacture, sell, and distribute their products, despite previous warning from the FDA that they were in violation of the law.
The injunctions would require the companies and named individuals to stop manufacturing, selling, and distributing their e-cigarettes. “Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King, director of the FDA’s Center for Tobacco Products. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
DOJ institutes judicial enforcement actions under the FD&C Act in court, according to a press release. Therefore, the injunctions were filed by DOJ on behalf of the FDA against the following defendants in their respective U.S. District Courts:
- Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota
- Soul Vapor LLC in the Southern District of West Virginia
- Super Vape’z LLC in the Western District of Washington
- Vapor Craft LLC in the Middle District of Georgia
- Lucky’s Convenience & Tobacco LLC d/b/a Lucky’s Vape & Smoke Shop in the District of Kansas
- Seditious Vapours LLC d/b/a Butt Out in the District of Arizona
The FDA states that the defendants continued to manufacture, sell, and distribute unauthorized e-cigarettes to consumers after receiving warning letters from the agency. The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction.
“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”
When companies are manufacturing and distributing unauthorized tobacco products, the FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law. If continuing violations are documented by the FDA, the agency may request that DOJ pursue a judicial enforcement action, such as an injunction or seizure.
The FDA also has administrative civil money penalty authority for violations of the FD&C Act relating to tobacco products.
