The U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers. This is the first time the FDA has used injunction proceeds to enforce the Federal Food, Drug and Cosmetic (FD&C) Act’s premarket review requirements for tobacco products.
“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King, Ph.D., M.P.H., 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.”
According to the FDA, the companies that are part of the injunction failed to submit Premarket Tobacco Applications (PMTAs) for their e-cigarette products. The FDA goes on to explain that these companies have continued to “illegally” manufacture, sell and distribute these products despite previous earnings from the FDA that they were in violation of the law. The injunctions would force these companies to stop manufacturing, selling and distributing their e-cigarettes. The injunctions would also require these companies to obtain marketing authorization from the FDA before they market these products, which is required by law.
These were the injunctions that were filed by the 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 doing business as Lucky’s Vape & Smoke Shop in the District of Kansas
- Seditious Vapours LLC doing business as Butt Out in the District of Arizona
Each of the defendant companies named above previously received a warning from the FDA and were told that they were in violation of the FD&C Act’s premarket review requirements for new tobacco products by manufacturing, selling and distributing new tobacco products without first obtaining marketing authorization from the FDA. Despite this, the defendants were said to have continued to manufacture, sell and distribute unauthorized e-cigarettes to consumers.
Defendants can agree to consent decrees of a permanent injunction, which would prevent them from directly or indirectly manufacturing, selling or distributing any new tobacco products unless and until certain prerequisites are met, including receiving FDA marketing authorization. If the defendants choose not to agree to the consent decrees, the government can request the relevant courts to enter injunctions that would prevent them from directly or indirectly making, selling or distributing any unauthorized tobacco products.