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.
These 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.
Each of these defendants failed to submit premarket applications 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. The injunctions would also require the defendants to obtain marketing authorization from the FDA before marketing such products, as required by law.