The U.S. Food and Drug Administration (FDA) has initiated joint actions with the U.S. Department of Justice (DOJ) against six e-cigarette manufacturers for repeated violations of the Federal Food, Drug, and Cosmetic (FD&C) Act. This joint operation initiated on October 18 marks the first time that the FDA has moved for a permanent injunction against manufacturers for failing to obey the premarket review requirements for new tobacco products. 

The DOJ has filed judicial enforcement actions on behalf of the FDA against six defendants in their home courts. Those defendants are:

  • Lucky’s Convenience & Tobacco LLC operating as Lucky’s Vape & Smoke Shop in the District Court for Kansas
  • Morin Enterprises Inc. doing business as E-Cig Crib in the District Court for Minnesota
  • Seditious Vapours LLC operating under the name Butt Out in the District Court for Arizona
  • Soul Vapor LLC in the Southern District Court of West Virginia
  • Super Vape’z LLC in the Western District Court of Washington
  • Vapor Craft LLC in the Middle District Court of Georgia

According to its announcement, the FDA stated that it had previously warned each defendant that they were in violation of the FD&C Act’s premarket review requirements. These violations included manufacturing, selling, and distributing new tobacco products without obtaining premarket authorization from the FDA. In prior warnings, the agency warned that one of the potential consequences of remaining in violation was an injunction.

According to the agency, “the defendants continued to manufacture, sell, and distribute unauthorized e-cigarettes to consumers” while repeatedly failing to submit premarket applications for their e-cigarettes. If granted, the FDA-DOJ joint injunction would force the defendants to stop manufacturing, selling, and distributing their e-cigarettes and compel them to obtain marketing authorization from the FDA.

Director of the FDA’s Center for Tobacco Products, Brian King, Ph.D., M.P.H., spoke about the enforcement actions, calling them “a significant step for the FDA in preventing tobacco product manufacturers from violating the law.” King stated that the agency would not stand by while manufacturers repeatedly break the law, especially after being given numerous opportunities to comply.