The United States has filed lawsuits against six companies and related individuals to end the illegal manufacture and sale of unauthorized vaping products, the Department of Justice announced today.

In civil complaints and related court documents filed in the United States District Court, the government alleges that the defendants illegally manufacture and sell electronic nicotine delivery system (ENDS) products, including “e-liquids » Finishes or liquids containing nicotine and colorings, flavorings and/or other ingredients.

The complaints allege that the defendants caused the tobacco products to be adulterated and mislabeled while intended for sale after one or more of their components were shipped in interstate commerce, and that they continued to manufacture, sell and distribute the adulterated and mislabeled tobacco products despite the warning received. letters from the FDA stating that they violated the law.

These actions are the first to sanction manufacturers of ENDS products for violating the premarket review requirements of the Federal Food, Drug, and Cosmetic Act (FDCA).

“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” said Senior Assistant Deputy Attorney General Brian M. Boynton, Chief of the Civil Division of the Department of Justice. “The Department of Justice will continue to work closely with the FDA to stop the distribution of illegal and unauthorized tobacco products.”

“Today’s enforcement actions represent an important step for the FDA to prevent tobacco product manufacturers from breaking the law,” said Brian King, Ph.D., MPH, director of the Center for Tobacco FDA products. “The FDA is committed to acting quickly when we learn of these violations. We will not sit idly by as manufacturers repeatedly break the law, especially after they have had multiple opportunities to comply.

“It is important that businesses – large and small – take the necessary steps to comply with federal regulations put in place to ultimately protect the consumer, especially with respect to potentially harmful products,” the prosecutor said. American Peter D. Leary for the Middle District. from Georgia. “Our office will enforce laws intended to keep the citizens of the Central District of Georgia safe.”

“Not only were Super Vape’z stores selling potentially adulterated tobacco products, they were selling vapes to underage children,” said U.S. Attorney Nick Brown for the Western District of Washington. “The owners were repeatedly told they needed to get FDA approval for their tobacco products, but they refused to take that step. The Department of Justice is suing to protect the public.”

The lawsuits announced today have been filed against defendants in six states:

  • Phoenix-based Seditious Vapors LLC and owner Matthew D. Berger filed in the District of Arizona;
  • Vapor Craft LLC, based in Columbus, Georgia, and its owner Melissa D. Anderson, registered in the Middle District of Georgia;
  • Lucky’s Convenience & Tobacco LLC, of ​​Wichita, Kansas, and its majority owners Kevin H. Nguyen and Thomas Rogers, registered in the District of Kansas;
  • Morin Enterprises Inc. and its owner Kevin Morin, operating multiple locations in Minnesota and registered in the District of Minnesota;
  • Super Vape’z LLC, based in Lakewood, Washington, and its co-owners Marco Hoffman and Heydee Hoffman, and Managing Director Judith A. Cramer, filed in the Western District of Washington;
  • Soul Vapor LLC, of ​​Princeton, West Virginia, and its owner Aurelius Jeffrey, filed in the Southern District of West Virginia.

Each of the defendants manufactured and sold ENDS products after being advised of the need to first obtain marketing clearances from the FDA. Defendants did not attempt to obtain FDA clearance for their subject tobacco products.

Christina Parascandola, Senior Litigation Counsel, Stephen C. Tosini, Senior Prosecutor, and Ellen Bowden McIntyre and Joshua Browning, Consumer Protection Branch, Civil Division, Department of Justice; and Assistant U.S. Attorney Todd P. Swanson for the Central District of Georgia, Assistant U.S. Attorney Brian Vanorsby for the District of Kansas, Assistant U.S. Attorney Kristen E. Rau for the District of Minnesota, Assistant U.S. Attorney Ashley C. Burns for the Western District of Washington and Assistant U.S. Attorney Jennifer Mankins for the Southern District of West Virginia are handling cases, with assistance from Jonathan Silberman, Danli Song, and William Thanhauser for the Attorney’s Office General of the Department of Health and Social Services.

Additional information about the Consumer Protection Branch and its enforcement efforts can be found at http://www.justice.gov/civil/consumer-protection-branch.

The claims made in the complaints are allegations that if the cases were to go to trial, the government had to prove by a preponderance of the evidence.

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