The United States filed complaints against six companies and related individuals to stop the illegal manufacture and sale of unauthorized vaping products, the Department of Justice announced today.
In civil complaints and accompanying court papers filed in U.S. District Court, the government alleges that the defendants illegally manufacture and sell electronic nicotine delivery system (ENDS) products, including finished “e-liquids,” or liquids that contain nicotine and colorings, flavorings and/or other ingredients.
The complaints allege that the defendants caused tobacco products to become adulterated and misbranded while held for sale after shipment of one or more of their components in interstate commerce, and that they continued to manufacture, sell and distribute the adulterated and misbranded tobacco products despite receiving warning letters from the FDA that they were violating the law.
These actions are the first seeking to enjoin manufacturers of ENDS products for violations of 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 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.”
“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. “The FDA is committed to acting swiftly when we are made aware of these violations. We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
“It’s important that businesses — large and small — take the necessary steps to comply with federal regulations that are put in place to ultimately protect the consumer, especially with regard to potentially harmful products,” said U.S. Attorney Peter D. Leary for the Middle District of Georgia. “Our office will enforce statutes intended to keep the citizens of the Middle District of Georgia safe.”
“Not only were the Super Vape’z shops selling potentially adulterated tobacco products, they sold vapes to underage kids,” said U.S. Attorney Nick Brown for the Western District of Washington. “The owners were told repeatedly that they needed to obtain FDA approval for their tobacco products, but they refused to take that step. The Department of Justice is filing suit to protect the public.”
The lawsuits announced today were filed against defendants in six states:
- Seditious Vapours LLC, a Phoenix-based company, and its owner Matthew D. Berger, filed in the District of Arizona;
- Vapor Craft LLC, based in Columbus, Georgia, and its owner Melissa D. Anderson, filed in the Middle District of Georgia;
- Lucky’s Convenience & Tobacco LLC, of Wichita, Kansas, and its majority owners Kevin H. Nguyen and Thomas Rogers, filed in the District of Kansas;
- Morin Enterprises Inc. and its owner Kevin Morin, operating multiple locations in Minnesota, and filed in the District of Minnesota;
- Super Vape’z LLC, based in Lakewood, Washington, and its co-owners Marco Hoffman and Heydee Hoffman, and general manager 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 receiving notice of the need to first obtain FDA marketing authorizations. The defendants did not attempt to obtain FDA authorization for their tobacco products at issue.
Senior Litigation Counsel Christina Parascandola, Senior Trial Attorney Stephen C. Tosini and Trial Attorneys Ellen Bowden McIntyre and Joshua Browning of the Justice Department’s Civil Division’s Consumer Protection Branch; and Assistant U.S. Attorney Todd P. Swanson for the Middle 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 the cases, with assistance from Jonathan Silberman, Danli Song and William Thanhauser for Department of Health and Human Services’ Office of General Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may 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 proceed to trial, the government must prove by a preponderance of the evidence.
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