For Immediate Release:

Today, the US Department of Justice (DOJ) filed a complaint on behalf of the US Food and Drug Administration against six e-cigarette manufacturers for permanent injunction in federal district courts. These cases represent the first time that the FDA has initiated injunctive relief proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s pre-market review requirements for new tobacco products.

Each of these defendants did not file pre-marketing applications for their e-cigarettes and continued to illegally manufacture, sell, and distribute their products, despite the FDA’s earlier warning that they were breaking the law. The measures require companies and named individuals to stop producing, selling and distributing their e-cigarettes. The measures will also require defendants to obtain marketing authorization from the FDA before marketing such products as required by law.

“Today’s enforcement actions represent an important step for the FDA in preventing tobacco product manufacturers from violating the law,” said Brian King, PhD, director of the FDA’s Center for Tobacco Products. “We will not stand by as manufacturers repeatedly break the law, especially after they have had many opportunities to comply.”

DOJ initiates enforcement actions in court under the FD&C Act. Therefore, injunctive relief orders have been issued on behalf of the FDA against the following defendants in U.S. District Courts:

  • Morin Enterprises Inc. does business as E-Cig Crib in the Minnesota Territory
  • 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 Central District of Georgia
  • Lucky’s Convenience & Tobacco LLC does business as Lucky’s Vape & Smoke Shop in the Kansas Area
  • Seditious Vapors LLC does business as Butt Out in the Arizona Territory

The FDA had previously warned each of the defendant companies that they were violating the FD&C Act’s pre-market review requirements for new tobacco products by producing, selling and distributing new tobacco products without obtaining marketing authorization from the FDA. But the defendants continued to manufacture, sell and distribute the unauthorized e-cigarettes to consumers. The FDA’s previous warnings indicated that further violations could lead to enforcement action, including injunctive relief.

Defendants have the opportunity to accept permanent injunctions that prevent them from directly or indirectly producing, selling or distributing new tobacco products unless and until certain prerequisites are met. These prerequisites include obtaining FDA marketing authorization for tobacco products, the agency inspecting defendants’ facilities to determine compliance, and the FDA notifying defendants in writing that they appear to comply with the law. For defendants who do not consent to the decrees, the government may request injunctions from the relevant courts that prevent these defendants from directly or indirectly producing, selling or distributing unauthorized tobacco products.

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

When companies manufacture and distribute unauthorized tobacco products, the FDA will often issue a warning letter for voluntary compliance with the law. If ongoing violations are documented by the FDA, the agency may request the DOJ to initiate an enforcement action, such as an injunction or lien. The FDA also has administrative fines for violations of the FD&C Act related to tobacco products.

From January 2021 to September 9, 2022, the FDA issued nearly 300 warning letters to companies with more than 17 million e-cigarettes collectively listed in the agency for failing to file a premarketing application in a timely manner. After receiving the warning letters, the majority of these companies complied and removed their products from the market.

These actions are part of a comprehensive approach to law enforcement. For example, earlier this month, the FDA issued a warning letter to EVO Brands LLC and PVG2 LLC, which do business as one of the most popular brands among US teens, the Puff Bar, for receiving and delivering e-cigarettes for free in the US. a marketing authorization order. Without legally required premarketing authorization, all e-cigarettes on the market are illegally marketed, risking FDA enforcement action. Selling or distributing e-cigarettes not authorized by the FDA is illegal, and those who engage in such behavior are at risk of FDA sanctions, such as confiscation, injunctive relief, or fines.

The FDA encourages retailers to discuss new tobacco products in their inventory with their suppliers to determine whether such products have the necessary marketing clearance. The FDA provides the names of authorized e-cigarettes on the FDA’s Tobacco Product Marketing Orders page. The FDA encourages the public to submit potential violations to us via our online form.

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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products and medical devices for human use. The agency is also responsible for regulating our nation’s food supply, cosmetics, dietary supplements, electronic radiation products, and tobacco products.