WASHINGTON—The U.S. Department of Justice (DOJ), on behalf of the Food and Drug Administration (FDA), has 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.
The FD&C Act requires makers of e-cigarettes to submit premarket tobacco product applications to the FDA before they can manufacture, sell or distribute new tobacco products. This also applies to products that were on the market before this provision took effect.
According to the DOJ, 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.
“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. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
DOJ institutes judicial enforcement actions under the FD&C Act in court. The Justice Department filed the injunctions on behalf of the FDA against the following defendants in their respective U.S. District Courts:
- Morin Enterprises Inc. dba E-Cig Crib in the District of Minnesota
- 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 Middle District of Georgia
- Lucky’s Convenience & Tobacco LLC dba Lucky’s Vape & Smoke Shop in the District of Kansas
- Seditious Vapours LLC dba Butt Out in the District of Arizona
The FDA had previously warned each of the defendant companies that they were in violation of the FD&C Act’s premarket review requirements for new tobacco products by manufacturing, selling and distributing new tobacco products without first obtaining marketing authorization from the FDA. However, the FDA says that the defendants continued to manufacture, sell and distribute unauthorized e-cigarettes to consumers. The FDA’s prior warnings noted that further violations could lead to enforcement action, including injunction.
Defendants have the opportunity to agree to consent decrees of a permanent injunction, which prevent them from directly or indirectly manufacturing, selling or distributing any new tobacco products unless and until certain prerequisites are met, the agency said. These prerequisites include that the tobacco products receive FDA marketing authorization, that the agency inspect the defendants’ facilities to determine compliance, and that the FDA notify defendants in writing that they appear to be in compliance with the law. For those defendants who do not agree to consent decrees, the government can request the relevant courts to enter injunctions preventing those defendants from directly or indirectly manufacturing, selling or distributing any unauthorized tobacco products, the FDA said.
“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.”
When companies are manufacturing and distributing unauthorized tobacco products, the FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law. If continuing violations are documented by the FDA, the agency may request that DOJ pursue a judicial enforcement action, such as an injunction or seizure. The FDA also has administrative civil money penalty authority for violations of the FD&C Act relating to tobacco products.
Between January 2021 and September 9, 2022, the FDA issued nearly 300 warning letters, to firms that collectively have more than 17 million e-cigarettes listed with the agency, for failure to submit a timely premarket application. After receiving warning letters, a majority of these companies have complied and removed their products from the market.
These actions are part of a comprehensive approach to enforcing the law. For example, earlier this month, the FDA issued a warning letter to EVO Brands LLC and PVG2 LLC, dba Puff Bar, which is one of the most popular brands among U.S. youth, for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order.
All e-cigarettes on the market without the statutorily required premarket authorization are marketed unlawfully and risk FDA enforcement action. It is illegal to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction or civil money penalty.
The FDA encourages retailers to discuss new tobacco products in their inventory with their suppliers, to determine whether such products have the required marketing authorization. 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 through our online form.