FDA Seeks First Injunctions Over PMTA Process

SILVER SPRING, Md. — The Food and Drug Administration (FDA) is taking action against six companies that continue to market vapor products despite previous warnings from the agency that they were in violation of the law.

On Oct. 18, the U.S. Department of Justice (DOJ), on behalf of the FDA, filed complaints for permanent injunctions in federal district courts against the electronic cigarette manufacturers. These cases represent the first time the agency has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic Act's (FD&C Act) premarket review requirements for new tobacco products.

Each of these defendants failed to submit premarket tobacco product applications (PMTAs) for their e-cigarettes and have continued to illegally manufacture, sell and distribute their products, according to the agency.

The injunctions would require the companies and named individuals to stop manufacturing, selling and distributing the products. 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, 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 injunctions were filed by the department on behalf of the FDA against the following defendants in their respective U.S. District Courts:

• Morin Enterprises Inc. doing business as 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 doing business as Lucky's Vape & Smoke Shop in the District of Kansas; and
• Seditious Vapours LLC doing business as Butt Out in the District of Arizona.

According to the FDA, the companies have continued to market their products even though the agency had previously warned they were in violation of the FD&C Act's premarket review requirements for new tobacco products.

The FDA's prior warnings noted that further violations could lead to enforcement action, including injunction.

"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."

Between January 2021 through Sept. 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 PMTA. After receiving warning letters, a majority of these companies have complied and removed their products from the market, the agency stated.