'We will not stand by': FDA, DOJ take action against six e-cigarette manufacturers

The U.S. Department of Justice has filed for permanent injunctions against six e-cigarette manufacturers on behalf of the FDA, according to a press release.

Earlier this month, after news that 2.5 million middle and high schoolers reported using e-cigarettes, the FDA issued warning letters to two brands doing business as Puff Bar for “receiving and delivering e-cigarettes” without a marketing authorization order. The agency also issued marketing denial orders for 32 premarket tobacco applications, because they “lacked sufficient evidence demonstrating that these flavored e-cigarettes would provide a benefit to adult users that would be adequate to outweigh the risks to youth.”

However, this is the first time that the FDA has begun injunction proceedings to enforce premarket review requirements under the Federal Food, Drug and Cosmetic Act, according to the release.

“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in the release. “We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”

Each of the six defendants — Lucky’s Convenience & Tobacco LLC doing business as Lucky’s Vape & Smoke Shop in the District of Kansas; Morin Enterprises Inc. doing business as E-Cig Crib in the District of Minnesota; Seditious Vapours LLC doing business as Butt Out in the District of Arizona; Soul Vapor LLC in the Southern District of West Virginia; Super Vape’z LLC in the Western District of Washington and Vapor Craft LLC in the Middle District of Georgia — illegally manufactured, sold and distributed their products, according to the release, even after receiving warnings from the FDA.

The defendants did not submit premarket applications for their e-cigarettes and subsequently received a warning from the FDA. The agency issued about 300 warning letters between January 2021 and September 2022 for the same error, but most of the companies complied and removed their products from the market.

“These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products,” Brian M. Boynton, principal deputy assistant attorney general and head of the Justice Department’s Civil Division, said in the release. “The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”