The court filings on behalf of the U.S. Food and Drug Administration mark the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug and Cosmetic Act’s premarket review requirements for new tobacco products, the agency said in a statement.
Under the FD&C Act’s parameters, the Justice Department institutes judicial enforcement actions on behalf of the FDA.
Authorities allege Morin Enterprises, doing business as E-Cig Crib in Minnesota; Soul Vapor in West Virginia; Super Vape’z in Washington; Vapor Craft in Georgia, Lucky’s Convenience & Tobacco, doing business as Lucky’s Vape & Smoke Shop in Kansas and Seditious Vapors, doing business as Butt Out in Arizona, all failed to submit premarket applications for their e-cigarettes.
All six continue to illegally manufacture and sell their products despite multiple warnings, the FDA contends. The agency said its individual warnings to all six companies, included the fact that further violations could lead to enforcement action, including the injunction.
“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” Brian King, director of the FDA’s Center for Tobacco Products said in a statement.
“We will not stand by as manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
Health advocates lauded the decision.
“The American Lung Association applauds this action from the DOJ and FDA and urges the Biden administration to continue their work to enforce the law. These companies were warned, but continued to violate the law,” American Lung Association National President and CEO Harold Wimmer said in a statement.
“This is the first time FDA and DOJ have taken these steps and comes just a couple weeks after the release of the 2022 National Youth Tobacco Survey, which revealed that more than 2.55 million youth are regularly using e-cigarettes.
” We have urged FDA to take action against manufacturers, wholesalers and distributors. We thank the DOJ and FDA for taking action and urge the agencies to vigorously enforce the Tobacco Control Act and protect the public from illegal and dangerous tobacco products.”
