Home Politics America The US FDA Sends Permanent Injunctions to Six Small Vape Manufacturers

The US FDA Sends Permanent Injunctions to Six Small Vape Manufacturers

On October 18th, the US Food and Drug Administration (FDA) and the Department of Justice (DOJ) revealed they had filed permanent injunctions against six small vape manufacturers for failure to submit the required premarket tobacco product applications (PMTAs).

Diane Caruana

November 8, 2022

Many smaller vape businesses could not afford the very costly and overwhelming PMTA process.

The companies are E-Cig Crib in Minnesota, Soul Vapor in West Virginia, Vapor Craft in Georgia, Super Vape’z in Washington, Lucky’s Vape & Smoke Shop in Kansas and Butt Out in Arizona. The FDA reported that none of these companies have submitted their PMTAs. The injunctions force the companies to stop making, selling and distributing their products.

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

The FDA said that each of the companies had received warning letters in the past, giving them the possibility to avoid the injunction. But sadly many smaller vape businesses did not bother going though the very costly and overwhelming PMTA process, especially given that they did not receive much guidance about the process from the FDA.

Only tobacco flavours are granted PMTAs

Meanwhile, the FDA has not granted PMTAs for any flavoured products, and only a handful of tobacco-flavoured vape products have been approved. Millions of applications have been rejected, including for menthol products.

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