On October 18, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) announced that they had filed for permanent injunctions against six small vape manufacturers in the United States.
Those companies include 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. None of them, according to the FDA, submitted premarket tobacco product applications (PMTAs)—an expensive and labor-intensive process that required vape producers to show their products would be more likely to help adults switch from cigarettes to safer alternatives than introduce a new generation to nicotine.
“We will not stand by as manufacturers repeatedly break the law.”
“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 injunctions would demand that the companies stop making, selling and distributing their vaping products. The FDA said that each of them had received warning letters in the past, altering them to the possibility of an injunction if they continued to operate without marketing authorization, but they did not abide. The defendants have the option of signing consent decrees, agreeing to the terms in order to stop further court proceedings.
The news came as little surprise to the independent vapor industry and the tobacco harm reduction (THR) community, however bleak they found it.
As Filter previously reported in mid-September, at least two companies had gotten notice that the FDA planned legal action soon. And King underlined the threats when he spoke at an industry conference in late September. “When it comes to enforcement and compliance, nothing is off the table,” he said, promising to enforce the law through “any means that we have that is legally defensible.”
Many smaller- and medium-sized manufacturers, with the burden of proof on them and little, if any, concrete direction from the regulator, simply did not bother to complete PMTAs. But even if they had, the outcome almost certainly would not have been in their favor.
“When you are a prohibitionist axe, everything looks like a beer barrel.”
The FDA has so far only authorized a handful of tobacco-flavored vape products, made exclusively by major companies with the resources to produce reams of scientific evidence. It has not authorized a single other flavor, including menthol. Millions of applications have been rejected.
Critics have contended that the FDA’s enforcement has either been callous, acting to just show the prohibitionist camp that something is being done, or misplaced, as they’re targeting targeting smaller- and medium-sized producers that typically do not distribute the disposables now favored by youth. New research, published in BMJ, has also suggested that “the focus of these enforcement actions”—sending warning letters to small online retailers—“comprises a small share of the market and the impact on use was likely minimal.”
“When you are a prohibitionist axe, everything looks like a beer barrel,” Amanda Wheeler, a vape shop owner in Arizona and the president of the American Vapor Manufacturers Association (AVM), said in a press statement. “Rather than helping foster a functional, common-sense market for nicotine vaping as the American public deserves, Brian King is posturing as a wannabe G-man. In reality this is a dereliction of duty, aimed mostly at appeasing the likes of Senator Durbin and other wealthy fanatics who are wrongfully strong-arming federal vaping policy.”
“My heart goes out to the 31 million smoking and 20 million vaping Americans and their families.”
CTP has been under pressure from members of Congress, like Sen. Dick Durbin (D-Illinois), who met with King right after he exited the September conference without taking any questions from the audience. Durbin and others have been concerned with how the FDA has failed to take enforcement action in the past.
“Today’s CTP announcement and Dr. King’s words are expected, disappointing, and disingenuous as they take the next logical step in the prejudicial, politically and financially motivated policy of eliminating millions of products helping millions of Americans to become and remain smoke-free,” Marc Slis, a vape shop owner in Michigan, told Filter. “My heart goes out to the 31 million smoking and 20 million vaping Americans and their families, who have once again been betrayed by those entrusted to help them.”