On October 18, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) took action against six small vape manufacturers in the United States by filing for permanent injunctions. These companies, namely 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, were targeted because they failed to submit premarket tobacco product applications (PMTAs). The PMTA process is a rigorous and costly procedure that requires vape producers to demonstrate that their products are more likely to assist adult smokers in transitioning to safer alternatives rather than enticing a new generation into nicotine addiction.
The FDA’s director of the Center for Tobacco Products (CTP), Brian King, emphasized the significance of these enforcement actions, stating, “Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law. We will not stand by as vape manufacturers repeatedly break the law, especially after being afforded multiple opportunities to comply.”
As a result of the injunctions, the companies are required to cease the production, sale, and distribution of their vaping products. Prior to these injunctions, the FDA had issued warning letters to the companies, alerting them to the possibility of facing legal action if they continued to operate without marketing authorization. However, they did not comply with the warnings. The defendants have the option to sign consent decrees, agreeing to the terms in order to halt further court proceedings.
This news did not come as a surprise to the independent vapor industry and the tobacco harm reduction (THR) community, although they view it with concern. As reported earlier, at least two companies were already aware of the FDA’s intentions to take legal action. Brian King himself reiterated the agency’s commitment to enforcement and compliance during an industry conference, stating that “nothing is off the table” and that they would employ any legally defensible means to enforce the law.
Many smaller- and medium-sized manufacturers, burdened with the responsibility of providing proof without clear guidance from regulators, chose not to complete the PMTA process. However, even if they had, the outcome would likely have been unfavorable. The FDA has only granted authorization for a few tobacco-flavored vape products produced by major companies with substantial resources to support extensive scientific evidence. No other flavors, including menthol, have been authorized, and millions of applications have been rejected.
Critics argue that the FDA’s enforcement actions have been either callous attempts to showcase their efforts to the prohibitionist camp or misplaced, as they primarily target smaller- and medium-sized producers who typically do not distribute the disposable products favored by youth. A recent study published in BMJ suggested that the enforcement actions focused on warning small online retailers, which constitute a small share of the market and have a minimal impact on usage.
Amanda Wheeler, a vape shop owner in Arizona and the president of the American Vapor Manufacturers Association (AVM), criticized the FDA’s approach, stating, “When you are a prohibitionist axe, everything looks like a beer barrel. 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.”
The FDA’s CTP has faced pressure from members of Congress, including Senator Dick Durbin (D-Illinois), who met with Brian King immediately after the September conference. Concerns have been raised about the FDA’s history of inadequate enforcement actions.
Marc Slis, a vape shop owner in Michigan, expressed his disappointment, stating, “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. 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.”
FAQs
What is the FDA’s action against small vape manufacturers?
The FDA, along with the Department of Justice, has filed for permanent injunctions against six small vape manufacturers in the United States. These companies failed to submit premarket tobacco product applications (PMTAs) and are now required to cease the production, sale, and distribution of their vaping products.
Why did the FDA take action against these companies?
The FDA’s aim is to prevent tobacco product manufacturers from violating the law. By enforcing the requirement for PMTAs, the FDA ensures that manufacturers demonstrate their products’ potential to help adult smokers switch to safer alternatives rather than introducing new generations to nicotine addiction.
What options do the defendants have?
The defendants can choose to sign consent decrees, agreeing to the terms set forth by the FDA and DOJ, which would bring an end to further court proceedings.
Why have many smaller manufacturers not completed PMTAs?
Smaller manufacturers often face the burden of proof without clear guidance from regulators. The PMTA process is rigorous and costly, and the outcome, even if completed, is unlikely to be favorable for smaller companies.
How has the FDA’s enforcement been criticized?
Critics argue that the FDA’s enforcement actions have either been callous attempts to show progress or misplaced, as they primarily target smaller- and medium-sized producers who do not distribute products favored by youth. Critics also question the impact of these actions on overall usage and argue that the FDA should foster a functional, common-sense market for nicotine vaping.