The U.S. Food and Drug Administration ordered Juul Labs Inc. to stop selling its vape devices and cartridges on Thursday, saying that there is “insufficient evidence to assess the potential toxicological risks” of using the products.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert Califf said in a statement announcing the move.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market,” he continued. “We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
The FDA acknowledged that it “has not received clinical information to suggest an immediate hazard associated” with the use of Juul’s devices or pods, but said the agency issued its marketing denial orders (MDOs) against the company because “there is insufficient evidence to assess the potential toxicological risks” of using the products.
Juul disputed the FDA’s claims in a statement, and said the company plans to appeal the agency’s decision.
“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” Joe Murillo, Juul’s chief regulatory officer, said in a statement.
“We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” Murillo said. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”
The move by the FDA – which was expected after The Wall Street Journal reported Wednesday that it was coming – is being hailed by critics of Juul and the vaping industry, and met with fury by adult users of the product, many of whom took to social media to question the decision.
“Juul is the only way I was able to quit [cigarettes],” one person Tweeted following the announcement that the products are now banned. “How are they gonna ban Juul’s (sic) but allow cigs? It’s all a ploy so big tobacco makes $$$.”
Critics have blamed Juul for allegedly targeting teens in its marketing with concerns about the rise of youth vaping in recent years.
The FDA, in its press release, directed smokers who want to quit to consider using other e-cigarette products the agency has authorized for use, such as R.J. Reynolds’ Vuse projects.
According to a Centers for Disease Control and Prevention (CDC) report from last year, Vuse e-cigarettes were found to be nearly twice as popular among high schoolers who vape as Juul products.
