The Food and Drug Administration (FDA) has officially ordered Juul to remove its e-cigarettes from the market.
In a press release issued on Thursday, the FDA ordered Juul to “stop selling and distributing these products” and noted that anything “currently on market must be removed, or risk enforcement action.” They emphasized that the products that fall under the ban include the Juul device and four types of “Juul pods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.”
FDA Commissioner Robert M. Califf, MD said in a statement that Thursday’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.”
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. 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,” he said.
Earlier this week,The Wall Street Journal reported that the ban was coming and that the FDA may reveal its decision as soon as Wednesday. The rejection would come following a review lasting two years of data presented by the company.
The vaping company has sought authorization for their tobacco- and menthol-flavoured e-cigarettes to remain on the US market.
The FDA first looked into Juul four years ago when its flavours and marketing strategy were blamed for a spike in vaping among underage individuals.
The company has since been trying to get back the trust of the authorities as well as the public. Juul restricted its marketing efforts and ceased the sale of sweet and fruit-flavoured e-cigarettes in 2019.
The company’s sales have decreased significantly in the last few years.
The FDA has banned the selling of all e-cigarette cartridges with sweet and fruity flavours, while it has allowed Juul competitors Reynolds American and NJOY Holdings to keep selling its tobacco-flavoured products.
Observers of the industry expected that Juul would receive a similar judgement, The Wall Street Journal noted.
Juul could appeal the possible FDA decision, challenge the agency’s measure in court, or file a new and revised application to sell its products.
In a press release issued on Tuesday, the FDA said that the Biden administration has announced plans for possible future regulations to put in place “a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. The goal of the potential rule would be to reduce youth use, addiction and death”.
Around “480,000 people die prematurely from a smoking-attributed disease” annually, according to the agency.
Tobacco is the “leading cause of preventable disease and death” in the US and “costs nearly $300bn a year in direct health care and lost productivity”, the FDA said.
The agency noted that “nicotine is not what makes smoking cigarettes so toxic,” but that “it’s the ingredient that makes it very hard to quit smoking”.
“More than half of adult cigarette smokers make a serious quit attempt each year (quitting for at least a day), but most do not succeed,” the FDA said.
The agency said the new standard could make the “products minimally- or non-addictive”.
In a statement, FDA Commissioner Robert Califf said on Tuesday that “making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives”.
The agency added that a 2018 paper “projected that by [the] year 2100, a potential nicotine product standard could result in more than 33 million people not becoming regular smokers, a smoking rate of only 1.4 per cent, and more than eight million fewer people dying from tobacco-related illnesses. The current smoking rate is 12.5 per cent”.
In a statement to The Independent, Joe Murillo, the Chief Regulatory Officer at Juul Labs, said that they “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”. “In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health’,” he added. “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. 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.”
