Packs of mint flavored Juul e-cigarettes are displayed in a smoking room in 2019. Justin Sullivan/Getty Images .
. Justin Sullivan/Getty Images
Justin Sullivan/Getty Images
The Food and Drug Administration has issued a marketing denial order to Juul, ordering the company to remove its e-cigarettes from the US market, a move that promises to disrupt the vaping market.
The decision applies to “all of their products currently marketed in the United States,” the FDA said.
Citing Juul’s review by the FDA, which represents a large portion of the US e-cigarette market, FDA Commissioner Robert M. Califf said, “We recognize that these are an important part of the products available and that many have played a disproportionate role in increasing youth vaping.”
In response, a representative for Juul said the company would fight the decision.
“We respectfully disagree with the FDA’s findings and decision,” Joe Murillo, chief regulatory officer of Juul Labs, said in a statement sent to NPR.
“We intend to seek a stay and are exploring all of our options under FDA regulations and the law,” Murillo said, “including appealing the decision and engaging with our regulator.”
FDA’s decision elicits strong reactions from both sides
The decision comes nearly two years after Juul submitted its application to the FDA, hoping to continue selling its products.
News of the FDA’s decision first emerged in preliminary reports on Wednesday. It has been praised by advocacy group PAVe, or Parents Against Vaping e-cigarettes.
“JUUL will finally be held responsible for creating the youth vaping epidemic and launching a new industry of highly addictive flavored products that harm millions of American children,” the group’s founders said, Meredith Berkman and Dorian Fuhrman, via email to NPR.
“It’s a huge step in the right direction,” they added.
But news of the decision infuriated Amanda Wheeler, president of the American Vapor Manufacturers Association.
Wheeler accused the FDA of waging a “campaign of arson against nicotine vaping products that millions of Americans rely on as an alternative to cigarettes.” It was a sign, she said, of the FDA’s “staggering indifference to ordinary Americans and their right to switch” to vaping.
Vaping is seen as a potential help for adults and a risk for children
The FDA’s denial could signal a sea change in how regulators view e-cigarettes. Their supporters credit Juul and other vape companies with providing addicted smokers with a less harmful alternative to cigarettes.
The FDA itself recognizes this potential. In recent months, it has licensed vaping devices and products from other companies, but only after the agency was convinced the companies were doing enough to steer clear of young people.
In March, for example, the FDA said that in one case it had reviewed, “the likely benefit to adult smokers who significantly reduce their cigarette consumption … outweighs the risk to young people, provided that the company adheres to post-marketing requirements to reduce youth access and youth exposure to their marketing.”
But critics say the process of vaping the highly addictive nicotine comes with its own health risks and they have accused Juul of targeting minors through its marketing practices and youth-friendly flavors. In recent years, pushback has prompted Juul to phase out flavors such as mango and cream. It now only sells two variants: tobacco and menthol.
According to the FDA, nearly 10.7 million young people between the ages of 12 and 17 have used e-cigarettes or are willing to try them.
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