The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes on the U.S. market, a profoundly damaging blow to a once-popular company whose brand was blamed for the teenage vaping crisis.
The order affects all of Juul’s products on the U.S. market, the overwhelming source of the company’s sales. Juul’s sleek vaping cartridges and sweet-flavored pods helped usher in an era of alternative nicotine products that were exceptionally attractive to young people. The company’s initial dominance invited intense scrutiny from antismoking groups and regulators who feared the products would do more harm to young people than good to cigarette smokers trying to quit.
Although teenage vaping rates have declined during the coronavirus pandemic, public health experts and lawmakers continue to express concerns about the additive nicotine in some e-cigarettes that remain on the market, including brands like Puff Bar, whose fruity flavors appeal to young people.
The F.D.A.’s decision did not deal with Juul’s relationship to youth vaping. Instead it was based on what the agency said was insufficient and conflicting data from the company about potentially harmful chemicals that could leach out of Juul’s e-liquid pods. There was not an imminent health threat to consumers, the F.D.A. said, but it did not have enough evidence to assess the potential risks.
“Today’s action is further progress on the F.D.A.’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” Dr. Robert M. Califf, the agency commissioner, said in a statement. And he acknowledged that many of the e-cigarette products had played a role in the rise in teenage vaping.
The move by the F.D.A. is part of a wide-ranging effort to remake the rules for smoking and vaping products and to reduce illnesses and deaths caused by inhalable products containing highly addictive nicotine.
On Tuesday, the agency announced plans to slash nicotine levels in traditional cigarettes as a way to discourage use of the most deadly of legal consumer products. In April, the F.D.A. said it would move toward a ban on menthol-flavored cigarettes.
The F.D.A.’s action against Juul in particular is part of a newer regulatory mission for the agency, which must determine which electronic cigarettes currently for sale, or proposed for sale, will be allowed to permanently remain on shelves. It has already granted permission for other companies’ e-cigarettes to stay on the market.
But it could take years before some of the agency’s new initiatives take effect — if they can withstand fierce resistance from the powerful tobacco lobby, antiregulatory groups and the vaping industry.
Juul said it disagreed with the F.D.A.’s findings and planned to appeal. The company could seek a stay from the agency or from a court pending an appeal to the F.D.A. The company has not said which path it will seek but it will try to keep its products on the market during any proceedings.
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“We intend to seek a stay,” Juul’s statement concluded, “and are exploring…
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