The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes on the US 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 US 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 became exceptionally popular among young people, and invited intense scrutiny from anti-smoking groups and regulators who feared they would do more harm to young people than good to former smokers.
In its ruling, the agency said that Juul had provided insufficient and conflicting data about potentially harmful chemicals that could leach out of Juul’s proprietary e-liquid pods.
“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,” Dr. Robert M. Califf, the agency commissioner, said in a statement. “The agency has dedicated significant resources to review products from the companies that account for most of the US 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.”
The move by the FDA 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 FDA said it would move toward a ban on menthol-flavored cigarettes.
The 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 onto US shelves permanently now that the FDA has authority over e-cigarettes.
But it could take years before these proposals take effect — if they can withstand fierce resistance from the powerful tobacco lobby, antiregulatory groups and the vaping industry.
Juul said it would appeal the FDA’s decision.
Public health groups hailed the ruling.
“The FDA’s decision to remove all Juul products from the marketplace is both most welcomed and long overdue,” said Erika Sward, national assistant vice president of advocacy for the American Lung Association. “Juul’s campaign to target and hook kids on tobacco has gone on for far too long.”
A statement from the American Vapor Manufacturing Association, an industry trade group, hinted at the fight ahead.
“Measured in lives lost and potential destroyed, FDA’s staggering indifference to ordinary Americans and their right to switch to the vastly safer alternative of vaping will surely rank as one of the greatest episodes of regulatory malpractice in American history,” Amanda Wheeler, the association’s president, said in a statement.
The agency’s ruling capped a nearly two-year review of data that Juul had submitted to try to win authorization to continue selling its tobacco- and menthol-flavored products in the United States. The application required the company to prove the safety of its devices and whether they were appropriate for the protection of public health.
The FDA ordered the removal from market of the Juul device and four different pods, including tobacco flavored pods with nicotine concentrations of 3 percent and 5 percent and menthol-flavored pods with the same levels.
Juul, in particular, had been the target of regulators, schools, and policymakers for years, starting in 2018, when the FDA began an investigation into Juul’s marketing efforts. Before that time, Juul had advertised its product using attractive young models and flavors such as cool cucumber and creme brulee that critics said attracted underage users.
By April 2018, the FDA announced a crackdown on the sale of such products, including Juul’s, to people younger than 21.
Use among young people had soared. In 2017, 19 percent of 12th graders, 16 percent of 10th graders, and 8 percent of eighth graders reported vaping nicotine in the past year, according to Monitoring the Future, an annual survey done for the National Institute on Drug Abuse.
For its part, Juul routinely denied that it targeted young people, but it was pursued in lawsuits and by state attorneys general, with some cases resulting in millions of dollars in damages against the company. In one settlement in 2021, Juul agreed to pay $40 million to North Carolina, which represented various parties in the state who asserted the company had helped lure underage users to vaping. More than a dozen other states have lawsuits and investigations that are still pending.