The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes in the U.S. market, a deeply damaging blow to a once-popular company whose brand has been blamed for the teenage vaping crisis.
The order affects all Juul products in the US market, the company’s overwhelming source of revenue. Juul’s sleek vaping cartridges and sweet-flavored pods helped usher in an era of alternative nicotine products for adults too, prompting intense scrutiny from anti-smoking groups and regulators who feared they would harm young people more than benefit ex-smokers.
“Today’s action is a further advance in FDA’s commitment to ensure that all e-cigarette and electronic nicotine delivery systems currently marketed to consumers meet our public health standards,” said Dr. Robert M. Califf, the agency’s commissioner, in a statement. “The agency has allocated significant resources to review products from companies that make up most of the US market. We recognize that these make up a significant portion of the products available and many have played a disproportionate role in the rise of vaping among youth.”
The FDA’s move is part of a broader effort to overhaul the rules governing smoking and vaping products and to reduce illness and deaths caused by inhalable products containing highly addictive nicotine.
On Tuesday, the agency announced plans to reduce nicotine levels in traditional cigarettes to discourage consumption of the deadliest legal consumer products. In April, the FDA announced it would seek a ban on menthol-flavored cigarettes.
The lawsuit against Juul, in particular, is part of a more recent regulatory task by the agency, which must determine which electronic cigarettes currently on sale or offered for sale will be allowed on U.S. shelves permanently after the FDA has authority over e-cigarettes .
But it could be years before these proposals come into force – if they can withstand fierce opposition from the powerful tobacco lobby, anti-regulatory groups, and the vaping industry.
Juul is expected to appeal the FDA’s decision.
Public health groups welcomed the verdict.
“The FDA’s decision to withdraw all Juul products is extremely welcome and long overdue,” said Erika Sward, national assistant vice president of advocacy for the American Lung Association. “Juul’s campaign to target children to tobacco has been going on for far too long.”
A statement from the American Vapor Manufacturing Association, an industrial trade group, hinted at the upcoming battle.
“Measured in terms of lives lost and potentially shattered, the FDA’s astounding indifference to ordinary Americans and their right to switch to the far safer alternative of vaping will surely stand as one of the greatest episodes of regulatory misconduct in American history,” Amanda Wheeler, the President of the association said in a statement.
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The agency’s decision ended a nearly two-year review of data that Juul submitted to try and get approval to continue selling its tobacco- and menthol-flavored products in the United States. For the application, the company had to prove the safety of its devices and their suitability for protecting public health.
Juul in particular has been the target of regulators, schools, and policymakers for years, beginning in 2018 when the FDA launched an investigation into Juul’s marketing efforts. Prior to that, Juul had promoted its product featuring attractive young models and flavors such as Cool Cucumber and Crème Brûlée, which critics said appealed to underage people.
By April 2018, the FDA announced a crackdown on the sale of such products, including Juul’s, to anyone under the age of 21.
Usage among young people had skyrocketed. According to Monitoring the Future, an annual survey by the National Institute on Drug Abuse, in 2017 19 percent of 12th graders, 16 percent of 10th graders, and 8 percent of 8th graders said they had vaped nicotine in the past year.
For its part, Juul routinely denied that it was targeting young people, but has been prosecuted in court cases and by attorneys general, with some cases resulting in millions of dollars in damages against the company. In a 2021 settlement, Juul agreed to pay $40 million to North Carolina, which represented various parties in the state that claimed the company helped entice underage users to vape. Lawsuits and investigations are still pending in more than a dozen other states.
dr Scott Gottlieb, the former FDA commissioner, on Wednesday agreed to the move against Juul, which was first reported in the Wall Street Journal.
Given the company’s declining market share, the news for the industry is a little lighter now than it was in Juul’s heyday. Once the dominant player with 75 percent market share, Juul now has a significantly smaller market share.
But the news is a huge blow to Altria, formerly known as Philip Morris and the maker of Marlboro, which bought 35 percent of Juul for $12.8 billion in December 2018. Due to lower market share and regulatory headwinds, Altria said the value of that holding had fallen to $1.7 billion by the end of 2021.
At its peak, Juul had more than 4,000 employees. It now has just over 1,000, mostly in the United States but some in Canada, the UK and other countries. Sales have fallen from $2 billion in 2019 to $1.3 billion in 2021, with US sales accounting for about 95 percent.
Nicotine itself is not the cause of lung cancer and other deadly diseases from smoking, but the drug is extremely addictive, making it difficult for smokers to quit despite the health risks. The adolescent brain is particularly vulnerable to nicotine, which can have an impact memory, concentration, learning and self-control.
The e-cigarette companies have already announced that they will challenge the decision in court.
E-cigarettes have been sold in the US market without formal FDA approval for more than a decade because they were outside the agency’s regulatory purview for several years.
In 2019, the FDA issued a warning letter to Juul, stating that the company had violated federal regulations by failing to obtain approval to advertise and sell its products as a healthier alternative to smoking.
The agency has been reviewing all types of vaping products for more than a year, some of which are under development, and companies awaiting a decision are allowed to continue selling some products.
The FDA recently said it has so far rejected more than a million applications for products it considered a health risk rather than a benefit. In October, RJ Reynolds was authorized to continue marketing Vuse. This was the first time the agency had approved a vapor product from a major cigarette company.
In its review of devices, which it compared to traditional cigarettes, the agency said the devices contained a “significant reduction” in harmful chemicals, although some were still present. The review found that the levels of toxins and potentially carcinogenic chemicals in the blood and urine of people using the Vuse device were far lower than those of smokers.
Still, California law required RJ Reynolds to warn Vuse buyers about exposure to glycidol, which “is known to the state to cause cancer” based on studies in mice and rats.
In March, the agency approved several tobacco-flavored products from Logic Technology Development and said the company could show its products were likely to help adults transition from traditional cigarettes while posing a low risk of attracting young, new users.
But the agency disappointed some prominent lawmakers and advocacy groups when it recently announced it would not be able to review all e-cigarette marketing applications until June 2023, a year after a court-imposed deadline.
Some tobacco control experts said the decision to ban Juul from the US market was misguided and ultimately counterproductive.
Clifford Douglas, director of the Tobacco Research Network at the University of Michigan School of Public Health, said the FDA appears to have penalized Juul for its past marketing activity to teenagers, and that many experts see Juul and other e-cigarettes as valuable tools, to help adult smokers quit conventional cigarettes.
“They are so-called off-ramps that can provide smokers with an alternative to combustibles, which are responsible for virtually every tobacco-related death,” he said. “But now that exit is being narrowed and somehow paved over, putting the lives of millions of adults at risk.”
Christina Jewett and Sheila Kaplan contributed coverage.