The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes in the US market, a very damaging blow to a once-popular company whose brand was blamed for the teenage vaping crisis.
The order affects all of Juul’s products in the US market, the company’s overwhelming source of sales. Juul’s sleek vaping cartridges and sweet-tasting pods helped usher in an era of alternative nicotine products that became exceptionally popular among young people, prompting intense scrutiny from anti-smoking groups and regulators who feared they would do young people more harm than good to former smokers.
In its ruling, the agency said Juul had provided insufficient and conflicting data about potentially harmful chemicals that could leak from Juul’s own e-liquid pods.
“Today’s action is a further advance toward the FDA’s commitment to ensure that all e-cigarette and electronic nicotine delivery system products currently sold to consumers meet our public health standards,” said Dr. Robert M. Califf, the agency’s commissioner, in a statement. “The agency has devoted significant resources to assessing products from the companies that represent the majority of the US market. We recognize that these make up a significant proportion of the products available and many have played a disproportionate role in the rise of vaping by young people.”
The FDA’s move is part of a broad effort to recreate the rules for 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 lower the nicotine content in traditional cigarettes as a way to discourage the use of the most deadly legal consumer products. In April, the FDA said it would move towards a ban on menthol-flavored cigarettes.
The action against Juul, in particular, is part of a newer regulatory mission for the agency to determine which electronic cigarettes currently on sale, or being offered for sale, will be allowed permanently on U.S. shelves now that the FDA has authority. about e-cigarettes.
But it could be years before these proposals take effect – if they stand up to fierce resistance from the powerful tobacco lobby, anti-regulatory groups and the vape industry.
Juul said it would appeal the FDA’s decision.
Public health groups welcomed the ruling.
“The FDA’s decision to remove all Juul products from the market is both very welcome and long overdue,” said Erika Sward, national assistant vice president of advocacy for the American Lung Association. “Juul’s campaign to hook and hook children has gone on far too long.”
A statement from the American Vapor Manufacturing Association, an industrial trade group, hinted at the battle ahead.
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Measured in lives lost and potentially destroyed, the FDA’s staggering indifference to ordinary Americans and their right to switch to the much safer alternative of vaping will certainly be regarded as one of the biggest malpractice episodes in the U.S. history,” Amanda Wheeler, the association’s president, said in a statement.
The agency’s ruling capped a nearly two-year review of data Juul had submitted to try to get permission to continue selling its tobacco and menthol-flavored products in the United States. The application required the company to demonstrate the safety of its devices and whether they were suitable for protecting public health.
The FDA ordered the removal of the Juul device and four different pods, including tobacco-flavored pods with 3 percent and 5 percent nicotine concentrations and menthol-flavored pods with the same levels.
Juul, in particular, has been targeted by regulators, schools, and policymakers for many years, starting in 2018, when the FDA began an investigation into Juul’s marketing efforts. Before that, Juul had advertised its product with attractive young models and flavors like cool cucumber and creme brulee that critics said attracted underage users.
In April 2018, the FDA announced a crackdown on the sale of such products, including Juul’s, to people under the age of 21.
The use among young people had increased enormously. In 2017, 19 percent of 12th graders, 16 percent of 10th graders and 8 percent of 8th graders reported vaping nicotine in the past year, according to Monitoring the Future, an annual survey conducted for the National Institute on Drug Abuse.
Juul, for his part, routinely denied targeting young people, but it was prosecuted in lawsuits and by prosecutors, 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 several parties in the state who claimed the company had helped entice underage users to vape. More than a dozen other states have lawsuits and investigations pending.
dr. Scott Gottlieb, the former FDA commissioner, declared his approval of the move against Juul on Wednesday, which was first reported in The Wall Street Journal.
The news is now slightly less important to the industry than it would have been in Juul’s heyday, given the company’s plummeting market share. Once the dominant player with 75 percent of the market, Juul now has a significantly smaller market share.
But the news is a major blow to Altria, formerly known as Philip Morris and the maker of Marlboro, which bought 35 percent of Juul in December 2018 for $12.8 billion. Due to smaller market share and regulatory headwinds, Altria said, the value of that stake 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 with some in Canada, Great Britain, and other countries. Revenue has fallen to $1.3 billion in 2021, from $2 billion in 2019, with about 95 percent in U.S. sales.
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 brains of adolescents are particularly sensitive to nicotine, which is a memory, concentration, learning and self-control.
The e-cigarette companies have already said they will challenge the decision in court.
E-cigarettes have been sold in the US market for more than a decade without official FDA approval, as they have not been under the agency’s regulatory purview for several years.
In 2019, the FDA sent Juul a warning letter, saying that the company was violating federal regulations because it had not received approval to promote and sell its products as a healthier smoking option.
The agency has been evaluating all types of vaping products for over a year, some in development, and companies awaiting a decision are allowed to continue to sell some products.
The FDA recently said it had so far rejected more than a million applications whose products deemed it more of a health risk than a benefit. In October, it authorized RJ Reynolds to continue marketing Vuse. This was the first time the agency had approved a vaping product made by a major cigarette company.
In its review of devices it compared to traditional cigarettes, the agency said the devices contained a “significant reduction” of harmful chemicals, although some were still present. The review said the toxins and potential cancer-causing chemicals were much lower in the blood and urine of people using the Vuse device compared to those of smokers.
Still, California law required RJ Reynolds to warn Vuse buyers about exposure to glycidol, which “is known to cause cancer” based on studies in mice and rats.
In March, the agency approved several tobacco-flavored products from Logic Technology Development, saying the company could demonstrate that its products would likely help adults make the switch from traditional cigarettes, while posing a low risk of attracting young, new users. to pull.
But the agency disappointed some prominent lawmakers and advocacy groups when it recently announced it wouldn’t 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 could be counterproductive.
Clifford Douglas, director of the Tobacco Research Network at the University of Michigan School of Public Health, said many experts have come to see Juul, along with other e-cigarettes, as valuable tools to help adult smokers quit conventional cigarettes.
“They are exits 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 somewhat cobbled, putting millions of adult lives at stake. It is hoped Juul can respond effectively to the request for more scientific analysis, make any possible product adjustments and re-offer their products to adults in need .”
Christina Jewett and Sheila Kaplan reported.