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 covers 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 were extremely appealing to young people. The company’s initial dominance led to intense scrutiny by anti-smoking groups and regulators who feared the products would do more harm to young people than good to cigarette smokers trying to quit.
While vaping rates among teens 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 FDA’s decision had no bearing on Juul’s relationship with 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 leak from Juul’s e-liquid pods. There was no immediate threat to consumer health, the FDA said, but there wasn’t enough evidence to rate the potential risks.
“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. And he acknowledged that many of the e-cigarette products had played a role in the rise of vaping among teens.
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 use of the most deadly legal consumer products. In April, the FDA said it would move towards a ban on menthol-flavored cigarettes.
The FDA’s action against Juul in particular is part of a newer regulatory mission for the agency, which must determine which electronic cigarettes currently on sale, or those listed for sale, can remain on shelves permanently. It has already authorized e-cigarettes from other companies to stay on the market.
But it could be years before some of the agency’s new initiatives take effect — if they stand up to fierce resistance from the powerful tobacco lobby, anti-regulatory groups and the vaping industry.
Juul said it disagreed with the FDA’s findings and planned to appeal. The company can request a reprieve from the agency or a court pending an appeal to the FDA. The company has not said which way it will look, but it will try to keep its products on the market during any proceedings.
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“We intend to seek residency,” Juul’s statement concluded, “and are investigating all of our options under FDA regulation and the law, including appealing the decision and contacting our regulator.”
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 Manufacturers Association, an industrial trade group, hinted at the battle ahead.
“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 episodes of malpractice in the U.S. history,” said Amanda Wheeler, the association’s president. , said in a statement.
Overall, the FDA is walking a thin line in recreating the landscape for nicotine products. It tries to distract the public from traditional cigarettes while allowing less harmful vapor products that do not attract a new generation of users: the new devices should be attractive for smoking cessation, but not so attractive as to entice young people en masse.
The agency’s ruling against Juul put a limit on a nearly two-year review of data the company had submitted to try to get permission to continue selling its tobacco and menthol flavored products in the United States. Specifically, Juul sought approval for — and the FDA rejected — a Juul vaping device and four different pods, including tobacco capsules with 3 percent and 5 percent nicotine concentrations and menthol-flavored pods with the same levels.
“Clearly the company has had the opportunity to raise questions and concerns regarding safety, toxicology and potential genotoxicity, and for whatever reason the company was unable to meet its burden and that led to a negative marketing order,” said Mitch Zeller, a former director of the agency’s tobacco center who retired in April.
He said Juul could file an entirely new application for an innovated product — an application believed to address the agency’s concerns about chemical leaching.
The FDA began an investigation into Juul’s marketing efforts four years ago. 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 has 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 previous 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.
The news is a little less important to the industry now 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.
Altria made the investment to counter slowing tobacco sales, while Juul looked to Altria as an ally to help it with increased regulatory oversight.
Neither strategy seems to have worked.
Altria has written off the value of its investment in Juul by more than $11 billion to $1.7 billion. Altria, which gets about 90 percent of its turnover from smoking products, saw turnover drop slightly last year. The stock has fallen more than 40 percent in the past five years and 20 percent in the past month alone. Juul, for its part, saw its revenue drop to $1.3 billion in 2021, from $2 billion in 2019, with about 95 percent in U.S. sales.
“We are disappointed with today’s decision and continue to believe that e-vapor can play an important role in reducing harm for adult smokers,” Altria said in a statement.
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.
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 FDA recently said it had so far rejected more than a million applications for products it viewed as a health risk rather than a benefit. In October, it authorized RJ Reynolds to continue marketing Vuse. This was the agency’s first time approving a vaping product made by a major cigarette company
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.
Some tobacco control experts said the decision to ban Juul from the US market could be counterproductive.
Clifford Douglas, director of the University of Michigan’s Tobacco Research Network, said many experts have come to see Juul and other e-cigarettes as valuable tools to help adult smokers quit conventional cigarettes.
“They are 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 somewhat cobbled, putting millions of adult lives at stake. It is hoped that Juul can respond effectively to the request for more scientific analysis, make any product changes and re-offer their products to adults in need.” .”
Lauren Hirsch, Christina Jewett and Sheila Kaplan reported.
