FDA orders Juul to remove e-cigarettes from US market

The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes in the US market, dealing a major blow to the once-popular company whose brand has been blamed for the teen vaping crisis.

Order affects all Juul products in the US market, which is the company’s main source of sales. Juul’s elegant, sweet-tasting cartridges and pods helped usher in an era of alternative nicotine products that were exceptionally appealing to young people. The company’s initial dominance drew scrutiny from anti-smoking groups and regulators, who feared the products would do more harm to young people than good to smokers trying to quit.

While vaping rates among teens have declined during the coronavirus pandemic, public health experts and lawmakers continue to raise concerns about the nicotine content of some e-cigarettes that remain on the market, including brands like Puff Bar, whose fruity flavors young people like it.

The FDA’s decision did not address Juul’s attitude towards youth vaping. Instead, it was based on what the agency called insufficient and conflicting data from the company about potentially harmful chemicals that can leach out of Juul e-liquid pods. The FDA has said there is no immediate threat to consumer health, but it does not have enough evidence to assess potential risks.

“Today’s action is further progress in fulfilling the FDA’s commitment to ensuring that all e-cigarettes and electronic nicotine delivery systems currently sold to consumers meet our public health standards,” Dr. This is stated in a statement by agency commissioner Robert M. Kaliff. And he acknowledged that many e-cigarettes have played a role in the rise of teen vaping.

The FDA move is part of a broader effort to change the rules on smoking and vaping, and to reduce morbidity and mortality caused by inhaled products containing highly addictive nicotine.

On Tuesday, The agency announced plans reduce the nicotine levels in traditional cigarettes to discourage the most lethal of legal consumer products. In April the FDA said he would move to ban on menthol cigarettes.

The FDA’s action against Juul in particular is part of the agency’s new regulatory mission to determine which e-cigarettes currently sold or offered for sale will be allowed to remain on the shelves permanently. He has already given permission for other companies’ e-cigarettes to remain on the market.

But it could be years before some of the agency’s new initiatives take effect – if they can withstand fierce opposition from powerful tobacco lobbies, anti-regulatory groups and the vaping industry.

Juul said he disagreed with the FDA’s findings and plans to appeal. The company may require the agency or court to stay the proceedings pending an appeal to the FDA. The company did not say which path it would take, but would try to keep its products on the market during any litigation.

“We intend to pursue the suspension,” Juul said in a statement, “and are exploring all of our options in accordance with FDA rules and the law, including appealing the decision and engaging with our regulator.”

Public health groups welcomed the decision.

“The FDA’s decision to remove all Juul products from the market is welcome and long overdue,” said Erica Sward, national assistant vice president of advocacy for the American Lung Association. “Juul’s campaign to get kids hooked on tobacco has gone on too long.”

A statement from the American Vapor Manufacturers Association, an industry trade group, hints at a fight to come.

“The FDA’s stunning indifference to ordinary Americans and their right to switch to a much safer alternative to vaping, as measured by the number of lives lost and potentially destroyed, will undoubtedly be one of the greatest episodes of regulatory malpractice in American history,” Amanda Wheeler, President associations. , the message says.

Overall, the FDA is walking a fine line in changing the landscape of nicotine products. It is trying to wean the public away from traditional cigarettes while allowing less harmful vaping products that do not appeal to a new generation of users: new devices should be attractive for quitting smoking, but not so attractive as to attract younger people en masse.

The agency’s decision against Juul ended almost a two-year review of data the company had submitted to try to get approval to continue selling its tobacco and menthol flavored products in the United States. Specifically, Juul sought approval for—and the FDA denied—the Juul vaping device and four different pods, including tobacco pods with 3 and 5 percent nicotine concentrations and menthol flavored pods with the same levels.

“Understandably, the company was given the opportunity to address questions and concerns related to safety, toxicology, and potential genotoxicity, and for some reason the company was unable to handle its burden, resulting in a negative marketing order,” Mitch said. Zeller. former director of the agency’s Tobacco Center, who retired in April.

He said Juul may be filing an entirely new application for an updated product that appears to address the issue of chemical leaching.

FDA launches investigation Juula Marketing Efforts four years ago. Prior to this, Juul advertised its product using attractive young models and flavors such as cool cucumber and creme brulee, which critics said attracted underage users.

In April 2018, the FDA announced suppression on the sale of such products, including Juul’s, to persons under the age of 21.

Usage among youth has skyrocketed. In 2017, 19 percent of 12th graders, 16 percent of 10th graders and 8 percent of 8th graders reported using nicotine in e-cigarettes in the previous year. according to the Monitoring of the Futurean annual survey done for the National Institute on Drug Abuse.

For its part, Juul has generally denied targeting young people, but has been prosecuted in lawsuits and by attorneys general, with the company suffering millions of dollars in damages in some cases. AT one settlement in 2021Juul agreed to pay $40 million to North Carolina, which represented various parties in the state that claimed the company helped bring underage users to vaping. More than a dozen other states have lawsuits and investigations still pending.

The news is slightly less weighty for the industry now than it would have been during Juul’s heyday, given the company’s sharp drop in market share. Once a dominant player with 75 percent of the market, Juul now has a significantly smaller market share.

But the news is a significant blow to Altria, formerly known as Philip Morris and maker Marlboro, which bought 35 percent of Juul for $12.8 billion in December 2018.

Altria made investments to counteract the slowdown in tobacco sales, while Juul looked to Altria as an ally to help it cope with increased regulatory scrutiny.

None of these strategies seem to have worked.

Altria wrote off the value of its investment in July by more than $11 billion, to $1.7 billion. Altria, which derives about 90 percent of its income from tobacco products, fell slightly last year. Its shares have fallen more than 40 percent in the last five years and 20 percent in the last month alone. In July, for its part, its revenue dropped to $1.3 billion in 2021 from $2 billion in 2019, with about 95 percent of sales coming from the US.

“We are disappointed with today’s decision and continue to believe that e-cigarettes can play an important role in harm reduction for adult smokers,” Altria said in a statement.

At its peak, Juul had over 4,000 employees. Now he has just over 1,000 people, mostly in the US, but also in Canada, the UK and other countries.

E-cigarettes have been sold in the US market for more than a decade without formal FDA clearance, as they have not been subject to the agency’s regulatory bodies for several years.

In 2019 FDA sent a warning email to Juulstating that the company violated federal regulations by not obtaining approval to promote and sell its products as a healthier smoking option.

The FDA recently said it has turned down more than a million applications to date for products that it believes pose a health risk rather than a benefit. In October, he authorized R. J. Reynolds to continue marketing. university. This was the first time the agency had approved 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 was able to show that its products are likely to help adults move away from traditional cigarettes, posing a low risk of attracting younger new users.

Some tobacco control experts have said that the decision to ban Juul from the US market could be counterproductive.

Clifford Douglas, director of the University of Michigan Tobacco Research Network, said many experts have concluded that Juul and other e-cigarettes are valuable tools to help adult smokers quit regular cigarettes.

“They are not intended for smoking and can provide smokers with an alternative to flammable substances, which are the cause of virtually every tobacco-related death,” he said. “But now this exit is narrowing and kind of paved, which puts millions of adult lives at stake. It is hoped that Juul can effectively respond to the request for more scientific analysis, make any product adjustments that may be required, and re-offer its products to adults in need.”

Lauren Hirsch, Christina Jewett and Sheila Kaplan contributed reporting.