FDA orders Juul to remove e-cigarette products from US market

The Food and Drug Administration (FDA) on Thursday ordered Juul to stop selling e-cigarettes in the US market, a deeply damaging blow to a once-popular company whose brand was blamed for the teen vaping crisis.

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

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

The FDA decision did not address Juul’s relationship with youth vaping. Instead, it relied 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 imminent threat to consumers’ health, the FDA said, but there was not enough evidence to assess potential risks.

“Today’s action is further progress in 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,” said Dr. Robert M. Califf, the agency’s commissioner, in a statement. . And he acknowledged that many of the e-cigarette products played a role in the rise of teenage vaping.

The FDA move is part of a broader effort to rewrite rules for smoking and vaping products and reduce illness and death caused by inhaled products that contain highly addictive nicotine.

On Tuesday, the agency announced plans to reduce nicotine levels in traditional cigarettes as a way to discourage the use of the deadliest of 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 new regulatory mission for the agency, which must determine which e-cigarettes currently on sale, or proposed for sale, may remain permanently on shelves. It has already authorized the permanence of other companies in the electronic cigarette market.

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

Juul said he disagreed with the FDA’s findings and planned to appeal. The company can ask for a suspension from the agency or a court pending appeal to the FDA. The company has not said which path it will take, but it will try to keep its products on the market during any process.

“We intend to seek a suspension,” Juul’s statement concluded, “and are exploring all of our options under FDA regulations and law, including appealing the decision and contacting our regulator.”

Public health groups welcomed the decision.

“The FDA’s decision to remove all Juul products from the market is a very welcome and long overdue one,” said Erika Sward, assistant national vice president of advocacy for the American Lung Association. “Juul’s campaign to target and hook children with tobacco has been going on for a long time.”

A statement from the American Vapor Manufacturers Association, an industry trade group, hinted at the struggle 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 surely rank as one of the biggest episodes of regulatory negligence in American history,” Amanda Wheeler , president of the association. , said in a statement.

In general, the FDA is walking a fine line in reshaping the landscape for nicotine products. It is trying to turn the public away from traditional cigarettes by allowing for less harmful vaping products that do not appeal to a new generation of users: the new devices should be attractive for smoking cessation, but not so attractive as to attract youth en masse.

The agency’s decision against Juul ended a nearly two-year review of data the company presented to try to obtain authorization 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 pods with nicotine concentrations of 3% and 5% and menthol-flavored pods with the same levels.

“It is clear that the company was given the opportunity to address issues and concerns related to safety, toxicology and potential genotoxicity and for whatever reason the company was unable to fulfill its onus and this led to a negative marketing request,” said Mitch Zeller, a former director of the agency’s tobacco center who retired in April.

He said Juul could file an entirely new order for a revamped product — one that presumably addressed 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 using attractive youthful models and flavors like fresh cucumber and creme brulee that critics said appealed to underage users.

In April 2018, the FDA announced a crackdown on the sale of such products, including Juul’s, to those under 21.

Usage among young people has soared. In 2017, 19% of 12th graders, 16% of 10th graders, and 8% of 8th graders reported vaping nicotine in the previous year, according to Monitoring the Future, an annual survey done for the National Institute. on Drug Abuse.

For its part, Juul has routinely denied targeting young people, but has been pursued in lawsuits and by state 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 had helped attract underage users to vaping. More than a dozen other states have lawsuits and investigations that are still pending.

The news is slightly less important to the industry now than it would have been in Juul’s heyday, given the company’s declining market share. Once the dominant player with 75% of the market, Juul now has a considerably smaller market share.

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

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

None of these strategies seem to have worked.

Altria reduced the value of its investment in Juul by more than $11 billion to $1.7 billion. Altria, which derives about 90 percent of its revenue from tobacco products, saw revenue fall slightly last year. Its shares are down more than 40% in the last five years and 20% in the last month alone. Juul, meanwhile, saw its revenue drop to $1.3 billion in 2021 from $2 billion in 2019, with about 95% of sales in the US.

“We are disappointed with today’s decision and continue to believe that e-vapor 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. It now has just over 1,000, mostly in the United States, but with a few in Canada, Great Britain and other countries.

E-cigarettes have been sold on the US market for more than a decade without formal authorization from the FDA because they have not been within the agency’s regulatory mandate for several years.

In 2019, the FDA issued a warning letter to Juul, saying the company violated federal regulations because it did not receive approval to promote and sell its products as a healthier option to smoking.

The FDA recently said it has so far rejected more than a million applications for products it considers 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 granted approval to a vaping product made by a major cigarette company.

In March, the agency authorized several tobacco-flavored products from Logic Technology Development, saying the company was able to show that its products were likely to help adults transition from traditional cigarettes, posing a low risk of attracting new young users.

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, said many experts have come to see Juul and other e-cigarettes as valuable tools to help adult smokers move away from conventional cigarettes.

“These are ramps that can offer smokers an alternative to fuels, which are responsible for virtually all tobacco-related deaths,” he said. “But now that ramp is being narrowed and kind of paved over, which is putting millions of adult lives at risk. It is hoped that Juul will be able to effectively respond to the request for more scientific analysis, make any product adjustments that may be needed, and again offer its products to adults in need.”

Lauren Hirsch, Christina Jewett and Sheila Kaplan contributed reporting.

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