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FDA orders Juul to stop selling e-cigarettes

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

The order affects all of Juul’s products in the US market, the overwhelming source of the company’s sales. Juul’s sleek vape cartridges and sweet-tasting pods helped usher in an era of alternative nicotine products that became exceptionally popular among young people, and drew intense scrutiny from anti-tobacco groups and regulators who feared doing more harm to young people than good to ex-smokers. .

In its ruling, the agency said Juul provided insufficient and conflicting data on potentially harmful chemicals that may leak from Juul’s proprietary e-liquid pods.

“Today’s action is further progress in the FDA’s commitment to ensure that all e-cigarette and e-nicotine delivery system products currently marketed to consumers meet our public health standards,” said agency commissioner Dr. Robert M. Califf in a statement. . “The agency has devoted significant resources to reviewing products from companies that represent the bulk 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 increasing youth vaping.

The FDA’s decision is part of a larger effort to redefine the rules for smoking and vaping products and reduce illness and death from highly addictive nicotine-containing inhalants.

On Tuesday, the agency announced plans to reduce nicotine levels in traditional cigarettes to discourage the use of the deadliest legal consumer products. In April, the FDA said it would be moving toward a ban on menthol-flavored cigarettes.

The 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 offered for sale, will be allowed permanently on US shelves now that the FDA has authority. on electronic cigarettes.

But it could be years before these proposals take effect – if they can withstand fierce resistance from the powerful tobacco lobby, anti-regulatory groups and the vaping industry.

Juul said it would appeal the FDA’s decision.

Public health groups welcomed the decision.

“The FDA’s decision to remove all Juul products from the market is both welcome and long overdue,” said Erika Sward, National Assistant Vice President of Advocacy for the American Lung Association. “Juul’s campaign to target and hook kids to tobacco has gone on far too long.”

A statement from the American Vapor Manufacturing Association, an industry trade group, hinted at the coming fight.

“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 is sure to be one of the greatest episodes of regulatory malpractice in the industry. American history,” Amanda Wheeler, president of the association, said in a statement.

The agency’s decision ended a nearly two-year review of data Juul had submitted in an attempt to gain approval to continue selling its tobacco and menthol flavored products in the United States. The request required the company to prove the safety of its devices and whether they were appropriate for the protection of public health.

The FDA ordered the removal of the Juul device and four different pods from the market, including tobacco-flavored pods with 3% and 5% nicotine strengths and menthol-flavored pods with the same levels.

Juul, in particular, had been a target of regulators, schools, and policymakers for years, starting in 2018 when the FDA opened an investigation into Juul’s marketing efforts. Prior to that time, Juul had advertised its product using attractive young models and flavors like fresh cucumber and creme brulee which critics said appealed to underage users.

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

Use among young people had exploded. In 2017, 19% of 12th graders, 16% of 10th graders and 8% of eighth graders said they had vaped nicotine in the past year, according to Monitoring the Future, an annual survey conducted for the National Institute on Drug Abuse.

For its part, Juul has regularly denied it was targeting young people, but it has been sued in lawsuits and by state attorneys general, with some cases resulting in millions of dollars in damages against the company. In a settlement in 2021, 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. More than a dozen other states have lawsuits and investigations that are still ongoing.

Dr. Scott Gottlieb, the former commissioner of the FDA, explained his approval of the decision against Juul on Wednesday, which was first reported in The Wall Street Journal.

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

But the news is a 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. Due to the smaller market share and regulatory headwinds, Altria said, the value of that stake has fallen to $1.7 billion by the end of 2021.

At its peak, Juul had over 4,000 employees. It now has just over 1,000, mostly in the United States, but also in Canada, Britain and other countries. Its revenue fell to $1.3 billion in 2021 from $2 billion in 2019, with around 95% of sales in the United States.

Nicotine itself is not the cause of lung cancer and other deadly smoking-related diseases, but the drug is overly addictive, making it difficult for smokers to quit despite the health risks. The adolescent brain is particularly sensitive to nicotine, which can affect memory, concentration, learning and self-control.

Already, e-cigarette makers have said they will challenge the decision in court.

E-cigarettes have been sold in the US market for more than a decade without formal FDA clearance, as they were outside the agency’s regulatory jurisdiction for several years.

In 2019, the FDA issued a warning letter to Juul, claiming the company violated federal regulations because it had not been granted permission to promote and sell its products as a healthier option to smoking.

The agency has been reviewing all types of vaping products, some in development, for more than a year, and companies awaiting a decision have been allowed to continue selling certain products.

The FDA recently said it had so far rejected more than a million applications whose products were seen as more of a health risk than a benefit. In October, he authorized RJ Reynolds to continue marketing Vuse. It was the first time the agency had granted approval to a vaping product made by a major cigarette company.

In its review of the devices it compared to traditional cigarettes, the agency said the devices contained a “significant reduction” in harmful chemicals, although some were still present. The review indicated that potentially carcinogenic toxins and 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 the state to cause cancer” based on studies in mice and rats.

In March, the agency cleared several tobacco-flavored products from Logic Technology Development, saying the company was able to show its products could help adults transition from traditional cigarettes while posing a low risk. to attract young new users.

But the agency disappointed some prominent lawmakers and advocacy groups when it recently announced it would not be able to complete reviews of all e-cigarette marketing applications until June 2023, a year after a deadline. imposed by the court.

Some tobacco control experts have said the move 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, as well as other e-cigarettes, as valuable tools to help adult smokers quit. conventional cigarettes.

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

Christina Jewett and Sheila Kaplan contributed reporting.

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