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this The Food and Drug Administration ordered Juul on Thursday to stop selling e-cigarettes In the US market, it’s 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, which is the overwhelming source of the company’s sales. Juul’s sleek vaping cartridges and sweet-flavored pods helped usher in an era of alternative nicotine products that were becoming immensely popular with youth, and have been invited for intense scrutiny by anti-smoking groups and regulators, who feared that they would do more harm to youth than ex-smokers. .

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

Agency commissioner Dr. “Today’s action is further progress in the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently marketed to consumers meet our public health standards,” Robert M. Califf said in a statement. . “The agency has dedicated significant resources to reviewing the products of companies that make up most of the US market. We recognize that these make up a significant portion of the products available, and many of them play a disproportionate role in the rise in youth vaping.

The FDA’s move is part of a far-reaching effort to reform cigarette and e-cigarette products and reduce morbidity and mortality from highly addictive nicotine-containing inhalable products.

Tuesday, The agency announced its plans lowering nicotine levels in conventional cigarettes as a way to deter the use of the deadliest legal consumer products. FDA in April Said he’d move right menthol flavored cigarettes ban.

Specifically, the lawsuit against Juul is part of a newer regulatory mission for the agency, which must determine which vapes are currently on sale or which vapes will go on sale.

But these proposals could take years to take effect – if they can withstand fierce resistance from the powerful tobacco lobby, anti-regulation groups, and the vape industry.

Juul said it will 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 overdue,” said Erika Sward, vice president of national advocacy for the American Lung Association. “Juul’s campaign to target and link children to tobacco has been going on for a very long time.”

A statement from the American Steam Manufacturing Association, an industry trade group, pointed to the challenge ahead.

“When measured by the lives lost and potentially destroyed, the FDA’s staggering indifference to ordinary Americans and their right to switch to a much safer e-cigarette alternative will certainly be one of the biggest incidents of regulatory malpractice in American history,” said Amanda Wheeler, president of the association. , in a statement.

The agency’s decision limited Juul’s nearly two-year review of data it submitted to gain authorization to continue selling its tobacco and menthol flavored products in the United States. The application required the company to prove the safety of its devices and whether they were fit for public health protection.

The FDA has ordered the removal of the Juul device and four different capsules, including tobacco-flavored capsules with 3 percent and 5 percent nicotine concentrations, and menthol-flavored capsules with the same levels.

Juul, in particular, has been the target of regulators, schools, and policymakers for years, starting in 2018 when the FDA began. Research Juul’s marketing efforts. Before then, Juul had advertised its product using attractive young models and flavors like cold cucumber and creme brulee, which critics said attracted underage users.

By April 2018 FDA announced a print Regarding the sale of such products, including Juul’s, to persons under the age of 21.

Use has increased among youth. In 2017, 19 percent of 12th graders, 16 percent of 10th graders, and 8 percent of eighth graders reported nicotine vaping in the past year, By Watching the FutureAn annual survey for the National Institute on Drug Abuse.

Juul has routinely denied targeting teenagers, but lawsuits have been pursued by state attorneys general and some have resulted in millions of dollars in damages against the company. Inside a settlement in 2021Juul has agreed to pay $40 million to North Carolina, which represents various parties in the state and claims the company is helping attract underage users to vaping. More than a dozen states still have ongoing lawsuits and investigations.

Former FDA commissioner Dr. Scott Gottlieb announced Wednesday that he has approved the motion against Juul. first reported At The Wall Street Journal.

Given the company’s falling market share, the news weighs slightly less for the industry than it would have been in Juul’s heyday. Juul, once the dominant player with 75 percent of the market, now has a fairly small share of the market.

But the news deals a significant blow to Altria, the maker of Marlboro, formerly known as Philip Morris, which bought 35 percent of Juul for $12.8 billion in December 2018. Altria said that due to smaller market share and regulatory headwinds, the value of that stake dropped to $1.7 billion at the end of 2021.

Juul had more than 4,000 employees at its peak. Currently, there are just over 1,000, mostly in the United States, but some in Canada, the United Kingdom, and other countries. Its revenue fell from $2 billion in 2019 to $1.3 billion in 2021, accounting for about 95 percent of U.S. sales.

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

Already, e-cigarette companies have said they will appeal the decision in court.

E-cigarettes have been sold on the U.S. market for over a decade without official FDA clearance because they have not been under the agency’s regulatory scope for several years.

FDA in 2019 Issued a warning letter to JuulHe said the company violated federal regulations by not getting approval to promote and sell its products as a healthier smoking option.

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

The FDA recently said it has rejected more than a million applications, where it sees its products as a health risk rather than a benefit. In October, he 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.

inside that review of devices Compared to conventional cigarettes, the agency said the devices contained “significant reductions” in harmful chemicals, although some are still available. Compared to smokers, people who used the Vuse device had much lower levels of toxins and potential cancer-causing chemicals in their blood and urine, the review said.

Still, California law required RJ Reynolds to warn Buyers about “state-known” glycidol exposure cause cancer” based on studies on mice and rats.

In March, the agency approved several tobacco-flavored products from Logic Technology Development, saying the company was able to demonstrate that its products pose a low risk of attracting young, new users while helping adults transition from traditional cigarettes.

But the agency recently disappointed some prominent lawmakers and advocacy groups when it announced it wouldn’t be able to finish reviewing all e-cigarette marketing apps by June 2023, a year after a court-imposed deadline.

Some tobacco control experts said the decision to ban Juul from the US market could have the opposite effect.

Clifford Douglas, director of the Tobacco Research Network at the University of Michigan School of Public Health, said many experts have come to view the Juul, along with other e-cigarettes, as valuable tools for helping adult smokers quit traditional cigarettes.

“Ramps that could provide smokers with an alternative to the combustibles that are responsible for nearly every tobacco-related death,” he said. “But now the ramp is being narrowed and sort of paved, which puts the lives of millions of adults at risk. He hopes Juul can effectively respond to the demand for more scientific analysis, make any product adjustments that may be necessary, and reoffer its products to adults who need it.”

Christina Jewett and Sheila Kaplan contributed to the reporting.