FDA orders Juul to stop selling e-cigarettes

The Food and Drug Administration ordered Juul on Thursday 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 US market, the overwhelming source of the company’s sales. Juul’s sleek vape cartridges and sweet-tasting pods also helped usher in an era of alternative nicotine products among adults, inviting intense scrutiny from anti-smoking groups and regulators who feared they would more harm to young people than good to ex-smokers.

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

The FDA action is part of a broader effort to remake rules for smoking and vaping products and to reduce illnesses and deaths caused by inhalable products that contain highly addictive nicotine.

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

The action against Juul in particular is part of a new regulatory mission by the agency, which must determine which e-cigarettes currently for sale, or proposed for sale, will be allowed on U.S. shelves permanently now that The FDA has authority over 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 is expected to appeal the FDA decision.

Public health groups praised the ruling.

“The FDA’s decision to remove all Juul products from the market is very welcome and long overdue,” said Erika Sward, national deputy vice president for advocacy at the American Lung Association. “Juul’s campaign to target and hook kids on tobacco has gone on too long.”

A statement from the American Steam Manufacturing Association, an industry trade group, hinted at the fight to come.

“Measured in lives lost and potentially destroyed, the FDA’s staggering disregard for ordinary Americans and their right to switch to the much safer alternative of vaping is sure to rank as one of the greatest episodes of regulatory neglect in United States history.” United”, Amanda Wheeler, president of the association. she said in a statement.

The agency’s ruling capped a nearly two-year review of data Juul had submitted to try 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 protecting public health.

Juul, in particular, had been the target of regulators, schools and lawmakers for years, starting in 2018 when the FDA launched an investigation into Juul’s marketing efforts. Before that time, Juul had advertised its product using attractive young 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 people under the age of 21.

Usage among young people had skyrocketed. In 2017, 19% of 12th graders, 16% of 10th graders, and 8% of 8th graders reported vaping 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 routinely denied targeting youth, but was pursued 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 had helped lure underage users into vaping. More than a dozen other states have lawsuits and investigations still pending.

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

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

But the news deals a significant blow to Altria, formerly known as Philip Morris and maker of Marlboros, which in December 2018 bought 35 percent of Juul for $12.8 billion. Due to declining market share and regulatory hurdles, Altria said, the value of that stake fell to $1.7 billion by the end of 2021.

At its peak, Juul had more than 4,000 employees. It now has a little over 1,000, mostly in the United States, but with a few in Canada, Britain, and other countries. Its revenue fell to $1.3 billion in 2021, down from $2 billion in 2019, with about 95 percent of it from sales in the US.

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

The e-cigarette companies have already 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 authorization, because they were not under the agency’s regulatory purview for several years.

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

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

The FDA recently said it had so far rejected more than a million applications whose products it deemed 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 large 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 said that toxins and chemicals that can cause cancer were much lower in the blood and urine of people using the Vuse device compared to smokers.

Still, California law required RJ Reynolds to warn Vuse shoppers about exposure to glycidol, which is “known to the state to cause cancer” based on studies of mice and rats.

In March, the agency licensed 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 while posing a low risk of attracting new young users. .

But the agency disappointed some prominent lawmakers and advocacy groups when it recently announced it might not finish reviewing all e-cigarette marketing applications until June 2023, a year after the court-imposed deadline.

Some tobacco control experts said the decision to ban Juul from the US market was misguided and ultimately counterproductive.

Clifford Douglas, director of the Tobacco Research Network at the University of Michigan School of Public Health, said the FDA appeared to be punishing Juul for its past marketing activity to teens, and that many experts had come to view Juul as and other electronic cigarettes as valuable tools to help adult smokers quit conventional cigarettes.

“It’s the so-called exit ramps that can provide smokers with an alternative to fuels, which are responsible for virtually all tobacco-related deaths,” he said. “But now that off-ramp is being narrowed and paved over, which is putting the lives of millions of adults at risk.”

Christina Jewett and Sheila Kaplan contributed reporting.

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