FDA Instructs Juul to Stop Selling E-Cigarettes

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

The order affects all of Juul’s products in the U.S. market, a remarkable source of the company’s sales. Juul’s sleek vaping cartridges and sweet -flavored pods help usher in the era of alternative nicotine products among adults as well, and invite in -depth scrutiny from anti -smoking groups and regulators who fear they will do more harm to young people than good to ex -smokers.

“Today’s action is a further advance on the FDA’s commitment to ensure all e-cigarette and electronic nicotine delivery system products being marketed to consumers meet our public health standards,” Drs. Robert M. Califf, agency commissioner, in a statement. . “The agency has dedicated substantial resources to reviewing products from companies that account for a large portion of the U.S. market. We recognize that this is a large part of the products available and many have played a disproportionate role in the increase in youth vape. “

The FDA’s move is part of a broader effort to redefine regulations for smoking and vape products and to 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 most lethal legal consumer products. In April, the FDA said it would move toward a ban on bulb -flavored cigarettes.

The action against Juul in particular is part of a newer regulatory mission for the agency, which must determine electronic cigarettes currently being sold, or proposed for sale, will be allowed onto U.S. shelves permanently now because the FDA has authority over e-cigarettes.

But the proposal may take years before it takes effect-if it can withstand fierce opposition from powerful tobacco lobbies, anti-regulatory groups and the vape industry.

Juul is expected to appeal the FDA decision.

Public health groups praised the decision.

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

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

“Measured in the lives lost and potentially destroyed, the FDA’s shocking indifference to ordinary Americans and their right to switch to far safer vape alternatives would certainly be listed as one of the largest episodes of regulatory abuses in American history,” Amanda Wheeler , president of the association. , he said in a statement.

The agency’s decision limits a nearly two -year review of data that Juul has submitted to try to win permission to continue selling its tobacco -flavored products and bulbs in the United States. The application requires the company to prove the safety of its device and whether it is suitable for public health protection.

Juul, in particular, has been a target of regulators, schools and policymakers for years, beginning in 2018, when the FDA began an investigation into Juul’s marketing efforts. Prior to that, Juul had advertised its products using attractive young models and flavors like cold cucumber and creme brulee which according to critics appealed to underage consumers.

By April 2018, the FDA announced crackdowns on the sale of such products, including Juul, to people under the age of 21.

Consumption among young people has soared. In 2017, 19 percent of grade 12, 16 percent of grade 10 and 8 percent of grade eight reported nicotine vape in the past year, according to Monitoring the Future, an annual survey conducted for the National Institute on Drug Abuse.

For his part, Juul routinely denies that it targets young people, but it is pursued in lawsuits and by the attorney general, with several 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 represents various parties in the state that claim the company has helped lure underage consumers to do vape. 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 a bit less weighty for the industry now than it was in Juul’s heyday, given the company’s plummeting market share. Once a dominant player with 75 percent of the market, Juul now has a much smaller market share.

But the news dealt a huge blow to Altria, formerly known as Philip Morris and the Marlboro maker, which in December 2018 bought 35 percent of Juul for $ 12.8 billion. Due to smaller market share and regulatory barriers, Altria said, the value of the holdings will fall to $ 1.7 billion by the end of 2021.

At its peak, Juul had more than 4,000 employees. It now has just over 1,000, mostly in the United States, but with a few in Canada, Britain and other countries. Revenue has fallen to $ 1.3 billion in 2021, down from $ 2 billion in 2019, with about 95 percent in U.S. sales.

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

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

E-cigarettes have been sold in the U.S. market for more than a decade without official FDA approval, as they were not included under the agency’s regulatory jurisdiction for several years.

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

The agency has been reviewing all types of vape products, some in development, for more than a year, and the pending company has been allowed to continue selling some products.

The FDA recently said it has so far rejected more than a million applications whose products are deemed to have more health risks than benefits. In October, it allowed RJ Reynolds to continue marketing Vuse. This is the first time the agency has given approval to vape products made by large cigarette companies.

In a review of the device compared to traditional cigarettes, the agency said that the device contained “significant reductions” in harmful chemicals, although some are still present. The study said toxins and chemicals that could potentially cause cancer were significantly lower in the blood and urine of people who use Vuse devices compared to smokers.

Still, California law requires RJ Reynolds to warn Vuse buyers about exposure to glycidol, which is “known by the state to cause cancer” based on rat and mouse studies.

In March, the agency approved several tobacco -flavored products from Logic Technology Development, saying the company could show that its products are likely to help adults make the transition from traditional cigarettes while posing a low risk of attracting young new consumers.

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

Some tobacco control experts said the decision to ban Juul from the U.S. market was wrong and ultimately unproductive.

Clifford Douglas, director of the Tobacco Research Network at the University of Michigan School of Public Health, said that the FDA appears to be punishing Juul for marketing his past activities to teens, and many experts have come to see Juul and other e-cigarettes as valuable tools to help adult smokers quit smoking. conventional.

“It’s called a ramp that can give smokers an alternative to flammable substances, which are responsible for almost every tobacco -related death,” he said. “But now the ramps outside are being narrowed and paved, which is putting millions of adult lives in danger.”

Christina Jewett and Sheila Kaplan contributed reports.

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