FDA orders Juul to stop selling e-cigarettes

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

Demand affects all Juul products in the US market, the company’s greatest source of sales. Juul’s nifty e-cigarette cartridges and sweet-flavored pods helped usher in the era of nicotine replacement products among adults, too, and called for intense scrutiny by anti-smoking groups and regulators who feared they were doing more harm to young adults than former smokers.

In its judgment, the agency said Juul had provided insufficient and conflicting data about potentially harmful chemicals that could leach from Juul’s e-liquid capsules.

“Today’s action represents further progress on the FDA’s commitment to ensuring that all e-cigarettes and e-nicotine delivery system products currently marketed to consumers meet our public health standards,” Commissioner Dr. Robert M. Califf, the agency’s commissioner, said in a statement. . “The agency has devoted significant resources to reviewing products from companies that represent most of the US market. We recognize that these items make up a large portion of the available products and many have played a disproportionate role in the increased prevalence of youth vaping.”

The FDA’s move is part of a broader effort to rewrite the rules for smoking and vaping products and to reduce illness and death caused by inhaled products containing the addictive nicotine.

On Tuesday, the agency announced plans to reduce nicotine levels in conventional cigarettes as a way to discourage use of the most deadly legal consumer product. In April, the U.S. Food and Drug Administration said it would move toward banning menthol-flavored cigarettes.

The action against Juul in particular is part of the agency’s new regulatory mission, which should define e-cigarettes currently for sale, or proposed for sale, that will be allowed on U.S. shelves permanently now that the Food and Drug Administration has authority over e-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 e-cigarette industry.

Jules said she would appeal the FDA’s decision.

Public health groups praised the ruling.

“The FDA’s decision to remove all Juul products from the market is a welcome and long overdue decision,” said Erica Sward, assistant national vice president for the American Lung Association. “Juul’s campaign to target children and associate them with tobacco has gone on for a very long time.”

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

“Given the lives lost and potential devastation, the Food and Drug Administration’s astonishing indifference toward ordinary Americans and their right to switch to the safer alternative to vaping would certainly rank as one of the greatest episodes of regulatory malpractice in American history,” Amanda Wheeler, president of the association said in a statement.

The agency’s decision culminated in a nearly two-year review of data provided by Juul to try to obtain permission to continue selling its tobacco and menthol-flavored products in the United States. The app asked the company to prove the safety of its devices and whether they were suitable to protect public health.

Juul, in particular, has been a target of regulators, schools, and policy makers for years, beginning in 2018, when the Food and Drug Administration (FDA) began investigating Juul’s marketing efforts. Prior to that time, Juul advertised its products using attractive young models and flavors such as the great cucumber and brulee which critics said appeals to underage users.

By April 2018, the US Food and Drug Administration (FDA) announced a crackdown on the sale of these products, including Juul products, to people under the age of 21.

Use has risen among young people. In 2017, 19 percent of 12th graders, 16 percent of 10th graders, and 8 percent of eighth graders reported having used nicotine in vaping in the past year, according to Watching the Future, an annual survey conducted for the National Institute on Drug Abuse .

Juul, for its part, has routinely denied targeting youth, but has been pursued in lawsuits and by the state’s attorney general, with some cases resulting in millions of dollars in damages against the company. In one settlement in 2021, Juul agreed to pay $40 million to North Carolina, which represented various parties in the state who asserted that the company helped lure underage users to use e-cigarettes. More than a dozen other states have lawsuits and investigations still pending.

Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, made clear his approval of the move against Juul on Wednesday, which was first reported in the Wall Street Journal.

The news is somewhat less relevant to the industry now than it was at Juul’s heyday, due to the company’s low market share. Once the dominant player with 75 percent of the market, Juul now has a much smaller market share.

But the news is dealing a huge blow to Altria, formerly known as Philip Morris and maker of Marlboro, which in December 2018 bought 35% of Juul for $12.8 billion. Altria said the value of that stake had fallen to $1.7 billion by the end of 2021, due to its smaller market share and regulatory headwinds.

At its peak, Juul had over 4,000 employees. It now has just over 1,000, mostly in the United States, but with some 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 in US sales.

Nicotine by itself is not a 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 affected by nicotine, which can affect Memory, concentration, learning and self-control.

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

E-cigarettes have been sold on the US market for more than a decade without official permission from the Food and Drug Administration, because they have not fallen under the agency’s regulatory jurisdiction for several years.

In 2019, the US Food and Drug Administration (FDA) issued a warning letter to Juul, saying the company had violated federal regulations because it had not received approval to promote and sell its products as a healthy smoking option.

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 some products.

The Food and Drug Administration recently said it has so far rejected more than 1 million applications whose products it considers a health risk rather than a benefit. In October, RJ commissioned Reynolds to continue marketing Vuse. This was the first time the agency had given approval to a vaping product from a major cigarette company.

In its review of the devices, which compared them to conventional cigarettes, the agency said the devices contained a “significant reduction” in harmful chemicals, although some are still present. The review said that the toxins and cancer-causing chemicals were significantly lower in the blood and urine of people using the Vuse compared to smokers.

However, California law requires RJ Reynolds to warn Vuse buyers against exposure to glycidol, which is “known to the state to cause cancer” based on studies in mice and rats.

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 while reducing the risk of attracting new, younger users.

But the agency disappointed some prominent lawmakers and advocacy groups when it recently announced that it would not be able to 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 could backfire.

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, along with other e-cigarettes, as valuable tools to help adult smokers quit traditional cigarettes.

“They are ramps that can provide smokers with an alternative to combustibles, which are responsible for every tobacco-related death,” he said. But now that slope is narrowing and somewhat smoothing, putting the lives of millions of adults at risk. One hopes that Juul can respond effectively to the request for further scientific analysis, make any product modifications that may be required, and bring their products back to adults in need.”

Christina Jewett and Sheila Kaplan contributed to the report.

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