The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes on the US market, a profoundly damaging blow to a once-popular company whose brand was blamed for the teenage vaping crisis.
The order affects all of Juul’s products on the US market, the overwhelming source of the company’s sales. Juul’s sleek vaping cartridges and sweet-flavored pods helped us in an era of alternative nicotine products as well, and invited intense scrutiny from antismoking groups and regulators who feared they would do more harm to younger people than good to former smokers.
“Today’s action is to further progress the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products are currently marketed to consumers to meet our public health standards,” Dr. Robert M. Califf, the agency commissioner, said in a statement. “The agency has dedicated significant resources to review products from the companies that account for most of the US market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping. “
The move by the FDA is part of a wide-ranging effort to remake rules for smoking and vaping products and to reduce illnesses and deaths caused by inhalable products containing highly addictive nicotine.
On Tuesday, the agency announced plans to slash nicotine levels in traditional cigarettes as a way to discourage the use of most deadly 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 for the agency, which must determine which electronic cigarettes currently for sale, or offered for sale, will be allowed on the US shelves permanently now that the FDA has authority over e-cigarettes.
But it could take years before these proposals take effect – if they can withstand fierce resistance from the powerful tournament lobby, antiregulatory groups and the vaping industry.
Juul is expected to appeal the FDA’s decision.
Public health groups hailed the ruling.
“The FDA’s decision to remove all Juul products from the marketplace is both most welcome and long overdue,” said Erika Sward, national vice president of advocacy for the American Lung Association. “Juul’s campaign to target and hook kids over is gone for far too long.”
A statement from the American Vapor Manufacturing Association, an industry trade group, hinted at the fight ahead.
“Measured in lives lost and potential destroyed, FDA’s staggering indifference to ordinary Americans and their right to switch to vaping of vastly safer alternatives will surely rank as one of the greatest episodes of regulatory malpractice in American history,” Amanda Wheeler, president of the association. , said in a statement.
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The agency’s ruling capped a nearly two-year review of data that Juul had submitted to try-to-sell authorization to continue selling its anti- and menthol-flavored products in the United States. The application requires the company to prove the safety of its devices and whether they were appropriate for the protection of public health.
Juul, in particular, has been a target of regulators, schools and policymakers for years, starting in 2018, when the FDA began an investigation into Juul’s marketing efforts. Before that time, Juul had advertised its product using attractive young models and flavors like cool cucumber and creme brulee that critics said attracted underage users.
By April 2018, the FDA announced a crackdown on the sale of such products, including Juul’s, to people under the age of 21.
Use among young people had soared. In 2017, 19 percent of 12th graders, 16 percent of 10th graders and 8 percent of eighth graders reported vaping nicotine in the past year, according to Monitoring the Future, an annual survey for the National Institute on Drug Abuse.
For its part, Juul routinely denied that it targeted young people, but it was pursuing lawsuits and by state attorneys 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 the company had helped lure underage users. More than a dozen other states have lawsuits and investigations that are still pending.
Dr. Scott Gottlieb, a former FDA commissioner, explained his move against Juul on Wednesday, which was first reported in The Wall Street Journal.
The news is slightly less weighty for the industry than it has been in Juul’s heyday, given the company’s plummeting market share. Once the dominant player with 75 percent of the market, Juul now has a significantly smaller share of the market.
But the news delivers a significant blow to Altria, formerly known as Philip Morris and the maker of Marlboro, which in December 2018 bought 35 percent of Juul for $ 12.8 billion. Because of the smaller market share and regulatory headwinds, 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 is now slightly over 1,000, mainly in the United States, but with some in Canada, Britain and other countries. Its revenue has dropped to $ 1.3 billion in 2021, down from $ 2 billion in 2019, with about 95 percent in US sales.
Nicotine itself is not the cause of smoking from lung cancer and other deadly ills, but the drug is exceedingly 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.
Already, the 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 formal FDA authorization, as they did not fall under the agency’s regulatory purview for several years.
In 2019, the FDA issued a warning letter to Juul, saying that the company violated federal regulations because it had not received approval to promote and sell its products as a healthier alternative to smoking.
The agency has been reviewing all types of vaping products, some in development, for more than a year, and companies have been awaiting a decision to keep selling some products.
The FDA recently said it had so far rejected more than a million applications whose products considered it 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 granted approval to create a vaping product by a large cigarette company.
In its review of devices that compared it with traditional cigarettes, the agency said the devices contained a “significant reduction” in harmful chemicals, though some were still present. The review said the toxins and potential cancer-causing chemicals were far lower in blood and urine than people using the Vuse device compared with those smokers.
Still, California law requires RJ Reynolds to warn Vuse buyers about exposure to glycidol, which is “known to cause the state cancer” based on studies of mice and rats.
In March, the agency authorized several tobacco-flavored products from Logic Technology Development, saying the company was able to show its products were helping individuals transition to traditional cigarettes while posing a low risk of attracting young, new users.
But the agency disappointed some prominent lawmakers and advocacy groups when it announced recently that it would not be able to finish reviewing all of the e-cigarette marketing applications until June 2023, a year after a 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’s School of Public Health, said the FDA has appeared to penalize juul for its past activity marketing to teenagers, and that many experts have come to see Juul and other e-cigarettes as Valuable tools for helping adult smokers quit traditional cigarettes.
“They are so-called off-ramps that can provide smokers an alternative to combustibles, which are responsible for virtually every death-related illness,” he said. “But now that off-ramp is narrowing and sort of paved over, which is putting millions of adult lives at risk.”
Christina Jewett and Sheila Kaplan contributed reporting.