The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes in the US market, a deeply devastating blow to a once-popular company whose brand has been blamed for the teen cigarette crisis.
The order affects all Juul products in the US market, the company’s predominant source of sales. Juul’s elegant vaping cartridges and sweet-tasting pods helped usher in the era of alternative nicotine products among adults as well, and called for intense scrutiny by anti-smokers and regulators, who feared they would do more harm than good to young people. ex-smokers.
In its decision, the agency said Juul had provided insufficient and conflicting data on potentially harmful chemicals that could leak from Juul’s patented e-liquid capsules.
“Today’s action is a further step forward in the FDA’s commitment to ensuring that all e-cigarette products and e-nicotine delivery systems currently available to consumers meet our public health standards,” he said in a statement. Robert M. Calif., Commissioner of the Agency. . “The agency has allocated significant resources to review products from companies that make up the majority of the US market. We recognize that they make up a significant proportion of the products available, and many of them have played a disproportionate role in the growth of young vapers. “
The FDA’s move is part of a comprehensive effort to revise the rules on smoking and vaping products and to reduce diseases and deaths from inhaled products containing 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 deadliest legal consumer products. In April, the FDA said it would move to ban menthol-flavored cigarettes.
The action against Juul in particular is part of a newer regulatory mission of the agency, which must determine which e-cigarettes currently sold or offered for sale will be permanently allowed on US shelves once the FDA has power over e-cigarettes.
But it could be years before these proposals take effect – if they can withstand the fierce resistance of the powerful tobacco lobby, anti-regulatory groups and the vaping industry.
Juul said he would 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 long-term,” said Erika Suard, national assistant vice president of advocacy for the American Lung Association. “Jule’s campaign to direct and hook children to tobacco has lasted too long.”
A statement from the American Vapor Manufacturing Association, an industrial trade group, hinted at the impending battle.
Read more about smoking and vaping
“Measured in lost lives and destroyed potential, the FDA’s stunning indifference to ordinary Americans and their right to move to a much safer alternative to vaping is sure to be one of the greatest episodes of regulatory abuse in American history,” Amanda said. Wheeler, president of the association, said in a statement.
The agency’s decision limited the nearly two-year review of data provided by Juul to try to gain permission to continue selling its tobacco and menthol products in the United States. The application requires the company to prove the safety of its devices and whether they are suitable for public health protection.
Juul, in particular, has been a target of regulators, schools and politicians for years, starting in 2018, when the FDA launched an investigation into Juul’s marketing efforts. Juul has previously advertised its product, using attractive young models and flavors such as cool cucumber and creme brulee, which critics say attract underage consumers.
Until April 2018, the FDA announced repression against the sale of such products, including Juul’s, to people under the age of 21.
Use among young people has increased. In 2017, 19% of 12th graders, 16% of 10th graders and 8% of eighth graders reported using nicotine in the past year, according to Monitoring of the Future, an annual study conducted for the National Institute on Drug Abuse.
Juul, for its part, routinely denied targeting young people, but was also prosecuted by prosecutors general, some of which resulted in millions of dollars in damages against the company. In an agreement in 2021, Juul agreed to pay $ 40 million to North Carolina, which represented various countries in the state, which claimed that the company had helped attract underage consumers to vaping. More than a dozen other countries are conducting lawsuits and investigations that are 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 little less severe for the industry now than it would have been in Juul’s heyday, given the company’s declining market share. Once a dominant player with 75 percent of the market, Juul now has a significantly smaller market share.
But the news has dealt a significant blow to Altria, formerly known as Philip Morris and Marlboro maker, which bought 35% of Juul in December 2018 for $ 12.8 billion. Due to lower market share and regulatory difficulties, Altria said the value of that share had fallen to $ 1.7 billion by the end of 2021.
At its peak, Juul had more than 4,000 employees. There are now 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, from $ 2 billion in 2019, with about 95 percent of sales in the United States.
Nicotine is not in itself a cause of lung cancer and other deadly diseases from smoking, but the drug is extremely addictive, making it difficult for smokers to quit despite health risks. Adolescents’ brains are particularly susceptible to nicotine, which can affect memory, concentration, learning and self-control.
E-cigarette companies have already said they will challenge the decision in court.
Electronic cigarettes have been marketed in the United States for more than a decade without official approval from the FDA, as they have not been under the regulatory competence of the agency for several years.
In 2019, the FDA issued a warning letter to Juul stating that the company had violated federal regulations by failing to get approval to promote and sell its products as a healthier smoking option.
The agency has been reviewing all types of vaping products, some under development, for more than a year, and companies awaiting a decision are allowed to continue selling some products.
The FDA recently said it has so far rejected more than a million applications whose products it considers to be more of a health risk 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 large cigarette company.
In its review of the devices, which it compares to traditional cigarettes, the agency said the devices contained a “significant reduction” in harmful chemicals, although some were still present. The review says that toxins and potential chemicals that cause cancer are much lower in the blood and urine of people who use the Vuse device than smokers.
However, California law requires RJ Reynolds to warn Vuse buyers about exposure to glycidol, which is “known to the state to cause cancer” based on studies in mice and rats.
In March, the agency approved several tobacco-flavored products from Logic Technology Development, saying the company was able to show that its products are likely to help adults make the transition from traditional cigarettes while at low risk of attracting young people. new users.
But the agency disappointed some prominent lawmakers and advocacy groups when it recently announced that it would not be able to complete a review of all e-cigarette marketing applications by June 2023, a year after a court deadline.
Some tobacco control experts have said the decision to ban Juul from the US market could be counterproductive.
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 older smokers quit conventional cigarettes.
“They are off the ramp, which can provide smokers with an alternative to the combustible substances that are responsible for almost every tobacco-related death,” he said. “But now the one outside the ramp is narrowing and somehow paved, which puts millions of adult lives at stake. One hopes that Juul can effectively respond to the demand for more scientific analysis, make any adjustments to the product that may be needed, and re-offer its products to adults in need.
Christina Juit and Sheila Kaplan contributed to the report.
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