The Food and Drug Administration ordered Juul on Thursday to stop selling e-cigarettes in the U.S. market, a blow that was deeply damaging to a formerly popular company, whose brand was blamed for the teen vapeo crisis. .
The order affects all Juul products in the US market, the overwhelming source of the company’s sales. Juul’s sleek spray cartridges and sweet-tasting pods also helped usher in an era of alternative nicotine products among adults and called for intense scrutiny by anti-smoking groups and regulators who feared they would do more harm to young people than not. passage to former smokers.
In its ruling, the agency said Juul had provided insufficient and conflicting data on potentially harmful chemicals that could come out of Juul’s patented electronic liquid pods.
“Today’s action is a further step in the FDA’s commitment to ensuring that all e-cigarette products and electronic nicotine delivery systems currently marketed to consumers meet our public health standards,” he said. said Dr. Robert M. Califf, commissioner of the agency, in a statement. . “The agency has devoted significant resources to reviewing products from companies that account for most of the U.S. market. We recognize that these are an important part of the products available and many have played a disproportionate role in increasing youth vaporization.” .
The FDA measure is part of a comprehensive effort to redo the rules for smoking and vaporizing products and reduce diseases and deaths caused by highly addictive nicotine-containing inhalable products.
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 go for a ban on menthol-flavored cigarettes.
The lawsuit against Juul, in particular, is part of the agency’s newer regulatory mission, which is to determine which e-cigarettes are for sale or proposed for sale will be permanently allowed on U.S. shelves now that the FDA has authority over electronic cigarettes.
But it could be years before these proposals come into force if they can withstand fierce resistance from the powerful tobacco lobby, anti-regulatory groups and the vaping industry.
Juul said he would 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 a long time ago,” said Erika Sward, vice president of national defense for the American Lung Association. “Juul’s campaign to target and engage children in tobacco has taken too long.”
A statement from the American Steam Manufacturing Association, a trade group in the industry, hinted at the struggle ahead.
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“Measured in lost lives and destroyed potential, the FDA’s startling indifference to Americans and its right to switch to the much safer alternative to vaping will surely be ranked as one of the biggest episodes of regulatory malpractice in history. of the United States, “said Amanda Wheeler, president of the association. , said in a statement.
The agency’s ruling limited a nearly two-year review of the data Juul had submitted to trying to obtain permission to continue selling its tobacco and menthol-flavored products in the United States. The application required the company to demonstrate the safety of its devices and whether they were suitable for the protection of public health.
Juul, in particular, had been the 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 product using attractive young models and flavors such as fresh cucumber and creme brulee that critics said attracted to underage users.
In April 2018, the FDA announced a crackdown on the sale of these products, including Juul, to people under the age of 21.
Use among young people had skyrocketed. In 2017, 19 percent of 12th graders, 16 percent of 10th graders, and 8 percent of eighth graders reported using nicotine over the past year, according to a Monitoring the Future survey. conducted by the National Institute on Drug Abuse.
For his part, Juul routinely denied that he was targeting young people, but was prosecuted in lawsuits and by state attorneys general, with some cases resulting in millions of dollars in damages to the company. In a deal in 2021, Juul agreed to pay $ 40 million to North Carolina, which represented several parts of the state that the company had helped attract minors to vaporize. More than a dozen more states have lawsuits and investigations that are still pending.
Dr. Scott Gottlieb, the former FDA commissioner, explained on Wednesday his approval of the measure against Juul, which was first reported in The Wall Street Journal.
The news is a little less important to the industry now than it would have been in Juul’s heyday, given the company’s falling market share. Once the dominant player with 75 percent of the market, Juul now has a considerably smaller market share.
But the news hits Altria, formerly known as Philip Morris and Marlboro maker, which in December 2018 bought 35 percent of Juul for $ 12.8 billion. Due to lower market share and adverse regulatory winds, 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 just over 1,000, most in the United States, but some in Canada, Britain, and other countries. Its revenue has dropped to $ 1.3 billion in 2021, below $ 2 billion in 2019, with nearly 95 percent of U.S. sales.
Nicotine itself is not the cause of lung cancer and other deadly diseases of smoking, but the drug is extremely addictive, making it difficult for smokers to quit smoking despite the health risks. The adolescent brain is especially susceptible to nicotine, which can affect memory, concentration, learning, and self-control.
Electronic cigarette companies have already said they will challenge the decision in court.
Electronic cigarettes have been sold in the U.S. market for more than a decade without formal FDA approval, because they were not under the agency’s regulatory competence 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 smoking option.
The agency has been reviewing all kinds of vaping products for more than a year, some in development, and companies waiting for a decision have been able to continue selling some products.
The FDA recently said it had so far rejected more than a million applications whose products it considered 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 vaporization product manufactured by a large cigarette company.
In its review of the devices, which 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 possible cancer-causing chemicals were much lower in the blood and urine of people who used the Vuse device compared to smokers.
However, California law required RJ Reynolds to warn Vuse buyers about exposure to glycidol, which “the state knows causes cancer,” according to 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 make the transition from traditional cigarettes to low-risk ones. young and new users.
But the agency disappointed some prominent lawmakers and advocacy groups when it recently announced that it could not finish reviewing all 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 U.S. market could be counterproductive.
Clifford Douglas, director of the University of Michigan School of Public Health’s Tobacco Research Network, said many experts had come to see Juul, along with other e-cigarettes, as valuable tools to help smokers adults to quit conventional cigarettes.
“These are exit ramps that can offer smokers an alternative to fuels, which are responsible for virtually all tobacco-related deaths,” he said. “But now this exit ramp is being narrowed and paved, putting millions of adult lives at stake. Juul is expected to be able to respond effectively to the demand for more scientific analysis, make any adjustments. and to re-offer your products to adults who need it. “
Christina Jewett and Sheila Kaplan contributed to the report.