June 23 (Reuters) – Sales of Juul e-cigarettes were blocked by the U.S. Food and Drug Administration on Thursday, dealing a blow to the once high-flying company whose products have been linked to a rise in vaping in adolescents.
The agency said the claims “lack sufficient evidence” to show that the sale of the products would be appropriate for public health, following a nearly two-year review of data provided by the company.
Some of the findings raised concerns due to insufficient and conflicting data, including whether potentially harmful chemicals could leak from Juul pods, the FDA said.
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“We respectfully disagree with the FDA’s findings… intend to seek a stay and are exploring all of our options under FDA regulations and the law, including appealing the decision and engaging with our regulator. “said Joe Murillo, chief regulatory officer at Juul.
The company said it had adequately characterized the toxicological profile of its products and that the data met the legal standard of being “appropriate for the protection of public health”.
Juul and other e-cigarette brands, including British American Tobacco’s Vuse (BATS.L) and Imperial Brands’ Blu (IMB.L), had to meet a September 2020 deadline to file claims with the FDA showing that the products provided a net benefit to public health.
The health regulator had to judge whether each product was effective in getting smokers to quit and, if so, whether the benefits to smokers outweighed the potential harm to the health of new users of the product. electronic cigarettes, including teenagers, who have never smoked.
BAT’s Vuse Solo was the first e-cigarette to gain agency clearance in October. Read more
“The agency has devoted significant resources to reviewing products from companies that represent the bulk of the U.S. market. We recognize … that many have played a disproportionate role in driving the rise in youth vaping,” said the FDA Commissioner Robert Califf in a statement.
E-cigarette use by teens increased with the rise in popularity of Juul in 2017 and 2018. Its use among high school students increased from 11.7% in 2017 to 27.5% in 2019, but fell to 11, 3% in 2021, according to a federal survey.
Juul did not provide evidence to show the products met its standards and that raised “significant questions”, the FDA said, but added that it had so far received no clinical information suggesting an immediate danger related to the device or the pods.
“Without the data necessary to determine the relevant health risks, the FDA issues these marketing denial orders,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products.
Shares of tobacco giant Altria Group Inc (MO.N), which partly owns Juul, have fallen about 7%, or nearly $6 billion in market value, since Wednesday, when the Wall Street Journal reported for the first time the FDA was preparing to order e-cigarettes off the market.
Juul had sought approval for its vaping device and tobacco-menthol flavored pods that had 5% and 3% nicotine content.
E-cigarette makers have been selling products in the United States for years without being officially licensed by the FDA, as regulators have repeatedly delayed deadlines for companies to comply with federal guidelines.
Thursday’s decision was applauded by public health groups, who had long warned that e-cigarettes were making a new generation of teenagers addicted to nicotine after major strides in reducing cigarette smoking among young people.
In 2020, the FDA banned all flavors except tobacco and menthol for cartridge e-cigarettes such as Juul. The company retired all other flavors, including mint and mango, in late 2019.
The Biden administration has been looking for other ways to help people quit smoking in an effort to reduce preventable cancer deaths. It announced this week its intention to propose a rule setting a maximum level of nicotine in cigarettes and other finished tobacco products to make them less addictive. Read more
The surprise decision was an indication of a more hawkish FDA, some analysts said, as some Juul products were expected to be approved, after the agency cleared several other e-cigarette products.
BAT overtook Juul as the U.S. vaping market leader in April, according to data Nielsen provided to brokerage firm JP Morgan. Juul led the market in 2021, with a 38% share of the $11 billion retail market.
“Juul’s only opportunity to create value may be in international markets, but we expect other regulators to take a similar stance to the FDA in limiting the marketing of e-cigarettes to minors,” he said. said Morningstar analyst Philip Gorham.
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Reporting by Chris Kirkham and Aishwarya Venugopal; Additional reporting by Praveen Paramasivam, Ananya Mariam Rajesh and Uday Sampath in Bengaluru; Editing by Bill Berkrot, Sriraj Kalluvila and Shounak Dasgupta
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