US FDA suspends sales of Juul e-cigarettes

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The Food and Drug Administration on Thursday banned e-cigarette maker Juul Labs Inc from selling its nicotine products in the United States, in a move that could deal a death blow to the once-high-profile San Francisco company.

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After a nearly two-year review of the company’s scientific and public health data, the FDA said the filings “lacked sufficient evidence” regarding the products’ toxicological profile to demonstrate that their marketing would be appropriate to protect the public. health.

Juul, along with other e-cigarette brands including British American Tobacco Plc’s Vuse and Imperial Brands Plc’s Blu, had to meet the September 2020 deadline to file FDA filings showing its products provide a net public health benefit.

The agency had to evaluate whether each product was effective in getting smokers to quit, and if so, whether the benefits to smokers outweigh the potential health harms to new e-cigarette users, including teens who have never smoked.

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“We recognize that they make up a significant portion of the products available, and many of them have played a disproportionate role in the rise of youth vaping,” FDA Commissioner Robert Califf said Thursday.

Juul did not immediately respond to a Reuters request for comment.

Juul and other e-cigarette makers have been selling products in the United States for years without official FDA clearance as regulators have repeatedly delayed deadlines for e-cigarette companies to comply with federal regulations.

The use of e-cigarettes by teenagers has skyrocketed with the rise of Juul in 2017 and 2018.

E-cigarette use among high school students rose from 11.7% in 2017 to 27.5% in 2019 before falling to 11.3% in 2021, according to a federal survey.

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Researchers who conducted the survey for the US Centers for Disease Control and Prevention said the most recent youth e-cigarette data cannot be compared to previous years due to changes in how the survey was conducted during the COVID-19 pandemic.

In 2020, the FDA banned all flavors other than tobacco and menthol from cartridge e-cigarettes like Juul. At the end of 2019, the company phased out all other flavors, including mint and mango, after scrutiny by regulators and outrage from smoking advocates.

The Biden administration is looking for other ways to help people quit smoking to cut preventable cancer deaths. The company said this week that it plans to propose a rule setting maximum levels of nicotine in cigarettes and other finished tobacco products to make them less addictive.

Altria Group Inc, which owns a 35% stake in Juul, closed up 9% on Wednesday after the Wall Street Journal first reported, citing people familiar with the matter, that the FDA was preparing to order Juul to take its e-cigarettes off the market. .

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