The US Food and Drug Administration has suspended sales of JUUL e-cigarettes as part of the anti-nicotine campaign

June 23 (Reuters) – The Food and Drug Administration on Thursday banned Juul Labs Inc from selling its e-cigarettes in the United States, potentially dealing a fatal blow to the once-high-flying San Francisco company.

After a nearly two-year review of scientific and public health data provided by the company, the agency said the apps “lack sufficient evidence” to show that selling the products would be appropriate for public health.

Some of the findings have raised concerns due to insufficient and conflicting data, including whether potentially harmful chemicals could leach from Juul’s capsules, the agency said.

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Juul and other electronic cigarette brands, including British American Tobacco Plc’s (BATS.L) Vuse and Imperial Brands Plc’s (IMB.L) Blue had to meet the September 2020 deadline for submissions to the Food and Drug Administration to show that the products provide a net public health benefit.

The agency had to determine whether each product was effective in quitting smokers and, if so, whether the benefits to smokers outweighed the potential health harms of new e-cigarette users — including teens — who had never smoked.

Robert Califf, commissioner of the U.S. Food and Drug Administration, said in a statement regarding Thursday.

The US Food and Drug Administration said Juul did not provide evidence that the products met the agency’s standards and raised “important questions”.

“Without the data necessary to identify relevant health risks, the FDA would issue these marketing denial orders,” said Michelle Mittal, acting director of the FDA’s Center for Tobacco Products.

Juul did not respond to a Reuters request for comment.

The company has sought approval for its vaping device and tobacco- and menthol-flavored pods containing nicotine concentrations of 5% and 3%.

E-cigarette makers have been selling products in the United States for years without formal permission from the Food and Drug Administration, as regulators have delayed deadlines for companies to comply with federal guidelines.

Teens’ use of e-cigarettes rose with the increase in Juul’s popularity in 2017 and 2018. E-cigarette use among high school students grew from 11.7% in 2017 to 27.5% in 2019, before declining to 11.3% in 2021, the survey showed.

In 2020, the US Food and Drug Administration (FDA) banned all flavors except tobacco and menthol for e-cigarettes that contain a cartridge such as Juul. The company pulled all other flavors including mint and mango in late 2019, after regulatory scrutiny and protests from anti-smoking advocates.

The Biden administration has been looking at other ways to help people quit smoking in an effort to reduce preventable cancer deaths. It said this week that it plans to propose a rule that sets a maximum level of nicotine in cigarettes and other off-the-shelf tobacco products to make them less addictive. Read more

Some analysts said Juul might appeal the decision.

“This will then allow Juul products to remain in the market while this demand continues,” said Owen Bennett, an analyst at Jefferies, adding that the process could take more than a year.

Altria Group Inc (MO.N)which owns 35% of Juul’s shares, closed 9% lower Wednesday after the Wall Street Journal first reported that the Food and Drug Administration was preparing to ban Juul’s e-cigarettes in the United States.

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Additional reporting by Chris Kirkham, Aishwarya Venugopal and Praveen Paramasivam in Bengaluru; Editing by Bill Bercrot and Sriraj Kalovella

Our criteria: Thomson Reuters Trust Principles.

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