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

An e-cigarette gadget made by Juul is seen on this illustrative photograph taken on September 14, 2018. REUTERS/Mike Blake/Illustration

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(Reuters) – The Meals and Drug Administration on Thursday banned Juul Labs Inc from promoting its e-cigarettes in the US, doubtlessly dealing a deadly blow to the once-high-flying San Francisco firm.

After a virtually two-year assessment of scientific and public well being information offered by the corporate, the company stated the apps “lack enough proof” to indicate that promoting the merchandise could be applicable for public well being.

Among the findings raised considerations on account of inadequate and conflicting information, together with whether or not doubtlessly dangerous chemical compounds may leach from Juul’s capsules, the company stated.

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Juul and different e-cigarette manufacturers, together with British American Tobacco Plc’s (BATS.L) Vuse and Imperial Manufacturers Plc’s (IMB.L) Blue needed to meet a September 2020 deadline for submissions to the Meals and Drug Administration to indicate that the merchandise present a internet public well being profit.

The company needed to decide whether or not every product was efficient in quitting people who smoke, and in that case, whether or not the advantages to people who smoke outweighed the potential well being harms of latest e-cigarette customers — together with teenagers — who had by no means smoked.

The Commissioner of the Meals and Drug Administration, Robert Califf, stated in a press release concerning Thursday.

The US Meals and Drug Administration stated Juul didn’t present proof that the merchandise met the company’s requirements and raised “essential questions”.

“With out the information essential to establish related well being dangers, the FDA would difficulty these advertising denial orders,” stated Michelle Mittal, appearing director of the FDA’s Heart for Tobacco Merchandise.

Juul didn’t reply to a Reuters request for remark.

The corporate has sought approval for its vaping gadget and tobacco- and menthol-flavored pods containing nicotine concentrations of 5% and three%.

E-cigarette makers have been promoting merchandise in the US for years with out formal permission from the Meals and Drug Administration, as regulators have delayed deadlines for firms to adjust to federal tips.

Teenagers’ use of e-cigarettes rose with the rise in Juul’s reputation in 2017 and 2018. E-cigarette use amongst highschool college students grew from 11.7% in 2017 to 27.5% in 2019, earlier than declining to 11.3% in 2021, the survey confirmed.

In 2020, the US Meals and Drug Administration (FDA) banned all flavors besides tobacco and menthol for e-cigarettes that include a cartridge similar to Juul. The corporate pulled all different flavors together with mint and mango in late 2019, after regulatory scrutiny and protests from anti-smoking advocates.

The Biden administration has been taking a look at different methods to assist individuals stop smoking in an effort to scale back preventable most cancers deaths. It stated this week that it plans to suggest a rule that units a most stage of nicotine in cigarettes and different off-the-shelf tobacco merchandise to make them much less addictive. Learn extra

Some analysts stated Juul would possibly attraction the choice.

“This may then enable Juul merchandise to stay available in the market whereas this demand continues,” stated Owen Bennett, an analyst at Jefferies, including that the method may take greater than a 12 months.

Altria Group Inc (MO.N)which owns 35% of Juul’s shares, closed down 9% Wednesday after the Wall Road Journal first reported that the Meals and Drug Administration was getting ready to ban Juul’s e-cigarettes in the US.

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Further reporting by Chris Kirkham, Aishwarya Venugopal and Praveen Paramasivam in Bengaluru; Enhancing by Invoice Bercrot and Sriraj Kalovella

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