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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June 23 (Reuters) – The Meals and Drug Administration on Thursday banned Juul Labs Inc from promoting its e-cigarettes in america, probably dealing a deadly blow to the once-high-flying San Francisco firm.

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

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

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Juul and different digital 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 point out that the merchandise present a web public well being profit.

The company needed to decide whether or not every product was efficient in quitting people who smoke, and if that’s the case, whether or not the advantages to people who smoke outweighed the potential well being harms of recent 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 relating to Thursday.

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

“With out the info essential to establish related well being dangers, the FDA would concern these advertising and marketing denial orders,” stated Michelle Mittal, appearing director of the FDA’s Middle for Tobacco Merchandise.

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

The corporate had requested 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 america 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 comprise a cartridge comparable 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 give up 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 degree of nicotine in cigarettes and different off-the-shelf tobacco merchandise to make them much less addictive. Learn extra

Some analysts stated Juul may attraction the choice.

“This may then permit Juul merchandise to stay out there whereas this demand continues,” stated Owen Bennett, an analyst at Jefferies, including that the method may take greater than a yr.

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 making ready to ban Juul’s e-cigarettes in america.

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

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