U.S. FDA halts gross sales of Juul e-cigarettes in nicotine crackdown

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U.S. FDA halts gross sales of Juul e-cigarettes in nicotine crackdown
U.S. FDA halts gross sales of Juul e-cigarettes in nicotine crackdown

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 assessment of scientific and public well being knowledge supplied by the corporate, the company stated the apps “lack sufficient evidence” to indicate that promoting the merchandise could be acceptable for public well being.

Among the findings raised considerations resulting from inadequate and conflicting knowledge, 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 e-cigarette manufacturers, together with British American Tobacco Plc (BATS.L) Vuse and Imperial Manufacturers Plc (IMB.L) Blu, needed to meet the September 2020 deadline for submissions to the FDA ( FDA) displaying that the merchandise supplied a web 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 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 an announcement concerning Thursday.

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

“Without the data necessary to identify relevant health risks, the FDA would issue these marketing denial orders,” stated Michelle Mittal, performing 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 corporations to adjust to federal tips.

Teenagers’ use of e-cigarettes rose with the rise in Juul’s recognition 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 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 different methods to assist individuals give up smoking in an effort to cut 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 enchantment the choice.

“This will then allow Juul products to remain in the market while 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 Avenue Journal first reported that the U.S. Meals and Drug Administration was making ready to ban Juul e-cigarettes in america.

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

Our Requirements: Thomson Reuters Belief Ideas.

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