US FDA halts Juul e-cigarette sales in nicotine crackdown

On this illustration taken on September 14, 2018, an e-cigarette machine manufactured by JUUL is proven. REUTERS/Mike Blake/Illustration

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June 23 (Reuters) – The Meals and Drug Administration (FDA) on Thursday blocked Juul Labs Inc from promoting its e-cigarettes in the US, which might deal a deadly blow to the San Francisco firm that after had excessive flights.

After a virtually two-year evaluation of scientific and public well being information submitted by the corporate, the company mentioned the purposes “lacked adequate proof” to indicate that the sale of the merchandise can be applicable for public well being.

A few of the findings raised considerations resulting from inadequate and conflicting information, together with whether or not doubtlessly dangerous chemical substances might leak from Juul pods, the company mentioned.

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Juul and different e-cigarette manufacturers, together with British American Tobacco Plc (BAT.L) Vuse and Imperial Manufacturers Plc (IMB.L) Blu, needed to meet a September 2020 deadline to submit purposes to the FDA exhibiting that the merchandise supplied a web public well being profit.

The company needed to decide whether or not every product was efficient in getting people who smoke to stop and, if that’s the case, whether or not the advantages to people who smoke outweighed the potential hurt to the well being of recent e-cigarette customers, together with teenagers, who they by no means smoked.

“The company has devoted vital assets to reviewing the merchandise of corporations that symbolize nearly all of the US market. We acknowledge … that many have performed a disproportionate function within the rise of youth vaping,” the FDA commissioner mentioned. , Robert Califf, in an announcement Thursday.

Juul supplied no proof to indicate the merchandise met company requirements and raised “vital questions,” the FDA mentioned.

“With out the information needed to find out the related well being dangers, the FDA is issuing these advertising and marketing denial orders,” mentioned Michele Mital, appearing director of the FDA’s Heart for Tobacco Merchandise.

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

The corporate had sought approval for its tobacco- and menthol-flavored vaping machine and pods that had nicotine concentrations of 5% and three%.

E-cigarette makers have been promoting merchandise in the US for years with out official FDA clearance, as regulators repeatedly delayed deadlines for corporations to adjust to federal tips.

E-cigarette use amongst teenagers elevated with the rise in recognition of Juul in 2017 and 2018. E-cigarette use amongst highschool college students elevated from 11.7% in 2017 to 27.5% in 2019, earlier than fall once more to 11.3% in 2021, based on a federal examine. confirmed the survey.

In 2020, the FDA banned all flavors besides tobacco and menthol for cartridge-based e-cigarettes like Juul. The corporate phased out all different flavors, together with mint and mango, in late 2019 following 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 cut back preventable most cancers deaths. He mentioned this week that he plans to suggest a rule setting a most degree of nicotine in cigarettes and different completed tobacco merchandise to make them much less addictive. learn extra

Some analysts have mentioned that Juul might attraction the choice.

“This is able to enable Juul merchandise to stay available on the market whereas this attraction is ongoing,” Jefferies analyst Owen Bennett mentioned, including that the method might take greater than a yr.

Altria Group Inc. (MON)which has a 35% stake in Juul, closed down 9% on Wednesday after the Wall Road Journal first reported that the FDA was getting ready to ban Juul e-cigarettes in the US.

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Reporting from Chris Kirkham and Aishwarya Venugopal and Praveen Paramasivam in Bengaluru; Edited by Invoice Berkrot and Sriraj Kalluvila

Our requirements: The Thomson Reuters Belief Ideas.

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