The United States bans sales of electronic cigarettes Juul, the company to strive to stay on implementation

June 23 (Reuters) – The U.S. Food and Drug Administration banned sales of Juul’s e-cigarettes on Thursday, in a major blow to the once-high-flying company whose products have been linked to a higher rate of teen vaping.

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

The Food and Drug Administration said some of the findings raised concerns due to insufficient and conflicting data, including whether potentially harmful chemicals could leach from Juul’s capsules.

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said Joe Morello, Juul’s chief regulatory officer.

The company said it had appropriately labeled the toxicological features of its products and that the data met the legal standard of being “appropriate to protect public health”.

Juul and other e-cigarette brands, including British American Tobacco (BATS.L) Vuse and Imperial Brands (IMB.L) Blu, had to meet a September 2020 deadline for submissions to the FDA. that show the products provide a net benefit to overall health.

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

BAT’s Vuse Solo was the first e-cigarette to receive clearance from the agency in October. Read more

“The agency has devoted significant resources to reviewing products from companies that represent most of the US market. We recognize that many of them have played a disproportionate role in the increased prevalence of youth vaping,” FDA Commissioner Robert Califf said in a statement.

Teens’ use of e-cigarettes rose with the rise in Juul’s popularity in 2017 and 2018. A federal survey showed that its use among high school students grew to 27.5% in 2019 from 11.7% in 2017, but dropped to 11.3% in 2021.

The FDA said Juul had not provided evidence that the products were meeting its standards and this raised “important questions,” but added that it had not yet received clinical information indicating an immediate risk associated with the device or pods.

“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.

Shares of tobacco giant Altria Group Inc (MO.N), which partially owns Juul, have lost about 7%, or nearly $6 billion in market value, since Wednesday when the Wall Street Journal first reported that the Food and Drug Administration She was preparing to order the Juul electronic company. Cigarettes are off the market.

“HAWKISH FDA”

Juul has sought approval for its vaping device and tobacco and menthol flavored pods containing 5% and 3% nicotine content.

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.

Thursday’s decision was welcomed by public health groups, which have long warned that e-cigarettes are making a new generation of teens addicted to nicotine after major strides in reducing cigarette use for young adults.

In 2020, the US Food and Drug Administration (FDA) banned all flavors except tobacco and menthol for cartridge-based e-cigarettes such as Juul. The company pulled all other flavors including mint and mango in late 2019.

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 the maximum nicotine level in cigarettes and other off-the-shelf tobacco products to make them less addictive. Read more

Some analysts said the surprise decision was indicative of a tougher Food and Drug Administration, as some Juul products were expected to be approved, following the agency’s approval of several other e-cigarette products.

BAT overtook Juul as the leader of the US vaping market in April, according to Nielsen data provided to brokerage JP Morgan. Juul led the market in 2021, with a 38% share of the $11 billion retail market.

“Juul’s only opportunity to create value may be in international markets, but we expect other regulators to take a similar position with the FDA to limit e-cigarette marketing to minors,” Morningstar analyst Philip Gorham said.

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(Report) by Chris Kirkham and Aishwarya Venugopal; Additional reporting by Praveen Paramasivam, Ananya Maryam Rajesh and Uday Sampath in Bengaluru. Editing by Bill Bercrot, Sriraj Kalovila and Shunak Dasgupta

Our Standards: Thomson Reuters Trust Principles.

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