The United States bans the sale of Juul e-cigarettes, a company to seek enforcement

June 23 (Reuters) – Sales of Juul e-cigarettes were blocked by the US Food and Drug Administration on Thursday, in a major blow to the once high-flying company whose products have been linked to an increase in teen steaming.

The agency said the applications “lacked sufficient evidence”[ads1]; to show that the sale of the products would be appropriate for public health, after a nearly two-year review of data provided by the company.

Some of the findings were of concern because of insufficient and conflicting data, including whether potentially harmful chemicals could leak out of the Juul pods, the FDA said.

“We respectfully disagree with the FDA’s findings … intending to seek residency and investigate all of our options under FDA regulations and law, including appealing the decision and contacting our regulator,” said Joe Murillo, chief regulator at Juul.

The company said that it had correctly characterized the toxicological profile of the products, and that the data met the statutory standard of being “appropriate for the protection of public health”.

Juul and other e-cigarette brands, including British American Tobaccos (BATS.L) Vuse and Imperial Brands (IMB.L) Blu, had to meet a deadline of September 2020 to submit applications to the FDA showing that the products provided a net benefit to public health .

The health regulator had to consider whether each product was effective in getting smokers to quit, and if so, whether the benefits to smokers outweighed the potential health damage to new e-cigarette users, including teenagers, who never smoked.

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

“The agency has dedicated significant resources to evaluating products from the companies that make up most of the U.S. market. We recognize that … many have played a disproportionate role in the rise in juvenile delinquency,” FDA Commissioner Robert Califf said in a statement.

Teenage use of e-cigarettes increased with the increase in popularity of Juul in 2017 and 2018. The use among high school students grew to 27.5% in 2019 from 11.7% in 2017, but fell to 11.3% in 2021, showed a federal investigation.

Juul did not provide evidence to show that the products were up to their standards, and it raised “significant questions”, the FDA said, but added that so far it has not received clinical information indicating an immediate danger related to the device or capsules.

“Without the data needed to determine relevant health risks, the FDA issues these marketing rejection orders,” said Michele Mital, executive director of the FDA’s center for tobacco products.

Shares in tobacco giant Altria Group Inc (MO.N), which partly owns Juul, have lost around 7%, or nearly $ 6 billion in market value, since Wednesday when the Wall Street Journal first reported that the FDA was preparing to order Juul’s e-cigarettes out of market.

‘HAWKISH FDA’

Juul had applied for approval for his vaping unit and tobacco- and menthol-flavored pods that had a nicotine content of 5% and 3%.

E-cigarette manufacturers have been selling products in the United States for years without being officially authorized by the FDA, as regulators repeatedly delayed deadlines for companies to comply with federal guidelines.

Thursday’s decision was applauded by public health organizations, which had long warned that e-cigarettes got a new generation of teenagers addicted to nicotine after major advances in reducing adolescent cigarette use.

In 2020, the 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 at the end of 2019.

The Biden administration has looked at other ways to help people quit smoking in an effort to cut back on preventable cancer deaths. It said this week that it plans to propose a rule that establishes a maximum nicotine level in cigarettes and other finished tobacco products to make them less addictive. read more

The surprising decision was an indication of a more hawkish FDA, some analysts said, as some Juul products were expected to be approved, following the agency’s approval of several other e-cigarette products.

BAT took over Juul as head of the American vaping market in April, according to data Nielsen gave the brokerage house JP Morgan. Juul led the market in 2021, with a 38% share of the $ 11 billion retail market.

“The only opportunity for Juul to create value may be in international markets, but we expect other regulators to take a similar stance as the FDA when it comes to restricting the marketing of e-cigarettes to minors,” said Morningstar analyst Philip Gorham.

Reporting by Chris Kirkham and Aishwarya Venugopal; Additional reporting by Praveen Paramasivam, Ananya Mariam Rajesh and Uday Sampath in Bengaluru; Edited by Bill Berkrot, Sriraj Kalluvila and Shounak Dasgupta

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