US bans sale of Juul e-cigarettes, company tries to keep enforcement going

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 are linked to a rise in vaping among teenagers in the United States were connected.

The agency said the applications “lacked sufficient evidence” to show the public health products would be appropriate for sale after reviewing data provided by the company for nearly two years.

Some of the results raised concerns due to insufficient and conflicting data, including whether potentially harmful chemicals could be leaking from the Juul capsules, the FDA said.

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“We respectfully disagree with the FDA’s findings… intend to request a stay and are evaluating all of our options in accordance with FDA rules and law, including appealing the decision and cooperating with our regulator,” said Joe Murillo , Chief Regulatory Officer at July.

The company said it adequately characterized the toxicological profile of its products and the data met the legal standard of being “appropriate to protect public health”.

Juul and other e-cigarette brands, including British American Tobacco’s Vuse (BATS.L) and Imperial Brands’ Blu (IMB.L), had to meet a September 2020 deadline to submit applications to the FDA showing that the Products provide a net benefit Healthcare.

The health agency had to assess whether each product was effective in getting smokers to quit, and if so, whether the benefits to smokers outweighed the potential health harms to new e-cigarette users, including teens who had never smoked.

BAT’s Vuse Solo was the first e-cigarette to receive agency approval in October. Continue reading

“The agency has allocated significant resources to review products from companies that make up most of the US market. We recognize that many have played a disproportionate role in the rise in youth vaping,” FDA Commissioner Robert Califf said in a statement.

Teenage e-cigarette use surged in 2017 and 2018 with the rise in popularity of Juul. Usage among high school students increased from 11.7% in 2017 to 27.5% in 2019, but fell to 11.3% in 2021, a federal survey found.

Juul failed to provide evidence that the products met its standards, and that raised “significant questions,” the FDA said, adding that it has not received any clinical information suggesting an imminent danger associated with the virus connected to the device or the pods.

“Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders,” said Michele Mital, acting director of the FDA’s Tobacco Products Center.

Shares in tobacco giant Altria Group Inc (MO.N), which partly owns Juul, have been down since Wednesday, when the Wall Street Journal first reported that the FDA had withdrawn orders for Juul’s e-cigarettes.

‘HAWKISH FDA’

Juul had applied for approval for its vape device and its tobacco and menthol flavored capsules with 5% and 3% nicotine levels.

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

Thursday’s decision was hailed by public health groups, which had long warned that e-cigarettes would addict a new generation of teenagers to nicotine, following major strides in reducing teenage cigarette consumption.

In 2020, the FDA banned all flavors except tobacco and menthol for cartridge-based e-cigarettes like Juul. The company withdrew all other flavors, including mint and mango, in late 2019.

The Biden administration has been looking for other ways to help people quit smoking to reduce preventable cancer deaths. It said this week it plans to propose a rule setting a maximum nicotine content in cigarettes and other finished tobacco products to make them less addictive. Continue reading

The surprise decision was indicative of a more restrictive FDA, some analysts said, as some Juul products were expected to be approved after the agency cleared several other e-cigarette products.

According to data Nielsen provided to brokerage firm JP Morgan, BAT overtook Juul as the leader in the US vaping market in April. 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 in restricting the marketing of e-cigarettes to minors,” said Philip Gorham, analyst at Morningstar.

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

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