US Bans Sale of Juul E-Cigarettes, Company Will Seek Enforcement Suspension

June 23 (Reuters) – Sales of Juul e-cigarettes were blocked on Thursday by the U.S. Food and Drug Administration (FDA), in a blow to the once-high-flying firm whose products have been linked to a rise in vaping among teens

The agency said the applications “lacked sufficient evidence” 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 raised concerns due to insufficient and conflicting data, including whether potentially harmful chemicals could leak from Juul pods, the FDA said.

Sign up now for FREE unlimited access to Reuters.com

“We respectfully disagree with the FDA’s findings…we intend to seek a stay and are exploring all of our options under FDA law and regulations, including appealing the decision and collaborating with our regulator.” said Joe Murillo, Juul’s director of regulation.

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

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

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

BAT’s Vuse Solo was the first e-cigarette to gain authorization from the agency in October. read more

“The agency has devoted significant resources to reviewing the products of companies that represent the majority of the US market. We recognize … that many have played a disproportionate role in the rise of youth vaping,” the FDA commissioner said. , Robert Califf, in a statement.

Teen e-cigarette use increased with the rise in popularity of Juul in 2017 and 2018. E-cigarette use among high school students grew from 11.7% in 2017 to 27.5% in 2019, but fell to 11. 3% in 2021, a federal survey showed.

Juul did not provide evidence to show that the products met its standards and that raised “important questions,” the FDA said, but added that it has so far received no clinical information suggesting an immediate danger related to the device or the capsules.

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

Shares in tobacco giant Altria Group Inc. (MON.N)which partly owns Juul, has lost about 7%, or nearly $6 billion in market value, since Wednesday, when the Wall Street Journal first reported that the FDA was preparing to mandate that cigarettes Juul electronics were recalled.

‘FDA HAWK’

Juul had sought approval for its tobacco- and menthol-flavored vaping device and pods that had 5% and 3% nicotine content.

E-cigarette makers have been selling products in the United States for years without official FDA clearance, as regulators repeatedly delayed deadlines for companies to comply with federal guidelines.

Thursday’s decision was applauded by public health groups, which had long warned that e-cigarettes were hooking a new generation of teens on nicotine after major strides in reducing youth smoking.

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

The Biden administration has been looking at other ways to help people quit smoking in an effort to reduce preventable cancer deaths. He said this week that he plans to propose a rule setting a maximum level of nicotine in cigarettes and other finished tobacco products to make them less addictive. read more

The surprise decision was a sign of a tougher FDA, some analysts said, as some Juul products were expected to be approved, following the agency’s authorization of several other e-cigarette products.

BAT overtook Juul as the US vaping market leader in April, according to data Nielsen provided to brokerage 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 in limiting the marketing of e-cigarettes to minors,” said Morningstar analyst Philip Gorham.

Sign up now for FREE unlimited access to Reuters.com

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

Our standards: The Thomson Reuters Trust Principles.

Leave a Comment