US bans Juul e-cigarette sales, company seeks to maintain enforcement

Jun 23 (Reuters) – Sales of Juul e-cigarettes were blocked by the U.S. Food and Drug Administration on Thursday, in a major blow to the once successful company whose products are linked to a surge in e-cigarette consumption. among teenagers.

The agency said the claims “lacked sufficient evidence” to show that selling the products would be appropriate for public health, following 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 capsules, the FDA said.

Register now for FREE unlimited access to Reuters.com

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

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

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

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 health harms of new e-cigarette users, including teenagers, who had never smoked.

BAT’s Vuse Solo was the first e-cigarette to obtain the agency’s authorization in October. see More information

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

E-cigarette use by teens increased with the rise in popularity of Juul in 2017 and 2018. Its use among high school students grew to 27.5% in 2019 from 11.7% in 2017, but dropped to 11.3 % in 2021, a federal survey showed.

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

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

Shares in 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 reported on Wednesday. first time the FDA was getting ready to order the e-. cigarettes off the market.

‘FDA HAWKISH’

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

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

Thursday’s decision was applauded by public health groups, who had long warned that e-cigarettes were making a new generation of teenagers addicted to nicotine after major strides in reducing cigarette use among young people.

In 2020, the FDA banned all flavors except tobacco and menthol for cartridge-based e-cigarettes such as Juul. The company dropped 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. The company said this week that it plans to propose a rule setting a maximum level of nicotine in cigarettes and other finished tobacco products to make them less addictive. see More information

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

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

“The only opportunity for Juul to create value may be in international markets, but we expect other regulators to take a similar stance to the FDA in limiting the sale of e-cigarettes to minors,” said Philip Gorham, an analyst at Morningstar.

Register 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; Editing by Bill Berkrot, Sriraj Kalluvila and Shounak Dasgupta

Our Standards: The Thomson Reuters Trust Principles.

Leave a Reply

%d bloggers like this: