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The United States has banned the sale of Juul e-cigarettes to demand termination

The United States has banned the sale of Juul e-cigarettes to demand termination
Written by boustamohamed31

June 23 (Reuters) – Sales of Juul e-cigarettes were blocked by the US Food and Drug Administration on Thursday, a major blow to the former company, whose products were linked to the rise of teen vaping.

The agency said the apps “lack enough evidence” to show that selling the products would be good for public health, after nearly two years of reviewing the data provided by the company.

Some of the findings have raised concerns about insufficient and conflicting data, including whether potentially harmful chemicals could come out of Juul pods, the FDA said.

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“We respectfully disagree with the FDA’s findings … we intend to seek a stay and explore all our options under FDA and law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer in July. .

The company stated that it had properly characterized the toxicological profile of its products and that the data met the legal standard of “suitable for public health protection”.

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 apply to the FDA, showing that the products provide a net benefit to public health.

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

BAT’s Vuse Solo was the first e-cigarette to be approved by the agency in October. Read more

“The agency has allocated significant resources to review products from companies that make up the majority of the US market. We acknowledge that … many of them have played a disproportionate role in the growth of young vapers, “said FDA Commissioner Robert Calif in a statement.

The use of e-cigarettes by teenagers increased with the increase in popularity in July in 2017 and 2018. Its use among high school students increased to 27.5% in 2019 from 11.7% in 2017, but fell to 11.3% in 2021, a federal study shows.

Juul did not provide evidence to show that the products met its standards, and this raised “significant issues,” the FDA said, but added that it had not yet received clinical information suggesting an immediate hazard associated with the device or capsules.

“Without the data needed to determine the relevant health risks, the FDA issues these marketing denial orders,” said Michel Mittal, acting director of the FDA’s Tobacco Center.

Shares of tobacco giant Altria Group Inc. (MO.S.)which owns part of 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 order Juul’s e-cigarettes off-market.

HAWKISH FDA

Juul has sought approval for its vaping device and tobacco and menthol flavored pods, which have nicotine contents of 5% and 3%.

Manufacturers of e-cigarettes have been selling products in the United States for years without being officially authorized by the FDA, as regulators repeatedly delay deadlines for companies to comply with federal guidelines.

Thursday’s decision was welcomed by public health groups, who have long warned that e-cigarettes are attracting a new generation of teenagers to nicotine after major strides in reducing cigarette use among young people.

In 2020, the FDA banned all flavors except tobacco and menthol for e-cigarettes based on cartridges such as Juul. The company withdrew all other flavors, including mint and mango at the end of 2019.

The Biden administration is looking for other ways to help people quit smoking in an effort to reduce preventable cancer deaths. This week, the company said it plans to propose a rule to set maximum levels of nicotine in cigarettes and other finished tobacco products to make them less addictive. Read more

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

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

“The only way for Juul to create value may be in international markets, but we expect other regulators to take a similar position from the FDA in restricting e-cigarette marketing to minors,” said Morningstar analyst Philip Gorham.

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Report by Chris Kirkam and Aishwarya Venugopal; Additional reports from Praveen Paramasivam, Ananya Mariam Rajesh and Uday Sampath in Bengaluru; Edited by Bill Bercrot, Sriraj Kaluvila and Shunak Dasgupta

Our standards: Thomson Reuters Trust Principles.

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