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U.S. bans sales of Juul e-cigarettes, company to seek stay on enforcement - Reuters

U.S. bans sales of Juul e-cigarettes, company to seek stay on enforcement - Reuters

U.S. bans sales of Juul e-cigarettes, company to seek stay on enforcement - Reuters
Jun 23, 2022 1 min, 44 secs

The agency said the applications "lacked sufficient evidence" to show that sale of the products would be appropriate for public health, following a nearly two-year-long 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 leach out of the Juul pods, the FDA said.

The company said it had appropriately characterized the toxicological profile of its products and that the data met the statutory standard of being "appropriate for the protection of the 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 a September 2020 deadline to file applications to the FDA showing the products provided a net benefit to public health.

Juul did not provide evidence to show the products were up to its standards and that raised "significant questions", the FDA said, but added it has so far not received clinical information to suggest an immediate hazard tied to the device or pods.

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

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

The surprise decision was an indication of a more hawkish FDA, some analysts said, as it was expected that some Juul products would be approved, following the agency's clearance of several other e-cigarette products.

vaping market in April, according to data Nielsen provided to brokerage J.P.

"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 marketing of e-cigarettes to minors," Morningstar analyst Philip Gorham said.

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