Sales of Juul e-cigarettes were jam by the U.S. Food and Drug Administration; in a major blow to the once high-flying firm whose products have been tie to a surge in teenage vaping.
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.
Juul and other e-cigarette brands, including British American Tobacco Plc’s (BATS.L) Vuse and Imperial Brands Plc’s (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.
The heath 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 damage to new e-cigarette users – including teenagers – who never smoked.
Teenage use of e-cigarettes surged 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 fell to 11.3% in 2021.
‘HAWKISH FDA’
Juul, partly owned by tobacco giant Altria Group Inc (MO.N), had sought approval for its vaping device and tobacco and menthol flavored pods that had nicotine content of 5% and 3%.
E-cigarette makers have been selling products in the US for years without being officially authorize by the FDA; as regulators repeatedly delayed deadlines for the companies to comply with federal guidelines.
In 2020, the FDA banned all flavors except tobacco and menthol for cartridge-based e-cigarettes such as Juul. The company pulled all other flavors including mint and mango in late 2019.
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.
