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 per cent in 2019 from 11.7 per cent in 2017, but fell to 11.3 per cent in 2021, a federal survey showed.
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 Centre for Tobacco Products, said.
Juul, partly owned by tobacco giant Altria Group Inc, had sought approval for its vaping device and tobacco and menthol-flavoured pods that had nicotine content of 5 per cent and 3 per cent.
E-cigarette makers have been selling products in the US for years without being officially authorised by the FDA, as regulators repeatedly delayed deadlines for the companies to comply with federal guidelines.
Thursday’s decision was cheered by public health groups, who had long warned that e-cigarettes were getting a new generation of teenagers hooked on nicotine after major strides in reducing youth cigarette use.
In 2020, the FDA banned all flavours except tobacco and menthol for cartridge-based e-cigarettes such as Juul. The company pulled all other flavours 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 cut down on preventable cancer deaths. It said this week it plans to propose a rule establishing a maximum nicotine level in cigarettes and other finished tobacco products to make them less addictive.
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 after BAT’s Vuse Solo items became the first-ever vapor products to receive the agency’s clearance in October.
BAT overtook Juul as the leader of the U.S. vaping market in April, according to data Nielsen provided to brokerage JP Morgan. Juul led the market in 2021, with a 38 per cent share of the $US11 billion ($16 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 marketing of e-cigarettes to minors,” Morningstar analyst Philip Gorham said.
Get a note directly from our foreign correspondents on what’s making headlines around the world. Sign up for the weekly What in the World newsletter here.