The Food and Drug Administration announced Thursday that it will ban the sale of Juul e-cigarettes in the United States
The decision is part of the vaping industry agency’s broader review after years of pressure from politicians and public health groups to regulate the segment as strictly as other tobacco products after vaping became more common among high school students.
Juul requested FDA approval for his tobacco and menthol-flavored vaporizer and pods, which are available in 5% and 3% nicotine concentrations. The agency has already banned vape products with mint and fruit in 2020 in an effort to reduce teen vaping, leaving only tobacco and menthol-flavored products on the market.
Juul’s decision to ban the sale of these remaining products is a blow to the company. Juul’s international expansion efforts have been hampered by regulations and a lack of consumer interest. The US remains its largest market.
The FDA said Juul’s applications provided insufficient or conflicting data on the potential risks of using the company’s products, including whether potentially harmful chemicals could come out of Juul’s pods.
“Without the data needed to determine the relevant health risks, the FDA issues these marketing denial orders,” Michele Mital, acting director of the FDA’s Tobacco Products Center, said in a statement.
The FDA said it did not see any clinical information suggesting an immediate risk for using Juul products. However, as a result of Thursday’s decision, Juul must stop selling and distributing its products in the United States. The FDA cannot enforce the possession or use of the company’s electronic cigarettes by consumers.
A Juul representative did not immediately respond to a request for comment from CNBC.
In FDA decisions over the past year, rival e-cigarette manufacturers British American Tobacco and NJOY obtained approval for their e-cigarettes, although the FDA rejected some of the flavored products presented by the companies. The agency said it approved the two companies’ tobacco-flavored products because they showed they could benefit adult smokers and outweighed the risk to underage users.
The FDA has also been making great strides in reducing nicotine use in traditional tobacco products. On Tuesday, the agency said it plans to require tobacco companies to reduce the nicotine content of cigarettes to minimally addictive or non-addictive levels.
In 2019, federal data found that more than 1 in 4 high school students had used an e-cigarette in the past 30 days, up from 11.7% just two years earlier. An outbreak of vaping-related lung disease in 2020 only raised concerns about e-cigarettes.
Last year, use among high school students fell to 11.3% amid increased regulatory control and the coronavirus pandemic.
Juul had been the leader in the e-cigarette market since 2018, according to Euromonitor International. As of 2020, the company had a share of 54.7% of the U.S. electronic steam market of $ 9.38 billion.
Electronic cigarettes provide users with nicotine by vaporizing the liquid in cartridges or pods. Nicotine is the ingredient that makes tobacco addictive and can have other negative health effects. However, e-cigarette makers have argued that their products can deliver nicotine to addicted adult smokers without the health risks of burning tobacco.
Marlboro owner Altria bought a 35% stake in Juul for $ 12.8 billion at the end of 2018. However, Altria has reduced the value of the investment as Juul and the wider e-cigarette industry go see involved in controversies. In March this year, Altria valued its stake at $ 1.6 billion, one-eighth of its original investment, and Juul itself at less than $ 5 billion.
The FDA’s decision will likely also hurt Juul’s defense in U.S. courts, as it faces lawsuits from a dozen states and Washington over allegations that it marketed its products to minors and played a major role. in the vaporization epidemic. It has already been agreed with North Carolina for $ 40 million and the state of Washington for $ 22.5 million.
The FDA gained the power to regulate new tobacco products in 2009. Over the past decade, thousands of e-cigarettes have appeared on store shelves without any approval from the agency, which has allowed the sale of ‘these products as the standards for the growing industry were gradually introduced. .
A court ruling created a timetable for the FDA’s approval process for tobacco product applications prior to the company’s marketing of e-cigarettes. The agency is reviewing approximately 6.5 million applications from about 500 companies and has already denied nearly a million applications from smaller players such as JD Nova Group and Great American Vapes for their flavored spray products. .
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