The Food and Drug Administration announced Thursday that it will ban the sale of Juul e-cigarettes in the United States.
Juul intends to stay in the decision and is exploring options such as appealing the decision and engaging with the FDA, Chief Regulatory Officer Joe Murillo said in a statement.
The ban is about the vaping industry, under long-standing 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. Part of an extensive FDA review.
Juul has sought approval from its distributors for its vaping device and tobacco and menthol-flavored pods available at 5% and 3% nicotine intensities. These flavors were not subject to the 2020 agency ban on mint and fruit flavored vaping products that are popular with teens.
Juul’s ban on the sale of these remaining products will have a major impact on the company. Juul’s international expansion efforts have been hampered by regulations and lack of consumer interest. The United States remains the largest market.
The FDA states that Juul’s applications lack or inconsistent data on potential risks of using the company’s products, such as whether potentially harmful chemicals can leak from the Juul pod. I did.
“If we don’t have the data needed to determine the associated health risks, the FDA has issued these marketing denial orders,” Michele Mittal, deputy director of the FDA’s Tobacco Product Center, said in a statement.
The FDA said it has not seen any clinical information suggesting that there is an imminent risk of using Juul products. Still, as a result of Thursday’s decision, Juul must immediately stop selling and distributing its products in the United States. The FDA may not force individual consumers to own or use the company’s e-cigarettes.
“We respectfully disagree with the FDA’s findings and decisions and continue to believe that we have provided sufficient information and data based on quality research to address all issues raised by the FDA. “Masu,” Juul’s Murillo said in a statement.
Last year’s FDA decision was to rival e-cigarette makers British American Tobacco The FDA rejected some of the flavored products submitted by the company, but NJOY received e-cigarette approval. The agency said it approved both companies’ tobacco flavored products because they proved that their tobacco flavored products could benefit adult smokers and outweigh the risks of minors.
The FDA is also making progress to reduce the use of nicotine in traditional tobacco products.On Tuesday, the agency said it plans to request a tobacco company Reduce nicotine content Tobacco has minimal or non-addictive levels.
In 2019, more than one in four high school students have used e-cigarettes in the last 30 days, up from 11.7% just two years ago, according to federal data. The outbreak of vaping-related lung disease in 2020 raised concerns about e-cigarettes.
last year, Utilization rate of high school students drops to 11.3% In the midst of regulatory scrutiny and a coronavirus pandemic.
According to Euromonitor International, Juul has been the market leader in e-cigarettes since 2018. As of 2020, the company had a 54.7% share of the US e-vapor market of $ 9.38 billion.
E-cigarettes supply users with nicotine by vaporizing the liquid in the cartridge or pod. Nicotine is an addictive ingredient in tobacco and can have other adverse health effects. However, e-cigarette makers claim that their products can deliver nicotine to addicted adult smokers without the health risks associated with burning cigarettes.
Marlboro owner Altria In late 2018, we purchased a 35% stake in Juul for $ 12.8 billion. However, as Juul and the broader e-cigarette industry got caught up in the dispute, Altria significantly reduced the value of its investment. As of March, Altria valued its stake at $ 1.6 billion, one-eighth of its original investment, and Juul itself valued it at less than $ 5 billion.
The FDA’s decision could also adversely affect Juul’s defense in US courts. This is because Juul faces lawsuits from 12 states and Washington over allegations that it sold its products to minors and played a major role in the e-cigarette epidemic. It has already settled with North Carolina for $ 40 million and Washington for $ 22.5 million.
The FDA gained authority to regulate new tobacco products in 2009. Over the last decade, thousands of e-cigarettes have been displayed in stores without FDA approval, making it possible to sell these products as they gradually shift to the standards of a fast-growing industry. ..
The court ruling created a timeline for the FDA’s approval process for applying for e-cigarette companies’ premarket tobacco products. The agency is reviewing about 6.5 million applications from about 500 companies and has already rejected about 1 million applications for flavored vape products from small businesses such as the JDNova Group and Great American Vapes.