The Food and Drug Administration announced on Thursday that it is banning the sale of Juul e-cigarettes in the US.
Juul intends to seek a stay of the decision and is exploring options, including appealing the decision or engaging with the FDA, Chief Regulatory Officer Joe Murillo said in a statement.
The ban is part of a broader FDA scrutiny of the vaping industry after years of pressure from politicians and public health groups to regulate the segment as strictly as other tobacco products as vaping became more common among high school students.
Juul has sought agency approval for its vaping device and tobacco and menthol flavored pods, which are available in 5% and 3% nicotine. The flavors were not subject to the agency’s 2020 ban on mint and fruit flavored vaping products, which were popular among teenagers.
Banning Juul from selling its remaining products would hit the company hard. Juul’s efforts to expand internationally have been hampered by regulations and a lack of consumer interest. The US remains its largest market.
The FDA said the Juul apps provided insufficient or conflicting data about the potential risks of using the company’s products, including whether potentially harmful chemicals could leak from Juul capsules.
“Without the data needed to determine the relevant health risks, the FDA is issuing these do not market orders,” Michel Mital, acting director of the FDA’s Tobacco Product Center, said in a statement.
The Food and Drug Administration (FDA) said it sees no clinical information indicating an immediate risk of using Juul products. However, as a result of Thursday’s decision, Juul must immediately stop selling and distributing its products in the US. The FDA cannot force individual consumers to own or use the company’s e-cigarettes.
“We respectfully disagree with the FDA’s findings and decision and continue to believe that we have provided enough information and data based on high-quality studies to address all of the issues raised by the agency,” Juul’s Murillo said.
In FDA rulings over the past year, competing e-cigarette manufacturers british american tobacco and NJOY received approval for their e-cigarettes, although the FDA rejected some flavored products submitted by the companies. The agency said it endorsed both companies’ tobacco-flavored products because they have proven they can benefit adult smokers and outweigh the risk for underage smokers.
The FDA is also taking steps to reduce the use of nicotine in traditional tobacco products. On Tuesday, the agency said it plans to require tobacco companies to cut down on nicotine in cigarettes to minimally addictive or non-addictive levels.
In 2019, federal data showed that more than one in four high school students used an e-cigarette in the last 30 days, up from 11.7% just two years earlier. The outbreak of vaping-related lung disease in 2020 has heightened concerns about e-cigarettes.
Last year, usage among high school students dropped to 11.3% amid tighter regulatory oversight and the coronavirus pandemic.
Juul has been the market leader in e-cigarettes since 2018 according to Euromonitor International. As of 2020, the company owned 54.7% of the US$9.38 billion e-cigarette market.
E-cigarettes deliver nicotine to users by vaporizing liquid in cartridges or pods. Nicotine is an ingredient that is addictive to tobacco and can have other negative health effects. However, e-cigarette manufacturers claim that their products can deliver nicotine to addicted adult smokers without the health risks associated with tobacco burning.
Marlboro owner Altria bought a 35% stake in Juul for $12.8 billion at the end of 2018. However, Altria cut the cost of the investment as Juul and the wider e-cigarette industry became embroiled in controversy. As of March, Altria valued its stake at $1.6 billion, an eighth of its original investment, and Juul itself at less than $5 billion.
The FDA decision is also likely to hurt Juul’s defense in US courts as the company faces lawsuits from a dozen states and Washington over allegations that it sold its products to minors and played a major role in the vaping epidemic. He has already settled with North Carolina for $40 million and Washington State for $22.5 million.
The FDA gained the authority 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, allowing these products to be sold as it sets standards for a growing industry. .
The court decision set a time frame for the FDA’s approval process for up-sale pre-sale tobacco product applications from an e-cigarette company. The agency is reviewing about 6.5 million applications from about 500 companies and has already turned down about 1 million applications from smaller players like JD Nova Group and Great American Vapes for their flavored vape products.