The Food and Drug Administration announced on Thursday that it bans the sale of Juul e-cigarettes in the United States
Juul intends to seek a postponement of the decision and is exploring options that include 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 review of the vaping industry after years of pressure from politicians and public health groups to regulate the segment as tightly as other tobacco products as vaping has become more prevalent among high school students.
Juul sought approval from the agency for its vaping device and pods with tobacco and menthol flavors, which are available in nicotine concentrations of 5% and 3%. The fragrances have not been banned by the agency since 2020 for vape products with mint and fruit flavors, which were popular among teenagers.
A ban on the sale of these other Juul products would deal a serious blow to the company. Juul’s efforts to expand internationally have been hampered by regulations and a lack of consumer interest. The United States remains the 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 leak from Juul pods.
“Without the data needed to determine the relevant health risks, the FDA issues these marketing denial orders,” said Michel Mittal, acting director of the FDA’s Tobacco Center.
The FDA said it had not seen any clinical information suggesting that there was an imminent risk of using Juul products. However, as a result of Thursday’s decision, Juul must immediately stop selling and distributing its products in the United States. The FDA may not impose individual ownership or use of 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 research to answer all the questions raised by the agency,” Murillo of Juul said in a statement. .
In FDA decisions over the past year, competing e-cigarette makers British American Tobacco and NJOY have won approvals for their e-cigarettes, although the FDA has rejected some of the flavored products offered by the companies. The agency said it had approved tobacco-flavored products from both companies because they had proven they could benefit older smokers and outweigh the risks to underage users.
The FDA is taking steps to reduce nicotine use in traditional tobacco products. On Tuesday, the agency said it planned to ask tobacco companies to reduce the nicotine content of cigarettes to a minimum level of addiction or no addiction.
In 2019, federal data showed that more than one in four high school students had used an e-cigarette in the past 30 days, compared to 11.7% just two years earlier. The outbreak of vaping-related lung disease in 2020 has heightened concerns about e-cigarettes.
Last year, use among high school students fell to 11.3% amid increased control by regulators and the coronavirus pandemic.
Juul has been the market leader in e-cigarettes since 2018, according to Euromonitor International. By 2020, the company has a 54.7% share of the US electronic money market worth $ 9.38 billion.
E-cigarettes supply nicotine to consumers by evaporating liquid into cartridges or capsules. Nicotine is an ingredient that causes tobacco addiction and can have other negative health consequences. However, e-cigarette manufacturers claim that their products can supply nicotine to addicted adult smokers without the health risks that come with burning tobacco.
Marlboro owner Altria bought a 35% stake in Juul for $ 12.8 billion at the end of 2018. However, Altria reduced the value of the investment as Juul and the wider e-cigarette industry were embroiled in controversy. As of March, Altria valued its stake at $ 1.6 billion, one-eighth of its initial investment, and Juul itself at less than $ 5 billion.
The FDA’s decision is also likely to hurt Juul’s defense in US courts, as she faces lawsuits from a dozen states and Washington over allegations that she sold her products to minors and played a key role in the vaping epidemic. He has already settled with North Carolina for $ 40 million and the state of Washington for $ 22.5 million.
The FDA was given 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, allowing the sale of these products as standards for a thriving industry are gradually introduced.
A court ruling has set a timetable for the FDA’s approval process for e-cigarette tobacco applications. The agency reviews approximately 6.5 million applications from about 500 companies and has already rejected about 1 million applications from smaller players such as JD Nova Group and Great American Vapes for their flavored vape products.