The agency said some of the company’s study results raised concerns about possible DNA damage and “potentially harmful chemical leaching” from the pre-filled cartridges, which contain liquid nicotine, flavorings and other chemicals.
“It’s about anyone who would use the product and potential safety issues that the company has not adequately addressed,” said Mitch Zeller, former director of the FDA’s Tobacco Products Center.
In the FDA statement, Michele Mital, acting director of the FDA’s Tobacco Center, said that Juul was given an opportunity to respond to the agency’s questions, “but instead left us with important questions.” Without the data needed to determine relevant health risks, the FDA is issuing these denial-of-marketing orders.”
In a statement, Joe Murillo, Juul’s chief regulatory officer, said the company disagrees with the FDA and will appeal the decisions. Murillo said it provided “sufficient information and data based on high-quality research” to address the issues raised by the agency.
Murillo said the firm will seek a stay of FDA decisions and is exploring “all of our options within FDA rules and the law, including appealing the decision and working with our regulator.”
Juul has several ways to respond to the FDA. The company could begin appealing within the agency and seeking a stay while the matter is pending. It could also sue the FDA in federal appeals court.
The FDA said it will closely monitor Juul’s distributors and retailers to ensure sales stop. If the products are not withdrawn from the market, the authorities can issue warnings, impose fines or carry out confiscations.
The agency said it has not received any information that suggests consumers using Juul products face any imminent danger.
The FDA’s decisions are part of a campaign to review e-cigarettes to ensure they are “suitable for protecting public health.” That means a product needs to help adults quit smoking rather than entice young people to start vaping — and potentially become addicted to nicotine. Although the youth vape aspect has drawn the most attention, the agency ratings are also designed to ensure that the products are safe for adults.
On Juul, “there were clearly questions and concerns at the agency that the company was unable to resolve,” Zeller said. He added that his comments are based on the agency’s testimony and not information he received during his time with the FDA.
The rejection of Juul’s applications is a major blow to a company whose popularity skyrocketed after the 2015 launch of a sleek vape device — that looked like a flash drive — and pre-filled nicotine capsules in flavors like crème brûlée, mango and cucumber .
Touted in early marketing videos that featured young models partying and puffing on vapes, Juul’s innovative approach revolutionized the sleepy vaping industry. But it also sparked a backlash from parents and regulators, who accused the company of sparking a surge in vaping among teens. In response, the company eventually withdrew all of its flavored pre-filled capsules — with the exception of tobacco and menthol.
Anti-vaping advocates praised the FDA’s decision.
Matthew L. Myers, President of the Campaign for Tobacco-Free Kids, called the FDA decision “the most significant action the FDA has taken to reverse the e-cigarette epidemic among youth. More than any other product or company, Juul has been responsible for creating and fueling the youth vaping epidemic.”
Because the decision was based on safety concerns, Myers said it does not address Juul’s role in fueling the youth epidemic and “the continuing role of flavored e-cigarettes, including menthol-flavored products, sold by Juul and other manufacturers.” perpetuating youth use e-cigarettes.” He urged the FDA to deny applications for all flavored e-cigarettes, including other menthol-flavored products and the disposable vapes that are gaining popularity among young people.
Gregory Conley, President of the American Vaping Association, claimed on Twitter that the Juul decisions were “fabricated” and “utter nonsense.”
Even some anti-tobacco advocates wondered if the FDA’s move was going too far.
“Given the political pressure being exerted by tobacco control groups, parent groups and members of Congress to ban Juul, one wonders if that decision was based solely on safety,” said Clifford E. Douglas, director of Tobacco Research at the University of Michigan Network and former Vice President for Tobacco Control at the American Cancer Society.
He said that while Juul was “the poster child for being a bad actor,” it has grown into a responsible company — one that has helped his brother-in-law quit smoking.
In recent months, the agency has ruled on applications affecting millions of e-cigarette products and rejected applications from manufacturers wanting to resume sales of sweet and fruity vapes. But the FDA has slacked off completing reviews involving some of the market leaders, disgruntled anti-tobacco groups and some members of Congress. Nearly 50 companies have sued the FDA over their decisions about their products.
In 2020, concerned about teenage vaping, the FDA banned the sale of sweet and fruity vape tubes, which Juul had already discontinued. Juul and other companies were still allowed to sell tobacco and menthol-flavored cartridges — but only while the FDA reviewed their marketing applications.
Juul submitted its applications two years ago, including reams of scientific studies and other materials suggesting its e-cigarettes help adults quit smoking without attracting young users. The company has repeatedly denied that it is targeting young people.
Juul’s troubles with the agency began in 2018, when data showed a huge rise in vaping among teens, prompting a backlash from regulators. Scott Gottlieb, who was FDA commissioner, publicly accused Juul of starting a youth epidemic. He was furious when tobacco giant Altria bought a 35 percent stake in Juul at the end of the year.
In 2019, in the face of lawsuits and investigations, Juul announced a “reset” to regain public and regulatory trust, and took several steps to prevent teenagers from buying its products. The company ceased television, print, and digital advertising. After the company pulled its sweet and fruity flavors from the market, sales fell, although the company still has a large market share.
The FDA’s announcement on Juul came two days after another major tobacco action: The agency said it plans to develop a rule requiring tobacco companies to keep nicotine levels in cigarettes sold in the United States to a minimum or not addictive making levels, an effort that could have unprecedented impact in lowering smoking-related deaths and threatening a politically powerful industry.
The Wall Street Journal first reported that the FDA is ordering Juul products off the market.
In recent months, lawmakers from both parties have stepped up their criticism of the FDA for what they say is the agency’s unacceptably slow pace in banning flavored e-cigarettes from Juul and other companies.
In March, 15 senators, including Richard J. Durbin (D-Ill.) and Mitt Romney (R-Utah), wrote to FDA Commissioner Robert M. Califf, urging the agency to expedite its reviews of e-cigarette products and announced further delays meant: “E-cigarettes, which have the greatest potential for harm to public health, remain untested and on the market.” Durbin recently urged Califf to “step aside” if the agency does not do so immediately intervene to ban flavored products that appeal to young people.
In a Senate speech on Thursday, Durbin praised the FDA’s decision.
Lawmakers’ anger reflects the agency’s failure to meet a court-imposed September 9, 2021 deadline to determine which e-cigarette products are allowed to remain on the market. The FDA has said it has made significant progress in processing millions of applications, but that it has limited resources and will not complete the application review until July 2023.
Recently, the e-cigarette Vuse Alto, owned by American tobacco company Reynolds, surpassed Juul in terms of cartridge-based brand market share in the United States. In 2021, Juul’s annual revenue was $1.3 billion, compared to just under $1.5 billion in 2020 and $2 billion in 2019, according to a person familiar with the figures at the on condition of anonymity because she was not authorized to provide them.
The FDA and Centers for Disease Control and Prevention’s most recent survey of adolescent tobacco use shows that vaping among adolescents has declined since its peak in 2019. About 7.6 percent of middle and high school students in the 2021 survey reported using an e-cigarette at least once in the past 30 days, compared to 20 percent in 2019. Still, according to the FDA , e-cigarette use remains a problem as more than 2 million middle and high school students reported vaping in the last 30 days.
The agency warned that changes to the 2021 methodology due to the coronavirus pandemic made it difficult to compare results with previous years.
The Youth Tobacco Survey also revealed that Puff Bar, a disposable e-cigarette that doesn’t fall under cartridge restrictions and sells a range of flavored offerings, has become the most popular vaping brand among middle and high school students. Juul finished fourth.