The decisions are part of a campaign by regulators to ensure e-cigarettes are “appropriate for the protection of public health.” That means a product must be more likely to help adults to quit smoking than to entice young people to start vaping — and potentially get addicted to nicotine.
The FDA, in its announcement, said Juul must stop selling and distributing the products and that those on the US market must be removed.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert M. Califf said in a statement.
The agency said the applications “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
While the agency said it has not received information to suggest an immediate hazard associated with the use of Juul products, “there is insufficient evidence to assess the potential toxicological risks of using the JUUL products.”
Juul did not have an immediate comment on the FDA actions.
The FDA’s rejection of Juul’s applications is a stunning blow for a company whose popularity skyrocketed after its 2015 introduction of a sleek vaping device — which looked like a flash drive — and pre-filled nicotine pods in flavors such as creme brulee, mango and cucumber.
Juul’s innovative approach, touted in early marketing videos featuring young models partying and puffing on e-cigarettes, revolutionized the sleepy vaping industry. But it also prompted a fierce backlash from parents and regulators, who blamed the company for igniting a surge in teenage vaping. In response, the company ultimately took all of its flavored pre-filled pods — except for tobacco and menthol — off the market.
Some experts were surprised that the agency rejected Juul’s bid to keep selling its tobacco-flavored vapes. That flavor is not popular among young people and the agency has given the green light to other companies to sell tobacco-flavored vapes. But none are big sellers.
during the past several months, the agency has ruled on applications involving e-cigarette products. But the FDA has yet to complete reviews involving some of the market leaders, angering anti-tobacco groups and some members of Congress. Nearly 50 companies have sued FDA because of their decisions on their products.
In 2020, concerned about youth vaping, the FDA prohibited sales of sweet and fruity e-cigarette pods, which Juul had already stopped selling. Juul and other companies were permitted to continue selling tobacco- and menthol-flavored cartridges — but only while the FDA reviewed their marketing applications.
Juul submitted its applications almost two years ago, including reams of scientific studies and other materials trying to make the case that its e-cigarettes help adults quit smoking without attracting young users. The company has repeatedly denied that it targeted young people.
Juul’s problems with the agency began in 2018, when data showed a huge increase in teenage vaping, fueling a backlash from regulators. Scott Gottlieb, who was then FDA commissioner, publicly blamed Juul for setting off a youth vaping epidemic. He was infuriated when the tobacco giant Altria bought a 35 percent stake in Juul at the end of that year.
In 2019, Juul, faced with lawsuits and investigations, announced a “reset” designed to regain the trust of the public and regulators and took several steps to prevent teenagers from buying their products. The company halted television, print and digital advertising. After the company took its sweet and fruity flavors off the market, sales fell, though the company still commands a large share of the market.
The FDA announcement on Juul came two days after another major tobacco action: The agency said it plans to develop a rule requiring tobacco companies to reduce nicotine levels in cigarettes sold in the United States to minimally or nonaddictive levels, an effort that could have an unprecedented effect in slashing smoking-related deaths and threatens a politically powerful industry.
The agency said the action pertains to the distribution and sales of the products, and does not affect individual consumer possession or use.
The Wall Street Journal first reported that the FDA was ordering Juul products off the market.
Anti-vaping advocates praised the FDA’s ruling.
“Juul, more than any other product and any other company, has been responsible for creating and fueling the youth e-cigarette epidemic,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. He said ordering the products off the market “would be the most significant action the FDA has taken to date to end the youth e-cigarette epidemic and stop tobacco companies from using these nicotine-loaded products to addict another generation of kids.”
Myers said he was especially gratified that the agency rejected Juul’s menthol e-cigarettes.
“Prohibiting menthol e-cigarettes is critical if the FDA is serious about reversing the e-cigarette epidemic,” Myers said. “It’s the product the kids are using today.”
But some tobacco-control advocates said the FDA move went too far.
“Juul is believed to be quite an effective and much less harmful substitute for cigarettes for addicted adult smokers,” said Clifford E. Douglas, director of the University of Michigan’s Tobacco Research Network and former vice president for tobacco control at the American Cancer Society.
Vaping advocates denounced the FDA move.
“This shameful decision is hard proof that no matter how deeply resourced or how meticulous the research in the market application, FDA is hellbent to arbitrarily crush the most widely used vaping products preferred by adult Americans,” said Amanda Wheeler, president of the American Vapor Manufacturers association, which represents independent vapor manufacturers.
Some experts have speculated that the FDA, in banning Juul’s products, was punishing the company for past behavior. But others said the agency is permitted only to consider the company’s applications, not its previous behavior.
Applications for menthol e-cigarettes made by other companies are still pending at the agency. None has yet been approved. The agency has denied requests from manufacturers to summarize sales of sweet and fruity vapes.
Juul has several options in responding to the FDA. The company could file an appeal within the agency, requesting a stay of the denial orders while the matter is pending. It could also sue the FDA in federal appeals court and seek a stay pending the outcome of the case.
In recent months, lawmakers in both parties have stepped up their criticism of the agency for what they describe as the agency’s unacceptably slow pace in banning flavored e-cigarettes made by Juul and other companies.
In March, 15 senators, including Richard J. Durbin (D-Ill.) and Mitt Romney (R-Utah) wrote to Califf urging the agency to quickly wrap up its reviews of vaping products, saying further delays meant “e-cigarettes that hold the greatest potential harm to public health remain unreviewed and on the market.” Durbin recently called on Califf to “step aside” if the agency did not move immediately to ban flavored products that appeal to young people.
The lawmakers’ ire reflects the agency’s failure to meet a court-imposed deadline of Sept. 9, 2021, to determine which e-cigarette products should be allowed to remain on the market. The FDA has said it has made substantial progress in plowing through millions of applications but that it has limited resources and would not finish reviewing applications until July 2023.
Recently, Vuse Alto e-cigarettes, owned by Reynolds American tobacco company, has edged past Juul in terms of market share of cartridge-based brands in the United States. In 2021, Juul’s annual revenue was $1.3 billion, down from just under $1.5 billion in 2020 and $2 billion in 2019, according to a person familiar with the figures who spoke on the condition of anonymity because they were not authorized to provide them.
The most recent survey of youth tobacco use by the FDA and the Centers for Disease Control and Prevention shows that youth vaping has declined since its peak in 2019. About 7.6 percent of middle school and high school students in the 2021 survey said they had used an e-cigarette use at least once in the past 30 days, compared with 20 percent in 2019. Still, the FDA said, e-cigarette use remains a concern because more than 2 million middle and high school students reported vaping within the past 30 days.
The agency cautioned that changes to the 2021 methodology because of the coronavirus pandemic made it difficult to compare the results with previous years.
The youth-bacco survey also showed that Puff Bar, an e-cigarette was not covered in the restrictions that imposed on cartridges and students to sell an array of flavored offerings, has become the most popular vaping brand among middle high school. July was fourth.