The FDA ordered the company to remove any products currently for sale or risk enforcement action.
“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 Dr. Robert M. Califf said in a statement.
The FDA statement said the banned Juul products include the vaping device and four types of Juul Virginia tobacco and menthol-flavored pods.
The FDA said that the company’s product 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.”
The American Lung Association hailed the FDA’s action.
“Today’s announcement is long overdue and most welcome,” association CEO Harold Wimmer said in a written statement. “The American Lung Association commends FDA for following the science and denying Juul the ability to sell its products that are clearly marketed to addict a new generation of youth to tobacco.”
The ALA statement said Juul is “largely responsible for the youth vaping epidemic, where it used the same tactics as the major cigarette companies to prey on youth.”
The FDA previously banned the sale of fruit-flavored e-cigarettes after critics claimed the products targeted teens. Regulators have since been reviewing thousands of applications for vaping products after tightening their oversight of the electronic cigarette market.
The company can challenge the expected ruling one of three ways: appeal the decision through the FDA, file a challenge in court or submit a revised application for its products.
Several years ago, Juul’s fruity flavors and “hip marketing” were blamed for jumps in underage vaping. Among the criticisms was that Juul used young adult models, celebrities and social media influencers in its marketing campaigns.
In response, the company stopped using models, suspended all advertising in the United States and shut down its Facebook and Instagram accounts.
The company stopped selling its fruity and sweet flavors in 2019. In 2020, all manufacturers were required to submit their products to the FDA for review to stay on the market. They are considered a potentially less harmful alternative for adult smokers, but remain a concerning gateway to smoking for young people.
Juul’s submission to the FDA included only its menthol and Virginia Tobacco flavors in nicotine strengths of 3% and 5%. The company also pitched a new device that would only unlock for users who were 21 or older.
Juul’s popularity among young people is lower than it was in the past: It is now considered the No. 4 brand among high schoolers, according to a federal study released last September, the Wall Street Journal reported.
Underage vaping in general has dropped since federal restrictions raised the age to buy any tobacco products to 21, the newspaper added.
The FDA also plans to mandate the elimination of nearly all nicotine in cigarettes, saying it would upend the $95 billion U.S. cigarette industry. Tobacco companies could sue to fight it the ruling if it happens, the newspaper reported.
HealthDay News contributed to this report.