The U.S. Food and Drug Administration said Thursday it was ordering the removal of all vaping products made by Juul Labs from the market after it found the former industry leader failed to address some security. The decision paves the way for rival brands to increase their market share, which Juul once dominated.
“Today’s action is further progress in the FDA’s commitment to ensure that all e-cigarette and e-nicotine delivery system products currently marketed to consumers meet our public health standards,” FDA Commissioner Robert Califf said in a statement.
Affected products include the Juul device and its pods, which currently come in Virginia tobacco and menthol flavors in 5% and 3% nicotine strengths.
After completing a two-year review of the company’s marketing application, the FDA found that the submitted data “lacks sufficient evidence regarding the toxicological profile of the products,” she said.
“In particular, some of the company’s study findings have raised concerns due to insufficient and conflicting data, particularly with respect to genotoxicity and potentially harmful chemicals leaching from proprietary e-liquid pods. of society,” he added.
Juul has been accused of a surge in youth vaping for its marketing of fruit and candy flavored e-cigarettes, which it stopped selling in 2019.
In January 2020, the FDA declared that selling e-cigarettes in flavors other than tobacco or menthol would be illegal unless specifically authorized by the government.
The agency has approved some e-cigarette products from other manufacturers such as Reynolds American, the current market leader, NJOY and Logic Technology Development.
Juul argued that vaping products can provide a solution to the harmful health effects of conventional cigarettes.
Juul’s products “exist solely to keep adult smokers away from combustible cigarettes,” chief executive KC Crosthwaite said on the company’s website, adding that the company is “working hard” to rebuild its reputation after an “erosion of confidence over the past few years.”
On Tuesday, President Joe Biden’s administration announced it would develop a new policy requiring cigarette makers to reduce nicotine to non-addictive levels.
The initiative requires the FDA to develop and then publish a rule, which will likely be challenged by industry.