The U.S. Food and Drug Administration said Thursday it was ordering all vaping products manufactured by Juul Labs off the market after the former industry leader was found to have failed to address certain safety issues. The decision paves the way for competing brands to increase their market share, which Juul once dominated.
“Today’s actions are further progress with the FDA’s commitment to ensure that all e-cigarettes and electronic 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 the flavors of Virginia tobacco and menthol, at nicotine concentrations of five and three percent.
After completing a two-year review of the company’s marketing application, the FDA found that the data presented “lacked sufficient evidence regarding the toxicological profile of the products,” it said.
“Some of the company’s study findings have been of particular concern due to insufficient and conflicting data – including on genotoxicity and potentially harmful chemicals leaking from the company’s own e-liquid pools,” it added.
Juul was blamed for an increase in youth steaming over its marketing of fruit and candy-flavored e-cigarettes, which it stopped selling in 2019.
In January 2020, the FDA said the sale of 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 could provide a solution to the harmful health impacts of conventional cigarettes.
Juul’s products “exist only to eliminate adult smokers from flammable cigarettes,” KC Crosthwaite, chief executive, said on the company’s website, adding that the company was “working hard” to rebuild its reputation after a “erosion of confidence over the past few years.”
President Joe Biden’s administration announced on Tuesday that it will develop a new policy that requires cigarette manufacturers to reduce nicotine to non-addictive levels.
The initiative requires the FDA to develop and then publish a rule, which is likely to be challenged by the industry.