The US Food and Drug Administration on Thursday said it was ordering all vaping products produced by Juul Labs off the market after finding the former industry leader had failed to address certain safety concerns. The decision clears the way for rival brands to increase their share of the market, which Juul once dominated.
“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,” said FDA Commissioner Robert Califf in a statement.
After completing a two-year review of the company’s marketing application, the FDA found the data presented “lacked sufficient evidence regarding the toxicological profile of the products,” it said.
“In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods,” it added.
Juul was blamed for a surge in youth vaping over its marketing of fruit and candy flavored e-cigarettes, which it stopped selling in 2019.
In January 2020, the FDA said 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 makers such as Reynolds American, the current market leader, NJOY and Logic Technology Development.
Juul’s products “exist only to transition 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 following an “erosion of trust over the past few years.”
The initiative requires the FDA to develop and then publish a rule, which will likely be contested by industry.