The US Food and Drug Administration on Thursday said it was ordering all products produced by Juul Labs off the market after finding the vaping giant had failed to address certain safety concerns.
The decision, which Juul said it would appeal, clears the way for rival brands to increase their share of the market it once dominated.
It is also a blow for tobacco giant Altria, maker of Marlboro cigarettes, which acquired a 35 stake in Juul in 2018 to diversify its business strategy in the face of falling smoking rates.
"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.
Products affected include the Juul device and its pods, which currently come in the flavors Virginia tobacco and in menthol, at nicotine concentrations of five and three percent.
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 said in a statement that it "respectfully" disagrees with the FDA's findings and that its products met the statutory standard of being "appropriate for the protection of the public health."
"We intend to seek a stay and are exploring all of our options under the FDA's regulations and the law, including appealing the decision and engaging with our regulator," Juul's chief regulatory officer Joe Murillo said.
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.
- Ban is 'uncertain' -
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 has argued that vaping products can provide a solution to the harmful health impacts from conventional cigarettes.
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 impact of the FDA's decision is "far from certain" given the likelihood of an appeal, Goldman Sachs said in an analysis issued before the announcement. "There are already several precedents for reversal" of such orders, it noted.
Juul currently holds around 36 percent share of the US vaping market, a substantial reduction on the roughly 70 percent it held before the FDA's actions on flavored e-cigarettes, the Goldman Sachs note said.
On Tuesday, President Joe Biden's administration announced it would develop a new policy requiring cigarette producers to reduce nicotine to non-addictive levels, a move that, if successful could upend the tobacco industry.