The U.S. Food and Drug Administration announced Thursday that it is withdrawing all products made by Juul Labs from the market after finding that the vaping giant had failed to address certain safety concerns.
The decision, which Juul plans to appeal, paves the way for competing brands to increase their share of the once-dominated market.
It’s also a blow to 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 advancement in FDA’s commitment to ensure that all e-cigarette and electronic nicotine delivery systems currently marketed to consumers meet our public health standards,” FDA Commissioner Robert Califf said in a statement .
Among other things, the Juul device and its capsules are affected, which are currently available in the flavors Virginia tobacco and menthol with nicotine concentrations of five and three percent.
After completing a two-year review of the company’s regulatory submission, the FDA determined that the data presented “did not provide adequate evidence of the products’ toxicological profile,” it said.
“Some of the company’s study results in particular raised concerns about insufficient and conflicting data — including regarding genotoxicity and potentially harmful chemicals leaking 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 legal standard of being “fit to protect public health.”
“We intend to request a stay and are evaluating all of our options as required by the FDA and the law, including appealing the decision and working with our regulator,” said Joe Murillo, Juul’s chief regulatory officer.
Juul was blamed for a surge in teenage vapers because of its marketing of fruit and candy-flavored e-cigarettes, which it stopped selling in 2019.
In January 2020, the FDA declared that the sale of e-cigarettes with flavors other than tobacco or menthol was illegal unless specifically approved by the government.
– Ban is ‘uncertain’ –
The agency has approved some e-cigarette products from other manufacturers, including Reynolds American, the current market leader, NJOY and Logic Technology Development.
Juul has argued that vaping products can offer a solution to the harmful health effects of traditional cigarettes.
Juul’s products “exist only to get adult smokers off combustible cigarettes,” Chief Executive KC Crosthwaite said on the company’s website, adding that the company is “working hard” on its reputation for a “decrease in trust in recent years.” ” rebuild. “
The implications of the FDA’s decision are “far from certain given the likelihood of an appeal,” Goldman Sachs said in an analysis released prior to the announcement. “There are already several precedents for lifting” such orders, she noted.
Juul currently holds about 36 percent of the U.S. vaping market, a significant drop from the roughly 70 percent it held before the FDA’s actions on flavored e-cigarettes, Goldman Sachs said in the release.
On Tuesday, President Joe Biden’s administration announced it would develop a new policy that would require cigarette manufacturers to reduce nicotine to non-addictive levels, a move that, if successful, would turn the tobacco industry on its head could.
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