The Food and Drug Administration denied authorization to
The regulator said in a
“The agency has dedicated significant resources to review products from the companies that account for most of the US market,” Califf said in the statement. “We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
Joe Murillo, Juul’s chief regulatory officer, said the company disagreed with the decision and would seek a stay as it determines what to do next. Juul is “exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” Murillo said in an emailed statement.
The FDA indicated that its rejection of Juul was based on data the company submitted regarding its products’ public-health benefits. Juul’s application lacked sufficient evidence to show that allowing its products to be sold in the US would be appropriate for the protection of public health, and some of the company’s study findings “raised concerns due to insufficient and conflicting data,” the agency said in its statement.
In response, Murillo said Juul believed that its applications “appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products.”
Some Wall Street analysts said there was a chance that Juul could remain on store shelves pending an appeal. “We fully expect an appeal,”
Regulators had hoped that e-cigarettes would help adults quit smoking traditional tobacco products, which is a major cause of premature death. However, some public-health officials warned that the product is more popular among teenagers and that there are also health risks associated with vaping, such as acute lung-damaging illness.
The FDA’s decision sends the strongest possible message that Juul put the health of millions of young people at risk, Nancy Brown, chief executive officer of the American Heart Association, said in a statement Thursday. “We urge the FDA to take swift and severe enforcement action if the company defies the order,” Brown said.
More than any other product or company, Juul has been responsible for creating and fueling the youth e-cigarette epidemic,
Once a richly valued startup, Juul has seen its fortunes decline in recent years after regulators cracked down on flavored e-cigarette products and lawsuits accused the company of marketing to underage users. The company has said that it never targeted youth in its advertising.
“We are disappointed with today’s decision and continue to believe that e-vapor can play an important role in harm reduction for adult smokers,” an Altria spokesperson said in an emailed statement.
(Updates with Altria statement in last paragraph)
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