WASHINGTON — Federal health officials on Thursday ordered Juul to pull its electronic cigarettes from the U.S. market, the latest blow to the embattled company widely blamed for sparking a national surge in teen vaping.
The action is part of a sweeping effort by the Food and Drug Administration to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays.
The FDA said Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges. Those already on the market must be removed. Consumers aren’t restricted from having or using Juul’s products, the agency said.
To stay on the market, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.
The FDA noted that some of the biggest sellers like Juul may have played a “disproportionate” role in the rise in teen vaping. The agency said that Juul’s application didn’t have enough evidence to show that marketing its products “would be appropriate for the protection of the public health.”
Juul said it disagrees with the FDA’s findings and will seek to put the ban on hold while the company considers its options, including a possible appeal and talking with regulators.
In a statement, the FDA said Juul’s application left regulators with significant questions and didn’t include enough information to evaluate any potential risks. The agency said the company’s research included “insufficient and conflicting data” about things like potentially harmful chemicals leaching from Juul’s cartridges.
“Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.” Michele Mital, acting director of the FDA’s tobacco center, said in the statement.
The agency has granted some e-cigarette applications. Since last fall, the agency has given its OK to tobacco-flavored e-cigarettes from R.J. Reynolds, Logic and other companies.
The American Lung Association called Thursday’s decision “long overdue and most welcome,” and cited Juul for stoking youth vaping.
E-cigarettes first appeared in the U.S. more than a decade ago with the promise of providing smokers a less harmful alternative. The devices heat a nicotine solution into a vapor that’s inhaled, bypassing many of the toxic chemicals produced by burning tobacco.
But studies have reached conflicting results about whether they truly help smokers quit. And efforts by the FDA to rule on vaping products and their claims were repeatedly slowed by industry lobbying and competing political interests.
FILE – This Tuesday, Feb. 25, 2020 file photo shows packaging for an electronic cigarette and menthol pods from Juul Labs, in Pembroke Pines, Fla. Juul Labs Inc. will pay $40 million to North Carolina and take more action to prevent underage use and sales, according to a landmark legal settlement announced Monday, June 18, 2021, after years of accusations that the company had fueled an explosion in teen vaping. (AP Photo/Brynn Anderson)