FDA orders Juul to pull e-cigarette products off the market
WASHINGTON — Federal health officials 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 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 may have played a “disproportionate” role in the rise in teen vaping. The agency said 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.
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.
The American Lung Association called Thursday’s decision “long overdue and most welcome,” and it 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 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.