FDA bans Juul e-cigarettes tied to teen vaping surge
WASHINGTON — U.S. health regulators on Thursday ordered Juul to pull its electronic cigarettes from the 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 Thursday 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.
Joe Murillo, Juul’s chief regulatory officer, said in the company’s statement that Juul submitted enough information and data to address all issues raised by regulators. He noted that the company’s application, submitted more than two years ago, included comparisons to combustible cigarettes and other products.
He said it also included information on potential harmful effects of the company’s products.
Since last fall, the FDA has given the OK to tobacco-flavored e-cigarettes from R.J. Reynolds, Logic and other companies. But industry players and anti-tobacco advocates have complained that those products account for just a tiny percent of the $6 billion vaping market in the U.S.
The agency said Thursday that people who use Juul products or smokers who want to move away from cigarettes and cigars could switch to the FDA-authorized e-cigarettes.
Regulators repeatedly delayed making decisions on devices from market leaders, including Juul, which remains the best-selling vaping brand although sales have dipped.
Last year, the agency rejected applications for more than a million other e-cigarettes and related products, mainly due to their potential appeal to underage teens.
Anti-tobacco groups applauded the FDA’s move, with the American Lung Association calling it “long overdue and most welcome.” The American Vapor Manufacturers Association said it was a “shameful decision.”
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.