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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 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. But 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.
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.
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 United States. Regulators repeatedly delayed making decisions on devices from market leaders, including Juul, which remains the bestselling vaping brand.
E-cigarettes first appeared in the United States 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.
The vaping issue took on new urgency in 2018 when Juul's high-nicotine, fruity-flavored cartridges quickly became a craze among middle and high school students. The company faces a slew of federal and state investigations into its early marketing practices, which included distributing free products at concerts and parties.
In 2018, Juul enlisted Democratic Iowa Attorney General Tom Miller to advise it. A spokesman for Miller’s office told The Gazette on Thursday that the company asked Miller to give it “feedback on how it could keep its products out of the hands of minors” and that the association ended in 2018 or 2019.
In 2020, the Associated Press cited records showing that Miller’s role in advising Juul was more than what had been publicly known. Emails obtained by the AP showed Juul sought his counsel on how to respond to inquiries from government officials and reporters.
Juul sought Miller’s guidance or encouraged him to conduct interviews with journalists from the New York Times, NBC and CBS, amid nationwide reports of teens becoming addicted to Juul, the AP reported. Miller said he became involved with Juul to try to help stop underage use of the products.
In 2019, Juul was pressured into halting all advertising and eliminating its fruit and dessert flavors. The next year, the FDA limited flavors in small vaping devices to just tobacco and menthol. Separately, Congress raised the purchase age for all tobacco and vaping products to 21. But the question of whether e-cigarettes should remain on the market at all remained.
An Iowa Youth Survey, taken in late 2021 under the auspices of the state Department of Public Health, reported that 4 percent of six-graders, 10 percent of eight-graders and 24 percent of 11th-graders responded they had used e-cigarettes from any brand.
The FDA has been working under a court order to render its decisions. FDA regulators warned companies for years they would have to submit rigorous, long-term data showing a clear benefit for smokers who switch to vaping. But all but the largest e-cigarette manufacturers have resisted conducting the expensive research.
While Juul remains a top seller, a recent federal survey shows that teens have been shifting away from the company. Last year's survey showed Juul was the fourth most popular e-cigarette among high schoolers who regularly vape. The most popular brand was a disposable e-cigarette called Puff Bar that comes in flavors like pink lemonade, strawberry and mango. That company's disposable e-cigarettes had been able to skirt regulation because they use synthetic nicotine, which until recently was outside the FDA's jurisdiction. Congress recently closed that loophole.
Erin Murphy of The Gazette Des Moines Bureau contributed.