FDA bans Juul e-cigarettes linked to teen vaping surge

WASHINGTON (AP) — U.S. health officials on Thursday ordered Juul to phase out its electronic cigarettes, the latest blow to the embattled company widely blamed for sparking a national surge in vaping among teens.

The action is part of a broader effort by the Food and Drug Administration to put the multibillion-dollar e-cigarette industry under scientific scrutiny 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 are not barred from having or using Juul products, the agency said.

To stay in the market, companies must demonstrate that their e-cigarettes benefit public health. In practice, this means proving that adult smokers who use them are likely to quit or reduce smoking, while teens are unlikely to become dependent.

The FDA found that some of the biggest sellers, like Juul, may have played a “disproportionate” role in the rise in teenage vaping. The agency said Thursday that Juul’s application did not have sufficient evidence that marketing its products “would be appropriate to protect public health.”

Juul said it disagrees with the FDA’s findings and will seek a stay of the ban while the company considers its options, including a possible appeal and discussions with regulators.

In a statement, the FDA said Juul’s application left regulators with significant questions and did not provide enough information to assess potential risks. The agency said the company’s research contained “inadequate and conflicting data” on things like potentially harmful chemicals leaking 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 has provided enough information and data to resolve any issues raised by regulators. He pointed out that the company’s filing, filed more than two years ago, included comparisons to combustible cigarettes and other products.

He said it also contained information about potential harmful effects of the company’s products.

Since last fall, the FDA has approved tobacco-flavored e-cigarettes from RJ Reynolds, Logic, and other companies. However, industry players and anti-tobacco advocates have complained that these products make up a tiny percentage of the $6 billion US vaping market

The agency said Thursday that people who use Juul products or smokers looking to give up cigarettes and cigars could switch to the FDA-approved e-cigarettes.

Regulators have repeatedly delayed decisions on devices from market leaders, including Juul, which remains the top-selling vaping brand despite sales falling.

Over the past year, the agency turned down applications for more than a million other e-cigarettes and related products, largely because of their potential appeal to underage teenagers.

Anti-tobacco groups welcomed the FDA’s move, and the American Lung Association called it “long overdue and most welcome.” The American Vapor Manufacturers Association said it was a “shameful decision”.

E-cigarettes first appeared in the US more than a decade ago with the promise of offering smokers a less harmful alternative. The devices heat a nicotine solution into a vapor that is inhaled, bypassing many of the toxic chemicals produced when tobacco is burned.

However, studies have had conflicting results about whether they actually help smokers quit. And the FDA’s efforts to rule on vaping products and their claims have been repeatedly stymied by industry lobbying and competing political interests.

The vaping market has grown to include hundreds of companies selling a range of devices and nicotine solutions in different flavors and strengths.

The vaping issue took on renewed urgency in 2018, when Juul’s high-nicotine, fruit-flavored cartridges quickly became a nationwide craze among middle and high school students. The company faces a number of federal and state investigations into its early marketing practices, including handing out free Juul products at concerts and parties hosted by young influencers.

In 2019, the company was pressured to stop all advertising and eliminate its fruit and dessert flavors. Over the next year, the FDA restricted flavors in small vapor devices to tobacco and menthol. Separately, Congress raised the purchase age for all tobacco and vape products to 21.

But the question of whether e-cigarettes should stay on the market at all remained.

The FDA has been working under a court order to make its decisions; Anti-tobacco groups successfully sued the agency to expedite their review.

Kenneth Warner, a tobacco expert at the University of Michigan’s School of Public Health, suspects that political pressure from these groups played a role in the FDA’s decision.

“I think they would have had a hard time coming to a different conclusion,” said Warner, who hadn’t seen Juul’s application. He added that he doesn’t take tobacco money.

In response, an FDA spokesman said the company hadn’t provided enough information for a full risk assessment of its products, and that alone would prevent the agency from ruling in Juul’s favor.

While Juul continues to be a top seller, a recent federal survey shows teenagers are leaving the company.

Overall, the survey showed a nearly 40% drop in teen vaping rates as many children were forced to study from home during the pandemic. Still, federal officials cautioned against interpreting the results because they were first collected online and not in classrooms.

The brainchild of two Stanford University students, Juul was launched in 2015 and within two years rose to the top of the vaping market. Juul still accounts for nearly 50% of the U.S. vape market. It once controlled more than 75%.

Tobacco giant Altria, which makes Marlboro cigarettes, paid nearly $13 billion in 2018 for a 35 percent stake in Juul.

On Tuesday, the FDA also unveiled plans to set maximum nicotine levels for certain tobacco products to reduce their addictive potential. In that announcement, the agency also noted that it has invested in a multimedia public education campaign aimed at warning young people about the potential risks of using e-cigarettes.

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Murphy reported from Indianapolis.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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