Juul ordered to stop selling electronic cigarette products in the US

US federal health officials on Thursday ordered Juul to withdraw its electronic cigarettes from the national market, the latest blow to the embattled company widely accused of triggering a nationwide wave of vaping among teens.

The move is part of a sweeping effort by the US Food and Drug Administration (FDA) to bring scientific research to the multibillion-dollar vape industry after years of regulatory delays.

The FDA said Juul should stop selling its vaping device and its tobacco and menthol flavored cartridges. Those that are already on the market should be removed. Consumers are not restricted from having or using Juul’s products, the agency said.

To stay on the market, companies must demonstrate that their e-cigarettes benefit public health. In practice, this means proving that adult smokers using the devices are likely to stop smoking or smoke less, while teens are unlikely to become addicted to them.

The FDA noted that some of the biggest sellers, such as Juul, may have played a “disproportionate” role in the increase in teen vaping. The agency said Thursday that Juul’s application did not contain enough evidence to show that marketing its products “would be appropriate for the protection of public health”.

Juul said it disagrees with the FDA’s findings and will try to suspend the ban while the company considers its options, including a potential appeal and talking to regulators.

‘Insufficient and contradictory data’

In a statement, the FDA said Juul’s application left regulators with important questions and did not contain enough information to evaluate potential risks.

The agency said the company’s investigation included “inadequate and conflicting data” on things like potentially harmful chemicals leaking from Juul’s cartridges.

“Without the data needed to establish relevant health risks, the FDA is issuing this denial of marketing.” Michele Mital, acting director of the FDA’s Tobacco Center, said in the statement.

The agency has granted some applications for e-cigarettes. Since last fall, the agency has approved tobacco-flavored e-cigarettes from RJ Reynolds, Logic, and other companies.

A woman holds an e-cigarette device and exhales a puff of vapor.
A woman exhales a vapor from a Juul pen in Vancouver, Washington, in April 2019. The US FDA said on Thursday that Juul did not have enough evidence to show that marketing its products “would be appropriate for protection.” of the public’ Health.’ (Craig Mitchelldyer/The Associated Press)

But industry players and anti-tobacco advocates have complained that those products make up only a small portion of the $6 billion US vaping market.

Regulators have repeatedly delayed making decisions on devices from industry leaders, including Juul, which remains the top-selling vaping brand, although sales have fallen.

Last year, the agency turned down applications for more than a million other e-cigarettes and related products, primarily because of their potential appeal to underage teens.

The American Lung Association called Thursday’s decision “long ago and very welcome,” and said Juul was “largely responsible” for what it called the “youth vaping epidemic.”

The Rapid Rise of Vaping

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 by burning tobacco.

But studies have shown conflicting results as to whether they really help smokers quit. And FDA’s efforts to rule on vape products and their claims have been repeatedly delayed by industry lobbying and competing political interests.

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

The vaping problem took on a new urgency in 2018 when Juul’s high-nicotine, fruity-tasting cartridges quickly became a nationwide craze among middle and high school students.

The company faces a slew of federal and state investigations into its early marketing practices, including distributing 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. The following year, the FDA restricted flavors in small vaping devices to just tobacco and menthol. Separately, the US Congress has raised the purchase age for all tobacco and vaping products to 21 years.

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

The FDA has been operating under a court order to make its decisions; anti-tobacco groups successfully sued the agency to speed up the review.

FDA regulators have been warning companies for years that they would need to submit rigorous long-term data showing a clear benefit to smokers switching to vaping. But all but the largest e-cigarette manufacturers have resisted conducting that kind of expensive, time-consuming research.

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