Juul has been ordered to stop selling e-cigarette products in the United States

US federal health officials on Thursday ordered Juul to recall its e-cigarettes from the national market, in the latest blow to the ailing company widely blamed for sparking a national wave in teen vaping.

The action is part of a sweeping effort by the US Food and Drug Administration (FDA) to impose scientific scrutiny on the multibillion-dollar e-cigarette industry after years of regulatory delays.

The U.S. Food and Drug Administration said Juul should stop selling vaping device, tobacco flavor cartridges, and menthol. Those already on the market should be removed. The agency said consumers are not restricted from owning or using Juul products.

To survive in the market, companies must show that e-cigarettes benefit public health. In practice, this means demonstrating that adult smokers who use the devices are more likely to quit or reduce smoking, while adolescents are less likely to engage in them.

The Food and Drug Administration has suggested that some of the biggest sellers such as Juul may have played a “disproportionate” role in the high rate of teen vaping. The agency said Thursday that Juul’s request did not contain sufficient evidence to show that marketing of its products “would be appropriate to protect public health.”

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

‘Insufficient and conflicting data’

The Food and Drug Administration, in a statement, said Jules’ request left regulators important questions and did not include enough information to assess any potential risks.

The agency said the company’s research included “insufficient and conflicting data” about things like leakage of potentially harmful chemicals from Joule cartridges.

“Without the data necessary to identify relevant health risks, the Food and Drug Administration is issuing these marketing denial orders.” Michelle Mittal, acting director of the Food and Drug Administration’s Tobacco Center, said in the statement.

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

A woman exhales puffs of steam from a Juul pen in Vancouver, Washington, in April 2019. The U.S. Food and Drug Administration said Thursday that Juul did not have enough evidence to prove that marketing its products would be appropriate to protect public health.’ (Craig Michelder/The Associated Press)

But industry players and tobacco control advocates have complained that these products represent only a tiny fraction of the $6 billion US vaping market in the United States.

Regulators have repeatedly postponed decisions on devices from market leaders, including Juul, which remains the best-selling vaping brand despite declining sales.

Last year, the agency denied applications for more than 1 million other e-cigarettes and related products, mainly because of their potential appeal to underage teens.

The American Lung Association called Thursday’s decision “a long overdue and very welcome” and said Jules was “largely responsible” for what it called a “youth vaping epidemic.”

The rapid rise in vaping

E-cigarettes first appeared in the United States over a decade ago with the promise of providing smokers with a less harmful alternative. The devices heat a nicotine solution into a vapor that is inhaled, bypassing many of the toxic chemicals from burning tobacco.

But studies have come up with conflicting results about whether they actually help smokers quit. Efforts by the FDA to judge e-cigarette products and claims have repeatedly been slowed by industry pressure and competing political interests.

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

The issue of vaping gained new prominence in 2018 when Juul’s high-nicotine, fruity cartridges quickly became a nationwide craze among middle and high school students.

The company is facing a slew of federal and state investigations into its early marketing practices, which included distributing free Juul products at concerts and parties hosted by young influencers.

In 2019, the company came under pressure to stop all advertising and phase out fruit and sweet flavors. The following year, the U.S. Food and Drug Administration (FDA) limited the flavors in small vaping devices to tobacco and menthol only. Separately, the US Congress raised the age for the purchase of all tobacco and vaping products to 21.

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

The Food and Drug Administration operates under a court order to make its decisions; Anti-tobacco groups successfully sued the agency to speed up its review.

FDA regulators have warned companies for years that they will have to provide rigorous, long-term data showing a clear benefit for smokers switching to vaping. But all but the largest e-cigarette manufacturers have resisted doing this kind of expensive and time-consuming research.

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