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FDA bans Juul e-cigarettes from US market

WSJ reports that Juul e-cigarettes will be ordered in the US market


On Thursday, the United States Food and Drug Administration ordered the removal of e-cigarettes from Juul Labs Inc., saying the products played an outsized role in increasing youth vaping.

The sales ban follows nearly two years of back-and-forth between the regulator and the San Francisco-based company, which had sought permission to keep its tobacco and menthol products on the market.

To stay in the market, companies must demonstrate that their e-cigarettes are beneficial to public health, which means proving that adult smokers who use them are likely to quit or cut down their smoking, while teenagers have little chances of becoming addicted.

The company has not provided evidence that its products meet legal standards, Michele Mital, acting director of the FDA’s Center for Tobacco Products, said in a statement.

“The FDA is responsible for ensuring that tobacco products sold in this country meet the standards set by law, but the responsibility for demonstrating that a product meets those standards ultimately rests with the company,” he said. she declared.

“However, the company has not provided this evidence and instead left us with important questions. Without the data necessary to determine the relevant health risks, the FDA is issuing these marketing denial orders,” Mital said.

The FDA’s decision is part of a broader review of the vaping industry. For years, the agency has faced calls from lawmakers and public health advocates to strengthen its regulation of vaping products as they grow in popularity among teens.

Juul might appeal

In a statement, Juul Labs said it would seek a stay of the FDA’s decision and considered appealing.

The company said its application “appropriately characterizes the toxicological profile of JUUL products, including comparisons with combustible cigarettes and other vapor products,” and that “these data, together with the full evidence , meet the legal standard of being “appropriate for the protection of public health,” according to a statement from Chief Regulatory Officer Joe Murillo.

“We intend to seek a stay and are exploring all of our options under FDA regulations and the law, including appealing the decision and engaging with our regulator. We remain committed to doing all that is in our power to continue to serve the millions of American adult smokers who have successfully used our products to move away from combustible cigarettes, which remain available on market shelves nationwide,” the statement read.

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The FDA previously banned the sale of fruit-flavored and sugary e-cigarettes after critics claimed the products were intended for minors. Earlier this year, the agency allowed certain products made by Juul competitor NJOY to remain on the market and licensed British American Tobacco’s Vuse e-cigarette.

But industry players and anti-tobacco advocates have complained that these products make up only a tiny percent of the $6 billion vaping market in the United States. Juul remains the top-selling vaping brand, with more than 50% of the market, although its sales have increased. dived, the Associated Press reported.

The American Lung Association called Thursday’s decision “long overdue and welcome” and cited Juul for fueling youth vaping.

Science on co-ed vaping

Marketed as an alternative for smokers trying to kick the habit, e-cigarettes have helped some adults do just that. However, the products also ushered in an epidemic of youth vaping.

Studies have come up with conflicting results about whether vaping really helps smokers quit, and the FDA’s efforts to rule on vaping products and their claims have been repeatedly slowed by lobbying from industry and competing political interests, the Associated Press reported.

The vaping problem took on new urgency in 2018 when Juul’s high-nicotine, fruity-tasting cartridges became a national craze among middle and high school students. The company, which is part-owned by tobacco giant Altria, faces a slew of federal and state investigations into its early marketing practices, which included giving away free Juul products at concerts and parties hosted by young influencers. .

In 2020, the FDA limited the flavors of small vaping devices to tobacco and menthol. Separately, Congress has raised the age of purchase for all tobacco and vaping products to 21.

The FDA noted Thursday that some of the industry’s biggest sellers, like Juul, may have played a “disproportionate” role in the rise in teen vaping. More than 2 million American middle and high school students reported using e-cigarettes in 2021, according to a study released in September by the FDA and the US Centers for Disease Control and Prevention.

Juul’s regulatory defeat is the second inflicted on the tobacco industry in recent days. The Biden administration said this week it would order cigarette manufacturers to reduce nicotine levels in an attempt to reduce smoking-related deaths.

The Associated Press contributed reporting.


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