Juul gains temporary grip on FDA ban: NPR

A woman exhales while vaping a Juul pen e-cigarette in 2019. A federal court has temporarily suspended an FDA ban on the company’s vape products.

Craig Mitchelldyer/AP


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Craig Mitchelldyer/AP


A woman exhales while vaping a Juul pen e-cigarette in 2019. A federal court has temporarily suspended an FDA ban on the company’s vape products.

Craig Mitchelldyer/AP

Juul may continue to sell its electronic cigarettes, at least for now, after a federal appeals court on Friday temporarily blocked a government ban.

Juul filed an emergency motion earlier Friday to demand the temporary ban while appealing the sales ban.

The e-cigarette manufacturer had asked the court to pause what it called an “extraordinary and illegal action” by the Food and Drug Administration, which should have forced it to stop its operations immediately.

The FDA said on Thursday that Juul must stop selling its vaping device and its tobacco and menthol-flavored cartridges.

The move was part of a sweeping effort by the agency to bring scientific research to the multi-billion dollar vaping industry after years of regulatory delays.

To stay on 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 stop smoking or smoke less, while teens are unlikely to become addicted to them.

The FDA said Juul’s application left regulators with important questions and did not contain enough information to evaluate potential health risks. Juul said it has submitted enough information and data to address all of the issues raised.

A panel of three judges on the U.S. Court of Appeals for the District of Columbia Circuit has granted Juul’s request for detention while the court reviews the case.

While Juul remains a top seller, its share of the US e-cigarette market has fallen to about half. The company was widely blamed for an increase in underage vaping a few years ago, but a recent federal survey showed a decline in teen vaping and a shift in Juul’s products.

The devices heat a nicotine solution into a vapor that is inhaled, bypassing many of the toxic chemicals produced by burning tobacco.

The company said in Friday’s court filing that it filed a 125,000-page filing with the FDA nearly two years ago. It said the application contained several studies to evaluate the health risks among Juul users.

Juul said the FDA cannot claim that there was a “critical and urgent public interest” in immediately removing its products from the market when the agency allowed them to sell during the review.

The company noted that the FDA rejected its application while allowing the applications filed by competitors with similar products.

The FDA has approved e-cigarettes from RJ Reynolds, Logic, and other companies, while rejecting many others.

In 2019, Juul was pressured to stop all ads and eliminate the fruit and dessert flavors after they became popular among middle and high school students. The following year, the FDA restricted flavors in small vaping devices to just tobacco and menthol.

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