Juul gets temporary ban suspension from FDA : NPR

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

Craig Mitchelldyer/AP


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Craig Mitchelldyer/AP


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

Craig Mitchelldyer/AP

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

Juul filed an emergency motion earlier Friday, asking for the temporary suspension while it appeals the sales ban.

The e-cigarette maker had asked the court to suspend what it called an “extraordinary and unlawful action” by the Food and Drug Administration that would have forced it to immediately cease operations.

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

The action was part of a broad effort by the agency to bring scientific scrutiny to the multibillion-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 quit or reduce their smoking, while teenagers are unlikely to become addicted.

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

A three-judge panel of the United States Court of Appeals for the District of Columbia Circuit granted Juul’s stay request while the court considers the case.

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

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

The company said in its Friday court filing that it submitted a 125,000-page request to the FDA nearly two years ago. He said the app included several studies to assess the health risks for Juul users.

Juul said the FDA cannot say there was a “critical and urgent public interest” in immediately removing its products from the market when the agency cleared them for sale during its review.

The company noted that the FDA rejected its application while allowing those submitted 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 forced to halt all advertising and phase out its fruit and dessert flavors after they became popular among middle and high school students. The following year, the FDA limited the flavors of small vaping devices to tobacco and menthol.