Federal judge blocks FDA’s Juul ban

The action was part of a broader effort by the agency to put the multibillion-dollar e-cigarette industry under scientific scrutiny after years of regulatory delays.

A federal court on Friday temporarily blocked the government’s order for Juul to stop selling its electronic cigarettes.

Juul filed an urgent motion with the US Circuit Court of Appeals in Washington on Friday to allow it to appeal the ban, and the court later granted the motion.

The e-cigarette maker had asked the court to stop what it called an “extraordinary and unlawful act” by the Food and Drug Administration that would have required it to go out of business immediately.

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

The action was part of a broader effort by the agency to put the multibillion-dollar e-cigarette industry under scientific scrutiny after years of regulatory delays.

To stay in 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 smoking, while teens are unlikely to become dependent.

The FDA said Juul’s filing left regulators with significant questions and did not provide enough information to evaluate potential health risks. Juul said it submitted enough information and data to resolve any issues raised. The company said the FDA denied its request to suspend its order to avoid massive disruption to its business.

While Juul remains a top seller, its share of the U.S. vape market has fallen to about half. The company was widely blamed for a surge in underage vaping a few years ago, but a recent federal survey showed a decline in teenage vaping rates and a move away from Juul’s products.

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

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

Juul said the FDA could not argue that there was a “critical and urgent public interest” in immediately withdrawing its products from the market when the agency allowed sale during its review.

The company noted that the FDA denied its application but approved 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 pressured to stop all advertising and eliminate its fruit and dessert flavors after they became popular with middle and high school students. Over the next year, the FDA restricted flavors in small vapor devices to tobacco and menthol.

https://www.fox43.com/article/news/nation-world/federal-court-fda-ban-juul/507-dff9c63b-222f-48fd-bba2-6e0b9bd58cdc Federal judge blocks FDA’s Juul ban

Alley Einstein

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