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Thursday, August 11, 2022

Federal court blocks FDA ban on sale of Juul e-cigarettes in the US

A federal court on Friday temporarily blocked a government order to stop the sale of Juul e-cigarettes.

Earlier Friday, Juul filed an emergency motion with the U.S. Court of Appeals in Washington so it could appeal the ban on the sale, and the court later granted the request.

The e-cigarette maker asked the court to suspend what it called an “extraordinary and illegal action” by the Food and Drug Administration that would have required its immediate cessation of operations.

On Thursday, the FDA said Juul should stop selling its tobacco and menthol flavored vaping device and cartridges.

The action was part of the agency’s wide-ranging effort to scientifically examine the multi-billion dollar vaping industry after years of regulatory delays.

To stay in the market, companies must show that their e-cigarettes benefit public health. In practice, this means proving that adult smokers who use them are more likely to quit or reduce their smoking, while teenagers are less likely to become addicted.

The FDA said Juul’s filing left serious questions for regulators and did not provide enough information to assess any potential health risks. Juul said it provided enough information and data to resolve all issues raised. The company said the FDA denied its request to put the order on hold to avoid major disruption to its business.

Although Juul remains the top seller, its share of the U.S. e-cigarette market has shrunk to about half. A few years ago, the company was widely blamed for the spike in underage vaping, but a recent federal survey showed a decline in teen vaping and a move away from Juul products.

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

The company said in its lawsuit on Friday that it filed a 125,000-page application with the FDA almost two years ago. The statement says that the app includes several studies assessing health risks among Juul users.

Juul said the FDA could not argue that there was a “critical and urgent public interest” in removing its products from the market immediately when the agency authorized their sale at the time of review.

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

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

In 2019, Juul was forced to stop all advertising and drop its fruit and dessert flavors after they became popular with middle and high school students. The following year, the Food and Drug Administration (FDA) limited flavors in small vaping devices to tobacco and menthol only.

The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute Department of Science Education. Associated Press is solely responsible for all content.

World Nation News Desk
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