Juul to appeal in US federal court to lift e-cigarette ban

by Barbara R. Abercrombie
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The company has been widely blamed for the increase in underage vaping, but recent research shows a decline in teen vaping in the U.S.

Juul, the manufacturer of electronic cigarettes, has asked a federal court in the United States to block a government order to stop the sale of its products in the country.

On Friday, the company asked the court to suspend what it calls an “extraordinary and illegal action” by the Food and Drug Administration (FDA), which would require it to cease its operations immediately.

The company filed an emergency motion with the U.S. Court of Appeals in Washington as it prepares to appeal the FDA’s decision.

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

The development comes amid a sweeping effort by the agency to bring scientific research to the multi-billion dollar vaping industry after years of regulatory delays.

The FDA said earlier this week that Juul must stop selling its products in the U.S. [File: Elijah Nouvelage/Reuters]

Companies must demonstrate that their e-cigarettes benefit public health to stay on the market. In practice, this means proving that adult smokers who use them are likely to quit or reduce smoking, while teens are unlikely to become addicted.

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 had submitted enough information and data to address the issues raised. The company said the FDA rejected its request to suspend the order to avoid a massive disruption to its operations.

While Juul remains a top seller, its share of the U.S. 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 an inhaled vapor, 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 could not 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.

It also said the FDA’s decision to block the sale of its products was “extraordinary and illegal,” citing the agency’s approval of similar e-cigarette products from competing manufacturers, among other things.

The e-cigarette devices heat a nicotine solution into a vapor that is inhaled [File: Craig Mitchelldyer/A.P. Photo]

Juul added that the ban was a departure from the agency’s normal practices, which typically include a transition period, and questioned the agency’s “immense political pressure from Congress.”

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 tobacco and menthol.

The once-red-hot vape company has also been working with its legal advisers on options, including a possible bankruptcy filing if it’s unable to get relief from the government’s ban, the Wall Street Journal reported Friday, citing people who be familiar with the matter.

The FDA declined to comment on Juul’s application when the Reuters news agency contacted them.

Juul also declined to comment on the WSJ report.

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