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Federal Appeals Court Halts Biden Admin’s FDA Ban on Juul

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OPINION: This article may contain commentary which reflects the author's opinion.


A federal appeals court has halted the Food and Drug Administration’s ban on the sale of Juul e-cigarettes.

The ruling comes after President Joe Biden’s FDA ordered Juul to stop selling e-cigarettes and four types of pods in the United States.

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“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review,” the court order said, “and should not be construed in any way as a ruling on the merits of that motion.”

“The e-cigarette maker had asked the U.S. Court of Appeals for the D.C. Circuit to stay what it calls an ‘extraordinary and unlawful action’ by the FDA that would require it to immediately halt its business. The company, which is partly owned by tobacco giant Altria, filed an emergency motion with the appeals court as it prepares to appeal the FDA’s decision,” CBS News reported.

“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 sweeping 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 show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them,” the outlet continued.

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“The FDA said Juul’s application left regulators with significant questions and didn’t include enough information to evaluate any potential health risks. Juul said it submitted enough information and data to address all issues raised. The company said the FDA refused its request to put its order on hold to avoid a massive disruption to its business. Marketed as an alternative for smokers trying to kick the habit, e-cigarettes have helped some adults do exactly that. However, the products have also ushered in an epidemic of youth vaping,” CBS News continued.

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The FDA issued “marketing denial orders” to Juul last Thursday, stating that the company “must stop selling and distributing” all of its products marketed in the United States.

It accused Juul of issuing “insufficient and conflicting data” regarding the “toxicological profile” of some of its products and claimed the company could not demonstrate that “marketing of the products would be appropriate for the protection of the public health.”

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“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s center for tobacco products.

“JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” she said in a statement. “However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

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Juul hit back, calling the FDA’s decision to block sales of its products was “extraordinary and unlawful.”

“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” Juul chief regulatory officer Joe Murillo said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers.”

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