Juul plans to extend stay on FDA ban citing unevaluated evidence

American electronic cigarette company Juul Labs Inc is reportedly trying to extend an interim stay on the Food and Drug Administration (FDA)’s ban on e-cigarettes.

In a court filing, Juul pointed out that the FDA disregarded over 6,000 pages of data provided regarding the aerosols produced by liquid heated in the pods which users eventually inhale.

Last week, the FDA stated that the market approval application sent by Juul provided conflicting or insufficient data about the possible dangers of using its products. This includes the potential leak of harmful chemicals from Juul pods.

But Juul believes that a more extensive FDA evaluation could have proven the absence of those harmful chemicals in the aerosols inhaled by Juul users.

The company also remarked that the FDA’s decision was influenced by immense political pressure. Even a temporary ban on Juul products would completely damage its brand image thereby favoring its competitors.

Over the past year, e-cigarette companies NJOY and British American Tobacco have received FDA approvals for their products. But the agency rejected some of their flavored products.

FDA stated that it approved the tobacco-flavored products of these companies as they proved to be beneficiary to adult smokers and exceeded the risk to underage users.

On the other hand, Juul has been seeking approval for its menthol-and tobacco-flavored pods and vaping devices. The company emphasized that none of its competitors were denied approval for similar reasons and the agency had no explanation for holding Juul to a separate standard.

The San Francisco-based vaping company was denied product authorization by FDA last Thursday and the agency informed Juul to immediately stop selling its products.

A day later, the Columbia Circuit Court of Appeals granted a stay over the FDA ban. The court is contemplating whether to permit Juul to sell its e-cigarettes and pods while it appeals the FDA’s decision.

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https://www.cnbc.com/2022/06/28/juul-seeks-to-extend-stay-on-fda-ban-saying-agency-did-not-evaluate-all-its-evidence.html