Juul Calls FDA Rejection “Substantively Flawed” in Combative Appeal

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On October 21, Juul Labs published its administrative appeal of the marketing denial order (MDO) issued by the Food and Drug Administration at the end of June 2022.

The move, and Juul’s decision to make it public, reflects the company’s apparent offensive pivot from its longstanding defensive strategy.

It calls into question the decision made by the FDA’s Center for Tobacco Products (CTP)—which Juul maintains came from an incorrect and incomplete assessment of its data, leading to an insufficient review of its premarket tobacco product applications (PMTAs).

Days after receiving the MDO, Juul obtained a temporary court stay, and has been able to sell its products “pending additional review” from the agency. The FDA granted the company an administrative stay but did not rescind the initial MDO.

The company—long the leading target of anti-vaping advocates after allegations that its early marketing stoked a so-called youth vaping “epidemic”—has now called the MDO “substantively and procedurally flawed.”

Read full article here.

Alex Norcia – Filter- 2022-10-24

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