To vape, or not to vape

July 20, 2022

Despite a contrary view of the case by a motions panel, a majority of the the panel that received the merits briefing denied the petitions for review in Wages & White Lions Investments LLC v. FDA, a case about the regulation of “vaping” products: “Petitioners advance two primary arguments: (1) FDA acted arbitrarily and capriciously by pulling a ‘surprise switcheroo‘ on Petitioners and failing to consider important aspects of the PMTAs; and (2) FDA lacks statutory authority to impose a comparative efficacy requirement. We are unpersuaded by either argument.” 

A dissent saw matters otherwise: “In a mockery of ‘reasoned’ administrative decision making, FDA (1) changed the rules for private entities in the middle of their marketing application process, (2) failed to notify the public of the changes in time for compliance, and then (3) rubber-stamped the denial of their marketing applications because of the hitherto unknown requirements.” A petition for en banc rehearing seems a near certainty. No. 21-60766 (July 18, 2022).

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