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Eleventh Circuit Finds FDA Treatment of Vaping Product Marketing Applications to be Arbitrary & Capricious

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Yesterday, a divided panel of the U.S. Court of Appeals for the Eleventh Circuit concluded that the Food and Drug Administration was arbitrary and capricious when it rejected marketing applications from several vaping companies. Because the FDA has deemed vaping products to be “tobacco products” for purposes of federal law, FDA approval is necessary for such products to be sold. The Eleventh Circuit’s decision in Bidi Vapor LLC v. FDA, deepens a conflict among the circuit courts over how the FDA should evaluate marketing applications for vaping products and makes eventual Supreme Court review of the question more likely.

Chief Judge Bill Pryor wrote the opinion for the court, joined by Judge Brasher. Judge Rosenbaum dissented (in what is the first dissent I can recall that begins with an all-caps “SPOILER ALERT.”)

The basis for the Eleventh Circuit’s decision is fairly straight-forward: In rejecting the vaping product applications, the FDA expressly refused to consider the firms’ marketing and sales-access-restriction plans to reduce youth access to and consumption of their products. According to the FDA, such measures are not sufficient to reduce youth access, so they did not need to be considered, even though the relevant statute requires the agency to consider whether new tobacco products will attract consumers who do not currently use tobacco products and the FDA had issued prior guidance documents indicating that marketing and sales-access-restrictions were “factors” the FDA “intend[ed] to consider” when evaluating applications, and applicants relied upon the FDA’s guidance when preparing their applications.

While the FDA was free to conclude that the marketing and sales-access-restrictions proposed by the various applicants were insufficient, it was not free to simply disregard those parts of the applications. To do so would be to ignore a relevant aspect of the question before the agency, which is a textbook example of arbitrary and capricious decision-making.

The panel majority not only disagreed with their dissenting colleague. They also disagreed with recent decisions from the U.S. Courts of Appeals for the Fifth Circuit and D.C. Circuit rejecting similar claims from vaping companies.  Among other things, the Eleventh Circuit disagreed with its sister circuits’ interpretation of the FDA’s 2020 guidance to concerning product applications. This, combined with the string of other decisions in which federal appellate courts have found fault with the FDA’s treatment of vaping product applications, makes me suspect this question could soon be ripe for Supreme Court review.

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