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Reason
Reason
Jonathan H. Adler

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

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.")

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