Today the U.S. Court of Appeals granted rehearing en banc in Wages and White Lion Investments v. Food & Drug Administration, in which a vaping company (Triton Distribution) is challenging the FDA's rejection of its product applications. This could indicate the Fifth Circuit is poised to deliver a substantial legal setback to the FDA.
This case has some history. In October 2021, the Fifth Circuit granted Triton's application for a stay of enforcement after the FDA initially refused to approve its vaping products. In a forceful opinion, the panel majority accused the FDA of a regulatory "switcheroo" because the agency changed its standards for how it would evaluate vaping product applications in the midst of the process. How the FDA handles and assesses such application is important because vaping products that contain nicotine cannot be sold in the U.S. without FDA approval (because the FDA has "deemed" such products to be "tobacco products" under federal law).
A subsequent panel of the Fifth Circuit upheld the FDA's rejection of Triton's applications on the merits, over a forceful dissent from Judge Edith Jones. Not only was this decision in tension with the prior panel decision granting Triton a stay, it was also at odds with that of the U.S. Court of Appeals for the Eleventh Circuit, which found fault in the FDA's approach in a parallel case. That the Fifth Circuit wants to rehear this case en banc suggests more than a few judges on the court are concerned with the how the FDA has been handling vaping product applications, and there is good reason for that.
