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 substnatial legal setback to the FDA.
This case has some history. In October 2021, the Fifth Circuit granted Triton’s applicaiton 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.
In addition to the issues raised in this litigation, there is increasing evidence that the FDA’s approach to vaping and other tobacco products is ad hoc and more political than scientific. A recent external evaluation of the FDA’s tobacco regulatory program (which the FDA itself commissioned) was highly critical of the program’s dysfunction.
A firm rebuke from the en banc Fifth Circuit would be an additional wake-up call to the FDA that it needs to reorient its approach to non-combustible nicotine products. The FDA acknowledges that non-combustible products (like electronic cigarettes) pose less risk than combustible cigarettes, and yet since the FDA began regulating vaping products, public understanding of the these reletive risks has actually gotten worse. Insofar as the FDA regulation of such products is supposed to advance public health, it is failing.
The Fifth Circuit will hear the en banc argument in Wages and White Lion Investments v. Food & Drug Administration in May.