Fifth Circuit Grants En Banc Rehearing to Challenge to FDA Rejection of Vaping Products
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 pro
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