Today, the U.S. Court of Appeals for the Fifth Circuit issued its long-awaited en banc decision in Wages and White Lion Investments, L.L.C. v. Food & Drug Administration, in which it considered a challenge to the FDA's denial of vaping product applications. By a vote of 10-6, the court handed the FDA a substantial loss, and deepened the circuit split over the FDA's handling of vaping product applications.
This is the Fifth Circuit's third Wages & White Lion opinion. A panel of the court had initially stayed the FDA's enforcement of its prohibition on the sale of unapproved vaping products (decrying the agency's "surprise switcheroo"), but a separate panel reversed course, upholding the FDA. Now, sitting en banc, the Fifth Circuit has again ruled against the FDA, taking the agency to task for its arbitrary treatment of Wages & White Lion's product applications and, by implication, those submitted by dozens of other manufacturers as well.
Judge Oldham wrote for the Court. He was joined by Chief Judge Richman and Judges Jones, Smith, Elrod, Willett, Ho, Duncan, Engelhardt, and Wilson. Judge Haynes wrote the principal dissent, joined by Judges Stewart, Southwick, Higginson, and Douglas. Judge Graves also dissented separately.
