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 unapproved vaping products, 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 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.
Judge Oldham’s opinion begins:
While the majority expected the FDA to comply with administrative law norms of fair notice and non-arbitrary treatment, the dissenters adopted a more permissive posture, concluding that vaping product manufacturers had failed to demonstrate that their products satisfied the FDA’s regulatory standards.
This view may have commanded majorities on most circuit courts to consider the quesiton, but it did not command a majority of the Fifth Circuit. Wrote Judge Oldham:
The question now is whether the Just Department will seek Supreme Court review. Thus far, the Court has shown little interest in taking a vaping case, at least when cert petitiotns have been filed by manufacturers of denied products. Now that there is a clearer circuit split, and the FDA may be seeking review, perhaps the Court will change its mind.