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 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.
Judge Oldham’s opinion begins:
Over several years, the Food and Drug Administration (“FDA”) sent manufacturers of flavored e-cigarette products on a wild goose chase.
First, the agency gave manufacturers detailed instructions for what information federal regulators needed to approve e-cigarette products. Just as importantly, FDA gave manufacturers specific instructions on what regulators did not need. The agency said manufacturers’ marketing plans would be “critical” to the success of their applications. And the agency promulgated hundreds of pages of guidance documents, hosted public meetings, and posted formal presentations to its website—all with the (false) promise that a flavored-product manufacturer could, at least in theory, satisfy FDA’s instructions. The regulated manufacturers dutifully spent untold millions conforming their behavior and their applications to FDA’s say-so.
Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all one million flavored e-cigarette applications for failing to predict the agency’s volte face. Worse, after telling manufacturers that their marketing plans were “critical” to their applications, FDA candidly admitted that it did not read a single word of the one million plans. Then FDA denied that its voluminous guidance documents and years-long instructional processes meant anything. Why? Because, the agency said, it always reserved the implied power to ignore every instruction it ever gave and to require the very studies it said could be omitted, along with the secret power to not even read the marketing plans it previously said were “critical.” It was the regulatory equivalent of Romeo sending Mercutio on a wild goose chase—and then admitting there never was a goose while denying he even suggested the chase. Cf. William Shakespeare, Romeo and Juliet act 2, sc. 4.
FDA justifies its behavior with two principal arguments. First, FDA argues that its years’ worth of regulatory guidance was not worth the paper it was printed on because it was hedged with cautious qualifiers and never guaranteed that any particular submission would be granted. Second, and most disturbingly, FDA argues that its capriciousness should be forgiven as harmless because the agency promises to deny petitioners’ applications even if we remand to make the agency follow the law.
Today we reject both propositions. As the Supreme Court recently reminded us: “If men must turn square corners when they deal with the government, it cannot be too much to expect the government to turn square corners when it deals with them.” Niz-Chavez v. Garland, 593 U.S. 155, 172 (2021). No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people. And FDA’s regulatory switcheroos in this case bear no resemblance to square corners. As for the agency’s harmless-error argument, the Supreme Court recently, unanimously, and summarily rejected it. Calcutt v. FDIC, 598 U.S. 623 (2023) (per curiam). We do the same here with the expectation that FDA will give petitioners the benefit of a full and fair regulatory proceeding on remand, notwithstanding its prior promises to reject their applications no matter what.
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:
FDA’s counterargument boils down to this: Some other circuits agree with the agency. It is true that five circuits have sided with FDA, while the Eleventh Circuit and ours have found the agency acted arbitrarily and capriciously. But law is not a nose-counting exercise. Compare, e.g., Cochran v. SEC, 20 F.4th 194, 237 (5th Cir. 2021) (en banc) (Costa, J., dissenting) (“Five circuits have considered the question. By a count of 15-0, every judge deciding those cases has [found no jurisdiction.]”), with Axon Enter., Inc. v. FTC, 598 U.S. 175, 195–96 (2023) (unanimously finding jurisdiction in Cochran). Rather, the relevant question is whether our sister circuits have spotted a defect in petitioners’ arguments that we have missed. With deepest respect for our colleagues who have seen this case the other way, we think not.
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.
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