What is a case about the U.S. Court of Appeals for the Fifth Circuit's en banc opinion on the FDA's approval procedures for e-cigarettes, Wages and White Lion Invs, L.L.C. v. Food & Drug Admin., No. 21-60766 (Jan. 3, 2023), doing here?
We consider it worthy of your time and post it here because of the way the majority addresses the FDA's central argument: that even though the public took the FDA's public instructions (including statements on its website) at face value, these procedures meant nothing.
Government shouldn't play such games, the court concluded. It can't go back on what it holds out to the public, especially as a later litigation posture. See, e.g., slip op.at 20 ("In the MDO's, however, FDA explicitly stated that its instructions were all for naught."). Government "about-face[s]" are not appreciated. Slip op. at 28. We rightfully expect more from our government.
You land users should read this, and see if sounds familiar:
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.
Slip op. at 1-2.
Sounds like the approach many local planning departments take: an owner wants to know what she can do with her property, and instead of helping clarify what can or can't be done -- or worse yet, holding out with what it only later asserts is an illusory procedure -- the government goes opaque and plays "gotcha" with the owner. We have our regulations and procedures, but it's up to you, property owner, to figure out how those regulations limit your property, and how to navigate our process. Do so at your peril, property owners.
If only more courts would refuse to tolerate this.
Hat tip to our law firm colleague Deb La Fetra for noticing this one.
Check it out.
