Last January, the U.S. Court of Appeals for the Fifth Circuit ruled that the Food and Drug Administration (FDA) acted “arbitrarily and capriciously” in refusing to allow flavored nicotine e-cigarettes to be marketed, violating the Administrative Procedure Act. of liquid. On Tuesday, the U.S. Supreme Court agreed to review the decision. The case highlights the FDA’s deeply unfair process for enforcing its ruling that e-cigarette products in flavors other than tobacco and menthol are inherently intolerable, even though former smokers prefer those options.
“For several years,” 5th Circuit Judge Andrew Oldham wrote for the majority Wages and White Lion Investments v. FDA, the agency “sends manufacturers of flavored e-cigarette products on a wild goose chase.” The agency initially stated that “manufacturers’ marketing plans are critical to the success of their applications.” It “issued hundreds of pages of guidance documents, hosted public meetings, and posted formal presentations on its website—all with the (false) promise that flavoring product manufacturers could, at least in theory, meet FDA Directives. Manufacturers “conscientiously spend millions of dollars to bring their practices and applications into compliance with FDA regulations.”
All the efforts were in vain. Oldham noted that “just months after receiving hundreds of thousands of applications based on its instructions, the FDA “turned around and pretended that it had never provided anyone with any instructions about anything, without any notice. implemented new testing requirements and rejected all 1 million flavors of electronic products. the number of times he did this. Worse, after telling manufacturers that their marketing plans were “critical” to their application, the FDA frankly admitted that it hadn’t read a word of a million plans. Then the FDA denied that its extensive guidance documents and years-long guidance process meant anything.
Under the Family Smoking Prevention and Tobacco Control Act of 2009, the FDA is responsible for determining whether approval of nicotine products is “appropriate to protect the public health.” The agency should consider “risks and benefits to the entire population, including users and non-users.” This, in turn, requires taking into account “the increased or decreased likelihood that existing users of tobacco products will cease using such products” and “the increased or decreased likelihood that those who do not use tobacco products will begin using such products.”
This collectivist calculation requires controversial predictions and consideration of risks and benefits, but no instructions on how to measure or weigh risks and benefits, leaving the FDA with wide discretion in deciding what evidence manufacturers must provide right. The FDA not only takes full advantage of this discretion; It said it was exercising it in a specific way and then changed its mind after the manufacturer followed its instructions. By then, it was too late for them to comply with the FDA’s newly announced requirements.
In applying the Tobacco Control Act’s “public health” standards to e-cigarette products, the FDA sees one major benefit and one major risk. It acknowledges that smokers can significantly reduce health risks by switching to e-cigarettes. But it is concerned that certain flavors may encourage use by minors because they are particularly attractive to them. In practice, this means rejecting almost all “pre-market” applications from e-cigarette companies. So far, the FDA has approved only 27 products, and the only flavors that have passed testing are tobacco and menthol.
Oldham noted that in order to enforce the de facto ban on other flavors, the FDA resorted to “regulatory switches” that contradicted its own guidance to industry. While it initially emphasized the importance of marketing programs designed to prevent use by minors, it ultimately ignored the details of the company’s submissions. Although it initially stated that product-specific clinical studies and long-term studies were not necessary, it later noted that the lack of such evidence automatically doomed the application. While the company initially said it was focused on easily concealable, pod-based products popular with teens, it also rejected every application for e-liquid for use in refillable devices.
E-cigarette oil manufacturers Triton Distribution and Vapetasia argued that the FDA’s “regulatory switch” was patently arbitrary and capricious, and the Fifth Circuit agreed. The appeals court ruled that the agency violated four respected principles of administrative law.
First, “Institutions cannot invent afterwards Provide reasons for its decisions in court and outside the administrative record. recognizes and explains fourth, “Even if an agency acknowledges and explains a change in its position, it cannot accuse a regulated entity of relying in good faith on the prior entity.”
Oldham concluded that the FDA’s rejection of Triton and Vapetasia’s applications was “arbitrary and capricious.” “The agency failed to provide manufacturers with fair notice of these rules; the agency failed to acknowledge or explain changes in its position; and the agency ignored the reasonable and serious reliance interests manufacturers had in the rules. [pre-denial] guidance; the agency attempted to cover up its errors by afterwards Grounds for Oral Argument. The opposing views expressed by some of our sister agencies do not address our primary concerns about FDA’s decision-making. Therefore, we believe the agency’s actions were unlawful.
As Oldham noted, while the 11th Circuit agreed in 2022 that the FDA’s refusal to consider marketing plans it required manufacturers to submit was arbitrary and capricious, several appeals courts have taken the opposite position. Depending on how the Supreme Court resolves this circuit split, it could force the FDA to reconsider applications from companies like Triton and Vapetasia. But the end result is probably the same.
Oldham noted that the FDA “believes its erratic conduct should be viewed as harmless because the agency is committed to denying applicants’ applications even though we require the agency to comply with the law.” He said the appeals court nonetheless expected FDA “will provide applicants during remand the benefit of a full and fair regulatory process, despite FDA’s prior commitment to deny their applications regardless.” Given the broad powers granted by the Tobacco Control Act, the vague standards set forth, and The FDA’s determination to prevent adults from purchasing the e-cigarette products they love seems unrealistic to expect.
