Supreme Court Sides With FDA on Flavored Vape Denials

In Food and Drug Administration v. Wages and White Lion Investments, LLC, 604 U.S. ____ (2025), the U.S. Supreme Court held that the 5th Circuit erred in setting aside as arbitrary and capricious the FDA’s orders denying the authorization of new e-cigarette products pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009. The Court further held that the Fifth Circuit relied on an incorrect standard to reject the FDA’s claim of harmless error regarding the agency’s failure to consider marketing plans submitted by respondents.

Facts of the Case

The case centers on whether the Food and Drug Administration (FDA) lawfully denied authorizations to market certain electronic nicotine delivery system products—known as electronic cigarettes, e-cigarettes, or vapes. As the Supreme Court noted in its opinion, these products have rapidly gained popularity during the past 20 years, offering existing smokers a potentially safer alternative to traditional combustible cigarettes. At the same time, e-cigarettes carry their own health risks, and the wide variety of cigarette flavors, including not only tobacco and menthol but also fruit, candy, and dessert flavors, appeals to non-smokers, particularly younger Americans.

Under the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), the FDA has broad jurisdiction to regulate tobacco products. Although the Act barred the FDA from banning all regulated tobacco products outright, it prohibited a manufacturer from marketing any “new tobacco product” without FDA authorization. One pathway to authorization of a “new tobacco product” is the submission of a premarket tobacco product application.

The TCA requires the FDA to deny such an application unless an applicant shows that its product “would be appropriate for the protection of the public health.” To determine this, the FDA must consider, among other things, “the risks and benefits to the population as a whole” and “tak[e] into account” the likelihood that users of existing tobacco products will stop. In 2016, in response to the surging youth demand for flavored products, the FDA deemed e-cigarettes “tobacco products.” Given that most e-cigarette products were not marketed in the United States before February 15, 2007, the vast majority of these products qualified as “new tobacco product” under the TCA. Accordingly, most manufacturers of e-cigarette products would need to comply with the TCA’s premarket-authorization regime to continue to sell their products.

To provide manufacturers with adequate time to submit premarket tobacco product applications, the FDA delayed enforcement for two to three years. This permitted e-cigarette products to remain on the market while manufacturers filed their applications

In the lead up to the application deadline, the FDA issued numerous forms of guidance concerning premarket tobacco product applications that orbited around four central themes: (1) the types of scientific evidence that would be required; (2) the importance of cross-product comparisons and investigations; (3) the FDA’s enforcement priorities with respect to device type; and (4) manufacturers’ marketing plans, which were described as “specific restrictions on sale and distribution” meant to deter new smokers from taking up e-cigarette products.

Respondent Wages and White Lion Investments, LLC, doing business as Triton Distribution, and Vapetasia, LLC, submitted applications seeking approval to market and sell flavored e-liquids for open-system e-cigarettes. The FDA denied the applications, concluding they had not provided sufficient scientific evidence to demonstrate that the marketing of their products would be appropriate for the protection of public health. Specifically, the FDA held respondents had not provided evidence from a randomized controlled trial, longitudinal cohort study, or other “robust and reliable” evidence that their dessert-, candy-, and fruit-flavored products had benefits over tobacco-flavored products. Despite previously describing marketing plans as “critical,” the FDA decided “for the sake of efficiency” not to evaluate respondents’ marketing plans. To each denial order, the FDA appended a “Technical Project Lead (TPL) Review,” which reflect the FDA’s evolving understanding of how flavor, regardless of e-cigarette device type, drives youth smoking initiation and nicotine addiction.

Respondents petitioned for judicial review of the FDA’s denial orders under the Administrative Procedure Act (APA). The Fifth Circuit, sitting en banc, granted respondents’ petitions for review and remanded to the FDA. The en banc majority held that the FDA had acted arbitrarily and capriciously by applying application standards different from those articulated in its predecisional guidance documents regarding scientific evidence, cross-flavor comparisons, and device type. The appeals court expressed particular concern about the FDA’s failure to review marketing plans it previously deemed critical and also rejected the FDA’s argument that any errors were harmless.

Supreme Court’s Decision

The Supreme Court vacated the Fifth Circuit’s decision, holding that the FDA’s orders denying the authorization were not arbitrary and capricious. Justice Samuel Alito wrote on behalf of the unanimous Court.

In reaching its decision, the Supreme Court emphasized that the Fifth Circuit’s analysis boils down to a central concern: it faulted the FDA for allegedly changing the requirements for premarket tobacco product applications between the time of itsguidance and the denials of respondents’ applications. To determine whether the appeals court erred, the Court applied its change-in-position doctrine, under which the justices must ask whether the FDA changed course and, if it did, whether it offered satisfactory reasons for the change.

The Court ultimately concluded that FDA’s denial orders were sufficiently consistent with its predecisional guidance—as to scientific evidence, comparative efficacy, and device type—and thus did not run afoul of the change-in-position doctrine.

“Affected parties may have come away with the impression that the agency would apply a less demanding standard of proof than is evident in the denial orders the FDA ultimately issued, but in the end, we cannot say that the FDA improperly changed its position with respect to scientific evidence, comparative efficacy, or device type,” Justice Alito wrote. “With respect to the FDA’s guidance on marketing plans, we clarify the appropriate legal standard governing claims of harmless error, and we remand to the Fifth Circuit to apply that standard in the first instance.”

In his opinion, Justice Alito stressed that court “must exercise appropriate deference” in such cases and can’t substitute their own judgment for that of the agency. “FDA told them in guidance documents that it would do one thing and then turned around and did something different when it reviewed their applications.” But federal administrative law, he added, allows agencies to alter their positions so long as they “provide a reasoned explanation for the change, display awareness that they are changing position, and consider serious reliance interests.”