On April 2, 2025, the U.S. Supreme Court issued its decision in the Wages and White Lion Investments d/b/a Triton Distribution (hereafter “Triton”) Premarket Tobacco Product Application (PMTA) Marketing Denial Order (MDO) challenge. In a 9-0 unanimous ruling, the Supreme Court held that FDA did not act arbitrarily and capriciously when it denied the PMTA for Triton’s flavored electronic nicotine delivery systems (ENDS) (open-system e-liquid products) under the “fatal flaw” review standard. Food & Drug Admin. v. Wages & White Lion Invs., L.L.C., 604 U.S. ___ (2025). While the decision reaffirmed the deference owed to FDA under the Administrative Procedure Act (APA), at least with respect to the agency’s ability to change its position on PMTA requirements, the Court left open several critical issues, including whether the agency committed a potentially prejudicial error by failing to consider applicants’ marketing plans.
As previously reported, Triton’s MDO challenge in the U.S. Court of Appeals for the Fifth Circuit attracted significant attention within the vaping industry’s broader efforts to secure market access for flavored ENDS products. In the lead-up to the Supreme Court’s review, numerous manufacturers had filed petitions in circuit courts across the country challenging FDA’s issuance of boilerplate MDOs for millions of flavored ENDS products. To date, FDA has denied or refused virtually all (>99%) of applications for flavored ENDS products and has only authorized two menthol-flavored products. The MDO appeals yielded conflicting outcomes: the Fifth and Eleventh Circuit held that certain MDOs were arbitrary and capricious under the APA, while the D.C., Second, Third, Fourth, Ninth, and Tenth Circuits upheld the denials. The Supreme Court’s decision to review Triton’s case was widely regarded as pivotal for the regulated industry, public health stakeholders, and FDA, as it promised to resolve the circuit split.
Justice Samuel Alito’s narrowly focused 46-page opinion ultimately fell short of the broader expectations many in the industry had for the Court’s review. Rather than addressing the full range of legal and regulatory questions raised by the parties, the Supreme Court confined its analysis to the APA’s “change-in-position” doctrine—specifically, whether FDA had assured applicants like Triton, through its guidance documents and other public statements, that it would apply one evidentiary standard, only to apply a different one during PMTA review. As Justice Alito framed it, the question was whether FDA “told [Triton] in guidance documents that it would do one thing and then turned around and did something different.” While the ruling provided clarity on this narrow issue, it left several critical questions unresolved, as we discuss below.
Background
Triton submitted its PMTA for flavored e-liquid products ahead of the September 9, 2020, court-ordered deadline. The applications included, among other components, detailed marketing plans developed in reliance on FDA’s guidance documents, the agency’s proposed PMTA rule, and statements made during public meetings. In 2021, however, FDA denied Triton’s applications—along with thousands of others covering millions of non-tobacco flavored ENDS products, the vast majority of which were open-system e-liquids manufactured by small U.S. businesses and vape shops—on the grounds that they lacked “robust and reliable” evidence. Specifically, in order for an accepted and filed application to proceed to the scientific review phase, the agency required the PMTA contain a “comparative efficacy” analysis, supported by clinical or longitudinal studies, such as randomized controlled trials or cohort studies, demonstrating that flavored ENDS products provided a greater benefit to adult smokers than comparable tobacco-flavored ENDS products. Because Triton’s applications did not include such studies, FDA deemed them fatally deficient and denied them without conducting a full scientific review.
Triton petitioned the Fifth Circuit to review the MDO and requested a stay of enforcement. In October 2021, a unanimous three-judge panel granted the stay, finding that the MDO was likely arbitrary and capricious. The stay panel emphasized that FDA must consider the reasonable reliance interests of regulated entities and acknowledge any departure from established policy. The panel criticized FDA for failing to justify its abrupt imposition of a comparative efficacy study requirement, noting that the agency had previously indicated other forms of evidence, such as consumer perception and intention surveys, might be sufficient. The court characterized this shift as a “surprise switcheroo” and faulted the agency for moving the regulatory goalposts. It also concluded that FDA acted arbitrarily and capriciously by failing to consider proposed youth access and marketing restrictions included in Triton’s application.
In July 2022, however, a separate panel reviewing the case on the merits upheld FDA’s MDO. The panel reasoned that Triton had not established legitimate reliance interests because FDA had never unequivocally stated that applicants could rely solely on literature reviews and consumer surveys. The court emphasized that the agency’s guidance and proposed PMTA rule used conditional language, merely suggesting that clinical or long-term studies may not be required in all cases. Similarly, the MDO itself noted that FDA may consider “other” forms of evidence beyond clinical or longitudinal studies. The panel also upheld FDA’s decision not to evaluate Triton’s proposed youth access and marketing restrictions, relying on a 2020 FDA guidance document that expressed skepticism about the effectiveness of such measures—despite the absence of any specific evidence of underage use of Triton’s products. Triton subsequently petitioned the full court for en banc review.
In January 2023, the Fifth Circuit granted Triton’s petition for rehearing en banc. Nearly a year later, on January 3, 2024, the full court reversed the earlier merits panel decision and held that FDA’s denial of Triton’s PMTAs was arbitrary and capricious. The en banc majority concluded that FDA had altered its evidentiary standards without notice and had entirely disregarded the applicants’ marketing plans—despite previously characterizing such plans as “critical” to PMTA review. Writing for the majority, Judge Oldham found that the agency failed to provide fair notice of its requirements, did not acknowledge or explain its change in position, ignored manufacturers’ reasonable reliance on pre-MDO guidance, and attempted to justify its actions through post hoc rationalizations during oral argument. As a result, the court vacated Triton’s MDO and remanded the matter to FDA for further review. The agency subsequently petitioned the Supreme Court for certiorari, which was granted, and an oral argument took place in December 2024.
Supreme Court Ruling
In its opinion authored by Justice Alito, the Supreme Court concluded that FDA had not executed a “surprise switch” in its guidance leading up to the PMTA deadline. Rather, the Court found that the MDOs were reasonably consistent with the agency’s prior guidance—particularly with respect to the type of scientific evidence required, the comparative efficacy standard (i.e., requiring applicants to demonstrate that their flavored ENDS products provide a greater benefit than tobacco-flavored alternatives in helping adult smokers switch from combustible cigarettes), and the treatment of different device types (open vs. closed systems). As to the comparative efficacy requirement specifically, the Court pointed to FDA’s 2020 Enforcement Priorities Guidance, which stated that sweet-flavored ENDS products were more likely to appeal to youth than tobacco- or menthol-flavored products. Accordingly, when FDA denied Triton’s PMTAs for failing to demonstrate that its flavored products outperformed tobacco-flavored ones, the Court found that the agency was simply “following a natural consequence of its predecisional guidance.”
In reaching its determination on fair notice, the Court acknowledged that FDA had issued “voluminous and discursive documents” prior to the PMTA deadline—documents that “paint a picture of an agency that was feeling its way toward a final stance and was unable or unwilling to say in clear and specific terms precisely what applicants would have to provide”—the Court nevertheless concluded that the MDOs were “sufficiently consistent” with the agency’s prior guidance and satisfied the APA’s requirements for a change in policy position.
Next Steps
The litigation surrounding Triton’s MDO is far from resolved. Although the ruling was unanimous for FDA with respect to whether the agency arbitrarily changed its position on the PMTA requirements for flavored products, the Supreme Court avoided addressing several significant APA and constitutional issues raised in both the parties’ and amici briefs. The Court did not address, for example, the constitutional right to due process or the applicability of the major questions doctrine. Nor did it engage in a deeper examination of FDA’s PMTA review process, sidestepping key concerns such as the absence of appropriate tobacco-flavored comparators for companies like Triton, or the lack of clarity regarding the level of benefit required to satisfy the agency’s comparative efficacy standard. Although it vacated the en banc decision, the Supreme Court has remanded the case back to the Fifth Circuit, specifically to consider whether FDA’s refusal to consider Triton’s marketing plans during the application review process was a harmless error, especially given FDA’s prior characterization of such marketing plans as being “critical” to the PMTA.
The remand focusing on FDA’s failure to consider Triton’s marketing plans takes on added weight in light of the Eleventh Circuit’s 2022 decision in Bidi Vapor LLC v. FDA, where the court held that a similar omission by the agency rendered the MDO arbitrary and capricious. Furthermore, the Supreme Court declined to reach (and expressed no view on) Triton’s argument that FDA erred in evaluating its PMTA under standards developed in adjudication rather than standards promulgated in notice-and-comment rulemaking. The Fifth Circuit’s resolution of these issues could have sweeping implications for how FDA must evaluate future PMTAs and respond to procedural challenges under the APA. The remand also presents the vaping industry with a renewed opportunity to advance alternative administrative law claims in a court that has historically viewed FDA’s approach to flavored ENDS products with skepticism.
Whether these challenges move forward, however, may ultimately depend on FDA’s litigation strategy under a new Administration that has forced out many of the leaders and staff at the FDA Center for Tobacco Products, and previously signaled support for flavored vaping products. All eyes now turn to the Fifth Circuit, as both sides consider their next moves in this closely watched case.