On April 2, 2025, the U.S. Supreme Court issued its decision in the Wages and White Lion Investments (d/b/a Triton Distribution) Premarket Tobacco Product Application (PMTA) Marketing Denial Order (MDO) challenge. In a 9-0 unanimous ruling, the Supreme Court held that the FDA did not act arbitrarily and capriciously when it denied the PMTA for Triton’s flavored electronic nicotine delivery systems (ENDS) under the “fatal flaw” review standard. 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, according to an article published by Keller and Heckman LLP.
“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,” Keller and Heckman wrote. “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.
“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,” Keller and Heckman wrote. “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.
