Two federal circuit courts reached opposite conclusions in August 2026 on the same regulatory question, creating a circuit split that is likely headed for Supreme Court review. The split involves the FDA's authority to deny premarket tobacco product applications for flavored e-cigarettes by applying a comparative-efficacy standard, which the agency adopted through guidance rather than notice-and-comment rulemaking. The outcome of that dispute will shape the regulatory posture of vaping-product manufacturers for years and, in the process, affect how plaintiffs in product liability cases against those manufacturers are positioned at trial.
The FDA's PMTA Framework
Under the Family Smoking Prevention and Tobacco Control Act, no new tobacco product may be sold without FDA premarket authorization through a premarket tobacco product application. The PMTA standard requires the applicant to show that permitting the marketing of the product would be "appropriate for the protection of the public health." That determination is a population-level analysis: the FDA evaluates both the benefit to existing smokers who might switch to a less harmful product and the risk of initiating tobacco use among non-smokers, particularly youth.
Beginning in 2021, the FDA began denying PMTAs for flavored e-cigarettes by applying a comparative-efficacy standard, concluding that manufacturers had not shown that their flavored products offered meaningfully greater cessation benefits than tobacco-flavored alternatives. The FDA applied this standard through guidance documents and review procedures rather than through a notice-and-comment rulemaking under the Administrative Procedure Act.
The Ninth Circuit Upholds the FDA
In August 2026, a unanimous Ninth Circuit panel upheld the FDA's denial of premarket applications for a manufacturer's flavored e-liquid products. The panel concluded that the FDA's comparative-efficacy framework was a reasonable exercise of the agency's scientific judgment under the PMTA statute and that the framework did not constitute a substantive rule requiring APA notice-and-comment procedures. The Ninth Circuit's reasoning emphasized the scientific and interpretive nature of the FDA's comparative analysis, treating it as an application of existing statutory criteria rather than the creation of new legal obligations.
The ruling denied the manufacturer's petition for review, leaving intact the Marketing Denial Orders that covered its full line of fruit- and candy-flavored products. The decision added the Ninth Circuit to the group of circuits that have sustained FDA's PMTA denial authority under the comparative-efficacy approach.
The Fifth Circuit Reaches the Opposite Result
Six days before the Ninth Circuit's ruling, the Fifth Circuit issued NicQuid LLC v. FDA (5th Cir. Aug. 2026), holding that the FDA's comparative-efficacy standard was a substantive rule that could not lawfully be imposed on PMTA applicants without first undergoing APA notice-and-comment rulemaking. The Fifth Circuit concluded that the standard imposed new legal obligations on manufacturers and fundamentally changed the criteria against which their applications were evaluated, requiring the procedural protections of the APA's rulemaking process.
The result was a grant of the manufacturer's petition, vacating the marketing denial orders for NicQuid's flavored products in the Fifth Circuit's geographic footprint. Depending on where a manufacturer's products are sold and distributed, the applicable circuit's position now determines whether FDA marketing denial orders are valid or vacated, creating a geographic patchwork of regulatory authority.
What the Split Means for SCOTUS Review
The circuit split is clean and direct: two circuits, the same regulatory question, opposite results on the same administrative law issue. That configuration is the paradigm case for Supreme Court certiorari review, and practitioners should assume the question will reach the Court. A grant in the October 2026 or October 2027 term is plausible given the significance of the regulatory stakes and the breadth of commercial interests on both sides.
The outcome matters beyond e-cigarette regulation. The case touches on a recurring administrative law debate about when agency guidance documents and interpretive rules cross the line into substantive rulemaking. In the post-Chevron environment following Loper Bright Enterprises v. Raimondo (2024), courts are independently evaluating the statutory authority for agency standards rather than deferring to agency interpretations. How the Supreme Court resolves the vaping split will be watched by administrative law practitioners across every regulated industry.
Product Liability Implications for PI Practitioners
For plaintiff counsel pursuing claims against e-cigarette manufacturers, the regulatory split has several concrete effects:
- FDA denial as evidence of inadequate product testing. A marketing denial order, even where vacated by the Fifth Circuit's ruling, reflects the FDA's documented conclusion that the manufacturer did not adequately demonstrate population-level safety. In jurisdictions where FDA denial orders remain valid, plaintiff counsel can argue that the manufacturer sold a product the agency determined was not justified by the evidence. That argument supports both warning-defect and design-defect theories.
- Preemption analysis shifts by circuit. The Tobacco Control Act's preemption provisions bar state-law requirements that are "different from or in addition to" federal FMTCA requirements. Where the FDA's comparative-efficacy standard is upheld as a valid federal requirement, the preemption analysis tightens. Where the Fifth Circuit vacates the standard, the federal regulatory floor may be lower, paradoxically giving more room for state-law failure-to-warn claims in those jurisdictions.
- Manufacturer preemption defenses weaken where the denial is vacated. A manufacturer whose PMTA was vacated by the Fifth Circuit cannot argue that compliance with a valid federal approval regime preempts state tort law claims, because the federal approval was legally defective. This is a counterintuitive result of the circuit split that plaintiff counsel in Fifth Circuit states should understand and anticipate when facing preemption motions.
For PI practitioners tracking the vaping litigation in their jurisdictions, the circuit position of the relevant federal court now controls part of the preemption analysis in pending cases. The product liability framework for defect claims against manufacturers, including chain-of-custody and warning-defect theories, is covered at lawyerstrend.com/category/product-liability. Settlement benchmarks and ongoing appellate developments in multi-party products cases are tracked at lawyerstrend.com/category/case-law-settlements.