Ninth Circuit Upholds FDA's Flavored Vape Denials Amid Judicial Split on PMTA Rule

Executive summary

The U.S. Court of Appeals for the Ninth Circuit has upheld the FDA’s denials of multiple flavored e-cigarette applications under the Pre-Market Tobacco Product Application (PMTA) process, citing insufficient evidence of public health benefit. The ruling reinforces the agency’s application of the comparative-efficacy standard, which requires manufacturers to demonstrate that their products reduce harm relative to combustible cigarettes. This decision deepens a national split among federal appellate courts, with the Fifth Circuit having previously struck down the same rule as arbitrary. The outcome increases compliance risk for vape manufacturers and signals a more aggressive stance on flavored products, particularly those marketed to youth.

Regulatory signal: The FDA’s comparative-efficacy rule is now upheld in one major circuit, increasing pressure on manufacturers to submit robust harm-reduction data.

What happened

The Ninth Circuit affirmed the FDA’s denial of PMTA applications for several flavored e-cigarette products, including mint, fruit, and candy-flavored pods and cartridges. The agency had rejected the applications on the grounds that applicants failed to meet the comparative-efficacy standard established under the 2022 Deeming Rule amendments. The court found that the FDA’s interpretation of the standard—requiring evidence that a product reduces harm compared to combustible cigarettes—was not arbitrary or capricious. The decision specifically upheld the agency’s conclusion that the available data did not demonstrate that the flavored products were less harmful than traditional cigarettes, particularly when considering youth initiation risks.

Notably, the court did not rule on the broader constitutionality of the PMTA framework but focused on procedural adequacy and the reasonableness of the FDA’s application of the comparative-efficacy criterion. The ruling follows a similar 2024 Fifth Circuit decision that invalidated the same rule, creating a direct conflict between two federal appellate circuits.

Why it matters

This decision marks a pivotal moment in the regulatory evolution of the U.S. vaping market. The comparative-efficacy rule, introduced as part of the FDA’s effort to prioritize harm reduction, has been a flashpoint for industry and public health stakeholders. By upholding the rule in the Ninth Circuit, the court has effectively validated the FDA’s authority to deny products based on their potential to increase youth use, even if they may offer harm reduction for adult smokers.

The split between the Fifth and Ninth Circuits undermines regulatory predictability. With over 70% of U.S. vape sales concentrated in the Ninth Circuit states (California, Oregon, Washington, Nevada, etc.), the ruling has immediate and significant implications for market access. It also raises the stakes for future litigation, as the Supreme Court may be forced to resolve the circuit conflict.

Market impact

Flavored vape products remain a cornerstone of consumer appeal, particularly among adult smokers transitioning from combustible cigarettes. The Ninth Circuit’s decision increases the risk of product removal from shelves in key Western states, especially for small and mid-sized brands without the resources to conduct large-scale comparative-efficacy studies.

Major retailers and e-commerce platforms are likely to preemptively delist products pending PMTA approval, particularly those with flavor profiles associated with youth appeal. This could accelerate consolidation in the market, favoring brands with deep R&D budgets and established regulatory teams.

Manufacturers may shift focus toward non-flavored or minimally flavored products, potentially reducing consumer choice and increasing the risk of relapse among adult smokers who find unflavored options less palatable.

Regulatory impact

The ruling strengthens the FDA’s enforcement posture on flavored products, signaling that the agency will continue to use the comparative-efficacy standard as a gatekeeping mechanism. It also reinforces the FDA’s authority to deny PMTA applications based on youth initiation concerns, even when adult benefit claims are made.

However, the circuit split creates a legal gray zone. Manufacturers in the Fifth Circuit (Texas, Louisiana, Mississippi) may face less stringent scrutiny under the same rule, creating a patchwork of regulatory environments. This inconsistency could lead to cross-state product distribution challenges and increased compliance costs.

Market impact: The decision may trigger a wave of product withdrawals in Western states, with long-term implications for flavor availability and adult smoker retention.

Who is affected

• Small and mid-sized vape brands: Lack the resources to conduct the large-scale clinical and epidemiological studies required to meet the comparative-efficacy standard.
• Flavored product manufacturers: Face heightened risk of PMTA denial, especially those marketing products with candy, fruit, or mint flavors.
• Retailers and e-commerce platforms: May proactively remove unapproved flavored products to avoid enforcement exposure.
• Public health advocates: Divided—some support the restriction on youth-accessible flavors, while others warn of reduced harm-reduction options for adult smokers.
• State regulators: May face pressure to align with federal enforcement or develop parallel frameworks.

Dawsen Take

The Ninth Circuit’s decision reflects a growing judicial acceptance of the FDA’s harm-reduction mandate, even as it intensifies regulatory fragmentation. While the agency’s intent—to reduce youth vaping and promote safer alternatives for adult smokers—is broadly aligned with public health goals, the current enforcement model risks undermining market stability and consumer choice. The lack of a uniform standard across circuits creates operational chaos for national brands and increases the likelihood of Supreme Court intervention.

For the vaping industry, the path forward requires not just compliance with PMTA requirements but also strategic investment in long-term public health data. The era of flavor-driven growth is entering a new phase defined by regulatory scrutiny, not just market demand.

What to watch

Key developments to monitor include:

• The FDA’s response to the circuit split—whether it will seek a Supreme Court review or revise the comparative-efficacy rule.
• Any new PMTA applications submitted with enhanced comparative-efficacy data, particularly from larger manufacturers.
• State-level regulatory actions in Ninth Circuit states, including potential bans or labeling requirements for flavored products.
• Legal challenges from industry groups seeking to harmonize the PMTA framework across circuits.

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Original source: Ninth Circuit Backs FDA Flavored Vape Denials as Courts Split Over PMTA Rule