The U.S. Ninth Circuit Court of Appeals upheld the Food and Drug Administration’s (FDA) decision to deny MH Global LLC’s marketing applications for flavored electronic nicotine delivery systems (ENDS). The court held that the FDA’s requirement for companies to demonstrate that flavored products offer greater benefits for cessation or switching compared with tobacco-flavored products during Premarket Tobacco Product Application (PMTA) reviews is consistent with the Tobacco Control Act’s (TCA) “appropriate for the protection of the public health” (APPH) standard. The court also determined that the FDA did not need to establish this comparative-efficacy framework through formal notice-and-comment rulemaking.
Key Takeaways From the Ninth Circuit Ruling
- The Ninth Circuit rejected MH Global LLC’s appeal against the FDA’s denial of its flavored ENDS marketing applications.
- The court affirmed that the FDA can require applicants for flavored ENDS products to provide evidence demonstrating greater cessation or switching benefits compared with tobacco-flavored products.
- The court held that this comparative-efficacy framework is consistent with the TCA’s “appropriate for the protection of the public health” (APPH) standard.
- The court determined that the FDA does not need to go through notice-and-comment rulemaking before applying this framework in individual PMTA reviews.
- The ruling reinforces the evidentiary requirements facing companies seeking authorization for flavored ENDS products in the U.S. market.
Ninth Circuit Upholds FDA Decision in MH Global Case
On August 18, 2026, the U.S. Court of Appeals for the Ninth Circuit issued its memorandum decision in MH Global LLC v. U.S. Food and Drug Administration, No. 21-71327. The court upheld the FDA’s denial of MH Global’s applications to market flavored ENDS products. The ruling was reported publicly on August 26, but the court filing itself was dated August 18, 2026.
The court held that the FDA’s requirement for applicants to demonstrate additional cessation or switching benefits compared with tobacco-flavored alternatives is consistent with the Tobacco Control Act’s APPH standard.
The case centered on MH Global’s applications submitted through the TCA’s Premarket Tobacco Product Application (PMTA) pathway. The FDA had denied the applications after concluding that MH Global had not provided reliable evidence showing that its flavored products offered greater cessation or switching benefits than tobacco-flavored alternatives. The agency also considered the potential risks associated with youth initiation.
Why the FDA Uses a Comparative-Efficacy Framework
The Ninth Circuit upheld the FDA’s comparative-efficacy framework, finding that it is consistent with the TCA’s APPH requirement.
Under the TCA, the FDA must consider the risks and benefits of a tobacco product to the population as a whole. This includes considering the likelihood that non-users will begin using tobacco products and the likelihood that existing tobacco users will stop using them. The court noted that these considerations are inherently comparative.
For flavored ENDS products, this means the FDA can weigh potential benefits for adult users against the risks of attracting new or younger users. The agency can therefore compare a flavored product with a tobacco-flavored alternative when evaluating whether the product is appropriate for the protection of public health.
Youth Risk and Adult Switching Benefits Remain Central to PMTA Review
The FDA found that flavored ENDS could present a substantial risk of youth initiation because flavors may increase product appeal and encourage repeated use. At the same time, the agency recognized that ENDS products may provide potential benefits for adults who completely switch from combustible tobacco products.
The issue in the MH Global case was therefore not whether flavored products could provide benefits to adult consumers. Instead, the question was whether MH Global had provided sufficient product-specific evidence showing that its flavored products offered greater cessation or switching benefits than tobacco-flavored alternatives.
The court agreed with the FDA’s approach. Because tobacco-flavored products could potentially provide similar switching benefits while presenting less youth appeal, the FDA was entitled to require reliable evidence demonstrating an additional benefit from the flavored products.
MH Global Did Not Provide Sufficient Comparative Evidence
The Ninth Circuit also upheld the FDA’s conclusion that MH Global had not met its evidentiary burden.
According to the court, MH Global did not submit randomized controlled trials, longitudinal studies, or comparable evidence establishing that its flavored ENDS products produced greater cessation or switching benefits than tobacco-flavored alternatives.
The court therefore concluded that the FDA reasonably determined that MH Global had not demonstrated that marketing the products would be APPH under the TCA.
FDA Did Not Need Notice-and-Comment Rulemaking
MH Global also argued that the FDA could not establish its comparative-efficacy framework through individual PMTA decisions and instead needed to use the formal notice-and-comment rulemaking process.
The Ninth Circuit rejected that argument.
The court explained that the comparative framework is grounded in the statutory language of the TCA. Unless Congress specifically requires an agency to proceed through rulemaking, an agency may generally develop regulatory standards through either rulemaking or individual adjudications.
In this case, the court found no provision of the TCA requiring the FDA to complete notice-and-comment rulemaking before applying its comparative-efficacy framework to PMTA applications.
What the Ruling Means for Flavored ENDS Applications
The decision does not create an automatic ban on all flavored ENDS products. Instead, it provides further clarification about the type of evidence the FDA may consider when reviewing flavored products under the PMTA pathway.
The court also noted that the FDA remained open to sufficiently reliable evidence and to applications that could demonstrate benefits capable of outweighing or mitigating youth-related risks. The decision therefore does not establish that flavored products can never receive authorization.
For companies seeking to enter the U.S. market, however, the ruling highlights the importance of product-specific scientific evidence. Applicants may need to demonstrate not only potential benefits for adult tobacco users but also why those benefits are greater than those available from tobacco-flavored alternatives, particularly when youth-initiation risks are a concern.
Implications for Future PMTA Submissions
The MH Global decision adds another important development to the ongoing legal debate surrounding FDA’s PMTA review of flavored ENDS products.
For manufacturers and applicants, the case highlights several practical considerations: robust scientific evidence, product-specific data, credible evidence of cessation or switching benefits, and a clear assessment of potential youth risks.
The Ninth Circuit’s ruling also confirms that the FDA can apply its comparative-efficacy approach during individual PMTA reviews without necessarily establishing the framework through a separate notice-and-comment rulemaking process.
As a result, companies preparing flavored ENDS applications for the U.S. market should expect scrutiny of both the potential adult benefits and the possible population-level risks associated with their products.
