By Timothy S. Donahue
Top Takeaways:
- Courts split: Fifth and Ninth circuits reached opposite APA conclusions.
- FDA wins: Ninth Circuit upheld Streamline Vape’s denial.
- Rulemaking fight: Fifth Circuit says comparative efficacy requires notice and comment.
Two federal appeals courts are now at odds over how the FDA can apply its vape review rules.
The U.S. Court of Appeals for the Ninth Circuit upheld the U.S. Food and Drug Administration’s denial of MH Global LLC’s premarket tobacco product applications (PMTAs) for flavored vaping products.
The court ruled that the agency can require comparative evidence showing that flavored products offer greater benefits than tobacco-flavored alternatives and can apply that standard without first conducting notice-and-comment rulemaking — the opposite conclusion reached by the Fifth Circuit last week.
The unpublished decision in MH Global LLC v. FDA, No. 21-71327 sharply contrasts with the Fifth Circuit’s Aug. 19 ruling in NicQuid LLC v. U.S. Food and Drug Administration, which held that the FDA’s comparative-efficacy standard was a substantive rule that could not be imposed lawfully without notice and comment.
MH Global, doing business as Streamline Vape Co., challenged FDA marketing denial orders for flavored electronic nicotine delivery system (ENDS) products. The company argued that the comparative-efficacy requirement was inconsistent with the Tobacco Control Act and that the agency improperly established the standard through individual PMTA decisions rather than formal rulemaking.
The Ninth Circuit rejected both arguments.
The court said the Tobacco Control Act’s appropriate-for-the-protection-of-public-health standard requires the FDA to consider risks and benefits across the population, including whether existing tobacco users will stop using tobacco products and whether nonusers will start using them.
Those considerations are inherently comparative, the court said.
The panel cited its recent Drip More decision, finding that the FDA can require evidence comparing flavored ENDS with tobacco-flavored alternatives.
The FDA determined that flavored vaping products pose substantial risks of youth initiation and nicotine addiction, while acknowledging that ENDS can benefit adults who completely switch from combustible cigarettes.
Because tobacco-flavored vaping products may offer similar benefits with less youth appeal, the agency required MH Global to demonstrate that its flavored products provided greater cessation or switching benefits.
According to the decision, the company did not submit a randomized controlled trial, a longitudinal study, or comparably robust product-specific evidence demonstrating that advantage.
The Ninth Circuit concluded that the FDA reasonably found MH Global failed to meet its burden. The more significant portion of the ruling may be the court’s treatment of the Administrative Procedure Act.
MH Global argued that the FDA’s repeated application of comparative efficacy across flavored ENDS applications effectively created a binding rule that required notice-and-comment proceedings.
The Ninth Circuit disagreed.
The panel said that agencies generally have discretion to develop regulatory standards through either rulemaking or individual adjudications unless Congress requires otherwise. It found no provision in the Tobacco Control Act that requires the FDA to establish comparative efficacy through rulemaking before applying it to individual PMTAs.
The court also concluded that applying similar reasoning across multiple applications did not transform those adjudications into a legislative rule. That conclusion places the Ninth Circuit directly at odds with the Fifth Circuit’s reasoning in the NicQuid case.
Last week, the Fifth Circuit held that comparative efficacy was a substantive rule because it applied prospectively to a broad class of applicants and effectively served as a threshold requirement for flavored ENDS applications.
“We hold that FDA’s comparative efficacy standard amounts to a substantive rule, and that its adoption through informal adjudication contravenes the APA’s notice-and-comment rulemaking requirement,” the Fifth Circuit said in that case.
The Ninth Circuit reached the opposite conclusion, finding that the FDA retained sufficient flexibility to consider different forms of reliable evidence and applications capable of demonstrating benefits that outweigh or mitigate youth risks.
The court cited the FDA’s recent authorization of four flavored Glas vaping products — two menthol, one mango, and one blueberry — with product-specific youth-access restrictions as evidence of that flexibility.
The split involves an issue the Supreme Court left unresolved in its 2025 Wages & White Lion decision. The high court largely sided with the FDA in that case but declined to decide whether the agency’s comparative-efficacy approach required notice-and-comment rulemaking under the APA.
The conflicting appellate rulings now leave the FDA’s comparative-efficacy approach subject to materially different interpretations in two federal circuits, potentially increasing the importance of further appellate proceedings on how the agency may apply the standard.
