Mh Global LLC v. Fda

NOT FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

MH GLOBAL LLC,

Petitioner, v.

U.S. FOOD & DRUG ADMINISTRATION, Respondent.

No. 21-71327

MEMORANDUM^*

On Petition for Review of an Order of the Food & Drug Administration

Argued and Submitted June 11, 2026 San Francisco, California

Before: NGUYEN and VANDYKE, Circuit Judges, and HUIE, District Judge.^** This case arises from the Food and Drug Administration's ("FDA") denial of MH Global's applications to market flavored electronic nicotine delivery systems ("ENDS") under the Tobacco Control Act's ("TCA") premarket authorization regime. To obtain authorization, MH Global was required to demonstrate that * This disposition is not appropriate for publication and is not precedent except as provided by Ninth Circuit Rule 36-3.

** The Honorable Robert S. Huie, United States District Judge for the Southern District of California, sitting by designation.

FILED

AUG 18 2026

MOLLY C. DWYER, CLERK

U.S. COURT OF APPEALS

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2 21-71327 marketing its flavored ENDS products would be "appropriate for the protection of the public health" ("APPH"). 21 U.S.C. § 387j(c)(4). FDA denied MH Global's applications because MH Global failed to provide reliable evidence that its flavored products offered cessation or switching benefits beyond those available from tobacco-flavored alternatives, while the evidence of youth-initiation risk was substantial. MH Global raises two principal challenges on appeal. It argues that

(1) FDA's comparative-efficacy framework misreads the TCA's APPH standard by requiring evidence that flavored products provide greater cessation benefits than tobacco-flavored products; and (2) FDA could adopt that framework only through notice-and-comment rulemaking.

We have jurisdiction under 21 U.S.C. § 387l(a)(1)(B). We review FDA's marketing denial orders under the Administrative Procedure Act ("APA"), see 21 U.S.C. § 387l(b), and set them aside only if they are "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," 5 U.S.C. § 706(2)(A). See Lotus Vaping Tech., LLC v. FDA, 73 F.4th 657, 668 (9th Cir. 2023). We deny the petition.

1. FDA's comparative-efficacy framework is consistent with the TCA's APPH standard. The TCA requires FDA to evaluate "the risks and benefits to the population as a whole," including the likelihood that nonusers will begin using tobacco products and that existing users will stop. 21 U.S.C. § 387j(c)(4). "These

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3 21-71327 considerations are inherently comparative." Lotus Vaping, 73 F.4th at 669. In the ENDS context, FDA therefore must "weigh the risk of hooking new users on tobacco products against a product's potential to help existing users switch from unhealthier forms of tobacco." Id. As we recently explained in Drip More LLC v. FDA, No. 21-71380, --- F.4th ---, Slip Op. (9th Cir. Aug. 10, 2026), FDA has the authority to require comparative evidence, including evidence comparing flavored products with tobacco-flavored products. See id. at 20-22; see also FDA v. Wages & White Lion Investments, LLC, 604 U.S. 542, 578-79 (2025); Lotus Vaping, 73 F.4th at 661, 668-70.

FDA reasonably applied that statutory framework. It found that flavored ENDS pose a substantial risk of youth initiation and nicotine addiction because flavors increase palatability, repeated use, and nicotine exposure. FDA also recognized that ENDS may benefit adults who switch completely from combustible cigarettes. But because tobacco-flavored products may offer similar benefits with less youth appeal, FDA reasonably required reliable, product-specific evidence that MH Global's flavored ENDS would produce greater cessation or switching benefits. See 21 U.S.C. § 387j(c)(4). MH Global submitted no randomized controlled trial, longitudinal study, or comparably robust evidence establishing such an advantage. FDA therefore reasonably concluded that MH Global had not carried its burden.

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4 21-71327 MH Global's remaining contentions do not alter that conclusion. FDA considered the relevant population-level risks and benefits, including the effects on adult smokers and youth nonusers. Without reliable evidence that MH Global's flavored products would yield greater cessation or switching benefits than tobacco- flavored alternatives, neither the products' asserted downstream benefits nor their greater popularity established that marketing them would be APPH. FDA's comparative framework is grounded in the TCA's text and supported by precedent, and the agency reasonably applied it to MH Global's applications. MH Global therefore has not shown that FDA acted arbitrarily, capriciously, or contrary to law.

2. FDA was not required to adopt its comparative-efficacy framework through notice-and-comment rulemaking. As discussed above, that framework flows from the TCA's text. See 21 U.S.C. § 387j(c)(4); Wages, 604 U.S. at 578-

79. And unless Congress provides otherwise, an agency generally may develop regulatory standards "either by general [legislative] rule or by individual order" in an adjudication. Wages, 604 U.S. at 565 (alteration in original) (quoting SEC v. Chenery Corp., 332 U.S. 194, 202-03 (1947)); see also Drip More, Slip Op. at 28-

33. MH Global identifies no provision of the TCA requiring FDA to proceed by rulemaking before applying the framework to premarketing applications. See Drip More, Slip Op. at 28-33. Moreover, Wages recognized that FDA has "discretion

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5 21-71327 to work out the meaning of the TCA's comparative standard when evaluating premarket tobacco product applications." 604 U.S. at 582. FDA exercised that discretion here by applying the TCA's statutory criteria through its comparative- efficacy framework, balancing the evidence of youth-initiation risk against the absence of evidence that MH Global's flavored products offered greater cessation or switching benefits than tobacco-flavored alternatives. Nor does FDA's use of similar reasoning in denying other flavored ENDS applications transform its product-specific adjudications into a legislative rule. See Drip More, Slip Op. at 35. FDA remained open to other forms of sufficiently reliable and robust evidence and to applications capable of demonstrating benefits sufficient to outweigh—or measures sufficient to mitigate—the risks to youth. That flexibility is underscored by FDA's recent authorization of four additional flavored ENDS products—two menthol, one mango, and one blueberry—based in part on product-specific measures designed to restrict youth access. See id. FDA therefore applied statutory criteria in an adjudication rather than promulgating a binding rule.¹ See id. at 27-33; cf. Lotus Vaping, 73 F.4th at 670- 72, 678 (holding that FDA neither imposed a new evidentiary standard nor engaged in a "surprise switcheroo").

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PETITION DENIED.²

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