Vertigo Vapor, L.L.C. v. FDA

Case: 24-60272 Document: 252-1 Page: 1 Date Filed: 08/19/2026 United States Court of Appeals for the Fifth Circuit United States Court of Appeals ____________ Fifth Circuit FILED No. 24-60272 August 19, 2026 ____________ Lyle W. Cayce Clerk NicQuid, L.L.C.; Wood Creek Vapory, Petitioners, versus Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services, Respondents, consolidated with _____________ No. 24-60304 _____________ Breeze Smoke, L.L.C.; Texas Wholesale, Petitioners, versus Food & Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services; Marty Makary, Commissioner, U.S. Food and Drug Administration, Respondents, Case: 24-60272 Document: 252-1 Page: 2 Date Filed: 08/19/2026 consolidated with _____________ No. 24-60332 _____________ Vertigo Vapor, L.L.C., doing business as Baton Vapor; Max & Zach’s Vapor Shops Incorporated, Petitioners, versus Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services, Respondents, consolidated with _____________ No. 24-60424 _____________ Lead by Sales, L.L.C., doing business as White Cloud Cigarettes; JP-MAXX, L.L.C., doing business as Jail Puff Max, Petitioners, versus Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services, Respondents, 2 Case: 24-60272 Document: 252-1 Page: 3 Date Filed: 08/19/2026 consolidated with _____________ No. 24-60628 _____________ Vapermate, L.L.C.; Vape Away, L.L.C., Petitioners, versus Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services, Respondents, consolidated with _____________ No. 25-60098 _____________ Elite Brothers, L.L.C.; Clouds Vapors, L.L.C., Petitioners, versus U.S. Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services, Respondents, 3 Case: 24-60272 Document: 252-1 Page: 4 Date Filed: 08/19/2026 consolidated with _____________ No. 25-60369 _____________ American Vapor Company, L.L.C., Petitioner, versus Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services, Respondents. ______________________________ Petitions for Review of an Order of the Food and Drug Administration Agency No. PM0003712PD1 Agency No. PM0003303.PD1 Agency No. PM0000975.PD21 Agency No. PM0003477 Agency No. PM0003735 Agency No. PM0002354.PD27-PD28 Agency No. PM0004614.PD01-PD43, PD48-PD95 ______________________________ Before Higginbotham, Smith, and Oldham, Circuit Judges. Jerry E. Smith, Circuit Judge: These petitioners petition for review of a marketing denial order of the Food and Drug Administration (“FDA”). For the reasons explained, we grant review, vacate the order, and remand. 4 Case: 24-60272 Document: 252-1 Page: 5 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 The Family Smoking Prevention and Tobacco Control Act (“TCA”) prohibits marketing new tobacco products without authorization from the FDA and provides that the agency “shall deny” a new premarket tobacco product application (“PMTA”) unless the applicant shows that its product would be “appropriate for the protection of the public health” (the “APPH” standard). 21 U.S.C. § 387j(c)(2)(A). The TCA defines “tobacco product” as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any com- ponent, part, or accessory of a tobacco product.” Id. § 321(rr)(1). To identify whether a tobacco product is APPH, the FDA must eval- uate “the risks and benefits to the population as a whole,” taking into account both the “likelihood that those who do not use tobacco products will start using such products” and the “likelihood that existing users of tobacco prod- ucts will stop.” Id. § 387j(c)(4). For cessation-oriented products such as e-cigarettes, the APPH standard introduces a calculus comparing initiation of new users with cessation by old users, which FDA calculates based on “well-controlled investigations” or other “valid scientific evidence” that is “sufficient to evaluate the tobacco product.” 1 Petitioner NicQuid, LLC, is a maker of electronic nicotine delivery systems (“ENDS”), while co-petitioner Wood Creek Vapory sells various vaporized-nicotine related products. 2 NicQuid submitted a PMTA applica- _____________________ 1 21 U.S.C. 387j(c)(5); FDA v. Wages & White Lion Invs., L.L.C., 604 U.S. 542, 572 (2025). 2 NicQuid manufactures nicotine salt liquids, which are used in “open-system” ENDS, as distinguished from the pre-filled cartridges that are combined with delivery devices in “closed-system” ENDS. For consistency across the several consolidated cases, we use ENDS throughout, while acknowledging that NicQuid makes an ENDS-related tobacco product regulated under the same law. The consolidated cases all present substan- tially equivalent fact-patterns and legal claims, including No. 24-60304, Breeze Smoke, 5 Case: 24-60272 Document: 252-1 Page: 6 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 tion, which the FDA denied under its “comparative-efficacy standard” 3 on May 3, 2024, through a marketing denial order (“MDO” or “the Order”). Petitioners timely petitioned for review per 21 U.S.C. § 387l(a)(1)(B). FDA centrally contends that its denial of the company’s application complies with FDA v. Wages & White Lion Investments, L.L.C., 604 U.S. 542 (2025) (“Wages”), reversing Wages and White Lion Invs., L.L.C. v. FDA, 90 F.4th 357 (5th Cir. 2024) (en banc). Petitioners primarily assert that FDA’s application of the comparative efficacy standard, as shown in the MDO itself and two internal agency mem- oranda that allegedly mandated FDA employees to apply the “comparative efficacy study requirement” to all PMTAs and thereby forced denial of any application lacking such a study, was arbitrary and capricious or otherwise violated due process. Petitioners posit that the comparative efficacy standard counts as a substantive standard under governing principles of administrative law and was adopted in circumvention of the statutory notice-and-comment rulemaking procedure in the TCA or in violation of the foundational notice- and-comment rulemaking requirements of the Administrative Procedure Act (“APA”). Petitioners further maintain that FDA failed to give NicQuid fair notice of its change in position regarding the comparative efficacy analysis and regarding its enforcement policy specifically with respect to menthol- flavored products. Petitioners’ contention that application of the comparative efficacy standard was arbitrary and capricious is foreclosed by Wages, 4 where the Court held that FDA did not unlawfully change its position regarding what _____________________ L.L.C. v. FDA, under which heading petitioners previously consolidated their briefing. 3 VDX Distro, Inc. v. FDA, 179 F.4th 356, 360 (5th Cir. 2026). 4 Wages, 604 U.S. at 571–72; id. at 578–79. 6 Case: 24-60272 Document: 252-1 Page: 7 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 information must be included in a PMTA when applying the comparative efficacy standard to PMTAs for non-tobacco flavored vapes (fruit, candy, and dessert-flavored products). The question whether the comparative effi- cacy standard amounts to a “tobacco product standard” within the statutory definition of the TCA—and therefore whether it would need to be adopted under the TCA’s notice-and-comment rulemaking procedure—is likewise foreclosed by VDX Distro. Nevertheless, we credit petitioners’ APA argument regarding the notice-and-comment requirement under this circuit’s doctrine that a sub- stantive rule binding an agency to one course of action and prospectively applying to an unbounded set of parties triggers APA requirements and due process concerns. 5 A fortiori, we observe that both the Supreme Court in Wages and this court in VDX Distro specifically reserved rulings on APA notice-and-comment rulemaking, in each case refusing to rule on those grounds. 6 We take up those courts’ invitations and hold that the comparative _____________________ 5 R.J. Reynolds Vapor Co. v. FDA, 65 F.4th 182, 192–94 (5th Cir. 2023) (quoting Texas v. EEOC, 933 F.3d 433, 441 (5th Cir. 2019) (quoting Syncor Int’l Corp. v. Shalala, 127 F.3d 90, 94 (D.C. Cir. 1997))); id. at 193 (“[A] substantive rule ‘affects the rights of broad classes of unspecified individuals.’”) (quoting City of Arlington v. FCC, 668 F.3d 229, 242 (5th Cir. 2012) (citing MacLean v. DHS, 543 F.3d 1145, 1161 (9th Cir. 2008) (agency action constituting “de facto rulemaking” “may require a notice and comment period”))); see also Texas v. United States, 809 F.3d 134, 171 (5th Cir. 2015) (“While mindful but suspi- cious of the agency’s own characterization, we . . . focus[] primarily on whether the rule has binding effect on agency discretion or severely restricts it.”) (citation omitted)), aff’d by an equally divided Court, 136 S. Ct. 2271 (2016); Phillips Petroleum Co. v. Johnson, 22 F.3d 616, 619 (5th Cir. 1994) (“This court, however, must determine the category into which the rule falls: ‘[T]he label that the particular agency puts upon its given exercise of admin- istrative power is not, for our purposes, conclusive; rather it is what the agency does in fact.’” (citation omitted) (alteration in original)). 6 Wages, 604 U.S. at 565 ((“[T]heir brief also suggests that the FDA’s decision to issue denials based on standards developed in adjudication violated other provisions of the APA and TCA that . . . required notice-and-comment rulemaking . . . . We did not grant certiorari on that question . . . . Accordingly, we do not reach that question and express no 7 Case: 24-60272 Document: 252-1 Page: 8 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 efficacy standard is a substantive rule that needed to be adopted under the APA’s notice-and-comment requirements so as not to imperil the due- process-protected interests of bound parties. 7 We direct the FDA, on re- mand, either to rethink the rule, to re-adopt it consistently with the APA’s information-forcing procedure that permits the many bound parties to have their say and contribute to rational and sound policy, or to undertake other appropriate proceedings consistent with this opinion. I. Under the TCA’s framework for balancing free market interests in tobacco production and sale with the public health effects and widely recog- nized addictive potential of vaporized tobacco, FDA has provided significant guidance on the APPH standard: If such products result in minimal initiation by children and adolescents while significant numbers of smokers quit, then there is a potential for the net impact at the population level to _____________________ view on its merits.”) (citation omitted); VDX Distro, 179 F.4th at 367 n.9 (“Petitioners’ TCA notice-and-comment attack on the comparative efficacy standard is distinct from a claim based on the APA’s notice-and-comment provisions . . . . We therefore leave for another day the merits of an APA notice-and-comment argument.”). Depending upon how broadly one reads the ratio decidendi of the Supreme Court’s reversal, this court’s en banc suggestion that FDA failed to follow notice-and-comment rulemaking procedures is still convincing. See Wages, 90 F.4th at 384 n.5. 7 R.J. Reynolds, 65 F.4th at 193–94. That opinion has not been vacated, and though its holding on change-in-position is abrogated by the intervening Wages decision, its holding that identifies what is essentially the comparative efficacy standard survives and binds this panel. See id. at 191–92 (discussing the FDA’s internal 2021 memorandum, since re- scinded, showing that “‘the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e., the products could be found [appropriate for the protection of the public health] only if the evidence showed that the benefits of the menthol-flavored ENDS were greater than tobacco-flavored ENDS, which pose lower risk to youth.’”) (quoting Alex Norcia, Memos Show FDA Overruled Science-Office Call to OK Menthol Vapes, Filter Magazine (Dec. 14, 2022), https://bit.ly/3JjjcVi), and declaring the compara- tive efficacy standard a substantive rule, id. at 193 (citing City of Arlington, 668 F.3d at 242). 8 Case: 24-60272 Document: 252-1 Page: 9 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 be positive . . . . If, on the other hand, there is significant initi- ation by young people, minimal quitting, or significant dual use of combustible and non-combustible products, then the public health impact could be negative.[ 8] Following the adoption and implementation of this proposed rule in August, 2016, it became unlawful to market all new ENDS without FDA authoriza- tion. Wages, 604 U.S. at 555. For those products already on the market, the agency announced that it would not take enforcement action based on a product’s lack of premarket authorization for two to three years, ultimately leading to a September 2020 deadline for applications. Id. at 555–56. In the face of rising youth initiation, FDA’s 2020 enforcement policy prioritized action on cartridge-based e-cigarettes with flavors other than tobacco or menthol, such as fruit, candy, and dessert flavors. 9 FDA main- tains that “[t]he evidence shows that the availability of a broad range of flav- ors is one of the primary reasons for the popularity of [e-cigarettes] among youth.” The agency also warned that the crackdown on cartridge-based e-cigarettes in sweet and appealing flavors, such as Juuls, led to a substantial offsetting rise in youth use of fully-disposable models in the same flavors, such as Elf Bars, “underscoring the fundamental role of flavor in driving appeal.” FDA received a large number of PMTAs at the time of the 2020 dead- line and authorized more than three dozen e-cigarette products, most of which are tobacco flavored. 10 The agency determined that those products pose a comparatively low risk of initiation because “interest in tobacco flavor _____________________ 8 79 Fed. Reg. 23,142, 23,147 (Apr. 25, 2014) (FDA proposed rule). 9 FDA, FDA ENDS PMTA Enforcement Guidance (Apr. 2020). 10 FDA, E-Cigarettes Authorized by the FDA (July 2025) (Tobacco Product Market- ing Orders). 9 Case: 24-60272 Document: 252-1 Page: 10 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 is low among youth,” while the same products can benefit “established ciga- rette smokers” who often identify tobacco as their “flavor of interest” and could switch to e-cigarettes “as a way to stop or reduce smoking.” 11 While generally finding that e-cigarettes with flavors other than tobacco pose greater risks to youth, FDA has granted marketing authorization to six menthol-flavored e-cigarettes for which the “evidence submitted by the applicant showed that these menthol-flavored products provided a benefit for adults who smoke cigarettes relative to that of the applicant’s previously authorized tobacco-flavored products.” 12 FDA generally submits PMTAs to an APPH analysis that “considers many factors,” including overall popu- lation health, individual health risk, effects on vulnerable populations, con- sumer understanding and perception, and liability for abuse. 13 At the same time, FDA has refused “to create a series of criteria” that all products must meet to satisfy the APPH standard, while maintaining its intent to conduct an “individualized” assessment of “the risks and benefits of a specific tobacco product . . . based on all of the contents of [the] application.” 14 In guidance, FDA suggested that new long-term clinical or non- clinical studies would likely not be required to support a PMTA, while also recommending that applicants include evidence on the comparative health risks of their ENDS products versus existing products on the market. FDA guidance on flavored products added that “[t]he term flavored ENDS in this review refers to any ENDS other than tobacco-flavored and menthol-flavored _____________________ 11 FDA, Technical Project Lead (TPL) Review of PMTAs 27–32 (May 12, 2022). 12 FDA, FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review (June 21, 2024); FDA, FDA Authorizes Marketing of Tobacco- and Menthol-Flavored JUUL E-Cigarette Products (July 17, 2025). 13 86 Fed. Reg. 55,300; 55,314. 14 Id. at 55,320; 55,390; 55,386. 10 Case: 24-60272 Document: 252-1 Page: 11 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 ENDS . . . . Applications for menthol-flavored ENDS will be addressed separately. When it comes to evaluating the risks and benefits of a marketing authorization, the assessment for menthol ENDS, as compared to other non- tobacco flavored ENDS, raises unique considerations.” In 2020, NicQuid submitted PMTAs for e-liquids in flavors including Menthol Blend, Strawberry-Peach, Spearmint, and Sweet Leaf. All included flavors other than tobacco, while the latter three included sweet flavorings addressed in Wages. 15 NicQuid also submitted an application for a product called “NicQuid Added Burst,” available only in a 00 mg/mL nicotine concentration. In May 2024, FDA issued a marketing denial order (“MDO”), find- ing that NicQuid’s products were not APPH because its PMTA “lack[ed] sufficient evidence demonstrating that your flavored ENDS will provide a benefit to adult users that would be adequate to outweigh the risks to youth.” FDA explained that tobacco use “is almost always started and established during adolescence . . . [and] preventing tobacco use initiation in young peo- ple is a central priority for protecting public health.” FDA stated the availa- ble evidence showed that “flavored [e-cigarettes], including menthol” pres- ent “a known and substantial risk of youth initiation and use.” The agency observed that the rate of youth e-cigarette use had declined from its peak in 2019, coinciding with increased enforcement. _____________________ 15 Wages, 604 U.S. at 578–79. Though petitioners describe Sweet Leaf as a tobacco- flavored product, FDA claims “the record does not support that assertion.” Instead, the agency contends that it found sufficient substantial evidence in the record to evaluate Sweet Leaf as a characterized product—that is, any product containing flavors other than tobacco—citing petitioners’ descriptions of Sweet Leaf as “[a] sweet turn on your favorite bold tobacco flavor,” that “will excite your taste buds” due to its “undertone of sweet and spice.” FDA’s finding “is supported by ‘substantial evidence’ in the ‘existing administra- tive record.’” Id. at 586 (quoting Biestek v. Berryhill, 587 U.S. 97, 102 (2019)). 11 Case: 24-60272 Document: 252-1 Page: 12 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 Despite that decline, FDA still saw e-cigarettes as the most widely used tobacco product among youth, with as many as 2.55 million youth users in 2022, adding that “[t]he evidence shows that the availability of a broad range of flavors is one of the primary reasons for the popularity of [e-cigarettes] among youth” and that “flavors not only facilitate initiation but also promote established regular [e-cigarette] use.” FDA added that studies over time indicated that use of flavored e-cigarettes, as compared to tobacco e-cigarettes, is “associated with progression . . . as well as escalation in the number of days [e-cigarettes] were used.” FDA also rejected NicQuid’s voluntary marketing restrictions, stating that in its experience, such efforts fail to “mitigate the high risk to youth posted by flavored [e-cigarettes]” and that “youth have been able to obtain products, including flavored [e-cigarettes], despite sales restrictions.” The agency discounted NicQuid’s proposed sale restrictions methods as non- novel and inadequate. FDA also considered the evidence of benefits from NicQuid’s fla- vored e-cigarettes and found that the applications “lack[ed] sufficient evi- dence demonstrating that [the] flavored [products] will provide a benefit to adult users that would be adequate to outweigh the risks to youth.” The agency noted that the PMTAs lacked any Randomized Control Trial, longi- tudinal cohort study, or “other evidence that reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on complete switching or significant cigarettes reduction over time among adults who used combustible cigarettes.” FDA stated that the PMTA contained “cross- sectional surveys,” but rejected those as not “evaluat[ing] the specific prod- ucts in the application” or “evaluat[ing] these outcomes based on flavor type to enable comparisons between tobacco and other flavors.” Finally, after FDA’s original submission of a certified administrative 12 Case: 24-60272 Document: 252-1 Page: 13 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 record index in this matter, it filed an amended certified list including two internal agency memoranda. 16 Petitioners claim those memos clearly re- quired FDA employees to deny any PMTA lacking a comparative efficacy study, discussed infra. 17 II. Although the Supreme Court’s and this court’s recent decisions have reduced the number of issues, discounting petitioners’ arguments on fair notice and change-in-position for all flavored products other than menthol, as well as denying their TCA statutory argument, petitioners’ positions on the APA remain viable. We therefore take up the APA argument and do not reach the question of whether the FDA was arbitrary and capricious in applying the comparative efficacy standard to NicQuid’s menthol, tobacco- flavored or zero-nicotine products. A. As a preliminary matter, NicQuid properly petitioned for review in this court, even though its principal place of business is outside the Fifth Circuit. Respondent challenges NicQuid’s choice of venue, despite that co- _____________________ 16 FDA, Memorandum to File from Brian A. King, PhD, MPH: Process for Evaluating Menthol-Flavored ENDS PMTAs (Oct. 25, 2022); FDA, Memorandum to File from Benjamin Apelberg, PhD: Development of the Approach to Evaluating Menthol-Flavored ENDS PMTAs (Oct. 25, 2022). This court is also aware of the 2021 rescinded memo, which a previous panel has criticized as “followed in a check-box ‘scientific review’ form that indicated only whether a PMTA included a randomized controlled trial or longitudinal cohort study.” R.J. Reynolds, 65 F.4th at 193 n.9. 17 For one procedural point, NicQuid and Wood Creek Vapory’s petition was filed before the Supreme Court’s decision in Wages. This court stayed FDA’s marketing denial order under our then-controlling opinion in Wages. The Supreme Court’s decision has led to petitioners’ amending their briefing and waiving their claims with respect to fruit, candy, and dessert-flavored products. Only claims on menthol, tobacco-flavored, and zero- nicotine products remain. 13 Case: 24-60272 Document: 252-1 Page: 14 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 petitioner Wood Creek Vapory has its principal place of business in the Fifth Circuit. FDA posits that the statute governing judicial-review jurisdiction for the TCA, 21 U.S.C. § 387l(a)(1), “any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Colum- bia or for the circuit in which such person resides or has their principal place of business,” denies venue to an out-of-circuit co-petitioner. FDA acknowl- edges that in FDA v. R.J. Reynolds Vapor Co., 606 U.S. 226 (2025), the Court held that a retailer can be sufficiently injured by a marketing denial order to support a petition for review, but that that Court reserved the question whether “each petitioner in a joint petition for review must independently establish venue” under the TCA for this Court to resolve its petition in the first instance. Id. at 240–41. FDA also analogizes to Trump v. CASA, 606 U.S. 831 (2025), suggesting that the equitable relief of APA vacatur and remand should be limited to that necessary to redress a plaintiff’s injury. See id. at 839–47, 851–54. Petitioners insist that venue is proper as to NicQuid and that NicQuid may rely upon Wood Creek Vapory’s residence and principal place of busi- ness in Texas. Petitioners point to several of this court’s decisions, including National Association of Private Fund Managers v. SEC, 103 F.4th 1097 (5th Cir. 2024). There, interpreting an essentially identical jurisdiction and venue statute, 15 U.S.C. § 80b-13(a), this court held that venue was appropriate for all petitioners even though no petitioner apart from the organizational lead petitioner resided within this circuit. Id. at 1109. NicQuid also cites Global Van Lines, Inc. v. ICC, 691 F.2d 773, 774 n.1 (5th Cir. 1982), in which this court approved venue where only one of the petitioners was organized in Texas. Applied here, the analogous reasoning is that if venue is appropriate for Wood Creek Vapory, it works as well for NicQuid. Because these cases were decided pre-CASA, it is worth considering 14 Case: 24-60272 Document: 252-1 Page: 15 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 whether that decision unsettles this conclusion. It does not. CASA stands for the proposition that the Judiciary Act of 1789 does not authorize equitable or injunctive relief for parties that are virtually represented but not actually present. 18 The Court specifically distinguished between the “traditional[]” practice whereby “courts issued injunctions prohibiting executive officials from enforcing a challenged law or policy only against the plaintiffs in the lawsuit” and novel “injunctions—known as ‘universal injunctions’” which “prohibit enforcement of a law or policy against anyone.” 19 NicQuid is an actually present party in an administrative action seeking vacatur and remand, which are equitable remedies authorized under the APA. 20 NicQuid’s participation in this case might still turn on the propriety of joinder, but such argument is unbriefed and therefore forfeited—as well as obvious where a party shares a common demand for relief, as distinguished from making any virtual demand for equitable relief barred by CASA. In sum, National Association, 103 F.4th at 1109, controls this situation, where one of two co-petitioners is appropriately venued in this court. _____________________ 18 CASA, 606 U.S. at 841 (“A universal injunction can be justified only as an exer- cise of equitable authority, yet Congress has granted federal courts no such power.”). 19 Id. at 837. 20 5 U.S.C. § 706(2) (“The reviewing court shall . . . hold unlawful and set aside agency action found to be [variously unlawful]”). We view this as an equitable remedy. See Acheson Hotels, LLC v. Laufer, 601 U.S. 1, 16 (2023) (Jackson, J., concurring) (“As an equitable remedy, vacatur ‘is not granted as a matter of course.’ (quoting Salazar v. Buono, 559 U.S. 700, 714 (2010))); see also Aditya Bamzai, The Path of Administrative Law Remedies, 98 Notre Dame L. Rev. 2037, 2041 (2023) (“By the time of the APA’s adoption in 1946, the ‘set aside’ remedy had come to be equated in many . . . respects with the equitable remedies that formed the backdrop to the APA’s adoption.”); but see T. Elliot Gaiser, Mathura Sridharan & Nicholas Cordova, The Truth of Erasure: Universal Remedies for Universal Agency Actions, U. Chi. L. Rev. (Online) (2024) (“Universal remedies under the APA, however, remain within Article III limits because they are legal, not equitable, remedies created by Congress and available only to resolve true cases or controversies.”). 15 Case: 24-60272 Document: 252-1 Page: 16 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 B. Next, we consider whether the FDA violated the APA’s notice-and- comment rulemaking procedure in developing and applying the comparative efficacy standard to PMTAs. We hold that, in using informal adjudication to promulgate a substantive rule that binds the agency to its enforcement posi- tion, prospectively applies to an unbounded set of applicants, and amounts to a de facto ban, the FDA sidestepped the notice-and-comment rulemaking requirement of the APA. Although, as a policy matter, one might agree with the FDA’s decision severely to police youth access to e-cigarettes, the procedural safeguards of the APA serve to promote informed, rational decisionmaking by adminis- trative agencies. 21 Those safeguards cannot be so easily evaded by saying that the agency’s free choice under Chenery II to use adjudication 22 empowers it to make a prospective decision behind closed doors, adopting a standard that will apply to numerous non-present parties without affording them the due process appropriate to protect their extant and vested commercial interests. 1. Pre-Wages, petitioners claimed that FDA had instituted a de facto restriction or ban on non-tobacco flavored ENDS in violation of the TCA’s notice-and-comment rulemaking procedure. Although petitioners’ theory that the comparative efficacy standard amounts to a statutorily defined _____________________ 21 See Michigan v. EPA, 576 U.S. 743, 750 (2015) (“Federal administrative agencies are required to engage in ‘reasoned decisionmaking.’”) (quoting Allentown Mack Sales & Serv., Inc. v. NLRB, 522 U.S. 359, 374 (1998)). 22 Wages, 604 U.S. at 565 (“Unless Congress has specified otherwise, agencies are generally free to develop regulatory standards ‘either by general [legislative] rule or by indi- vidual order’ in an adjudication”) (quoting SEC v. Chenery Corp., 332 U.S. 194, 202–03 (1947) (Chenery II)). 16 Case: 24-60272 Document: 252-1 Page: 17 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 “tobacco product standard” has recently been rejected in VDX Distro, 179 F.4th at 364, petitioners continue to press their APA arguments in sup- plemental letter briefs. Petitioners centrally argue that the comparative efficacy standard, as applied, amounts to a substantive rule requiring notice-and-comment rule- making, citing R.J. Reynolds Vapor Co. v. FDA, 65 F.4th 182, 193 (5th Cir. 2023)). Petitioners adduce evidence that the FDA has issued MDOs for over 1.2 million flavored ENDS, while only approving four menthol-flavored closed-system ENDS, about 0.000333%. 23 In total, FDA has received applications for more than six million ENDS products, while only approving 45 total ENDS of any variety. 24 Petitioners allege that the agency reviewers were required to deny any PMTA that did not contain comparative efficacy data—binding the FDA to that position—and petitioners add that, while a 2021 internal memo was rescinded, this court has found it “has remained in full effect for all non- tobacco flavored” ENDS (citing R.J. Reynolds, id.). Petitioners therefore demand that the order be set aside under 5 U.S.C. § 706(2)’s provision allowing courts to review agency actions “found to be . . . without observance of procedure required by law.” Post-Wages, petitioners additionally point to the two late-filed FDA _____________________ 23 The FDA’s subsequent approval of four additional e-cigarette products in men- thol, mango, and blueberry flavors does not upset this point. See FDA, Marketing Granted Orders for Glas Inc. (May 5, 2026), https://perma.cc/B4YK-6KBN; FDA Press Release, FDA Expands Market Access, Authorizes New ENDS Products (May 5, 2026), https://perma.cc/4GKB-749T (Press Release). Four more products raise this percentage to only 0.000666%, which this court still considers a low rate of approval suggesting a de facto ban. 24 FDA, E-Cigarettes, “Vapes” and Other Electronic Nicotine Delivery Systems (ENDS) Authorized by the FDA (May 5, 2026), https://perma.cc/YSP4-AJ2M. 17 Case: 24-60272 Document: 252-1 Page: 18 Date Filed: 08/19/2026 No. 24-60272 c/w Nos. 24-60304, 24-60332, 24-60424, 24-60628, 25-60098, 25-60369 internal memoranda 25 as violations of the APA’s notice-and-comment re- quirement. They insist that the memos corroborate the alleged de facto ban and imposed a binding standard on FDA staff, to be applied rigidly and across-the-board in all PMTA reviews of menthol-flavored ENDS. Peti- tioners focus on the Supreme Court’s implication that some statutes may require rulemaking despite the general amphibious approach of Chenery II, while narrowing the Wages holding to reflect only a ruling on change-of- position by an administrative agency, rather than any holding on rulemaking versus adjudication. 26 FDA responds that it did not violate any procedural requirement in using the comparative efficacy standard, which the Supreme Court referred to in Wages as a “comparative-efficacy requirement,” 604 U.S. at 578, and which FDA contends is a permissible development of a point of law through adjudication under Chenery II. FDA notes that the Court stated that the Act “expressly contemplates comparisons of different tobacco products,” id., thereby covering the FDA’s use of cross-sectional survey data to assess com- parative risks. FDA insists that its choice to resolve PMTAs through informal adjudication was not a sufficient departure from prior guidance (which had generally been phrased in conditional language) to amount to an abuse of discretion through change-in-position. 27 FDA also points out that it conducted an individualized assessment of NicQuid’