LUCINDA DEA v. RB HEALTH US LLC (2025)

ORDER GRANTING MOTIONS TO DISMISS

These cases are two of numerous putative class actions filed around the country against manufacturers of over-the-counter (OTC) acne treatments that contain benzoyl peroxide (BPO)—an active ingredient approved by the Food and Drug Administration (FDA) as safe and effective. Plaintiffs contend that BPO unavoidably degrades into the carcinogen benzene and that they would not have bought Defendants' products had they known the products could contain dangerous levels of benzene. The Court previously dismissed three similar actions on preemption grounds, finding the claims that BPO is inherently dangerous inconsistent with the Food, Drug, and Cosmetics Act (FDCA) and FDA regulations. Howard v. Alchemee, LLC, No. 2:24-CV-01834-SB, 2024 WL 4272931, at *1 (C.D. Cal. Sept. 19, 2024). The Court also dismissed the prior complaints in these actions but gave Plaintiffs leave to amend to clarify the basis for their claims. In their continuing efforts to craft a theory of liability that escapes preemption, Plaintiffs now contend that not all BPO-based acne treatments contain unsafe levels of benzene, but Defendants' products do because they degrade to contain more than 2 parts per million (ppm) of benzene during their shelf lives. Defendants move to dismiss the latest amended complaints. The Court held a hearing on March 28, 2025, at which Plaintiffs conceded that their theory depends on a finding that federal law sets a 2 ppm limit on benzene in Defendants' products. Because Plaintiffs have not identified any federal law or regulation imposing such a limit, their claims are preempted.

I.

Although these two cases are not formally related or consolidated, they involve similar allegations by overlapping plaintiffs represented by the same counsel. In O'Dea v. RB Health (US) LLC, No. 2:24-CV-07048-SB, Plaintiffs Lucinda O'Dea and Jamie Heermann assert claims against RB Health (US) LLC for violations of Illinois and Missouri consumer protection statutes, breach of implied warranty, negligent misrepresentation or omission, and unjust enrichment. In O'Dea v. Alchemee, LLC, No. 2:24-CV-07049-SB, nine consumers, including O'Dea and Heermann, bring the same claims against Alchemee, LLC and Taro Pharmaceuticals U.S.A., Inc. (together, Alchemee), along with claims under California and Nebraska consumer protection statutes.¹ Almost all the relevant allegations in Plaintiffs' second amended complaints (SACs) are materially identical. Defendants in each case move to dismiss the SAC, raising substantially similar arguments. The Court therefore considers the motions together, citing to the record in Alchemee unless otherwise noted.

In its order granting Defendants' motions to dismiss the prior pleadings, the Court explained that Plaintiffs sought “to plead around Howard by advancing allegations that Defendants failed to follow the FDA's regulations on Current Good Manufacturing Practices (CGMPs) for manufacturing, processing, packing, and holding drug products,” but also seemed to be advancing the preempted theory that BPO could not be safely used in OTC acne products because it unavoidably degrades into benzene, making the products illegal to sell. Dkt. No. 92 at 3–4. These competing allegations made it impossible to determine what Plaintiffs were trying to allege:

Plaintiffs' contradictory allegations leave the Court—and Defendants—unable to discern Plaintiffs' theory of liability. At bottom, it is unclear whether Plaintiffs intend to allege that BPO can or cannot be safely used in OTC acne treatments. To the extent they contend it cannot, their claims are preempted for the reasons explained in Howard. To the extent Plaintiffs allege that BPO can be safely used as the active ingredient in acne treatments—as the FDA has concluded—they have not adequately alleged what Defendants could have done differently to safely manufacture and market the drugs in compliance with CGMPs while using BPO as the active ingredient. For example, they do not explain how Defendants could “change their formulation or manufacturing process” to safely use BPO. Their lack of specificity is especially problematic in light of their allegations that BPO unavoidably degrades to benzene and that the mere presence of benzene makes the products illegal to sell.

Id. at 4 (citation and footnote omitted). The Court therefore granted the motions to dismiss but, based on Plaintiffs' clarification of their theory at the hearing, allowed them the opportunity to file an SAC “to allege their claims based on CGMP violations resulting in more than 2 PPM of benzene in Defendants' products.” Id. at 6.

Plaintiffs' SACs retain most of their original allegations, with some notable changes. See Dkt. No. 95-2 (redline showing changes from prior pleading). Plaintiffs no longer allege that the mere presence of benzene renders the OTC drugs unsafe, but rather that they contain “unsafe levels of benzene” based on Defendants' failures to follow the CGMPs. See, e.g., Dkt. No. 94 ¶ 11. Relying on FDA and industry guidance, Plaintiffs allege that “benzene in amounts above 2 ppm render the Products unfit for their ordinary purpose.” Id. ¶ 64. The SAC cites a 2024 study for the proposition that not all BPO-based acne treatments contain benzene in unacceptable amounts. Id. ¶ 69. Rather, because benzene degradation occurs rapidly at higher temperatures, “[t]he key to ensuring safe BPO-based pharmaceuticals is ensuring that the BPO contained therein is stored and processed a[t] the proper temperatures,” and proper testing under the CGMPs throughout the products' shelf life will ensure that products containing more than 2 ppm of benzene will not be released. Id. ¶¶ 71–73. The SACs also provide new details about some of the CGMPs Defendants allegedly violated, mostly relating to testing.

The RB Health SAC alleges claims for: (1) violation of the Illinois Consumer Fraud and Deceptive Trade Practices Act (ICFA); (2) violation of the Missouri Merchandising Practices Act (MMPA); (3) breach of the implied warranty of merchantability; (4) negligent misrepresentation or omission; and (5) unjust enrichment. The Alchemee SAC alleges claims for: (1) violation of the ICFA; (2) violations of California's Consumer Legal Remedies Act; (3) violations of California's Unfair Competition Law; (4) violation of the MMPA; (5) violation of the Nebraska Consumer Protection Act; (6) breach of the implied warranty of merchantability; (7) negligent misrepresentation or omission; and (8) unjust enrichment.

Defendants move to dismiss the SACs, raising a variety of arguments under Rules 12(b)(1), 12(b)(6), and 9(b).²

II.

The Court begins, as it must, with Defendants' Article III standing challenges under Rule 12(b)(1). Both motions challenge Plaintiffs' standing generally and, more narrowly, their standing to seek injunctive relief.

A.

As the Court explained in Howard, a complaint must be dismissed under Rule 12(b)(1) if the plaintiff lacks Article III standing to bring suit. Maya v. Centex Corp., 658 F.3d 1060, 1067 (9th Cir. 2011). The standing doctrine is derived from Article III's limitation on the judicial power of federal courts to hear only “actual cases or controversies.” Spokeo, Inc. v. Robins, 578 U.S. 330, 337 (2016) (internal quotation marks omitted). “The doctrine limits the category of litigants empowered to maintain a lawsuit in federal court to seek redress for a legal wrong.” Id. at 338. Standing “is not dispensed in gross; rather, plaintiffs must demonstrate standing for each claim that they press and for each form of relief that they seek.” TransUnion LLC v. Ramirez, 594 U.S. 413, 431 (2021). “The irreducible constitutional minimum of standing consists of three elements. The plaintiff must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo, 578 U.S. at 338 (cleaned up) (quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 560–61 (1992)). A plaintiff must show that the injury was “an invasion of a legally protected interest” that is “concrete and particularized” and “actual or imminent, not conjectural or hypothetical.” Lujan, 504 U.S. at 560 (internal quotation marks omitted). The party invoking federal jurisdiction bears the burden of demonstrating standing. TransUnion, 594 U.S. at 430–31.

B.

In Howard, the Court rejected an argument that Plaintiffs' injury was hypothetical and found standing based on both the alleged unavoidable presence of benzene in the products Plaintiffs purchased and the allegation that Plaintiffs would not have purchased the products if they had known of the risk of benzene. 2024 WL 4272931, at *2–5. The Court noted, however, that “[t]o the extent Plaintiffs are suggesting that the degradation of BPO into benzene is not inevitable, Plaintiffs undermine their standing argument, as the Court could not then assume that the named plaintiffs purchased acne products that decompose into benzene without a more specific showing as to each plaintiff.” Id. at *3 n.4. Seizing on this language, Defendants argue that Plaintiffs lack standing because the SACs do not plausibly establish that they personally bought products with unsafe levels of benzene.

In the SACs, Plaintiffs each allege that they “would not have purchased the Product from Defendants if [they] had known that they were not, in fact, properly manufactured, free from defects, safe for their intended use, not adulterated and misbranded, and legal to sell.” E.g., Dkt. No. 94 ¶ 10. This is enough to establish an Article III injury under controlling law. Two weeks after the Court's ruling in Howard, the Ninth Circuit reversed a dismissal for lack of Article III standing in Bowen v. Energizer Holdings, Inc., 118 F.4th 1134 (9th Cir. 2024), a consumer lawsuit challenging the presence of benzene in sunscreen. There, the plaintiff alleged that she was injured “when she spent money to purchase sunscreen products that she would not otherwise have purchased, or would have paid less for, absent Defendants' misconduct.” Id. at 1144–45 (cleaned up). The Ninth Circuit found this theory of economic injury sufficient, holding that the district court had erred by requiring her to show that the sunscreen she purchased was noncompliant with FDA guidelines to establish injury. Id. at 1146–47. Thus, the plaintiff did not need to show that the sunscreen was actually unsafe to have standing; instead, she “need prove only that she ‘paid more for the product than she otherwise would have paid, or bought it when she otherwise would not have done so’ ” if not for Defendants' misconduct. Id. at 1147 (quoting Hinojos v. Kohl's Corp., 718 F.3d 1098, 1104 n.3 (9th Cir. 2013) (cleaned up)).³

Defendants identify no basis for distinguishing Bowen, and to the extent the Court's dicta in Howard is in tension with the Ninth Circuit's decision in Bowen (which is unnecessary to decide), Bowen controls. Accordingly, Plaintiffs have adequately alleged a cognizable injury in fact, and dismissal for lack of Article III standing is not warranted on this record.

C.

Defendants also raise a narrower challenge to Plaintiffs' standing to seek injunctive relief. The Court declined to address this argument on the prior motions to dismiss, explaining that “it is unclear what injunctive relief—if any—Plaintiffs will seek when they amend their pleadings.” Dkt. No. 92 at 2 n.2. Plaintiffs' amendments did not provide the expected clarity. The SACs contain several vague references to “injunctive relief” without specifying any particular relief Plaintiffs seek. E.g., Dkt. No. 94 ¶ 200 (“Plaintiff Judt and the Nebraska Subclass seek injunctive relief to end Defendants' unlawful practices.”). Their prayers for relief merely request “injunctive relief as pleaded or as the Court may deem proper.” Id. at 53; RB Health Dkt. No. 98 at 42. In their oppositions, Plaintiffs argue that they have standing to seek injunctive relief but again fail to identify any specific relief sought.

In the absence of any specific demand for injunctive relief, the Court cannot analyze whether the unspecified injunction sought “will prevent or redress” an “actual and imminent” concrete injury. Summers v. Earth Island Inst., 555 U.S. 488, 493 (2009). Plaintiffs bear the burden to “demonstrate standing ․ for each form of relief that they seek.” TransUnion, 594 U.S. at 431. Because Plaintiffs have not identified any desired injunctive relief for which they have Article III standing, they have not met their burden. Plaintiffs' claims for injunctive relief are therefore dismissed without prejudice for lack of standing.

III.

Defendants' remaining arguments for dismissal challenge the merits of Plaintiffs' claims under Rule 12(b)(6) and 9(b). Defendants argue globally that Plaintiffs' claims are inconsistent and that they are expressly and impliedly preempted. Defendants also raise pleading challenges to specific causes of action.

A.

To survive a motion to dismiss under Rule 12(b)(6), a plaintiff must allege “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). A claim has “facial plausibility” if the facts pleaded “allow[ ] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In resolving a Rule 12(b)(6) motion, a court must accept all well-pleaded factual allegations as true, but “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice,” and courts “are not bound to accept as true a legal conclusion couched as a factual allegation.” Id. (quoting Twombly, 550 U.S. at 555). Assuming the veracity of well-pleaded factual allegations, a court must “determine whether they plausibly give rise to an entitlement to relief.” Id. at 679. There is no plausibility “where the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct.” Id.

B.

Defendants raise a series of related challenges to the SACs as a whole, contending that the allegations remain internally inconsistent to the point of incoherence, are inconsistent with Plaintiffs' claims in other cases, and still do not provide adequate notice of Plaintiffs' theory of liability.

In Howard, the plaintiffs' allegations “boil[ed] down to a claim that all acne drugs containing BPO are unsafe because they contain benzene, or will degrade into benzene under normal conditions, and benzene is unsafe in any amount.” 2024 WL 4272931, at *7. This theory was expressly preempted because it was “essentially an attack on the FDA's determination that OTC acne drugs containing BPO are ‘generally recognized as safe and effective’ and ‘not misbranded’ if they comply with the monograph.” Id.

Plaintiffs' prior pleadings in these actions contained conflicting allegations that made it unclear whether Plaintiffs were continuing to assert, as in Howard, that BPO cannot be safely used in OTC acne treatments. The SACs improve somewhat on those pleadings and provide enough notice to identify Plaintiffs' central theory of the case. To be sure, they are sprawling (59 pages in Alchemee and 45 pages in RB Health) and contain numerous variations on Plaintiffs' claims of wrongdoing, some of which are not entirely consistent. But it is now clear that Plaintiffs no longer take the position that the use of BPO necessarily makes acne treatments unsafe. Instead, they assert that benzene in excess of 2 ppm is unsafe and prohibited by the FDA. This is more explicit in Plaintiffs' oppositions than in the SACs themselves. See, e.g., Dkt. No. 100 at 1 (“[I]t is not Plaintiffs' position that all BPO-based acne treatments are inherently dangerous or that BPO should not be used in such products. Indeed, most BPO-based acne treatment manufacturers are able get their products to market below the 2 ppm benzene limit, and keep them below that limit during their usable shelf life.”); id. at 2 (“[I]t is possible to manufacture and distribute benzene-free BPO-containing products.”). But the SACs also contain similar allegations. E.g.. Dkt. No. 94 ¶ 69 (“[T]his does not mean that all BPO-based acne treatments contain benzene in unacceptable amounts, if at all.”) (citing study finding that only 34 percent of products tested contained benzene above 2 ppm); id. (“Put differently, some brands are able to either formulate their BPO-based acne treatments or adopt proper manufacturing controls, to ensure that the BPO does not degrade into benzene during the manufacturing or holding process.”).

Thus, instead of alleging that the presence of any benzene in Defendants' products makes them unsafe, Plaintiffs restrict their challenge to products with more than 2 ppm of benzene, contending that they are prohibited by the FDA. See, e.g., id. ¶ 5 (“Benzene is restricted by the FDA to 2 ppm where its use in manufacturing ‘is unavoidable in order to produce a drug product with a significant therapeutic advance.’ ”); id. ¶ 50 (“FDA guidance provides: ‘Solvents in Class 1 [e.g. benzene] should not be employed in the manufacture of drug substances, excipients, and drug products because of [its] unacceptable toxicity.’ Only, if ‘unavoidable,’ may a drug product contain 2 ppm of benzene.”) (footnotes omitted); id. (“[T]he FDA has been clear, it considers benzene contamination above 2 ppm to render any drug adulterated.”); id. ¶ 56 (“[T]he FDA's adoption of the 2 ppm guidance is not limited to a particular class of drugs, but is a general standard that it enforces for all topical OTC drugs.”); id. ¶ 102 (“FDA guidance permits up to 2 ppm benzene in a pharmaceutical product if its use in the manufacturing process is ‘unavoidable.’ ”).

Defendants reasonably raise concerns about inconsistencies in the allegations both within the SACs and between the SACs, the prior pleadings in these cases, and the positions taken by some plaintiffs and their counsel in other similar lawsuits in other courts. The Court need not address these tensions further, however, because even accepting Plaintiffs' new theory of liability as they now seek to frame it, Plaintiffs' claims are preempted.

C.

Defendants argue that Plaintiffs' claims are expressly preempted by 21 U.S.C. § 379r(a), which provides that no state “may establish or continue in effect any requirement—(1) that relates to the regulation of a [nonprescription drug]; and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under” the FDCA. “Consistent with Congress's intent to promote uniform drug regulation, the preemptive effect of § 379r applies not only to state legislation or regulations, but also to claims under state law that would have the effect, if the defendant were liable, of imposing a requirement ‘at variance with FDA regulations.’ ” Howard, 2024 WL 4272931, at *7 (quoting Carter v. Novartis Consumer Health, Inc., 582 F. Supp. 2d 1271, 1283 (C.D. Cal. 2008)). In Howard, the plaintiffs' claims were expressly preempted because they sought “to require Defendants to make disclosures not required under the FDCA that would conflict with the FDA's conclusion that BPO is safe and effective.” Id. at *10.

Plaintiffs' new theory runs into a different preemption problem: it depends on the premise that the FDA limits the benzene that may be present in BPO-based acne medications to 2 ppm. Absent such a federal limit, Plaintiffs' claims are expressly preempted because they impose a requirement that is in addition to and not identical to the FDCA. Plaintiffs' counsel acknowledged as much at the hearing:

THE COURT: And your argument, I take it, does depend upon a finding by the Court that the FDA has set a 2 ppm limit?

[Counsel]: That's correct, Your Honor. And so—but every piece of evidence that has been submitted to the Court so far has suggested just that, including this recent notice of recall.

․

THE COURT: All right. But I want you to give me a direct answer. If the Court were to find that the FDA has not imposed a “2 parts per million” limit, this case would stand for the proposition that there is indeed a limit of 2 parts per million whether the FDA likes it or not.

[Counsel]: Yes, Your Honor.

Dkt. No. 121 at 21:3–9, 22:9–14.

Plaintiffs, however, are unable to identify any provision of the FDCA or any FDA regulation prohibiting benzene in excess of 2 ppm in BPO-based acne medications. The SACs' allegations that benzene is restricted to 2 ppm when its use is “unavoidable” cite to a June 2017 document available on the FDA's website that provides “guidance for industry” as to the amounts of residual solvents considered safe in pharmaceuticals (the Q3C Guidance). Dkt. No. 94 ¶ 5 & n.1. The document does not set benzene limits for Defendants' products for at least two reasons.

First, it is nonbinding. The Q3C Guidance begins with an explanation that “[t]his guidance represents the current thinking of the [FDA] on this topic. It does not establish any rights for any person and is not binding on FDA or the public.” Food and Drug Admin., Q3C—Tables and List Guidance for Industry, 1 (2017), https://www.fda.gov/media/71737/download (Q3C Guidance). Every page is headed by the statement, “Contains Nonbinding Recommendations.” Id. at 1–8. The Ninth Circuit in Bowen noted that such materials on the FDA's website do not “ha[ve] the force of federal law.” 118 F.4th at 1148 n.12. Plaintiffs' counsel conceded as much at the January 3, 2025 hearing on Defendants' motions to dismiss the prior pleadings. Dkt. No. 90 at 23:1–5 (“The federal guideline on 2 parts per million has always—and, you know, counsel will admit that has always been a guideline. It is nonbinding guidance, but it's nonbinding guidance that the FDA regularly asserts in these type[s] of situations.”). Thus, the Q3C Guidance does not impose a legal limit on the benzene in Defendants' products. See Eisman v. Johnson & Johnson Consumer, Inc., No. 2:24-CV-01982-ODW, 2025 WL 241024, at *5 (C.D. Cal. Jan. 17, 2025) (explaining that similar guidance “it is non-binding guidance lacking the force of law” such that “the FDA Guidance does not impose on Defendants an obligation to eliminate benzene from the Products, and [the plaintiff's] claims seeking to do so are not parallel to federal requirements”).

Second, even if the Q3C Guidance had the force of law, it is inapplicable on its face. It provides that solvents including benzene “should not be employed in the manufacture of ․ drug products because of their unacceptable toxicity or their deleterious environmental effect” but that “if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted as shown in Table 1, unless otherwise justified.” Q3C Guidance at 5. The corresponding table sets a 2 ppm concentration limit for benzene. Id. It is undisputed, however, that Defendants do not use benzene as a solvent in manufacturing their acne treatments. Rather, as the SACs allege, Defendants use BPO as the active ingredient in their products (as approved by the FDA), and any benzene they contain comes from degradation of the BPO. Thus, the Q3C Guidance does not even address the benzene in Defendants' products, which is not added as a solvent during their manufacture.

The SAC also cites to other FDA guidance, including a warning to drug manufacturers that they “should not use benzene in the manufacture of drugs,” which references the 2 ppm restriction in the Q3C Guidance. Dkt. No. 94 ¶¶ 50, 58, 111 (quoting FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs, Food and Drug Admin. (Dec. 22, 2022), https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs). That warning states that “[i]f any drug product batches with benzene above 2 ppm are already in distribution, the manufacturer should contact FDA to discuss the voluntary initiation of a recall.” Id. ¶ 58. Like the Q3C Guidance, this warning does not establish a federal prohibition on the sale of Defendants' products with benzene concentrations above 2 ppm. In any event, there is no allegation that Defendants use benzene to manufacture their acne treatments.

Nor have Plaintiffs identified any provision of the FDCA or FDA regulation imposing a 2 ppm benzene limit on Plaintiffs' products (either at the time of manufacture or during their shelf lives). Their citation to the broad definition of adulteration in 21 U.S.C. § 351(a), which encompasses products “consisting] in whole or in part of any filthy, putrid, or decomposed substance,” is insufficient. Dkt. No. 94 ¶ 88. Plaintiffs include this allegation as part of a section of their SACs contending that the presence of any benzene in Defendants' products renders them adulterated. Id. ¶¶ 87–92. The Court rejected this argument in Howard, 2024 WL 4272931, at *9, and Plaintiffs include it merely to preserve it for appeal. Dkt. No. 94 at 26 n.52 (“Plaintiffs acknowledge that this Court has already ruled on, and rejected, this argument. The allegations in ¶¶ 87-92 exist solely to preserve the argument for appeal.”).

In sum, Plaintiffs have not plausibly alleged that the FDCA prohibits Defendants from selling acne medications containing more than 2 ppm of benzene—let alone products that may degrade to contain more than 2 ppm of benzene during their shelf life. As Plaintiffs have appropriately conceded, their claims “depend upon a finding by the Court that the FDA has set a 2 ppm limit.” Dkt. No. 121 at 21:4–6. Because the FDCA and the FDA's regulations establish no such limit, Plaintiffs' claims seek to impose a restriction that is “different from or in addition to, or that is otherwise not identical with” the requirements of the FDCA. 21 U.S.C. § 379r(a)(2). Their claims are therefore expressly preempted and must be dismissed.⁴ See Howard, 2024 WL 4272931, at *7 (explaining that § 379r preempts “claims under state law that would have the effect, if the defendant were liable, of imposing a requirement at variance with FDA regulations”) (cleaned up).

IV.

Defendants' motions to dismiss the SACs are granted. Plaintiffs' claims for injunctive relief are dismissed for lack of Article III standing, and Plaintiffs' claims are otherwise dismissed on the merits for failure to state a claim. The Court will separately issue a final judgment in each case.

FOOTNOTES

1.   Both cases were filed in the Northern District of Illinois and transferred to this district because of their relation to Howard.

2.   Defendants' unopposed requests for judicial notice of various court filings and other matters of public record are granted, although the exhibits are not material to the Court's rulings. Plaintiffs' partial objection to the post-briefing request for judicial notice of the FDA's March 11 notice is sustained. The Court takes judicial notice of the notice's existence but not the truth of facts asserted therein.

3.   At the hearing, defense counsel argued that Koller v. Montsano Company, an unpublished Ninth Circuit decision issued a day earlier, undermined Plaintiffs' standing because it examined whether the plaintiffs in that case had adequately alleged the presence of a carcinogen in the weedkiller products they purchased. No. 24-43, 2025 WL 927188 (9th Cir. Mar. 27, 2025). But Koller reversed the district court's dismissal for failure to state a claim and did not address, let alone cast doubt on, the theory of standing upheld in Bowen and Hinojos. See id. at *3 (“[W]e conclude that the facts alleged in the FAC were sufficient to make plausible the contention that the level of NNG in the products purchased by Plaintiffs and other purchasers will exceed 1 ppm while the consumers possess the products.”).

4.   The Court therefore does not reach Defendants' additional arguments that Plaintiffs' claims are impliedly preempted, that they otherwise fail on the merits, or that they should be stayed or dismissed under the primary jurisdiction doctrine.

Stanley Blumenfeld, Jr. United States District Judge