1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 LINDSEY DAUGHERTY, et al., Case No. 24-cv-02066-EMC

8 Plaintiffs, ORDER ON DEFENDANTS' MOTION 9 v. TO DISMISS

10 PADAGIS US LLC, et al., Docket Nos. 51, 60 11 Defendants.

12 13 I. INTRODUCTION 14 Plaintiffs Lindsey Daugherty, Tuan Nguyen, Jarad Linn, and Cole Scroggs (collectively 15 “Plaintiffs”) bring this proposed class action against Defendants Padagis (US) LLC and L Perrigo 16 Company (collectively “Defendants”). First Amended Complaint (“FAC”) ¶¶ 1, 8-11 (Dkt. 50). 17 Plaintiffs purchased “Perrigo® branded benzoyl peroxide (‘BPO’) products (collectively the ‘BPO 18 Products’)” in California and Missouri. Id. Plaintiffs allege that Defendants’ BPO Products 19 “contain benzene and/or degrade to form benzene at high levels” and that benzene is a carcinogen. 20 Id. ¶¶ 1-2. Plaintiffs allege that Defendants failed to include product labels alerting or “otherwise 21 warning consumers” of benzene in the BPO Products. Id. ¶¶ 3-4. Plaintiffs only allege economic 22 harm, i.e. they “would not have purchased and used the Products at all or would have paid 23 significantly less for them” had they known that the BPO Products contained/degraded to form 24 benzene. Id. ¶¶ 8-11. 25 Plaintiffs bring seven state law claims against Defendants all related to the alleged 26 misrepresentation and/or warning omission. Before the Court is Defendants’ Motion to Dismiss 27 Plaintiffs’ FAC for: (1) lack of subject matter jurisdiction and (2) failure to state a claim. Motion 1 and Plaintiffs’ administrative motion is denied as moot. 2 II. BACKGROUND 3 A. Factual Background 4 Plaintiffs are four residents of California and Missouri who purchased “Perrigo® Benzoyl 5 Peroxide Acne Treatment Gel 10% BPO, Perrigo® Benzoyl Peroxide Acne Treatment Gel 5% 6 BPO, Perrigo® Benzoyl Peroxide Acne Treatment Gel 2.5% BPO, Perrigo® Benzoyl Peroxide 7 Acne Medication Wash 10% BPO, and Perrigo® Benzoyl Peroxide Acne Medication Wash 5% 8 BPO” (collectively “BPO Products”). FAC ¶ 1, n.1. 9 Defendants manufacture and sell BPO Products, and benzoyl-peroxide is an active 10 ingredient in all of Defendants’ BPO Products. Id. ¶¶ 19-20. Plaintiffs allege that “[a]ll of 11 Defendants’ BPO Products are manufactured in the same manner[, and] [a]ll lots of Defendants’ 12 BPO Products contain or systematically degrade to form benzene.” Id. ¶¶ 21-22. Plaintiffs rely on 13 testing by Valisure LLC, who tested sixty-six benzoyl-peroxide acne treatments, including 14 Defendants’ Perrigo® Benzoyl Peroxide Acne Treatment Gel 5% BPO. Id. ¶ 22. That product 15 was “found to contain over 14 ppm benzene” by Valisure. Id. Benzene has serious health impacts 16 and is a known carcinogen. Id. ¶¶ 24-40. Based on its testing, Valisure submitted a petition to the 17 FDA “requesting a recall and suspension of sales of benzoyl peroxide from the U.S. market.” Id. ¶ 18 41. “Independent testing conducted on BPO Products purchased by Plaintiffs similarly shows 19 benzene levels significantly above the FDA’s recall threshold of 2 ppm.” Id. ¶ 49. Benzene is not 20 listed as an ingredient on the BPO Products labeling, nor are the BPO Products designed to 21 contain benzene. Id. ¶ 50. In 2022 and 2023, the FDA issued alerts to manufacturers about the 22 risks of benzene contamination and the need for testing of ingredients and products. Id. ¶¶ 55-56. 23 Plaintiffs also claim that “Defendants could have avoided any potential for benzene contamination 24 in the BPO Products by changing the manufacturing process or raw ingredients” and that 25 Defendants knew or should have known about the contamination/degradation. Id. at ¶ 77. 26 Because the BPO Products contain and/or degrade to form benzene, Plaintiffs allege that 27 the products are adulterated or misbranded, and therefore illegal to sell. Id. ¶¶ 73, 83-94. 1 First, on behalf of the California subclass, Plaintiffs allege that Defendants have engaged 2 in “unlawful, unfair, or fraudulent business act or practices” and “unfair, deceptive, untrue or 3 misleading advertising,” in violation of California’s Unfair Competition Law. Id. ¶¶ 121-32. 4 Second, on behalf of the California subclass, Plaintiffs allege that Defendants engaged in 5 “unfair methods of competition and unfair or deceptive acts or practices in connection with the 6 sale of consumer goods,” in violation of California’s Consumer Legal Remedies Act. Id. ¶¶ 133- 7 48. 8 Third, on behalf of the California subclass, Plaintiffs allege that Defendants omission of 9 benzene information (ingredient or warning) constitutes false advertising, in violation of 10 California’s False Advertising Law. Id. ¶¶ 149-57. 11 Fourth, on behalf of the nationwide class, Plaintiffs allege that Defendants engaged in 12 deceptive trade practices by misrepresenting the safety and ingredients of the BPO Products. Id. 13 ¶¶ 158-69. 14 Fifth, on behalf of the nationwide class, Plaintiffs allege that Defendants breached the 15 implied warranty of merchantability that their BPO Products were merchantable, fit and 16 safe for ordinary use because the BPO Products contain benzene and/or degrade to form benzene 17 and were not adequately labeled. Id. ¶¶ 170-86. 18 Sixth, on behalf of the nationwide class, Plaintiffs allege that Defendants violated “a 19 common law duty to provide accurate and non-misleading information to consumers with respect 20 to the quality, safety, and purity characteristics of their BPO” Products by selling adulterated 21 products. Defendants also violated “a common law duty (and a duty under appliable drug safety 22 laws) to use reasonable care in the design and manufacture of its BPO Products, including the duty 23 to perform reasonable tests and inspections of its Products.” Id. ¶¶ 187-201. 24 Seventh, on behalf of the nationwide class, Plaintiffs bring a claim for unjust 25 enrichment/quasi-contract based on Defendants’ profiting from their misleading labeling. Id. ¶¶ 26 202-08. 27 Plaintiffs seek, inter alia: “[a]n order enjoining Defendants from selling the BPO 1 are safe for human application;” “[a]n order requiring Defendants to engage in a corrective 2 advertising campaign and engage in any further necessary affirmative injunctive relief, such as 3 recalling existing BPO Products;” restitution/damages; disgorgement; and statutory damages. Id. 4 at 55-56. 5 B. Regulatory Background 6 The BPO Products are nonprescription drugs or over-the-counter (“OTC”) drugs to treat 7 acne. The Food and Drug Administration (“FDA”) regulates OTC drugs and issues monographs 8 that establish conditions under which an OTC drug is generally recognized as safe and effective 9 for its intended use. See Nat. Res. Def. Council, Inc. v. U.S. Food & Drug Admin., 710 F.3d 71, 10 75, (2d Cir. 2013) (“Like a recipe, each monograph sets out the FDA-approved active ingredients 11 for a given therapeutic class of OTC drugs and provides the conditions under which each active 12 ingredient is [generally recognized as safe and effective].”). “Any product [that] fails to conform 13 to each of the conditions contained in … an applicable monograph is liable to regulatory action.” 14 21 C.F.R. § 330.1. 15 As Plaintiffs recognize, the FDA’s Acne Monograph regulates the BPO Products. FAC ¶¶ 16 62, 69. The Acne Monograph has been incorporated into the regulations. See 21 C.F.R. § 333.01 17 to 350 (Acne Monograph). The Acne Monograph provides that an “over-the-counter acne drug 18 product…is generally recognized as safe and effective and is not misbranded” if “it meets each of 19 the conditions in this…chapter.” 21 C.F.R. § 333.301.1 The Monograph expressly permits the use 20 of benzoyl peroxide (“BPO”) as an active ingredient in products in an amount of 2.5 to 10 percent 21 and imposes labeling and warning requirements for products containing BPO. Id. § 333.310. 22 Mandatory warnings are limited to: 23 (1) For products containing any ingredients identified in § 330.310. 24 (i) The labeling states “For external use only.” (ii) The labeling states “When using this product [bullet] skin 25 irritation and dryness is more likely to occur if you use 26 1 See 75 Fed. Reg. 9767, 9770 (March 4, 2010) (FDA’s “Topical Acne Drug Products for Over- 27 the-Counter Human Use; Final Rule”) (“We, the Food and Drug Administration (FDA), are another topical acne medication at the same time. If irritation 1 occurs, only use one topical acne medication at a time.” (2) For products containing sulfur identified in § 333.310(e) and (f). 2 (i) The labeling states “Do not use on [bullet] broken skin [bullet] large areas of the skin.” 3 (ii) The labeling states “When using this product [bullet] apply only to areas with acne.” 4 (3) For products containing any combination identified in § 333.320. (i) The labeling states “When using this product [bullet] rinse 5 right away with water if it gets in eyes.” (ii) The labeling states “Stop use and ask a doctor [bullet] if 6 skin irritation occurs or gets worse.” (4) For products containing benzoyl peroxide identified in § 7 333.310(a). (i) The labeling states “Do not use if you [bullet] have very 8 sensitive skin [bullet] are sensitive to benzoyl peroxide.” (ii) The labeling states “When using this product [bullet] 9 avoid unnecessary sun exposure and use a sunscreen [bullet] avoid contact with the eyes, lips, and mouth [bullet] avoid 10 contact with hair and dyed fabrics, which may be bleached by this product [bullet] skin irritation may occur, 11 characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the 12 product less frequently or in a lower concentration.” (iii) The labeling states “Stop use and ask a doctor if [bullet] 13 irritation becomes severe.” 14 21 C.F.R. § 333.350(c). 15 Moreover, OTC drugs are subject to federal current Good Manufacturing Practices 16 (“cGMPs”). The federal cGMP regulations mandate compliance with standards for safety, 17 identity, strength, quality, and purity. 21 U.S.C. § 351(a)(2)(B). Under § 351(a)(2)(B): 18 A drug…shall be deemed to be adulterated…if it is a drug and the 19 methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or 20 are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the 21 requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it 22 purports or is represented to possess; 23 21 U.S.C. § 351 (emphasis added). Conversely, it may be implied from this that if the drug 24 conforms with the current good manufacturing practice, it is not “adulterated.” 25 Certain states have adopted federal cGMP regulations in their respective equivalents of the 26 federal Food, Drug, and Cosmetic Act (“FDCA”). For example, California’s state equivalent is 27 the Sherman Food, Drug, and Cosmetic Laws (“Sherman Law”). California Health & Safety Code 1 All good manufacturing practices regulations for any food, drug, 2 device, or cosmetic and any amendments to the regulations adopted pursuant to the federal act in effect on November 23, 3 1970, or adopted on or after such date, are the good manufacturing practices regulations of this state. If the department finds that it is 4 necessary for the protection of consumers, it may adopt interpretative regulations as necessary to define “current good 5 manufacturing practice” as used in this part. 6 Cal. Health & Safety Code § 110105 (emphasis added). 7 C. Procedural Background 8 On April 4, 2024, Plaintiffs filed their Complaint. Dkt. 1. 9 During the parties’ initial case management conference on September 17, 2024, the Court 10 issued a stay on discovery. Dkt. 45. 11 On October 25, 2024, Plaintiffs filed their First Amended Complaint (“FAC”). Dkt. 50. 12 On March 14, 2025, Plaintiffs filed a motion for administrative relief, requesting limited discovery 13 for the purpose of establishing subject matter jurisdiction. Dkt. 60. 14 Before the Court is Defendants’ motion to dismiss Plaintiffs’ FAC. Dkt. 51. 15 III. LEGAL STANDARD 16 A. Lack of Subject Matter Jurisdiction (Rule 12(b)(1)) 17 Under Rule 12(b)(1), a party may move to dismiss for lack of subject matter jurisdiction. 18 Lack of such jurisdiction may occur where the plaintiff lacks standing; “lack of Article III 19 standing requires dismissal for lack of subject matter jurisdiction under [Rule] 12(b)(1).” Maya v. 20 Centex Corp., 658 F.3d 1060, 1067 (9th Cir. 2011). 21 The “irreducible constitutional minimum” of Article III standing requires that a “plaintiff 22 must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the 23 defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo, Inc. v. 24 Robins (“Spokeo II”), 136 S. Ct. 1540, 1547 (2016). These three elements are referred to as, 25 respectively, injury-in-fact, causation, and redressability. Planned Parenthood of Greater Was. & 26 N. Idaho v. U.S. Dep't of Health & Human Servs., 946 F.3d 1100, 1108 (9th Cir. 2020). “The 27 plaintiff, as the party invoking federal jurisdiction, bears the burden of establishing these 1 element.” Spokeo II, 136 S. Ct. at 1547 (quoting Warth v. Seldin, 422 U.S. 490, 518 (1975)). 2 A Rule 12(b)(1) jurisdictional attack may be factual or facial. See Safe Air for Everyone v. 3 Meyer, 373 F.3d 1035, 1039 (9th Cir. 2004). “In a facial attack,” “the challenger asserts that the 4 allegations contained in a complaint are insufficient on their face to invoke federal jurisdiction.” 5 Id. The Court “resolves a facial attack as it would a motion to dismiss under Rule 12(b)(6): 6 Accepting the plaintiff’s allegations as true and drawing all reasonable inferences in the plaintiff’s 7 favor, the Court determines whether the allegations are sufficient as a legal matter to invoke the 8 court’s jurisdiction.” Leite v. Crane Co., 749 F.3d 1117, 1121 (9th Cir. 2014). 9 “[I]n a factual attack, the challenger disputes the truth of the allegations that, by 10 themselves, would otherwise invoke federal jurisdiction.” Safe Air for Everyone, 373 F.3d at 11 1038. In resolving such an attack, unlike with a motion to dismiss under Rule 12(b)(6), the Court 12 “may review evidence beyond the complaint without converting the motion to dismiss into a 13 motion for summary judgment.” Id. Moreover, the Court “need not presume the truthfulness of 14 the plaintiff's allegations.” Id. 15 Either way, “it is within the trial court’s power to allow or to require the plaintiff to supply, 16 by amendment to the complaint or by affidavits, further particularized allegations of fact deemed 17 supportive of plaintiff’s standing.” Warth, 422 U.S. at 501; see also Table Bluff Reservation 18 (Wiyot Tribe) v. Philip Morris, Inc., 256 F.3d 879, 882 (9th Cir. 2001) (in assessing standing, the 19 Court may consider “the complaint and any other particularized allegations of fact in affidavits or 20 in amendments to the complaint”). 21 B. Failure to State a Claim (Rule 12(b)(6)) 22 Federal Rule of Civil Procedure 8(a)(2) requires a complaint to include “a short and plain 23 statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). A 24 complaint that fails to meet this standard may be dismissed pursuant to Rule 12(b)(6). See Fed. R. 25 Civ. P. 12(b)(6). To overcome a Rule 12(b)(6) motion to dismiss after the Supreme Court’s 26 decisions in Ashcroft v. Iqbal, 556 U.S. 662 (2009) and Bell Atlantic Corporation v. Twombly, 550 27 U.S. 544 (2007), a plaintiff’s “factual allegations [in the complaint] ‘must . . . suggest that the 1 Cir. 2014). The court “accept[s] factual allegations in the complaint as true and construe[s] the 2 pleadings in the light most favorable to the nonmoving party.” Manzarek v. St. Paul Fire & 3 Marine Ins. Co., 519 F.3d 1025, 1031 (9th Cir. 2008). But “allegations in a complaint . . . may not 4 simply recite the elements of a cause of action [and] must contain sufficient allegations of 5 underlying facts to give fair notice and to enable the opposing party to defend itself effectively.” 6 Levitt, 765 F.3d at 1135 (quoting Eclectic Props. E., LLC v. Marcus & Millichap Co., 751 F.3d 7 990, 996 (9th Cir. 2014)). “A claim has facial plausibility when the Plaintiff pleads factual 8 content that allows the court to draw the reasonable inference that the Defendant is liable for the 9 misconduct alleged.” Iqbal, 556 U.S. at 678. “The plausibility standard is not akin to a 10 ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted 11 unlawfully.” Id. (quoting Twombly, 550 U.S. at 556). 12 IV. DISCUSSION 13 A. Standing: Injury-in-Fact 14 Contrary to Defendants’ argument, Plaintiffs have alleged facts sufficient to establish an 15 injury-in-fact for Article III standing because Plaintiffs allege economic harm. See Mot. at 18; see 16 FAC ¶ 8 (“Plaintiff…lost money as a result of Defendants’ improper conduct.”). To establish 17 Article III standing, plaintiffs must plead facts demonstrating an injury-in-fact. Spokeo, Inc. v. 18 Robins, 578 U.S. 330, 340 (2016) (“Spokeo I”). “[P]alpable economic injuries have long been 19 recognized as sufficient to lay the basis for standing.” Sierra Club v. Morton, 405 U.S. 727, 733 20 (1972). In fact, economic harm is “a quintessential injury-in-fact.” Maya v. Centex Corp., 658 21 F.3d 1060, 1069 (9th Cir. 2011) (“[P]laintiffs [demonstrate] actual and concrete economic 22 injuries” when they claim that they “paid more for [goods] than the [goods] were worth” and 23 “claim that they would not have purchased [the goods] had defendants made the disclosures 24 allegedly required by law.”); see Hinojos v. Kohl’s Corp., 718 F.3d 1098, 1104 n.3 (9th Cir. 2013) 25 (“[W]hen…Plaintiffs contend that class members paid more for a product than they otherwise 26 would have paid, or bought it when they otherwise would not have done so,” there is “no 27 difficulty…regarding Article III injury in fact.”). 1 Products, or the risk that such Products would degrade into benzene, Plaintiffs…would not have 2 bought the Products, or paid less for them.” FAC ¶ 128. Thus, Plaintiffs plausibly allege that if 3 they knew about the risk of benzene contamination, they would either have paid less for or not 4 bought the BPO Products at all. “[T]hese allegations outline a theory of economic injury that 5 qualifies as an injury in fact under established Article III standing caselaw.” Bowen v. Energizer 6 Holdings, Inc., 118 F.4th 1134, 1146–47 (9th Cir. 2024) (holding that plaintiff alleged economic 7 injury sufficient to establish Article III standing by alleging that had she “known that any amount 8 of benzene was or risked being contained in…products she purchased, she would not have 9 purchased and used the products at all or would have paid significantly less for them”). 10 Therefore, Plaintiffs adequately allege a cognizable injury-in-fact to support Article III 11 standing. Defendant’s Rule 12(b)(1) motion is denied. 12 B. Federal Preemption 13 Under the Supremacy Clause, “Congress has the power to preempt state law.” Crosby v. 14 Nat’l Foreign Trade Council, 530 U.S. 363, 372 (2000); see also Oneok, Inc. v. Learjet, Inc., 135 15 S.Ct. 1591, 1595 (2015). Congress may exercise this power by expressly providing for 16 preemption. Crosby, 530 U.S. at 372. Preemption need not, however, be express; it also occurs 17 “[w]hen Congress intends federal law to occupy the field.” Id. Additionally, federal statutes will 18 preempt state law that conflicts with federal law. Id. Conflict preemption can arise where it is 19 impossible for a party to comply with both state and federal law (see, e.g., Florida Lime & 20 Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142–43 (1963)) or where “the challenged state law 21 stands as an obstacle to the accomplishment and execution of the full purposes and objectives of 22 Congress.” Crosby, 530 U.S. at 373 (citing Hines v. Davidowitz, 312 U.S. 52, 66–67 (1941)). 23 Two presumptions regarding preemption guide the courts. Medtronic, Inc. v. Lohr, 518 24 U.S. 470, 485 (1996). First, courts “start with the assumption that the historic police powers of the 25 States were not to be superseded by the Federal Act unless that was the clear and manifest purpose 26 of Congress,” because “the States are independent sovereigns in our federal system,” i.e., there is a 27 starting presumption “that Congress does not cavalierly pre-empt state-law causes of action.” Id. 1 Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 654–55 (1995); Astiana v. Hain Celestial Grp., 2 Inc., 783 F.3d 753, 757 (2015). Second, the “ultimate touchstone” in every preemption case is 3 Congressional purpose and intent. Medtronic, 518 U.S. at 485. “Congressional intent to preempt 4 state law must be clear and manifest.” Indus. Truck Ass’n, Inc. v. Henry, 125 F.3d 1305, 1309 5 (9th Cir.1997). See United States v. Locke, 529 U.S. 89, 108 (2000); Astiana, 783 F.3d at 757. 6 1. Benzene Warning on Label 7 The Federal Food, Drug, and Cosmetic Act (“FDCA”) expressly preempts Plaintiffs’ 8 claims that Defendants should have disclosed the presence or risk of benzene on their BPO 9 Product labels. See FAC ¶ 7 (“Defendants are…liable to Plaintiffs…for misrepresenting and/or 10 failing to disclose or warn consumers that the BPO Products contain benzene and/or degrade to 11 form benzene.”). 12 The FDCA, 21 U.S.C. § 301, et. seq., establishes national uniform labeling requirements 13 for food, drugs, and cosmetics. To preserve “[n]ational uniformity for nonprescription drugs” or 14 over-the-counter (“OTC”) drugs, § 379r(a)(2) expressly prohibits any state from establishing “any 15 requirement” that “is different from or in addition to, or that is otherwise not identical with, a 16 requirement under this chapter.” 21 U.S.C. § 379r. A “requirement” includes “any requirement 17 relating to public information or any other form of public communication relating to a warning of 18 any kind for a drug.” Id. § 379r(c)(2). Consequently, the FDCA preempts state law claims 19 imposing requirements that differ from those imposed by the FDCA. See Kroessler v. CVS Health 20 Corp., 977 F.3d 803, 808 (9th Cir. 2020) (“[P]rivate plaintiffs may bring only actions to enforce 21 violations of state laws imposing requirements identical to those contained in the FDCA.”) 22 (emphasis added) (internal citation omitted). “So if a product’s label complies with the Act, then 23 the Act preempts any state-law claim that the product is mislabeled.” Scheibe v. ProSupps USA, 24 LLC, No. 23-3300, 2025 WL 1730272, at *3 (9th Cir. June 23, 2025). 25 “[T]o state a ‘plausible’ mislabeling claim that is not preempted, [Plaintiffs] must plead 26 facts that ‘allow[] the court to draw the reasonable inference…that the [BPO Products are] not 27 only mislabeled under state law, but also misbranded under the [federal] Act.” Id. (citing Iqbal, 1 [Defendants] must show that [Plaintiffs’] complaint fails to support that inference.” Id. 2 Defendants “may establish preemption if [they] prove[] that the [products’] labeling complies with 3 the Act.” Id. at *5 (9th Cir. June 23, 2025). 4 Defendants have established preemption under § 379r(a) in the case at bar. Through their 5 state law claims, Plaintiffs seek to require a “supplemental statement on the [BPO Products’] 6 label,” “warning consumers about the presence of benzene in the Products.” Opp’n at 1, 11; see 7 FAC ¶ 162. Section 379r(a) preempts Plaintiffs’ state law claims because including a warning 8 about benzene and its risks would impose a requirement that is not “identical to those contained in 9 the FDCA.” Kroessler, 977 F.3d at 808 (9th Cir. 2020). As stated, the Acne Monograph regulates 10 the BPO Products and clearly specifies the mandatory labeling requirements. See 21 C.F.R. § 11 333.350(c). Notably, none of these requirements impose a duty to include a warning about 12 benzene or its risks. Thus, the FDA specifically identifies the warnings that must be provided for 13 acne drugs containing BPO and these provisions impose no requirement to include warnings of 14 benzene or its risks. See id. §§ 333.310(c) and 333.350(c)(1)(i)-(ii), (c)(4)(i)-(iii). Plaintiffs have 15 not demonstrated that the BPO Products at issue fail to comply with the labeling requirements of 16 the FDCA. Plaintiffs instead seek to require warnings different from and additional to those 17 required by the FDCA, warnings not “identical to those contained in the FDCA.” Kroessler, 977 18 F.3d at 808 (“[P]rivate plaintiffs may bring only actions to enforce violations of state laws 19 imposing requirements identical to those contained in the FDCA.”). As such, FDCA § 379r(a) 20 preempts Plaintiffs’ state law claims. 21 Many courts which have addressed the issue have held that § 379r(a) preempts consumer 22 claims seeking to mandate under state law disclosure of benzene or its risks. For example: 23 • Howard v. Alchemee, LLC, 2024 WL 4272931, at *10 (C.D. Cal. Sept. 19, 2024) 24 (“Plaintiffs seek to require Defendants to make disclosures not required under the FDCA 25 that would conflict with the FDA’s conclusion that BPO is safe and effective. Because 26 Plaintiffs’ claims would impose requirements that differ from and are in addition to those 27 in the FDCA, they are preempted under § 379r.”); 1 (“Because the FDCA and the FDA’s regulations establish no…limit” on “selling acne 2 medications containing more than 2 ppm of benzene,” Plaintiffs’ claims seek to impose a 3 restriction that is “different from or in addition to, or that is otherwise not identical with” 4 the requirements of the FDCA” and “[t]heir claims are therefore expressly preempted and 5 must be dismissed.”); 6 • Smoter v. Mentholatum Co., Inc., 2025 WL 273437, at *2 (N.D. Ill. Jan. 17, 2025) (“[T]o 7 the extent the plaintiffs argue the labels of the OXY products should have warned them of 8 the possibility of benzene or included benzene as an ingredient, these claims are preempted 9 by federal law and must fail.”); 10 • Bodunde v. Walgreens Boots All., Inc., 2025 WL 1411306, at *12 (E.D. Cal. May 15, 11 2025) (“[T]o the extent Plaintiff’s claims are based on allegations that Walgreens should 12 have warned about the presence of benzene on Walgreen’s BPO product labels, that theory 13 is expressly preempted because it would be an addition not required by federal law.”) 14 (internal citation omitted); 15 • Eisman v. Johnson & Johnson Consumer, Inc., 2025 WL 241024, at *4 (C.D. Cal. Jan. 17, 16 2025) (“Whether Eisman’s theory of liability is that the presence of benzene requires a 17 disclosure that Defendants omit, or that it renders the Products adulterated and misbranded, 18 each of his claims seeks to impose requirements that are ‘different from or in addition to, 19 or that are otherwise not identical with the FDA’s.”) (internal citation omitted). 20 These rulings are hardly surprising because a ruling otherwise would allow state-mandated labels 21 to contradict the FDA’s determination that BPO is safe and effective.2 See Silva v. Haleon US 22 Inc., 758 F. Supp. 3d 1082, 1088 (N.D. Cal. 2024) (“With respect to the labeling of over-the- 23 counter (“OTC”) drugs, ‘the whole point of section 379r is that it is not up to private litigants—or 24 judges—to decide what is ‘false or misleading.’ It is up to the FDA.’”) (citing Eckler v. 25 Neutrogena Corp., 238 Cal. App. 4th 433, 454 (Cal. Ct. App. 2015)) (finding that § 379r(a) 26

27 2 Plaintiffs may consult the FDA to change the labeling or seek disapproval of the BPO Products. 1 preempted plaintiffs’ claims). 2 Plaintiffs offer no caselaw demonstrating otherwise. In Ebner v. Fresh, Inc., the Ninth 3 Circuit held that § 379r(a) did not preempt the plaintiff’s claim regarding a cosmetic product 4 because the plaintiff sought to enforce a law “identical to [the] federal duty under the FDCA: the 5 duty to avoid false or misleading labeling.” 838 F.3d 958, 965 (9th Cir. 2016). 6 Plaintiffs’ reliance on Astiana v. Hain Celestial Grp., Inc. is similarly misplaced. There, 7 the Ninth Circuit held that the FDCA did “not expressly preempt state causes of action predicated 8 on federal cosmetics labeling laws” because “the FDA did not intend to permit indiscriminate use 9 of the word ‘natural’ on cosmetics labels.” Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753, 758 10 (9th Cir. 2015). But, there is no indication that the cosmetic products at issue in Astiana were 11 subject to an FDA monograph. As Astiana noted, the FDA had never issued regulations regarding 12 the use of the term ‘natural’ on cosmetic labels. Again, the BPO Products at issue here are subject 13 to the FDA’s Acne Monograph which specifies in detail by regulation the required warnings. 14 Thus, Astiana is readily distinguishable. 15 This Court joins its sister courts in holding that the FDCA preempts Plaintiffs’ state law 16 claims which challenge the omission of warnings on BPO products that are different from and not 17 required by the FDCA and which assert that that the BPO products are not safe and effective as 18 found by the FDCA regulations. 19 2. cGMP Violations 20 Next, Plaintiffs assert state law claims that Defendants failed to comply with federal 21 cGMPs and adulteration standards which are incorporated by reference in state regulations. See 22 FAC ¶ 70. 23 a. Some Parallel Claims May Proceed 24 As noted above, “private plaintiffs may bring only actions to enforce violations of state 25 laws imposing requirements identical to those contained in the FDCA.” Kroessler, 977 F.3d at 26 808 (emphasis added); see 21 U.S.C. § 379r (expressly prohibiting any state from establishing 27 “any requirement” that “is different from or in addition to, or that is otherwise not identical with, a 1 violations of federal standards adopted in state regulations where “the state requirements at issue 2 are identical to their federal counterparts.” Davidson v. Sprout Foods, Inc., 106 F.4th 842, 845-50 3 (9th Cir. 2024), cert. denied, 145 S. Ct. 1922 (2025) (finding that a California Sherman Law claim 4 was “expressly permitted” and “not expressly preempted” because the Sherman Law statute 5 incorporated federal regulations by reference and thus enforced a requirement identical to federal 6 standards). 7 Here, Plaintiffs allege that Defendants violated state regulations incorporating federal 8 cGMPs and adulteration standards by reference. FAC ¶ 70.3 Specifically, Plaintiffs allege that the 9 “BPO Products” are “contaminated and/or adulterated with benzene,” which “indicates that there 10 was a critical failure in Defendants’ quality control and testing protocols as required by [federal] 11 cGMPs.” Id. Plaintiffs provide a long list of thirty-seven state statutes that purport to mirror the 12 FDCA. Id. ¶ 59. The Court takes the California statute as an example.4 Like the California food 13 labeling regulation at issue in Sprout, the California good manufacturing practices regulation 14 incorporates federal regulations by reference: 15 All good manufacturing practices regulations for any food, drug, 16 device, or cosmetic and any amendments to the regulations adopted pursuant to the federal act in effect on November 23, 1970, or 17 18 3 “[S]tate…laws impose an independent duty on drug manufacturers to ensure that end purchasers 19 receive drugs that are made in accordance with cGMPs. This duty emanates from each state’s adoption or adherence to federal cGMP and adulteration standards, including…parallel state 20 statutes.” The fact that there is no federal private right of action under the FDCA (21 U.S.C. § 21 337(a)) therefore does not preclude a state from providing a cause of action for violation of its laws provided the state law is not preempted by the FDCA. See Sprout, 106 F.4th at 849 (“This 22 case fundamentally differs from Buckman, Perez, and Nexus” because “plaintiffs are claiming violations of California law, the Sherman Law, not the federal FDCA” and “Congress said” that 23 “standards…identical to the federal standards…are not preempted and hence permitted states to adopt them…There is no reason we can perceive why Congress would permit states to enact 24 particular legislation and then deny enforcement by their citizens.”). 4 Plaintiffs cite to California Health and Safety Code § 111260, which provides that a “drug…is 25 adulterated if the methods, facilities, or controls used for its manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with current good 26 manufacturing practice to assure that the drug or device meets the requirements of this part as to safety and has the identity and strength, and meets the quality and purity characteristics that it 27 purports or is represented to possess.” FAC ¶ 59; Cal. Health & Safety Code § 111260 (emphasis adopted on or after such date, are the good manufacturing practices 1 regulations of this state.

2 3 Cal. Health & Safety Code § 110105. Because the California regulation incorporates federal 4 requirements by reference, the California law is identical to the federal requirement on cGMPs. 5 Sprout, 106 F.4th at 848. Accordingly, like in Sprout, claims under state laws enforcing 6 “standards…identical to the federal standards” are thus not prima facie preempted. Id. at 849. See 7 Navarro v. Walgreens Boots All., Inc., 2025 WL 1411406, at *14 (E.D. Cal. May 15, 2025) (“[T]o 8 the extent Plaintiffs’ state law claims are parallel claims brought for violations of cGMPs, those 9 claims are not categorically preempted.”). 10 b. Claims that Require Interpretation of the FDCA are Impliedly 11 Preempted 12 However, if Plaintiffs’ state law claims based on cGMP violations require the Court to 13 interpret the FDCA and regulations thereunder, these claims will be impliedly preempted. As 14 noted above, implied preemption (“obstruction preemption”) arises where “the challenged state 15 law stands as an obstacle to the accomplishment and execution of the full purposes and objectives 16 of Congress.” Crosby, 530 U.S. at 373 (citing Hines, 312 U.S. at 67). “What is a sufficient 17 obstacle is a matter of judgment, to be informed by examining the federal statute as a whole and 18 identifying its purpose and intended effects.” Id. 19 Here, Plaintiffs’ claim based on asserted violations of the cGMPs appears to obstruct the 20 accomplishment and execution of Congress’s objectives of: (1) delegating the specifics of 21 generating and enforcing good manufacturing practices to the FDCA which has the expertise to do 22 so, and (2) ensuring national uniformity in the quality of manufacturing of nonprescription drugs. 23 i. Objectives at Issue 24 Two federal objectives are at issue here: 1) preserving national uniformity of 25 nonprescription drugs, and 2) deference to the FDA’s expertise in realizing the former objective. 26 The FDCA provides mechanisms to accomplish both objectives. First, Section 379r 27 enables preservation of national uniformity by expressly preempting state requirements that are 1 Second, Section 337(a) bars private enforcement of the FDCA, which empowers the FDA 2 to determine when a violation of the FDCA has occurred. Section 337(a) of the FDCA vests 3 exclusive enforcement authority in the United States. Section 337(a) provides that “all such 4 proceedings for the enforcement, or to restrain violations, of [the Act] shall be by and in the name 5 of the United States.” 21 U.S.C. § 337(a). The Supreme Court has held that § 337(a) is “clear 6 evidence that Congress intended that the [FDCA] be enforced exclusively by the Federal 7 Government.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 352 (2001) (finding that 8 the FDCA impliedly preempted private plaintiffs’ state law claims to police fraud on the FDA). 9 Thus, “‘[b]ecause the FDCA forbids private rights of action under that statute, a private action 10 brought under [other laws] may not be pursued when…the claim would require litigation of the 11 alleged underlying FDCA violation in a circumstance where the FDA has not itself concluded that 12 there was such a violation.’” Nexus Pharms., Inc. v. Cent. Admixture Pharmacy Servs., Inc., 48 13 F.4th 1040, 1049 (9th Cir. 2022) (citing PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 924 (9th Cir. 14 2010)). While the FDCA allows for the private enforcement of state law identical to the federal 15 law, Congress vested exclusive enforcement of the FDCA in the FDA – thereby ensuring national 16 uniformity and delegating exclusive enforcement to the FDA which has technical expertise in the 17 field. 18 Third, Congress enacted laws authorizing the FDA to issue regulations for the efficient 19 enforcement of the FDCA, including cGMP regulations, (21 U.S.C. § 371(a)), establishing the 20 federal cGMP regulations (21 U.S.C. § 351(a)(2)(B)), and empowering the FDA with several 21 enforcement mechanisms such as injunctions (21 U.S.C. § 332), penalties (21 U.S.C. § 333), and 22 seizure (21 U.S.C. § 334). 23 ii. Discussion 24 Here the long list of cGMPs assertedly violated would appear to require a substantial 25 amount of interpretation. The cGMP requirements asserted herein are extremely general. 5 Below 26 are three examples from cGMP violations in Plaintiffs’ complaint and why adjudicating the claim 27 1 would appear to require the trier of fact to interpret the regulation. 2 Plaintiffs allege a violation of the federal cGMP regulation on testing and release for 3 distribution. FAC ¶ 68(i); see 21 C.F.R. § 211.165(a). This cGMP regulation provides: 4 For each batch of drug product, there shall be appropriate 5 laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and 6 strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on specific batches of 7 shortlived radiopharmaceuticals, such batches may be released prior to completion of sterility and/or pyrogen testing, provided such 8 testing is completed as soon as possible. 9 21 C.F.R. § 211.165(a) (emphasis added). When is a laboratory determination “appropriate,” such 10 that a manufacturer can be said to have complied with § 211.165(a)? What constitutes 11 “satisfactory conformance”? What kind of “sterility testing” is adequate? How quick is 12 “as soon as possible”? Would the answers depend on the kind of drug at issue? At different times 13 in the drug’s life cycle? 14 Plaintiffs allege a violation of the federal cGMP regulation on retesting of approved 15 components, drug product containers, and closures. FAC ¶ 68(o); see 21 C.F.R. § 211.87. This 16 regulation provides: 17 Components, drug product containers, and closures shall be retested 18 or reexamined, as appropriate, for identity, strength, quality, and 19 purity and approved or rejected by the quality control unit in accordance with § 211.84 as necessary, e.g., after storage for long 20 periods or after exposure to air, heat or other conditions that might adversely affect the component, drug product container, or closure. 21 22 21 C.F.R. § 211.87 (emphasis added). When is it “appropriate” or “necessary” to retest or 23 reexamine, such that the manufacturer has complied with § 211.87? What constitutes an adequate 24 “quality control unit”? What is a “long Period,” what temperature range constitutes “heat,” and 25 how substantial must the effect be to be something that “might adversely affect the component”? 26 Again, would the answers vary from drug to drug? 27 Plaintiffs allege a violation of the federal cGMP regulation on production record review. 1 All drug product production and control records, including those for 2 packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, 3 approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of 4 theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure 5 of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has 6 already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may 7 have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include 8 the conclusions and followup. 9 21 C.F.R. § 211.192 (emphasis added). What constitutes a “thorough” investigation, such that a 10 manufacturer can be said to have complied with § 211.87? What process of “review and 11 approval” is sufficient? How does one determine which drugs “may have been associated with the 12 specific failure” and what degree of probability should be applied? Again, the answers would 13 seem to depend, inter alia, on the drug at issue. 14 As illustrated above, the cGMP-based claims likely require statutory interpretation which 15 may be specific to a particular drug and circumstance. Allowing courts from around the nation to 16 render interpretations on such a broad slate risks a threat to national uniformity in the quality 17 standards applied to the manufacturing of nonprescription drugs. It would also intrude on 18 Congress’s delegation of the exclusive enforcement authority to the FDA (21 U.S.C. § 337(a)) 19 which has the expertise to oversee the quality of manufacture of nonprescription drugs through its 20 application and enforcement of the cGMPs and applicable regulations. Permitting local state and 21 federal courts – through the vehicle of state law incorporating these federal standards – to render 22 varying interpretations of highly general provisions of federal law and regulations threatens to 23 frustrate the national uniformity Congress enforced by the FDA as intended for nonprescription 24 drugs (21 U.S.C. § 379r). Thus, Plaintiffs’ cGMP-related claims may be impliedly preempted. 25 By way of contrast, the claim in Sprout involved an application of federal law (through a 26 parallel state law) which did not require interpretation of a broad federal law. The plaintiff in 27 Sprout alleged a violation of a Sherman Law statute which enforced a wholesale prohibition on 1 (Defendant “nevertheless produced pouches of baby food with labels on the front of the package,” 2 in direct violation of the FDA’s labeling standard). The violation in Sprout was categorical: the 3 defendant either produced pouches of baby food with nutrient content claims on the front (in 4 violation of federal law), or it produced pouches of baby food without nutrient content claims on 5 the front. Thus, the court was not required to interpret the regulation at issue. The answer was a 6 clear and simple binary choice. Without the need for interpretation and the attendant risk of 7 variation in that interpretation, allowing the Sherman Law claim to proceed in Sprout did not 8 obstruct the accomplishment of the dual objectives of preserving national uniformity and deferring 9 to the FDA’s expertise. 10 As pled, it is impossible to decipher whether Plaintiffs’ state-law theory on cGMP 11 violations involves only binary determinations as in Sprout or, more likely, requires statutory 12 interpretation. Thus, at this stage, that question cannot be determined and so the Court allows 13 Plaintiffs’ cGMP-based claims to proceed. However, the Plaintiff must be mindful of the high 14 risk of implied preemption if interpretation of the cGMPs is required. 15 C. Failure to State a Claim 16 While Plaintiff’s cGMP-based claims survive preemption, these claims are likely to be 17 dismissed because Plaintiffs fail to 1) adequately allege that the state statutes enforce requirements 18 that are identical to federal standards (i.e. parallelism), and 2) allege with specificity how 19 Defendant has violated each cGMP requirement identified in Plaintiffs’ complaint, specificity 20 necessary not only as a matter of fair notice to the defendant and to meet the pleading standard of 21 Rule 9 but also to determine whether the claims are preempted. 22 1. Parallel Requirements 23 First, Plaintiffs fail to allege with specificity that the state statutes in Plaintiffs’ list impose 24 requirements that are “parallel…to federal requirements,” i.e. identical to those imposed by federal 25 law. Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008) (internal citation omitted). Plaintiffs 26 provide a laundry list of state statutes without demonstrating that these state regulations actually 27 impose requirements identical to federal ones. The Court notes that certain appear to merely bar 1 35 Pa. Stat. § 780-113(a)(1); Ga. Code § 26-3-3(1). Plaintiffs have failed adequately to allege 2 with specificity parallelism of each state law asserted. 3 2. cGMP Violations 4 Second, Plaintiffs’ allegations regarding Defendants’ cGMP violations fail to provide 5 “sufficient allegations of underlying facts to give fair notice and to enable the opposing party to 6 defend itself effectively” as required by Rule 8 and fail to allege with sufficient detail how 7 Plaintiffs were deceived as required to assert fraud under Rule 9. Levitt, 765 F.3d at 1135; 8 Lancaster Cmty. Hosp. v. Antelope Valley Hosp. Dist., 940 F.2d 397, 405 (9th Cir. 1991) (Under 9 Rule 9(b), “a pleader of fraud” must “detail with particularity the time, place, and manner of each 10 act of fraud, plus the role of each defendant in each scheme.”). 11 In particular, Plaintiffs list twenty-one cGMP requirements and portions of the regulatory 12 language of each. FAC ¶ 68. Plaintiffs allege that Defendants’ BPO Products “did not conform to 13 its final monograph specifications . . . which demonstrates inadequate production, process, and 14 quality oversight by Defendants.” Id. at ¶ 69. Then, Plaintiffs allege that Defendants failure to 15 conform to the cGMP requirements demonstrates a “critical failure in Defendants’ quality control 16 and testing protocols as required by the above-referenced cGMPs.” Id. at ¶ 70. Such a “critical 17 failure” in Defendants’ oversight led to the “production, and ultimate sale to consumers, of BPO 18 Products” that were contaminated with benzene. Id. In other words, Plaintiffs allege that 19 Defendants must have violated one of, if not all of, the twenty-one cGMP standards that they list 20 simply because benzene-contaminated BPO Products were allowed to enter the marketplace. 21 However, Plaintiffs do not assert how Defendants violated or deviated from specific cGMP 22 standards and how such deviations led to the adulteration of its BPO Products. Because of the 23 lack of specificity, the complaint fails to state claims based on state law under Rule 12(b)(6). 24 Iqbal, 556 U.S. at 678; Twombly, 550 U.S. at 556. 25 Moreover, to the extent Plaintiffs assert an omission theory of consumer fraud for omitting 26 or concealing that the BPO Products contained or degraded to contain benzene, Plaintiffs’ 27 allegations fail to meet the pleading standard of Federal Rule of Civil Procedure 9(b). One 1 content of an omission as precisely as would a plaintiff in a false representation claim’” because “a 2 plaintiff…alleging a failure to act instead of an affirmative act…cannot point out the specific 3 moment when the defendant failed to act.” Baggett v. Hewlett-Packard Co., 582 F. Supp. 2d 4 1261, 1267 (C.D. Cal. 2007) (citing Falk v. General Motors Corporation, 496 F.Supp.2d 1088, 5 1098–99 (N.D. Cal.2007). Thus, “a fraud by omission or fraud by concealment claim “‘can 6 succeed without the same level of specificity required by a normal fraud claim.’” Id. Nonetheless 7 assertions of omissions cannot be conclusory. Here, Plaintiffs have not alleged facts 8 demonstrating how Defendants violated cGMPs or adulteration standards or how these alleged 9 deviations deceived Plaintiffs (or the consuming public) in any consequential way. Plaintiffs’ 10 allegation that “had Defendants adequately tested their BPO Products for benzene, they would 11 have discovered that the Products contained benzene” is too conclusory. FAC ¶ 99. 12 Finally, greater specificity as to how the cGMPs were violated is necessary to determine 13 whether the alleged violation(s) require interpretation of the cGMP requirements which would 14 implicate implied preemption. Again, theories that require interpretation of the cGMPs rather than 15 a clear binary determination as in Sprout would be impliedly preempted. 16 The Court is inclined to grant Defendants’ motion to dismiss. See Ebrahimi v. Mentor 17 Worldwide LLC, 804 F. App’x 871, 872 (9th Cir. 2020) (affirming district court’s Rule 12(b)(6) 18 dismissal where a plaintiff “essentially contend[ed] that the court can plausibly infer that [a 19 defendant] must have violated at least one of the FDA’s CGMPs by not catching her allegedly 20 defective [product]” because “mere allegations suggesting that [the plaintiff’s] particular 21 [products] were defective do not show that [the defendant] failed to comply with the FDA’s 22 Current Good Manufacturing Practices.”) (internal citation omitted); see also Weber v. Allergan, 23 Inc., 940 F.3d 1106, 1114 (9th Cir. 2019 (affirming district court’s grant of summary judgment for 24 defendant where “mere evidence suggesting that [the plaintiff’s] particular [product] was defective 25 does not show that [the defendant] failed to comply with the FDA’s Current Good Manufacturing 26 Practices” and “evidence that some other [products] produced by [the defendant] were defective 27 does not demonstrate noncompliance.”). 1 V. CONCLUSION 2 Although the Court is inclined to grant Defendants’ motion to dismiss, it will permit 3 Plaintiffs to amend their complaint to allege with specificity the parallel state laws it asserts and 4 || specific facts establishing Defendants’ violations of particular cGMPs and how such violations 5 rendered the BPO Products adulterated, provided that those asserted violations are limited to those 6 || which can be proven without interpretation of the cGMPs. 7 The Court will stay the current motion to dismiss and lift the stay on discovery to permit 8 Plaintiffs the opportunity to conduct limited and focused discovery on the alleged cGMP 9 violations. Such discovery will be limited to written discovery designed to determine whether the 10 || cGMPs were violated in a manner that does not require interpretation or scientific/technical 11 || judgment, i.e. violations provable in a manner similar to that in Sprout. Plaintiffs shall have 60 12 || days to conduct such limited and focused written discovery and file any amended complaint 5 13 consistent with their Rule 11 obligations. Failure to timely file an amended complaint will result 14 || in dismissal of this case with prejudice for the reasons stated herein.

a 16 IT IS SO ORDERED.

18 Dated: August 6, 2025 19 20

EDWARD M. CHEN

United States District Judge 22 23 24 25 26 27 28