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8 United States District Court 9 Central District of California

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11 JORDAN EISMAN, Case № 2:24-cv-01982-ODW (AJRx)

12 Plaintiff,

ORDER GRANTING

13 v. 14 JO HNSON & JOHNSON CONSUMER, MOTION TO DISMISS [18] INC. et al., 15

Defendants. 16

17 18 I. INTRODUCTION 19 Plaintiff Jordan Eisman brings this putative class action against Defendants 20 Johnson & Johnson Consumer, Inc. and Kenvue, Inc., asserting causes of action for 21 fraud, breach of warranties, and violation of consumer protection laws, based on the 22 undisclosed presence of benzene in two of Defendants’ Neutrogena T/Gel Therapeutic 23 Shampoos (the “Products”). (Compl. ¶¶ 1, 43–133, ECF No. 1.) Defendants move to 24 dismiss Eisman’s claims pursuant to Federal Rules of Civil Procedure (“Rule” or 25 “Rules”) 12(b)(1) and 12(b)(6). (Mot. Dismiss (“Motion” or “Mot.”), ECF No. 18.) 26 For the reasons below, the Court GRANTS the Motion.1 27

28 1 Having carefully considered the papers filed in connection with the Motion, the Court deemed the matter appropriate for decision without oral argument. Fed. R. Civ. P. 78; C.D. Cal. L.R. 7-15. 1 II. BACKGROUND2 2 Defendants manufacture, sell, market, and distribute the Products in the United 3 States as an over-the-counter (“OTC”) nonprescription treatment for scalp conditions. 4 (Compl. ¶¶ 3–4, 7–8; Opp’n 1, ECF No. 41.) The active ingredient in the Products is 5 Coal Tar, a complex compound comprised of “as many as 10,000” naturally occurring 6 constituent components. (Compl. ¶¶ 1, 16–17.) Benzene is one of the constituent 7 components of Coal Tar. (Id. ¶ 17.) 8 Eisman is a citizen of California who purchased Neutrogena T/Gel Therapeutic 9 Shampoo—Extra Strength in February 2021. (Id. ¶ 6.) Eisman recently discovered 10 through “testing” that the Products contain “dangerously high, undisclosed levels of 11 benzene, a hazardous genotoxic substance.” (Id. ¶¶ 2, 22.) Benzene is typically used 12 in the manufacture of gasoline, industry chemicals, and textiles. (Id. ¶ 3.) It is known 13 to be a human carcinogen, and is “associated with numerous side effects.” (Id. ¶ 14.) 14 Eisman claims that the undisclosed presence of benzene renders Defendants’ 15 representations that the Products are “safe and effective” false and misleading. (Id. 16 ¶¶ 1–5; see, e.g., id. ¶ 46.) He also asserts that the undisclosed presence of benzene 17 means the Products are improperly manufactured, tested, marketed, packaged, and 18 labeled, because Defendants were obligated to remove all traces of benzene during the 19 manufacturing process. (See id. ¶¶ 1–5, 20.) Eisman claims he would not have paid 20 money for the Products had he known of the presence of benzene. (Id. ¶ 6.) 21 Based on the above allegations, Eisman filed this putative class action against 22 Defendants. He asserts seven causes of action based on the undisclosed presence of 23 benzene in the Products: (1) breach of express warranties; (2) breach of implied 24 warranties; (3) fraud (affirmative misrepresentation, omission, and concealment); 25 (4) negligent misrepresentation and omission; (5) violation of the consumer protection 26 laws of all states; (6) negligence; and (7) unjust enrichment. (Id. ¶¶ 43–133.) Eisman 27 2 All factual references derive from Eisman’s Complaint, unless otherwise noted, and well-pleaded 28 factual allegations are accepted as true for purposes of this Motion. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). 1 seeks economic damages, declaratory relief, and “appropriate . . . injunctive relief.” 2 (Id., Prayer.) Eisman does not seek to recover for physical injuries, but he alleges 3 “physical,” “undisclosed sub-cellular or structural impact” to his body. (Id. ¶ 71.) 4 Defendants move to dismiss Eisman’s claims pursuant to Rules 12(b)(1) and 5 12(b)(6), raising grounds for dismissal including federal preemption, lack of 6 Article III standing, collateral estoppel, and failure to state a claim. (Mot. 1–4, 13.)3 7 As the Court agrees with Defendants that Eisman’s claims are expressly preempted by 8 the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., the Court 9 declines to reach Defendants’ additional arguments for dismissal. 10 III. LEGAL STANDARD 11 A court may dismiss a complaint under Rule 12(b)(6) for lack of a cognizable 12 legal theory or insufficient facts pleaded to support an otherwise cognizable legal 13 theory. Balistreri v. Pacifica Police Dep’t, 901 F.2d 696, 699 (9th Cir. 1988). To 14 survive a dismissal motion, a complaint need only satisfy the minimal notice pleading 15 requirements of Rule 8(a)(2)—a short and plain statement of the claim. Porter v. 16 Jones, 319 F.3d 483, 494 (9th Cir. 2003). The factual “allegations must be enough to 17 raise a right to relief above the speculative level.” Bell Atl. Corp. v. Twombly, 18 550 U.S. 544, 555 (2007). That is, the complaint must “contain sufficient factual 19 matter, accepted as true, to state a claim to relief that is plausible on its face.” Iqbal, 20 556 U.S. at 678 (internal quotation marks omitted). 21 The determination of whether a complaint satisfies the plausibility standard is a 22 “context-specific task that requires the reviewing court to draw on its judicial 23 experience and common sense.” Id. at 679. A court is generally limited to the 24 pleadings and must construe all “factual allegations set forth in the complaint . . . as 25 true and . . . in the light most favorable” to the plaintiff. Lee v. City of Los Angeles, 26 250 F.3d 668, 679 (9th Cir. 2001). However, a court need not blindly accept 27 3 The parties request that the Court take judicial notice of certain documents. (Defs. Req. Judicial 28 Notice (“RJN”) Exs. A–E, ECF No. 19; Pl. RJN Exs. A–B, ECF No. 43.) As the Court resolves the Motion without relying on the documents, it denies the requests. 1 conclusory allegations, unwarranted deductions of fact, and unreasonable inferences. 2 Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001). 3 IV. DISCUSSION 4 Defendants argue Eisman’s claims are expressly preempted by the FDCA and 5 the Food and Drug Administration’s (“FDA”) regulations promulgated thereunder. 6 (Mot. 3.) Specifically, Defendants cite 21 U.S.C. § 379r(a), which prohibits states 7 from “establish[ing] or continu[ing] in effect any requirement . . . that is different from 8 or in addition to, or that is otherwise not identical with, a requirement under [the 9 FDCA].” 21 U.S.C. § 379r(a)–(c)(2). Defendants contend Eisman seeks to use state 10 laws to force Defendants to include disclosures and comply with conditions that are 11 different from and additional to those that the FDA requires in the applicable OTC 12 Coal Tar drug product monograph. (Mot. 3 (citing 21 C.F.R. § 358.701 et seq.).) 13 A. Express Preemption—FDCA, 21 U.S.C. § 379r 14 “A fundamental principle of the Constitution is that Congress has the power to 15 preempt state law.” Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372 (2000). 16 However, federal preemption of state law “will not lie unless it is the clear and 17 manifest purpose of Congress.” CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664, 18 (1993) (internal quotation marks omitted). If a federal statute contains an express 19 preemption clause, the court “focus[es] on the plain wording of the clause, which 20 necessarily contains the best evidence of Congress’ pre-emptive intent.” Puerto Rico 21 v. Franklin Cal. Tax-Free Tr, 579 U.S. 115, 125 (2016) (quoting Chamber of Com. of 22 U.S. v. Whiting, 563 U.S. 582, 594 (2011)). 23 To ensure uniformity in the regulation of OTC drugs, like Defendants’ Products, 24 the FDCA contains a broad express preemption provision: 21 U.S.C. § 379r. That 25 provision generally prohibits states from establishing “any requirement . . . (1) that 26 relates to the regulation of a [nonprescription drug]; and (2) that is different from or in 27 addition to, or that is otherwise not identical with, a requirement under [the FDCA].” 28 Id. § 379r(a) (emphasis added). The statute defines “requirement” to include “any 1 requirement relating to public information or any other form of public communication 2 relating to a warning of any kind for a drug.” Id. § 379r(c)(2). 3 The Supreme Court has recognized that the FDA alone can balance “the 4 potentially competing concerns of safety and effectiveness,” meaning that “common 5 law and state law liability that is also premised on a product’s safety and effectiveness 6 can only upset that balance.” Carter v. Novartis Consumer Health, Inc., 582 F. Supp. 7 2d 1271, 1281 (C.D. Cal. 2008) (discussing Riegel v. Medtronic, Inc., 552 U.S. 312, 8 324–25 (2008)). In the context of 21 U.S.C. § 379r, this means that “virtually any 9 state requirement that relates to the regulation of nonprescription drugs can be 10 preempted, regardless of the common law theory under which it is brought.” Id. 11 at 1282. “Simply stated, federal law expressly preempts any state law that applies to 12 OTC drugs and purports to impose additional or different requirements than the 13 requirements set forth by the FDA.” Faustino v. Alcon Lab’ys, Inc., No. 2:15-cv- 14 04145-RGK (AJWx), 2015 WL 12839161, at *2 (C.D. Cal. Sept. 22, 2015), aff’d sub 15 nom. Faustino v. Alcon Lab’ys, Inc. (a Division of Novartis AG), 692 F. App’x 819 16 (9th Cir. 2017). 17 In contrast, 21 U.S.C. § 379r does not preempt claims under state law that 18 impose identical or “parallel” requirements to FDA regulations, such as where a 19 plaintiff sues over a defendant’s violation of the FDCA. Riegel, 552 U.S. at 330; 20 Seale v. GSK Consumer Health, Inc., 718 F. Supp. 3d 1208, 1223 n.6 (C.D. Cal. 2024) 21 (“[F]ederal preemption does not necessarily apply where certain common law claims 22 and remedies are parallel or equivalent to federal regulations.”). 23 B. OTC Coal Tar Monograph 24 The FDA regulates OTC Coal Tar drugs such as the Products via a 25 comprehensive set of FDA regulations called a monograph. 21 C.F.R. §§ 330.1, 26 358.701. The FDA promulgated its monograph for OTC Coal Tar drug products after 27 an extensive review process involving the recommendations of an expert advisory 28 panel and public notice and comment. See id. § 330.10. 1 The OTC Coal Tar drug product monograph specifies, among other things, the 2 permissible active ingredients and their concentrations and combinations, as well as 3 indications for use, warnings, directions, and other mandatory labeling requirements. 4 See id. §§ 358.701, 358.703, 358.710, 358.720, 358.750, 358.760. In particular, the 5 monograph expressly permits Coal Tar to be an active ingredient in the Products in 6 specified amounts. Id. §§ 358.703, 358.710(a)(1). It also provides detailed 7 instructions for labeling covered products, including specific warnings and directions 8 that must be included for OTC drug products containing Coal Tar. See id. § 358.750. 9 The regulations provide that an OTC Coal Tar drug product “is generally 10 recognized as safe and effective and is not misbranded if it meets each of the 11 conditions” in the monograph and “each general condition” in 21 C.F.R. § 330.1. Id. 12 § 358.701(a). Section 330.1, in turn, specifies that OTC drugs must meet the 13 conditions described therein concerning manufacture, labeling, dosage, containers, 14 and language permitted and prohibited. Id. § 330.1(c)(1). Any product that fails to 15 comply with these requirements is subject to regulatory action as “adulterated” or 16 “misbranded,” and prohibited from sale. See id.; 21 U.S.C. §§ 331, 351 (adulterated), 17 352 (misbranded). 18 As Defendants’ Products contain Coal Tar, (see Compl. ¶ 1), they are regulated 19 by the OTC Coal Tar drug product monograph and subject to “requirement[s] under 20 [the FDCA],” 21 U.S.C. § 379r(a). 21 C. Analysis 22 The Court agrees with Defendants that 21 U.S.C. § 379r(a) preempts Eisman’s 23 claims regarding the Products. Eisman broadly premises each of his causes of action 24 on allegations that Defendants misrepresented the Products via statements in the 25 “labeling and packaging that described the [P]roduct[s] as safe and effective without 26 disclosing the presence or levels of benzene.” (Compl. ¶¶ 47 (breach express 27 warranties), 60 (breach implied warranties), 76 (fraud), 92 (negligent 28 misrepresentation/omission), 108 (violation consumer protection laws); see id. ¶¶ 119 1 (negligence), 129 (unjust enrichment).) Eisman alleges that, consequently, “the 2 [P]roduct[s] w[ere] not manufactured, tested, or marketed properly to account for 3 undisclosed impurities, substances, or risks.” (Id. ¶¶ 48; see id. ¶¶ 60, 75–76, 92, 4 107–08, 111, 119, 129.) 5 As Eisman does not identify any specific statement or representation on which 6 he relied, his allegations make clear that he premises his claims primarily on an 7 omission theory, and secondarily on an adulterated and misbranded product theory. 8 (See id. ¶¶ 1–6, 48, 60, 75–76, 92, 107–08, 111, 119, 129.) Whether Eisman’s theory 9 of liability is that the presence of benzene requires a disclosure that Defendants omit, 10 or that it renders the Products adulterated and misbranded, each of his claims seeks to 11 impose requirements that are “different from or in addition to, or that [are] otherwise 12 not identical with” the FDA’s. 21 U.S.C. § 379r(a). 13 1. Disclosure or Warning 14 Eisman claims that Defendants fraudulently and negligently misrepresented the 15 Products as safe and effective without disclosing the presence of a harmful substance, 16 i.e., benzene. (Compl. ¶¶ 1–5, 13–23, 46–48, 60–61, 75–76, 92, 107–08, 119, 129.) 17 Under this omission theory, Eisman essentially seeks to force Defendants to add a 18 disclosure or warning about benzene to the label of its Products. But the FDA’s 19 monograph for OTC Coal Tar drug products already regulates the labeling of the 20 Products, and the monograph requires neither the disclosure nor the warning that 21 Eisman seeks. See 21 C.F.R. § 358.701 et seq. (OTC Coal Tar drug product 22 monograph). Insofar as Eisman’s claims require disclosures in addition to the FDA’s 23 labeling requirements, these claims are preempted. See Seale, 718 F. Supp. 3d 24 at 1221–22 (finding state law claims preempted where plaintiff sought an antitussive 25 disclosure different from the FDA’s applicable monograph); Faustino, 2015 WL 26 12839161, at *2 (finding state law claim preempted where plaintiff sought a warning 27 for eye drops different from or additional to the FDA’s regulations). 28 1 Moreover, to the extent Eisman may argue that Defendants must include 2 benzene as a component of the Products, the OTC Coal Tar drug monograph requires 3 disclosure of the active and inactive ingredients. 21 C.F.R. §§ 201.66(c) (content 4 requirements), 358.710 (OTC Coal Tar drug products monograph—active 5 ingredients). Benzene does not fit the definition of either active or inactive 6 ingredients, because it is not a purposefully added component of the drug. See 7 21 C.F.R. § 210.3(b)(3) (defining a “component” as “any ingredient intended for use 8 in the manufacture of a drug product” (emphasis added)); id. §§ 201.66(b)(2) 9 (defining active ingredient), (b)(8) (defining inactive ingredients as “any component 10 other than an active ingredient”); (see also Compl. ¶¶ 15–17 (alleging benzene is one 11 of potentially thousands of constituents existing in Coal Tar)). As such, the 12 monograph does not require Defendants to include benzene on the label, and imposing 13 such a requirement would be inconsistent with the FDA’s regulations. See Howard v. 14 Alchemee, LLC, No. 2:24-cv-01834-SB (BFMx), 2024 WL 4272931, at *8 (C.D. Cal. 15 Sept. 19, 2024) (finding state law claims preempted where they would require 16 defendants to disclose benzene as an ingredient in OTC acne products when the 17 monograph did not require the disclosure), appeals filed, Nos. 24-6404, 24-6431, 18 24-6684 (9th Cir. Nov. 2024).4 19 2. Adulterated or Misbranded 20 Turning to Eisman’s secondary theory, Eisman alleges that the Products are 21 “adulterated” or “misbranded,” pursuant to 21 U.S.C. §§ 351 and 352, because 22 benzene is unsafe in any amount. (See Compl. ¶ 5; Opp’n 10 (“[B]enzene should not 23 be present in drug products,” and “benzene’s presence renders a drug unsafe and 24 therefore adulterated or misbranded.”).) He contends that Defendants are obligated, 25 but failed to, “properly manufacture their [Products] to . . . eliminate benzene or 26 27 4 Eisman makes a passing suggestion that Defendants should ask the FDA to change the monograph. 28 (Opp’n 11.) However, the Court is not persuaded by Eisman’s out of circuit and inapposite authority on this point. 1 properly test and monitor their [Products] for the presence of benzene.”5 (Compl. 2 ¶¶ 18–20; see id. ¶¶ 48, 61, 76, 92, 108, 111, 119, 129; Opp’n 10.) Thus, he argues his 3 claims are parallel to the federal requirements, and not preempted, because he merely 4 seeks to require “Defendants to do that which they already must do under federal 5 law,” i.e., eliminate the benzene. (Opp’n 10.) 6 Eisman’s claims are not parallel to the FDCA’s bar on the sale of adulterated or 7 misbranded drugs because the relief Eisman seeks—the removal of benzene—is 8 “fundamentally at odds with the FDA’s monograph.” Howard, 2024 WL 4272931, 9 at *7. When the FDA approved the OTC Coal Tar drug product monograph, it did so 10 with full knowledge that Coal Tar contains benzene. See Dandruff, Seborrheic 11 Dermatitis, and Psoriasis Drug Products for Over-the-Counter Human use; Tentative 12 Final Monograph, 51 Fed. Reg. 27348 (July 30, 1986) (noting “it is well-established 13 that coal tar contains substances that possess carcinogenic properties”); OTC Drug 14 Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis; 15 Establishment of a Monograph, 47 Fed. Reg. 54656 (Dec. 3, 1982) (“Coal tar consists 16 generally of 2 to 8 percent light oils (benzene, toluene, and xylene) . . . .”) (emphasis 17 added). Thus, the FDA approved OTC Coal Tar drug products as generally safe and 18 effective, and not adulterated, with the understanding that they would contain some 19 level of benzene. 20 Moreover, the FDA deems an OTC drug “generally recognized as safe and 21 effective and is not misbranded if it meets each of the conditions” imposed by 22 21 C.F.R. § 330.1 and the applicable monograph. 21 C.F.R. § 358.701(a); Seale, 23 718 F. Supp. 3d at 1222. Eisman does not argue the Products fail to comply with the 24 monograph or any specific conditions in 21 C.F.R. § 330. (See generally Compl.; 25 Opp’n.) Yet he nevertheless asserts “the presence of benzene in the [P]roducts 26

5 Although Eisman initially alleged that Defendants must “reduce or eliminate benzene,” (Compl. 27 ¶ 18), his arguments in opposition clarify his position that benzene in any amount is unsafe and 28 renders the Products adulterated, (Opp’n 11 (arguing “the Products are not manufactured properly because they contain benzene”).) 1 rendered them ‘adulterated and/or misbranded’ under federal and parallel state law.” 2 (Opp’n 9 (internal citation omitted).) Consequently, Eisman essentially challenges the 3 FDA’s determination that OTC drugs “containing [Coal Tar] are ‘generally recognized 4 as safe and effective’ and ‘not misbranded’” if they comply with the monograph and 5 21 C.F.R. § 330.1. See Howard, 2024 WL 4272931, at *7 (finding state law claims 6 preempted and not parallel to federal requirements where plaintiffs argued OTC acne 7 drugs were adulterated because they contained a component known to degrade into 8 benzene); Seale, 718 F. Supp. 3d at 1222 (finding state law claims preempted and not 9 parallel to federal requirements where plaintiff argued antitussive products were 10 misbranded because they omitted a disclosure not required by the monograph). 11 Eisman argues the FDA, in recent industry guidance, declared that “benzene 12 should not be present in drug products,” and that this supports that Products 13 containing benzene are “adulterated.” (Opp’n 10 (citing Pl. RJN Ex. A 14 (“Reformulating Drug Products that Contain Carbomers Manufactured with 15 Benzene—Guidance for Industry” or “FDA Guidance”), ECF No. 43-1.6).) The FDA 16 Guidance provides recommendations specific to “drug products that use carbomers 17 manufactured with benzene.” (FDA Guidance 1 (emphasis added).) As Eisman 18 alleges benzene is one of thousands of compounds existing within Coal Tar, (Compl. 19 ¶¶ 15–17), the Products are not “manufactured with benzene.” The cited FDA 20 Guidance is thus inapplicable as it is directed to an entirely different class of drug 21 products. See Howard, 2024 WL 4272931, at *9, n.9 (rejecting similar argument 22 because “Plaintiffs have not alleged that the ‘presence of benzene in [the product] 23 stems’ from the manufacturing process . . . . On the contrary, they allege that the cause 24 is the inevitable degradation of [the active ingredient].”). Even were the FDA 25 6 The Court notes Defendants’ objection to judicial notice of the FDA Guidance, (Defs. Opp’n 26 Pl. RJN, ECF No. 46), that as Eisman does not reference the FDA Guidance in his Complaint, he may not introduce new allegations based thereon in opposition to Defendants’ Motion. While the 27 Court does not take judicial notice of the FDA Guidance, the Court considers it for the limited 28 purpose of evaluating the propriety of leave to amend. In any event, as discussed herein, the Court finds the FDA Guidance inapplicable. 1 Guidance applicable to the Products, it is non-binding guidance lacking the force of 2 law. (See FDA Guidance 1 (“Contains Nonbinding Recommendations”; “This 3 guidance . . . does not establish any rights for any person and is not binding on FDA or 4 the public.”)); Bowen v. Energizer Holdings, Inc., 118 F.4th 1134, 1148 n.12 (9th Cir. 5 2024) (finding FDA Alert and FDA FAQs lacked the force of federal law and would 6 not be subject to deference by the court). Therefore, the FDA Guidance does not 7 impose on Defendants an obligation to eliminate benzene from the Products, and 8 Eisman’s claims seeking to do so are not parallel to federal requirements. 9 In sum, Eisman impermissibly seeks via his state law claims to impose 10 requirements that are “different from or in addition to, or that [are] otherwise not 11 identical with” the FDCA. 21 U.S.C. § 379r(a)(2). His claims are therefore 12 preempted by federal law and must be dismissed. 13 D. Leave to Amend 14 Though courts “should freely give leave [to amend] when justice so requires,” 15 Fed. R. Civ. P. 15(a)(2), leave may be denied when “amendment would be futile,” 16 Carrico v. City & County of San Francisco, 656 F.3d 1002, 1008 (9th Cir. 2011). 17 Preemption generally cannot be cured by amendment. See Webb v. Trader Joe’s Co., 18 999 F.3d 1196, 1205 (9th Cir. 2021) (affirming dismissal with prejudice because 19 plaintiff could not “amend her complaint to avoid preemption”); Chae v. SLM Corp., 20 593 F.3d 936, 943 (9th Cir. 2010) (“[P]reemption cannot be avoided simply by 21 relabeling an otherwise-preempted claim.”). As the Court finds that Eisman’s claims 22 are preempted by 21 U.S.C. § 379r because Eisman’s theories of liability are 23 fundamentally at odds with the FDA’s conclusions about the safety and effectiveness 24 of OTC Coal Tar drug products, the Court concludes amendment would be futile. 25 Accordingly, the Court declines to grant leave to amend. 26 27 28 1 Vv. CONCLUSION 2 For the reasons discussed above, the Court GRANTS Defendants’ Motion to 3 || Dismiss with prejudice. (ECF No. 18.) 4 5 IT IS SO ORDERED. 6 7 January 17, 2025 g SB ol

10 OTIS D. HT, II

UNITED STATES DISTRICT JUDGE

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