1 2 3 4 5 6 7 8 9 UNITED STATES DISTRICT COURT 10 SOUTHERN DISTRICT OF CALIFORNIA 11 12 KRISTEN BRINKERHOFF, On Case No.: 3:18-cv-2034-BTM-WVG Behalf of Herself and All Others 13 Similarly Situated, ORDER GRANTING IN PART, 14 DENYING IN PART Plaintiff, DEFENDANT’S MOTION TO 15

DISMISS AND STAYING ACTION

v. 16 PENDING ADMINISTRATIVE 17 L’ORÉAL USA, INC., ACTION

18 Defendant. [ECF No. 10] 19 Defendant L'Oréal USA, Inc. manufactures, markets, distributes, and sells 20 various skin care products, including CeraVe Eye Repair Cream (the "Cream"). 21 (ECF No. 7, ¶ 1.) The Cream’s packaging prominently displays various 22 representations regarding the Cream, including that it "help[s] repair and restore 23 the . . . skin barrier around [users'] eyes" (hereinafter, the “Repair 24 Representations”). (Id. ¶¶ 2, 12 & Ex. A.) In Fall 2017, Plaintiff Kristen Brinkerhoff 25 purchased the Cream from an independent retailer for approximately fifteen 26 dollars. (Id. ¶ 10.) Plaintiff alleges she relied upon the Repair Representations 27 when she purchased the Cream, forgoing “less expensive competitor cosmetic eye 28 1 products” based thereon. (Id.) Plaintiff subsequently learned, however, that 2 Defendant had not presented the United States Food & Drug Administration (the 3 “FDA”) with evidence of the Cream’s safety and effectiveness before its marketing 4 and sale. (Id.) Plaintiff alleges she “would not have purchased the [Cream] and 5 certainly would not have paid a premium price for it” had she known that the Repair 6 Representations had not been approved by the FDA.1 (Id.) 7 Plaintiff’s sole claim in her First Amended Complaint is that Defendant’s 8 marketing and sale of the Cream was “unlawful” under California’s Unfair 9 Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200, et seq., because 10 Defendant did not receive approval from the FDA prior to marketing and selling the 11 Cream, which Plaintiff contends is a “drug” under the Federal Food, Drug, and 12 Cosmetic Act (“FDCA”), 21 U.S.C. § 301, et seq., and California’s Sherman Food, 13 Drug, and Cosmetic Law (“Sherman Law”), Cal. Health & Safety Code § 109875, 14 et seq., in violation of the FDCA and Sherman Law. (Id. ¶¶ 2-4, 32-41.) Indeed, 15 unlike purely cosmetic items, “new drugs” generally may not be marketed or sold 16 without preapproval from the FDA through the New Drug Application (“NDA”) 17 process.2 21 U.S.C. §§ 331(d) & 355; Cal. Health & Safety Code § 111550. 18

19 1 Notably, Plaintiff does not allege that she believed the Cream had been submitted 20 to or otherwise been approved by the FDA at the time of her purchase. (See ECF 21 No. 7, ¶ 10 (“Had Plaintiff known that the FDA prohibits manufacturers from selling products with repair and restore representations that the FDA had not determined 22 are both safe and effective and that Defendant had not presented the FDA with the 23 required evidence of safety and effectiveness, Plaintiff would not have purchased the [Cream] and certainly would not have paid a premium price for it.” (emphasis 24 added)). 25 2 Under the FDCA, a “cosmetic” includes “articles intended to be rubbed, poured, 26 sprinkled, or sprayed on, introduced into, or otherwise applied to the human body 27 or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.” 21 U.S.C. § 321(i)(1); see also Cal. Health & Safety Code § 28 1 Plaintiff contends that that the Repair Representations rendered the Cream a drug 2 for which FDA preapproval via the NDA process was necessary. (ECF No. 7, ¶¶ 3 2, 16-19, 35.) Further, Plaintiff alleges that, “[b]y making the unlawful [Repair 4 Representations,] Defendant is . . . able to charge a substantial premium for [the 5 Cream] over what competitors charge for similar cosmetic eye products which . . . 6 claim only to moisturize and visibly improve the skin’s appearance or look and do 7 not make . . . unlawful drug claims.” (Id. ¶ 21.) Plaintiff alleges that “but for 8 Defendant’s illegal conduct” of marketing the Cream with the Repair 9 Representations without obtaining approval from the FDA, “the [Cream] would not 10 have been on the market” and therefore she would have been unable to purchase 11 it. (Id. ¶¶ 35-36.) In addition to seeking declaratory relief and an injunction 12 preventing sale of the Cream with the Repair Representations until the NDA 13 process is completed, Plaintiff seeks restitution of all money she paid for the Cream 14 “or, at a minimum, the premium paid for the [Cream].” (Id. ¶ 39-41.) Defendant 15 subsequently moved to dismiss Plaintiff’s claims for lack of standing, federal 16 preemption, or, in the alternative, to stay this action or dismiss Plaintiff’s claim 17 without prejudice and refer Plaintiff’s claim to the FDA pursuant to the “primary 18 jurisdiction” doctrine. (ECF No. 10.) 19 Because standing under Article III of the U.S. Constitution is an essential 20 element of the Court’s subject matter jurisdiction, see Lujan v. Defs. of Wildlife, 21 504 U.S. 555, 560 (1992), the Court addresses it first. “[T]o satisfy Article III's 22 23 24 the structure or any function of the body of man or other animals.” 21 U.S.C. § 25 321(g)(1)(C); 21 U.S.C. § 359; see also Cal. Health & Safety Code § 109925(c)(3). Notably, the FDCA differentiates between “drugs” and “new drugs.” Compare 21 26 U.S. § 321(g)(1) & (p). Only “new drugs” need to undergo the NDA process. 21 27 U.S.C. § 355(a) (“No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to 28 1 standing requirements, a plaintiff must show[:] (1) it has suffered an ‘injury in fact’ 2 that is (a) concrete and particularized and (b) actual or imminent, not conjectural 3 or hypothetical; (2) the injury is fairly traceable to the challenged action of the 4 defendant; and (3) it is likely, as opposed to merely speculative, that the injury will 5 be redressed by a favorable decision.” Friends of the Earth, Inc. v. Laidlaw Envtl. 6 Servs. (TOC), Inc., 528 U.S. 167, 180–81 (2000) (citing Lujan, 504 U.S. at 560-61) 7 see also Lujan, 504 U.S. at 561 (“The party invoking federal jurisdiction bears the 8 burden of establishing these elements.”). Where a 12(b)(1) motion to dismiss is 9 based on lack of standing, the Court must defer to the plaintiff's factual allegations 10 and must “presume that general allegations embrace those specific facts that are 11 necessary to support the claim.” Lujan, 504 U.S. at 561 (internal quotation marks 12 omitted). Indeed, “[a]t the pleading stage, general factual allegations of injury 13 resulting from the defendant’s conduct may suffice.” Id. at 560. 14 “To have standing under California's UCL, as amended by California's 15 Proposition 64,3 plaintiffs must establish that they (1) suffered an injury in fact and 16 (2) lost money or property as a result of the unfair competition.” Birdsong v. Apple, 17 Inc., 590 F.3d 955, 959 (9th Cir. 2009) (citations omitted); Cal. Bus. & Prof. Code 18 19 20 3 “In 2004, the electorate substantially revised the UCL’s standing requirement; 21 where once private suits could be brought by any person acting for the interests of itself, its members or the general public, now private standing is limited to any 22 person who has suffered injury in fact and has lost money or property as a result 23 of unfair competition. The intent of this change was to confine standing to those actually injured by a defendant's business practices and to curtail the prior practice 24 of filing suits on behalf of clients who have not used the defendant's product or 25 service, viewed the defendant's advertising, or had any other business dealing with the defendant. While the voters clearly intended to restrict UCL standing, they just 26 as plainly preserved standing for those who had had business dealings with a 27 defendant and had lost money or property as a result of the defendant's unfair business practices.” Kwikset Corp. v. Superior Court, 51 Cal. 4th 310, 320–21, 28 1 § 17204 (“Actions for relief pursuant to this chapter shall be prosecuted exclusively 2 in a court of competent jurisdiction . . . by a person who has suffered injury in fact 3 and has lost money or property as a result of the unfair competition.”). “Thus, to 4 plead a UCL claim, the plaintiffs must show, consistent with Article III, that they 5 suffered a distinct and palpable injury as a result of the alleged unlawful or unfair 6 conduct.” Birdsong, 590 F.3d at 960 (citations omitted). “The requisite injury must 7 be an invasion of a legally protected interest which is (a) concrete and 8 particularized, and (b) actual or imminent, not conjectural or hypothetical.” Id. 9 (internal quotations and citations omitted)). Moreover, Proposition 64’s 10 amendments to the UCL require “that a plaintiff must now demonstrate some form 11 of economic injury,” although “[t]here are innumerable ways” in which to do so. 12 Kwikset Corp. v. Superior Court, 51 Cal. 4th 310, 323 (2011). For example, “[a] 13 plaintiff may (1) surrender in a transaction more, or acquire in a transaction less, 14 than he or she otherwise would have; (2) have a present or future property interest 15 diminished; (3) be deprived of money or property to which he or she has a 16 cognizable claim; or (4) be required to enter into a transaction, costing money or 17 property, that would otherwise have been unnecessary.” Id. “Because . . . 18 economic injury is itself a form of injury in fact, proof of lost money or property will 19 largely overlap with proof of injury in fact.” Id. at 325 (“If a party has alleged or 20 proven a personal, individualized loss of money or property in any nontrivial 21 amount, he or she has also alleged or proven injury in fact.”). 22 Defendant argues that Plaintiff lacks standing under both Article III and the 23 UCL because she fails to allege a cognizable injury-in-fact. In support thereof, 24 Defendant highlights that Plaintiff has not challenged the veracity of the Repair 25 Representations or the Cream’s safety or effectiveness, but only Defendant’s 26 failure to engage in the NDA process and obtain FDA approval prior to marketing 27 and selling the Cream with the Repair Representations. (ECF No. 10-1, at 9-13 28 (citing ECF No. 7, ¶ 5).) Further, Defendant takes issue with Plaintiff’s failure to 1 allege that she would have paid less for the Cream had it gone through the NDA 2 process or that, at the time of her purchase, she believed the Cream was a drug 3 based upon the Repair Representations or that the FDA had deemed the Cream 4 to be safe and effective or otherwise approved it for marketing or sale. (Id. (citing 5 ECF No. 7, ¶ 10).) Defendant argues that Plaintiff “got exactly what [she] expected 6 and wanted” when she purchased the Cream and therefore has not suffered an 7 economic loss simply because she bought a product for which Defendant lacked 8 legal permission to sell. (Id. at 11; see also ECF No. 15, at 8 (“Absent an allegation 9 that [Plaintiff] is unhappy with the Cream, she received the benefit of her bargain, 10 lost no money or property, and there is no standing.”).) 11 Yet, during the parties’ briefing of the instant motion, the Ninth Circuit issued 12 a memorandum holding that a plaintiff who made nigh-identical allegations as to a 13 competing lotion had standing to pursue the same claim Plaintiff now asserts. See 14 Franz v. Beiersdorf, Inc., 745 F. App’x 47 (9th Cir. 2018). As stated by the Ninth 15 Circuit: 16 Plaintiff alleges that Defendant sold a “drug” – Nivea CoQ10 – without 17 FDA approval. Plaintiff contends that doing so violates the [FDCA], 18 see 21 U.S.C. §§ 331(d), 355(a), and California’s Sherman Law, see Cal. Health & Safety Code § 111550. Plaintiff alleges that, as a result, 19 she spent money on a product that should not have been on the 20 market. Those allegations are sufficient to establish standing under the UCL. See Medrazo v. Honda of N. Hollywood, 205 Cal. App. 4th 21 1, 11–13 (2012), modified on denial of reh’g (Apr. 16, 2012). Plaintiff 22 need not plead reliance because neither the alleged FDCA violation nor the alleged Sherman Law violation requires allegations of fraud or 23 deception. See id. at 12 (explaining that claims based on a theory of 24 fraud require a plaintiff to demonstrate reliance to establish standing because “reliance is the causal mechanism of fraud.” (quoting In re 25 Tobacco II Cases, 46 Cal. 4th 298, 326 (2009))). . . . Plaintiff likewise 26 has standing under Article III of the United States Constitution. Plaintiff alleged injury in fact – she spent money on Nivea CoQ10. Defendant’s 27 allegedly illegal conduct caused that injury, insofar as Defendant 28 allegedly sold a product in commerce that it should not have sold. And 1 the injury is redressable – in restitution – by a favorable court decision. Spokeo, Inc. v. Robins, ___ U.S. ___, 136 S. Ct. 1540, 1547 (2016). 2

3 Franz, 745 F. App'x at 48; see also Medrazo, 205 Cal. App. 4th at 13 (plaintiff 4 established economic injury where “[s]he testified that she made the first two 5 months payments, and owes more than $12,000 on a motorcycle that [the 6 defendant] allegedly was not legally allowed to sell (or at least was not allowed to 7 sell at the price for which it was sold) because it failed to disclose the dealer-added 8 charges on a hanger tag attached to the motorcycle”). Moreover, the cases 9 Defendant argue “better reflect California UCL standing law” are distinguishable 10 from the instant case because, unlike those cases, Plaintiff has alleged that the 11 Cream she purchased was overpriced compared to competing products that had 12 not undergone the NDA process but which did not display the Repair 13 Representations or other representations rendering them drugs that must undergo 14 the NDA process. See Demeter v. Taxi Computer Servs., Inc., 21 Cal. App. 5th 15 903, 916–17 (2018) (“Demeter has not provided evidence that the service he 16 purchased from TAXI was somehow not up to par, nor has he established a dispute 17 of fact concerning whether the amount he paid for his TAXI membership was more 18 than it was worth because of TAXI’s (then) unbonded status.”); Peterson v. Cellco 19 P'ship, 164 Cal. App. 4th 1583, 1591 (2008) (plaintiffs failed to allege economic 20 injury from an insurance agent’s unlicensed sale of insurance policy where they 21 did “not allege they could have bought the same insurance for a lower price either 22 directly from the insurer or from a licensed agent”); Medina v. Safe-Guard Prod., 23 Internat., Inc., 164 Cal. App. 4th 105, 114 (2008), as modified (July 11, 2008) 24 (“Medina has not alleged that he didn't want wheel and tire coverage in the first 25 place, or that he was given unsatisfactory service or has had a claim denied, or 26 that he paid more for the coverage than what it was worth because of the 27 unlicensed status of Safe–Guard.”). Accordingly, the Court concludes that Plaintiff 28 has demonstrated standing to assert her present claim. 1 Defendant argues that Plaintiff’s claim under the UCL and Sherman Law are 2 preempted by the FDCA and that Plaintiff can not assert a private cause of action 3 under the FDCA. “Under the Supremacy Clause, U.S. Const., Art. VI, cl. 2, the 4 enforcement of a state regulation may be pre-empted by federal law in several 5 circumstances: first, when Congress, in enacting a federal statute, has expressed 6 a clear intent to pre-empt state law; second, when it is clear, despite the absence 7 of explicit preemptive language, that Congress has intended, by legislating 8 comprehensively, to occupy an entire field of regulation and has thereby left no 9 room for the States to supplement federal law; and, finally, when compliance with 10 both state and federal law is impossible or when the state law stands as an 11 obstacle to the accomplishment and execution of the full purposes and objectives 12 of Congress.” Capital Cities Cable, Inc. v. Crisp, 467 U.S. 691, 698–99 (1984) 13 (internal quotations and citations omitted). “[T]he purpose of Congress is the 14 ultimate touchstone in every pre-emption case[,]” which “primarily is discerned 15 from the language of the pre-emption statute and the statutory framework 16 surrounding it.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485-86 (1996) (internal 17 quotations, citations, and alterations omitted). “Also relevant . . . is the structure 18 and purpose of the statute as a whole, as revealed not only in the text, but through 19 the reviewing court's reasoned understanding of the way in which Congress 20 intended the statute and its surrounding regulatory scheme to affect business, 21 consumers, and the law.” Id. at 486. “Where the field which Congress is said to 22 have pre-empted includes areas that have been traditionally occupied by the 23 States, congressional intent to supersede state laws must be clear and manifest.” 24 English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990) (internal quotations, citations, 25 and alterations omitted); Lohr, 518 U.S. at 485 (“[W]e start with the assumption 26 that the historic police powers of the States were not to be superseded by the 27 Federal Act unless that was the clear and manifest purpose of Congress.” (internal 28 quotations and citations omitted)). “Parties seeking to invalidate a state law based 1 on preemption bear the considerable burden of overcoming the starting 2 presumption that Congress does not intend to supplant state law.” Stengel v. 3 Medtronic Inc., 704 F.3d 1224, 1227–28 (9th Cir. 2013) (citing 1228 De Buono v. 4 NYSA–ILA Med. & Clinical Servs. Fund, 520 U.S. 806, 814 (1997)); but see 5 Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 347-48 (2001) 6 (“presumption against pre-emption” did not apply to “state-law fraud-on-the-FDA 7 claims” where the defendant’s pertinent “dealings with the FDA were prompted by 8 the [the Medical Device Amendments of 1976 to the FDCA], and the very subject 9 matter of [the defendant’s] statements were dictated by that statute’s provisions.”). 10 Defendant argues that the provisions of the FDCA “cannot be enforced by 11 private citizens.” (ECF No. 10-1, at 14 (citing 21 U.S.C. § 337(a) (“Except as 12 provided in subsection (b), all such proceedings for the enforcement, or to restrain 13 violations, of this chapter [i.e., the FDCA] shall be by and in the name of the United 14 States.”)).) Defendant argues Plaintiff’s attempt to circumvent this prohibition by 15 couching her claim in state law fails because the predicate “unlawful” act she relies 16 upon as the basis of her UCL claim is nevertheless Defendant’s failure to undergo 17 the NDA process and obtain preapproval from the FDA in violation of the FDCA. 18 (Id. at 16-19.) Defendant further argues that Plaintiff’s references to the Sherman 19 Law are unavailing, as it “merely adopts the FDCA as California law” and “does 20 not create a stand-alone, state-law drug approval process or standard that can be 21 separately enforced without referring to and applying the FDCA standards and 22 FDA premarket approval process.” (Id. (citing Cal. Health & Safety Code § 23 110111); see also Cal. Health & Safety Code § 111550.) Thus, Defendant argues, 24 “[a]ny claim brought to enforce premarket approval under the Sherman Law 25 originates from, is governed by, and terminates according to federal law and is 26 really just a violation of the FDCA.” (Id. at 19 (internal quotations and citations 27 omitted).) Defendant further argues that permitting Plaintiff and other private 28 citizens to enforce the FDCA through the Sherman Law and UCL would conflict 1 with the FDCA’s enforcement scheme, which grants the FDA discretion in 2 enforcement. (ECF No. 10-1, at 16-17 (citing 21 U.S.C. § 336 (“Nothing in this 3 chapter shall be construed as requiring the Secretary to report for prosecution, or 4 for the institution of libel or injunction proceedings, minor violations of this chapter 5 whenever he believes that the public interest will be adequately served by a 6 suitable written notice or warning.”)).) Moreover, Defendant argues that unlike 7 “[o]ther state law claims that parallel federal rules” that have been held to not be 8 preempted by the FDCA, such as common law fraud based upon misleading food 9 labeling, Plaintiff’s claims do not rely upon traditional theories of state law that 10 predate the FDCA. (ECF No. 10-1, at 19.) In response, Plaintiff argues that her 11 instant claim “is within states’ historic police powers” and thus subject to a starting 12 presumption of no preemption, that the Sherman Law’s imposition of obligations 13 identical to the FDCA “does not substantively transform [her] action into one 14 seeking to enforce federal law,” and that “while allowing private remedies based 15 on violations of state laws identical to the FDCA may arguably result in actions that 16 the FDA itself may not have pursued,” such private claims pose little risk of 17 disrupting federal enforcement of the FDCA. (ECF No. 13, at 13-17 (citing Farm 18 Raised Salmon Cases, 42 Cal. 4th 1077 (2008).) 19 The Court need not decide whether Plaintiff’s claim is preempted at this time 20 because Defendant argues in the alternative that the Court should either dismiss 21 this case without prejudice or stay its proceedings because Plaintiff’s claims 22 implicitly seek a ruling that the Cream is a “new drug” that must undergo the NDA 23 process, which Defendant contends is a predicate issue that lays within the primary 24 jurisdiction of the FDA. The “primary jurisdiction” doctrine is not a jurisdictional 25 doctrine, but “[r]ather . . . a ‘prudential’ one, under which a court determines that 26 an otherwise cognizable claim implicates technical and policy questions that 27 should be addressed in the first instance by the agency with regulatory authority 28 over the relevant industry rather than by the judicial branch.” Clark v. Time Warner 1 Cable, 523 F.3d 1110, 1114 (9th Cir. 2008) (citations omitted). “[I]t is to be used 2 only if a claim requires resolution of an issue of first impression, or of a particularly 3 complicated issue that Congress has committed to a regulatory agency, and if 4 protection of the integrity of a regulatory scheme dictates preliminary resort to the 5 agency which administers the scheme. Id. (internal quotations and citations 6 omitted); see also Brown v. MCI WorldCom Network Servs., Inc., 277 F.3d 1166, 7 1172 (9th Cir. 2002) (“[P]rimary jurisdiction is properly invoked when a case 8 presents a far-reaching question that requires expertise or uniformity in 9 administration.” (internal quotations and citations omitted)). “Although no fixed 10 formula exists for applying the doctrine of primary jurisdiction, . . . [the Ninth Circuit] 11 held that the doctrine applies in cases where there is: (1) a need to resolve an 12 issue that (2) has been placed by Congress within the jurisdiction of an 13 administrative body having regulatory authority (3) pursuant to a statute that 14 subjects an industry or activity to a comprehensive regulatory authority that (4) 15 requires expertise or uniformity in administration.” Clark, 523 F.3d at 1115 (internal 16 quotations, citations, and alterations omitted); cf. Maronyan v. Toyota Motor Sales, 17 U.S.A., Inc., 658 F.3d 1038, 1048–49 (9th Cir. 2011) (“The primary jurisdiction 18 doctrine prescribes deference to an administrative agency where (1) the issue is 19 not within the conventional experiences of judges, (2) the issue involves technical 20 or policy considerations within the agency's particular field of expertise, (3) the 21 issue is particularly within the agency's discretion, or (4) there exists a substantial 22 danger of inconsistent rulings.”). Notably, the Supreme Court has stated that: 23 “In cases raising issues of fact not within the conventional experience of judges or cases requiring the exercise of administrative discretion, 24 agencies created by Congress for regulating the subject matter should 25 not be passed over. This is so even though the facts after they have been appraised by specialized competence serve as a premise for 26 legal consequences to be judicially defined. Uniformity and 27 consistency in the regulation of business entrusted to a particular agency are secured, and the limited functions of review by the judiciary 28 1 are more rationally exercised, by preliminary resort for ascertaining and interpreting the circumstances underlying legal issues to agencies 2 that are better equipped than courts by specialization, by insight gained 3 through experience, and by more flexible procedure.”

4 Weinberger v. Bentex Pharm., Inc., 412 U.S. 645, 654 (1973) (internal quotations, 5 citations, and alterations omitted). 6 Here, the Court concludes that the primary jurisdiction doctrine is applicable 7 to this matter and it should therefore be referred to the FDA. First, Plaintiff alleges 8 that Defendant acted unlawfully by selling the Cream without undergoing the NDA 9 process and obtaining FDA approval. This requires a determination that the Repair 10 Representations were not just cosmetic marketing puffery, but rather 11 representations of the Cream’s ability to “affect the structure or any function of the 12 body of man or other animals.” See 21 U.S.C. § 321(g)(1)(C). Further, because 13 only “new drugs” are required to go through the NDA process, see 21 U.S.C. § 14 355(a), the Court must also determine whether the Cream’s “composition . . . is 15 not generally recognized, among experts qualified by scientific training and 16 experience to evaluate the safety and effectiveness of drugs, as safe and effective 17 for use under the conditions prescribed, recommended, or suggested in the 18 labeling thereof.” 21 U.S.C. § 321(p)(1). Second, “[t]he Supreme Court has ruled 19 that while the federal courts and the FDA share concurrent jurisdiction to determine 20 whether a drug sought to be marketed constitutes a ‘new drug’ subject to the 21 provisions of the [FDCA], the FDA has primary jurisdiction.” Biotics Research 22 Corp. v. Heckler, 710 F.2d 1375, 1376 (9th Cir. 1983) (citing Weinberger v. 23 Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 627 (1973)); see also Hynson, 24 Westcott & Dunning, 412 U.S. at 624 (“It is clear to us that FDA has power to 25 determine whether particular drugs require an approved NDA in order to be sold 26 to the public.”); 21 C.F.R. § 10.25(b) (“FDA has primary jurisdiction to make the 27 initial determination on issues within its statutory mandate, and will request a court 28 1 to dismiss, or to hold in abeyance its determination of or refer to the agency for 2 administrative determination, any issue which has not previously been determined 3 by the agency or which, if it has previously been determined, the agency concluded 4 should be reconsidered and subject to a new administrative determination.”). 5 Third, the FDCA subjects the drug and cosmetic industries to a comprehensive 6 regulatory authority. See 21 U.S.C. § 301, et seq. Fourth, determining “[w]hether 7 a particular drug is a ‘new drug,’ depends in part on the expert knowledge and 8 experience of scientists based on controlled clinical experimentation and backed 9 by substantial support in scientific literature.” Bentex Pharm., 412 U.S. 645, 652 10 (1973). And while Plaintiff argues that policy memoranda and warning letters 11 issued by the FDA provide guidance as to whether the FDA would consider the 12 Cream a “drug” based upon the Repair Representation, she points to no guidance 13 as to whether the FDA would consider the Cream a “new drug.” 4 (See ECF No. 14 13, 18-21.) 15 Accordingly, all factors favor the application of the primary jurisdiction 16 doctrine and the referral to the FDA. To avoid statute of limitations concerns, the 17 Court will stay this matter to allow the parties a reasonable opportunity to seek an 18

19 4 In support of her response in opposition to Defendant’s motion to dismiss, Plaintiff 20 filed a request for judicial notice (“RJN”) of a “Cosmetic Labeling Guide” issued by 21 the FDA and attached as Exhibit B to Plaintiff’s response. (ECF No. 14; see also ECF No. 13-3.) Defendant did not oppose or otherwise respond to the RJN. 22 Because the FDA’s Cosmetic Labeling Guide was made publicly available by a 23 government entity and neither party disputes its authenticity or accuracy, the Court will grant Plaintiff’s RJN and take judicial notice of Cosmetic Labeling Guide. See 24 Daniels-Hall v. Nat'l Educ. Ass'n, 629 F.3d 992, 998 (9th Cir. 2010); see also Fed. 25 R. Evid. 201(b)(2) (courts may take judicial notice of “a fact that is not subject to reasonable dispute because it . . . can be accurately and readily determined from 26 sources whose accuracy cannot reasonably be questioned); Tellabs, Inc. v. Makor 27 Issues & Rights, Ltd., 551 U.S. 308, 322 (2007) (when considering Rule 12(b)(6) motion, courts may consider “matters of which a court may take judicial notice”). 28 1 ||administrative ruling from the FDA as to whether the Cream constitutes a “new 2 drug” that must undergo the NDA process.° See Brown, 277 F.3d at 1173 (courts 3 || may stay proceedings where statute of limitations may expire in the event the court 4 |/does not retain jurisdiction during referral to administrative agency). Moreover, 5 || because the administrative process may obviate the need for further proceedings 6 this matter, the Court denies without prejudice Defendant’s preemption 7 ||arguments. Defendant may renew its preemption arguments after the completion 8 || of the administrative process. 9 CONCLUSION 10 Based upon the foregoing and due consideration, Defendant’s motion to 11 ||dismiss (ECF No. 10) is GRANTED IN PART, DENIED IN PART, DEFERRED IN 12 ||PART. Plaintiff's request for judicial notice (ECF No. 14) is GRANTED. Further, 13 ||the Court STAYS this action pending a determination by the FDA as to whether 14 ||the Cream is a “new drug” that must undergo the NDA process. The parties shall 15 || cooperate in expediting the presentation and explanation of this question to the 16 ||FDA and will notify the Court promptly of any determination by the FDA. A status 17 ||conference is hereby scheduled for Tuesday, May 12, 2020 at 2:00 p.m., at which 18 || counsel for the parties shall appear. 19 IT 1S SO ORDERED. 20 ||Dated: October 8, 2019 21 Tid 99 Honorable Barry Ted Moskowitz United States District Judge 23 24 25 ||° FDA regulations provide that interested persons may petition the FDA “to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other 26 |lform of administrative action” via, inter alia, a citizen’s petition. 21 C.F.R. § 27 ||10.25(a); see also 21 C.F.R. § 10.30 (citizen’s petition requirements). Generally, 28 a response to such citizen’s petition must be provided within 180 days of its receipt. 21 C.F.R. § 10.30(e)(2).