1 2 3 4 5 6 7 8 9 10 UNITED STATES DISTRICT COURT 11 SOUTHERN DISTRICT OF CALIFORNIA 12 13 CHELSEA GARLAND et al., Case No. 25-cv-03437-BAS-SBC
14 Plaintiffs, ORDER GRANTING IN PART, 15 v. DENYING IN PART DEFENDANTS’ MOTION TO DISMISS (ECF No. 8) 16 MEAD JOHNSON & COMPANY, LLC,
et al., 17 Defendants. 18 19 Pending before the Court is Defendants’ Mead Johnson & Co., LLC; Mead Johnson 20 Nutrition Co.; and Reckitt Benckiser LLC motion to dismiss (ECF No. 8) Plaintiffs’ 21 Chelsea Garland, Estelita Rey, and Zachary Williams first amended complaint (ECF No. 22 6). For the reasons below, the Court GRANTS IN PART and DENIES IN PART 23 Defendants’ motion to dismiss. (ECF No. 8.) 24 I. BACKGROUND 25 Defendants allegedly used misleading labels on two products: Enfagrow PREMIUM 26 Toddler Nutritional Drink and Enfagrow NeuroPro Toddler Nutritional Drink 27 (“Products”). (ECF No. 6 ¶ 1.) The Products, intended for toddlers, include labels stating, 28 “IMMUNE HEALTH Dual Prebiotics & Vitamins,” “Supports BRAIN DEVELOPMENT 1 Omega-3 DHA & Iron,” and “22 NUTRIENTS to help support growth.” (Id. ¶¶ 27, 47.) 2 Defendants allegedly “misbrand[ed] the Products by making nutrient content claims and 3 fortification-related representations which are strictly prohibited by the [Food and Drug 4 Administration (“FDA”)] for products intended for children under two years of age in order 5 to fetch a price premium for their products from consumers.” (Id. ¶ 46.) Accordingly, 6 Plaintiffs were allegedly “harmed financially because they paid a price premium for the 7 Products.” (Id. ¶ 69.) Plaintiffs first sued Defendants in San Diego County Superior Court 8 on July 5, 2024; then, removed the suit from San Diego County Superior Court on 9 December 4, 2025. (ECF No. 1.) Plaintiffs amended their complaint on December 22, 10 2025. (ECF No. 6.) 11 Plaintiffs’ first cause of action under California’s Unfair Competition Law (“UCL”) 12 claims that Defendants’ conduct was “unlawful” (“Count 1”). (Id. ¶ 97.) Specifically, 13 Plaintiffs claim Defendants’ Products were mislabeled in violation of California’s Sherman 14 Law which incorporates FDA and Food, Drug & Cosmetic Act (“FDCA”) regulations (Id. 15 ¶¶ 35, 46–47). See Cal. Bus. & Prof. Code § 17200; see 21 C.F.R. § 101. Additionally, 16 Plaintiffs bring a second cause of action for unjust enrichment and claim they are entitled 17 to restitution for the overpayment and profits Defendants obtained as a result of the 18 challenged conduct (“Count 2”). (Id. ¶¶ 108–113.) Furthermore, Plaintiffs seek 19 declaratory relief. (Id. ¶ 115.) 20 Defendants move to dismiss pursuant to Federal Rules of Civil Procedure (“Rules”) 21 12(b)(1) and 12(b)(6) arguing (1) Plaintiffs’ UCL claim is preempted by the FDCA; (2) 22 Plaintiffs’ unjust enrichment claim is similarly preempted because it is based on Plaintiffs’ 23 UCL claim; and (3) Plaintiffs’ request for declaratory relief should be dismissed. (ECF 24 No. 8.) Plaintiffs respond (ECF No. 9); and Defendants reply (ECF No. 10). 25 II. LEGAL STANDARD 26 A motion to dismiss pursuant to Rule 12(b)(6) of the Federal Rules of Civil 27 Procedure tests the legal sufficiency of the claims asserted in the complaint. Fed. R. Civ. 28 P. 12(b)(6); Navarro v. Block, 250 F.3d 729, 731 (9th Cir. 2001). The court must accept 1 all factual allegations pleaded in the complaint as true and must construe them and draw 2 all reasonable inferences from them in favor of the nonmoving party. Cahill v. Liberty 3 Mut. Ins. Co., 80 F.3d 336, 337–38 (9th Cir. 1996). To avoid a Rule 12(b)(6) dismissal, a 4 complaint need not contain detailed factual allegations, rather, it must plead “enough facts 5 to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 6 544, 570 (2007). A claim has “facial plausibility when the plaintiff pleads factual content 7 that allows the court to draw the reasonable inference that the defendant is liable for the 8 misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Twombly, 550 9 U.S. at 556). “Where a complaint pleads facts that are ‘merely consistent with’ a 10 defendant’s liability, it stops short of the line between possibility and plausibility of 11 ‘entitlement to relief.’ ” Id. (quoting Twombly, 550 U.S. at 557). 12 “[A] plaintiff’s obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief’ 13 requires more than labels and conclusions, and a formulaic recitation of the elements of a 14 cause of action will not do.” Twombly, 550 U.S. at 555 (quoting Papasan v. Allain, 478 15 U.S. 265, 286 (1986)). A court need not accept “legal conclusions” as true. Iqbal, 556 16 U.S. at 678. Despite the deference the court must pay to the plaintiff’s allegations, it is not 17 proper for the court to assume that “the [plaintiff] can prove facts that [he or she] has not 18 alleged or that defendants have violated the ... laws in ways that have not been 19 alleged.” Assoc. Gen. Contractors of Cal., Inc. v. Cal. State Council of Carpenters, 459 20 U.S. 519, 526 (1983). 21 When a court dismisses a complaint under Rule 12(b)(6), it must then decide whether 22 to grant leave to amend. Under Rule 15(a), leave to amend “shall be freely given when 23 justice so requires.” However, the court may deny leave to amend for reasons of “repeated 24 failure to cure deficiencies by amendments previously allowed, undue prejudice to the 25 opposing party by virtue of allowance of the amendment, [or] futility of amendment.” 26 Foman v. Davis, 371 U.S. 178, 182 (1962). 27 III. ANALYSIS 28 A. Whether Plaintiffs’ Claims are Preempted by FDCA 1 “The Supremacy Clause is the source of preemption doctrine, which invalidates state 2 laws that are contrary to federal statutes.” Nexus Pharms., Inc. v. Cent. Admixture 3 Pharmacy Servs., Inc., 48 F.4th 1040, 1045 (9th Cir. 2022). Relevant in all preemption 4 cases is the presumption “that the historic police powers of the States were not to be 5 superseded by the Federal Act unless that was the clear and manifest purpose of 6 Congress.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (quoting Rice v. Santa Fe 7 Elevator Corp., 331 U.S. 218, 230 (1947)). “[T]he party who asserts that a state law is 8 preempted bears the burden of so demonstrating.” Farm Raised Salmon Cases, 42 Cal. 4th 9 1077, 1088 (2008) (citations omitted). This presumption against preemption is applied to 10 both the “existence as well as the scope of preemption.” Id. (citing Medtronic, 518 U.S. at 11 485). “In determining whether federal law preempts state law, a court’s task is to discern 12 congressional intent.” Farm Raised Salmon Cases, 42 Cal. 4th at 1087 (2008). 13 Here, Plaintiffs bring a cause of action for violation of California’s Unfair 14 Competition Law (“UCL”) against Defendants. (ECF No. 6.) California’s UCL prohibits 15 “unfair competition” including any “unlawful, unfair, or fraudulent business practice” and 16 “unfair, deceptive, untrue or misleading advertising.” Cal. Bus. & Prof. Code §§ 17200 et 17 seq. As the basis for Plaintiffs’ UCL claims, Plaintiffs allege Defendants have violated 18 various provisions of the Sherman Food Drug & Cosmetic Law, Cal. Bus. & Prof. Code 19 §§ 109875, et seq. More specifically, Plaintiffs allege Defendants violated Sherman Law 20 advertising provisions, including Cal. Health & Safety Code §§ 110390, 110395, 110398, 21 110400; and Sherman Law misbranded food provisions, including Cal. Health & Safety 22 Code §§ 110665, 110760, 110765, and 110770. (ECF No. 6 ¶¶ 65, 66, 99.) Plaintiffs also 23 allege Defendants have violated Cal. Health & Safety Code §§ 110100(a), 110380, and 24 110505 through violating FDCA and FDA regulation provisions that Sherman Law has 25 incorporated by reference. (ECF No. 6 ¶ 99.) More specifically, Plaintiffs allege 26 Defendants violate the following federal misbranding provisions in 21 U.S.C. § 343, et 27 seq., and 21 C.F.R. §§ 101.13(b), 101.13(c), 101.54(e), and 104.20. (ECF No. 6 ¶¶ 67, 99.) 28 1 Defendants move to dismiss Plaintiffs’ UCL cause of action, arguing the claims are 2 preempted by the FDCA’s prohibition on private enforcement. (ECF No. 8-1 at 4:2– 3 11:15.) Plaintiffs rebut Defendants’ arguments and claim that they are not enforcing the 4 FDCA but are instead, bringing identical state-law claims under the UCL grounded in 5 California’s Sherman Law. (ECF No. 9 at 10:18–15:20.) 6 For the reasons below, the Court finds that Plaintiffs’ UCL claims based on Sherman 7 Law violations are neither expressly nor impliedly preempted by the FDCA. 8 1. Plaintiffs’ Claims are Not “Expressly Preempted” because They 9 are Based in Parallel State Law Requirements 10 “Congress in 1990 amended the FDCA [(‘Food, Drug, and Cosmetic Act’)] by 11 enacting the NLEA [(‘Nutrition Labeling and Education Act’)] in order to provide 12 nationally uniform standards for nutrition labeling.” Davidson v. Sprout Foods, Inc., 106 13 F.4th 842, 845 (9th Cir. 2024), cert. denied, 145 S. Ct. 1922 (2025); see 21 U.S.C. § 343- 14 1 (“Section 343-1”). Section 343-1 “permits states to enact labeling standards so long as 15 they are identical to the federal standards.” Davidson, 106 F.4th at 845. Section 343-1 16 “expressly preempts . . . only state standards that deviate from the federal.” Id. at 846 17 (citing 21 U.S.C. § 343-1(a)). 18 In Davidson, the Ninth Circuit held that plaintiff’s UCL claims were not expressly 19 preempted by Section 343-1 because they are based in California Sherman Law provisions 20 incorporating federal regulations by reference, which are identical to FDCA provisions 21 doing the same. Id., 106 F.4th at 845. 22 Davidson’s approach is spelled out as follows. First, Cal. Health & Safety Code 23 § 110100(a) (part of the California Sherman Law) expressly incorporates “[a]ll food 24 labeling regulations and any amendments to those regulations adopted pursuant to the 25 federal act, in effect on January 1, 1993, or adopted on or after that date [as] . . . the food 26 labeling regulations of this state.” Id. Second, 21 U.S.C. § 343 (“Section 343”) 27 incorporates requirements in FDA regulations related to food nutrient and health-related 28 labels as actionable under the FDCA. Third, 21 U.S.C.A. § 343-1(a)(5) (“Section 343- 1 1(a)(5)”) permits states to pass food labeling laws with “identical” requirements to Section 2 343. Taken together, the Davidson court reasons that Cal. Health & Safety Code 3 § 110100(a) incorporates FDA food labeling regulations into the California Sherman Law 4 in the same manner that Section 343 incorporates the same FDA food labeling regulations 5 into the FDCA—rendering the state and federal requirements “identical.” Davidson, 106 6 F.4th at 849 (citing Section 343-1(a)) (“It is true that the Sherman Law standards are 7 identical to the federal standards, but Congress said such standards are not preempted and 8 hence permitted states to adopt them.”) 9 Thus, Davidson found plaintiffs’ claims under Cal. Health & Safety Code 10 § 110100(a) to enforce prohibitions in FDA regulation 21 C.F.R. § 101.13(b)(3) on 11 advertising products for children less than two years old with labels containing nutrient 12 content claims were not expressly preempted by Section 343-1, since Cal. Health & Safety 13 Code § 110100(a) does not “deviate” from federal labeling standards in the FDCA. 14 Davidson, 106 F.4th at 846 (citing 21 U.S.C. § 343-1(a)) (“[Section 343-1] expressly 15 preempts only state standards that deviate from the federal.”). 16 Here, Plaintiffs’ California Sherman Law claims under Cal. Health & Safety Code 17 §§ 110390, 110395, 110398, 110400, 110665, 110770 (see ECF No. 6 ¶ 99) are not 18 expressly preempted by Section 343-1—since their text does not apparently deviate from 19 any substantive requirements in the FDCA. Additionally, Defendants do not point out how 20 the text of these laws deviates from substantive requirements in the FDCA in their motion 21 to dismiss; so, Defendants do not meet their burden to overcome the presumption against 22 preemption. (See generally ECF No. 8-1.) 23 Next, Plaintiffs bring California law claims under Cal. Health & Safety Code 24 §§ 110100(a), 110505, and 110380—asserting violations of 21 C.F.R. §§ 101.13(b), 25 101.13(c), 104.20 as their underlying bases. Following the reasoning in Davidson and 26 reviewing the text of these state laws, this Court finds that they are “parallel” state laws 27 incorporating federal regulations by reference, and thus, do not “deviate” from FDCA 28 provisions that do the same. See Davidson, 106 F.4th at 850 (“Plaintiffs’ claim is that 1 [Defendant] violated these parallel state requirements . . . [b]ecause the FDCA places no 2 limitations on enforcement of these state parallels, plaintiffs’ Sherman Law claim is not 3 preempted.”); see also id. at 856 (Judge Collins, concurring in part, dissenting on other 4 grounds) (“[T]he relevant substantive prohibition set forth in 21 C.F.R. § 101.13(b)(3) is 5 incorporated by reference into California law [in § 110100(a)] as a “food labeling 6 regulation” under California law . . . because that incorporated-by-reference regulation was 7 adopted under § 403(q) and § 403(r) of the FDCA, the resulting California-law obligation 8 derived from 21 C.F.R. § 101.13(b)(3) is ‘identical’ to the requirements of § 403(q) and 9 § 403(r).”). 10 Since the food labeling requirements under Cal. Health & Safety Code §§ 110100(a), 11 110505, and 110380 do not appear to deviate from those incorporated by reference into the 12 FDCA, the Court finds Plaintiffs have sufficiently pled that their Cal. Health & Safety Code 13 §§ 110100(a), 110505, and 110380 claims are also not expressly preempted by Section 14 343-1. 15 One caveat with Cal. Health & Safety Code §§ 110505 and 110380 is that, in 16 addition to incorporating federal law (including the FDCA and FDA regulations) by 17 reference, these provisions also appear to permit states to promulgate regulations that 18 deviate from federal standards. 19 Cal. Health & Safety Code § 110505 states (emphasis added): 20 Definitions and standards of identity, quality, and fill of container, and any amendment . . . adopted pursuant to the federal act . . . are the 21 definitions and standards of . . . this state . . . The [California state 22 health] department may, by regulation, establish definitions and standards of identity, fill . . . whether or not the definitions and 23 standards are in accordance with the federal regulations, when in 24 its judgment such action will promote honesty and fair dealing in the interest of consumers. 25 26 Cal. Health & Safety Code § 110380 states (emphasis added): 27 All regulations and their amendments pertaining to foods, drugs, 28 devices, and cosmetics that are . . . pursuant to the Fair Packaging and 1 Labeling Act (80 Stat. 1296; 15 U.S.C. Sec. 1451 et seq.) shall be the regulations of this state. The department may, when necessary, 2 prescribe any packaging and labeling regulation for foods . . . 3 whether or not the regulation is in accordance with regulations adopted under the Fair Packaging and Labeling Act. 4
5 Even so, Defendants have not asserted that Plaintiffs’ Cal. Health & Safety Code 6 §§ 110505 and 110380 claims are based on state regulations or laws deviating from federal 7 labeling requirements in the FDCA—as necessary for express preemption under Section 8 343-1. Indeed, Defendants focus their arguments on Plaintiffs’ enforcement of FDA 9 regulations incorporated by reference into Sherman Law provisions. (ECF No. 8-1 at 10 14:24–15:2.) 11 For the reasons above, the Court finds Plaintiffs have sufficiently alleged that the 12 claims underlying their UCL cause of action are not expressly preempted to survive 13 Defendants’ motion to dismiss. (ECF No. 8.) 14 2. Plaintiffs’ State Law and FDA Regulatory Claims are Not 15 “Impliedly Preempted” Because Not Private Enforcement of FDCA 16 Substantive Requirements 17 In addition to express preemption of a state law by federal statute, the Ninth Circuit 18 has also reasoned that there may be implied preemption of that state law “where preemption 19 ‘was the clear and manifest purpose of Congress’,” such as “when it stands in the way of 20 fulfilling a Congressional objective.” Davidson, 106 F.4th at 846 (citing McClellan v. I- 21 Flow Corp., 776 F.3d 1035, 1039 (9th Cir. 2015)). 22 21 U.S.C. § 337 (“Section 337”) reserves enforcement of all FDCA provisions for 23 the FDA and state governments, excluding private citizens. The Ninth Circuit has held that 24 Section 337 can impliedly preempt private state law actions not brought by the FDA and 25 that “require litigating” an underlying FDCA violation. Davidson, 106 F.4th at 849 26 (“claim[s] . . . [that] require litigating . . . whether an FDCA violation had occurred” are 27 impliedly preempted because enforcement of FDCA violations is a “task reserved for the 28 FDA.”); Nexus Pharms., Inc. v. Cent. Admixture Pharmacy Servs., Inc., 48 F.4th 1040, 1 1048 (9th Cir. 2022) (quoting PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 924 (9th Cir. 2010)) 2 (state law claims that “ ‘would require litigation of the alleged underlying FDCA violation 3 in a circumstance where the FDA has not itself concluded that there was a violation [e.g., 4 false assertion of FDA approval]’ . . . [are] barred by the FDCA’s prohibition of private 5 enforcement. ”); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353 (2001) 6 (private enforcement of “claims [that] exist solely by virtue of the FDCA disclosure 7 requirements” are impliedly preempted by Section 337). 8 Most recently, the Ninth Circuit reasoned in a memorandum disposition in Bubak 9 that the plaintiff’s UCL claim was impliedly preempted by Section 337 because it was 10 premised upon defendant’s alleged violation of the FDCA’s express statutory prohibition 11 on labels misrepresenting dietary supplements as capable of mitigating and preventing 12 disease (21 U.S.C. § 343(r)(6)). Bubak v. Golo, LLC, No. 24-492, 2025 WL 2860044, at 13 *1 (9th Cir. Oct. 9, 2025) (Mem. Disp.). As another example, in Nexus, the Ninth Circuit 14 held that Section 337 impliedly preempted private plaintiff’s claims based in state laws 15 prohibiting the sale and manufacture of non-FDA approved drugs—since ruling on 16 plaintiff’s state law claim would require interpreting the FDCA to determine whether the 17 defendant’s drug compounding facilities render defendant exempt from FDA approval. 18 Nexus Pharms., Inc. v. Cent. Admixture Pharmacy Servs., Inc., 48 F.4th 1040, 1050 (9th 19 Cir. 2022) (citing the Food and Drug Administration Modernization Act of 1997, Pub. L. 20 No. 105-115, 111 Stat. 2296 (1997) and the Drug Quality and Security Act, Pub. L. No. 21 113-54, 127 Stat. 587 (2013)—which are amendments to the FDCA that taken together, 22 permit large-scale compounding drug facilities without FDA approval as long as those 23 facilities do not produce drugs that are “essentially a copy of one or more [FDA-]approved 24 drugs.”). 25 Davidson supports the proposition that state law claims can evade implied 26 preemption if they do not require interpreting substantive provisions of the FDCA. 27 Davidson, 106 F.4th at 848. More specifically, the Davidson court found that Section 337 28 does not impliedly preempt private enforcement of Sherman Law provisions with identical 1 terms as the FDCA, since Plaintiffs’ claims could be resolved by solely referring to those 2 state laws and without directly interpreting FDCA provisions. Davidson, 106 F.4th at 848. 3 Though finding that the plaintiff’s Sherman Law claims were impliedly preempted, 4 the Ninth Circuit’s memorandum disposition in Bubak does not call Davidson’s holding 5 into question. Instead, the Ninth Circuit in Bubak distinguished its case from Davidson— 6 in that the plaintiff’s Sherman Law claims in Bubak required directly examining 7 substantive language in the FDCA (21 U.S.C. § 343(r)(6)), but plaintiff’s Sherman Law 8 claims in Davidson require examining FDA food labeling regulations instead. Bubak, 9 2025 WL 2860044, at *2 (discussing Davidson, 106 F.4th at 846). In doing so, this Court 10 observes that Bubak draws a distinction between the enforceability of two kinds of 11 Sherman Law claims: 12 (1) Section 337 impliedly preempts Sherman Law claims that require interpreting 13 substantive language in the text of the FDCA (e.g., 21 U.S.C. § 343(r)(6) at issue 14 in Bubak and the FDCA amendments governing exceptions to FDA approval for 15 compounded drug production at issue in Nexus); but 16 (2) Section 337 does not impliedly preempt Sherman Law claims that are based on 17 violating FDA regulations (e.g., 21 C.F.R. § 101.13(b)(3) at issue in Davidson) 18 incorporated by reference into the California Sherman Law—even if those 19 regulations may also be incorporated by reference into the FDCA (e.g., through 20 Section 343’s incorporation of FDA labeling regulations). 21 22 Another test of whether a state statutory provision can evade implied preemption by 23 Section 337 is if the origin of those state statutory provisions “predates” the relevant FDCA 24 provision at issue. Id. at 859; see also Bubak, 2025 WL 2860044, at *3 (Judge Callahan, 25 concurring in part, dissenting in part) (quoting Caplinger v. Medtronic, Inc., 784 F.3d 1335, 26 1340 (10th Cir. 2015)) (“[I]f a [state law claim] predate[s] the FDCA, [it] would exist in 27 the absence of the Act.”). 28 1 Here, several of the claims underlying Plaintiffs’ UCL cause of action rely upon 2 California statutes that do not explicitly refer to the FDCA (Cal. Health & Safety Code 3 §§ 110380, 110390, 110395, 110398, 110400, 110660, 110760, 110765, 110770). (See 4 ECF No. 6 ¶ 99). Although some of these statutes may depend on term definitions from 5 the FDCA copied into California statutes (e.g., Cal. Health & Safety Code § 110660 6 borrowed language from 21 U.S.C.A. § 343 to define “misbranded” food as food with 7 “misleading” labeling, and Cal. Health & Safety Code § 110765 renders it unlawful for 8 any person to “misbrand” food), they do not rely upon interpreting substantive FDCA 9 provisions post-enactment. Thus, Section 337 does not preempt their private enforcement. 10 See Davidson, 106 F.4th at 848. 11 In addition, the origin of the above state statutory provisions predates the enactment 12 of Section 343-1 in 1990—which indicates these statutes do not “exist solely by virtue of 13 the FDCA.” Bubak, 2025 WL 2860044, at *3 (Judge Callahan, concurring in part, 14 dissenting in part) (citing Buckman, 531 U.S. at 353); see also Cal. Health & Safety Code 15 § 110390 (derived from state laws enacted in 1939); see also Cal. Health & Safety Code 16 § 110395 (derived from state laws enacted in 1970); see also Cal. Health & Safety Code 17 § 110398 (derived from state laws enacted in 1971); see also Cal. Health & Safety Code 18 § 110400 (derived from state laws enacted in 1939); see also Cal. Health & Safety Code 19 § 110660 (derived from state laws enacted in 1939); see also Cal. Health & Safety Code 20 § 110760 (derived from state laws enacted in 1939); see also Cal. Health & Safety Code 21 § 110765 (derived from state laws enacted in 1939); see also Cal. Health & Safety Code 22 § 110770 (derived from state laws enacted in 1939); see also Cal. Health & Safety Code 23 § 110380 (derived from state laws enacted in 1970). 24 Since Defendants have not presented adequate reasoning that the aforementioned 25 state laws require the interpretation of substantive provisions within FDCA and/or “exist 26 solely by virtue of the FDCA,” Buckman, 531 U.S. at 353, the Court finds Plaintiffs’ Cal. 27 Health & Safety Code §§ 110390, 110395, 110398, 110400, 110660, 110760, 110765, 28 1 110770, 110380 claims are not impliedly preempted by Section 337 at the motion to 2 dismiss stage. 3 On the other hand, a few of Plaintiffs’ state law claims underlying Plaintiffs’ UCL 4 cause of action rely upon statutes (Cal. Health & Safety Code § 110665, 110100(a), 5 110505) that do explicitly refer to the FDCA’s nutrition labeling requirements. (See ECF 6 No. 6 ¶ 99). 7 Cal. Health & Safety Code § 110665 states (emphasis added): 8 Any food is misbranded if its labeling does not conform with the requirements for nutrition labeling as set forth in Section 403(q) (21 9 U.S.C. Sec. 343(q)) of the federal act and the regulations adopted 10 pursuant thereto. Any food exempted from those requirements under the federal act shall also be exempt under this section. 11 Cal. Health & Safety Code § 110100(a) states (emphasis added): 12 All food labeling regulations and any amendments to those 13 regulations adopted pursuant to the federal act, in effect on January 14 1, 1993, or adopted on or after that date shall be the food labeling regulations of this state. 15 16 Cal. Health & Safety Code § 110505 states: 17 Definitions and standards of identity, quality, and fill of container, and any amendments to the definitions and standards, adopted 18 pursuant to the federal act . . . are the definitions and standards of 19 identity, quality, and fill of container in this state . . . 20 Nonetheless, Defendants have not shown that interpretation of substantive labeling 21 requirements in the text of the FDCA itself is necessary for resolving Plaintiffs’ Cal. Health 22 & Safety Code §§ 110665, 110100(a), 110505 claims in this particular case. Centrally, 23 Defendants claim that Plaintiffs’ state law claims are primarily based on Defendants’ 24 alleged violation of FDA regulation 21 C.F.R. § 101.13(b)(3)’s prohibition on nutrient 25 content information on labels on products for children under two. (ECF No. 8-1 at 13:8- 26 12.) 27 At oral argument, Defendants further asserted that Plaintiffs’ claims based on 21 28 C.F.R. § 101.13(b)(3) required interpreting whether Defendants’ labels represent a “level” 1 of nutrients prohibited by a misbranding provision of the FDCA (21 U.S.C. 2 § 343(r)(1)(A)), and are thus, impliedly preempted. (ECF No. 15.) However, Davidson 3 itself does not depend on any FDCA provision—including 21 U.S.C. § 343(r)(1)(A)—to 4 interpret its plaintiffs’ Cal. Health & Safety Code § 110100(a) claim to enforce the 5 prohibition in 21 C.F.R. § 101.13(b)(3). See Davidson, 106 F.4th at 846 (“The relevant 6 federal regulation prohibits ‘nutrient content claims . . . on food intended for use by infants 7 and children less than 2 years of age’ . . . California law incorporates the same 8 prohibition.”). 9 Moreover, 21 C.F.R. § 101.13(b)(2)(ii) provides that “nutrient content claims” 10 (prohibited on products intended for children under two in 21 C.F.R. § 101.13(b)(3)) 11 include general assertions or implications that a food “may be useful in maintaining healthy 12 dietary practices . . . (e.g., ‘healthy’).” 21 U.S.C. § 343(r)(1)(A)’s narrow prohibition on 13 misrepresentations about nutrition “levels” is, therefore, separable from whether nutrient 14 content claims are actionable under 21 C.F.R. § 101.13(b)(3). In other words, Plaintiffs’ 15 Cal. Health & Safety Code § 110100(a) claim to enforce 21 C.F.R. § 101.13(b)(3) does not 16 rely upon the text of 21 U.S.C. § 343(r)(1)(A). As such, Plaintiffs’ claim does not 17 “require[] litigating” the express requirements in 21 U.S.C. § 343(r)(1)(A); and 21 U.S.C. 18 § 343(r)(1)(A) is not a basis for impliedly preempting Plaintiffs’ claim. See Davidson, 106 19 F.4th at 846. 20 Defendants also asserted at oral argument that Loper Bright Enters. v. Raimondo, 21 603 U.S. 369 (2024) requires the Court to directly interpret 21 U.S.C. § 343(r)(1)(A) to 22 determine the meaning of “nutrient content claims” in 21 C.F.R. § 101.13(b)(3). (ECF No. 23 15.) Loper Bright, 603 U.S. 369 considered whether a federal statute (i.e., the Magnuson- 24 Stevens Fishery Conservation and Management Act (“MSA”), 16 U.S.C. § 1801 et seq.) 25 authorized an agency (i.e., the National Marine Fisheries Service, as part of the U.S. 26 Department of Commerce) to promulgate a regulation requiring domestic fishing vessels 27 to bear the costs of hiring observers to collect data for fishery management where federal 28 funding falls short. Loper Bright found that the text of APA § 706 requires the reviewing 1 courts to directly interpret federal statutes to determine if an agency could promulgate 2 certain regulations—rather than defer to agency interpretation of those federal statutes 3 where their text is ambiguous. Loper Bright, 603 U.S. at 413. 4 However, as discussed above, interpreting 21 U.S.C. § 343(r)(1)(A) is not necessary 5 for determining whether Plaintiffs’ Cal. Health & Safety Code § 110100(a) claim 6 predicated upon a violation of 21 C.F.R. § 101.13(b)(3) can be preempted—since 7 determining a violation of 21 C.F.R. § 101.13(b)(3) does not depend upon interpreting 21 8 U.S.C. § 343(r)(1)(A). Put differently, Plaintiffs’ Cal. Health & Safety Code § 110100(a) 9 claim enforces a federal regulation (i.e., 21 C.F.R. § 101.13(b)(3)) and does not turn on an 10 agency’s (i.e., FDA’s) interpretation of a federal statute (i.e., FDCA). Cf. Kisor v. Wilkie, 11 588 U.S. 558, 591 (Roberts, J., concurring) (2019) (“Issues surrounding judicial deference 12 to agency interpretations of their own regulations are distinct from those raised in 13 connection with judicial deference to agency interpretations of statutes enacted by 14 Congress”) (emphasis added). 15 Additionally, according to their operative complaint, Plaintiffs seek to enforce FDA 16 regulations 21 C.F.R. §§ 101.13(b), 101.13(c), 101.54(e), and 104.20 through Cal. Health 17 & Safety Code §§ 110665, 110100(a), and 110505. (ECF No. 6 ¶ 99.) 18 Similar to Davidson, 106 F.4th at 852 (plaintiff’s UCL claim based on violation of 19 nutrient labeling requirements in 21 C.F.R. § 101.13(b)(3)) and dissimilar to Bubak, 2025 20 WL 2860044, at *2 (plaintiff’s UCL claim based on violation of supplement labeling 21 requirements in 21 U.S.C. § 343(r)(6)), Plaintiffs’ allegations that Defendants have 22 violated the aforementioned FDA regulations do not require interpreting requirements 23 embedded in the text of the FDCA itself. Thus, the Court finds Plaintiffs’ Cal. Health & 24 Safety Code §§ 110665, 110100(a), 110505 claims are not impliedly preempted by Section 25 337—and neither are their underlying allegations that Defendants violated 21 C.F.R. 26 §§ 101.13(b), 101.13(c), 101.54(e). 27 * * * 28 1 For the reasons above, the Court DENIES Defendants’ motion to dismiss Plaintiffs’ 2 UCL cause of action on grounds of FDCA preemption. (ECF No. 8.) 3 B. Whether Plaintiffs’ Unjust Enrichment Claim is Preempted 4 Davidson also briefly addressed whether an unjust enrichment claim survives along 5 with claims brought under California statutory prohibitions on nutrient labeling and 6 concluded that it did. See Davidson, 106 F.4th at 853. Accordingly, because Plaintiffs’ 7 UCL cause of action and its underlying statutory claims survive preemption, Plaintiffs’ 8 unjust enrichment claim may also proceed. See Forrett v. W. Thomas Partners LLC, 746 9 F. Supp. 3d 780, 791 (N.D. Cal. 2024) (finding the same for plaintiff’s unjust enrichment 10 claim based upon plaintiff’s Sherman Law claims because there is an “underlying basis for 11 recovery.”). Thus, the Court similarly DENIES Defendants’ motion to dismiss Plaintiffs’ 12 unjust enrichment claim. (ECF No. 8.) 13 C. Whether Plaintiffs’ Request for Declaratory Relief Should be Dismissed 14 The Declaratory Judgment Act creates a remedy, not a cause of action. Buck v. Am. 15 Airlines, Inc., 476 F.3d 29, 33 n.3 (1st Cir. 2007); accord Jimenez v. OE Fed. Credit Union, 16 2025 WL 2402137, at *9 (N.D. Cal. Aug. 19, 2025). However, Federal Rule of Civil 17 Procedure 57 provides that “the existence of another adequate remedy does not preclude a 18 declaratory judgment that is otherwise appropriate.” Courts have declined to dismiss 19 declaratory relief claims at the pleading stage where they seek forward-looking relief 20 distinct from damages for past conduct. See Peralta v. Certified Emp. Screening, Inc., 21 2025 WL 1723142, at *9 (C.D. Cal. May 7, 2025); Reyes v. Nationstar Mortg. LLC, 2015 22 WL 4554377, at *7 (N.D. Cal. July 28, 2015). Declaratory relief is inappropriate, however, 23 if the claim merely duplicates the relief available through the underlying causes of action. 24 See Reyes, 2015 WL 4554377, at *7–8; see also In re PowerSchool Holdings, Inc. and 25 PowerSchool Group, LLC Customer Security Breach Litigation, No. 25-MD-03149-BEN- 26 MSB, 2026 WL 818335, at *17 (S.D. Cal. Mar. 25, 2026). 27 Here, Defendants move to dismiss Plaintiffs’ request for declaratory relief on 28 grounds that Plaintiffs’ claim does not appear to be meaningfully distinct from the 1 || substantive claims underlying Plaintiffs’ UCL cause of action. 2 || Though Plaintiffs contest instead that their request for declaratory relief is forward-looking 3 ||(e.g., aimed to prevent future mislabeling on Defendants’ products) (ECF No. 9 at 20:27- 4 ||21:5), Plaintiffs’ request for declaratory relief ultimately seems to seek the same damages 5 || and restitution that Plaintiffs’ UCL claims do (ECF No. 6 J 114 (Plaintiffs seek restitution 6 ||for UCL cause of action), 115(e) (Plaintiffs seek a declaration that Defendants must 7 || disgorge all ill-gotten profits or make full restitution to Plaintiffs)). Thus, “Plaintiffs have 8 ||not shown that declaratory relief is necessary in this case, nor can they.” Cervantes v. 9 || Zimmerman, No. 17-CV-1230-BAS-NLS, 2019 WL 3413508, at *10 (S.D. Cal. July 29, 10 |}2019) (citing Olagues v. Russoniello, 770 F.2d 791, 799 (9th Cir. 1985)). 11 The Court GRANTS WITH PREJUDICE Defendants’ motion to dismiss 12 || Plaintiffs’ request for declaratory relief. (ECF No. 8.) 13 CONCLUSION 14 For the reasons above, the Court GRANTS IN PART and DENIES IN PART 15 || Defendants’ motion to dismiss. (ECF No. 8.) 16 More specifically, the Court DENIES Defendants’ motion to dismiss Plaintiffs’ 17 ||UCL cause of action (Count 1) and unjust enrichment cause of action (Count 2). (ECF No. 18 ||8.) However, the Court GRANTS WITH PREJUDICE Defendants’ motion to dismiss 19 || Plaintiffs’ request for declaratory relief. (/d.) 20 IT IS SO ORDERED. 21 22 ||DATED: June 1, 2026 (pallu Bahar te 73 H n. Cynthia Bashant, Chief Judge United States District Court 24 25 26 27 28 1K.