1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 ALFREDO HERNANDEZ, Case No. 21-cv-04065-JST
8 Plaintiff, ORDER DENYING IN PART, 9 v. GRANTING IN PART MOTION TO DISMISS 10 DTI GMBH, Re: ECF No. 53 Defendant. 11
12 13 Before the Court is Defendant DTI GmbH’s (“DTI”) motion to dismiss. The Court will 14 deny the motion in part and grant the motion in part. 15 I. BACKGROUND 16 A. Parties 17 On June 9, 2023, Plaintiff Alfredo Hernandez filed his second amended complaint 18 (“SAC”) in this action against DTI, whom he claims fails to identify its product, Dr. Tobias 19 Omega 3 Fish Oil Triple Strength dietary supplement, by its common and usual name. Rather 20 than fish oi, Hernandez claims the product contains “a lab-synthesized solution resulting from a 21 chemical process in which an industrial solvent and ethanol are used to alter and substantially 22 transform otherwise unmarketable fish waste into a consumable product known as a fatty acid 23 ethyl ester, which Defendant deceptively pawns off on the unsuspecting public as fish oil.” ECF 24 No. 49 ¶ 6. Hernandez claims that through this obfuscation, DTI has “deceived [him] and 25 members of the class,” thereby “depriving them of a consumer’s most basic right to make an 26 informed purchasing decision.” Id. ¶ 65. 27 Hernandez filed his first amended complaint (“FAC”) in this putative class action against 1 Vitalabs subsequently moved to dismiss Hernandez’s FAC for lack of personal jurisdiction and 2 failure to state a claim upon which relief can be granted. ECF Nos. 39, 42. In granting those 3 motions to dismiss, the Court concluded that Hernandez failed to establish that MRI and Vitalabs 4 purposefully directed their activities at California, and therefore the Court lacked personal 5 jurisdiction over either Defendant. 6 B. Scientific Background 7 Before delving into the specific claims that Hernandez levies, a brief discussion concerning 8 fish oil, molecular chemistry, and Omega-3 fatty acid ethyl esters is in order.1 9 Omega-3’s “are polyunsaturated carboxylic acids that provide numerous health benefits to 10 the human body including a variety of critical organs and systems.” ECF No. 49 ¶ 23 (citing 11 Omega-3 Fatty Acids, National Institutes of Health, Office of Dietary Supplements (July 18, 12 2022), available at https://ods.od.nih.gov/factsheets/Omega3FattyAcids-Consumer) (permalink: 13 https://perma.cc/VB4N-FAXZ2) (last accessed August 23, 2024) (“Omega-3 Fatty Acids”). 14 Although 11 types of Omega-3’s exist, “the three most important to human physiology are alpha- 15 linolenic acid (“ALA”), docosahexaenoic acid (“DHA”) and eicosapentaenoic acid (“EPA”).” Id. 16 ¶ 24. The human body can only convert ALA into EPA and then to DHA in small amounts. Id. ¶ 17 23 (citing Omega-3 Fatty Acids). Therefore, the only practical way to increase one’s levels of 18 EPA and DHA is to increase the dietary intake of Omega-3 fatty acids. Id. 19 Notably, only in 2019 did the Food and Drug Administration (“FDA”) approve qualified 20 health claims relating to the consumption of EPA and DHA and its positive effect on human 21
22 1 Throughout the SAC, Hernandez includes detailed information regarding the processing of fish oils for packaging in dietary-supplement capsules. The referenced materials—a compilation of 23 published scientific journals, scientific textbooks, mass spectra, and compound summaries of various molecules, among others—are found in 38 footnotes appearing in the first 49 pages of the 24 SAC. See generally ECF No. 49 at 6–22. While the Court is neither an expert in organic chemistry nor the commercial fishing industry, it has been careful to apply its own plain-language 25 reading to the materials and to review all documents in the light most favorable to Hernandez. Where the text of the referenced material differs from the factual allegations in the SAC, the 26 Court, as it must, considers the referenced material in full. See Lazy Y Ranch Ltd. v. Behrens, 546 F.3d 580, 588 (9th Cir. 2008) (holding that courts “need not accept as true allegations 27 contradicting documents that are referenced in the complaint.”). 1 health. Id. ¶ 27 (citing FDA Constituent Update, U.S. Food and Drug Administration (June 19, 2 2019), available at https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-new- 3 qualified-health-claims-epa-and-dha-omega-3-consumption-and-risk-hypertension-and3) (last 4 accessed August 23, 2024). Specifically, the FDA stated that it would not object to the use of the 5 following qualified health claims regarding EPA and DHA Omega-3 fatty acids in food or dietary 6 supplements:
7 1. Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of 8 hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or 9 dietary supplement] provides [ ] gram(s) of EPA and DHA.
10 2. Consuming EPA and DHA combined may reduce blood pressure and reduce the risk of hypertension, a risk factor for CHD (coronary 11 heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or 12 dietary supplement] provides [ ] gram(s) of EPA and DHA.
13 3.a. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by lowering blood pressure. However, 14 FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary 15 supplement] provides [ ] gram(s) of EPA and DHA.
16 3.b. Consuming EPA and DHA combined may reduce the risk of CHD (coronary heart disease) by reducing the risk of hypertension. 17 However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary 18 supplement] provides [ ] gram(s) of EPA and DHA.
19 4. Research shows that consuming EPA and DHA combined may be beneficial for moderating blood pressure, a risk factor for CHD 20 (coronary heart disease). However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of 21 the food or dietary supplement] provides [ ] gram(s) of EPA and DHA. 22 Id. 23 Fish oil—commonly found in a variety of fatty fish, including menhaden, sardines, 24 anchovies, salmon, and tuna—is one of the main sources of Omega-3 fatty acids. Id. ¶ 30. 25 Omega-3 fatty acids, which include EPA and DHA, exist naturally in a triglyceride form and can 26 be synthetically made in an ethyl ester form. Id. ¶¶ 33, 35. Standard fish oil in the triglyceride 27 1 form is “derived using a physical, rather than a chemical process,” that is typically referred to as 2 the “wet reduction” method. Id. ¶ 32 (citing Anthony P. Bimbo, Marine Oils; Edible Oil 3 Processing, AOCS Lipid Library, December 2016, available at https://lipidlibrary.aocs.org/edible- 4 oil-processing/marine-oils) (permalink: https://perma.cc/MN7K-J5WQ) (last accessed August 23, 5 2024) (“Bimbo Article”). During this process, oil is physically pressed out of cooked fish without 6 solvent extraction, yielding unrefined fish oil in the “triglyceride form.” Id. At a molecular level, 7 fish oil in the triglyceride form contains lower concentrations of EPA and DHA compared to fish 8 oil in the ethyl ester form. Id. ¶¶ 34, 38 (citing Peter Lembke, Production Techniques for Omega- 9 3 Concentrates, in Omega-6/3 Fatty Acids. Nutrition and Health (2013), 10 https://doi.org/10.1007/978-1-62703-215-5_19) (permalink: https://perma.cc/VP2W-9XLE). 11 By contrast, a chemical process of extracting fish oil, trans-esterification, was developed in 12 the 1980’s. Id. ¶ 35. At a high-level, trans-esterification removes the glycerol backbone of EPA 13 and DHA, effectively freeing EPA and DHA molecules from the glycerol. Id. ¶ 37 (citing 14 Douglas MacKay, A Comparison of Synthetic Ethyl Ester Form Fish Oil vs. Natural Triglyceride 15 Form (2007)) (“MacKay Article”).4 EPA and DHA free fatty acids are subsequently re-esterified 16 with ethanol to form ethyl esters. Id. Additional steps, including a process called “molecular 17 distillation,” then ensue. Id. Critically, the trans-esterification process “irrevocably transforms the 18 Omega-3’s in fish oil from their natural triglyceride form into Omega-3 fatty acid ethyl esters.” 19 Id. ¶ 41. This process also yields a product with a substantially higher concentration of EPA and 20 DHA at a much lower cost. Id. ¶ 35 (citing Bimbo Article). Indeed, the SAC notes that the trans- 21 esterification process “enabled scientists to increase the yield of omega-3s from 30% to upwards 22 of 70%.” Id. 23 The molecular differences between DHA and EPA containing ethyl esters and triglycerides 24 are represented below:5 25 26 4 The website link included in Hernandez’s SAC to the MacKay Article did not work. However, 27 the Court was able to review the article because it was attached as Exhibit B to DTI’s motion to 1 DHA: 2 Moe & 7 3 0 4 H H | 5 : i i 6 Hoos 8 DHA-EE:
10 } 11 WA | Hl a 12 H. = | Ho A | H
14 EPA: 16 7 ~ H ~ Sy H 5 | | H 18 Y 19 = 20 Tr 21 22 EPA-EE: 23 24 Noy ks I, 26 , | 27 0 1 = A H O i 28
1 Id. at 14–15.6 2 To the untrained eye, the differences between the above-pictured molecules appear minute. 3 Nonetheless, molecular-level differences exist between the molecules, as the DHA and EPA fatty 4 acids in ethyl-ester form are “esterified to an ethanol backbone,” while the DHA and EPA fatty 5 acids in triglyceride form “are esterified to a glycerol alcohol backbone.” ECF No. 53-4 at 3 6 (Mackay Article). Hernandez alleges that, in light of these molecular changes, fish oil and omega- 7 3 fatty acid ethyl esters “are distinguishable on a molecular level such that it is impossible as a 8 matter of law or logic for them to share a common or usual name.” Id. ¶ 41. He further claims 9 that, “[a]long with their molecular differences, [these substances] have different common or usual 10 names which must be properly represented on labeling of any dietary supplement in which they 11 are contained. To do otherwise is deceptive, misleading, fraudulent and illegal.” Id. 12 One final note on the differences between the triglyceride and ethyl-esterified forms of 13 DHA and EPA deserves mention. Neither Hernandez’s SAC nor any of the scientific materials 14 annexed to the complaint definitively claim that one form of DHA/EPA is superior to the other. 15 The MacKay Article opines that “current research evidence points toward the triglyceride form for 16 better absorption and assimilation.” However, it ultimately concludes that “[m]ost consumers and 17 health care professionals are unaware that there are two different delivery forms of these valuable 18 nutrients,” and that “the scarcity of data concerning the relative bioavailability of ethyl ester and 19 triglyceride forms of EPA and DHA does not allow for definitive conclusions, and more research 20 is warranted” regarding which form is better absorption and assimilation. 21 C. Causes of Action and Motion to Dismiss 22 Hernandez’s SAC sets forth seven causes of action, including unlawful, unfair, and 23 fraudulent business practices under Cal. Bus. & Prof. Code §§ 17200, et seq. (Claims I–III); false 24 6 The molecules can be found through the National Library of Medicine website, and at the 25 following links (last accessed August 23, 2024): https://pubchem.ncbi.nlm.nih.gov/compound/445580 (permalink: https://perma.cc/574N-F98G) 26 (DHA); https://pubchem.ncbi.nlm.nih.gov/compound/9831416 (permalink: https://perma.cc/ANY8-JARH) (DHA-EE); https://pubchem.ncbi.nlm.nih.gov/compound/446284 27 (permalink: https://perma.cc/4FGX-HKKS) (EPA); and 1 advertising under Cal. Bus. & Prof. Code §§ 17500, et seq. (Claim IV); violation of the 2 Consumers Legal Remedies Act under Cal. Civ. Code. §§ 1750, et seq. (Claim V); breach of 3 express warranty (Claim VI); and restitution based on quasi-contract and unjust enrichment 4 (Claim VII). Additionally, Hernandez requests an order certifying a class, appointing him as class 5 representative, and appointing his counsel lead counsel for the class. DTI moves to dismiss the 6 SAC pursuant to Fed. R. Civ. P. 12(b)(6) and Fed. R. Civ. P. 12(b)(1). 7 II. JURISDICTION 8 The Court has jurisdiction under 28 U.S.C. § 1332(d)(2). 9 III. LEGAL STANDARD 10 A. Rule 12(b)(6) 11 To survive a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), a 12 complaint must contain “a short and plain statement of the claim showing that the pleader is 13 entitled to relief.” Fed. R. Civ. P. 8(a)(2). Dismissal “is appropriate only where the complaint 14 lacks a cognizable legal theory or sufficient facts to support a cognizable legal theory.” 15 Mendiondo v. Centinela Hosp. Med. Ctr., 521 F.3d 1097, 1104 (9th Cir. 2008). “[A] complaint 16 must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible 17 on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 18 550 U.S. 544, 570 (2007)). Factual allegations need not be detailed, but facts must be “enough to 19 raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555. 20 “A claim has facial plausibility when the plaintiff pleads factual content that allows the 21 court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” 22 Iqbal, 556 U.S. at 678. While this standard is not “akin to a ‘probability requirement,’ . . . it asks 23 for more than a sheer possibility that a defendant has acted unlawfully.” Id. (quoting Twombly, 24 550 U.S. at 556). “Where a complaint pleads facts that are ‘merely consistent with’ a defendant's 25 liability, it ‘stops short of the line between possibility and plausibility of entitlement to relief.’ ” 26 Id. (quoting Twombly, 550 U.S. at 557). In determining whether a plaintiff has met the plausibility 27 requirement, a court must “accept all factual allegations in the complaint as true and construe the 1 Cir. 2005). A plaintiff may “plead[ ] facts alleged upon information and belief where the facts are 2 peculiarly within the possession and control of the defendant or where the belief is based on 3 factual information that makes the inference of culpability plausible.” Soo Park v. Thompson, 851 4 F.3d 910, 928 (9th Cir. 2017) (quoting Arista Records, LLC v. Doe 3, 604 F.3d 110, 120 (2d Cir. 5 2010)). 6 B. Rule 12(b)(1) 7 “Article III of the Constitution confines the federal judicial power to the resolution of 8 ‘Cases’ and ‘Controversies.’” TransUnion LLC v. Ramirez, 594 U.S. 413, 423 (2021). “For there 9 to be a case or controversy under Article III, the plaintiff must have a ‘personal stake’ in the 10 case—in other words, standing.” Id. (quoting Raines v. Byrd, 521 U.S. 811, 819 (1997)). A 11 defendant may attack a plaintiff’s assertion of jurisdiction by moving to dismiss under Rule 12 12(b)(1) of the Federal Rules of Civil Procedure. Cetacean Cmty. v. Bush, 386 F.3d 1169, 1174 13 (9th Cir. 2004); see also Maya v. Centex Corp., 658 F.3d 1060, 1067 (9th Cir. 2011) (“[L]ack of 14 Article III standing requires dismissal for lack of subject matter jurisdiction under Federal Rule of 15 Civil Procedure 12(b)(1).”). 16 “A Rule 12(b)(1) jurisdictional attack may be facial or factual.” Safe Air for Everyone v. 17 Meyer, 373 F.3d 1035, 1039 (9th Cir. 2004). “In a facial attack, the challenger asserts that the 18 allegations contained in a complaint are insufficient on their face to invoke federal jurisdiction. 19 By contrast, in a factual attack, the challenger disputes the truth of the allegations that, by 20 themselves, would otherwise invoke federal jurisdiction.” Id. “The district court resolves a facial 21 attack as it would a motion to dismiss under Rule 12(b)(6)[.]” Leite v. Crane Co., 749 F.3d 1117, 22 1121 (9th Cir. 2014). 23 IV. MATERIALS CONSIDERED 24 A. Judicial Notice 25 DTI requests that the Court take judicial notice of various excerpts from the 2013 FDA 26 Food Labeling Guide. See ECF No. 53-3. Pursuant to Federal Rule of Evidence 201(b), courts 27 may take judicial notice of any fact “not subject to reasonable dispute because it can be accurately 1 records and information on government agency websites are properly subject to judicial notice.” 2 Wilson v. Frito-Lay N. Am., Inc., 260 F. Supp. 3d 1202, 1206 (N.D. Cal. 2017). Because these 3 excerpts are taken from a government agency website not subject to reasonable dispute, the Court 4 grants DTI’s request. 5 B. Incorporation By Reference 6 Hernandez cited numerous documents in the footnotes of his SAC. Under the doctrine of 7 incorporation by reference, “a district court [may] consider documents ‘whose contents are alleged 8 in a complaint and whose authenticity no party questions, but which are not physically attached to 9 the . . . pleadings.’” Al -Ahmed v. Twitter, Inc., 603 F. Supp. 3d 857, 866 (N.D. Cal. 2022), appeal 10 dismissed, No. 22-15914, 2022 WL 4352712 (9th Cir. July 7, 2022) (quoting In re Silicon 11 Graphics Sec. Litig., 183 F.3d 970, 986 (9th Cir. 1999)). The Court may incorporate such a 12 document “if the plaintiff refers extensively to the document or the document forms the basis of 13 the plaintiff’s claim.” United States v. Ritchie, 342 F.3d 903, 908 (9th Cir. 2003). Therefore, the 14 Court incorporates the documents that are referenced throughout the complaint and considers each 15 in its entirety. 16 V. DISCUSSION 17 Hernandez’s complaint, at its core, is that DTI has pulled a “bait and switch” by referring 18 to its trans-esterified Omega-3 product as “fish oil.” See ECF No. 49 ¶ 40. DTI responds that the 19 product label does not deceive reasonable consumers, that Hernandez’s claims regarding the 20 product’s name are preempted, that his other claims regarding statements on the label fail as a 21 matter of law, and that he lacks standing to seek equitable and injunctive relief because he cannot 22 allege an inadequate remedy at law and does not plausibly allege imminent future harm. See ECF 23 No. 53 at 9. The Court begins by addressing standing for equitable and injunctive relief. 24 A. Standing for Equitable and Injunctive Relief 25 1. Equitable Relief 26 DTI asserts that Hernandez must demonstrate that he “lacks an adequate remedy at law” 27 before securing equitable relief. ECF No. 53 at 9 (quoting Sonner v. Premier Nutrition Corp., 971 1 authority prohibiting a federal court plaintiff from pleading alternative remedies,” and at this 2 juncture, he “should not have to choose his claim or remedy.” ECF No. 56 at 26. 3 In Sonner, the Ninth Circuit held that “a federal court must apply traditional equitable 4 principles before awarding restitution under the UCL and CLRA.” 971 F.3d at 841. However, 5 “[t]his Court, together with the majority of courts in this district, understands Sonner to require far 6 less at the pleading stage.” In re Natera Prenatal Testing Litig., 664 F. Supp. 3d 995, 1012 (N.D. 7 Cal. 2023); see Murphy v. Olly Public Benefit Corp., No. 22-cv-03760-CRB, 651 F.Supp.3d 1111, 8 1129 (N.D. Cal. Jan. 17, 2023) (“Sonner does not require Plaintiffs to ‘demonstrate’ anything at 9 the pleadings stage. Plaintiffs alleged that legal remedies were not as certain as equitable 10 remedies. That is sufficient.”) (internal citation omitted); Carroll v. Myriad Genetics, No. 22-cv- 11 00739-YGR, 2022 WL 16860013, at *6 (N.D. Cal. Nov. 9, 2022) (“Sonner does not address what 12 a plaintiff must allege at the pleading stage in order to proceed on her equitable claims.”); Warren 13 v. Whole Foods Mkt. Cal., Inc., No. 21-cv-04577-EMC, 2022 WL 2644103, at *9 (N.D. Cal. July 14 8, 2022) (“[The plaintiff] is not barred by Sonner . . . from pursuing alternative remedies at this 15 early stage of the suit.”); Jeong v. Nexo Fin. LLC, No. 21-cv-2392-BLF, 2022 WL 174236, at *27 16 (N.D. Cal. Jan. 19, 2022) (“There is no binding precedent that holds that pleading equitable 17 restitution in the alternative is improper.”); Johnson v. Trumpet Behav. Health, LLC, No. 3:21-cv- 18 03221-WHO, 2022 WL 74163, at *3 (N.D. Cal. Jan. 7, 2022) (“[B]ecause Sonner was decided at a 19 later posture, . . . if a plaintiff pleads that she lacks an adequate legal remedy, Sonner will rarely (if 20 ever) require more this early in the case.”). 21 Here, Hernandez pleads that he is entitled to “restitutionary disgorgement of the profits 22 [that DMI] obtained from” the sale of its product. ECF No. 49 at 37. Critically, however, 23 Hernandez fails to allege that he lacks an adequate legal remedy. Accordingly, Hernandez’s 24 claims for equitable relief are dismissed with leave to amend. 25 2. Injunctive Relief 26 Next, DTI alleges that Hernandez is not entitled to injunctive relief because he merely 27 alleges that “under certain circumstances “he would consider” or “would be willing” to purchase 1 To seek injunctive relief, a consumer must allege that he (1) “will be unable to rely on the 2 product’s advertising or labeling in the future, and so will not purchase the product although []he 3 would like to,” or (2) that he “might purchase the product in the future, despite the fact it was once 4 marred by false advertising or labeling, as []he may reasonably, but incorrectly, assume the 5 product was improved.” Davidson v. Kimberly-Clark Corp., 889 F.3d 956, 969–70 (9th Cir. 6 2018). 7 Here, Hernandez alleges that if he “has occasion to believe that [DMI’s] marketing and 8 labeling is truthful, non-misleading, and lawful, he would consider purchasing the Product in the 9 future.” ECF No. 49 ¶ 21; see id. ¶ 81 (“Plaintiff would be willing to purchase Defendant’s 10 Products again in the future should he be able to rely on Defendant’s labeling and marketing as 11 truthful and non-deceptive.”). The Court finds this sufficient to confer standing for injunctive 12 relief. See, e.g., Ruiz v. Celsius Holdings, Inc., No. 3:21-CV-00128-GPC(KSC), 2021 WL 13 5811264, at *3 (S.D. Cal. July 28, 2021) (“Because Plaintiffs are previously deceived consumers 14 who would purchase Defendant's product in the future if the beverages were not misleadingly 15 marketed, they have alleged standing to seek an injunction.”); Milan v. Clif Bar & Co., 489 F. 16 Supp. 3d 1004, 1006 (N.D. Cal. 2020) (finding plaintiffs had standing to seek injunctive relief 17 where they alleged that they “would purchase the challenged Clif Products in the future if they 18 were in fact healthy”). 19 Accordingly, DTI’s motion to dismiss for lack of standing for injunctive relief is denied. 20 B. Preemption 21 Turning to the issue of preemption, Hernandez alleges that “fish oil is not the common or 22 usual name of this product.” ECF No. 49 at 22. DTI, however, contends that Hernandez’s 23 complaint is subject to express preemption because referring to the product as “omega-3 fatty acid 24 ethyl esters” would not be “common, usual, simple, direct, or otherwise appropriate.” ECF No. 53 25 at 15. In the alternative, DTI argues that Hernandez’s claims are subject to conflict preemption 26 because it would “be impossible for DTI to comply with both federal and state requirements under 27 [Hernandez’s] theory of liability.” Id. at 17. 1 legislation that preempts state law. See Gibbons v. Ogden, 22 U.S. 1, 211 (1824). “Federal 2 preemption occurs when: (1) Congress enacts a statute that explicitly pre-empts state law; (2) state 3 law actually conflicts with federal law; or (3) federal law occupies a legislative field to such an 4 extent that it is reasonable to conclude that Congress left no room for state regulation in that field.” 5 Chae v. SLM Corp., 593 F.3d 936, 941 (9th Cir. 2010). In determining whether certain claims are 6 preempted, the Court heeds the long-established presumption against preemption. See Medtronic, 7 Inc. v. Lohr, 518 U.S. 470, 485 (1996). 8 1. Express Preemption 9 As relevant here, the Federal Food Drug and Cosmetic Act (the “FDCA”) forbids the 10 misbranding of foods and supplements by way of false or misleading labeling. 21 U.S.C. § 343; 11 see POM Wonderful, LLC v. Coca-Cola Co., 573 U.S. 102, 106 (2014). Specifically, the FDCA, 12 as amended by the Nutrition Labeling and Education Act (“NLEA”), contains an express 13 preemption provision, making clear that state laws imposing labeling requirements not identical to 14 FDCA mandates are preempted. See 21 U.S.C. § 343–1(a). 15 FDCA regulations require a product to bear the name “required by any applicable Federal 16 law or regulation; or, in the absence thereof, [t]he common or usual name . . . ; or, in the absence 17 thereof, [a]n appropriately descriptive term[.]” 21 C.F.R. § 101.3(a)-(c); see also 21 U.S.C. §§ 18 341, 343(i)(1). A product’s common or usual name must “accurately identify or describe, in as 19 simple and direct terms as possible, the basic nature of the food or its characterizing properties or 20 ingredients,” and “may be established by common usage.” 21 C.F.R. § 102.5(a), (d). Here, the 21 parties do not contest that the name of the product at issue is not subject to a federal regulation, 22 and thus, that the product must bear its “common or usual name.” 21 C.F.R. § 101.3(a), (b)(1)-(2). 23 The Court finds that Hernandez’s claims are not expressly preempted. Hernandez alleges 24 that using the name “fish oil” for an Omega-3 fatty acid ethyl ester product is misleading because 25 “[t]hey are different on a molecular level and have different common and usual names.” Some of 26 the authorities annexed to the SAC refer to both the triglyceride form and ethyl ester form as types 27 of “fish oil.” For example, the MacKay Article notes that one “study suggests that both ethyl 1 meal containing 27 g of EPA and DHA.” ECF No. 53-4 at 4. Nonetheless, other authorities 2 incorporated by reference to the SAC, such as the monographs published by the Global 3 Organization for EPA and DHA Omega-3s (“GOED”), distinguish between “EPA and/or DHA 4 Omega-3 Oil Ethyl Ester Concentrates” and fish oil. Id. ¶ 51 (citing GOED Voluntary 5 Monograph, Version 8.2, January 6, 2022, available at https://goedomega3.com/goed-monograph) 6 (permalink: https://perma.cc/XZ8A-EJBE) (last visited August 23, 2024). To paraphrase the 7 reasoning of the Second Circuit in a fairly analogous case, “[t]hese sources may be evidence 8 relevant to determining the common name of the product, if it has one, but standing alone they are 9 not enough to establish the common name definitively. Ultimately, they do not provide a 10 sufficient basis to conclude [Hernandez’s] claims are preempted at this early stage in the 11 litigation.” Baines v. Nature’s Bounty (NY), Inc., No. 23-710-CV, 2023 WL 8538172, at *2 (2d 12 Cir. Dec. 11, 2023).7 13 Therefore, in accepting all factual allegations in the complaint as true and construing the 14 pleadings in the light most favorable to Hernandez, the nonmoving party, the Court concludes his 15 claims are not expressly preempted by the FDCA. 16 2. Conflict Preemption 17 DTI’s cursory arguments regarding conflict preemption are similarly unpersuasive.8 18 Conflict preemption occurs when compliance with both federal and state laws is impossible, and 19 when a state law “stands as an obstacle to the accomplishment and execution of the full purposes 20 and objectives of Congress.” Hillsborough Cnty., Fla. v. Automated Med. Lab’ys, Inc., 471 U.S. 21 707, 713 (1985) (internal quotations and citations omitted). DTI asserts that “federal law requires 22 the Product bear its common or usual name,” while Hernandez “alleges that the Product must be 23 called something not common or usual.” ECF No. 53 at 17. Thus, DTI contends, “[i]t would . . . 24
25 7 Other courts have also declined to find false labelling claims preempted at the motion to dismiss stage, including Corpuz v. Walmart, Inc., No. 3:22-CV-00901-RBM(AHG), 2023 WL 5154509, at 26 *5 (S.D. Cal. Aug. 10, 2023) (declining “to make such a determination [about preemption] at this juncture.”) and Rodriguez v. Target Corp., No. 22 CIV. 2982 (LGS), 2022 WL 18027615, at *5 27 (S.D.N.Y. Dec. 30, 2022) (holding that “the Court cannot weigh the evidence or choose between 1 be impossible for [it] to comply with both federal and state requirements under [Hernandez’s] 2 theory of liability.” Id. For the reasons set forth in the preceding section on express preemption, 3 the Court concludes that the common or usual name of the product has not been definitively 4 established. Accordingly, conflict preemption is not appropriate. 5 C. Reasonable Consumer 6 Because the Court concludes that Hernandez’s claims are not preempted at this early stage 7 of the litigation, the Court turns to the merits of his claims. DTI moves to dismiss Hernandez’s 8 claims on ground that the product label at issue is not likely to deceive a reasonable consumer. 9 Under California’s Unfair Competition Law (“UCL”), False Advertising Law (“FAL”), 10 and Consumers Legal Remedies Act (“CLRA”), “claims based on deceptive or misleading 11 marketing must demonstrate that a ‘reasonable consumer’ is likely to be misled by the 12 representation.” Moore v. Trader Joe’s Co., 4 F.4th 874, 881 (9th Cir. 2021) (citing Ebner v. 13 Fresh Inc., 838 F.3d 958, 965 (9th Cir. 2016)). “This standard is higher than a ‘mere possibility’ 14 that the statement at issue ‘might conceivably be misunderstood by some few consumers viewing 15 it in an unreasonable manner.’” Amin v. Subway Restaurants, Inc., No. 21-CV-00498-JST, 2022 16 WL 20184652, at *3 (N.D. Cal. July 7, 2022) (quoting Lavie v. Procter & Gamble Co., 105 Cal. 17 App. 4th 496, 508 (2003)). “Rather, the standard requires a likelihood ‘that a significant portion 18 of the general consuming public or of targeted consumers, acting reasonably in the circumstances, 19 could be misled.’” Id. (quoting Lavie, 105 Cal. App. 4th at 508). “Indeed, a plaintiff’s 20 unreasonable assumptions about a product’s label will not suffice.” Moore, 4 F.4th at 882 (citing 21 Becerra v. Dr. Pepper/Seven Up., Inc., 945 F.3d 1225, 1229–30 (9th Cir. 2019)). 22 While the Ninth Circuit has made clear that granting a motion to dismiss is appropriate 23 only in “the rare situation” where “it impossible for the plaintiff to prove that a reasonable 24 consumer was likely to be deceived,” the Court finds this is one of such situations. Williams v. 25 Gerber Prod. Co., 552 F.3d 934, 939 (9th Cir. 2008). Hernandez alleges that because DTI’s 26 product has undergone a change at the molecular level (namely, esterification), the product may no 27 longer bear the name “fish oil.” ECF No. 49 ¶ 40. To bolster these claims, he references a litany 1 differences between Omega-3s in the triglyceride and ethyl-ester form. But the complaint is 2 devoid of factual allegations that demonstrate that average, reasonable consumers would believe 3 an Omega-3 supplement must explain when it contains DHA/EPA esterified to a glycerol 4 backbone, and when it does not.9 No doubt, molecular differences between triglyceride and ethyl- 5 ester Omega-3s exist. However, to paraphrase our sister circuit, the complaint must “provide [] 6 supporting allegations that make it plausible that consumers who purchase [DTI’s] product are 7 actually thinking about the molecular form of their fish-oil-derived omega-3s at all.” Baines, 2023 8 WL 8538172, at *2. And finally, even if “some consumers” are aware of these molecular 9 distinctions, DTI’s label cannot be deemed “false and deceptive merely because [it] may be 10 ‘unreasonably misunderstood by an insignificant and unrepresentative segment of the class of 11 persons’ that may purchase the product.” Ebner, 838 F.3d at 966 (quoting Lavie, 105 Cal. App. 12 4th at 508). 13 In his opposition, Hernandez asserts that determining “what a reasonable consumer would 14 believe is rarely an appropriate subject for a motion to dismiss.” ECF No. 56 at 17. While true, 15 the reasonable consumer standard is also not without limits. Whether a reasonable consumer is 16 likely to be deceived demands “more than a mere possibility that the [product] might conceivably 17 be misunderstood by some few consumers viewing it in an unreasonable manner.” Lavie., 105 18 Cal. App. 4th at 508. Courts have not hesitated to dismiss consumer fraud claims in appropriate 19 circumstances where allegedly deceptive advertisements would not have misled a reasonable 20 consumer. See, e.g., Lee v. Mikimoto (Am.) Co., No. 22-CV-01923-PAC, 2023 WL 2711825, at 21 *6 (S.D.N.Y. Mar. 30, 2023) (dismissing plaintiff’s claim on the basis that “[c]ourts have 22 repeatedly rejected that reasonable consumers are even aware of specialized standards, let alone 23
24 9 The closest the SAC gets is this sentence from Paragraph 7:
25 Critically, the trans-esterification process eliminates the majority of natural fish oil’s constituent ingredients and substantially transforms 26 its Omega-3 triglycerides into ethyl esters – a substance that is materially distinct from the fish oil reasonably expected by 27 consumers and is something not found anywhere in nature. 1 that they rely on them in their day-to-day marketplace expectations.”); Lederman v. Hershey Co., 2 No. 21-CV-4528, 2022 WL 3573034, at *4 (N.D. Ill. Aug. 19, 2022) (concluding that “even if the 3 reasonable confectionery expert deems milkfat essential to fudge, Plaintiff has not shown that the 4 reasonable 21st century consumer has the same expectations.”); Clark v. Westbrae Nat., Inc., No. 5 20-CV-03221-JSC, 2021 WL 1580827 at *2 (N.D. Cal. Apr. 22, 2021) (holding that “there is 6 nothing about the word ‘vanilla’ itself which suggests to the reasonable consumer that the flavor 7 comes exclusively from the vanilla bean.”); Sibrian v. Cento Fine Foods, Inc., 19-CV-0974 (JS) 8 (ST), 2020 WL 3618953, at *4 (E.D.N.Y. July 2, 2020) (rejecting plaintiff’s false labelling claims 9 because “while there may be ‘some few consumers’ who expect that a San Marzano tomato must 10 be certified by the Consortium . . . drawing upon common sense and common experience, [] the 11 vast majority of reasonable consumers expect no such thing.) 12 In sum, the Court concludes that Hernandez has not pled plausible claims for violations of 13 the UCL, FAL, or CLRA, and it dismisses these claims with leave to amend. 14 D. Express Warranty and Unjust Enrichment Claims 15 Hernandez’s claims for breach of express warranty and unjust enrichment are also 16 premised on the false or misleading nature of DTI’s product labeling. Dismissal of Hernandez’s 17 false labeling claims on the grounds set forth above disposes of the remainder of his claims for 18 breach of express warranty and unjust enrichment. See Wallace v. Wise Foods, Inc., 20-CV-6831, 19 2021 WL 3163599, at *3 (S.D.N.Y. July 26, 2021) (holding that dismissal of false labeling claims 20 as implausible requires dismissal of express warranty and unjust enrichment claims); cf. Ham v. 21 Hain Celestial Grp., Inc., 70 F. Supp. 3d 1188, 1195 (N.D. Cal. 2014) (denying motion to dismiss 22 breach of express warranty claim “for the same reasons as the consumer protection and 23 misrepresentation-based claims.”). Hernandez’s claims for breach of express warranty and unjust 24 enrichment are likewise dismissed with leave to amend. 25 E. Other Claims 26 1. Failure to List All Ingredients in Supplemental Facts Section 27 Hernandez claims that “[s]upplement manufacturers are generally required to disclose all 1 §101.36(b)(3)—which governs “[i]nformation on dietary ingredients for which [reference daily 2 intakes] and [daily reference values] have not been established—applies to the product at issue. 3 DTI emphasizes that its product complies with this regulation because “[t]he constituents 4 of a dietary ingredient . . . may be listed,” but this is not a per se requirement. 21 C.F.R. 5 § 101.36(b)(3)(iii) (“The constituents of a dietary ingredient . . . may be listed indented under the 6 dietary ingredient and followed by their quantitative amounts by weight per serving[.]” (emphasis 7 added). Hernandez’s opposition neither references any statutory provision to the contrary nor does 8 it cite any relevant caselaw. Accordingly, the Court agrees with DTI that it is not required to 9 include every constituent of a dietary ingredient in its supplemental fact panel, and it dismisses 10 this claim with prejudice. 11 2. Supplement Fact Panel Is False and Misleading 12 Next, Hernandez alleges that that there is an “obligation to describe [] ingredients by their 13 common or usual name . . . in the Supplement Fact section,” and that DTI breaches this obligation 14 by “erroneously” listing EPA and DHA on its product. ECF No. 49 ¶ 67. In support of this 15 assertion, Hernandez broadly cites to 21 C.F.R. §101.36, but includes no specific subsections. 16 In moving to dismiss, DTI claims that federal regulations do not require that constituents 17 of dietary ingredients, such as EPA and DHA, bear their common or usual names. “Rather, only 18 those ‘[i]ngredients required to be declared on the label . . . shall be listed by common or usual 19 name[.]’” ECF No. 53 at 18 (quoting 21 C.F.R. § 101.4(a)(1)) (emphasis added). As set forth 20 above, constituent ingredients are not required in the supplemental fact panel. See 21 C.F.R. § 21 101.36(b)(3)(iii). Once again, Hernandez’s opposition fails to cite any authority to the contrary. 22 Accordingly, the Court agrees with DTI that its supplement fact panel is neither false nor 23 misleading, and it dismisses this claim with prejudice. 24 3. Triple Strength 25 Finally, Hernandez alleges that the product label falsely claims to be “Triple Strength.” 26 ECF No. 49 ¶ 74. He states that “[w]hile comparative nutrient content claims are generally 27 allowed, they require notice of the comparable product[,]” and that DTI “fails to identify such a 1 DTI argues that Hernandez has “not identified any specific statute or regulation that 2 requires DTI to identify a comparable product in order to make its ‘Triple Strength’” claim. ECF 3 No. 53 at 19. Hernandez clarifies in his opposition that he is asserting a claim under 21 C.F.R. 4 101.13(q)(3)(ii)(B). True, courts need not consider a claim where a plaintiff fails to identify the 5 particular statute(s) upon which the claim is based in the complaint. See Cecil Campbell v. 6 Rushmore Loan Mgmt. Servs., LLC, No. 8:20-CV-01695-MCS(JDE), 2021 WL 3284816, at *3 n.2 7 (C.D. Cal. Jan. 3, 2021) (dismissing claim where plaintiff’s “theory [was] not expressly presented 8 in the Complaint.”); Fed. R. Civ. P. 8(a) (“A pleading that states a claim for relief must contain a 9 short and plain statement of the claim showing that the pleader is entitled to relief.”). Even 10 assuming that this claim is properly plead, however, it still not sufficient to survive a motion to 11 dismiss. Stated in full, 21 C.F.R. 101.13(q)(3)(ii)(B) reads:
12 Whenever a statement is made that characterizes the percentage level of a dietary ingredient for which there is no RDI or DRV and 13 the statement draws a comparison to the amount of the dietary ingredient in a reference food, the reference food shall be clearly 14 identified, the amount of that food shall be identified, and the information on the actual amount of the dietary ingredient in both 15 foods shall be declared in accordance with paragraph (j)(2)(iv) of this section (e.g., “twice the omega-3 fatty acids per capsule (80 mg) 16 as in 100 mg of menhaden oil (40 mg)”). 17 For this statute to apply, there must be a comparison to a “reference food.” As DTI points out, the 18 product label at issue does not include a reference food, and Hernandez has “not identified any 19 specific statute or regulation that requires DTI to identify a comparable product in order to make 20 its ‘Triple Strength’ claim.” ECF No. 57 at 13. The Court therefore finds that DTI’s “Triple 21 Strength” claims are neither vague nor misleading. Because the Court concludes that amendment 22 of this claim would be futile, it dismisses this claim with prejudice. 23 CONCLUSION 24 For the foregoing reasons, DTI’s motion is denied in part and granted in part. The Court 25 finds that Hernandez has not adequately alleged that he is entitled to equitable relief; however, his 26 claims for injunctive relief are otherwise sufficient. In addition, the Court finds that Hernandez’s 27 claims are not preempted. Hernandez’s claims under the UCL, FAL, CLRA, as well as his claims 1 Hernandez’s remaining claims—that DTI fails to list all ingredients, that its supplemental fact 2 || section is misleading, and that its “triple strength” claim is misleading—are dismissed with 3 prejudice. 4 Hernandez may file an amended complaint within twenty-eight days of this order solely to 5 || cure the deficiencies identified by this order. Failure to file a timely amended complaint will 6 || result in dismissal of his claims with prejudice. 7 IT IS SO ORDERED.
8 Dated: August 26, 2024 9 JON S. TIGA 10 nited States District Judge 11 a 12
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