courts may consider “extra-label material when 2 identifying implied disease claims and that those considerations are best made by district courts on 3 a case-by-case basis”
How later courts described this case
- courts may consider “extra-label material when 2 identifying implied disease claims and that those considerations are best made by district courts on 3 a case-by-case basis”
Written by the judges who cited it.
The opinion
1
2
3
4 UNITED STATES DISTRICT COURT
5 NORTHERN DISTRICT OF CALIFORNIA
6
7 PEARL MAGPAYO, Case No. 24-cv-01350-WHO
8 Plaintiff,
ORDER GRANTING MOTION TO
9 v. DISMISS
10 WALMART INC., Re: Dkt. No. 30
Defendant.
11
12 Plaintiff Pearl Magpayo filed this putative class action seeking to challenge the advertising
13 and label disclosures on defendant’s Spring Valley Fish Oil Omega-3 dietary supplements
14 (“Products”). First Amended Complaint (“FAC,” Dkt. No. 25) ¶¶ 35-36. Magpayo claims that the
15 packaging on defendant Walmart’s fish oil supplements convey to reasonable consumers that
16 Omega-3 supplements in general and Omega-3 fish oil supplements in particular prevent heart
17 disease, but that those claims are false or misleading and that supplements may, in fact, be
18 detrimental to heart health. FAC ¶¶ 4-8, 10-17. She purchased a bottle of Spring Valley Omega-3
19 Fish Oil Soft Gels Dietary Supplement from a Walmart store in Northern California in June 2023.
20 FAC ¶ 31. Walmart argues that the claims are preempted by federal law or otherwise fail and
21 moves to dismiss the FAC.
22 BACKGROUND
23 Magpayo alleges that the following health representations are prominently displayed on the
24 front label of Walmart’s Products:
25 • “Fish Oil is a source of Omega-3 fatty acids that support heart
health”
26 • “Heart Health”
• A heart symbol
27
1 FAC ¶¶ 13; 36.1 She contends that these “heart health representations lead reasonable consumers
2 to believe the Products’ Omega-3s support heart health (i.e., that the Omega-3s in the Products
3 reduce the risk of heart disease).” Id. ¶ 14. That disease message, according to Magpayo, is
4 reinforced by online advertising that expressly links the Product to reducing the risk of heart
5 disease. Id. ¶¶ 15-16.
6 These representations are allegedly false and misleading “because the Products’ Omega-3s
7 do not support heart health (i.e., the Omega-3s in the Products do not reduce the risk of heart
8 disease).” Id. ¶ 17. Magpayo contends that the “heart health representations also lead reasonable
9 consumers to believe there is—at least some—conclusive research to show that the Products’
10 Omega-3s reduce the risk of heart disease. . . . [but] there is no conclusive research to show that
11 the Products’ Omega-3s reduce the risk of heart disease.” Id. ¶ 18.
12 Magpayo asserts that the Product’s label is making a type of claim that the Food and Drug
13 Administration (“FDA”) would consider an implied health claim. As such, Walmart is required to
14 but does not make a disclaimer on the Product’s label that: “‘Supportive but not conclusive
15 research shows that consumption of EPA and DHA Omega-3 fatty acids may reduce the risk of
16 coronary heart disease.’ (emphasis added). This is because the FDA has found that health claims
17 related to heart disease on Omega-3 supplements lack significant scientific agreement.” Id. ¶¶ 20,
18 69-81. Magpayo notes that she is not basing any cause of action on Walmart’s violation of the
19 FDA regulations but cites to the disclosure the FDA requires for health claims to support her
20 assertion that the health claims Walmart makes are significant and material to consumers. See
21 FAC ¶ 21 (“the fact that the FDA requires such a disclaimer shows that reasonable consumers can
22
23
1 The products included are: Spring Valley Omega-3 Fish Oil Soft Gels, Heart Health Dietary
Supplement, 1000 mg, 60 Count; Spring Valley Proactive Support Omega-3 Mini from Fish Oil
24
Dietary Supplement, 1000 mg, 120 Count; Spring Valley Omega-3 Fish Oil For Heart and Brain
Health, Dietary Supplement Soft gels, 1000 mg, 60 Count; Spring Valley Maximum Care Omega-
25
3 from Fish Oil Eye Brain Bone & Heart Health Dietary Supplement Soft gels, 2000 mg, 120
Count; Spring Valley Fish Oil Omega-3 General & Heart Health Dietary Supplement Soft gels,
26
500 mg, 60 Count, 120, & 180 count; Spring Valley Proactive Support Omega-3 from Fish Oil
Heart General & Brain Health Dietary Supplement Soft gels, 1000 mg, 120 Count; Spring Valley
27
Omega-3 Fish Oil Soft Gels, 1000 mg, 180 Count; Spring Valley Omega-3 Fish Oil Brain & Heart
1 be misled about the level of scientific support that exists for a health claim.”); see also id. ¶¶ 88-
2 89.
3 To support her claim that the labels are false and misleading, Magpayo identified a number
4 of recent studies and sources that purportedly conclude there are no cardiovascular benefits from
5 taking fish oil Omega-3 supplements and very few benefits that might be secured from other types
6 of Omega-3 products. See FAC ¶¶ 45-57. She also identified studies and sources concluding
7 there are “potential risks” from taking Omega-3 fish oil supplements, because “some”
8 supplements may contain cholesterol, oxidized fatty acids, saturated fatty acids, or other
9 contaminants that can negate the purported benefits of certain fish oil supplements. Id. ¶¶ 58-65.
10 Magpayo pleads causes of action based on violations of: (1) California’s Consumers Legal
11 Remedies Act (“CLRA,” Cal. Civ. Code § 1750 et seq.); (2) California’s False Advertising Law
12 (“FAL,” Cal. Bus. & Prof. Code § 17500 et seq.); (3) California Unfair Competition Law (“UCL,”
13 Cal. Bus. & Prof. Code §17200 et seq.); (4) Breach of Express Warranty (Cal. Com. Code §
14 2313); (5) Breach of the Implied Warranty; and (6) Quasi-Contract/Unjust Enrichment/Restitution.
15 Walmart moves to dismiss all claims.
16 LEGAL STANDARD
17 Under Federal Rule of Civil Procedure 12(b)(6), a district court must dismiss a complaint
18 if it fails to state a claim upon which relief can be granted. To survive a Rule 12(b)(6) motion to
19 dismiss, the plaintiff must allege “enough facts to state a claim to relief that is plausible on its
20 face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). A claim is facially plausible when
21 the plaintiff pleads facts that “allow the court to draw the reasonable inference that the defendant
22 is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citation
23 omitted). There must be “more than a sheer possibility that a defendant has acted unlawfully.” Id.
24 While courts do not require “heightened fact pleading of specifics,” a plaintiff must allege facts
25 sufficient to “raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555, 570.
26 In deciding whether the plaintiff has stated a claim upon which relief can be granted, the
27 Court accepts the plaintiff’s allegations as true and draws all reasonable inferences in favor of the
1 the court is not required to accept as true “allegations that are merely conclusory, unwarranted
2 deductions of fact, or unreasonable inferences.” In re Gilead Scis. Sec. Litig., 536 F.3d 1049,
3 1055 (9th Cir. 2008). If the court dismisses the complaint, it “should grant leave to amend even if
4 no request to amend the pleading was made, unless it determines that the pleading could not
5 possibly be cured by the allegation of other facts.” Lopez v. Smith, 203 F.3d 1122, 1127 (9th Cir.
6 2000). In making this determination, the court should consider factors such as “the presence or
7 absence of undue delay, bad faith, dilatory motive, repeated failure to cure deficiencies by
8 previous amendments, undue prejudice to the opposing party and futility of the proposed
9 amendment.” Moore v. Kayport Package Express, 885 F.2d 531, 538 (9th Cir. 1989).
10 DISCUSSION
11 I. PREEMPTION
12 While the FAC discusses in depth the FDA’s system and treatment of regulated health
13 claims and contends that Walmart is making claims that the FDA would consider implied health
14 claims, Magpayo is not seeking to enforce those FDA regulations. FAC ¶¶ 21, 88. Instead, she
15 cites the FDA regulations and regulatory guidance as evidence showing the plausibility of her
16 claims regarding consumer perception concerning fish oil Omega-3 supplements and as evidence
17 why Walmart’s statements, without additional disclosures, would mislead reasonable consumers.
18 Magpayo’s central theory is that Walmart’s heart health statements are false and
19 misleading because they convey to consumers that the Product has an impact on cardiovascular
20 disease; a claim that the FDA would consider an implied health claim. FAC ¶¶ 1, 14. Walmart,
21 on the other hand, argues that when the statements and the rest of the label are considered in full
22 context, the statements would instead be considered by the FDA to be permissible
23 “structure/function claims” that merely imply the Products can support heart health.
24 A. Structure/Function or Implied Health Claim
25 In Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019), the Ninth Circuit explained the
26 difference between regulated health claims and permissible structure/function claims.
27 A structure/function claim “describes the role of a nutrient or dietary
dietary ingredient acts to maintain such structure or function,’ but
1 ‘may not claim to diagnose, mitigate, treat, cure, or prevent a specific
disease or class of diseases.” 21 U.S.C. § 343(r)(6) (emphasis added).
2 A disease claim, conversely, “claims to diagnose, mitigate, treat, cure,
or prevent disease,” either explicitly or implicitly (such as by claiming
3 that a product treats a disease’s “characteristic signs or symptoms”).
21 C.F.R. § 101.93(g)(2)(ii). Structure/function claims must meet
4 three requirements: (1) the manufacturer has substantiation that the
statement is truthful and not misleading; (2) the statement contains a
5 prominent disclaimer that the Food and Drug Administration (‘FDA’)
has not evaluated the statement and that the product ‘is not intended
6 to diagnose, treat, cure, or prevent any disease’; and (3) the statement
itself does not ‘claim to diagnose, mitigate, treat, cure, or prevent’
7 disease. 21 U.S.C. § 343(r)(6).
8
Id. at 846-47; see also Ferrari v. Vitamin Shoppe Indus. LLC, 70 F.4th 64, 67–68 (1st Cir. 2023)
9
(“Congress amended the FDCA through the Dietary Supplement Health and Education Act of
10
1994 (‘DSHEA’) to establish a uniform framework to regulate dietary supplements. Pub. L. No.
11
103-417, 108 Stat. 4325, 4325–26 (1994). Under the FDCA and DSHEA, manufacturers may
12
make so-called “structure/function claims” about dietary supplements.”).
13
The Dachauer court considered a vitamin E supplement’s claim to “support cardiovascular
14
health.” Similar to this case, plaintiff’s theory was that the supplement did not prevent
15
cardiovascular disease and, therefore, it was false and misleading under the CLRA and UCL. Id.
16
at 846. At summary judgment, plaintiff’s expert testified only that the supplement did not prevent
17
cardiovascular disease and failed to address whether the supplement met the FDA’s standard for
18
structure/function claims (i.e., provide evidence that the statement was false and misleading
19
because it had no “effect on a small aspect of the related structure/function.”). Id. at 847-49. In
20
that posture, the court concluded that plaintiff was simply rejecting “the discrete categories of
21
claims that the FDCA establishes” and was improperly attempting to “require proof that the
22
supplement treats or prevents cardiovascular disease” contrary to the requirements of the statue.
23
Id. at 848 (“Yet Plaintiff seeks to impose a requirement under California law that
24
structure/function claims—at least those related to cardiovascular, circulatory, and heart health—
25
made on a supplement’s label require proof that the supplement treats or prevents cardiovascular
26
disease. That requirement ‘is not identical to the requirement of section 343(r).’ 21 U.S.C.§ 343-
27
1(a)(5).”).
1 The Ninth Circuit in Greenberg v. Target Corp., 985 F.3d 650 (9th Cir. 2021) likewise
2 foreclosed a plaintiff from challenging a structure/function claim under California consumer
3 protection statutes based on a theory that the claim falsely conveyed to reasonable consumers the
4 product treated a disease. “Greenberg’s state law claims challenging the biotin product’s efficacy
5 are preempted because the statute only requires substantiation for the ingredient’s function on the
6 human body, not the health impact of the product as a whole. Put differently, Congress appears to
7 have created two classes of claims: (1) a structure/function claim that refers only to the ingredient
8 or nutrient’s role in the human body, and (2) a disease claim that speaks to the product’s effect on
9 the consumer's disease. Greenberg cannot implicitly import a disease claim requirement —
10 evidence showing the product's impact on the consumer’s health or disease — into the
11 structure/function claim, given the differences in the statutory requirements for each.” Id. at 656.
12 The question before me is whether the challenged statements on the Products are
13 structure/function claims or are implied health claims. If they are structure/function claims,
14 Magpayo’s central theory of liability on her state law claims is preempted.2 While fact-based, this
15 is a determination for the court. Yamagata v. Reckitt Benckiser LLC, 445 F. Supp. 3d 28, 33 (N.D.
16 Cal. 2020) (“But the idea that the FDA’s dictates may conflict with intuitions only confirms that
17 this preemption determination, while fact-based, depends ultimately on application of the law.”).
18 Magpayo’s position is that the FDA would find Walmart’s label an implied health claim
19 and not a structure/function claim and, therefore, she is not seeking to impose labelling
20 requirements under California law that differ from the FDCA’s requirements. She distinguishes
21 her case from Dachauer on two grounds. First, Dachauer was determined on summary judgment.
22 Second, in this case the challenge is not only to defendant’s use of “heart health” but also to the
23 use of the “heart symbol.” It is the use of the heart symbol, according to Magpayo’s opposition,
24 that creates the implied health claim. She points to FDA guidance that use of the heart symbol
25
26
2 Preemption would not, however, preclude a claim based on the theory that advertising statements
are misleading by failing to disclose “a harmful aspect of the nutrient” or that the
27
structure/function claim is “factually false or lacks substantiation.” See Greenberg, 985 F.3d at
1 alone “typically” conveys an implied health claim. Oppo. at 12. There is some support for these
2 distinctions. In a footnote, the Dachauer panel rejected plaintiff’s “suggestion” that he be granted
3 leave to “allege that Defendants make false implied-health claims instead of structure/function
4 claims.” Id., 848 at n.2. That is what Magpayo is alleging here.
5 Magpayo also relies on 21 C.F.R. § 101.14(a)(1) which explains:
6 Health claim means any claim made on the label or in labeling of a
food, including a dietary supplement, that expressly or by implication,
7 including “third party” references, written statements (e.g., a brand
name including a term such as “heart”), symbols (e.g., a heart
8 symbol), or vignettes, characterizes the relationship of any substance
to a disease or health-related condition. Implied health claims include
9 those statements, symbols, vignettes, or other forms of
communication that suggest, within the context in which they are
10 presented, that a relationship exists between the presence or level of
a substance in the food and a disease or health-related condition.
11
She also relies on guidance from FDA explaining that the:
12
FDA does agree, however, that under §101.14(a)(1), a dietary
13 supplement name that included the word “heart” could be a health
claim, depending on the context. Thus, a dietary supplement could be
14 called “HeartTabs” if its claim was “to maintain healthy circulation,”
or some other role related to the structure or function of the heart that
15 did not imply treatment or prevention of disease. If, however, the
product name was not qualified by any further claim in the labeling,
16 the product could be considered, under §101.14(a)(1), to be intended
for treatment or prevention of cardiovascular disease.
17
FDA also believes that the heart symbol has become so widely
18 associated with prevention of heart disease that its use in the labeling
of a dietary supplement would be ordinarily considered an implied
19 heart disease prevention claim. Consistent with the examples
provided in the January 6, 1993, Federal Register document on health
20 claims (58 FR 2486), however, there may be unusual cases in which,
in context, the use of a heart symbol does not imply heart disease
21 prevention.
22 Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on
23 the Structure or Function of the Body, 65 FR 1000-01 at 1022 (Jan. 6. 2000).3
24
3 See also id. at 1026 (“One comment requested that the agency clarify whether a picture of an
25
organ is permitted if the claims are appropriate and within the scope of permitted
structure/function claims. The comment offered as an example a statement that a product
26
maintains cardiovascular health accompanied by a picture of a heart and circulatory system.
FDA agrees that in most cases, a picture of a healthy organ would not be considered a disease
27
claim, if, in the context of the labeling as a whole, it did not imply treatment or prevention of
1 Magpayo’s authorities demonstrate that the FDA looks to the context of the whole label to
2 determine whether the use of the symbol creates an implied health claim. See, e.g., Yamagata v.
3 Reckitt Benckiser LLC, 445 F. Supp. 3d 28, 33–34 (N.D. Cal. 2020) (“So even when an
4 advertising statement is best viewed as a structure/function statement in isolation, it can
5 improperly imply an effect on a disease if other parts of the label associate the supplement with a
6 disease. The product name, any pictures or symbols, citations to journal articles, and statements
7 about the formulation of the product, if printed on the label, are all relevant.”). She, however,
8 does not identify anything else on the label – other than use of the heart symbol – that conveys that
9 Walmart is making an implied health claim.
10 Walmart argues that in context there can be no dispute that it is not making an implied
11 health claim because all heart health statements on the label are accompanied by an asterisk that
12 refers consumers to the “DSHEA statement” on the side panel that the “heart health” statements
13 “have not been evaluated by the Food and Drug Administration. This product is not intended to
14 diagnose, treat, cure, or prevent any disease.” Because of that disclaimer and the fact that nothing
15 on the label refers to damage to an organ or treatment of a disease, Walmart argues that the
16 challenged statements cannot be considered implied health claims.
17 It also cites an FDA letter that found use of a heart symbol on the label of a dietary
18 supplement was not an implied health claim where the product’s label also stated, “Support
19 Cardiovascular Function.” See Declaration of William P. Cole, Dkt. No. 30-3, Ex. 1. Magpayo
20 contends that this letter and label are distinguishable because the use of the word “Function”
21 clearly denotes a structure/function claim, and the label provided additional context indicating the
22 products were to support “heart tissue” and “blood circulation” which satisfy the structure/function
23 requirement of an “effect on a small aspect of the related structure/function” of heart tissue and
24 circulation, as opposed to conveying anything about heart disease.
25 In Gallagher v. Bayer AG, No. 14-CV-04601-WHO, 2015 WL 1056480, at *6 (N.D. Cal.
26 Mar. 10, 2015), I rejected plaintiffs’ argument “that by using ‘supports heart health’ on its
27
1 packaging and advertising, Bayer is representing that its Supplements can prevent, mitigate, or
2 treat ‘cardio vascular disease.’” Id. at *6. I concluded “supports heart health” – standing on its
3 own – was a structure/function claim. Plaintiffs did not identify any packaging or advertising
4 statements that could shift the statement to an implied health claim. Id.; see also Gallagher v.
5 Bayer, 2015 WL 4932292 (Aug. 18, 2015) (same). In Gallagher, however, I expressly noted that:
6 Plaintiffs apparently argue that the heart and immunity claims also
violate 21 C.F.R. § 101.14(a)(1). Oppo. at 8 & fn. 43. But that
7 regulation explains that “use Health claim means any claim made on
the label or in labeling of a food, including a dietary supplement, that
8 expressly or by implication, including ‘third party’ references, written
statements (e.g., a brand name including a term such as ‘heart’),
9 symbols (e.g., a heart symbol), or vignettes, characterizes the
relationship of any substance to a disease or health-related condition.”
10 Plaintiffs do not allege that Bayer uses the term heart in its brand
names or otherwise uses symbols or vignettes in conjunction with the
11 Statements.
12 Gallagher v. Bayer AG, No. 14-CV-04601-WHO, 2015 WL 1056480, at *6 (N.D. Cal. Mar. 10,
13 2015).
14 The question here is whether the use of the heart symbol in connection with “supports
15 heart health” changes the analysis in Gallagher. Although recognizing that this is a close call, I
16 find that it does not. While the FDA guidance indicates that use of the heart symbol would
17 ordinarily imply a health claim, there is nothing else on Products’ label that could imply use of the
18 product to treat heart disease. Instead, as Walmart points out, there is something on this label that
19 expressly disclaims treatment of heart disease; the “DSHEA statement” on the side panel that
20 “[t]his product is not intended to diagnose, treat, cure, or prevent any disease.” The mere use of
21 the heart symbol, even in connection with the “heart health” and “support heart health” statements,
22 does not create an implied health claim given that the statements are asterisked and lead to the
23 express label disclosure that the product is not intended to treat or prevent any disease.
24 The only other source of context to shift what is facially a structure/function claim to an
25 implied health claim is Magpayo’s reference to an online Amazon advertisement that expressly
26 states that the Products “REDUCE THE RISK OF CORONARY HEART DISEASE.” FAC ¶ 15.
27 Extra-label advertising statements may be considered when determining whether an otherwise
1 Corp., 977 F.3d 803, 815 (9th Cir. 2020) (courts may consider “extra-label material when
2 identifying implied disease claims and that those considerations are best made by district courts on
3 a case-by-case basis”); see also id. at fn. 9 (in assessing whether an implied health claim is made,
4 “District courts within this circuit have considered factors such as the product’s advertisements,
5 the consumer’s experience with the product, and market research showing consumer’s typical uses
6 of the product.”).
7 That said, there is no allegation that Walmart was responsible for the Amazon
8 advertisement. Even if that allegation could be made, one advertisement without more facts
9 regarding the duration and scope of an advertising campaign is an insufficient basis to turn the
10 structure/function claims on the Products’ labels into implied health claims.
11 At base, the FAC pleads an implied health claim related to the challenged statements and
12 heart symbol. That claim is preempted. See Seegert v. Rexall Sundown, Inc., No. 20-55486, 2022
13 WL 301553, at *2 (9th Cir. Feb. 1, 2022) (“To the extent that Seegert argues Rexall's
14 representations are false or misleading because they present implied disease claims, her state law
15 claims are preempted.”). Absent evidence of other statements on the product labels or allegations
16 of widespread or consistent advertising put out by Walmart that could create an implied health
17 claim when considered with the challenged statements, Magpayo cannot pursue a cause of action
18 in this case based on a false implied health claim. The only claim she can assert – based on the
19 current FAC identifying the challenged statement and the one advertisement that she has not
20 shown is attributable to Walmart or part of a widespread advertising campaign for the Products –
21 is a structure/function claim. That claim is discussed below.
22 Because Magpayo may theoretically be able to amend to identify additional language on
23 the labels for some or all of the Products or additional extra-label statements made by Walmart
24 that could preserve her implied health claim theory, she will be given leave to amend.
25 B. If A Structure/Function Claim
26 Magpayo argues that even if I conclude that Walmart is making a structure/function claim,
27 that claim is not preempted – at least not at the motion to dismiss stage – because she has plausibly
1 structure/function” of heart health and in fact can be detrimental to heart health.
2 With respect to her first theory, it is unclear if Magpayo is alleging a substantiation claim;
3 i.e., that the Products have not been shown to support the function of heart health in some discrete
4 manner. See Kroessler, 977 F.3d at 811 (“Therefore, under California law, a plaintiff retains the
5 burden of production and the burden of proof but can nevertheless challenge a defendant’s
6 substantiation . . . By permitting discovery and proceeding to summary judgment, the district
7 court in Dachauer confirmed that plaintiffs can challenge defendants’ substantiation by pointing
8 to ‘matching evidence’ contradicting those claims.”). She is given leave to amend to expressly
9 plead, if she chooses to do so, a lack of substantiation claim.
10 On the second theory, the Ninth Circuit has allowed California consumer protection claims
11 to proceed, even on a structure/function claim, where there are plausible allegations that the
12 supplement could cause harm to consumers. See Krossler supra; see also Dachauer, 913 F.3d at
13 849 (“Conceivably, evidence that a supplement endangered users by increasing their risk of death
14 could prove that a structure/function claim that omitted the risk was misleading. But the record
15 lacks evidence that vitamin E supplements are actually harmful, as opposed to simply useless at
16 reducing all-cause mortality (which they do not claim to reduce).”). Magpayo appears to invoke
17 this second theory in her FAC where she alleges potential harm from taking “some” fish oil
18 supplements. FAC ¶¶ 52 (data suggest these supplements may increase the risk of atrial
19 fibrillation), 58-65 (in order to secure recommended amounts of PA and DHA recommended by
20 AHA, consumers would have to take 10 or more fish oil supplements a day negating benefits by
21 increasing intake of saturated fats and oxidized lipids).
22 Walmart points out, however, that these potential harms – resulting either from
23 contaminants, spoiled oil, or the need to take high doses of fish oil supplemental to achieve any
24 purported benefits – are not alleged in the FAC to be present in or created by use of Walmart’s
25 fish oil supplements. She responds that she does not need to make these allegations at this stage
26 because what she has alleged suggests that it is at least plausible that Walmart’s supplements
27 suffer from contamination or are otherwise harmful to consumers. She points as support to some
1 shows that an elevated risk for high cholesterol is created by Walmart’s supplements because a
2 consumer would need to take 15 capsules a day of the Products to achieve the highest level of
3 recommended EPA/DHA (4g), resulting in 150 mg of cholesterol which is 50% of the
4 recommended daily intake. See Oppo. at 15-17.
5 Magpayo’s allegations regarding harm supported by “studies” as well as the “simple math”
6 are not alleged or identified in the FAC. Magpayo is given leave to amend to allege a
7 structure/function claim that would not be preempted as based on a “lack of substantiation” theory
8 or a “causes harm” theory, by alleging facts supporting the plausibility of those theories with
9 respect to Walmart’s Products.
10 II. PRIMARY JURISDICTION
11 Walmart asks me to dismiss or stay this case under the doctrine of primary jurisdiction.
12 “The primary jurisdiction doctrine allows courts to stay proceedings or to dismiss a complaint
13 without prejudice pending the resolution of an issue within the special competence of an
14 administrative agency.” Clark v. Time Warner Cable, 523 F.3d 1110, 1114 (9th Cir. 2008). The
15 doctrine is a “prudential” one, “under which a court determines that an otherwise cognizable claim
16 implicates technical and policy questions that should be addressed in the first instance by the
17 agency with regulatory authority over the relevant industry rather than by the judicial branch.” Id.
18 (citing Syntek Semiconductor Co. v. Microchip Tech. Inc., 307 F.3d 775, 780 (9th Cir. 2002)).
19 However, “[n]ot every case that implicates the expertise of federal agencies warrants invocation of
20 primary jurisdiction. Rather, the doctrine is reserved for a ‘limited set of circumstances’ that
21 ‘requires resolution of an issue of first impression, or of a particularly complicated issue that
22 Congress has committed to a regulatory agency.’” Astiana v. Hain Celestial Group, Inc., 783 F.3d
23 753, 760 (9th Cir. 2015) (quoting Clark, 523 F.3d at 1114).
24 To determine whether to defer to an agency, the Ninth Circuit has traditionally examined
25 the factors set forth in General Dynamics, and found that the doctrine applies in cases where there
26 is: “(1) [a] need to resolve an issue that (2) has been placed by Congress within the jurisdiction of
27 an administrative body having regulatory authority (3) pursuant to a statute that subjects an
1 uniformity in administration.” Syntek, 307 F.3d at 781 (citing U.S. v. Gen. Dynamics Corp., 828
2 F.2d 1356, 1362 (9th Cir. 1987)). “[C]ourts must also consider whether invoking primary
3 jurisdiction would needlessly delay the resolution of claims,” and under Ninth Circuit precedent, “
4 ‘efficiency’ is the ‘deciding factor’ in whether to invoke primary jurisdiction.” Astiana, 783 F.3d
5 at 760 (quoting Rhoades v. Avon Prods., Inc., 504 F.3d 1151, 1165 (9th Cir. 2007)).
6 In support of dismissal or stay, Walmart argues that it is up to the FDA to determine
7 whether its use of the heart symbol automatically converts the structure/function claim into an
8 implied health claim given the FDA’s jurisdiction and responsibility to issue guidance on the issue
9 in response to citizen petitions. Mot. at 24-25. It posits that Magpayo should ask the FDA,
10 through the citizen petition mechanism, to address Walmart’s specific label for the Omega-3
11 supplement, before being allowed to proceed with this case. Id.
12 The request to dismiss or stay based on primary jurisdiction is DENIED. As discussed
13 above, the FDA has already issued significant guidance regarding the types of claims at issue in
14 this case. Moreover, neither side identifies any ongoing proceedings or request for guidance
15 pending before the FDA that might bear on the resolution of this case. In this posture, there are no
16 efficiencies to be gained by staying this case under the doctrine of primary jurisdiction. See e.g.,
17 Gatling-Lee v. Del Monte Foods, Inc., No. 22-CV-00892-JST, 2023 WL 11113888, at *7 (N.D.
18 Cal. Mar. 28, 2023), reconsideration denied sub nom. Nacarino v. Del Monte Foods, Inc., No. 22-
19 CV-00892-JST, 2024 WL 847925 (N.D. Cal. Feb. 28, 2024 (denying motion to defer based on
20 primary jurisdiction because “this is not a case in which further guidance from the FDA is
21 necessary in order for the Court to decide the case.”)
22 III. FAILURE TO STATE CLAIMS
23 Finally, Walmart moves to dismiss Magpayo’s state law claims and requests for relief on
24 their merits, arguing that she lacks standing or has otherwise failed to allege facts supporting her
25 state law claims. Mot. at 16-23. Whether she can plausibly allege her state law deception-based
26 claims depends on whether she can state a not-preempted theory of deception or harm. Walmart
27 may reassert its failure to state a claim arguments, attacking the revised and clarified theory of
1 deception asserted, if she files an amended complaint.4
2 CONCLUSION
3 Walmart’s motion to dismiss the FAC is GRANTED because Magpayo’s theory of
4 || deception and state law claims as currently alleged are preempted. Walmart’s request to dismiss
5 || or stay this case under the doctrine of primary jurisdiction is DENIED. Magpayo is given leave to
6 amend to attempt to plead a theory of deception or harm that is not preempted. Any such amended
7 complaint must be filed within twenty (20) days of the date of this Order.
8 IT IS SO ORDERED.
9 Dated: October 18, 2024
10 .
11
iam H. Orrick
12 United States District Judge
©
15
16
= 17
Z 18
19
20
21
22
23
24
25
26
27 * In any further amended complaint, plaintiff should not reallege claims that she admitted in her
28 Opposition she was no longer pursuing; specifically, a UCL unlawful claim based on violation of
federal law and a claim for equitable restitution. Oppo. at 3 n.2.