BOWLER v. NESTL HEALTH SCIENCE LLC (2025)

ORDER RE: MOTION TO DISMISS (ECF NO. 25)

Defendant Nestlé Health Science U.S., LLC, doing business as Nature's Bounty, moves to dismiss the complaint of Plaintiff Yesenia Bowler. (Mot., ECF No. 25-1.) Plaintiff filed a brief opposing the motion, (Opp'n, ECF No. 26), and Defendant filed a reply, (Reply, ECF No. 27). The Court deems the motion appropriate for decision without oral argument. Fed. R. Civ. P. 78(b); C.D. Cal. R. 7-15.

I. BACKGROUND

This is a putative class action concerning alleged false advertising of a consumer product—a snake oil case about fish oil. Defendant sells Nature's Bounty–branded fish oil capsules. (FAC ¶ 20, ECF No. 19.) Plaintiff identifies four products that purportedly feature one or more false or misleading statements about the products on their front label, including “HEART HEALTH,” a statement featured on all the products. (Id. ¶ 21.)¹ Each label's statement or statements at issue are accompanied by an asterisk denoting qualifying information elsewhere on the label. (Id.; Delgado Decl. Exs. G–J, ECF Nos. 25-10 to -13.)² The labels provide:

• Qualifying “HEART HEALTH” and “May Reduce Risk of Coronary Heart Disease,” “Supportive but not conclusive research shows that consumption of EPA and DHA Omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of Fish Oil provides 600 mg total of EPA, DHA, and other Omega-3 fatty acids. See nutrition information for total fat and cholesterol content.” (Delgado Decl. Ex. G.)3

• Qualifying “HEART HEALTH” and “Promotes Heart & Vascular Health,” “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” (Delgado Decl. Ex. H.)

• Qualifying “HEART HEALTH,” “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” (Delgado Decl. Ex. I.)

• Qualifying “HEART HEALTH” and “Supports Heart & Immune Health,” “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” (Delgado Decl. Ex. J.)

Without reference to the qualifying statements, Plaintiff asserts that the statements on the front label are false or misleading, as “there is no proof fish oil supplements improve your heart health,” and “multiple recent studies have found that fish oil supplements may be harmful to heart health.” (FAC ¶¶ 14–15 (internal quotation marks omitted); see id. ¶¶ 16–18.) According to Plaintiff, “when a bottle prominently states on the label, ‘Heart Health,’ consumers expect that to be accurate—that the product does help support a healthy heart.” (Id. ¶ 26.)

Plaintiff seeks to represent a qualified class of “all persons who, while in the state of California and within the applicable statute of limitations period, purchased one or more Nature's Bounty Fish Oil Capsules.” (Id. ¶ 43; see id. ¶¶ 44–49.) She brings claims of (1) violation of California's False Advertising Law, (2) violation of California's Consumer Legal Remedies Act (“CLRA”), and (3) violation of California's Unfair Competition Law (“UCL”). (Id. ¶¶ 50–91.)

II. LEGAL STANDARD

Only the Rule 12(b)(6) standard needs to be recited here.⁴ Federal Rule of Civil Procedure 12(b)(6) allows an attack on the pleadings for “failure to state a claim upon which relief can be granted.” “To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id.

The determination of whether a complaint satisfies the plausibility standard is a “context-specific task that requires the reviewing court to draw on its judicial experience and common sense.” Id. at 679. Generally, a court must accept the factual allegations in the pleadings as true and view them in the light most favorable to the plaintiff. Park v. Thompson, 851 F.3d 910, 918 (9th Cir. 2017); Lee v. City of Los Angeles, 250 F.3d 668, 679 (9th Cir. 2001). But a court is “not bound to accept as true a legal conclusion couched as a factual allegation.” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 555).

III. DISCUSSION

A. Preemption

Defendant argues Plaintiff's claims are preempted by the Food, Drug, and Cosmetic Act (“FDCA”), which “establishes a national and uniform standard for certain labeling statements.” Greenberg v. Target Corp., 985 F.3d 650, 655 (9th Cir. 2021); (see Mot. 8–16). The FDCA preempts state laws that purport to regulate “structure/function claims,” Greenberg, 985 F.3d at 655, which “ ‘describe[ ] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans’ or ‘characterize[ ] the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function,’ but ‘may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.’ ” Dachauer v. NBTY, Inc., 913 F.3d 844, 846 (9th Cir. 2019) (quoting 21 U.S.C. § 343(r)(6)). The parties agree the statements at issue on three of the products present structure/function claims. (Opp'n 2 n.1); cf. Magpayo v. Walmart Inc., No. 24-cv-01350-WHO, 2024 U.S. Dist. LEXIS 190259, at *15–16 (N.D. Cal. Oct. 18, 2024) (concluding “heart health” and “supports heart health” statements linked by asterisks to disclaimers that the products were “not intended to diagnose, treat, cure, or prevent any disease” were structure/function claims).⁵

State law causes of action based on a structure/function claim are preempted unless the “claim is factually false or lacks substantiation.” Greenberg, 985 F.3d at 657. Plaintiff, resting on a theory that the statements are factually false, has not done so. (Opp'n 9–11; see id. at 11–12 (disclaiming lack-of-substantiation theory).) None of the scientific publications Plaintiff cites in her pleading stands for the general proposition that the nutrients contained in Defendant's fish oil supplements do not promote or are harmful to heart health. (FAC ¶¶ 14–15; see generally Delgado Decl. Exs. K–P, ECF Nos. 25-14 to -19.)⁶ Two studies analyzed omega-3 supplements’ role in prevention of cardiovascular diseases, (Delgado Decl. Ex. K, at 23 (“Supplementation with n-3 fatty acids did not result in a lower incidence of major cardiovascular events or cancer than placebo.”); id. Ex. L, at 1540 (finding “no significant difference in the risk of serious vascular events” as to diabetic patients who received n-3 fatty acid supplements)), but the statements at issue disclaim any allegation toward the prevention of disease, (id. Exs. H–J). Those studies do not bridge the logical gap between the neutral effect of the nutrients on the incidence of cardiovascular events among the patients studied and the role the nutrients play in general cardiovascular health. See Greenberg, 985 F.3d at 655–56 (“[A] structure/function claim addresses only the general role of an ingredient/nutrient on the human body. It does not purport to convey the product's health impact on the general population ․”).

Similarly, publications Plaintiff cites for the proposition that nutrients in fish oil increase the risk of atrial fibrillation in certain populations do not stand for that proposition or do not call into question the broader role such nutrients play with respect to the human cardiovascular system in the general population. (See Delgado Decl. Ex. M, at 11 (describing study of patients with established cardiovascular disease, diabetes, and other risk factors who were administered four grams of icosapent ethyl daily); id. Ex. N, at 1061 (describing study of patients 50 years of age or older who were administered omega-3 fatty acids and vitamin D, and concluding that treatment “resulted in no significant difference in the risk of incident [arterial fibrillation]” compared with placebo); id. Ex. O, at 1, 8 (concluding “[r]egular use of fish oil supplements might be a risk factor for atrial fibrillation and stroke among the general population but could be beneficial for progression of cardiovascular disease,” and acknowledging “no causal relations can be drawn from our findings”); id. Ex. P, at 1073 (summarizing findings of icosapent ethyl trial, noting that the participants received a “high dose” of omega-3 fatty acids).) In any event, Defendant's products do not warrant anything about the risk of arterial fibrillation in making representations about “HEART HEALTH.” Cf. Dachauer, 913 F.3d at 849 (“The FDCA does not require that manufacturers substantiate structure/function claims about immune health with proof that their supplements reduce the risk of all-cause mortality. (Nor do Defendants claim that their supplements reduce that risk.)” (citation omitted)). Plaintiff has not raised a plausible inference that the structure/function claims are factually false.

Plaintiff's claims are preempted by federal law.

B. Reasonable Consumer Standard

As an independent ground for dismissal, the Court agrees with Defendant that Plaintiff does not plausibly plead confusion among reasonable consumers. (Mot. 16–20.)

“California's UCL, FAL, and CLRA require basic fairness in advertising and permit a civil remedy against those who deceive consumers.” Whiteside v. Kimberly Clark Corp., 108 F.4th 771, 777 (9th Cir. 2024). Claims thereunder “are governed by the reasonable consumer standard, which requires a plaintiff to show that members of the public are likely to be deceived by the defendant's marketing claims.” Id. (internal quotation marks omitted). “[T]he reasonable consumer standard requires a probability that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled.” Id. at 777–78 (internal quotation marks omitted). The standard usually presents a question of fact inappropriate for decision on the pleadings, but in rare cases claims may be dismissed “when the advertisement itself makes it impossible for the plaintiff to prove that a reasonable consumer is likely to be deceived.” Id. at 778 (cleaned up); see also Moore v. Trader Joe's Co., 4 F.4th 874, 882–83 (9th Cir. 2021) (“[W]here plaintiffs base deceptive advertising claims on unreasonable or fanciful interpretations of labels or other advertising, dismissal on the pleadings may well be justified.” (internal quotation marks omitted)).

This is one of those rare cases, as the fish oil labels are not capable of deceiving a reasonable consumer. The Court begins with the statement featured on all the challenged products, “HEART HEALTH.” Plaintiff understands the statement to convey that the products will promote, support, or improve heart health. (E.g., FAC ¶¶ 26, 32; Opp'n 15.) But the statement is ambiguous as to what effect on “HEART HEALTH” the product might have, beneficial or detrimental; at most, the words associate the product with cardiovascular fitness without providing any clear or meaningful representations about their efficacy. Nonetheless, some authorities suggest the word “health” in labeling raises an inference of a promotional effect sufficient to survive a pleading challenge in certain circumstances. See, e.g., Hadley v. Kellogg Sales Co., 273 F. Supp. 3d 1052, 1084–85 (N.D. Cal. 2017) (reasoning the statement “[i]nvest in your health invest in yourself” connoted beneficial health effect sufficient to withstand motion to dismiss). Further, the labels on which “HEART HEALTH” is coupled with other statements at issue—“Promotes Heart & Vascular Health” and “Supports Heart & Immune Health”—in totality produce an inference of a health-positive effect.

Even so, the Court “must consider what additional information other than the front label was available to consumers.” McGinty v. Procter & Gamble Co., 69 F.4th 1093, 1098 (9th Cir. 2023). Doing so dooms Plaintiff's claims, as representations made on the back label and linked by an asterisk to “HEART HEALTH” and the other statements at issue “ameliorate any tendency of the label to mislead.” Moore v. Mars Petcare US, Inc., 966 F.3d 1007, 1017 (9th Cir. 2020) (quoting Brady v. Bayer Corp., 26 Cal. App. 5th 1156, 1167 (2018)). Even without considering the substance of the representations on the back label, “the presence of an asterisk alone puts a consumer on notice that there are qualifications or caveats” to the statements at issue. Whiteside, 108 F.4th at 785. The back-label qualifications themselves—that the statements “ha[ve] not been evaluated by the Food and Drug Administration,” that the products are “not intended to diagnose, treat, cure or prevent any disease,” and that “[s]upportive but not conclusive research” indicates consumption of nutrients in the products “may reduce the risk of coronary heart disease”—dispel any false or misleading implications a reasonable consumer might understand the front-label statements to convey. In other words, the consuming public would not understand the statements at issue to indicate the products will “help support a healthy heart” because the labels elsewhere disclaim any representation that the products would do so. (FAC ¶ 26.)

Plaintiff's claims are implausible.

C. Amendment

As a general rule, leave to amend a dismissed complaint should be freely granted unless it is clear the complaint could not be saved by any amendment. Fed. R. Civ. P. 15(a); Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031 (9th Cir. 2008). Futility alone may warrant denial of leave to amend “only if no set of facts can be proved under the amendment to the pleadings that would constitute a valid and sufficient claim or defense.” Barahona v. Union Pac. R.R. Co., 881 F.3d 1122, 1134 (9th Cir. 2018) (quoting Sweaney v. Ada County, 119 F.3d 1385, 1393 (9th Cir. 1997)). Amendment would clearly be futile. Even if Plaintiff could muster facts or scientific publications that actually support an inference that the label statements are factually false without violating Federal Rule of Civil Procedure 11(b) upon amendment, Plaintiff cannot plead facts suggesting a reasonable consumer could be deceived by the label statements. The asterisked qualifications on the product labels render deception implausible.

IV. CONCLUSION

The motion is granted. Leave to amend is denied.

IT IS SO ORDERED.

FOOTNOTES

1.   Plaintiff asserts these four products are “non-limiting examples,” but she identifies no other products giving Defendant fair notice of her claims as they pertain to other products, and she has identified no other products in her briefing. (FAC ¶ 21.) Accordingly, the Court evaluates the claims only as they pertain to the identified products.

2.   Plaintiff's claims rest on representations made on the product labels, but only the front labels are presented in the pleading. The Court considers the full labels Defendant submitted with the motion papers. See Marder v. Lopez, 450 F.3d 445, 448 (9th Cir. 2006) (“A court may consider evidence on which the complaint ‘necessarily relies’ if: (1) the complaint refers to the document; (2) the document is central to the plaintiff's claim; and (3) no party questions the authenticity of the copy attached to the 12(b)(6) motion.”).

3.   Plaintiff clarifies in her brief that her claims do not pertain to the statement “May Reduce Risk of Coronary Heart Disease.” (Opp'n 2 n.1.) To the extent Plaintiff's pleading may be read to challenge that statement, her claims are abandoned.

4.   Defendant raises a challenge to Plaintiff's constitutional standing to seek injunctive relief. (Mot. 20–23.) Generally, issues of subject-matter jurisdiction must be resolved before others. See Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574, 578 (1999). Because the Court's resolution of a merits issue obviates the need to consider Plaintiff's standing to seek a certain type of remedy, the Court declines to address the standing issue.

5.   Having disclaimed any challenge to the qualified health claims presented on the product featuring the statements “HEART HEALTH” and “May Reduce Risk of Coronary Heart Disease,” Plaintiff effectively concedes that her action is preempted as to that product. (Opp'n 2 n.1; see Mot. 3–4 (citing, inter alia, 21 U.S.C. § 343(r)(3)(B)(i) and 21 C.F.R. § 101.14(a)(1)).)

6.   Plaintiff's claims of falsity necessarily rely on these publications, so the Court can consider them at the Rule 12 stage under the incorporation by reference doctrine. Marder, 450 F.3d at 448; but cf. Kroessler v. CVS Health Corp., 977 F.3d 803, 814 (9th Cir. 2020) (declining to consider substance of studies cited in the pleading “because they are not ․ part of the record” (emphasis added)).

MARK C. SCARSI, UNITED STATES DISTRICT JUDGE