Wednesday, April 08, 2026

two cases reach opposite results over whether "health" claims are misleading if products are lead-contaminated

Lopez v. Mead Johnson Nutrition Co., 2026 WL 788492, No. 24-cv-03573-HSG (N.D. Cal. Mar. 20, 2026)

Lopez alleged that Mead infant formulas’ packaging contains deceptive statements that imply that they are generally nutritious and have “no detrimental, harmful, or genetically engineered ingredients.” For example, the challenged labels state that the formulas are “brain building” or “support[ ] brain... development,” and are “recommended” or “trusted” by experts and pediatricians. Others contain statements that the formulas promote immune health, bone health; eye health; were inspired by breast milk; and do not contain artificial colors, flavors, sweeteners, or growth hormones. But independent testing allegedly revealed a presence of arsenic, cadmium, or lead in each of the formulas, and that other infant formulas may be manufactured without detectable levels of heavy metals. She also alleged that consumer surveys revealed that people would expect a company to test for those substances and disclose whether “detectable levels” were found, and that consumers would understand the formulas’ packaging to imply there were no heavy metals.  

The court disagreed, although it rejected Mead’s primary jurisdiction argument and arguments that Lopez couldn’t sue over products with different ingredients from those she purchased (there are milk-based, soy-based or amino-based options), because they were substantially similar in the relevant characteristics to the products she did purchase.  

Lopez did fail to plead that damages would insufficiently compensate her for the alleged overpayment, so her restitution and disgorgement claims failed.

More importantly, her UCL, FAL, and CLRA claims failed. She didn’t allege that any of Mead’s claims were literally false, but rather that “each challenged statement speaks directly to the quality and nutritional benefits of the Products” without mentioning the potential presence of heavy metals. “[T]his argument is based on implausible assertions about what a reasonable consumer would understand the challenged representation to say about the Products…. There is nothing that logically connects an expert’s recommendation or the presence of certain substances in an infant formula with the absence of some other substance.” [Would an expert really recommend feeding a baby cadmium and lead?]

The survey didn’t help. Over 91 percent of a subset of parents answered “yes” to the questions “Do you expect a company to test for arsenic, cadmium, lead, and/or mercury in infant formula that will be fed to infants?” and “Would you expect a company to disclose if there were detectible levels, or risk, of arsenic, cadmium, lead, and/or mercury in an infant formula?” And 77 percent of consumers would not “expect arsenic, cadmium, lead, and/or mercury in the infant formula” after seeing the label. “But these generalized questions to an undisclosed number of people, detached from any legal standard, fail to support the plausibility of Plaintiff’s reasonable consumer allegation.”

Nor did Lopez plead that Mead has a “duty to disclose” because the suppressed facts are “contrary to a representation actually made by the defendant.” The challenged statements read together didn’t represent that the products didn’t contain any detectable levels of heavy metals. “It is not enough for the disclosure to only provide more information about the product.” This defeated all the claims.

Meanwhile: The Court directed defense counsel to show cause why they should not be sanctioned for including a non-existent quotation from Becerra v. Dr Pepper/Seven Up, Inc., 945 F.3d 1225 (9th Cir. 2019). The required response indicated that the quote was actually from a district court case that cited Becerra whose citation was inadvertently deleted. The filing included a screenshot purporting to show that counsel had previously accessed that district court case on Westlaw and specifically disavowed any generative AI use, which was clearly part of the court’s suspicions. “Counsel for Mead Johnson apologizes for the mistake and has informed Mead Johnson of both this error and the Court’s Order.”  

Pellegrino v. Procter & Gamble Co., 2026 WL 880573, No. 23-CV-10631 (KMK) (S.D.N.Y. Mar. 31, 2026)

Plaintiffs brought claims under New York General Business Law §§ 349 and 350, New York Agriculture and Markets Law § 199-a, and negligence per se based on P&G’s marketing of Metamucil, a psyllium fiber supplement.

Plaintiffs alleged that “[t]he labels on the Products suggest ... that [they] are generally healthy and safe for consumption and provide specific health benefits ....” and that they “have been inspected and sealed to ensure each is safe for human consumption” and free from tampering. P&G’s website has a dedicated “Product Safety” section, which discusses the “rigorous safety process” it uses “to analyze every ingredient” used in its products and claims to “go beyond regulatory compliance to ensure every ingredient’s safety through a four-step, science-based process” used by various regulatory agencies, including “US FDA, [the] EPA, the EU, the WHO, and others.” P&G “reassures consumers it ‘define[s] the safe range of every ingredient’ by ‘apply[ing] the same science-based approach as regulatory agencies around the world.’ ” The website specifically states that it does not use “[h]eavy metals” such as “[a]rsenic, [l]ead, [and] [c]hromium” as ingredients in its products.

But the products allegedly “contain dangerous amounts of the heavy metal lead[,]” supported by the results of “[i]ndependent laboratory testing completed in July 2023 by an ISO-accredited laboratory.” P&G allegedly knew this since 2021, when “Consumer Lab published a report concerning the lead content of various psyllium fiber supplements, showing up to 14.6 μg of lead per serving in Metamucil Sugar Free Orange Flavored.”

P&G argued that plaintiffs didn’t allege facts sufficient to show that the products they purchased actually contained dangerous amounts of lead. The court agreed in part; it didn’t think there was enough detail in most of the independent testing allegations.

“To validly assert an injury under a price-premium theory, a plaintiff must ‘allege[ ] facts demonstrating it is at least plausible that a plaintiff purchased a misbranded product.’ ” Plaintiffs can test the products they personally purchased, but “[c]aselaw in this Circuit recognizes ... that it may not always be possible to test the actual product purchased by a plaintiff.”

John v. Whole Foods Mktg. Grp., 858 F.3d 732 (2d Cir. 2017), accepted the results of a third-party investigation, which found the defendant’s pre-packaged foods were mislabeled 89% of the time. “[T]he samples in the independent investigation included the particular type of products that the plaintiff bought from the two store locations where he bought the products during the same time period in which the plaintiff made his purchases.” John requires plaintiffs to “meaningfully link the results of their independent testing to the product actually purchased.” This can be done, for example, “by showing that the mislabeling was systematic and routine.”  Relevant factors include temporal proximity, geographic proximity of the testing to the plaintiff’s purchases, the number of samples tested, and the name and testing methodology of the tester. “The pleading also should disclose the number of samples tested, and the testing should involve more than a small number.”

Only one plaintiff’s claims survived this inquiry. The court declined to dismiss those claims on the grounds that plaintiffs didn’t show that the amount of lead was dangerous: what constitutes too much lead is a fact question, and plaintiffs alleged that “[t]here is no level of exposure to lead that is known to be without harmful effects” and “[t]here is no known safe blood lead concentration.”

P&G argued that “[s]everal of the representations Plaintiffs challenge are structure/function claims that are authorized by the [Federal Food, Drug, and Cosmetics Act (the “FDCA”),]” which “expressly preempts Plaintiffs’ attempt to attack these structure/function claims as deceptive under state law.” The Second Circuit hasn’t weighed in on the relevant preemption provision, but the court here applied the rule that “there are two ways plaintiffs may escape preemption under that provision: (1) if their claims seek to impose requirements that are identical to those imposed by the FDCA; or (2) if the requirements plaintiffs seek to impose are not with respect to the sort described in [that part of the statute].”

Plaintiffs do not assert that Defendant failed to adhere to the labeling requirements posed by the FDCA, nor do they quarrel with the effectiveness of the Products or the primary ingredients that are in the Products. Instead, Plaintiffs claim that the representations Defendant made about the Products are false and misleading because the Products contain undisclosed amounts of lead….  Because “Plaintiffs’ argument is that the representations Defendant has made about its Products are false and misleading, ... Plaintiffs do not attempt to impose any additional requirements on Defendant other than those already imposed by the [FDCA].”  

The issue wasn’t whether the structure/function claims were false in the abstract, but whether these products were contaminated with lead.

Stating a claim under GBL §§ 349 and 350: Plaintiffs alleged that various statements on the Products’ packaging “suggest to reasonable consumers that the Products are generally healthy and safe for consumption[ ] and provide specific health benefits,” but these “statements and suggestions ... are false and misleading because the Products’ high lead content means the Products are, in fact, neither healthy nor safe for regular consumption.”

P&G argued that the challenged statements didn’t explicitly say the Products are healthy and safe for consumption and “courts have rejected efforts like Plaintiffs’ to ‘allege[ ] that a consumer will read a true statement on a package and will then ... assume things about the products other than what the statement actually says.’ ”

But the reasonable consumer test is usually a question of fact unless a plaintiff’s proposed reading is “patently implausible and unrealistic.” So the court proceeded to evaluate specific package statements.

“#1 Doctor Recommended Brand”: Bates v. Abbott Lab’ys, 727 F. Supp. 3d 194 (N.D.N.Y. 2024), aff’d, No. 24-CV-919, 2025 WL 65668 (2d Cir. Jan. 10, 2025) (summary order), rejected an argument “#1 Doctor Recommended Brand” was actionable under the GBL because the product—a nutrition drink—had added sugar. But “[a] consumer who agrees that any added sugar in a nutrition drink undermines its health benefits can obtain that information from the label,” which listed sugar as an ingredient, so “#1 Doctor Recommended Brand” was not misleading. But “the deception alleged here is different in kind than that alleged in Bates, both in terms of the scope of the omission (some disclosure about the sugar versus none about the lead) and the danger presented by the ingredient at issue (lead versus sugar). And, this difference is dispositive because the complete failure to mention the presence of a harmful substance such as lead makes any claim about the Products’ brand being doctor recommended plausibly misleading since it suggests that ‘the Products have been evaluated and approved by doctors as healthy and safe when taken as directed.’”

However, it was not plausible that claims that the packaging was tamper-evident misled reasonable consumers by “reassur[ing] [them] that a product is free from toxic adulterants like lead.” This wasn’t a case about tampering.

So too with the “Better Choices for Life” statement that appears as part of the American Diabetes Association seal on the packaging. When viewed in context of the logo in which it appears, no reasonable consumer could read “Better Choices for Life” as anything other than an endorsement by the American Diabetes Association.

“Helps Support: Appetite Control* ... [and] Digestive Health*”: Even though the challenged statement refers to “the specific effects of consuming fiber” and not the overall ingredients, deceptiveness was a fact question.

Omission: P&G argued that, because a March 2021 Consumer Lab report revealed that lead was found in various Metamucil products, plaintiffs couldn’t allege that its presence was “material information” that was exclusively within P&G’s control. Some courts interpreting NY law have gone so far as to require plaintiffs to plausibly allege they “could not ‘reasonably have obtained the [omitted] information[,]’ ” with “[o]ne example—though not the only example—of how to meet that standard is if the defendant ‘alone possesses [the omitted] information.’ ” Figuring out whether the information was discoverable by a reasonable consumer would require factual development.


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