DARLENE HOLLINS, ET AL V. WALMART INC., ET AL, No. 21-56031 (9th Cir. 2023)
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The Federal Food, Drug, and Cosmetic Act (“FDCA”) prohibits the misbranding of any food. A food is deemed to be misbranded if it meets any of the definitions in 21 U.S.C. Section 343. To implement this subsection, the Food and Drug Administration (“FDA”) promulgated regulations governing the nutrition labeling of dietary supplements. Plaintiff alleged that she and other consumers were damaged because “they paid for a product that they would not have purchased had it truthfully disclosed that it did not contain Glucosamine Sulfate.” The second amended complaint claimed violations of the California Consumers Legal Remedies Act, the California Unfair Competition Law, the California False Advertising Law, unjust enrichment, restitution, and breach of warranty. The district court concluded that Walmart had carried its burden of showing Plaintiff’s state-law claims were preempted by federal law.
The Ninth Circuit affirmed the district court’s order granting summary judgment for Walmart Inc. The panel held that Defendant’s proposed rule to the contrary was preempted. The holding in Durnford v. MusclePharm Corp., 907 F.3d 595 (9th Cir. 2018), did not provide otherwise. Nothing in Durnford suggested its analysis applied only to the nutrition panel. The panel concluded that Defendant’s claims were preempted, and Walmart was entitled to judgment as a matter of law.
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Court Description: Federal Food, Drug, and Cosmetic Act. The panel affirmed the district court’s order granting summary judgment for Walmart Inc. in a consumer class action alleging that Walmart’s product, Spring Valley Glucosamine Sulfate, contained glucosamine hydrochloride, not glucosamine sulfate or glucosamine sulfate potassium chloride, and that the plaintiffs were allegedly damaged by the misleading labeling.
The Federal Food, Drug, and Cosmetic Act (“FDCA”) prohibits the misbranding of any food. A food is deemed to be misbranded if it meets any of the definitions in 21 U.S.C. * The Honorable Danny J. Boggs, United States Circuit Judge for the U.S. Court of Appeals for the Sixth Circuit, sitting by designation. § 343. Section 343(q) includes a subsection specific to dietary supplements. To implement this subsection, the Food and Drug Administration (“FDA”) promulgated regulations governing the nutrition labeling of dietary supplements. See 21 C.F.R. § 101.36. Dietary ingredients such as glucosamine sulfate potassium chloride, for which the FDA has not established a Reference Daily Intake or Daily Reference Values, are governed by § 101.36(b)(3), which provides that such dietary ingredients “shall be declared by their common or usual name.” Compliance with this requirement is determined in accordance with specified testing protocols. The FDCA preempts specified state requirements relating to food labeling.
The named plaintiff, Darlene Hollins, alleged that she and other consumers were damaged because “they paid for a product that they would not have purchased had it truthfully disclosed that it did not contain Glucosamine Sulfate.” The second amended complaint claimed violations of the California Consumers Legal Remedies Act, the California Unfair Competition Law, the California False Advertising Law, unjust enrichment, restitution, and breach of warranty. The district court held that the methods used by Hollins’ expert witness, Dr. Neil Spingarn, raised Daubert concerns and were not reliable and appropriate under 21 C.F.R. § 101.9(g)(2) for determining whether Walmart’s product was mislabeled. The district court concluded that Walmart had carried its burden of showing that Hollins’s state-law claims were preempted by federal law.
Hollins contended that her state-law mislabeling claim, which would require the state to impose the rule that a blend of glucosamine hydrochloride and potassium sulfate cannot be labeled glucosamine sulfate or glucosamine sulfate potassium chloride, is not preempted because such a rule is identical to the federal rule. The panel held that Hollins’s claim that Walmart’s product was mislabeled due to being a blend would allow a state to impose a different labeling requirement of Walmart’s product than is imposed § 343(q), and is therefore preempted.
Hollins argued that her claim would not allow a state to impose a labeling requirement on Walmart’s product different from that imposed by § 343(b). She argued that a label can violate § 343(b) even if the label uses the product’s “common or usual name,” as determined by federal testing requirements under § 343(q), because such testing requirements apply only to the information provided in the nutrition panel. The panel disagreed. Section 343(s)(2)(B) permits Walmart to label its dietary supplement with the name of its active ingredient, and the “common and usual” name of that ingredient may be determined pursuant to federal testing requirements. The panel held that Hollins’s proposed rule to the contrary was preempted. The holding in Durnford v. MusclePharm Corp., 907 F.3d 595 (9th Cir.
2018), did not provide otherwise. Nothing in Durnford suggested its analysis applied only to the nutrition panel. This case is governed by Durnford’s holding that the manufacturer’s method for determining the amount of protein in the supplement was authorized by regulation and therefore preempted Hollins’s proposed state-law rule. In addition, the panel rejected the dissent’s reliance on Hawkins v. Kroger Co., 906 F.3d 763 (9th Cir. 2018), and held that Hawkins was inapposite here.
The panel concluded that Hollins’s claims were preempted, and Walmart was entitled to judgment as a matter of law.
Judge Wardlaw dissented in part. In her view, Hollins was not required to comply with the FDA’s testing requirements with respect to her claims outside of the nutrition facts panel. Challenges to the label under 21 U.S.C. § 343(q) are distinct from those to the nutrition facts panel under 21 U.S.C, § 343(q), such that the 21 C.F.R. § 101.9(g) federal testing requirements do not apply to the label outside of the nutrition panel, and, therefore, these state law claims are not preempted by federal law, and can proceed. She wrote that the majority opinion misapplied Durnford, and ran counter to the presumption against preemption.
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