67 F.4th 1011
9th Cir.2023Background
- Consumer class action by Hollins and others against Walmart and International Vitamin Corp. over a dietary supplement labeled “Glucosamine Sulfate” (or “Glucosamine Sulfate Potassium Chloride”).
- Plaintiffs’ expert tested bottles and concluded the product was a blend of glucosamine hydrochloride plus potassium sulfate, not a single-crystal glucosamine sulfate potassium chloride; plaintiffs alleged mislabeling and asserted California consumer-protection and warranty claims.
- FDA regulations require dietary-ingredient names to be the product’s “common or usual name,” determined by validated/compendial test methods (e.g., AOAC, USP, or other reliable validated procedures) and sampling rules (12-sample composite per 21 C.F.R. §101.9(g)).
- District court excluded or found unreliable the plaintiff expert’s methods under Daubert and §101.9(g)(2), and granted summary judgment holding plaintiffs’ state-law claims preempted because they would impose labeling requirements not identical to the FDCA/regulations.
- Ninth Circuit majority affirmed: federal testing/labeling scheme permits Walmart’s labeling and preempts plaintiffs’ contrary state-law rule; Judge Wardlaw partially dissented, arguing the federal testing/sampling requirements apply only to the nutrition panel and thus §343(b) label claims outside the panel are not preempted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Hollins’s state-law mislabeling claims are preempted by the FDCA (21 U.S.C. §343-1) | Hollins: state rule (blend cannot be labeled “glucosamine sulfate”) mirrors federal requirements and is therefore not preempted | Walmart: plaintiffs seek to impose a labeling requirement different from federal regs (which allow the common/usual name determined by federal testing) | Held: Preempted — plaintiffs’ proposed state rule would impose different labeling requirements and is barred by §343-1(a)(3),(4) |
| Whether a blended formulation may be labeled using the federally determined “common or usual name” | Hollins: a blend of glucosamine hydrochloride + potassium sulfate is a different substance and cannot be sold as glucosamine sulfate/KCl | Walmart: federal regs permit labeling by the common/usual name as determined under federal testing; compendial standards (e.g., EP/USP) can cover blends | Held: Using the federally determined common/usual name is permissible; state rule forbidding it is preempted |
| Whether the FDA’s testing/sampling protocols (21 C.F.R. §101.9(g)) apply only to the nutrition panel (so label claims outside panel escape preemption) | Hollins/Wardlaw: §101.9(g) sampling/testing governs the nutrition panel only; challenges to §343(b) labeling outside the panel need not meet those federal testing protocols and therefore are not preempted | Walmart/Majority: federal testing determines the common/usual name of an ingredient used on the label generally; Durnford supports that federal testing/authorization preempts state rules about how ingredients are named | Held: Majority rejected the nutrition-panel-only distinction and held the federal testing/labeling regime preempts plaintiffs’ state rule; Wardlaw dissented on this point |
| Reliability of plaintiff’s expert methodology (Daubert / validation under §101.9(g)(2)) | Hollins: expert FTIR/XRD/EDX testing showed a blend and supported mislabeling claims | Walmart: expert methods were not validated, not compendial, not peer-reviewed; thus unreliable for establishing a label violation under federal regulations | Held: District court found the methods unreliable and inappropriate under §101.9(g)(2) and Daubert, supporting summary judgment in favor of Walmart |
Key Cases Cited
- Durnford v. MusclePharm Corp., 907 F.3d 595 (9th Cir. 2018) (federal regulations authorizing a manufacturer’s testing method preempt state-law claims to the extent they challenge the regulated measurement method)
- Hawkins v. Kroger Co., 906 F.3d 763 (9th Cir. 2018) (distinguished nutrition-panel rules from other label claims; involved nutrient-content rounding and conflicting regulations)
- Kroessler v. CVS Health Corp., 977 F.3d 803 (9th Cir. 2020) (private plaintiffs may enforce only state laws identical to FDCA requirements)
- Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019) (state requirements that differ from FDCA/regulations are preempted)
- Wyeth v. Levine, 555 U.S. 555 (2009) (discusses presumption against preemption principles in the regulatory/labeling context)
- Puerto Rico v. Franklin Cal. Tax-Free Trust, 579 U.S. 115 (2016) (express preemption clauses curtail the presumption against preemption)
- FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) (agency authority and statutory interpretation in regulatory context)
- Altria Group, Inc. v. Good, 555 U.S. 70 (2008) (ambiguous preemption clauses are ordinarily construed to disfavor preemption)