DARLENE HOLLINS; CHRISTIAN LEMUS; ALAIN MICHAEL; MARIE ANGELINE FALCONE, Individually and on Behalf of All Others Similarly Situated v. WALMART INC.; INTERNATIONAL VITAMIN CORPORATION
No. 21-56031
UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT
May 11, 2023
D.C. No. 2:19-cv-05526-SVW-GJS
FOR PUBLICATION
Plaintiffs-Appellants,
and
ANGELA DIAMOS,
Plaintiff,
v.
Defendants-Appellees.
OPINION
Appeal from the United States District Court for the Central District of California Stephen V. Wilson, District Judge, Presiding
Argued and Submitted November 22, 2022 Pasadena, California
Filed May 11, 2023
Before: Danny J. Boggs,* Kim McLane Wardlaw, and Sandra S. Ikuta, Circuit Judges.
Opinion by Judge Ikuta; Partial Dissent by Judge Wardlaw
SUMMARY**
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
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
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
Hollins argued that her claim would not allow a state to impose a labeling requirement on Walmart‘s product different from that imposed by
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
COUNSEL
Matthew Insley-Pruitt (argued), Carl L. Stine, and Philip M. Black, Wolf Popper LLP, New York, New York; Jonathan M. Rotter and Danielle L. Manning, Glancy Prongay & Murray LLP, Los Angeles, California; for Plaintiffs-Appellants.
Jean-Claude Andre (argued) and Jennifer A. Jackson, Bryan Cave Leighton Paisner LLP, Santa Monica, California; A. Elizabeth Blackwell, Darci F. Madden, Stefani L. Wittenauer, and Steven J. Alagna, Bryan Cave Leighton Paisner LLP, St. Louis, Missouri; Simren K. Gill, Law Offices of Simren K. Gill, Fresno, California; Jon Pfeiffer I, Pfeiffer FitzGibbon & Ziontz LLP, Santa Monica, California; for Defendants-Appellees.
IKUTA, Circuit Judge:
Darlene Hollins and three other consumers brought a class-action lawsuit against Walmart Inc. and International Vitamin Corporation under California law.1 In her complaint, Hollins alleged that Walmart‘s product, “Spring Valley Glucosamine Sulfate,” manufactured by International Vitamin Corporation, contained glucosamine hydrochloride, not glucosamine sulfate or glucosamine sulfate potassium chloride, and claimed she was damaged by the misleading labeling. We hold that Hollins‘s claims are preempted because they seek to impose state labeling requirements that are not identical to the requirements of
I
We begin by providing the legal background. The Federal Food, Drug, and Cosmetic Act (FDCA),
A
The FDCA prohibits the “misbranding of any food.”
The parties focus on two of these definitions. First, a food is misbranded “[i]f it is offered for sale under the name of another food.”
Second, a food is misbranded if its label does not bear nutrition information that meets the requirements set forth in
Section 343(q) includes a subsection specific to dietary supplements. See
To implement this subsection, the FDA has promulgated regulations governing the nutrition labeling of dietary supplements. See
Compliance with [§ 101.36] will be determined in accordance with
§ 101.9(g)(1) through (g)(8), (g)(10), and (g)(11), except that the sample for analysis shall consist of a composite of 12 subsamples (consumer packages) or 10 percent of the number of packages in the same inspection lot, whichever is smaller, randomly selected to be representative of the lot.
Under
If there is no AOAC official method available or appropriate for a particular dietary supplement, the manufacturer may use an alternative methodology. FDA, Guidance for Industry: Nutrition Labeling Manual - A Guide for Developing and Using Data Bases (1998), 1998 WL 34327548, at *15. An alternate method used “to support a nutrient declaration value” must have “appropriate validation” unless the method was previously validated by collaborative studies. 58 Fed. Reg. 2079, 2109 (Jan. 6, 1993). According to the FDA, validation means “demonstrating performance characteristics such as accuracy, precision, sensitivity, selectivity, limit of detection, limit of quantitation, linearity, range, and ruggedness, to ensure that results are meaningful.” FDA, Guidelines for the Validation of Chemical Methods in Food, Feed, Cosmetics, and Veterinary Products (3rd ed. 2019), at 4. Certified reference materials, which are reference samples issued by an authoritative body to provide one or more specified property values, are a tool used to validate the accuracy of a test method.
Methods that are validated are often referred to as “compendial” test methods. As defined in the FDCA, an “official compendium” includes “the official United States Pharmacopoeia [(USP)].”
In sum, a dietary supplement such as glucosamine sulfate potassium chloride is deemed misbranded if it is sold under the name of a different food or dietary supplement,
B
The FDCA preempts specified state requirements relating to food labeling. Two such preemption provisions are relevant here. First, “no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce . . . any requirement for the labeling of food of the type required by
Second, “no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement for nutrition labeling of food that is not identical to the requirement of
A state law is “not identical to the requirement of” a specified section if “the State requirement directly or indirectly imposes obligations or contains provisions concerning the composition or labeling of food [that] . . . [a]re not imposed by or contained in the [FDCA or applicable federal regulation] . . . or [d]iffer from those specifically imposed by or contained in the applicable provision” of the FDCA or applicable federal regulation.
II
We now turn to the facts of this case. In her second amended complaint, Hollins asserted that Walmart‘s product labeled “Spring Valley Glucosamine Sulfate” contained glucosamine hydrochloride, not glucosamine sulfate or glucosamine sulfate potassium chloride. Hollins asserted that glucosamine sulfate potassium chloride is comprised of glucosamine, sulfate, potassium, and chloride bonded to form a single crystal, but Walmart‘s glucosamine sulfate instead consists of a blend of glucosamine hydrochloride and potassium sulfate. Hollins based this conclusion on tests of 13 bottles of Walmart‘s product, using a test method called Fourier-transform infrared
According to the second amended complaint, although glucosamine is sold in two commercial formulations, glucosamine sulfate and glucosamine hydrochloride, only glucosamine sulfate has demonstrated clinical effectiveness for certain conditions, so consumers are willing to pay more for this formulation. Therefore, Hollins claimed 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.” Based on these allegations, 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.
In October 2020, Walmart moved for summary judgment on the ground that Hollins‘s claims were based on a testing protocol that was different than the protocol required by federal law, and her claims were therefore preempted. Specifically, Walmart claimed that Hollins‘s testing methodology deviated from federal requirements under
The district court denied the motion, because Walmart had not established that AOAC Method 2005.01 was the appropriate method for determining whether Walmart‘s product was glucosamine sulfate potassium chloride or glucosamine hydrochloride. The AOAC Method 2005.01 is “[a]pplicable to the analysis of glucosamine in raw materials and dietary supplements containing glucosamine sulfate and/or glucosamine hydrochloride.” However, the district court deemed it unclear whether the method was appropriate for distinguishing between glucosamine sulfate (or glucosamine sulfate potassium chloride) and glucosamine hydrochloride. Nor had Walmart met its burden of showing that Hollins‘s test methodology was not “reliable and appropriate.” Instead, the court granted Hollins‘s discovery request to obtain 12 samples from a single lot in order to conduct testing in compliance with federal law, see
After Hollins obtained the 12 samples from the same lot and conducted testing, the district court held an evidentiary hearing. At the hearing, Hollins‘s expert witness, Dr. Neil Spingarn, testified that he tested 12 unopened bottles from the same lot using FTIR, X-Ray Diffraction (XRD), and Energy Dispersive X-Ray Spectroscopy (EDX). According to Spingarn, the tests showed that Walmart‘s product contained a blend of glucosamine hydrochloride and potassium sulfate, rather than a single crystal of glucosamine sulfate potassium chloride.
With respect to Spingarn‘s three test methods (FTIR, XRD, and EDX), Spingarn conceded that he had not published his methods, submitted them for peer review, or documented them in a standard operating procedure. He agreed that his methods were neither validated nor accepted by the FDA to validate label claims for either glucosamine sulfate or glucosamine hydrochloride dietary supplements, and were not considered compendial methods. Finally, Spingarn conceded that he had not found (nor was he aware of anyone finding) any product or material that met his criteria of being a single crystal of glucosamine sulfate potassium chloride rather than a blend.
After the evidentiary hearing, the district court granted Walmart‘s summary judgment motion. The court concluded that Spingarn‘s methods raised Daubert concerns and were not “reliable and appropriate” under
III
We review de novo a district court‘s grant of summary judgment, Martinez v. City of Clovis, 943 F.3d 1260, 1269 (9th Cir. 2019), and “questions of preemption.” Silvas v. E*Trade Mortg. Corp., 514 F.3d 1001, 1004 (9th Cir. 2008) (citation omitted); see also Kroessler, 977 F.3d at 807.
On appeal, Hollins argues that the district court erred in holding that Walmart carried its burden of proving, as a matter of law, that Hollins‘s claims are preempted. Hollins contends 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. “FDCA preemption, like all federal preemption, is an affirmative defense,” Durnford, 907 F.3d at 603 n.8 (citation omitted), as to which the defendant bears the burden of proof. To prevail on summary judgment, Walmart has to show that, as a matter of law, Hollins‘s proposed state rule would impose labeling requirements different than those imposed by
We begin with Hollins‘s contention that her claim would not impose a different labeling requirement on Walmart‘s product than is imposed by
the EP reference standard was itself mislabeled, this allegation is irrelevant for purposes of determining what federal law requires. In short, Hollins‘s claim that Walmart‘s product was mislabeled due to being a blend would allow a state to impose a different labeling requirement on Walmart‘s product than is imposed by
We next turn to Hollins‘s argument that her claim would not allow a state to impose a labeling requirement on Walmart‘s product different from that imposed by
We disagree. As explained above, Spingarn‘s testing and concessions indicated that under federal law, glucosamine sulfate or glucosamine sulfate potassium chloride are common or usual names for the blended formulation of glucosamine sulfate. Logically, using the “common or usual” name of a product to identify the product on the label does not constitute offering that product for sale “under the name of another food,” in violation of
Durnford does not hold otherwise. Contrary to Hollins‘s and the dissent‘s argument, Durnford‘s conclusion did not rest on any distinction between federal requirements for information in the nutrition panel or information elsewhere on the label. In Durnford, a consumer brought state-law claims against a manufacturer of a nutritional supplement for false or misleading statements about protein contained in one of its products. 907 F.3d at 597. The consumer claimed that the protein in the supplement was augmented by nitrogen-spiking agents, and argued that two types of claims on the label were misleading: (1) the claim that the product contained 40 grams of protein per serving, and (2) the claim that the protein was from “hydrolyzed beef protein and lactoferrin.” Id. at 598-99. These claims appeared on the nutrition panel as well as in a description of the product‘s “5-stage mass delivery system” elsewhere on the label. Id. at 598. On appeal, we held that the district court correctly dismissed the first claim based on the amount of protein. Id. at 601-03. We reasoned that federal regulations, see
We reversed the district court‘s dismissal of the consumer‘s second claim, that the product‘s label misled him into believing that the protein came entirely from hydrolyzed beef protein and lactoferrin, rather than partly from nitrogen-spiking agents. Id. at 603-04. Because the consumer‘s argument did not go “to the amount of protein, but to its composition,” there were no federal testing requirements on point, and so the claim was not preempted. Id. at 603.
Nothing in Durnford suggests its analysis applied only to the nutrition panel, and indeed, the same information
about the quantity and source of protein was available both in the panel and elsewhere on the label. Id. at 598.9 Therefore, our case is
In arguing against the conclusion that FDA regulations preempt Hollins’s state-law mislabeling claims, the dissent raises a new argument not made by either party. According to the dissent, Hawkins v. Kroger Co., 906 F.3d 763 (9th Cir. 2018) supports the argument that regulatory requirements applicable to the nutrition panel are not applicable to information elsewhere on the label. Dissent at 28. But Hawkins is inapposite here. Hawkins involved two inconsistent FDA regulations governing a label’s claims about the amount of trans fat in a product. One regulation mandated that the nutrition panel follow certain “rounding rules” with respect to nutrient levels, id. at 772, including the rule that “[i]f the serving contains less than 0.5 gram [of trans fat], the content shall be expressed as zero,” id. at 770 (quoting
Hawkins is inapposite here. This case does not involve a nutrient content claim, conflicting regulations, or any regulation requiring a manufacturer to make a misleading claim. Rather, the regulations here detail an appropriate testing method to determine the “common or usual name” of an ingredient for purposes of the nutrition panel,
Applying the summary judgment standard, there is “no genuine dispute as to any material fact” that Hollins’s mislabeling claims would “permit a state to impose requirements” for labeling a dietary supplement such as Walmart’s glucosamine sulfate potassium chloride product “different from those permitted under the FDCA.” Durnford, 907 F.3d at 603. Therefore, the claims are preempted, see
AFFIRMED.
WARDLAW, J., dissenting in part:
I write separately to clarify the applicability of the Federal Drug Administration’s (FDA’s) testing and sampling requirements to Hollins’s state-law mislabeling claims. In my view, Hollins is 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
I.
According to the National Institute of Health’s website, glucosamine sulfate potassium chloride (what Hollins believed she was purchasing) and glucosamine hydrochloride with potassium sulfate (what Hollins actually purchased) are chemically and molecularly different. See Appendix A. “[N]ot all glucosamines are the same . . . [G]lucosamine sulfate has demonstrated clinical effectiveness for certain [health] conditions, whereas other forms of glucosamine have not. The common perception of glucosamine sulfate is that it performs better than glucosamine hydrochloride; consumers therefore prefer the former, and companies charge more for it.” Rigo Amavizca v. Nutra Mfg., LLC, No. 20-01324, 2021 WL 682113, at *1 (C.D. Cal. Jan. 27, 2021).1 While Hollins is unable to
II.
A.
The majority opinion misapplies Durnford v. MusclePharm Corp., 907 F.3d 595, 604 (9th Cir. 2018). The majority interprets our decision in Durnford narrowly, finding that it stands only for the proposition that challenges to a label’s characterization of the source of an ingredient are exempt from the Food, Drug, and Cosmetic Act (FDCA). Maj. Op. 21. In fact, Durnford’s reasoning supports Hollins’s position—at least in part—that some of her claims are not preempted by federal law.
In Durnford, a consumer brought claims against MusclePharm Corporation, a manufacturer of nutritional supplements, “for making false or misleading statements about the protein in one of its products.” Id. at 597. We concluded that some, but not all, of Durnford’s state-law misbranding claims were preempted by federal law. Id.
We made two distinctions between claims which were preempted and those which were not. First, we noted that the “FDCA and its implementing regulations concern only the calculation and disclosure of protein amounts.” Id. But “[t]hey say nothing about the source or composition of protein,” and “Durnford’s claims are therefore not preempted to the extent they arise under that theory.” Id.
But we made a second distinction which the majority ignores. We explained that Durnford’s mislabeling theory which referred to misrepresentations on the nutrition panel was preempted, but that his theory which referred to misrepresentation on the rest of the label was not. See id. at 602-604. Specifically, we held that “[u]nder Durnford’s theory of misbranding [related to the label outside of the nutrition panel], whether or not there was compliance with the FDA’s 12-sample testing protocol [did] not matter.” Id. at 603.
The second distinction is pertinent here. As the Durnford Court aptly explained in a footnote:
We refer to the product’s packaging as a whole as the “label.” We refer to the federally mandated declaration of nutritional content within the label as the “nutrition panel” . . . [T]he latter is subject to a unique set of stringent federal regulations.
Id. at 598 n.1 (emphasis added).
The majority focuses on only one of Durnford’s distinctions—the amount versus the content of the protein in the supplement. But Durnford’s second distinction—between “[t]he label — separately from the mandatory nutrition panel” — is controlling here such that the testing requirements under
Further, even assuming there is no distinction between glucosamine sulfate potassium chloride and glucosamine hydrochloride with potassium sulfate, Hollins has an additional mislabeling claim because when the suit was filed the supplement’s front label stated the product’s name as “glucosamine sulfate,” but the nutrition panel listed the product as “glucosamine sulfate potassium chloride,” a different supplement.
B.
We also recognized the distinction between claims on the nutrition panel and those “made elsewhere on the [label]” in Hawkins v. Kroger Co., 906 F.3d 763, 770 (9th Cir. 2018). In Hawkins, we were tasked with determining “whether [ ] FDA trans fat regulations governing the content of the Nutrition Facts Panel preempt” state mislabeling claims “elsewhere on a food product’s label.” Id. at 767. We held that the “rules[ ] contained in
To be sure, the nutrition panel versus packaging label distinction in Hawkins focused on nutrient content claims, which are not at issue here. But our holding that “the FDA regulations did not preempt a plaintiff’s state-law claim that a statement on a product’s label (and not within the nutrition panel) . . . was misleading,” Maj. Op. 22, highlights the distinction between the nutrition panel and the rest of the product’s label and further lends support to the conclusion that only Hollins’s
C.
The majority opinion is also inconsistent with a related district court case, Amavizca. Amavizca dealt with nearly identical facts to the case before us. There, plaintiffs brought state law mislabeling claims against a supplement manufacturer arguing that the supplement they purchased was labeled as glucosamine sulfate, when in fact the substance was actually glucosamine hydrochloride and sodium sulfate. 2021 WL 682113 at *2. The Amavizca defendants argued, as Walmart does here, that the plaintiff consumers’ claims were preempted. Id. at *4.
Although not binding on us, Amavizca’s analysis is persuasive. Relying on the FDA preemption framework we laid out in Durnford, the Amavizca court concluded that the consumer plaintiffs were not required to comply with the federal testing requirements for their label-related claims, but were required to comply if they sought to prove their nutrition panel-related claims. Id. at *5. The Amavizca court explained:
Plaintiff’s allegations thus implicate different provisions of the FDCA and FDA regulations. Plaintiff’s allegation that the “Supplement Facts” panels on Defendants’ products contain misrepresentations implicates 21 U.S.C. § 343(q) and21 C.F.R. § 101.36 , which govern the nutrition labeling of dietary supplements. Plaintiff’s allegation that Defendants’ Products have the words “Glucosamine Sulfate” displayed prominently on the label, however, implicates21 U.S.C. § 343(b) , under which a food is deemed misbranded “[i]f it is offered for sale under the name of another food.”21 U.S.C. § 343(b) .
Further, the Amavizca court emphasizes that the requirements of
The district court in Amavizca properly relied on our decision in Durnford in holding that the distinction between the overall label and the nutrition panel applies not only to nutrient content claims, but also to other mislabeling claims. By contrast, the majority opinion disregards our circuit precedent by failing to follow the distinction required by Durnford and applied in Amavizca.
III.
Finally, the majority opinion runs counter to the presumption against preemption. Hawkins, 906 F.3d at 769 (“[I]n all pre-emption cases, and particularly in those in which Congress has ‘legislated . . . in a field which the States have traditionally occupied,’ . . . we ‘start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’“) (alterations in original) (quoting Wyeth v. Levine, 555 U.S. 555, 565 (2009)).
Even assuming the majority is correct that this is an express preemption case, only when “the statute’s language is plain,” should the language of the preemption clause itself end our inquiry. Puerto Rico v. Franklin Cal. Tax-Free Tr., 579 U.S. 115, 125 (2016) (quoting United States v. Ron Pair Enter., Inc., 489 U.S. 235, 241 (1989)). Here, contrary to the majority’s assertion, the applicable FDCA preemption provision is unclear.
The FDCA limits preemption to “any requirement for nutrition labeling of food that is not identical to the requirements of section 343(q).”
IV.
In sum, I respectfully disagree with the majority’s holding to the extent it finds that the federal testing and sampling requirements apply to Hollins’s state-law mislabeling claims targeting the label outside of the nutrition panel. Accordingly, I would hold that such claims are not preempted by the FDCA and allow them to proceed.
APPENDIX A
Depictions of the different molecular structures of the molecules:
Glucosamine Sulfate Potassium Chloride
Glucosamine Hydrochloride with Potassium Sulfate
See PubChem Compound Summary for CID 76965765, Glucosamine Sulfate Potassium Chloride, Nat’l Ctr. for Biotechnology Info., https://pubchem.ncbi.nlm.nih.gov/compound/Glucosamine-sulfate-potassium-chloride (last visited Feb. 7, 2023); PubChem Compound Summary for CID 2723635, Glucosamine hydrochloride, Nat’l Ctr. for Biotechnology Info., https://pubchem.ncbi.nlm.nih.gov/compound/Glucosamine-hydrochloride (last visited Feb. 7, 2023); PubChem Compound Summary for CID 24507, Potassium Sulfate, Nat’l Ctr. for Biotechnology Info., https://pubchem.ncbi.nlm.nih.gov/compound/Potassium-Sulfate