The Ninth Circuit recently affirmed summary judgment in favor of a manufacturer of glucosamine dietary supplements, holding that plaintiffs’ state law claims sought to impose requirements different from those under the federal Food, Drug, and Cosmetic Act (FDCA) and were thus preempted.  Hollins v. Walmart Inc., 67 F.4th 1011 (9th Cir. 2023).

Plaintiffs’ case targeted Walmart’s “Spring Valley Glucosamine Sulfate” product, later relabeled “Spring Valley Glucosamine Sulfate Potassium Chloride,” alleging that the product was mislabeled under California law because it did not actually contain glucosamine sulfate or glucosamine sulfate potassium chloride.  Rather, plaintiffs alleged that the product was comprised only of glucosamine hydrochloride, which purportedly does not offer the same clinical benefits.  The Ninth Circuit, in a split decision, affirmed the district court’s conclusion that plaintiffs’ claims under California law were preempted.

First, the panel agreed that under Section 403(q) of the FDCA (21 U.S.C. § 343(q)) and related regulations, Walmart correctly listed the dietary ingredient as glucosamine sulfate potassium chloride in the Supplement Facts panel.  Under FDA’s regulations, a supplement containing dietary ingredients for which FDA has not established a Reference Daily Intake or Daily Reference Values, such as glucosamine sulfate potassium chloride, shall declare dietary ingredients in the Supplement Facts panel by “their common or usual name.”  The panel took the position that FDA’s regulations relating to determining compliance with the Supplement Facts requirements also extended to the naming of dietary ingredients, and thus found that a product’s “common or usual name” is determined by testing with an AOAC-approved method or other “reliable and appropriate analytical procedures.”  If there is no such AOAC-approved or other “appropriate” method, a manufacturer may use a “validated” method, which is typically known as a “compendial” test method.  The district court concluded that plaintiffs used test methods that were neither validated nor accepted by FDA, and observed that even plaintiffs’ expert conceded that the compound he found in the product would satisfy a compendial standard.  Furthermore, the panel cited the preamble to FDA’s proposed rule on dietary supplement labeling, which states that if a “dietary ingredient is covered by an official compendium, FDA would expect that the dietary ingredient’s common or usual name to be drawn from that source.”  The panel reasoned that because glucosamine hydrochloride satisfies the United States Pharmacopoeia (USP) compendial standard for glucosamine sulfate potassium chloride, Walmart was using the “common or usual name” of the dietary supplement.  In short, plaintiffs’ state law claims would preclude Walmart from labeling the product according to its “common or usual name” pursuant to FDA regulations.  In other words, because plaintiffs’ claims would impose a different labeling standard than federal law, those claims were preempted.

Second, plaintiffs also argued that even if glucosamine sulfate potassium chloride was the proper “common or usual name” for inclusion on the Supplement Facts panel, representing the product as “glucosamine sulfate” or “glucosamine sulfate potassium chloride” elsewhere on the label was still misleading, because such a label offered the product “for sale under the name of another food” in violation of Section 403(b) of the FDCA. The majority of the panel rejected this argument, reasoning that “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.’”  As such, this theory by plaintiffs also sought to impose under state law a labeling requirement different from federal law, and was preempted.  Judge Wardlaw dissented on this point, reasoning that the labeling requirements under Section 403(b) are distinct from those applicable to the Supplement Facts panel under Section 403(q).  As such, Judge Wardlaw would have found that the testing requirements required by Section 403(q) did not apply to plaintiffs’ claim based on Section 403(b), and that claim was accordingly not preempted.

The Ninth Circuit’s opinion confirms that supplement manufacturers should hew closely to the testing protocols required by FDA regulations; and that plaintiffs should face challenges asserting claims under state law that such products are mislabeled where their testing method deviates from those regulations.