On March 31, 2022, the U.S. District Court for the District of Massachusetts held that Plaintiffs’ claims— which alleged that the labels on three of Vitamin Shoppe, Inc.’s dietary supplements included false and misleading statements— were preempted by the Federal Food, Drug, and Cosmetic Act (the “Act”). The Court therefore granted summary judgment in favor of Vitamin Shoppe.

The challenged label statements were “structure/function” claims related to the benefits of glutamine, a major ingredient in all three products. Specifically, the labels of the three products stated that glutamine “has been shown to possess anti-catabolic properties to help preserve muscle,” “helps support muscle growth and recovery as well as immune health,” and that it “is involved in regulating protein synthesis.”

A structure/function claim “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” or “characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.” 21 USC 343 (r)(6); 21 CFR 101.93(f). A structure/function claim may not claim that a nutrient or dietary ingredient diagnoses, treats, cures, or prevents disease (e., a disease claim) and must be accompanied by a disclaimer that states that the claim has not been evaluated by FDA and that it is not a disease claim. Furthermore, the manufacturer must have evidence to substantiate that the claim is truthful and not misleading.

While Plaintiffs did not contest that glutamine has been shown to produce the claimed benefits, they did allege that the dose of glutamine in the products was insufficient to deliver the claimed benefits. The Court held that the Act requires that a structure/function claim be substantiated by evidence of the ingredient’s function in the body, and that it does not require evidence that the product produces the claimed benefits. Thus, Plaintiffs were preempted from claiming that the glutamine structure/function label claims were false and misleading.