Recent decisions from the First and Ninth Circuits may help defendants facing false advertising challenges to certain types of labeling statements known as “structure/function claims.”  Three courts have held that such challenges were preempted by the Food, Drug, and Cosmetic Act (FDCA).

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 U.S.C. § 343(r)(6)(A).  For example, the statement that “calcium helps build strong bones” is a typical structure/function claim.  Dietary supplement manufacturers may make structure/function claims without prior review from the FDA, so long as certain requirements are met. 

Two years ago, the Ninth Circuit held that the FDCA preempts challenges to valid structure/function claims about a nutrient based on a theory that the product as a whole is ineffective.  Greenberg v. Target Corp., 985 F.3d 650, 654 (9th Cir. 2021).  Federal law only requires the statement to be true as to the nutrient; state law cannot not impose a different standard by requiring the statement to be true as to the product in general.

The First Circuit recently joined the Ninth Circuit in Ferrari v. Vitamin Shoppe Industries LLC, No. 22-1332, 2023 WL 3911507 (1st Cir. June 9, 2023).  There, the court held that “the plain text of [the FDCA] requires a manufacturer to have substantiation that a nutrient’s claimed effect on the human body’s structure or function is truthful and not misleading, not that the product has the claimed effect.”  Id. at *5.  It thus affirmed summary judgment for The Vitamin Shoppe on claims that its glutamine supplements were ineffective when taken as directed.

The court in Amado v. The Procter & Gamble Company, No. 22-cv-05427-MMC, 2023 WL 3898984 (N.D. Cal. June 8, 2023), reached a similar result.  There, the plaintiffs alleged Metamucil’s labeling statements touting the benefits of dietary fiber were misleading because the product’s added sugar allegedly negated the fiber’s benefits.  The court found that the statements about the benefits of fiber qualified as structure/function claims, and it further held that challenges to those statements based on the product as a whole were preempted by the FDCA.  Notably, the court in Amado found the claims preempted on a motion to dismiss, suggesting that defendants may benefit from raising a preemption defense early in some circumstances. Covington represented P&G in the Amado matter.