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.

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Photo of Amy Heath Amy Heath

Amy Heath focuses on complex commercial litigation and class actions. She has handled matters involving contract, privacy, consumer protection, fraud, unfair competition, and intellectual property claims. She also has experience with internal investigations. Before practicing law, Amy served as an intelligence analyst.

Photo of Cort Lannin Cort Lannin

Cortlin Lannin is a litigator who defends clients in high-stakes complex matters, specializing in class action cases implicating consumer protection and competition claims. He approaches his matters with efficiency and creativity, developing thoughtful strategies to resolve cases and investigations early and on favorable…

Cortlin Lannin is a litigator who defends clients in high-stakes complex matters, specializing in class action cases implicating consumer protection and competition claims. He approaches his matters with efficiency and creativity, developing thoughtful strategies to resolve cases and investigations early and on favorable terms.

On behalf of a range of clients in the food, beverage, and consumer packaged goods industries, Cort has navigated pre-complaint disputes and defended multiple class actions implicating deceptive and false advertising practices under California’s UCL, FAL, and CLRA, and other states’ false advertising and unfair competition laws. Cort also has a depth of experience with competition matters, having represented clients in civil class action litigation, non-public governmental investigations of both the civil and criminal variety, and internal investigations. He has had a lead role in cases and investigations implicating the high tech industry, alleged “no-poach” agreements, and price-fixing and similar cartel conduct. He is also a leader in the antitrust bar and the recent chair of the Antitrust Section of the Bar Association of San Francisco.

Cort is a co-chair of Covington’s LGBT+ Affinity Group and is deeply involved in the firm’s efforts to recruit, mentor, and promote diverse attorneys, including LGBT+ attorneys.

Prior to joining Covington, Cort was a national political consultant who specialized in polling and focus group research. He leverages this research background in his litigation practice, particularly in defending consumer cases.