By Jeffrey H. Brochin, J.D.
Although the FDA has limited authority to regulate dietary supplements, it does require that supplement labeling be truthful and not misleading, and, if complied with, such labeling preempts state law claims that differ.
A federal appeals court in California has affirmed, on preemption grounds, the decision of the district court that dismissed a putative class action lawsuit brought by a consumer who purchased a bottle of the supplement Biotin and complained about its labeling. The state law claims were preempted by federal law due to the fact that the labeling complied with federal Food Drug and Cosmetic Act (FDC Act) requirements as to truthfulness and not being misleading, and because the state law under which the claims were brought imposed standards that were different from federal law (Greenberg v. Target Corporation, January 13, 2021, Lee, K.).
Claim of deceptive labeling. In hopes of battling his hair loss, a California consumer bought a bottle of Biotin at a Target store. The product label states that Biotin "helps support healthy hair and skin." The label also has an asterisk that points to a disclaimer stating: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." The label also stated that the amount of Biotin in the bottle far exceeded the recommended daily dosage.
The consumer thought that the Biotin product would stimulate hair growth, however, several weeks later after a friend informed him that the supplement does not provide any benefits, he filed suit alleging that the product labels are deceptive because most people do not benefit from Biotin supplementation. He brought claims under California law. The district court granted summary judgment in favor of Target, and the consumer appealed.
What the FDC Act requires. The appeals court noted that the FDA has limited authority under the FDC Act to regulate dietary supplements, and that unlike with drugs, the FDA does not pre-approve product labels for dietary supplements. It does however require that the labels be truthful and not misleading, and it authorizes several categories of statements that can be made on the product if certain requirements are met. For purposes of the instant case, the two relevant types of claims allowed under the FDC Act are disease claims and structure/function claims.
A disease claim refers to a statement about a product that claims to diagnose, mitigate, treat, cure, or prevent disease, either explicitly or implicitly. In contrast, a structure/function claim does not purport to treat a disease or even refer to the product itself; rather, it is a narrowly focused statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.
Three-part structure/function test. To make a structure/function claim, a manufacturer must meet three requirements: (1) The manufacturer must have substantiation that the statement is truthful and not misleading; (2) The statement must contain a prominent disclaimer that the FDA has not evaluated the statement and that the product "is not intended to diagnose, treat, cure, or prevent any disease;" and (3) The statement itself may not "claim to diagnose, mitigate, treat, cure, or prevent" disease.
Furthermore, in guidance published by the FDA, the agency has okayed structure/function claims that use general terms such as "strengthen," "improve," and "protect," so long as the claims do not suggest disease prevention or treatment. The guidance also references substantiation, and establishes that to substantiate a claim, supplement manufacturers need only show evidence of an effect on a small aspect of the related structure/function; they need not provide evidence of an effect on the disease linked to that structure/function.
National, uniform labeling standard. To avoid a patchwork of conflicting state labeling laws, the FDC Act includes a preemption provision that establishes a national and uniform standard for certain labeling statements. The statute preempts any state law that establishes any requirement respecting any claim of the type described in the relevant section of the Act that is made in the label that is not identical to the requirement of section 343(r) of the FDC Act. The FDC Act’s preemption provision covers structure/function claims.
Notably, the parties agreed that Biotin is a nutrient that supports healthy hair and skin, as the label claimed; however, the consumer’s expert concluded that most people obtain all the Biotin they need from their diets, and therefore, Biotin supplements are superfluous for all but a tiny percentage of people who have a Biotin deficiency.
All federal requirements met. The district court granted summary judgment to Target, ruling that the consumer’s state law claims were preempted by federal law that allows the challenged structure/function claim. The appeals court affirmed, finding that the plain language of the statute makes clear that a structure/function claim addresses only the nutrient’s role in the human body, not the product’s health impact on the general population. Accordingly, Target met all of the federal requirements for making a structure/function claim, including having substantiation showing that the Biotin nutrient can promote healthy hair and skin. Federal law therefore allowed Target to make the structure/function claim and preempted the consumer’s state law causes-of-action.
Based on the foregoing, the appeals court affirmed the district court’s grant of summary judgment to Target.
The case is No. 19-16699.
Attorneys: Elaine A. Ryan (Bonnett Fairbourn Friedman & Balint, PC) for Todd Greenberg. Matthew R. Orr (Call & Jensen, APC) for Target Corp., International Vitamin Corp. and Perrigo Co. of South Carolina, Inc.
Companies: Target Corp.; International Vitamin Corp.; Perrigo Co. of South Carolina, Inc.
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