This case dealt with the Food, Drug, and Cosmetic Act’s statutory and regulatory scheme for dietary supplements, such as vitamin and amino acids products. In general, the U.S. Food and Drug Administration does not pre-approve labels for dietary supplements. But it does require that statements on the labels be truthful and not misleading. 21 U.S.C. § 343(r)(6)(B). To that end, the FDA authorizes several types of statements that may be made on labels. One type was relevant here: “structure/function” claims, which are those that “describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.” 21 C.F.R. § 101.93(f).
This statutory scheme also includes a preemption provision that establishes a uniform, national standard for label statements. This provision preempts any state law that establishes any requirement for structure/function claims that is different from what the FDCA itself requires.
In this case, the plaintiff purchased a biotin product whose label stated that biotin “helps support healthy hair and skin.” The plaintiff thought the product would stimulate hair growth, but he found out that it likely would not. So he brought a class action under state consumer protection statutes, alleging that the product label was deceptive because most people do not benefit from biotin supplementation.
Parsing the text of the statute’s requirements for structure/function claims, the panel explained that the plain language clarifies that such claims need only address the general role of the ingredient in the human body, not its health impact on the general population. So the label was not misleading, because the defendant provided evidence that biotin does generally operate in the body to support healthy hair growth. The plaintiff’s claim sought to impose an extra-textual requirement—that structure/function claims can only be made if consumers are likely to benefit from the product. Therefore, his claim was preempted.