By Katie Bond, a Partner with Lathrop GPM LLP in its Washington, DC office, and Megan Olsen, Vice President and Associate General Counsel of the Council for Responsible Nutrition (CRN). CRN, the leading trade association representing dietary supplement and functional food manufacturers and ingredient suppliers, filed an amicus brief supporting Target Corp. before the Ninth Circuit in Greenberg.
The Ninth Circuit affirmed a grant of summary judgment in favor of Target Corp. and other defendants in a putative class action involving a Target Up&Up brand biotin dietary supplement. Greenberg v. Target Corp., No. 19-16699, 2021 WL 116537 (9th Cir. Jan. 13, 2021). The court reviewed whether the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempts state-law false advertising allegations leveled against the label claim “helps support healthy hair and skin.” Critical to the court’s holding was that the claim was truthful and non-misleading under the FDCA standards for “structure/function claims.” Importantly, this decision stands to cut off a line of attack by plaintiff’s firms that have sought to upend and add to the unique federal standards applicable to structure/function claims.
Before addressing the details of the case, a brief regulatory background is warranted. Under the 1990 Nutrition Labeling and Education Act (“NLEA”), Congress created new mandates and voluntary means for food and dietary supplement marketers to provide consumers nutrition information. See Pub. Law 101-535. The NLEA and its implementing regulations, for instance, first mandated that product labels disclose certain nutrition information such as the “Daily Value” needed for certain nutrients to maintain good health. Several years later, the Dietary Supplement Health and Education Act of 1994 (“DSHEA”) built on the NLEA, further expanding the scope of nutrition information companies could provide to consumers. See Pub. Law 103-417. Perhaps most notably, DSHEA amended the FDCA to allow for the sale of dietary supplements as a specific legal category and structure/function claims to be made for these products.
The plaintiff in this case, Greenberg, purchased the Up&Up biotin supplement in hopes of preventing hair loss, and he subsequently brought false advertising claims under the California Unfair Competition Law and Consumers Legal Remedies Act, Cal. Civ. Code §§ 1750, et. seq. Greenberg contended that the label claim “helps support healthy hair and skin” was misleading because only a “tiny percentage of people” would receive a benefit from taking the biotin supplement. Although Greenberg did not dispute that biotin is a nutrient that has beneficial effects on hair and skin, Greenberg’s expert opined that biotin supplements were unnecessary for all but a minute portion of the population who does not obtain enough biotin from the diet.
Because claims like “helps support healthy hair and skin” are considered structure/function claims under the FDCA, the court had to determine whether the FDCA preempted Greenberg’s allegations. The FDCA includes a preemption provision intended to establish uniform, national standards for a variety of claims for “food,” of which “dietary supplements” are a subset. Specifically, the FDCA preempts “any requirement” for claims, including structure/function claims, if the requirement “is not identical to” the relevant federal requirements. 21 U.S.C. § 343-1(a)(5). Thus, in short, if Greenberg’s allegations would change or add to the federal structure/function claim standards, his allegations would be preempted.
The Ninth Circuit began its analysis with a discussion of the FDCA definitions of a “structure/function claim” versus a “disease claim.” A structure/function claim is a 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 mechanisms by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims.” 21 C.F.R. § 101.93(f). In contrast, a disease claim is “a statement about a product [that] claims to diagnose, mitigate, treat, cure, or prevent disease.” 21 C.F.R. § 101.93(g)(2).
The FDCA broadly prohibits disease claims for foods and dietary supplements, with narrow exceptions for certain claims that require FDA pre-authorization. On the other hand, companies may use a structure/function claim for dietary supplements without agency pre-authorization as long as the following three requirements are met: (1) the company possesses substantiation that the statement is truthful and not misleading; (2) the statement is accompanied by a disclaimer that the product “is not intended to diagnose, treat, cure, or prevent any disease”; and (3) the statement avoids “claim[ing] to diagnose, mitigate, treat, cure, or prevent” disease. 21 U.S.C. § 343(r)(6)(B)-(C).
Because the biotin label in question included the required disclaimer and the claim at issue avoided any mention of disease, the court’s analysis turned on whether Target Corp. and the other defendants had provided substantiation that the label claim was truthful and not misleading. The court easily held that defendants had sufficient substantiation where the plaintiff “does not dispute that scientific evidence exists showing that biotin—the nutrient—supports healthy hair and skin.”
The court flatly rejected Greenberg’s argument that the claim at issue was deceptive where most people obtain enough biotin from the diet for healthy hair and skin. The court reasoned that the “plain language of the FDCA and its implementing regulations clarifies that a structure/function claim addresses only the general role of an ingredient/nutrient in the human body,” not “the product’s impact on the general population.” Drawing on the regulatory definitions of a structure/function claim (i.e., a claim about “the role of a nutrient or dietary ingredient”) versus a disease claim (i.e., a claim “about a product”), the court held that the plaintiff “cannot implicitly import a disease claim requirement—evidence showing the product’s impact on the consumer’s health or disease—into the structure/function claim [requirements].” Thus, the FDCA preempted the plaintiff’s state-law action, which would impose different requirements than the federal law.
The court observed that “under [the plaintiff’s] logic virtually any structure/function claim would potentially be misleading to the great majority of people.” The court noted two examples of similar claims—“vitamin C boosts immunity” and “calcium helps maintain bones”—and contended that the plaintiff’s rationale would bar both where most consumers are not vitamin C or calcium deficient. The court stated, “Simply put, manufacturers may make structure/function claims about a nutrient’s role [in] the human body without disclosing whether the product will provide a health benefit to each consumer.”
The court properly applied FDCA provisions added by the NLEA and DSHEA. Neither the NLEA, DSHEA, nor any other law or regulation governing structure/function claims has ever required that as part of the substantiation obligation, food and supplement makers must attempt to address whether and how a consumer might meet or exceed a nutrient’s Daily Value. Rather, through the NLEA and DSHEA, Congress intended to expand the scope of truthful information labels might provide about important nutrients, regardless of the nutrient source. See, e.g., Pub. Law 103-417, at § 2. Where a company apprised consumers of the role of biotin, and provided a source for consumers to obtain biotin, the company met the well-reasoned requirements of the applicable federal law.
In addition to this case against Target Corp., plaintiff’s firms have filed numerous nearly identical cases against other companies over hair, nail, and skin claims for biotin supplements. Most cases have settled, and any remaining now likely have slim (or at least slimmer) chances of survival. This Ninth Circuit decision provides significant precedent protecting companies from future challenges based on similar arguments that a structure/function claim is false unless a company endeavors to predict how consumers might obtain a nutrient. This case is a win for the unique federal regulatory regime meant to empower consumers and expand the scope of nutrition information available in the marketplace.