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Volume XI, Number 289

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9th Circuit Holds that Structure/Function Claims Are Preempted

Last month, the United States Court of Appeals for the 9th Circuit affirmed a grant of summary judgment in favor Target and other defendants in a class action lawsuit that alleged that Target’s Up&Up biotin dietary supplement violated various California consumer protection statutes because it claimed to  “help[ ] support healthy hair and skin.” Specifically, the Court held that (1) the statement was a “structure/function” claim governed by the Federal Food Drug and Cosmetic Act (the “Act”), (2) Plaintiff sought to impose different requirements from the Act, and (3) therefore, the claim was preempted.

By way of background, a “structure/function” claim is one that describes the function or role of an ingredient or nutrient in the human body. See Act § 403(r)(6)see also 21 C.F.R. 101.93 (f). Section 403(r)(6) of the Act authorizes such structure/function claims to be made provided that they (1) are  substantiated so that the statement is truthful and not misleading; (2) do not claim to diagnose, mitigate, treat, cure, or prevent a disease; and (3) include a mandatory disclaimer informing the consumer that the product has not been evaluated by the FDA and is not intended to treat or otherwise address disease.

Plaintiff had purchased the biotin product to battle hair loss and stimulate hair growth, but later learned that because he — like the majority of the population — was not deficient in biotin, supplementation would not increase his hair growth. Plaintiff alleged that because few consumers would see improvements in health of their hair or skin, the structure/function statement was false and misleading.

In rejecting this argument, the Court first found that structure/function claims were expressly preempted by the Act. The Court also found that the Act only required that there be substantiation for an ingredient’s function on the human body, and not the product’s impact on the general health of the population. The Court contrasted this to a disease claim which “speaks to the product’s effect on the consumer’s disease.” Therefore, because the only effect of the product on the consumer’s disease (i.e. hair loss) was challenged, and biotin’s role in supporting health and hair health was not, the statement was truthful and not misleading. Finally, the Court found that the Act’s other two requirements for structure/function claims were met; the product contained the mandatory disclaimer language and did not claim to treat or otherwise address disease.

The opinion underscores that structure/function claims that are properly substantiated and that otherwise meet federal requirements are not ripe targets for consumer class action lawsuits.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 33
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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