Court of Appeals upholds ruling that federal dietary supplement framework preempts state law

January 15, 2021
Sebastian Krawiec

The Ninth Circuit Court of Appeals upholds ruling that federal dietary supplement framework preempts state law in case against biotin claims.

The Ninth Circuit Court of Appeals upheld a previous decision of the U.S. District Court of the Northern District of California in favor of the defendants: Target Corporation, International Vitamin Corporation, and Perrigo Company of Southern California Inc. The plaintiff challenged the labeling of the dietary supplement biotin, which stated that the supplement “helps support healthy hair and skin.” The Ninth Circuit Court of Appeals ruled that the plaintiff’s state law claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), which under 21 U.S.C. § 343(r)(6)(B) authorizes statements such as disease claims and structure/function claims. In the case of the biotic product, the court ruled that the challenged claim met the criteria for a permissible structure/function claim.

“The defendants met the first requirement for its structure/function claim because it had substantiation that biotin ‘helps support healthy hair and skin,’ and that statement was truthful and not misleading. Manufacturers may make structure/function claims about a nutrients’ general role on the human body without disclosing whether the product will provide a health benefit to each consumer,” stated the ruling. “Second, the biotin product label had the appropriate disclosures. Third, the biotin product label did not claim to treat diseases. Because the structure/function claim about biotin met the FDCA’s requirements, plaintiff’s state law claims amounted to an imposition of different standards from the FDCA.”

The Council for Responsible Nutrition (CRN; Washington, D.C.) praised the decision, which protects both industry and consumers by maintaining the federal framework. “We applaud this decision as it protects both industry and consumers by maintaining the federal framework, allowing dietary supplement manufacturers to disseminate information about how nutrients affect the health and function of the body and empowering consumers to make informed choices about nutrition,” said Megan Olsen, vice president and associate general counsel for CRN, in a statement. “CRN submitted an amicus brief in support of product claims surrounding biotin in April 2020. CRN recognizes the importance of filing these amicus briefs on behalf of industry to protect the federal standards that are in place and prevent private actors from overhauling this carefully crafted framework and creating a patchwork of conflicting substantiation standards inconsistent with the federal system.”