The Ninth Circuit Court of Appeals has issued a ruling regarding product claims for biotin, a decision that the Council for Responsible Nutrition (CRN) has applauded.
The suit was filed against Target, International Vitamin Corporation, and Perrigo Company of South Carolina. The plaintiff purchased a bottle of biotin that claimed to “help support healthy hair and skin” at Target, and sued the companies involved with the argument that the statement is misleading because most people obtain enough biotin from their regular diets and thus the product provides no health benefit for them.
The Ninth Circuit backed the district court’s judgment in favor of the defendants, with the argument that the claim is legal under FDCA. The claim “helps support healthy hair and skin” truthfully describes the function of biotin within the body, the product label had appropriate disclosures, and the product did not claim to treat diseases, meeting all requirements for a legal claim.
Judge Kenneth K. Lee explained in his opinion: “We affirm the district court’s order because 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…Federal law thus allows the defendants to make this structure/function claim and preempts the plaintiff’s state law causes-of-action.”
In a press release from CRN, Megan Olsen, VP and Associate General Counsel, stated that CRN is pleased with this ruling. “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.”
CRN submitted an amicus brief in support of product claims in April 2020, one of a series of briefs CRN has submitted to the Ninth Circuit regarding lawsuits that challenge substantiation standards for supplement claims. “CRN recognizes the importance of filing these amicus briefs on behalf of industry,” Olsen continued, “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.”