State law causes-of-action challenging a structure/function claim for a vitamin called biotin are preempted because the defendants met federal requirements for making the claim, a U.S. appeals court held Wednesday.
“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,” wrote Circuit Judge Kenneth K. Lee on behalf of the three-judge panel of the U.S. Court of Appeals for the Ninth Circuit. “The defendants have met all of the federal requirements for making a structure/function claim, including having substantiation showing that the biotin nutrient can promote healthy hair and skin. Federal law thus allows the defendants to make this structure/function claim and preempts the plaintiff’s state law causes-of-action.”
The decision marked a victory for the defendants, including Target Corp., which sold a bottle of Up & Up biotin to the plaintiff in 2015 for $8. The other defendants, International Vitamin Corp. (IVC) and Perrigo Company of South Carolina Inc., manufactured the biotin products for Target’s private label brand, Up & Up.
Todd Greenberg, the plaintiff who was suffering hair loss, believed the biotin product would grow hair, but he was advised several weeks later by a friend that the supplement does not provide any benefits. According to the Supplements Facts panel on the bottle, the biotin amount in the product exceeded the recommended daily dosage between 333% and 3,333%, depending on the tablet’s size, the Ninth Circuit observed.
In his putative class action lawsuit asserting claims under California’s Unfair Competition Law and Consumers Legal Remedies Act, Greenberg alleged the product labels are deceptive because biotin supplementation does not benefit most people.
While the parties conceded biotin supports healthy hair and skin, Greenberg’s expert concluded most individuals get all of the latter nutrient they need from their specific diets, and consequently, biotin vitamins are unnecessary except for a very small percentage of individuals suffering a deficiency in biotin, according to the Ninth Circuit’s opinion.
In granting summary judgment for the defendants, U.S. District Judge Richard Seeborg ruled federal law preempts Greenberg’s state law claims because the biotin statement met the statutory requirements for a structure/function claim. The Ninth Circuit agreed the claim was truthful and not misleading, backed by scientific evidence and contained the proper disclaimer that the product “is not intended to diagnose, treat, cure or prevent any disease.” It also found the product label did not claim to treat diseases.
“Simply put, manufacturers may make structure/function claims about a nutrient’s general role on the human body without disclosing whether the product will provide a health benefit to each consumer,” Lee wrote.
The Council for Responsible Nutrition (CRN) intervened in the Greenberg case as amicus curiae, or "friend of the court" in Latin. In April 2020, the trade association, through outside counsel, submitted a brief to the Ninth Circuit.
“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,” Megan Olsen, vice president and associate general counsel of CRN, said in an emailed statement, in response to the Ninth Circuit's opinion.
Attorneys with Amin Talati Wasserman LLP represented CRN. Katie Bond, now a partner with Lathrop GPM, was one of the Amin Talati Wasserman attorneys whose name appeared on CRN's brief.
The Ninth Circuit’s decision, Bond said in an interview, “is certainly good news for industry.”
“One, it cuts off a line of attack that plaintiffs’ firms have been using”—namely the argument that a structure/function claim can’t be made if it only supports a person with a deficiency in a specific nutrient like biotin.
“The Ninth Circuit got it right in terms of interpreting the FDA’s rule on structure/function claims, and that is good news for the industry in getting some protection,” Bond concluded.
Dan Fabricant, president and CEO of the Natural Products Association (NPA), also welcomed the decision as positive news for industry.
“The court was crystal clear that a structure/function claim that is substantiated with regard to the nutrient itself (not the product) and is otherwise consistent with federal labeling regulations is immune from state law consumer protection laws,” he said in an email.
Attorneys representing the plaintiffs and defendants did not immediately respond to requests for comment. Target, IVC and Perrigo also did not immediately respond to requests for comment.