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Ninth Circuit:
Label for Vitamin Need Not Disclose General Uselessness
Opinion Says That If Representation As to Benefit Is Truthful, an Action Will Not Lie Based On Failure to Reveal That Most Persons Do Not Suffer From a Deficiency of the Nutrient
By a MetNews Staff Writer
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The Ninth U.S. Circuit Court of Appeals yesterday affirmed summary judgment in favor of Target and others in a putative class action based on claims for biotin, a food supplement. Depicted above is the product purchased by the plaintiff. |
A man who is balding and bought a bottle of biotin based on the representation on the label that it promotes healthy hair cannot state a claim under California’s consumer protection statutes because the representation is true, the Ninth U.S. Circuit Court of Appeals held yesterday, rejecting the plaintiff’s contention that falsity lies in concealment of the fact that most person’s diets supply an adequate amount of the vitamin.
Circuit Judge Kenneth K. Lee wrote the opinion which affirms a summary judgment awarded by District Court Judge Richard Seeborg of the Northern District of California to defendant Target Corporation, which sold the biotin to plaintiff Todd Greenberg, and two companies that manufacture the product. Greenberg purchased a bottle at a Target store in 2015 for $8 and, when he found it did not help him, brought a putative class action, suing under California’s Unfair Competition Law and its Consumers Legal Remedies Act.
State claims relating to dietary supplements, Lee noted, are permitted only if they are in conformity with the Seaborg preemptive federal Food, Drug, and Cosmetic Act (“FDCA”), which defines the authority of the Food and Drug Administration (“FDA”) to regulate such products.
FDA Requirements
Lee wrote:
“Millions of Americans buy dietary supplements each year. The…FDA…does not require pre-approval of labels on these products, but it insists that the statements be truthful and not misleading. The FDA also allows the product labels to feature so-called ‘structure function’ claims that describe the role of a nutrient or ingredient on the structure or function of the human body. So, for example, a vitamin product can tout that ‘calcium supports strong bones’ because scientific evidence backs that claim, even if not everyone needs or benefits from more calcium.”
The claim made for biotin was that it “helps support healthy hair and skin.” Greenberg acknowledged the truth of that assertion, but argued that the defendants were derelict in not revealing that the supplement affords no health benefit to the majority of users because their bodies are not lacking in biotin.
“But only a fraction of people suffers a deficiency of any nutrient,” Lee responded. He continued:
“For example, according to Greenberg’s reasoning, a product that bears the true statement that ‘vitamin C boosts immunity’ would be misleading because most people are not vitamin C deficient and would not benefit from the product. Similarly, the accurate claim that ‘calcium helps maintain bones’ would be misleading to most consumers because an extra dosage of calcium would be superfluous for them. In short, under Greenberg’s logic, virtually any structure function claim for dietary supplements would potentially be misleading to the great majority of people. Such reasoning conflicts with the FDCA’s statutory language and the FDA’s stated purpose for allowing structure/function claims.”
That purpose, he said, is to maximize information available to the consumer.
Disclosure Not Required
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.”
He said a state claim is barred where three requirements in the FDCA are met: where the representation about a product is truthful, which Greenberg admitted; the label states that that the product “is not intended to diagnose, treat, cure, or prevent any disease” which the label on the bottle purchased by Greenberg did; and a statement is not made—as was not—that the supplement will “diagnose, mitigate, treat, cure, or prevent” disease.
“We thus hold that the FDCA authorizes the defendants” structure function claim about biotin and preempts Greenberg s state law claims challenging them,” Lee wrote.
The case is Greenberg v. Target, 19-16699.
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