Greenberg v. Target Corp., No. 19-16699 (9th Cir. 2021)
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To fight his hair loss, Greenberg bought an $8 bottle of biotin. The product label states that biotin “helps support healthy hair and skin” and has an asterisk that points to a disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” A Supplement Facts panel on the bottle states that the biotin amount in the product far exceeds the recommended daily dosage. Greenberg filed a putative class action under California’s Unfair Competition Law, alleging that the labels are deceptive because most people do not benefit from biotin supplementation.
The panel affirmed summary judgment in favor of the manufacturer and distributors. The plaintiff’s state law claims were preempted by the federal Food, Drug, and Cosmetic Act (FDCA), under which the FDA requires that dietary supplement labels be truthful and not misleading; 21 U.S.C. 343(r)(6)(B) authorizes several categories of statements, including disease claims and structure/function claims. The FDCA includes a preemption provision to establish a national, uniform standard for labeling. The challenged statement was a permissible structure/function claim. There was substantiation that biotin “helps support healthy hair and skin”; that statement was truthful and not misleading. The label had the appropriate disclosures and did not claim to treat diseases. The state law claims amounted to imposition of different standards from the FDCA.
Court Description: Federal Food, Drug, and Cosmetic Act / Preemption The panel affirmed the district court’s summary judgment in favor of defendant manufacturer and distributors, and its ruling that the plaintiff’s state law claims, challenging the labeling of the dietary supplement biotin, were preempted by federal law – the Federal Food, Drug, and Cosmetic Act (“FDCA”). Plaintiff bought a bottle of biotin with a label stating that Biotin “helps support healthy fair and skin.” The Food and Drug Administration has limited authority under the FDCA to regulate dietary supplements, and it requires that the label be truthful and not misleading. 21 U.S.C. § 343(r)(6)(B) authorizes several categories of statements, including disease claims and structure/function claims. The FDCA includes a preemption provision to establish a national and uniform standard for certain labeling statements. * The Honorable Edward R. Korman, United States District Judge for the Eastern District of New York, sitting by designation. GREENBERG V. TARGET 3 The panel held that the FDCA preempted plaintiff’s state law claim because the challenged statement was a permissible structure/function claim. Specifically, the panel held that if defendants’ biotin statement met the FDCA’s three requirements for a structure/function claim, then any state law claims challenging that claim fell to the wayside. 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. 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.
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