UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT

TODD GREENBERG, On Behalf of No. 19-16699 Himself and All Others Similarly Situated, D.C. No. Plaintiff-Appellant, 3:17-cv-01862- RS v. TARGET CORPORATION, a Minnesota OPINION Corporation; INTERNATIONAL VITAMIN CORPORATION, a New Jersey Corporation; PERRIGO COMPANY OF SOUTH CAROLINA, INC., Defendants-Appellees.

Appeal from the United States District Court for the Northern District of California Richard Seeborg, District Judge, Presiding

Argued and Submitted October 16, 2020 Pasadena, California

Filed January 13, 2021 2 GREENBERG V. TARGET

Before: Mary H. Murguia and Kenneth K. Lee, Circuit Judges, and Edward R. Korman, * District Judge.

Opinion by Judge Lee

SUMMARY **

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. ** This summary constitutes no part of the opinion of the court. It has been prepared by court staff for the convenience of the reader. 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.

COUNSEL Elaine A. Ryan (argued) and Carrie A. Laliberte, Bonnett Fairbourn Friedman & Balint P.C., Phoenix, Arizona; Patricia N. Syverson, Bonnett Fairbourn Friedman & Balint P.C., San Diego, California; for Plaintiff-Appellant. Matthew R. Orr (argued), William P. Cole, and Samuel G. Brooks, Call & Jensen ACP, Newport Beach, California, for Defendants-Appellees. J. Kathleen Bond, and Jennifer M.S. Adams, Amin Talati Wasserman LLP, Chicago, Illinois, for Amicus Curiae Council for Responsible Nutrition. 4 GREENBERG V. TARGET

OPINION LEE, Circuit Judge:

Millions of Americans buy dietary supplements each