SAN FRANCISCO — A vitamin maker accused of mislabeling its products and falsely advertising health claims has obtained a victory in court.
U.S. Circuit Judge Susan Graber, on the bench of the U.S. Court of Appeals for the Ninth Circuit, issued a 14-page ruling on Jan. 10 affirming the U.S. District Court for the Northern District of California's decision in a lawsuit filed by Paul Dachauer against NBTY Inc. and Nature's Bounty Inc.
The panel of judges affirmed that Dachauer "failed to meet his burden" to create a true issue of material facts on whether the claims on the products label were misleading.
Dachauer sued NBTY and Nature's Bounty alleging that their health supplement products came with claims of supporting cardiovascular health and promoting immune functions on their labels, claiming the statements violate California's false advertising laws and the Federal Food, Drug, and Cosmetics Act (FDCA), as the products do not prevent cardiovascular diseases.
"The FDA has published guidance in the Federal Register discussing, among other things, acceptable structure/function claims" recognizing that "structure/function claims may use general terms such as 'strengthen,' 'improve,' and 'protect,' as long as the claims 'do not suggest disease prevention or treatment,'” the ruling said.
Even though the FDCA requires "manufacturers to have substantiation for their structure/function claims, California law does not allow private plaintiffs to demand substantiation for advertising claims," leading plaintiffs to bear the burden "of producing evidence to prove that the challenged statement is false or misleading," the ruling said.
In her ruling, Judge Graber confirmed the summary judgment, stating that "on this record, Plaintiff failed to meet his burden to create a genuine issue of material fact as to whether Defendants’ immune-health structure/function claim is misleading."
Judges Sidney R. Thomas, and Leslie E. Kobayashi concurred to the judgment.
U.S. Court of Appeals for the Ninth Circuit Case number 17-16242