GNC Class Action Alleges Misleading FDA Approval

A group of consumers say GNC deceptively labels its dietary supplements regarding FDA approval — or lack thereof.

Lead plaintiffs, Richa Arora, Randy Clinton, and Walter Johnston, state that required FDA disclaimers are hidden or not present on certain GNC products.

These disclaimers tell consumers that the supplements are “not intended to diagnose, treat, cure or prevent any disease.” Failure to include these warnings make the nutritional supplements drugs, specifically non-FDA approved drugs.

“GNC is prohibited from labeling, marketing, or selling dietary supplements bearing claims that ‘describe[] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, [or that] characterize[] the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function’…unless the label carries a prominent disclaimer on each panel bearing such claims,” explains the GNC supplements class action lawsuit.

Further, alleges the GNC class action lawsuit, additional statements proclaiming the products are “clinically studied,” “scientifically designed,” “physician formulated,” or “physician endorsed” are included on the labels, along with medical symbols and references to diseases and other health conditions.

The plaintiffs say that they would not have purchased the GNC supplements if they had known the products were “not intended to treat, cure, or prevent any disease.”

“Owing to their reliance on GNC’s deceptive labeling, marketing, and sales of the Supplements, Plaintiffs and the members of the Class purchased GNC Supplements believing them to have characteristics and qualities that they do not have,” alleges the GNC class action. “Plaintiffs and the members of the Class have been injured because they would not have purchased the Supplements or paid as much for them had they known the truth.”

According to the GNC dietary supplement class action lawsuit, the supplements that are misleading labeled include GNC Men’s Prostate Formula and GNC Diabetic Support Dietary Supplements.

GNC’s earnings reached $3 billion in 2018, say the plaintiffs. However, the supplement giant has been subject to several investigations over allegations of deceptive labeling in Oregon and New York.

Additionally, the company’s Super Bowl ads were rejected by the National Football League because their products contained substances banned by the organization.

The GNC class action lawsuit points out that under U.S. Food and Drug Administration regulations, drugs require approval before they are put on the market. There is an exception to this requirement, provided the products contain “prominent” disclaimers about any health claims for nutritional supplements.

In fact, say the plaintiffs, the FDA has stated that “few dietary supplements have been the subjects of adequately designed clinical trials.” Disclaimers inform consumers that the product may not live up to the therapeutic treatment claims made by the manufacturer, the GNC class action states.

The plaintiffs and proposed Class are represented by Lawrence King, Mario M. Choi and Maia C. Kats of Kaplan Fox & Kilsheimer LLP and Michael R. Reese and George V. Granade of Reese LLP.

The GNC Dietary Supplements Class Action Lawsuit is Arora, et al. v. GNC Holdings Inc., Case No.  3:19­-cv-­02414, in the U.S. District Court for the Northern District of California.

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