Allegedly deceptive and misleading labeling found on certain GNC-brand dietary supplements is at the center of a proposed class action lawsuit filed in California’s Northern District.
The crux of the lawsuit is the allegation that defendant GNC Holdings, Inc. has run afoul of the Federal Food, Drug and Cosmetic Act of 1938 (FFDCA) by selling misbranded dietary supplements. According to the plaintiffs, GNC has misled, deceived and ultimately profited off of consumers by selling dietary supplements with labels that lack a mandatory, prominently displayed disclaimer that reads, “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
The “statements” referenced in that disclaimer pertain to legally required descriptions of the role particular dietary ingredients play in affecting the “structure or function” of humans, as wells as a characterization of “the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function,” the lawsuit says. To that extent, the suit claims the apparently misbranded GNC supplements qualify as drugs under the FFDCA since the company “markets them with structure/function claims but does not include the disclaimers.” Such products, according to the case, required pre-market approval from the FDA.
As the lawsuit tells it, GNC cannot legally sell the below products, among others, due to their misbranding and lack of FDA approval:
- GNC Men’s Prostate Dietary Supplement;
- GNC Diabetic Support Dietary Supplement;
- GNC Preventive Nutrition Healthy Blood Pressure Formula Supplement;
- GNC Women’s Ultra Mega Active Supplement; and
- GNC Mega Men Health Testosterone.
Notwithstanding the apparent lack of prominently displayed, FFDCA-required disclaimers, GNC, the lawsuit continues, wields phrases such as “clinically studied,” “scientifically designed,” “physician formulated,” and “physician endorsed” alongside medical symbols and references to diseases and conditions in its dietary supplement marketing. Consumers have relied on GNC’s product label representations, the complaint stresses, and would not have purchased certain GNC supplements had they known the products were misbranded, not reviewed by any governmental authority, and were not intended to actually treat, cure or prevent diseases.