This is a class action regarding Defendant’s false and misleading advertisement of its health-supplement, Staminol, which it falsely represents will serve to increase male sexual performance and vitality and, additionally, will treat prostate and urinary flow issues. None of those claims regarding Staminol are true and none have been evaluated or tested by the FDA. To the contrary, each of Defendant’s claims is flatly contradicted by scientific research and testing.
Defendant distributes, markets, and sells Staminol, an over the counter dietary supplement for men which Defendant claims, on the product packaging and, additionally, via its nationwide marketing, will enhance the sexual performance of its users. The primary ingredients in Staminol include “Horny Goat Weed” (Epimedium Extract), “Maca Root Powder,” “L-arginine,” “Catuaba Bark,” “Oat Straw Stems,” “Damiana Leaf,” “Saw Palmetto Berry,” and “Muira Root.” Specifically, Defendant represents, via an extensive and uniform nation-wide advertising campaign, that Staminol “supports male vitality” and “sexual health,” “supports urinary flow and prostate health,” and is “formulated with premium ingredients to provide maximum potency.”
As alleged, the packaging of Staminol states that the product is designed to “enhance male sexual performance.” Defendant has also represented, on the packaging of Staminol, that the product is “scientifically formulated to provide maximum potency.” The statements represented on the Staminol product packaging are “structure-function” claims which must be limited to a description of the role that a dietary ingredient is “intended to affect the structure or function in humans.” 21 U.S.C. § 343 (r)(6). In order for a dietary supplement manufacturer to make a structure-function claim, the manufacturer must have substantiation that such statements are truthful and not misleading.
According to the complaint, the Defendant does not have any credible, competent scientific evidence that substantiates its representations regarding the sexual health and performance benefits of consuming Staminol. In fact, even a cursory examination of reliable scientific evidence relating to Defendant’s representations strongly indicates that Staminol has no efficacy at all, is ineffective in the treatment of prostate related health issues, and provides no benefit relating to enhancing the sexual performance and vitality of its users. Multiple valid scientific studies have been conducted on the aforementioned primary ingredients in and these studies have revealed that the ingredients in question are not reliable means of treating health issues related to prostate functioning, or enhancing the sexual performance, vitality, and potency of its users.
The complaint also alleges GNC makes an unsubstantiated disease claim. Federal regulations prohibit Defendant from making “disease claims” about s product. See 21 C.F.R. § 101.93. Disease claims are generally described as statements which claim to diagnose, mitigate, treat, cure or prevent disease where the statements claim “explicitly or implicitly, that the product…Has an effect on the characteristic signs or symptoms of a specific disease or class of diseases, using scientific or lay terminology.” Id. Defendant clearly makes such representations on the product label for Staminol, which directly relate to the treatment of health issues related to urinary flow and prostate health.
Defendant did not secure the requisite New Drug Application before marketing and selling Staminol. Accordingly, making these statements and representations without a New Drug Application (“NDA”) approval from the FDA constitutes misbranding and false and misleading conduct in violation of 21 C.F.R. § 101.93.
As a result of Defendant’s deceptive advertising and false representations regarding the efficacy of Staminol, Plaintiff and the proposed class have purchased a product which does not perform as represented and they have been harmed in the amount they paid for the product, which, in the Plaintiff’s case is approximately $19.99 bottle.
Plaintiff brings this action on behalf of himself and other similarly situated consumers who have purchased Defendant’s Staminol product to halt the dissemination of this false, misleading, and deceptive advertising message, correct the false and misleading perception it has created in the minds of consumers, and obtain redress for those who have purchased this product. Based on violations of state unfair competition laws and Defendant’s breach of express warranty, Plaintiff seeks injunctive and monetary relief for consumers who purchased Staminol.