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Vigil v. General Nutrition Corporation

United States District Court, S.D. California

May 13, 2015

RYAN VIGIL, on behalf of himself and all others similarly situated, Plaintiff,
GENERAL NUTRITION CORPORATION, a Pennsylvania corporation, Defendant.


JEFFREY T. MILLER, District Judge.

This order addresses Defendant General Nutrition Corporation's ("GNC's") motion to dismiss Plaintiff Ryan Vigil's first amended complaint ("FAC") pursuant to Federal Rules of Civil Procedure 8, 9(b), and 12(b)(6). (Doc. No. 25.) The motion was fully briefed and found suitable for resolution without oral argument under Local Civil Rule 7.1.d.1. For the reasons set forth below, the court grants GNC's motion to dismiss all claims, but also grants Plaintiff's request for leave to amend.


This case concerns the labeling and marketing for GNC's product Staminol, which, Plaintiff claims, is incapable of delivering the promised benefits. Plaintiff asserts causes of action for (1) violation of California's Unfair Competition Law ("UCL"), California Business & Professions Code § 17200 et seq.; (2) violation of the California's Consumers Legal Remedies Act ("CLRA"), California Civil Code § 1750 et seq.; and (3) breach of express warranty.

Plaintiff alleges as follows: GNC markets and distributes Staminol as an over-the-counter supplement for men. (Id. ¶ 2.) The labeling and marketing for Staminol represent that it is designed to enhance male sexual performance, is scientifically formulated to provide maximum potency, and supports male vitality, sexual health, urinary flow, and prostate health. (Id.) The front panel of the Staminol package contains the following statements:

• Supports male vitality with proprietary blend including L-arginine and maca*
• Features horny goat weed and yohimbe, herbs traditionally used to support sexual health*
• Supports urinary flow and prostate health with saw palmetto*
• Formulated with premium ingredients to provide maximum potency*

(Doc. No. 25-3, Exh. 1.)

The left side panel of the package reads:

GNC Staminol™ is physician endorsed by Frank J. Costa, M.D., an internationally acclaimed urological surgeon, men's health expert and member of the GNC Medical Advisory Board.
"Staminol ™ is a powerful male performance formula backed by GNC quality. This premium formula combines the best herbs with guaranteed potencies to support vitality and enhance performance. I highly recommend this product for men who are looking for a superior formula to address male performance concerns."
- Frank J. Costa, M.D.
Why Should I Use Staminol™? Staminol™ offers a premium formula containing a proprietary blend of key nutrients and exotic herbs to enhance male sexual performance.*
How Can Staminol™ Benefit Me? Staminol™ is designed to support male vitality and sexual health.* It is scientifically formulated to provide maximum potency, as well as support healthy urinary flow and prostate health.*
How Does Staminol™ Work? Staminol™ combines L-arginine, an important amino acid that supports nitric oxide production, with herbs traditionally used to support sexual health such as horny goat weed and yohimbe. Additionally, saw palmetto supports urinary health and normal prostate function.*
*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.


Under the heading "Supplement Facts, " the opposite side panel lists thirteen ingredients:

Proprietary Blend 200 mg* L-Arginine Epimedium Extract Maca Root Powder ( Lepidium meyenii ) Kola Nut ( Kola nitida ) 175 mg* Oat Straw Stems ( Avena sativa ) 150 mg* GABA (gamma-Aminuobutyric Acid) 100 mg* Nettle Leaf ( Urtica dioica ) 100 mg* Yohimbe Bark Extract 60 mg* ( Pausinystalia yohimbe ) Horny Goat Weed ( Epimedium sagittatum ) 20 mg* Catuaba Bark ( Erythroxylum catuaba ) 10 mg*

Muira Root ( Ptychopetalum olacoides ) 10 mg* Damiana Leaf ( Turnera aphrodisiaca ) 10 mg* Saw Palmetto Berry ( Serenoa repens ) 10 mg* * Daily Value not established.

(Id.) Gelatin and dicalcium phosphate are listed as "Other Ingredients."[2] (Id.)

Plaintiff alleges that the Staminol labeling is false because various studies have shown that Staminol's primary ingredients-which he identifies as horny goat weed, maca root powder, L-arginine, catuaba bark, oat straw stems, damiana leaf, saw palmetto berry, and muira root-do not provide any of the promised health or sexual performance benefits, either when taken alone or in combination with other ingredients. (FAC ¶¶ 16-17.) Further, he asserts, the minimal amount of remaining ingredients also cannot produce the promised effects, either when taken alone or in combination with one another. (Id. ¶ 17.) As support, he summarizes three scientific articles and information from the NYU Langone Medical Center's website.

Plaintiff's first article, Mario Dell'Agli et al., Potent Inhibition of Human Phosphodiesterase-5 by Icariin Derivatives, 71(9) Nat'l J. Products 1513 (2008), [3] assessed icariin and various icariin derivatives in comparison with Viagra. Preliminarily, the authors tested various plant extracts traditionally used for male potency for their ability to inhibit phosphodiesterase-5A1 ("PDE5"). Id . Medicines like sildenafil (Viagra) that are currently used for treating erectile dysfunction work by selectively inhibiting PDE5. See id. The authors found that only the extract of "Epimedii Herba, " which "is the common name for the dried aerial parts of E. brevicornum, E. sagittatum Maxim., or E. korneanum Nakai, collected in the summer, " was active against PDE5. Id . They state, "The observation that only E. brevicornum and its active principle [icariin] inhibited PDE5 in a significant manner, in agreement with previous results, suggests that other plant extracts may interfere with erectile function through mechanisms other than PDE5 inhibition." Id . (footnotes omitted). The authors focused on assessing the PGE5 inhibitory potency of icariin, the active component in E. brevicornum, and derivatives of icariin. Id. at 1513-15. They found that icariin itself "was a good PDE5 inhibitor... but required improvement in order to have equivalent potency to sildenafil." Id. at 1513. One derivative tested was "80 times more potent" than icariin, id., with PGE5 inhibitory potency "almost identical to that of sildenafil, " id. at 1515.

Plaintiff alleges that icariin is the active compound in horny goat weed, and, because icariin is 80 times less potent than Viagra, "consuming Horny Goat Weed is not an effective means of enhancing a man's sexual experience by alleviating the symptoms of erectile dysfunction." (FAC ¶ 18.)

Plaintiff's second article, Byung-Cheul Shin et al., Maca (L. Meyenii) for Improving Sexual Function: A Systematic Review, 10 BMC Complementary & Alternative Med. 44 (2010), [4] evaluated clinical research on the effectiveness of maca on sexual performance. A database search revealed 88 articles that discussed maca and sexual health, of which only four met the authors' inclusion criteria. Id. at 2-3. Of those, three tested the effects of maca on men. Id. at 4. The first trial studied the effects of maca versus placebo on men with erectile dysfunction, and "showed positive effects." Id . The second trial tested different dosages of maca on healthy men compared to placebo, and reported "positive effects" on sexual desire from both dosages. Id . The third trial, which studied male cyclists, "failed to show positive effects of maca in the improvement of sexual desire, " although the authors noted that it "had a very small sample size." Id . The authors conclude:

The results of our systematic review provide limited evidence for the effectiveness of maca in the improvement of sexual function. However, the total number of trials, the total sample size, and the average methodological quality of the primary studies were too limited to draw firm conclusions.

Id. at 5-6 (emphasis added).

Plaintiff's third article, R. Stanislov & V. Nikolova, Treatment of Erectile Dysfunction with Pycnogenol and L-arginine, 29(3) J. of Sex & Marital Therapy 207 (2003), [5] "investigated the possibility of overcoming erectile dysfunction (ED) by increasing the amounts of endogenous [nitric oxide]." Id. at 207. According to the article, "[n]itric oxide (NO) is considered to be the principal mediator of penile erection, " acting as both a neurotransmitter and vasodilator. Id. at 208. Oral supplementation with L-arginine is one method of achieving higher nitric oxide levels, and, according to a 1999 study, "was shown to be helpful for a limited number of men with ED. However, other studies have questioned the efficacy of L-arginine treatment." Id . (citation omitted). The present study assessed whether pycnogenol, an antioxidant that enhances nitric oxide production, was effective for treating erectile dysfunction in combination with L-arginine. See id. In the first month of the study, the 40 participants took daily doses of L-arginine aspartate. See id. at 209. In the second month, they also took a certain amount of pycnogenol, and in the third month, the amount of pycnogenol was increased. See id. The authors report that two study participants experienced normal erections using L-arginine alone in the first month, although "[ t ] he improvement... did not reach significance over pretreatment. " Id. at 210 (emphasis added). That result was consistent with the 1999 study, in which the "limited number" of recovered participants was " no [ t ] statistically significant. " Id. at 212 (emphasis added). However, 92.5% of study participants (37 out of 40) had recovered by the end of the trial when using both L-arginine and pycnogenol. See id. at 212.

Last, Plaintiff refers to the NYU Langone Medical Center's website. Under the heading "Impotence, "[6] the site states that oat straw, catuaba, damiana, muira, saw palmetto, and a number of other herbs "are also reputed to improve sexual function in men.... However, there is as yet no real evidence that they offer any benefits. " (Emphasis added.) Under the heading "Saw Palmetto, "[7] the site reports that "Saw palmetto oil is an accepted medical treatment for benign prostatic hyperplasia (BPH) in New Zealand and in France, Germany, Austria, Italy, Spain, and other European countries.... Most, thought [sic] not all, research suggests that saw palmetto can markedly improve" the typical urinary difficulties associated with BPH. However, the site also notes, " The scientific evidence for the effectiveness of saw palmetto in treating prostate enlargement is inconsistent. " (Emphasis added.) It elaborates that while numerous studies had shown some improvement from saw palmetto, "[a] more recent well designed, placebo-controlled trial involving 369 men found that saw palmetto even at high doses (three times the standard dose) did not improve urinary flow rate compared to placebo."

Thus, Plaintiff claims, although GNC represents that Staminol can enhance users' potency and sexual performance and that it supports urinary flow and prostate health, reliable scientific research reveals that many of the product's primary ingredients do not provide these benefits. (Id. ¶ 23.) In sum, he asserts, Staminol is totally ineffective at providing the benefits GNC touts, and those representations, in turn, lead consumers to buy the product. (Id.)

In April 2014, Plaintiff read the Staminol label at a GNC store, including the representations regarding the product's sexual-health and performance benefits. (Id. ¶ 13.) He relied on the labeling, desired to enhance his sexual experience and enjoyment, believed Staminol would provide the advertised benefits, and bought a bottle for $19.99. (Id.) He did not, however, receive any benefits from using it. (Id. ¶ 37.) Had he been aware that the representations were not true, he would not have bought the product. (Id. ¶ 13.)

Plaintiff alleges that this court has jurisdiction pursuant to the Class Action Fairness Act, 28 U.S.C. § 1332(d)(2), as he is a California resident, GNC is a Pennsylvania corporation headquartered in Pennsylvania, and the amount in controversy exceeds $5, 000, 000. (Id. ¶¶ 10, 13-14.) He seeks to litigate on behalf of consumers who purchased Staminol in California and states with similar laws within the relevant limitations period, up until the time of class notice. (Id. ¶ 27.) He seeks actual, punitive, and statutory damages; restitution and disgorgement; declaratory and injunctive relief; and costs and fees. (Id. ¶¶ A-H.)

On February 3, 2015, GNC moved to dismiss the first amended complaint for failure to state a claim under Federal Rules of Civil Procedure 8, 9(b), and 12(b)(6). (Doc. No. 25.) Plaintiff opposed the motion on March 2, 2015, ...

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