Tuesday, September 12, 2017

Allegedly disingenuous "not for human consumption" label can't avoid supplement false ad. claims

Nutrition Distribution LLC v. PEP Research, LLC, No. 16cv2328, 2017 WL 3972509 (S.D. Cal. Sept. 7, 2017)

Plaintiff sells natural supplements, specifically for bodybuilding.  It alleged that its natural supplements directly competed with PEP’s “Research Chemicals.”  PEP allegedly falsely advertised its “research peptides and chemicals,” including prescription-only drugs such as Sildenafil Citrate (brand name Viagra), Selective Androgen Receptor Modulators (‘SARMS’) and synthetic peptides. PEP allegedly mislabeled these products as “not for human consumption” and intended for laboratory research only.  SARMs allegedly pose significant health and safety risks to consumers, which PEP didn’t disclose, nor the fact that SARMs are specifically prohibited for use in sporting events by the World Anti-Doping Agency and the U.S. Anti-Doping Agency, even though PEP marketed its products to bodybuilders, competitive athletes, and other similar consumers for personal use.  [Interesting falsity question: if the falsehood is “not for human consumption,” but you’re not supposed to believe that, can there be any reliance on the falsehood?  It wouldn’t be a problem under California “unlawful” jurisprudence, but under the Lanham Act?  Or is the relevant falsity the alleged implication that these can be safely and legally consumed by humans? The complaint seems a little cagey, claiming that consumers were likely to be deceived “into believing that they are purchasing a product with different characteristics,” and also relies on failure to disclose the serious risks of using the substances.]

PEP allegedly advertised that its “research chemical” Sermorelin was commonly used as a “doping substance in sports,” and assures consumers of the product’s safety for personal use: “Sermorelin alone or combined with GHRP-2 and GHRP-6 is a harmless and efficient way to stimulate and enhance your body’s growth hormone production.”  Similarly, PEP advertised, “Clenbuterol has been popularized in the public mind recently by media potrayals of off-label use for fat loss, as well as some professional athlete doping scandals involving the drug.”  A contest for a free bottle ended with a bottle given to a fitness instructor—not a researcher (query whether winning your research substances in a contest is a valid/reproducible method).

PEP challenged standing, but the court accepted the plaintiff’s argument that PEP’s customers “have little incentive to use Plaintiff’s natural nutritional supplements until they are hurt or the ‘Research Chemicals’ are taken off the market.”  The "we really are competitors" argument seems quite sensible, given the allegations.

The court also declined to apply the primary jurisdiction doctrine.  Determining whether PEP’s ads were false and misleading because they market “research chemicals” for personal use and consumption despite also labeling the products as “not for human consumption” would not require the FDA’s technical and policy expertise.

The RICO claims failed because they were RICO claims.

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