Wyoming substantiation case sets the bar high for testing

This past September, in the U.S. District Court of Wyoming, the Federal Trade Commission (FTC) won a case against a company, and its owner in a case where the FTC alleged that the company made unfounded claims that its products could prevent or reverse gray hair. The resulting judgment against the company gives additional insight into the FTC's approach to substantiating marketing claims. The heart of the judgment prohibits the company (and its owner) from making any representations that its supplements would reverse, prevent or help protect against grey hair or cure any disease unless the company possesses and relies upon "competent and reliable scientific evidence" substantiating that the representation is true.

In explaining what is meant by "competent and reliable scientific evidence" the judgment sets the bar very high. It describes "competent and reliable scientific evidence" as consisting of human clinical testing of the product that is "sufficient in quality and quantity, based on standards generally accepted by experts in the relevant disease, condition, or function to which the representation relates, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing shall be: (1) randomized, double-blind, and placebo-controlled; and (2) conducted by researchers qualified by training and experience to conduct such testing."

The detail of scientific proof that the FTC contends is required for substantiation eliminates less rigorous scientific testing and the pseudo-scientific testing or assertions that is seen in support of the health claims made about supplements and other dietary products.

The case is Federal Trade Commission v. COORGA Nutraceuticals Corp.

If you are in need of assistance in meeting the substantiation claims, please feel free to contact Harmony Law for assistance.