Wyoming substantiation case sets the bar high for testing

Posted by Clyde Hutchins | Oct 31, 2016 | 0 Comments

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.

About the Author

Clyde Hutchins

Clyde Hutchins is the founder of Harmony Law. Prior to opening Harmony Law, Mr. Hutchins worked in the Wyoming Attorney General's Office for several years where he developed a strong consumer protection enforcement unit. In that position he led over 120 investigations and enforcement actions under the Consumer Protection Act. He worked on numerous joint cases with the Federal Trade Commission and other states, including Colorado, on consumer protection matters. Mr. Hutchins is also a contributing author to Consumer Protection Law Developments, Second Edition. Previous to his work in the Attorney General's Office, Mr. Hutchins was in private practice in Anchorage, Alaska where he was the chief litigator for a firm. Mr. Hutchins represented municipalities on various matters. Mr. Hutchins provided counsel to businesses and investment advisors regarding compliance with securities laws. He was also a bond lawyer and worked on municipal financing matters. Prior to that, Mr. Hutchins practiced civil litigation with a law firm in Cheyenne, Wyoming. Mr. Hutchins devotes his spare time to his family, traveling and enjoying the great outdoors.


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Harmony Law is one of the few law firms in Colorado and Wyoming that focuses on consumer law. Mr. Hutchins is a member of the National Association of Consumer Advocates and state chair for Wyoming. If you have a consumer law issue, please feel free to call 970-488-1857 and speak with Mr. Hutchins.

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