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Focus on Regulation

FTC Requires Two “Gold-Standard” Studies in Sketchers Consent Decree

For the second time in eight months, the Federal Trade Commission (FTC) has obtained a multi-million dollar settlement as the price paid for alleged deceptive advertising of footwear promoted to help customers lose weight and strengthen muscles. The FTC announced its $40 million settlement with Sketchers earlier this week. According to the FTC, Sketchers incorrectly reported the results of clinical studies on weight loss achieved with its Shape-ups shoes.

Notably, the consent decree entered into by Sketchers requires the company to have at least two well-controlled human clinical studies to substantiate weight loss claims. The Sketchers case is the most recent example of FTC’s pattern of implementing the potentially more stringent requirement of two placebo-controlled, double-blind clinical studies as substantiation for health-related claims (the so-called gold standard), rather than the traditional standard of “competent and reliable evidence.” Interestingly, FTC’s order in the Reebok case only required one gold-standard study. Although FTC has stated that it is not requiring two clinical studies as a blanket substantiation standard, the Sketchers case provides another example of the types of claims FTC views as requiring a more precise level of support.