The Federal Trade Commission (FTC) recently entered a settlement order with Reebok International Ltd. to resolve charges that the company deceptively advertised that its “toning shoes” would provide extra tone and strength to leg and buttock muscles. The settlement arises out of an action the FTC brought in the United States District Court for the Northern District of Ohio alleging the Reebok engaged in deceptive acts or practices and false advertisements in violation of Sections 5(a) and 12 of the FTC Act. Among other things, the FTC took issue with a TV ad in which a fit woman explains to the audience the benefits of the toning shoe, pointing to a chart that showing that the shoes are proven to strengthen hamstrings and calves up to 11 percent and tone the buttocks up to “28 more than regular sneakers, just by walking.” The FTC also contended that the use of the word “tone” in the product name was deceptive. The FTC’s contention was that these claims were deceptive because they not supported by adequate substantiation.

What is notable about the settlement are the provisions regarding the level of substantiation for making claims about the health and fitness benefits of a product. The settlement requires that such claims must be supported by “competent and reliable scientific evidence”, which is a fairly common standard for health-related claims. However, the settlement goes further and states that this evidence must consist of at least one “Adequate and Well-Controlled Human Clinical Study” that conforms to acceptable designs and protocols. In the context of this settlement, such a study is defined as a clinical study that is randomized, controlled, blinded to the maximum extent practicable, and of at least six weeks in duration. The study must use appropriate measurement tools and must be conducted by persons qualified by training and experience to conduct such a study.

This settlement illustrates the importance of carefully evaluating not only product claims, but also product names, and determining the level of substantiation required. In the case of health and fitness claims, the manufacturer may be required to conduct the type of clinical study outlined in the Reebok settlement. This requires careful planning and preparation to ensure the substantiation will withstand scrutiny by the FTC and other regulators. Such substantiation must be obtained before the claim is made.