Last week, the Federal Trade Commission (“FTC”) announced a $40 million settlement with Skechers USA, Inc. (“Skechers” or “the Company”) to resolve charges that the Company made deceptive and unfounded claims that its Shape-up sneakers would help consumers lose weight, strengthen and tone their buttocks, legs, and abdominal muscles. The FTC also claimed that Skechers made deceptive claims about its Resistance Runner, Toners, and Tone-ups shoes. See Complaint 12- 16, Federal Trade Commission v. Skechers USA, Inc., No. 1:12-cv-01214 (N.D. Ohio May 16, 2012).
Like the FTC’s similar settlement with Reebok in 2011, reported here, the Skechers settlement provides “compliance nuggets” that can help all advertisers better understand the FTC’s current policies and priorities. Importantly, the settlement contains a definition of “adequate and well-controlled human clinical study” that likely represents the FTC’s current understanding of that phrase as applied to weight-loss studies:
a clinical study that is randomized, controlled (including but not limited to controlled for dietary intake if testing for weight loss or a reduction in body fat), blinded to the maximum extent practicable, uses an appropriate measurement tool or tools, and is conducted by persons qualified by training and experience to conduct and measure compliance with such a study.
Stipulated Final Judgment and Order for Permanent Injunction and Other Equitable Relief 3-4, No. 1:12-cv-01214 (N.D. Ohio May 16, 2012).
Further, the settlement reinforces the FTC’s prior view that even multiple clinical studies may not satisfy the substantiation standard unless (1) the study results correlate to claims; (2) the study design and data are reliable; and (3) the individual or entity conducting the study is independent of the advertiser. The FTC claimed that Skechers characterized two of its Shape-ups studies as “independent case studies,” when in fact they were not independent because they were conducted by a chiropractor — Dr. Gautreau — who was a compensated endorser for Shape-ups, and was married to a Skechers senior vice president of marketing. Complaint at 7. The FTC’s complaint called into question the reliability of the studies conducted by Dr. Gautreau, alleging that of the four studies Skechers sponsored in support of its Shape-up claims, one lacked a control group, and data from a second were altered or incomplete such that some participants were falsely reported as having lost weight and/or reduced their body fat percentage when in fact they had gained weight and/or increased their body fat percentage. Id. at 7-8. The FTC also alleged that some of the second study’s participants were personally connected to the researchers. Id.
Finally, with this settlement the FTC continues a pattern of focusing on weight-loss claims and imposing a high standard for substantiation on marketers who make such claims. Under the terms of its FTC settlement, if Skechers chooses to make weight-loss claims in the future the Company will need two adequate and well-controlled human clinical studies, conducted by different researchers independently of each other, to substantiate those claims. Stipulated Final Judgment at 5-6. Only one adequate and controlled human clinical study is required for strengthening claims, but it must be at least six weeks in duration. Id.