FDA reports $40 million settlement with Skechers over unfounded health claims

If you have a dietary supplement or any product for that matter, be sure you have substantiation for your claims. Complying with substantiation legal rules is part of dietary supplement / FDA and FTC legal compliance. Claims regarding weight loss are particularly thorny for those advertising and marketing products in this industry. Recently, the FTC has been stepping up enforcement activity with regard to false and misleading claims:

• The FDA just reported 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. Complaint 12- 16, Federal Trade Commission v. Skechers USA, Inc., No. 1:12-cv-01214 (N.D. Ohio May 16, 2012). Among other things, the FTC defines “adequate and well-controlled human clinical study” to mean: “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 [pdf] 3-4, No. 1:12-cv-01214 (N.D. Ohio May 16, 2012).
• The FTC called Skechers to task for characterizing studies as “independent” where these studies were essentially paid for by the company.
• The FTC also looked to methodological flaws to question the reliability of the studies.

The lesson is that the FTC pays attention to substantiation, and companies can no longer afford to ignore this requirement. If you are a manufacturer of dietary supplements seeking FDA legal compliance, simply having a compliant structure/function claim for a dietary supplement will not satisfy FDA and FTC enforcement concerns. (The FTC has some overlapping jurisdiction but tends to enforce violations of advertising laws, especially for products marketed over the Internet). Substantiation is also important. And this case shows how very specific the FTC can be about substantiation. Consult an experienced FDA and FTC lawyer for your regulatory needs. Contact our attorneys today.