Court Rules that a Dietary Supplement Company Needed Clinical Trials with Human Subjects to Support Advertising Claims

By Riëtte van Laack –

In a short, unpublished decision issued on December 10, 2010, the D.C. Circuit denied a petition filed by Daniel Chapter One and James Fejio (“DCO”) seeking review of an FTC cease and desist order.  The FTC Order, issued in 2009, concluded that DCO had made advertising claims that were not substantiated.

The Court’s decision concerns a lawsuit that began in 2008 as part of the FTC’s Operation False Cures,  which the FTC claims is a law enforcement program aimed at marketers of “phony cancer remedies.”  In September 2008, the FTC filed an administrative complaint against DCO alleging that DCO’s advertising that its products, Bioshark, 7 Herb Formula, GDU and BioMixx, prevent, treat, or cure cancer, inhibit tumors, or ameliorate the adverse effect of chemotherapy and radiation, was false and misleading.   In December 2009, the FTC’s Commissioners adopted the FTC’s Administrative Law Judge’s decision from August 2009, that DCO’s claims were not substantiated by scientific evidence.   

In the lawsuit that DCO subsequently filed against the FTC, DCO raised a number of issues, including that the FTC exceeded its statutory authority by requiring clinical trials with human subjects as substantiation.  Citing the FTC’s dietary supplement advertising guidance, the Court ruled that the FTC’s requirement for substantiation by competent and reliable scientific evidence, including clinical trials with human subjects, was not unreasonable.  The Court ruled that because DCO did not support its claims with competent and reliable evidence, including clinical trials with human subjects, DCO’s advertising was unlawful.