September 17, 2014
Partner John E. Villafranco was quoted in the Nutritional Outlook article “Does FTC Require Two Clinical Studies for Structure-Function Claims?” The article discusses how over the last several years the FTC has placed a growing emphasis on requiring substantiation exclusively in the form of randomized clinical trials (RCTs), while ignoring other types of scientific evidence demonstrating effect and benefit. Mr. Villafranco commented that this isn’t necessary a bad thing for supplement firms, saying that the FTC may now actually be applying the “competent and reliable scientific evidence” standard with more care.
Mr. Villafranco also points out another trend that those in the supplements industry should heed. Weight-management companies may actually face a higher bar, as FTC actions show the agency generally requiring weight-management companies to substantiate claims with two clinical trials, whereas other types of structure/function claims may require just one trial.
To read the full article, please click here.