The Federal Trade Commission ("FTC"), in the last couple of years, has made clear that it expects advertisers making strong cause-and-effect claims (e.g., “Lose weight,” “Helps prevent irregularity”) to possess, at a minimum, at least one well-designed and reliable clinical study. Yet, at the same time, FTC staff—those who conduct FTC investigations—have made statements that suggest a growing skepticism of clinical trials conducted abroad.
An article co-authored by partner John Villafranco
, published in Nutritional Outlook
, "Foreign Territory: Dietary Supplement Clinical Trials Conducted Abroad
," discusses this dilemma and provides practical pointers on minimizing risk, whether a company seeks to commission a trial abroad or rely on an existing study for claims.