Kelley Drye

Publications & Blogs 

Foreign Territory: Dietary Supplement Clinical Trials Conducted Abroad

April 2012 | Nutritional Outlook

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 by partner John E. Villafranco and associate Katie Bond, 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.

Foreign Territory: Dietary Supplement Clinical Trials Conducted Abroad (PDF, 668.00 K)

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