FTC’s Substantiation Bar: Iovate Health Sciences (July 2010)

Shortly after the FTC finalized Nestlé’s consent order, it issued Iovate Health Sciences’ stipulated

on July 29, 2010, with the same requirement of “at least two adequate and well-controlled human clinical studies” for any weight-loss-related claims, specifically. (The company was also barred from making disease claims.)

But for bodybuilding-related and other health claims, the FTC did not require a particular number of studies, only stating that "competent and reliable scientific evidence" means “tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and are generally accepted in the profession to yield accurate and reliable results.”

FTC Requirement: At least two human studies (for weight-loss claims, but not for other claims)

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Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine jennifer.grebow@ubm.com

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