According to Todd Harrison, partner of the Washington, D.C.-based law firm Venable, and
Nutraceuticals World’s “Capitol Comments” columnist, the FTC is very close to changing the way it handles product claims in the dietary supplement and functional food market. “I have good information that the FTC is about to introduce a new definition of competent and reliable scientific substantiation into new consent decrees with various marketers—with the likely goal to extend it to the whole industry through changes to its dietary supplement advertising guide.”
Specifically, the FTC will require the following:
1. At least two adequate and well-controlled human studies
2. Of the product or of a substantially similar product
3. Conducted by different experts, independently of each other
4. That conform to acceptable designs and protocols, and whose results when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representations are true.
“In other words,” Mr. Harrison said, “you will need actual studies on your product. And even if those studies are positive, if the body of evidence says it is not true, you cannot make the claim. This will fundamentally change the industry and how it conducts business.”
Mr. Harrison added, “Perversely and unfairly, while a company can’t rely on third party studies to back their claims, the FTC can use third party studies to refute a company’s studies. This is a significant change in the existing interpretation of the law. It flies in the face of longstanding legal precedent and is legally dubious.”