This was forwarded to us regarding another companies dealings with FTC / FDA regulations on free speech.
A few months ago, we notified you that the Federal Trade Commission (“FTC” or “Commission”) intended to change its standard for “competent and reliable scientific evidence” as it applies to claims for over-the-counter (“OTC”) drugs, dietary supplements and functional foods, starting by imposing the new standard on individual companies through consent decrees. Now, as predicted, the FTC has introduced that new standard into consent decrees with Iovate Health Sciences, Inc. (“Iovate”) and Nestle HealthCare Nutrition, Inc. (“Nestle”).
Specifically, yesterday’s FTC consent decree with Iovate Health Sciences imposed a provision under which Iovate is barred from representing that its products cause weight loss or rapid weight loss unless the claims are truthful and backed by “competent and reliable scientific evidence” in the form of:
1. At least two adequate and well-controlled human clinical studies,
2. of the product at issue or an essentially equivalent 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 the claim.