A dietary supplement marketer cannot base claims on human studies where the outcomes are improvement of disease symptoms or prevention of diseases.  The law that is enforced by FDA dictates that a dietary supplement is not indented to diagnose, treat, cure or prevent a disease. So we are faced with the challenge of conducting studies where a supplement is given to fairly healthy subjects and measure detectable and meaningful changes. This is tough!

The exceptions to this rules include diseases resulting from essential nutrient deficiencies e.g. folic acid and neural tube defects and qualified health claims. However there are very few qualified health claims and you have to use with specific wordings e.g. Omega-3 Fatty Acids & Coronary Heart Disease.

The bottom line, be careful when designing a human clinical study and making claims.