United States of America — The Food and Drug Administration has published its final rule defining the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body. This rule describes how disease claims can be distinguished from structure/function claims. Although this rule will not affect the availability of dietary supplements, it may affect whether certain claims can be made and will result in some labelling changes.
As an example, the rule precludes express and implied disease claims, but permits claims that do not relate to disease. Serious conditions such as ageing, pregnancy, and menopause will continue to be treated as diseases.
Publication of the rule is an important part of the FDA's overall dietary supplement strategy aimed at providing consumers with a high level of confidence in the safety, composition and labelling of dietary supplements.
Reference: FDA Talk Paper, T00-1, 2000.