What is the Origin of Structure/Function Claim?

This specific term is formally defined within the regulatory framework established for dietary supplements, most notably by the Dietary Supplement Health and Education Act (DSHEA) in the United States. This landmark legislation created a separate, distinct category of claims for supplements, clearly differentiating them from the far more rigorous requirements for pharmaceutical drug claims.

What is the Mechanism of Structure/Function Claim?

The regulatory mechanism permits the use of these claims provided they are factually substantiated by competent and reliable scientific evidence and are invariably accompanied by a mandatory disclaimer. This disclaimer must explicitly state that the statement has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease. This structure allows for informational labeling while maintaining a clear, legally defined boundary between supplements and regulated pharmaceutical endocrine treatments.

Structure/Function Claim

Meaning

A Structure/Function Claim is a statement legally authorized for use on the labeling of dietary supplements that accurately describes the specific role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body. Crucially, these claims are legally prohibited from explicitly or implicitly claiming to diagnose, mitigate, treat, cure, or prevent any specific disease or medical condition. For example, a claim may state that a supplement “supports healthy thyroid function” but cannot claim to “treat hypothyroidism.”