Definition: A structure/function claim is a statement on a dietary supplement label about how an ingredient affects the normal structure or function of the body, such as supporting bone health. Federal rules (21 CFR 101.93) allow these claims only if they are not disease claims and carry an FDA disclaimer.
When a label makes one of these claims, the rule requires this disclaimer, in bold type at least one-sixteenth of an inch high:
This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
It sits next to the claim or is linked to it with a symbol such as an asterisk. The maker must also notify FDA within 30 days of first marketing the product with the claim, and certify it has evidence that the claim is truthful and not misleading.
The rule defines a disease as damage to an organ or body system so it does not work properly, or a state of health leading to that, such as high blood pressure. A statement becomes a disease claim if it says or implies, among other things, that the product:
A supplement label that makes a disease claim is regulated as a drug, unless it is an authorized health claim.
The claim tells you what the maker is allowed to say, not what FDA has checked. When you log a supplement in Dose Track, note what you are taking it for in your own words, so you and your prescriber can judge whether it is doing anything.
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