Structure/function claim

FDA's own example of a structure/function claim is "calcium builds strong bones" [1]. These claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading [1]. Under 21 CFR 101.93, the manufacturer, packer or distributor must notify FDA no later than 30 days after it first markets a supplement that carries one [2].

Each claim must carry a disclaimer with set wording: "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." [2] A label with several claims may use a plural version that begins "These statements have not been evaluated" [2]. The disclaimer sits next to the claim or is linked to it by a symbol such as an asterisk [2].

The line that matters is between a structure/function claim and a disease claim. If a product sold as a dietary supplement makes a disease claim on its label or labeling, it becomes subject to regulation as a drug, unless the claim is an authorized health claim the product qualifies for [2]. DSHEA, passed in 1994, set up special requirements and procedures for these claims [1].

A structure/function claim is the company's statement of what an ingredient is meant to do, and FDA does not approve it in advance [1]. FDA also does not approve the supplements themselves before they are marketed [3]. The claim and its disclaimer therefore say nothing about how many trials exist, who took part or what they found.

That is why NootropicsWork reports findings rather than product benefits. When this site reports a finding, it names the test, the population, the comparison group and the source, instead of saying what a product does.

The rules above are American. For Canada's licensed product claims, see NPN; for Australia's register, see ARTG.

• DSHEA
• NPN (Canada)
• ARTG (Australia)
• Label claim