Structure/Function Claim

What is Structure/Function Claim?

A structure/function claim describes how a supplement supports normal body function (“supports immune health”) without claiming to diagnose, treat, cure, or prevent a disease, and the category comes from DSHEA, the Dietary Supplement Health and Education Act of 1994.

The line between a supported claim and a drug claim

A supplement may claim to support or maintain normal structure or function, but the moment copy names or implies a disease it becomes a claim only an approved drug can legally make. The distinction lives in the wording:

The mandatory disclaimer

Every structure/function claim must carry the standard FDA disclaimer: “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.” The disclaimer does not license an otherwise-illegal disease claim, though; a claim that crosses the line is still a drug claim no matter what fine print sits beneath it. A claim can also cross implicitly, not just in the headline text: a disease name in an image, a customer testimonial describing a cure, or a before-and-after tied to a condition can each turn compliant copy into a disease claim, and structure/function claims are separately expected to be truthful and backed by competent evidence, not invented for the ad.

The ad account usually breaks before the regulator arrives

In practice the FDA and FTC are the distant risk; the immediate one is the platform. Meta and Google reviewers pattern-match disease language and reject or flag the ad first, and a pattern of borderline claims can put the whole ad account at risk, not just the one creative. That is why an angle library built on compliant mechanism-and-routine claims is what keeps creative testing volume sustainable in supplements: claims-safe angles can be iterated indefinitely, while a single disease claim is one rejection away from flagging the account.

Why it matters for health and DTC brands

For supplement and wellness advertisers, staying on the structure/function side of the line is not a legal nicety filed away from marketing; it is what lets the creative pipeline run at all. Pair claims discipline with the platform-level requirements around it, such as LegitScript certification for regulated categories, and treat compliant tracking (keeping health and quiz data off ad pixels) as the tracking-side equivalent of the same principle, which is the heart of HIPAA-compliant marketing. Write the angle to the mechanism and the routine, keep the disclaimer present, and let compliant claims be the thing that makes volume testing possible.

Related terms