Structure/function vs disease claims (and the FDA disclaimer)

"Supports immune health." "Cures colds." One of those is a permissible structure/function claim; the other is a disease claim that turns a supplement into an unapproved drug. The line between them is one of the most important — and most litigated — boundaries in US supplement marketing. Cross it, and the FDA treats your product as something it is not.

Structure/function claims: what supplements may say

Under the US framework, dietary supplements may make structure/function claims — statements describing the role of a nutrient or ingredient in affecting the normal structure or function of the body. "Calcium builds strong bones" or "supports the immune system" are the classic shape of these claims.

These claims do not require FDA pre-approval, but the manufacturer must have substantiation that they are truthful and not misleading, and must notify the FDA of the claim within a set time of marketing.

Disease claims: the line you cannot cross

A disease claim states or implies that a product diagnoses, treats, cures, prevents, or mitigates a disease. Supplements are not permitted to make disease claims — doing so makes the product an unapproved drug in the FDA's eyes, with serious consequences.

The difficulty is that the boundary is not always obvious. "Supports cardiovascular health" reads as structure/function; "lowers cholesterol" or "prevents heart disease" cross into disease territory. The wording, the context, and even imagery can tip a claim from one side to the other.

The mandatory disclaimer

Structure/function claims come with a price: the mandatory disclaimer. When a supplement makes such a claim, the label must carry a statement that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease.

This disclaimer is a defining feature of US supplement labels and has no equivalent in the EU's authorised-claims system. It is the trade-off for being allowed to make the claim without pre-approval.

A shifting requirement

Even this long-standing rule is under review. The FDA has signaled it is considering changes to how often and where the disclaimer must appear on labels, with the aim of reducing clutter and cost. The principle of the disclaimer is not going away, but the specifics of its placement may change — a reminder that even settled-seeming rules in this space move.

Because the disclaimer requirements and claim guidance are actively being reviewed, confirm the current FDA rules before finalising your labels and claims.

Why the claim is tied to the formula

A structure/function claim is not just a marketing line — it has to be substantiated, and substantiation connects to what the product actually contains and at what dose. A claim about an ingredient's effect implies the product delivers a meaningful amount of that ingredient. As in other markets, the claim and the composition are linked: the formula has to support what the label says.

Managing claims across a catalogue

For a manufacturer with many products, the risk is not one careless claim but drift across the range — a claim left on a label after a reformulation, a borderline phrase copied between products, a disclaimer missing where a claim was added. Keeping claims aligned with each product's composition, and ensuring the disclaimer travels with every structure/function claim, is an ongoing discipline.

Keeping claims and formula in step

The robust approach is to tie claims to the formula, so the claims a product carries are connected to what it actually delivers, and a claim the composition no longer supports is flagged. When claims are managed alongside the formula rather than in separate marketing files, the structure/function boundary and the disclaimer stay under control as products evolve.

The takeaway

US supplements may make substantiated structure/function claims with the mandatory disclaimer, but may not make disease claims — and the line between the two is subtle and consequential. The claim has to be supported by the formula, the disclaimer has to accompany it, and the rules themselves are in flux. Managing claims tied to composition, across the whole catalogue, is what keeps a brand on the right side of the boundary.

Lemoniq ties claims to the formula, so you can see which claims a product's composition supports and keep them aligned as products change — keeping structure/function claims and their disclaimer under control. We solve this exact problem. See how it works