Health claims, structure/function claims, and qualified health claims: the US claim hierarchy

US supplement claims fall into distinct legal categories, and using the wrong one — or blurring them — is a fast track to trouble. Knowing the difference between a health claim, a structure/function claim, and a qualified health claim is essential before any wording goes near a label.

Structure/function claims

Structure/function claims describe how an ingredient affects the normal structure or function of the body and don't require FDA pre-approval, but do require the DSHEA disclaimer, substantiation, and FDA notification within 30 days. These are the workhorse claims for most supplements — 'supports,' 'helps maintain,' 'promotes.'

Authorized health claims

An authorized health claim describes a relationship between a substance and a reduced risk of a disease or health condition, and is permitted only when the FDA has authorized it based on significant scientific agreement. These are limited, specific, and tightly worded — a brand can only use one that already exists and must follow its required language.

Qualified health claims

Qualified health claims sit between the two: the science is emerging but not conclusive, and the FDA permits the claim only with qualifying language that conveys the limited evidence. The exact wording matters enormously, because the qualifier is what keeps the claim lawful. Using the strong version of a claim the FDA only allows in qualified form is a violation.

Why the category decides the wording

Each category carries its own evidentiary bar, disclaimer, and notification duty. The same underlying benefit might be expressible as a structure/function claim with a disclaimer, but not as a disease-risk claim. Deciding the category first, then writing to its rules, is the only safe order — and keeping claims tied to their substantiation is part of managing a compliant catalog.

This is general information, not regulatory or legal advice. US requirements change and turn on specifics, so confirm the current rules with the FDA, FTC, or a qualified US regulatory expert before relying on them.

Where Lemoniq fits

Lemoniq holds each product as one structured formula — ingredients, amounts, specifications, sourcing, and the documentation behind them — and generates what a US dietary supplement needs from that single source: the Supplement Facts panel, the claim and disclaimer wording, the records that cGMP expects, and the data to back overages, dating, and origin. Compliance becomes a property of the formula, not a pile of separate documents.

The takeaway

The US supplement model trades pre-market approval for full manufacturer responsibility, which means the work shifts onto documentation, accurate labeling, and defensible formulas. The brands that scale in the US are the ones whose single source-of-truth formula generates each label, specification, and record correctly — every time, across every product.

Lemoniq turns one formula into compliant, US-ready outputs — panel, claims, specs, and documentation — from a single source. We solve this exact problem. See how it works