Structure/function claims and the DSHEA disclaimer: what a US supplement can and can't say

What you write on a US supplement label is policed as tightly as what's inside it. The line between a permitted structure/function claim and an illegal drug claim is the single most important marketing-compliance question for any US brand — and crossing it turns your supplement into an unapproved drug in the FDA's eyes.

Structure/function claims, defined

A structure/function claim describes the role of a nutrient or ingredient in maintaining the normal structure or function of the body — 'supports immune health,' 'helps maintain healthy joints.' DSHEA allows these for dietary supplements without pre-approval, provided they are truthful, not misleading, and substantiated.

The disclaimer that has to appear

When a supplement makes a structure/function claim, the label must carry the FDA disclaimer: that the statement has not been evaluated by the FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease. Manufacturers must also notify the FDA of the claim within 30 days of first marketing. The disclaimer is not optional decoration — it is a condition of making the claim at all.

Where it becomes a drug claim

The forbidden territory is disease claims: any statement that the product treats, prevents, or cures a disease turns it into an unapproved drug. 'Supports cardiovascular health' is a structure/function claim; 'lowers cholesterol' or 'prevents heart disease' is a drug claim. The distinction is subtle, consequential, and the most common reason supplement brands receive warning letters.

Substantiation is required

A structure/function claim must be substantiated — the manufacturer needs competent and reliable scientific evidence supporting it before it goes on the label. 'Truthful and not misleading' is a legal standard, not a slogan, and the FTC enforces it alongside the FDA. A claim you can't back up is a liability even if the wording is otherwise compliant.

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