One sentence on your label can turn your supplement into an unapproved drug in the FDA’s eyes. That’s not hyperbole — it’s the line between a legal structure/function claim and an illegal disease claim, and brands cross it every day without realizing it. The words you choose aren’t marketing polish; they’re a compliance decision that can trigger a warning letter, a retailer delisting, or worse.
Here’s what you can and can’t say on a supplement label, in plain terms.
Dietary supplements are allowed to make structure/function claims — statements about how an ingredient supports the normal structure or function of the body. They are not allowed to make disease claims — statements that a product diagnoses, treats, cures, prevents, or mitigates a disease. The first is legal with a disclaimer; the second turns your supplement into an unapproved drug.
| Allowed (Structure/Function) | Not Allowed (Disease) |
|---|---|
| “Supports a healthy immune system” | “Prevents colds and flu” |
| “Helps maintain healthy cholesterol already in the normal range” | “Lowers high cholesterol” |
| “Supports joint comfort” | “Treats arthritis” |
| “Promotes restful sleep” | “Cures insomnia” |
| “Supports a positive mood” | “Treats depression” |
Any structure/function claim triggers a mandatory disclaimer: 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. Missing this disclaimer is one of the most common and easily avoided label violations. If you make the claim, you must carry the disclaimer.
Even a legal structure/function claim must be truthful and backed by evidence. The FTC expects competent and reliable scientific support for the claims you make. That’s another reason to formulate to studied doses with credible ingredients — your claims are only as defensible as the evidence and the dose behind them. Keep a substantiation file for every claim.
Your contract manufacturer makes the product; you make the claims. The FDA and FTC hold the brand owner responsible for the marketing, so claim compliance is squarely your job. The safest path is to write claims as structure/function, carry the disclaimer, keep substantiation, and get a regulatory review before anything prints. A label review costs a fraction of a warning letter.
A statement that an ingredient supports the normal structure or function of the body — for example, “supports immune health.” It’s legal for supplements when accompanied by the FDA disclaimer, unlike a disease claim.
Yes — any structure/function claim requires the disclaimer stating the claim hasn’t been evaluated by the FDA and the product isn’t intended to diagnose, treat, cure, or prevent disease. Omitting it is a common, avoidable violation.
Yes. You don’t have to name a disease to make a disease claim — implication through symptoms, imagery, product names, or testimonials can cross the line. The rules apply to all your marketing, not just the label.
Want a partner who understands the claims line? UniWell Labs helps brand owners formulate to studied doses with credible ingredients, so your structure/function claims have a foundation. Talk to our team about your product.