What can a supplement ingredient supplier say? Disease claims vs. structure/function claims
Most ingredient suppliers never write a label, yet their emails, spec sheets and LinkedIn posts often end up in a brand’s marketing. A sentence like “our extract lowers blood sugar” can travel all the way to a product page. This is the line regulators draw, and how to stay on the right side of it.
The FDA line: no disease claims
- A dietary supplement may describe how a nutrient or ingredient affects the structure or function of the body. It may not claim to diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases (21 CFR 101.93(g)).
- Implied claims count. FDA looks at the context: naming a disease, citing disease research, or a product name that points to a condition can all make a disease claim.
- Structure/function claims on a supplement need substantiation, the standard disclaimer (“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”), and an FDA notification by the marketer within 30 days of first marketing.
FTC and EU in one paragraph each
FTC. Advertising claims about health need competent and reliable scientific evidence; the FTC’s Health Products Compliance Guidance (December 2022, non-binding) explains what that means in practice, generally expecting good-quality human clinical evidence.
EU. Under Regulation (EC) No 1924/2006 only authorised health claims may be used on foods, including food supplements. Many botanical claims have never been authorised, so “supports immunity”-type wording that works in the US may not work in Europe.
What this means for an ingredient supplier
Sell the ingredient on what you can prove as a supplier — specification, testing, documents, supply — and leave finished-product claims to the brand, which carries the substantiation and the notification. When a buyer asks you to “confirm” a disease benefit, decline politely and offer documents instead.
| Risky | Why | Safer for a supplier |
|---|---|---|
| “Lowers blood sugar” | Disease marker (diabetes) | Describe the spec and testing; leave claims to the brand |
| “Lowers cholesterol” | Disease claim | Brands sometimes use “helps maintain cholesterol levels already within the normal range”* — the brand’s call, with substantiation |
| “Anti-cancer” | Disease claim | Remove — there is no compliant version |
| “Boosts immunity” | Borderline; prohibited wording in the EU unless authorised | “Supports normal immune function”* — brand’s claim, market-specific |
| “Clinically proven” | Needs the brand’s own substantiation | Cite the study and what it measured, not a conclusion |
* Structure/function wording for a finished product, shown for context. It still needs substantiation and the disclaimer, and is the brand’s decision.
A reply that keeps the deal and the line
On the blood sugar positioning: as an ingredient supplier we provide specifications and quality documents, and claims on the finished product are the brand's responsibility — so we can't confirm or support a disease-related claim. Happy to send the COA, spec sheet and any test data your regulatory team needs for its own review.
Try it on your own data: paste a buyer’s email and get a reply built from your spec sheet, with gaps marked [TBD] and disease claims blocked. Free plan included.
Check a draft for disease claims →FAQ
Is “supports immune health” a disease claim?
In the US it is generally treated as a structure/function claim when not tied to a disease, and it needs substantiation and the disclaimer on a supplement. In the EU, health claims must be authorised, so check the EU Register first.
Can an ingredient supplier say its extract lowers cholesterol?
That is a disease claim under 21 CFR 101.93(g). Keep supplier materials to specifications, testing and documents.
Who files the structure/function notification with FDA?
The manufacturer, packer or distributor whose name appears on the supplement label, within 30 days of first marketing the product with the claim.