What is a structure/function claim?
A structure/function claim describes how a nutrient or dietary ingredient affects, or helps maintain, the normal structure or function of the human body. FDA's own example is "calcium builds strong bones". These claims are the main way supplement brands describe benefits. They need substantiation, an FDA notification and a disclaimer, and they must never cross into treating or preventing disease.
- Structure/function claims describe normal body function; disease claims describe diagnosing, treating, curing, mitigating or preventing disease.
- FDA must be notified of the claim text no later than 30 days after the product is first marketed with it.
- FDA does not pre-approve these claims; the brand must hold substantiation.
- Ads using the claim are also judged by the FTC, which expects competent and reliable scientific evidence.
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Where is the line between a structure/function claim and a disease claim?
The line is whether the statement refers to a disease, or to its signs and symptoms. "Supports healthy digestion" talks about normal function. "Relieves irritable bowel syndrome" talks about a disease. FDA's rule at 21 CFR 101.93 lists criteria for spotting implied disease claims, and copywriters trip on the implied ones far more than the obvious ones.
| Usually structure/function | Likely a disease claim |
|---|---|
| Supports healthy digestion | Relieves IBS or ulcers |
| Helps maintain cholesterol levels already within the normal range | Lowers high cholesterol |
| Supports restful sleep | Treats insomnia |
| Supports the immune system | Prevents colds or flu |
| Supports joint comfort after exercise | Relieves arthritis pain |
Implied disease claims include product names that reference a disease, images such as an ECG tracing, citing a study titled after a disease, or describing the product as an alternative to a drug. The same claim can become a disease claim because of what surrounds it.
A practical test: could a reader take the statement to mean the product helps with a condition a doctor would diagnose? If yes, rewrite it or drop it.
What does a brand have to do before using a structure/function claim?
A brand needs three things: evidence that the claim is truthful and not misleading, a notification to FDA, and the required disclaimer on the label. These come from the Federal Food, Drug, and Cosmetic Act as amended by DSHEA, summarized on the FDA structure/function claims page.
- Substantiation. The manufacturer is responsible for having support for the claim. FDA does not review it in advance.
- Notification. The manufacturer, packer or distributor notifies FDA of the claim text no later than 30 days after first marketing the product with it, with a signed certification that the firm has substantiation.
- Disclaimer. The label must state that FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure or prevent any disease. See our supplement FDA disclaimer entry.
Conventional foods can also make structure/function claims based on nutritive value, but they do not file notifications or carry the disclaimer.
Keep a copy of each notification, and the date it was sent, next to the evidence for that claim. When a claim is reworded, treat it as a new claim and check whether a new notification is needed.
How do structure/function claims work in ads and on product pages?
The claim on the label is only the starting point. Every product page, ad, influencer script, email and marketplace listing is a new place where a structure/function claim can be stretched into a disease claim. The FTC Health Products Compliance Guidance applies to all of that advertising, and it asks for competent and reliable scientific evidence matched to the exact claim.
- Keep one approved claims library and make every channel draw from it.
- Write SEO titles, meta descriptions and image alt text from the same library; search snippets are advertising too.
- Review customer reviews and testimonials you republish; a customer saying a product "cured" something becomes your claim when you feature it.
- Check ad platform policies too; Google and Meta restrict some supplement claims and ingredients. See supplement ad policies on Meta and Google.
For a full go-to-market view, see our supplement and D2C health brand marketing page.
What are the most common structure/function claim mistakes?
- Symptom language. Words such as "relieves", "reduces swelling" or "fights infection" usually point to a disease.
- Assuming the disclaimer protects you. The disclaimer does not turn a disease claim into a lawful one.
- Skipping the notification for new claims added during a relaunch or new marketing angle.
- Evidence that does not match. A study on a different dose, form or population does not support your product's claim.
- Reused copy. Claims written for one product get pasted onto another with a different formula or dose.
- Hashtags and keywords. Disease terms in SEO titles, alt text or hashtags can imply a disease claim.
Related pages from the US team
Supplement & D2C health brand marketing
Compliant growth for US supplement brands.
FTC and FDA supplement advertising rules
How the two agencies divide the work.
Supplement FDA disclaimer
The required wording and where it goes.
US healthcare marketing glossary
Every term, defined in plain English.
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Common questions
What is an example of a structure/function claim?
FDA's example is "calcium builds strong bones". Others include "supports healthy digestion" or "supports restful sleep". Each describes how an ingredient affects or maintains normal body structure or function, rather than claiming to diagnose, treat, cure, mitigate or prevent a disease.
Does FDA approve structure/function claims?
No. FDA does not pre-approve structure/function claims for dietary supplements. The manufacturer must have substantiation that the claim is truthful and not misleading, notify FDA of the claim text within 30 days of first marketing, and carry the required disclaimer on the label.
Can a structure/function claim mention a disease?
Generally no. Under FDA's rule, a statement that refers to a specific disease, its signs or symptoms, or implies an effect on disease through names, pictures or context is treated as a disease claim. Supplements may not make disease claims without drug approval or an authorized health claim.
Do structure/function claims in ads need scientific evidence?
Yes. The FTC regulates supplement advertising and expects health-related claims to be backed by competent and reliable scientific evidence, generally well-designed human clinical trials matched to the product's dose, formulation and claimed benefit. The FDA disclaimer does not replace that evidence.
A note on this guide: it explains marketing practice, not legal advice. Rules on privacy, advertising and insurance change and vary by state, so confirm anything compliance-related with your own counsel.
Not sure which of your claims cross the line?
Book a call with the US team. We will review your product pages and ads against a single claims library your counsel can sign off.