What Is a Structure/Function Claim? What’s Allowed vs Not Allowed

Claim language is the fastest way to get a supplement listing taken down and the most common reason a label has to be reprinted. The line between a permitted structure/function claim and a prohibited disease claim is not always obvious, and it differs between the US, the EU and the UK. Here is where that line sits and how to stay on the right side of it.

On this page: The Basic Distinction · Where the Line Actually Sits · Keeping Your Label Compliant

The Basic Distinction

1. What is a structure/function claim?
   A statement that describes how a nutrient or ingredient affects the normal structure or function of the body — for example, its role in a normal biological process. It does not mention a disease and does not claim to treat, prevent or cure one.
2. What is a disease claim?
   A statement that a product treats, prevents, cures or mitigates a disease, or that it is intended for use in a diagnosed condition. In the US this crosses into drug territory and requires a drug approval; a supplement cannot carry it.
3. Can I say a product supports a condition?
   Carefully. Saying a nutrient contributes to the normal function of a system is a structure/function claim. Saying it helps with a named disease — even indirectly, through a symptom strongly associated with it — pulls you toward a disease claim.
4. Does a disclaimer make an otherwise bad claim acceptable?
   No. The FDA disclaimer that supplements carry is required, but it does not license a disease claim. You cannot make a drug claim and cure it with a footnote.

Where the Line Actually Sits

1. Why is the line hard to see?
   Because the same words can be fine or not depending on context. “Supports immune health” is generally a structure/function claim; “protects against colds and flu” is a disease claim. The difference is the noun and the verb, not the topic.
2. What words should I treat as danger signals?
   Treat as high-risk anything that names a condition (arthritis, insomnia, diabetes, depression), anything that implies treatment (cures, treats, relieves, prevents), and anything that compares the product to a medicine.
3. How does the EU differ from the US?
   The EU operates an authorised health-claims register. Only claims on the approved list can be used for foods, and the permitted wording is prescriptive — you cannot paraphrase freely. This is stricter than the US structure/function route.
4. What about the UK?
   Since Brexit the UK has its own register, which mirrors much of the EU list but is administered separately. Do not assume an EU-approved claim is automatically usable in the UK without checking.

Keeping Your Label Compliant

1. When should the review happen?
   Before the artwork goes to print. A compliance review of the label copy is cheap; a reprint of every carton and label is not. Build the review into the artwork stage, not after.
2. Who should do the review?
   Someone who knows the target market’s rules, not just the source market’s. A label compliant for the US may fail in the EU or the UK, and vice versa.
3. How do I keep marketing copy aligned with the label?
   Use the approved claim set as the single source of truth for both the label and the marketplace listing. When marketing drifts ahead of the label, listings get pulled even though the product is fine.
4. What should I do if a listing is taken down?
   Do not resubmit the same copy. Identify the specific phrase that triggered the action, replace it with an approved claim, and keep a record of the change. Repeat removals escalate.

Related Reading

For marketplace-specific rules see label compliance for Amazon listings. For claim risk on social channels see CBD and herbal claims on social media.

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.