What Is Health Claim?

Why It Matters for Supplement Brands

Health claims are distinct from structure-function claims and carry much stricter requirements. Most supplement brands use structure-function claims because health claims require FDA authorisation. Accidentally making a health claim when you intended a structure-function claim is one of the most common regulatory mistakes.

How It Works

There are three types of health claims:

1. **Authorised Health Claims**: Approved by FDA based on 'significant scientific agreement' (SSA). Example: 'Calcium may reduce the risk of osteoporosis.'

2. **Qualified Health Claims**: Allowed when evidence is promising but doesn't meet SSA. Must include qualifying language. Example: 'Some evidence suggests that selenium may reduce the risk of certain types of cancer. FDA has determined that this evidence is limited and not conclusive.'

3. **Structure-Function Claims**: These are NOT health claims — they describe how a nutrient affects the body's structure or function without referencing disease. Example: 'Calcium helps build strong bones.'

The critical distinction: if your claim mentions disease, diagnosis, treatment, cure, or mitigation — it's a health claim, not a structure-function claim.

Common Mistakes to Avoid

• ✗Making implied health claims by referencing disease symptoms or conditions without naming them directly
• ✗Confusing structure-function claims with health claims — both involve health, but the regulatory paths are entirely different
• ✗Not including the required disclaimer when making structure-function claims: 'This statement has not been evaluated by the FDA...'

Related Terms

See It in Action

Explore how this concept applies to real ingredient substantiation:

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