What Is Qualified Health Claim?
An FDA-authorised claim on a food or supplement label that describes a relationship between a substance and a disease or health condition, supported by some scientific evidence but not meeting the 'significant scientific agreement' standard required for authorised health claims.
Why It Matters for Supplement Brands
Qualified health claims allow supplement brands to communicate disease-related benefits that wouldn't be permitted as standard structure–function claims — but with required qualifying language. They're a middle ground between structure–function claims (which can't reference diseases) and full health claims (which require the highest evidence standard).
How It Works
The FDA evaluates qualified health claim petitions through a rigorous process:
1. **Petition submission**: The petitioner submits all available scientific evidence supporting the claim. 2. **FDA review**: The FDA reviews the totality of evidence and assigns a ranking: • **A**: Strong evidence (this would be an authorised health claim) • **B**: Good evidence but not conclusive • **C**: Some evidence but limited • **D**: Very limited evidence 3. **Qualifying language**: Based on the evidence ranking, the FDA prescribes specific disclaimer language that must accompany the claim.
Example: Omega-3 fatty acids and coronary heart disease: 'Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.'
This is a qualified health claim — it references a disease (coronary heart disease) but includes qualifying language ('supportive but not conclusive').
Common Mistakes to Avoid
- ✗Using qualified health claims without the exact FDA-prescribed qualifying language
- ✗Confusing qualified health claims with structure–function claims — they have different notification and compliance requirements
- ✗Assuming you can create your own qualified health claims — they require FDA petition and authorisation
- ✗Applying US qualified health claim rules internationally — other countries have different systems
Related Terms
See It in Action
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