What Is Label Claims?
An overview of the four main claim types that can appear on dietary supplement labels: structure-function claims, health claims, qualified health claims, and nutrient content claims — each governed by different FDA regulations.
Why It Matters for Supplement Brands
Understanding the four claim types is essential for correct labelling. Each type has different substantiation requirements, regulatory pathways, and risks. Using the wrong claim type or blurring the lines between them is the most frequent source of FDA enforcement actions against supplement brands.
How It Works
The four claim types at a glance:
| Claim Type | Example | Requires FDA Approval? | Substantiation Standard | |------------|---------|----------------------|------------------------| | **Structure-Function** | 'Supports healthy joints' | No (30-day notification) | Competent & reliable scientific evidence | | **Health Claim** | 'Calcium may reduce the risk of osteoporosis' | Yes (SSA standard) | Significant Scientific Agreement | | **Qualified Health Claim** | 'Some evidence suggests X may reduce risk of Y' | Yes (petition required) | Credible evidence (lower bar) | | **Nutrient Content** | 'High in Vitamin C' | No (if meets criteria) | Must meet 21 CFR quantitative thresholds |
Most supplement brands should focus on structure-function claims, which offer the most flexibility with the least regulatory friction. Health claims require significant FDA engagement and are rarely pursued by supplement companies.
Common Mistakes to Avoid
- ✗Mixing claim types on a single label without understanding the different requirements for each
- ✗Not including the required disclaimer for structure-function claims
- ✗Making implied health claims while thinking they're structure-function claims
Related Terms
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