Substantiation Risk Assessment
Assess the regulatory risk level of claims you plan to make about a dietary supplement product. Based on the FTC Health Products Compliance Guidance (2022) and FDA requirements.
This is an educational tool, not legal advice. Claim classification is subjective and context-dependent. The FTC evaluates the overall net impression of advertising, not just individual statements. Always consult a qualified regulatory attorney before making claims about dietary supplement products.
Example: how the assessment works
Moderate riskStructure/function claim with clinical evidence on file
Very high riskSame claim with no human clinical trial at the claimed dose
Answer the questions below to assess your specific claims.
1. Claim type
2. Risk factors
3. Assessment
What type of claim are you making?
Select the category that best describes the claim you want to make about your dietary supplement product.