What Is Structure–Function Claim?
A statement describing the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body. This is the primary type of claim permitted on dietary supplement labels under DSHEA.
Why It Matters for Supplement Brands
Structure–function claims are the backbone of supplement marketing. They determine what you can legally say on your label, website, Amazon listing, and advertising. Getting them wrong can trigger FDA warning letters, Amazon listing suspensions, or FTC enforcement action. Getting them right — with proper substantiation — is a competitive advantage.
How It Works
Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, supplement manufacturers can make claims about how their product affects the body's structure or function without FDA pre-approval, provided the claims are: (1) truthful and not misleading, (2) substantiated by competent and reliable scientific evidence, and (3) accompanied by the disclaimer: 'This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.' The manufacturer must notify the FDA within 30 days of first marketing with the claim.
Examples of compliant structure–function claims: • 'Supports healthy immune function' • 'Helps maintain joint comfort and mobility' • 'Promotes restful sleep'
Examples of non-compliant claims (these are disease claims): • 'Prevents colds' (implies disease prevention) • 'Reduces arthritis pain' (references a disease) • 'Cures insomnia' (implies treatment of a condition)
Common Mistakes to Avoid
- ✗Using language that implies disease treatment, prevention, or cure — even subtly ('protects against', 'fights', 'anti-inflammatory')
- ✗Failing to file the 30-day notification with FDA after first use of the claim
- ✗Omitting the required disclaimer from the product label
- ✗Making claims that are not substantiated by clinical evidence
- ✗Using the same claims on food products (different rules apply to conventional foods vs. supplements)
Related Terms
See It in Action
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