Master Structure/Function Claims: Boost Your Food Brand's Appeal
Unlock the power of structure/function claims to highlight your food product's benefits legally and effectively. This guide provides practical steps for CPG brands to craft compliant and compelling claims, enhancing consumer trust and market appeal. Learn how to differentiate your products with integrity.
- ✓ Verify all claims with solid scientific evidence.
- ✓ Use precise, compliant language and mandatory disclaimers.
- ✓ Link claims to production data for full traceability.
Understand FDA Claim Categories
Differentiate between structure/function, health, and nutrient content claims. Structure/function claims describe the role of a nutrient or ingredient in maintaining normal structure or function in the body (e.g., 'calcium builds strong bones'). They do not require pre-market FDA approval but must be truthful and substantiated, and the product cannot claim to diagnose, cure, mitigate, treat, or prevent disease.
Substantiate Your Claims Rigorously
Before making any structure/function claim, ensure you have robust scientific evidence to support it. This often involves peer-reviewed studies, clinical trials, or established scientific consensus. Document all substantiation thoroughly, as the FDA can request it. Lack of proper substantiation can lead to costly enforcement actions and damage your brand's reputation and consumer trust.
Craft Compliant Claim Language
Formulate claims that clearly describe the benefit without implying disease treatment or prevention. Use phrases like 'supports,' 'maintains,' or 'helps' rather than 'cures' or 'treats.' Always include the mandatory disclaimer: 'These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.' Place it prominently near the claim.
Implement Claims with Traceability
Integrate claim management with your CPG operations platform like Guidance. Ensure ingredient sourcing, formulation changes, and batch records align with your claims for full traceability. This helps in managing organic mass balance, lot traceability, and FSMA 204 compliance, providing an auditable trail for every product claim. Maintain consistent documentation from raw material to finished good.
Put This Into Practice with Guidance
Guidance automates the workflows behind this guide — built specifically for CPG brands.
Apply as a Design Partner →Frequently Asked Questions
What is the key difference between a structure/function claim and a health claim?
Structure/function claims describe the role of a nutrient in the body and do not require pre-market FDA approval. Health claims describe a relationship between a food substance and a reduced risk of a disease and require significant scientific agreement and FDA authorization.
Do I need FDA approval before using a structure/function claim?
No, structure/function claims do not require pre-market FDA approval. However, you must notify the FDA within 30 days of marketing a product with such a claim, and you are responsible for ensuring its truthfulness and scientific substantiation.
What happens if a structure/function claim is found to be unsubstantiated?
If a claim is found unsubstantiated, the FDA can issue warning letters, require product recalls, or impose fines. This can also severely damage your brand's reputation and consumer trust, leading to significant financial losses.