What is the Definition of a Health Claim?
A health claim is a statement linking a substance, like a food component, to a disease or health-related condition. These are voluntary statements on product labels and in advertising by manufacturers. They are distinct from nutrient content claims, which describe the amount of a nutrient (e.g., 'low-fat'). An example of a health claim is linking calcium to reduced osteoporosis risk. Due to their influence on consumer health choices, health claims are highly regulated to ensure they are truthful and not misleading.
Types of Health Claims
Regulatory bodies categorize health claims based on the supporting scientific evidence:
- Authorized Health Claims: Supported by robust evidence meeting a "significant scientific agreement" (SSA) standard. The FDA pre-approves these and often provides specific wording, such as the claim about soluble fiber from oats and reduced heart disease risk.
- Qualified Health Claims: Backed by some scientific evidence, but not meeting the SSA standard. These require a disclaimer stating the evidence is limited or not conclusive.
- Structure/Function Claims: Describe a nutrient's role in the body's normal structure or function, like 'Calcium builds strong bones'. They do not mention diseases and don't require FDA pre-approval for conventional foods. Dietary supplements using these claims typically require a disclaimer.
The Role of Regulatory Bodies
The FDA regulates health claims in the U.S.. The EU has the EFSA to evaluate scientific evidence, while FSANZ does the same in Australia and New Zealand. These bodies ensure claims are scientifically substantiated and not misleading.
The Substantiation Process for Health Claims
Substantiating a health claim is a rigorous process. For authorized U.S. claims, a petition with comprehensive scientific evidence must be submitted to the FDA, demonstrating significant scientific agreement. Qualified claims require credible supporting evidence, although the standard is lower.
Key substantiation requirements include:
- Evidence from well-designed studies, like clinical trials.
- Demonstration of the substance's beneficial effect.
- Reference to the food as consumed and quantity needed for the effect.
- Claims must not be misleading or raise safety concerns about other foods.
Health Claim vs. Structure/Function Claim: A Comparison
| Feature | Health Claim | Structure/Function Claim |
|---|---|---|
| Primary Purpose | Connects a substance to the reduced risk of a disease or health condition. | Describes the role of a substance in maintaining normal structure or function. |
| Regulatory Requirement | Requires regulatory body pre-approval (e.g., FDA authorization) based on rigorous scientific evidence (SSA). | Does not require regulatory pre-approval. Must be truthful and substantiated, but evidence is not submitted upfront. |
| Disease Reference | Expressly states or implies a relationship with a disease or health-related condition. | Cannot refer to a specific disease, but rather a normal physiological function. |
| Example | “Diets low in saturated fat and cholesterol may reduce the risk of heart disease.” | “Calcium helps build strong bones.” |
| Disclaimer | None required for authorized claims. Qualified claims require a disclaimer stating the evidence is not conclusive. | Required for dietary supplements stating the FDA has not evaluated the claim and it's not meant to treat any disease. Not required for conventional foods. |
Conclusion
The definition of a health claim involves a statement linking a food substance to a disease or health condition, distinct from structure/function claims which describe normal bodily roles. Regulatory bodies like the FDA rigorously regulate health claims to ensure they are scientifically supported and prevent consumer deception. Understanding these regulations helps consumers make informed choices and ensures manufacturers comply with legal requirements. More information on U.S. authorized health claims is available on the FDA website.
