What Defines a Health Claim?
A health claim is a statement made on a food label or in advertising that describes the relationship between a food component and a reduced risk of a disease or a health-related condition. In the United States, these claims are regulated by the U.S. Food and Drug Administration (FDA) to ensure they are based on publicly available scientific evidence and are truthful and not misleading. For a manufacturer to use a health claim, they must submit a petition to the FDA with scientific evidence to support it.
Types of Health Claims
The FDA recognizes two main types of health claims: authorized and qualified. Understanding the difference is crucial for interpreting food labels correctly.
- Authorized Health Claims: These claims are backed by significant scientific agreement (SSA) among qualified experts. The FDA has reviewed and approved the scientific evidence for these claims, publishing them in a final rule. This means there is a high degree of certainty about the relationship between the substance and the reduced disease risk. Examples include the relationship between calcium and a reduced risk of osteoporosis or the link between dietary fat and cancer risk.
- Qualified Health Claims: These claims are supported by scientific evidence, but they do not meet the more stringent SSA standard required for authorized claims. To prevent consumers from being misled, these claims must be accompanied by qualifying language. This language clearly states that the evidence is not conclusive. For example, a qualified claim might read, "Scientific evidence suggests, but does not prove, that X may reduce the risk of Y disease". The FDA issues a letter of enforcement discretion for these claims, permitting their use with the appropriate qualifiers.
Health Claims vs. Other Food Label Statements
It is easy to confuse health claims with other types of claims found on food labels. Recognizing the distinctions is key to making informed dietary choices. Two common types of statements that differ from health claims are nutrient content claims and structure/function claims.
Nutrient Content Claims
Unlike health claims, which focus on disease risk reduction, a nutrient content claim describes the level of a particular nutrient in a food. These claims use terms like "high in fiber," "low in fat," or "good source of calcium". To use these terms, manufacturers must meet specific, predefined criteria set by the FDA. For instance, a food labeled "low sodium" must contain 140 mg or less of sodium per serving.
Structure/Function Claims
Structure/function claims describe the role of a nutrient or ingredient in affecting the normal structure or function of the human body. A key difference is that these claims cannot mention a disease. For example, the statement "calcium helps build strong bones" is a structure/function claim because it refers to the function of bones, not a disease like osteoporosis. These claims do not require pre-market approval from the FDA, but they must be truthful and not misleading. Dietary supplements must also carry a disclaimer stating that the claim has not been evaluated by the FDA and the product is not intended to diagnose, treat, or cure any disease.
How to Interpret Health Claims Effectively
When you see a health claim on a food package, consider the following:
- Check the type of claim: Is it an authorized or a qualified claim? Look for qualifying language. A qualified claim indicates that the scientific evidence is not yet conclusive.
- Read the fine print: Health claims often have specific conditions. For example, a claim about whole grains and diabetes risk may specify the amount of whole grains needed per day as part of a low-fat, low-cholesterol diet.
- Analyze the product context: Just because a food has one health-benefiting component doesn't make it universally healthy. A cereal might boast a claim about whole grains, but it could also be high in added sugars. Always check the full Nutrition Facts panel.
- Look for disclaimers: If the product is a dietary supplement, there should be a clear disclaimer that the FDA has not evaluated the claim.
Navigating the Comparison: Health vs. Nutrient vs. Structure/Function Claims
| Feature | Health Claim | Nutrient Content Claim | Structure/Function Claim |
|---|---|---|---|
| Regulatory Body (U.S.) | FDA Pre-approval Required for Authorized Claims | FDA Defines Specific Terms | No FDA Pre-approval |
| Focus | Relationship between food substance and disease risk reduction | Level of a nutrient or substance in the food | Role of a nutrient in supporting normal bodily function |
| Scientific Evidence | Significant Scientific Agreement (SSA) for Authorized; Qualified evidence for Qualified | Based on specific, established criteria | Based on generally accepted scientific evidence |
| Example | “Adequate calcium may reduce osteoporosis risk” | “Good source of calcium” | “Calcium helps build strong bones” |
| Qualifying Language | Mandatory for Qualified Claims | Not Required (standardized terms) | Required for supplements (FDA has not evaluated) |
Conclusion
Understanding what is a health claim on a food label is a crucial skill for any health-conscious consumer. Health claims link a nutrient or food to a reduced risk of disease and are highly regulated by authorities like the FDA. By distinguishing between authorized health claims, qualified health claims, nutrient content claims, and structure/function claims, you can more accurately assess the benefits of a product and avoid falling for marketing ploys. Always scrutinize the label in its entirety, reading both the health claims and the nutrition information panel to get a complete picture of a food's nutritional value. This proactive approach ensures you make decisions based on science and not simply on marketing messages. This knowledge empowers you to be a savvier shopper, ultimately supporting a healthier lifestyle.
The FDA’s Role in Regulating Health Claims
The FDA's regulation of health claims serves a vital public health function by ensuring consumers are not misled by unproven statements. The process for authorizing a health claim is rigorous, involving a review of extensive scientific data, including human studies. For qualified health claims, the process is less strict, but the requirement for a disclaimer maintains transparency about the level of scientific support. The FDA's regulations for health claims, established under the Nutrition Labeling and Education Act of 1990 (NLEA), aim to strike a balance between allowing manufacturers to provide health-related information and protecting consumers from deceptive marketing practices.
