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What are health claims on food products?

4 min read

According to the U.S. Food and Drug Administration (FDA), a health claim is any statement that describes a relationship between a food substance and a reduced risk of a disease or health-related condition. Understanding what are health claims on food products is essential for making informed dietary choices.

Quick Summary

Health claims are manufacturer statements that connect a food or ingredient with a reduced disease risk. They are categorized as authorized, qualified, or structure/function claims, each with different regulatory standards. Evaluating these claims requires understanding regulatory oversight, interpreting scientific evidence, and distinguishing them from other nutritional messages.

Key Points

  • Categorization: Health claims fall into three main categories: Authorized (strongest evidence), Qualified (moderate evidence with a disclaimer), and Structure/Function (describes role in body function).

  • Regulatory Scrutiny: Authorized health claims require FDA pre-approval and are based on significant scientific agreement, while structure/function claims do not.

  • Distinction from Nutrient Claims: Health claims link a food to a disease risk reduction, whereas nutrient content claims simply state the level of a nutrient, e.g., 'low-fat'.

  • Crucial Caveat: Qualified and structure/function claims, especially on dietary supplements, often come with a disclaimer that consumers must read carefully to understand the level of scientific backing.

  • Informed Choice: Always evaluate the entire Nutrition Facts label, not just the health claim, to assess a product's overall nutritional quality.

  • Evidence Matters: For structure/function claims, manufacturers must have scientific evidence to back their claims, even though they don't need pre-approval from the FDA.

  • Purpose: Health claims are intended to provide consumers with valuable information but must be interpreted correctly to avoid misleading assumptions.

In This Article

Deciphering Health Claims on Food Packaging

Food labels can be a confusing mix of numbers, percentages, and marketing phrases. Among the most prominent are health claims, statements suggesting a relationship between a food and a health-related condition. These claims are not all created equal and are subject to varying levels of scientific scrutiny and regulation depending on the country. For example, in the United States, the Food and Drug Administration (FDA) is the primary regulatory body, while the European Food Safety Authority (EFSA) oversees regulations in the EU.

Types of Health Claims Explained

Regulatory bodies, such as the FDA, classify health claims into different categories based on the strength of the scientific evidence supporting them.

  1. Authorized Health Claims: These claims are backed by the highest level of scientific evidence and significant scientific agreement (SSA) among qualified experts. The FDA, in the U.S., must review and approve these claims through a formal petition process before they can be used. There is strong, conclusive evidence of the substance's effect. An example is the claim that a diet low in total fat and cholesterol and rich in whole grain foods may reduce the risk of heart disease.

  2. Qualified Health Claims: These claims are based on scientific evidence, but the standard of proof is lower than for authorized claims. They must be accompanied by a qualifying statement that explains the uncertainty of the science. The FDA allows these claims based on enforcement discretion. An example might state, “Scientific evidence suggests, but does not prove, that [substance] may reduce the risk of [disease]”.

  3. Structure/Function Claims: These claims describe the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body. Unlike health claims, they do not require FDA pre-approval, but the manufacturer must have scientific evidence to substantiate the claim. For dietary supplements, a specific disclaimer must be included, stating that the FDA has not evaluated the statement and the product is not intended to diagnose, treat, cure, or prevent any disease. Examples include “Calcium builds strong bones” or “Fiber promotes regularity”.

The Crucial Difference: Health vs. Nutrient Content Claims

It's important to distinguish health claims from nutrient content claims, which are also found on food packaging. While health claims link a food substance to a disease or health-related condition, nutrient content claims describe the level of a specific nutrient in a food.

  • Nutrient Content Claim Example: “Low-fat” or “high-fiber”. The regulations for these claims set specific criteria that must be met. For example, to be labeled “low-fat,” a food product must contain 3 grams of fat or less per serving.

  • Health Claim Example: “Diets low in saturated fat and cholesterol that include soluble fiber from whole grain oats may reduce the risk of heart disease”. This links the fiber to a specific health outcome.

A Comparative Look at Claim Types

Feature Authorized Health Claims Qualified Health Claims Structure/Function Claims
Scientific Evidence Significant Scientific Agreement (SSA) among experts. Supportive but less robust than SSA. Reasonable evidence to support the claim.
FDA Approval Requires pre-approval via a petition process. Requires FDA to issue a letter of enforcement discretion. No pre-approval required; notification must be sent to FDA.
Claim Language Direct statement of substance-disease relationship. Must include a qualifying statement indicating uncertainty. Describes nutrient's role in body structure/function.
Disease Reference Refers to disease or health-related condition risk reduction. Refers to disease or health-related condition risk reduction. Cannot reference or imply treatment or prevention of a disease.
Example “Adequate Calcium may reduce osteoporosis risk”. “Scientific evidence suggests...that whole grains...may reduce the risk of type 2 diabetes”. “Vitamin D supports immune function”.

How to Navigate Health Claims as a Consumer

To make the best choices for your diet, it's crucial to look beyond the marketing and understand the context of the claims being made.

  • Read the Small Print: Pay close attention to the disclaimer for qualified and structure/function claims, especially on dietary supplements.
  • Check the Evidence: For structure/function claims, be aware that manufacturers are not required to submit their evidence to the FDA for review, but they must be able to substantiate the claim if challenged.
  • Examine the Whole Product: A product may carry a health claim but still be high in sugar, fat, or sodium. Always read the Nutrition Facts label to understand the product's full nutritional profile.
  • Look for Reputable Sources: Check if the health claim has been authorized by a recognized body like the FDA, as these are subject to the highest level of scrutiny.
  • Consult a Professional: For serious health conditions, relying on a food label is never a substitute for advice from a healthcare provider or a registered dietitian.

Conclusion

Understanding what are health claims on food products is vital for modern consumers. They serve as a powerful marketing tool but are also regulated statements about a food's potential health benefits. By distinguishing between authorized, qualified, and structure/function claims, and by always cross-referencing with the Nutrition Facts panel, you can cut through the marketing noise. Relying on scientifically validated information and understanding regulatory oversight empowers you to make informed decisions that support a healthy and balanced diet.

Food and Drug Administration: Health Claims

Frequently Asked Questions

An authorized health claim is backed by the highest level of scientific evidence and is pre-approved by the FDA. A qualified health claim is supported by less robust evidence and must include a qualifying statement indicating the scientific uncertainty.

No, the FDA does not pre-approve all health claims. Only authorized health claims undergo a formal pre-approval process based on significant scientific agreement. Structure/function claims, for example, do not require FDA pre-approval but must be substantiated by the manufacturer.

No, 'low-fat' is a nutrient content claim, not a health claim. A nutrient content claim describes the level of a nutrient in a food, while a health claim links a substance to a health-related condition or reduced disease risk.

A structure/function claim describes the role of a nutrient or dietary ingredient in affecting the normal structure or function of the body, such as "calcium builds strong bones". It is different because it does not refer to reducing the risk of a specific disease and does not require FDA pre-approval.

Disclaimers are typically required for qualified health claims and structure/function claims on dietary supplements. They inform consumers that the scientific evidence is not as strong as for an authorized claim or that the FDA has not evaluated the statement.

Check if the claim is authorized by a reliable regulatory body, read any accompanying disclaimers carefully, and don't rely solely on the claim. Always review the product's full Nutrition Facts panel to understand its overall nutritional content.

Yes, regulations vary by country. For example, the European Food Safety Authority (EFSA) regulates health claims in the EU, with its own set of standards and approved claims. It is important to be aware of the specific regulatory body in your region.

No, food companies cannot simply invent health claims. In most regulated markets, any health claim must be based on scientific evidence and comply with specific regulations established by governing bodies like the FDA or EFSA. Unauthorized or unsubstantiated claims can lead to regulatory action.

Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.