What are health claims based on?

November 20, 2025 •

3 min read

According to the Food and Drug Administration (FDA), authorized health claims must be supported by "significant scientific agreement" among qualified experts. This stringent standard is at the core of what are health claims based on, ensuring that a product's health-related promises are grounded in robust, peer-reviewed data.

Quick Summary

Health claims are based on scientific evidence, clinical trials, and strict regulatory oversight from bodies like the FDA and EFSA. They must be truthful and not misleading, with different tiers of claims distinguished by the strength of evidence. The regulation aims to protect consumers and ensure transparency on food and supplement labels.

Key Points

Scientific Evidence: Health claims must be substantiated by a body of scientific research, which includes systematic reviews of relevant studies and a consensus among qualified experts.
Regulatory Oversight: Agencies like the FDA and EFSA regulate health claims to ensure they are truthful, not misleading, and based on valid scientific data.
Clinical Trials: Robust, ethically conducted clinical trials are often required to provide the human-specific data needed to support stronger health claims, especially those concerning disease risk reduction.
Claim Categorization: Regulatory frameworks, such as the FDA's, classify claims into categories like Authorized, Qualified, and Structure/Function, each with different evidentiary standards and labeling requirements.
Consumer Protection: Regulations exist to protect consumers by preventing misleading product labeling and ensuring claims are not made on foods with poor nutrient profiles, such as those high in sugar or salt.
Different Levels of Assurance: The level of scientific agreement dictates the strength of a claim. Higher-level claims referring to disease risk require more substantial proof and regulatory pre-approval.
Continuous Evolution: The scientific and regulatory landscape for health claims is always evolving, with ongoing research and updates to standards that dictate what claims are permissible.

The Scientific Foundation of Health Claims

Health claims on food and dietary supplements are regulated statements about the link between a substance and its effect on health. Determining what health claims are based on involves a review of scientific evidence by regulatory bodies. This process aims to prevent misleading information and build consumer trust. Scientific substantiation can include literature reviews and clinical trials. Regulatory bodies like the FDA and the EFSA set high standards for this evidence. Authorized claims require significant evidence accepted by the scientific community.

The Role of Clinical Trials

Clinical trials are vital for claims related to disease risk reduction. These studies involve human participants to answer health questions. Trials supporting health claims follow strict protocols and ethical guidelines to ensure safety and gather data. High-quality clinical trials help companies demonstrate product efficacy and safety, providing data for regulatory approval and marketing. Evidence must be relevant to the target population and align with scientific norms.

Regulation of Health Claims

Regulatory agencies evaluate and authorize health claims, with scrutiny varying by claim type. The U.S. FDA categorizes claims as follows:

Authorized Health Claims: These meet the highest standard of evidence, Significant Scientific Agreement (SSA), and are authorized by FDA rule after reviewing studies. An example is calcium and vitamin D reducing osteoporosis risk.
Qualified Health Claims: Supported by credible but less stringent evidence than SSA. They require a qualifying statement explaining the uncertainty.
Structure/Function Claims: Describe a nutrient's effect on body structure or function without mentioning specific diseases. Examples include "calcium builds strong bones". Manufacturers must ensure accuracy and notify the FDA, but pre-approval is not required.

Comparison of Health Claim Types (U.S. Regulation)


Feature	Authorized Health Claims	Qualified Health Claims	Structure/Function Claims
Level of Evidence	Significant Scientific Agreement (SSA)	Credible evidence, but less than SSA	Truthful and not misleading
Relationship Mentioned	Substance to a specific disease or health-related condition	Substance to a specific disease or health-related condition	Nutrient or ingredient to the structure/function of the body
Pre-Approval by FDA	Required	Required for claims regarding a disease risk reduction	Not required, but FDA must be notified
Qualifying Language	Not needed	Mandatory to explain uncertainty	Not needed, but often accompanied by a disclaimer stating "This statement has not been evaluated by the FDA."

How Consumers Perceive and Use Claims

Regulators aim for clear health claim information due to varied consumer understanding. Many consumers use label information, but the distinction between claim types can be unclear. Consumers may view claims with skepticism. Clear, accurate wording backed by science is essential. Regulators balance communicating benefits with protecting consumers from misleading claims. This includes regulating claim content and ensuring claims aren't on unhealthy products. The European Food Safety Authority (EFSA) also harmonizes scientific assessment of health claims in the EU.

Conclusion: The Evolving Basis of Health Claims

The scientific basis for health claims is dynamic, driven by research and regulation. What health claims are based on includes rigorous scientific evidence, clinical trials, and regulatory enforcement. Understanding claim types and oversight helps consumers make informed choices. As science and public health evolve, so do the standards for health claims, balancing truthful communication and consumer protection.

Frequently Asked Questions

An authorized health claim is a statement approved by a regulatory body, like the FDA, that links a substance to a disease or health-related condition, based on a high standard of scientific evidence known as 'significant scientific agreement'.

A qualified health claim is supported by credible scientific evidence, but the evidence does not meet the higher standard required for an authorized claim. It must include specific qualifying language to inform consumers of the lower level of scientific certainty.

No, structure/function claims, which describe a nutrient's role in the body, do not require FDA pre-approval but must be truthful and not misleading. The manufacturer is responsible for the claim's accuracy and must notify the FDA.

No. All health claims must be substantiated by scientific evidence and comply with regulatory standards. Regulatory bodies pre-approve certain claims, and companies can only use new, self-substantiated general claims after a detailed review and notification process.

Clinical trials provide crucial human-based data to scientifically substantiate health claims, particularly those related to disease risk reduction. They help prove a product's safety and efficacy under controlled, ethical conditions.

Regulators, such as the FDA, require that all health claims are based on substantial scientific evidence. They also prohibit claims on certain foods that don't meet nutritional criteria, like those high in sugar or fat, and demand clear qualifying language for claims with less conclusive evidence.

Significant Scientific Agreement (SSA) is the consensus among qualified scientific experts that a health claim is well-supported by a robust and conclusive body of evidence. It is the highest level of evidence required for an authorized health claim.