Can Food Products Make Health Claims? A Guide to Regulations

December 7, 2025 •

3 min read

According to regulatory bodies, all health claims on food products must be supported by adequate scientific evidence. While this is a universal truth, navigating the specific rules governing whether can food products make health claims can be a complex and confusing process for both consumers and manufacturers. This article will demystify the regulations and types of claims permitted on food packaging and in advertising.

Quick Summary

Food products can feature health claims, but only under strict national and international regulations, such as those from the FDA and EFSA. Claims must be scientifically substantiated and follow specific guidelines to prevent misleading consumers. Different types of claims, including authorized and qualified, have varying levels of required scientific evidence.

Key Points

Regulation by FDA and EFSA: Food health claims are regulated by governing bodies like the FDA in the US and the EFSA in the EU, both of which require scientific evidence.
Authorized vs. Qualified Claims: In the US, there are 'authorized health claims' with high scientific consensus and 'qualified health claims' with less evidence, requiring a disclaimer.
Structure/Function vs. Health Claims: It is crucial to distinguish between structure/function claims (e.g., 'calcium builds bones') and more regulated health claims (e.g., 'calcium reduces osteoporosis risk').
Scrutinize the 'Health Halo': Consumers should be wary of the 'health halo' effect, where marketing terms like 'natural' or 'low-fat' might misleadingly imply a product is healthier overall.
Full Label Examination is Key: To make informed decisions, consumers should always examine the full nutritional panel and ingredient list, not just the claims highlighted on the front of the package. For more details, consult the {Link: Congress.gov https://www.congress.gov/crs-product/R48623} document.

The Regulatory Landscape for Health Claims

The ability for food products to make health claims is tightly controlled by government agencies worldwide to protect consumers and ensure fair competition. The rules dictate not only the type of claim that can be made but also the level of scientific evidence required to support it. In the United States, the Food and Drug Administration (FDA) is the primary regulatory body, while the European Food Safety Authority (EFSA) oversees regulations within the European Union (EU). These agencies enforce strict standards to prevent deceptive marketing and misinformation, particularly since studies show that a health claim can create a 'halo' effect, causing consumers to perceive a product as healthier than it truly is.

Key Differences Between FDA and EFSA Regulations

The U.S. and EU approach health claims with distinct philosophies and processes. The EFSA's process for approving health claims is generally considered more stringent, with a comprehensive pre-market approval system. This often results in fewer approved claims in the EU compared to the U.S.. The FDA permits structure/function claims without pre-approval if truthful and not misleading, while health claims linking a substance to a disease require formal review.

EU Process: Requires a pre-market assessment by EFSA, based on well-established scientific data.
U.S. Process: Permits 'qualified health claims' with less scientific consensus than authorized claims, requiring a disclaimer.

Types of Claims and Their Requirements

Food products can bear several types of claims, each with different regulatory requirements, such as health claims, nutrient content claims, and structure/function claims. Health claims relate a substance to a disease or health condition, while nutrient content claims describe nutrient levels and structure/function claims describe a nutrient's effect on the body. Health claims may require high scientific consensus or a disclaimer in the U.S., while structure/function claims do not require pre-approval if truthful. To use a health claim, manufacturers must submit a petition with scientific evidence for review.

The Rigorous Path to Health Claim Approval

To use a health claim, manufacturers typically submit a petition with extensive scientific evidence to the relevant regulatory body. This evidence is reviewed to ensure the claim is credible and based on scientific data.

Comparison of Claim Types and Requirements


Claim Type	Scientific Evidence Level	Regulatory Oversight (USA)	Example	Pre-Approval Required (USA)
Authorized Health Claim	Significant Scientific Agreement (SSA)	FDA rulemaking & petition process	“Adequate calcium may reduce osteoporosis risk.”	Yes
Qualified Health Claim	Some credible scientific evidence	FDA enforcement discretion letter with disclaimer	“Scientific evidence suggests... whole grains... may reduce the risk of type 2 diabetes.”	No, but petition is reviewed
Structure/Function Claim	Truthful and not misleading substantiation	FDA (not pre-approved)	“Calcium builds strong bones.”	No
Nutrient Content Claim	Meets regulatory definitions	FDA rulemaking	“Low fat” or “Good source of fiber”	Yes (by definition)

Navigating Misleading Claims and the “Health Halo”

Regulators address the potential for misleading claims, including those not formally classified as health claims. Terms like "natural" are often unregulated and used to imply health benefits that aren't necessarily present. The "health halo" effect can lead consumers to believe a product is healthier based on one positive attribute. Consumers should examine the full nutrition panel and ingredient list to make informed decisions.

Conclusion: Navigating Claims for Better Health

Food products can make health claims under a strict framework of scientific evidence and regulatory oversight. Understanding the types of claims and the approaches of bodies like the FDA and EFSA is essential. For more information, consumers can review resources like the {Link: Congress.gov https://www.congress.gov/crs-product/R48623} document on health claims. Being aware of the 'health halo' effect and reviewing a product's full nutritional profile helps in making genuinely healthy food choices.

Food and Drug Administration: Health Claims

Frequently Asked Questions

A health claim links a food substance to a disease or health-related condition (e.g., 'oatmeal reduces heart disease risk'). A structure/function claim describes how a nutrient affects the body's structure or function (e.g., 'calcium builds strong bones'). Health claims are more strictly regulated and often require pre-approval.

Not necessarily. While 'low fat' is a regulated claim that means the product contains a specific amount of fat or less per serving, the product could still be high in sugar, sodium, or calories. It's important to check the full nutrition facts label.

The term 'natural' is often unregulated and used loosely in marketing to suggest a product is healthy, but it does not have a formal definition by agencies like the FDA. It does not indicate the overall nutritional value or processing of a food.

Regulatory bodies like the FDA and EFSA evaluate the 'totality of publicly available scientific evidence'. For authorized claims, the FDA requires 'significant scientific agreement,' and for qualified claims, it considers some 'credible scientific evidence'.

Yes, regulations differ. The EU, through the EFSA, has a more stringent pre-market approval process for health claims. The U.S. allows some structure/function claims without pre-approval, but requires either authorization or a disclaimer for health claims linking to disease risk.

No. In the U.S., a food cannot carry a health claim if it exceeds specified levels of 'disqualifying nutrients' like fat, saturated fat, sodium, and cholesterol. This is to prevent consumers from being misled by a single positive attribute.

The 'health halo' effect is a psychological phenomenon where consumers perceive a food as healthier than it is based on a single positive claim, like 'antioxidant-rich,' while ignoring other less-healthy aspects, such as high sugar content.