Understanding the Rules: Are nutrition and health claims regulated by the FDA?

October 17, 2025 •

2 min read

The U.S. Food and Drug Administration (FDA) confirms that all nutrition-related claims on food and dietary supplements must be truthful and not misleading, a requirement enforced under the Federal Food, Drug, and Cosmetic Act. However, the level of regulation and the requirements for using a claim depend heavily on the type of claim being made, creating a multi-tiered system for consumer protection.

Quick Summary

The FDA regulates various types of nutrition and health claims on food and dietary supplements, enforcing different standards based on the claim's category. Regulation is divided into health claims, nutrient content claims, and structure/function claims, with varying levels of review and approval requirements.

Key Points

Claim Types Vary in Regulation: The FDA regulates health claims, nutrient content claims, and structure/function claims differently based on their specific content.
Authorized Health Claims Need Pre-Approval: Claims linking a substance to reduced disease risk require FDA pre-approval based on 'significant scientific agreement'.
Qualified Health Claims Use Disclaimers: Claims with credible but less conclusive evidence must include a disclaimer.
Nutrient Content Claims Must Meet Definitions: Statements like 'low sodium' must meet strict, specific criteria defined by FDA regulations.
Structure/Function Claims Need Substantiation: Manufacturers are responsible for ensuring these claims are truthful and scientifically substantiated.
Dietary Supplements Have Special Rules: Dietary supplements using structure/function claims must carry a specific disclaimer.
Enforcement Occurs Post-Market: FDA primarily relies on post-market enforcement to ensure compliance and act against false claims.

The landscape of nutrition and health claims on product packaging can be confusing for consumers. When reading a label that boasts a product is “high in fiber” or “supports immune health,” it is natural to wonder what level of oversight ensures these statements are accurate. The short answer is yes, the U.S. Food and Drug Administration (FDA) actively regulates these claims, but the process is far from a one-size-fits-all approach. The agency enforces a layered regulatory system depending on the specific claim type.

The Different Types of Food and Supplement Claims

The FDA has established three categories of claims for foods and dietary supplements: Health Claims, Nutrient Content Claims, and Structure/Function Claims. Health Claims describe a relationship between a food substance and a reduced risk of a disease. Nutrient Content Claims characterize the level of a nutrient. Structure/Function Claims describe the role of a nutrient or ingredient in affecting the body's structure or function. Each category is subject to a different level of FDA scrutiny.

Health Claims and the FDA's Approval Process

Health claims, requiring FDA pre-market approval, fall into two categories: authorized and qualified. Authorized health claims need significant scientific agreement and require a petition to the FDA. Qualified health claims have less conclusive scientific evidence and must include a disclaimer.

Nutrient Content Claims: Defining Nutritional Levels

Nutrient content claims describe the level of a nutrient and must meet strict FDA criteria. The FDA recently updated the criteria for the “healthy” claim.

Structure/Function Claims: How Nutrients Affect the Body

Structure/function claims describe how a nutrient affects the body's structure or function. These do not require pre-market FDA approval for conventional foods but must be truthful, not misleading, and scientifically substantiated. For dietary supplements, these claims must include a specific disclaimer {Link: Congress.gov https://www.congress.gov/crs-product/R48623}. This distinguishes supplements from drugs, which require rigorous approval.

FDA Regulation Comparison: Health vs. Nutrient vs. Structure/Function Claims

A comparison of the regulation of Health Claims, Nutrient Content Claims, and Structure/Function Claims can be viewed in the table on {Link: Congress.gov https://www.congress.gov/crs-product/R48623}.

Oversight and Enforcement: Protecting Consumers

FDA oversight varies by claim type. The FDA monitors, inspects, and investigates. False claims can result in enforcement actions. DSHEA places initial responsibility for substantiating supplement claims on manufacturers.

Conclusion

The FDA's regulation of nutrition and health claims is vital for ensuring truthful labeling and protecting consumers. The system is complex, with varying levels of scrutiny based on claim type. Health claims undergo rigorous review, nutrient content claims must meet criteria, and structure/function claims require substantiation and, for supplements, a disclaimer. Consumers can make informed choices by understanding these regulations. For more details, consult the FDA's website.

Frequently Asked Questions

A health claim describes the relationship between a substance and reduced disease risk, requiring FDA review. A structure/function claim describes how a nutrient affects body structure or function, doesn't require pre-market approval, and cannot mention disease.

No, the FDA does not 'approve' qualified health claims. If there is credible but limited scientific evidence, the FDA may allow the claim with a disclaimer.

Dietary supplement claims fall under the same categories as food claims. Structure/function claims on supplements don't require FDA approval but must carry a disclaimer. Health claims on supplements require FDA review.

Examples include 'low fat,' 'good source of fiber,' 'excellent source of calcium,' or the updated 'healthy' claim. Each must meet specific FDA definitions.

No. Claims of diagnosing, treating, curing, or preventing a disease are drug claims and illegal for foods or dietary supplements. These products require full FDA drug approval.

If a company makes a false claim, the FDA can take enforcement action, including warning letters or recalls. Manufacturers are responsible for substantiating their claims.

Consumers can check the FDA's website for a list of authorized health claims. These are based on significant scientific agreement and backed by FDA regulations.