VITAMINS & SUPPLEMENTS · GUIDE
Structure-Function Claims vs Health Claims vs Disease Claims on Supplements
What the three kinds of supplement label claim mean under US FDA rules, how they differ in approval and wording, and what research says about how shoppers read them.
Content last updated . This page has not been medically reviewed.
Back to Compare SupplementsThe question
A supplement label that says "supports heart health" and one that says "reduces the risk of heart disease" sound close. Under United States rules they are different kinds of claim with different requirements. This page explains the three kinds, what each needs before it can appear, and what research says about how people understand them. It is about the US (FDA); other countries use other systems, see Supplement Regulation by Country. It does not say whether any product works.What each kind of claim is
| Claim type | What it is, in FDA's words or rules | What must happen first | Caution |
|---|---|---|---|
| Structure/function claim | Describes the role of a substance intended to maintain the structure or function of the body. [1] | The firm needs substantiation that it is truthful and not misleading, must include a set disclaimer, and must notify FDA within 30 days of first marketing. [1] FDA does not preapprove it. [1] | "Not preapproved" is not the same as "proven". |
| Health claim | An explicit or implied link between a substance and a disease or health-related condition. [1] | Requires FDA evaluation and authorization before use. [1] A "qualified" version rests on less scientific evidence and must carry an explanatory disclaimer. [1] | Only certain wording is permitted; check the exact words. |
| Disease claim | A statement that a product diagnoses, mitigates, treats, cures or prevents a disease. [2] | If a supplement label carries one, the product is regulated as a drug, unless the claim is an authorized health claim the product qualifies for. [2] | A supplement is not permitted to say this on its own authority. |
The required disclaimer
A structure/function claim must be accompanied by this wording: "This statement has not been evaluated by the Food and Drug Administration." [2] followed by the sentence that the product is not intended to diagnose, treat, cure, or prevent any disease. [2] It must appear in boldface type. [2] The disclaimer is the clue that a claim is the structure/function kind.How a "disease" is defined and how claims can slip across the line
FDA's rule defines a disease as damage to an organ, part, structure, or system of the body such that it does not function properly. [2] Classical nutrient-deficiency diseases such as scurvy are excluded from that definition. [2] FDA also says that implied claims count: a statement can be a disease claim through the effect it describes on signs or symptoms, [2] or through pictures, vignettes, symbols, or other means. [2] FDA says it considers the context in which the claim is presented. [2]What research says about how people read these claims
- Survey evidence, US adults (2025). In two randomized online surveys, people who saw a "Supports Heart Health" fish oil label were more likely than people who saw a no-claim label to say it prevents heart attacks (62.5% vs 53.9%). [3] The authors concluded these claims were often misinterpreted as implying a disease-specific benefit, contrary to their regulatory intent. [3]
- Experiment, nationally representative sample (2026, legal journal). Consumers clearly distinguished disease claims from nutrient content claims but treated structure/function and health claims as equivalent. [4]
- Proper evidence not found that shoppers can reliably tell structure/function and health claims apart. We searched PubMed for studies of label-claim interpretation; the two above were the relevant ones we read, and both are surveys, not tests of whether products work.
No universal winner
One type of claim is not "better" than another. They are different legal categories, and the strength of the evidence behind any one product is a separate question. For how to read the rest of a label see Reading Supplement Labels and Comparing Supplement Labels.Frequently asked questions
Does "supports immune health" mean the product prevents illness?
No. It is worded as a structure/function claim, which describes a role in the body and carries the disclaimer that the product is not intended to prevent any disease. [2] In a US survey, though, many shoppers read such claims as disease benefits. [3]
Does FDA approve structure/function claims?
No. They do not require preapproval; the firm must have substantiation and notify FDA within 30 days of first marketing. [1] This text is from FDA's 2005 labeling guide, which is marked as containing nonbinding recommendations. [1]
What is a qualified health claim?
It is a health claim supported by less scientific evidence than an authorized one, and FDA requires a disclaimer explaining the level of evidence. [1]
What happens if a supplement label says it treats a disease?
FDA's rule says the product will be regulated as a drug unless the claim is an authorized health claim it qualifies for. [2]
Does this apply outside the US?
These are US FDA rules. Other regions differ; see Supplement Regulation by Country. We did not read non-US claim rules for this page.
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
How to read the evidence labels
Labels used on this page: established regulatory definition (a rule the regulator publishes), survey evidence (what shoppers said in a study) and Proper evidence not found (we looked and did not find usable material).
Safety and who should ask a clinician
A permitted claim says nothing about safety or effect in a particular person. FDA says it is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. [5] It advises talking with a doctor, pharmacist, or other healthcare professional before deciding to use a supplement. [5] That matters most if you take medicines (see Medication Interactions), are pregnant or breastfeeding, are giving something to a child, have kidney or liver conditions, or have surgery planned. For a wider checklist see Supplement Safety Resources. Never replace a prescribed medicine because of a label.
References
- U.S. Food and Drug Administration. Dietary Supplement Labeling Guide: Chapter VI. Claims (April 2005, nonbinding recommendations). Read 2026-10-22.
- Electronic Code of Federal Regulations. 21 CFR 101.93, Certain types of statements for dietary supplements. Read 2026-10-22.
- Assadourian JN, Peterson ED, Navar AM. Label Statements and Perceived Health Benefits of Dietary Supplements. JAMA Netw Open. 2025;8(9):e2533118. Read 2026-10-22.
- Iuliano J, Kilbride M. Supplement Semantics: An Experiment on Health Claims. Am J Law Med. 2026;52(2):207-238. Read 2026-10-22.
- U.S. Food and Drug Administration. Information for Consumers on Using Dietary Supplements (content current as of 10/21/2022). Read 2026-10-22.
Education, not medical advice. This page is for general information. It does not diagnose or treat any condition and is not a substitute for care from a qualified health professional. Natural does not automatically mean safe. Ask a clinician or pharmacist before changing your care, especially if you take medication, are pregnant or breastfeeding, or have a health condition.