Claims on Labels: Structure/Function vs Disease Claims and the FDA Disclaimer
The kinds of claims allowed on US supplement labels, how a structure/function claim differs from a disease claim, what the FDA disclaimer means, and what it does not.
Content last updated . This page has not been medically reviewed.
The claim as marketed
"Supports a healthy immune system." "Calcium builds strong bones." "Not intended to diagnose, treat, cure or prevent any disease." Phrases like these appear on supplement labels. This page explains what each kind of claim means in US rules as FDA and NCCIH describe them, and what a reader can safely do. It does not rate any product. Other countries use different rules.
What the evidence for such claims is
NCCIH says strong evidence to back up claims made for dietary supplements is often lacking. [1] Its example: a 2022 review identified 27 ingredients frequently included in supplements with immune-function claims, searched for rigorous human studies of each, and found evidence of that type for only eight. [1] NCCIH adds that some of those studies suggested possible benefits but not strongly enough for definite conclusions. [1] Evidence label for this kind of claim in general: marketing claim, to be checked against the specific ingredient, form and population studied.
The claim types FDA describes
| Claim type | What FDA says it is | Pre-approved by FDA? |
|---|---|---|
| Health claim | A claim about the relationship between a dietary ingredient or other food substance and reduced risk of a disease or health-related condition. [2] | Certain types, such as health claims, require premarket review and authorization. [2] |
| Qualified health claim | Supported by less scientific evidence than an authorized health claim, and must carry a disclaimer explaining the level of evidence. [3] | FDA must have issued a letter on conditions for enforcement discretion. [3] |
| Structure/function claim | May describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example "calcium builds strong bones". [4] | No. Not pre-approved; the maker needs substantiation. [4] |
| General well-being claim | Describes general well-being from consumption of a nutrient or dietary ingredient. [4] | No. |
| Nutrient deficiency disease claim | A benefit related to a deficiency disease such as scurvy, allowed only with a statement of how widespread the disease is in the United States. [4] | No. |
| Nutrient content claim | A claim characterizing the level of a nutrient or dietary ingredient in the product. [2] | Different requirements apply. [2] |
Structure/function versus disease claims
NCCIH states that supplement labels cannot claim to diagnose, treat, cure, mitigate or prevent a disease, because such claims are permitted only for drugs. [1] FDA says the disclaimer says the product is not intended to "diagnose, treat, cure or prevent any disease" because only a drug can legally make such a claim. [4] FDA points to its regulation 21 CFR 101.93 and a 2000 final rule for the difference between structure/function claims and disease claims. [4] We did not read those texts, so this page does not draw the dividing line itself.
If a product is marketed with claims that it treats or prevents a disease, FDA says it may consider whether to act against the product as an unlawfully marketed drug. [5] A reader who sees a disease claim on a supplement can treat it as a reason to ask a pharmacist or clinician.
The FDA disclaimer, word for word
FDA's labeling guide gives the required text for a single claim: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." [3] Wording for several claims uses "These statements". The guide says the wording may not be modified. [3] It must be in boldface type no smaller than one-sixteenth of an inch. [3] NCCIH's version of the sentence adds "mitigate". [1]
FDA explains why it exists: these claims are not approved by FDA and do not require FDA evaluation before use, so the law requires a disclaimer informing consumers that FDA has not evaluated the claim. [2]
What the maker must do
FDA says the maker must have substantiation that a structure/function claim is truthful and not misleading, include the disclaimer, and notify FDA no later than 30 days after first marketing. [3] FDA generally does not approve dietary supplement claims or other labeling before use. [2] The Federal Trade Commission regulates advertising, which must be truthful and not misleading. [1]
Risks and what a reader can safely do
- A claim on a label is not evidence about your health, medicines or condition. Ask a pharmacist; see how interactions work.
- Treat words like "standardized", "verified" and "certified" as claims, not guarantees. [1]
- Never delay effective care because a label suggests a supplement helps a condition. Ask your clinician.
- Compare with evaluating safety claims and how supplements are regulated.
- To see how the wider label fits together, read reading supplement labels.
Frequently asked questions
Does the disclaimer mean FDA found the claim false?
No. It tells you FDA has not evaluated the claim. [2]
Can a supplement label say it cures or treats a disease?
NCCIH states it cannot; such claims are permitted only for drugs. [1]
Who checks structure/function claims before sale?
FDA says it generally does not approve them before use; the maker must have substantiation. [2] [4]
Is "supports immune health" proof it works?
No. NCCIH describes limited human evidence for ingredients in such products. [1]
Who regulates supplement advertising?
FDA and the Federal Trade Commission share oversight of dietary supplements and related promotion, with FDA generally responsible for safety, quality and labeling and FTC generally responsible for advertising. [2]
References
- NCCIH, Using Dietary Supplements Wisely. NCCIH, Using Dietary Supplements Wisely. Read 2026-10-22.
- FDA, Questions and Answers on Dietary Supplements. FDA, Questions and Answers on Dietary Supplements. Read 2026-10-22.
- FDA, Dietary Supplement Labeling Guide: Chapter VI. Claims (April 2005). FDA, Dietary Supplement Labeling Guide: Chapter VI. Claims (April 2005). Read 2026-10-22.
- FDA, Structure/Function Claims (content current as of 03/28/2024). FDA, Structure/Function Claims (content current as of 03/28/2024). Read 2026-10-22.
- FDA Consumer Update, Mixing Medications and Dietary Supplements Can Endanger Your Health. FDA Consumer Update, Mixing Medications and Dietary Supplements Can Endanger Your Health. Read 2026-10-22.