Structure/Function ClaimStructure/Function Claim (DSHEA §403(r)(6))
A structure/function claim is the on-label claim category created by DSHEA (FD&C Act §403(r)(6)) that lets a dietary supplement describe the role of a nutrient or dietary ingredient in maintaining the structure or function of the body — 'calcium builds strong bones,' 'fiber promotes regularity,' 'St.
Read the full summary
John's Wort supports a positive mood' — without triggering the drug-claim threshold of §201(g). It requires the FDA disclaimer, a 30-day post-market notification to FDA, competent and reliable scientific substantiation on file, and tight discipline at the line between a permitted maintenance claim and a forbidden disease claim.
On this page · 8 sections
- 1What a structure/function claim is — and what it is not
- 2Three claim types DSHEA permits, in increasing FDA involvement
- 3The line between structure/function and disease — where most Warning Letters land
- 4The mandatory FDA disclaimer (21 CFR 101.93(b)–(d))
- 5The 30-day post-market notification (FD&C §403(r)(6))
- 6Substantiation — 'competent and reliable scientific evidence'
- 7Five failure modes that recur in FDA Warning Letters
- 8How V5 Ultimate handles the claim-to-substantiation chain
How does Structure/Function Claim apply to your shop floor?
Pick your industry and scale — Ask V5 rewrites the definition in your context, gives a worked example, and shows what V5 does on day one.
01What a structure/function claim is — and what it is not
A structure/function claim describes the role of a nutrient or dietary ingredient in maintaining the normal structure or function of the human body — 'calcium builds strong bones,' 'antioxidants maintain cell integrity,' 'L-theanine supports relaxation' — or characterises the documented mechanism by which a nutrient or dietary ingredient acts. It is the broadest of the three on-label claim categories DSHEA opened to dietary supplements; the other two are 'nutrient-content' claims (101.13, e.g. 'high in vitamin C') and 'health' claims (101.14, FDA-authorised disease-risk-reduction claims). A structure/function claim does NOT require FDA premarket review; FDA only sees it after the manufacturer files the 30-day post-market notification.
02Three claim types DSHEA permits, in increasing FDA involvement
| Claim type | Regulation | Example | FDA premarket review? |
|---|---|---|---|
| Nutrient-content | 21 CFR 101.13 + 101.54-101.69 | 'High in vitamin C', 'good source of fibre' | No — must meet defined threshold |
| Structure/function | FD&C §403(r)(6), 21 CFR 101.93 | 'Calcium builds strong bones' | No — post-market notification only |
| Health | 21 CFR 101.14 / 101.70-101.83 | 'Adequate calcium may reduce risk of osteoporosis' | Yes — authorised by regulation, or by Qualified Health Claim petition |
The forbidden fourth category is the drug claim — any claim to diagnose, cure, mitigate, treat, or prevent disease. The instant an article on the label crosses into that territory it is no longer a dietary supplement, it is an unapproved new drug (§201(g)(1)(B)) and subject to seizure, recall, and Warning Letter — regardless of any disclaimer.
03The line between structure/function and disease — where most Warning Letters land
21 CFR 101.93(g) sets ten 'criteria for disease claims' that, if met, convert a putative structure/function claim into a forbidden disease claim. The most operative ones in practice:
- Naming a specific disease or class of disease ('arthritis', 'depression', 'diabetes', 'cancer', 'osteoporosis').
- Implying treatment with terms like 'cure', 'mitigate', 'prevent', 'heal', 'restore'.
- Using pictorial vocabulary that depicts a disease state (e.g. an arthritic joint, a tumour).
- Citing a published study whose title or focus is on the diagnosis or treatment of a disease.
- Belonging to a class of products historically associated with treatment of a disease (e.g. antimicrobials).
- Substituting for a recognised therapy (e.g. 'a natural alternative to statins').
- Augmenting a recognised therapy ('use with insulin to lower blood sugar').
- Names that themselves imply a disease effect ('Carpaltum', 'Heartbeat', 'BrainCure').
| Permitted structure/function | Forbidden disease claim |
|---|---|
| 'Helps maintain healthy cholesterol levels' | 'Lowers high cholesterol' |
| 'Supports prostate health' | 'Shrinks the prostate / treats BPH' |
| 'Promotes a healthy mood' | 'Treats depression' |
| 'Helps maintain healthy joints' | 'Relieves arthritis pain' |
| 'Supports the body's normal immune response' | 'Prevents colds and flu' |
| 'Helps maintain healthy blood sugar already within the normal range' | 'Lowers blood sugar in diabetes' |
04The mandatory FDA disclaimer (21 CFR 101.93(b)–(d))
Every structure/function claim on a label or in labeling must be accompanied by the exact disclaimer:
"'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.'"
The disclaimer must be placed:
- Adjacent to the claim, with no intervening material, OR with an asterisk linking the claim to the disclaimer at the bottom of the panel.
- In a typeface no smaller than 1/16 inch (101.93(d)(2)), and not smaller than half the size of the largest text in the claim.
- Boxed off by a separating line if at the bottom of the panel.
On websites and in advertising the same disclaimer rule applies wherever the structure/function claim appears — the FTC and FDA jointly enforce this. Multi-claim pages may carry a single asterisk-linked disclaimer that covers all claims on the page.
05The 30-day post-market notification (FD&C §403(r)(6))
Within 30 days of first marketing a dietary supplement bearing a structure/function claim, the manufacturer must notify FDA at the Office of Dietary Supplement Programs. The notification must include:
- The name and address of the manufacturer/distributor.
- The text of the structure/function claim.
- The name of the dietary supplement product (or ingredient) on which the claim is being made.
- A signed certification by an authorised person that the information is complete and accurate and that the manufacturer has substantiation for the claim.
FDA publishes notifications on its public database. FDA does not 'approve' the claim through this process — but it may send an objection letter (a so-called 'courtesy letter' or formal advisory) if the claim looks like a disease claim, in which case the manufacturer's calculus shifts immediately.
06Substantiation — 'competent and reliable scientific evidence'
The 2008 FDA guidance and the FTC's parallel substantiation standard converge on the same phrase: 'competent and reliable scientific evidence.' What that means in practice:
- The totality of evidence on the ingredient and claim, not cherry-picked positive studies.
- Studies conducted on humans, with the ingredient in the form and dose used in the product, in a population relevant to the consumer.
- Peer-reviewed publication and replication preferred; mechanistic in-vitro and animal data alone rarely sufficient for a finished-product claim.
- A written substantiation file maintained by the manufacturer, dated and signed, available for FDA/FTC on request — though there is no formal FDA pre-clearance step.
07Five failure modes that recur in FDA Warning Letters
- Disease claim embedded in website testimonials or third-party reviews repurposed on the brand page — FDA treats these as the manufacturer's own claim.
- Citing PubMed studies whose title contains a disease name ('Curcumin in the treatment of osteoarthritis').
- Naming the product after a disease ('ArthroFix', 'DiabetEase', 'MoodGuard').
- Listing the product in a category like 'natural treatments for [disease]' on an e-commerce taxonomy page.
- Missing or undersized disclaimer; disclaimer placed too far from the claim; disclaimer rewritten ('not intended to treat any condition' — FDA wants the exact wording).
08How V5 Ultimate handles the claim-to-substantiation chain
- claims table: SKU × claim_text × disclaimer_revision × notification_id × substantiation_doc_ids × status (active|under_review|withdrawn).
- Substantiation docs live in the document control module with version + review-due date; expired substantiation triggers an automatic NCR.
- Label artwork revisions reference claim_ids; mismatch = release block.
- Dispense kiosk gates on claim_register.status = 'active'.
- Marketing site copy is checked against the same claims table — no orphan claims on the website.
Frequently asked questions
Q.Do I need FDA approval before marketing a structure/function claim?+
No. You file a 30-day post-market notification with FDA after first marketing. FDA does not 'approve' the claim, but may issue an objection letter if it reads the claim as a disease claim.
Q.Does the disclaimer have to be word-for-word what 21 CFR 101.93(b) says?+
Yes. The exact text is mandatory and the typeface, placement, and prominence rules in 101.93(d) are enforced.
Q.Are testimonials safe if a customer wrote them, not the brand?+
No. FDA and FTC treat testimonials hosted on the brand's website as the brand's own claim. If a customer testimonial says the product 'cured my arthritis', that is a disease claim attributable to the manufacturer.
Q.Can I make a structure/function claim on a conventional food (not a supplement)?+
21 CFR 101.93 applies to dietary supplements. Conventional foods can make 'natural' structure/function claims under a separate FDA framework (62 FR 49826), but the disclaimer and 30-day notification rules are specific to dietary supplements.
Q.What about 'maintain healthy blood sugar' — is that a disease claim?+
FDA distinguishes 'helps maintain healthy blood sugar already within the normal range' (acceptable structure/function) from 'lowers blood sugar' or 'helps people with diabetes' (disease claim). The 'within the normal range' modifier matters.
Q.How long must I keep substantiation records?+
Indefinitely while the claim is being made, and FDA expects records to remain available for inspection. FTC consent decrees commonly require retention for 5+ years after the claim is discontinued.
Q.What is the penalty for an unauthorised disease claim?+
The product becomes an unapproved new drug under §201(g)(1)(B), exposing the firm to Warning Letter, recall, seizure, injunction, and criminal misdemeanour liability under §303(a)(1).
Primary sources
- FD&C Act §403(r)(6) — Statements of nutritional support (21 U.S.C. 343(r)(6))
- 21 CFR 101.93 — Certain types of statements for dietary supplements
- FDA Final Rule — Structure/Function Claims (65 FR 1000, 6 Jan 2000)
- FDA Guidance — Substantiation for Dietary Supplement Claims Made Under §403(r)(6) (2008)
- FTC Guides Concerning the Use of Endorsements and Testimonials (16 CFR Part 255)
Further reading
Want to see how Structure/Function Claim could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.