Structure Function Claim

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.

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.

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').

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.

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.

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.

1. Disease claim embedded in website testimonials or third-party reviews repurposed on the brand page — FDA treats these as the manufacturer's own claim.
2. Citing PubMed studies whose title contains a disease name ('Curcumin in the treatment of osteoarthritis').
3. Naming the product after a disease ('ArthroFix', 'DiabetEase', 'MoodGuard').
4. Listing the product in a category like 'natural treatments for [disease]' on an e-commerce taxonomy page.
5. Missing or undersized disclaimer; disclaimer placed too far from the claim; disclaimer rewritten ('not intended to treat any condition' — FDA wants the exact wording).

• 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.