Structure/Function Claim Readiness for Dietary Supplement Brands
Notify FDA within 30 days, print the disclaimer exactly and keep evidence tied to the claim as it actually appears.
In Short
- Notify FDA within 30 days.
- Use the exact disclaimer.
- Context can make a disease claim.
The Dietary Supplement Operations Guide
What the label says. What the batch proves.
- The rules and who decides
- Specification to finished batch
- Test, review, investigate
We ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Dietary Supplement Operations Guide
What the label says. What the batch proves.
A dietary supplement may describe how an ingredient affects the structure or function of the body, but only on conditions set by section 403(r)(6) of the FD&C Act and 21 CFR 101.93. This guide covers the notification, the disclaimer, the disease-claim line and keeping claims under control. It is orientation, not legal advice; your regulatory team approves claims. Sources checked 4 Oct 2026.
Notify FDA within 30 days of first marketing
Section 101.93(a) requires the manufacturer, packer or distributor to notify FDA no later than 30 days after first marketing a supplement that bears a structure/function statement. The notice names the firm, the exact text of the statement, the ingredient it concerns and the product name.
More on notify FDA within 30 days of first marketing
It must be signed by a responsible individual who certifies that it is complete and accurate and that the firm has substantiation that the statement is truthful and not misleading. Record the first marketing date for every claim, so the 30 days can be checked.
The disclaimer: exact words, placement and size
Section 101.93(c) sets the disclaimer text: the statement has not been evaluated by FDA, and the product is not intended to diagnose, treat, cure or prevent any disease, with a plural form where there are several statements. Under 101.93(d) and (e) it sits next to the statement or is linked to it by a symbol, appears on each panel or page carrying a statement, is boxed when not adjacent, and is in boldface type no smaller than one-sixteenth of an inch.
Disclaimer check (101.93(c)-(e))
More on the disclaimer: exact words, placement and size
Check the disclaimer every time artwork changes.
Where structure/function ends and disease claims begin
Section 101.93(g) explains that a statement is a disease claim if it claims, explicitly or implicitly, that the product diagnoses, mitigates, treats, cures or prevents disease, and lists criteria FDA uses, such as naming a disease or its characteristic signs, the product name, pictures and references to drug substitutes. Context counts: a compliant sentence can become a disease claim through an image or a testimonial on the same page.
More on where structure/function ends and disease claims begin
Review the whole label and marketing page, not the sentence alone.
Substantiation sits behind every claim
The notice certifies that the firm has substantiation, so each claim needs a file before it is used: the exact claim text, the ingredient and dose it relies on, the evidence and a dated approval. Advertising is also subject to the FTC Act, which this guide does not analyse.
Common gap. A claim edited by marketing after approval, so the file supports a sentence that no longer appears on the label.
Worked Example: Claim C-118
- 2 MarClaim text and evidence file approvedRegulatory
- 10 MarFirst marketing of product SKU-301Commercial
- By 9 AprSigned notice sent to FDAResponsible individual
- JuneFormula dose change reopens the claimQuality
More on substantiation sits behind every claim
Tie the file to the claim version, not just the product.
Keeping Claims under Change Control
Treat claims as controlled content. Keep one approved list, reference it from label and web artwork, and route any change through review by regulatory, quality and marketing.
More on keeping Claims under Change Control
When a formula changes the dose an approved claim relies on, reopen the claim. Track where each claim appears, so a withdrawn claim can be removed everywhere. People approve the wording; a system only keeps the record of who approved what and when.
Questions
When is the FDA notification due?
No later than 30 days after first marketing a supplement with the statement, under 21 CFR 101.93(a)(1).
Can we shorten the disclaimer?
No. Section 101.93(c) sets the wording, with a plural form for more than one statement.
Does FDA approve structure/function claims?
No. The notice tells FDA the statement is being used; the firm remains responsible for it being truthful and not misleading.
Where does V5 fit?
V5 keeps label versions, formulas and change control linked, with dated approvals, so a claim can be traced to the artwork and formula it appears on. Your regulatory team decides and approves claims.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Structure/Function Claims Readiness: DSHEA §6, Disclaimers & Substantiation
ASEAN Supplements Readiness: Singapore HSA and the Regional Hub
Australian Listed Medicines: What the Sponsor Certifies Under Section 26A
Brazil ANVISA Supplements: RDC 243/2018 Readiness Guide
Supplement Contract Manufacturing: Part 111 Duties and Quality Agreements
Digital Labels for Supplements: SmartLabel and EU QR Codes