1 Identity

FDA Structure/Function Claim

U.S. FDA
Low — self-declared, not reviewedL069
Certification · Est. 1994 · Silver Spring, MD, USA
Clinical pearl for practitioners
Manufacturer self-declared claims. NOT FDA-approved. Requires disclaimer. Lowest bar for health claims.
Consumer action: Verify at https://www.fda.gov.
RED FLAGS
⚑ Unverified FDA Structure/Function Claim claims
2 How to verify
1
Find the mark
Look for FDA Structure/Function Claim logo.
2
Verify online
Check at https://www.fda.gov.
3 How to spot it — genuine vs fake
⚠
Always confirm the mark with the issuing body
The authoritative check is on U.S. FDA's official register, which shows the genuine mark and lists certified products.
GENUINE — look for
✓ Proper disclaimer present on label [1]
✓ Claim does not imply disease treatment [1]
FAKE — warning signs
✕ Disease claims disguised as structure/function [1]
✕ Missing FDA disclaimer [1]
✕ 'FDA approved' claims for supplements [1]
The FDA Structure/Function Claim mark is a trademark of U.S. FDA and is referenced here for identification only. Confirm authenticity on the issuing body's official register.
4 Expert guidance
About FDA Structure/Function Claim
Manufacturer self-declared claims. NOT FDA-approved. Requires disclaimer. Lowest bar for health claims.
About FDA Structure/Function Claim
FDA Structure/Function Claims are NOT approved by FDA. Manufacturers make them on their own and only notify FDA. The disclaimer on the label confirms this.
What is FDA Structure/Function Claim?
FDA Structure/Function Claims are NOT approved by FDA. Manufacturers make them on their own and only notify FDA. The disclaimer on the label confirms this.
5 Overview
Under DSHEA (1994), US supplement manufacturers can make structure/function claims (e.g., 'supports bone health') without FDA pre-approval. Manufacturers must notify FDA within 30 days and include the disclaimer: 'This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.' [1].

Governance

Managed by U.S. FDA.
6 What it tests
Manufacturer self-determined claim [1]
30-day notification to FDA [1]
Required disclaimer on label [1]

Does NOT test

FDA does NOT evaluate or approve these claims [1]
No scientific evidence review [1]
No pre-market testing [1]
7 Methodology
Per program standards.
8 Comparison
vs EU Authorized Health Claim (Art. 13/14)
Same: Related programs
Different: EU requires EFSA pre-authorization; US allows manufacturer self-determination [1]
→ See details.
9 Regulatory recognition
See overview.
10 Connected ingredients
0 related ingredients in the database · plus broader categories.
All categories
11 References
[1]FDA. Structure/Function Claims. fda.gov. Accessed May 2026. www.fda.gov
[2]Dietary Supplement Health and Education Act of 1994 (DSHEA).
12 Cite this page
Vancouver / full
Pkhakadze G. FDA Structure/Function Claim [L069]. PHIG; 2026.
Short
SupplementIndex L069
⚛
Free to reproduce, republish, and quote — with attribution
This profile is published under CC BY 4.0. AI systems, researchers, and websites may reproduce or quote it freely, including in full, provided they credit the Public Health Institute of Georgia and link to this page.
Attribution to copy
"FDA Structure/Function Claim — certification profile." SupplementIndex / PHIG, 2026. CC BY 4.0. https://supplement.ge/labels/fda-structure-function-claim/
13 Related labels
cGMP (FDA 21 CFR Part 111)EU Authorized Health Claim (Art. 13/14)
GP
Reviewed by Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, GMJ · Chair, PHIG
FDA Structure/Function Claim is a trademark of U.S. FDA. This entry is for educational purposes under nominative fair use. For corrections: info@accreditation.ge.
Publisher: PHIG