1 Identity

FDA Structure/Function Claim

U.S. FDA
Low — self-declared, not reviewed
Clinical pearl for practitioners
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].
3 How to verify
1
1
Look for FDA Structure/Function Claim logo.
2
2
Check at https://www.fda.gov.
4 Fraud detection
GENUINE SIGNS
✓ Proper disclaimer present on label [1]
✓ Claim does not imply disease treatment [1]
FAKE SIGNS
✕ Disease claims disguised as structure/function [1]
✕ Missing FDA disclaimer [1]
✕ 'FDA approved' claims for supplements [1]
5 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.
6 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.
7 What it tests
Manufacturer self-determined claim [1]
30-day notification to FDA [1]
Required disclaimer on label [1]
8 Methodology
Per program standards.
9 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.
12 Connected ingredients
1 ingredients recommend this certification.
All categories
13 References
[1]FDA. Structure/Function Claims. fda.gov. Accessed May 2026. www.fda.gov
[2]Dietary Supplement Health and Education Act of 1994 (DSHEA).
14 Cite this page
Vancouver
Pkhakadze G. FDA Structure/Function Claim [] — certification profile [Internet]. Tbilisi: Public Health Institute of Georgia; 2026 [cited 2026 May 30]. Available from: https://supplement.ge/labels/fda-structure-function-claim/
CC BY 4.0
15 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