Structure/function claims for dietary supplements

Structure/function claims describe an effect on normal body structure or function. FDA requires these supplement claims to be truthful, substantiated and accompanied by the prescribed disclaimer, with notification no later than 30 days after first marketing the supplement bearing the claim.

Check what the words actually communicate

FDA distinguishes structure/function claims from statements that diagnose, mitigate, treat, cure or prevent disease. Review the full context, including product name and surrounding labeling. A disclaimer does not turn a disease claim into an acceptable structure/function claim.

FDA: small entity guide to structure/function claims

Assign the notification and evidence owner

FDA’s notification page explains the covered claim types, substantiation obligation, disclaimer and timing. Keep the exact approved wording, supporting evidence and notification record together. Our launch recommendation is to assign an owner before artwork approval so later edits receive the same review.

FDA: notifications for structure/function claims

Review other claim categories separately

Health claims and nutrient content claims have different requirements. Do not apply the structure/function workflow to every claim on a supplement. Use FDA’s claim categories guide to identify which rules apply before approving label language.

FDA: label claim categories

Next steps

Sources

Sources checked 2026-10-16. Company descriptions are their own statements; they are not certification verification.

Search the directory for certified or licensed manufacturers, or read how we verify each listing.