Multivitamin — Missing SAE Contact on the Label
There Was No U.S. Contact
Situation
A multivitamin/mineral combination product was being exported. The team was confident in its review — Supplement Facts, ingredient labeling, and Structure/Function Claims all checked out.
Problem
Nowhere on the label was there a U.S. contact — only a Korean address and phone number. Under FD&C Act §403(y), a supplement label without a U.S. domestic address or phone number for receiving SAE reports is misbranded.
Timeline
- Day 1 — FDA label inspection finds the missing U.S. contact
- Day 3 — misbranded determination, clearance held
- Day 7 — U.S. importer's address and phone number added to the label and resubmitted, conditional clearance granted
Losses
7 days of storageLabel correction costLate-delivery penaltyRe-inspection cost
📌 No U.S. contact means misbranded. A Korean address alone won't do — put it on the label checklist without fail.