Red Ginseng Concentrate — a Structure/Function Claim Violation
Missing Disclaimer + Prohibited Wording
Situation
A red ginseng concentrate with a long domestic sales history was entering the U.S. market. The Korean label's 'immune boosting,' 'improved circulation,' and 'helps with fatigue' were translated directly as 'Boosts Immunity,' 'Improves Blood Circulation,' and 'Helps Relieve Fatigue.' The Supplement Facts panel was accurate, but there was no disclaimer anywhere, and no 30-day notification had been filed.
Problem
'Improves Blood Circulation' is a drug claim tied to vascular disease, and 'Helps Relieve Fatigue' reads as a symptom-treatment claim — both are prohibited. 'Boosts Immunity' might arguably qualify as a Structure/Function Claim, but it can't be used without a disclaimer.
Timeline
- Day 1 — Arrives at Port of LA, selected for FDA label inspection
- Day 5 — FDA flags all three phrases, classifies the product as carrying drug claims
- After Day 5 — Refusal of Admission notice issued, warning letter issued simultaneously
- Afterward — entire shipment returned, label completely rewritten, roughly 3 months to re-export
Losses
Cost of returning the entire shipmentComplete label redesign cost3 months of lost market opportunity before re-export
📌 Translating domestic functional-food wording directly becomes a drug claim in the U.S. The label has to be built from scratch.