Black Garlic Concentrate — a Health Claim Violation
'Immunity,' 'Antioxidant,' 'Relieves Fatigue'
Situation
A popular Korean health-food product — black garlic concentrate — was entering the U.S. market. The marketing language used domestically was translated directly onto the label: 'Boosts Immunity,' 'Powerful Antioxidant,' 'Helps Relieve Chronic Fatigue,' 'Improves Blood Circulation.'
Problem
All four phrases were a problem. 'Boosts Immunity' is an unauthorized health claim; 'Helps Relieve Chronic Fatigue' names a condition (chronic fatigue syndrome) and reads as a treatment claim; 'Improves Blood Circulation' is an unauthorized claim tied to cardiovascular disease; and 'Powerful Antioxidant,' used alongside the other drug-like claims, helped push the whole label into drug-claim territory.
Timeline
- Day 1 — Arrives at the Port of LA, Prior Notice fine, selected for label inspection
- Day 5 — FDA flags all four phrases, classifies the entire product as a food carrying drug claims
- Day 12 — Refusal of Admission notice issued, cargo returned or destroyed, Warning Letter received
Losses
Cost of returning the entire shipmentFailed first U.S. export attemptBuyer contract canceledFuture export difficulty from the warning letter
📌 An English translation of a Korean label is not a U.S. label. The wording has to be rewritten from scratch.