BB Cream — Classified as a Drug
One 'Skin Regeneration' Claim Was the Problem
Situation
A popular Korean BB cream brand was entering the U.S. market. Keeping the domestic product's main marketing hook — 'skin regeneration effect' — intact, the team named the English product 'Skin Regeneration BB Cream' and added 'Regenerates and repairs skin cells.'
Problem
'Regenerates skin cells' is a drug claim implying an effect on body structure — the regeneration of skin cells. FDA used this wording as the basis to classify the entire product as a drug being sold without prior FDA approval.
Timeline
- Immediately on arrival — FDA label inspection flags both the product name and the claim
- Day 7 — refusal of admission, entire shipment returned or destroyed
- Afterward — product renamed ('Hydrating BB Cream') and the label completely redesigned
Losses
Cost of returning/destroying the entire shipmentComplete redesign of the product name and label
📌 The product name is part of the label too. 'Regeneration' or 'Repair' in the product name is itself a drug claim.