Hair Treatment — No Facility Registration
Exported Without Knowing the MoCRA Obligation
Situation
In the second half of 2024, a Korean hair-care brand entered the U.S. market for the first time. It carefully prepared English labeling and ingredient lists for a U.S. buyer's order, but had no idea about MoCRA's facility-registration requirement.
Problem
A manufacturer selling cosmetics in the U.S. for the first time after July 1, 2024 must list the product with FDA within 120 days of first sale, and product listing requires the facility registration number to exist first. None of this had been done.
Timeline
- Arrival — FDA's system shows no registration number for the facility, clearance held
- Clearance held — facility registration and product listing both demanded
- 2 weeks later — emergency facility registration completed, product listing submitted, cargo cleared
Losses
2 weeks of held clearanceEmergency registration processing cost
📌 U.S. cosmetics exports start with confirming MoCRA requirements. A perfect label still gets blocked without facility registration.