Service 06
FDA, MoCRA, and US regulatory filings.
Luxmetics handles the regulatory backbone for K-beauty brands entering the US — MoCRA registration, Responsible Person service, FDA OTC review, and labeling — plus Importer of Record responsibilities and India CDSCO cosmetic registration. Everything filed correctly the first time.
Who this is for
- Korean brands — Enter the US market with FDA, MoCRA, and labeling fully filed — without a US entity of your own.
- US importers — De-risk your imports. We confirm every SKU is compliant before it lands at customs.
- Private label clients — Custom formulations cleared for US sale — INCI, labeling, and Responsible Person on file.
What we file
Six core filing services covering everything from MoCRA to customs: MoCRA registration (facility & product listing), Responsible Person (US-based RP service), FDA OTC review (sunscreen & drug claims), INCI naming (bilingual ingredient decks), label compliance (FDA + state-level rules), and customs clearance (pre-cleared imports).
How we file
- Audit — We review every SKU — ingredients, claims, packaging artwork, country-of-origin — against current US rules.
- Gap report — Itemized list of what’s missing, what’s risky, and what needs to be reformulated or relabeled.
- Remediation — INCI translation, claim revision, bilingual artwork, and reformulation guidance where required.
- File — MoCRA submission, FDA facility registration, OTC monograph review, and Responsible Person designation.
- Maintain — Annual renewals, adverse event reporting, and regulatory change monitoring — handled on your behalf.
Case study
A 42-SKU Korean brand cleared MoCRA in 31 days.
A mid-size Seoul skincare house had been stuck for six months trying to file MoCRA on their own. We took over, restructured their ingredient decks, flagged 4 SKUs needing OTC review, and filed everything in just over a month. Results: 42 SKUs filed, 31 days to full clearance, 0 customs detentions.
Questions, answered
What is MoCRA and do I really need it?
MoCRA is the Modernization of Cosmetics Regulation Act, in force since 2024. Every cosmetic product sold in the US must have facility registration and product listing on file with the FDA. Yes, you really need it.
Can you act as our Responsible Person?
Yes — we provide US-based Responsible Person service so you don’t need your own US entity.
What counts as an FDA ‘drug’ claim?
Claims like SPF, anti-acne, or anti-aging treatment can trigger OTC drug status. We flag these during the audit.
How long does MoCRA registration take?
With clean inputs, filings typically complete within weeks; remediation can extend the timeline.
What happens if my product is non-compliant at customs?
It risks detention. We confirm compliance before shipment so product isn’t held.