MoCRA & FDA Cosmetic Compliance for K-Beauty

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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.

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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, from MoCRA through the customs line:

MoCRA registration — Facility registration for the plant that manufactures or processes your product, plus a product listing for every SKU, with the ingredient declaration attached.
Responsible Person — US-based RP service. The RP is the name and domestic address that must appear on the label, and the party the FDA contacts about adverse events. You do not need a US entity of your own to have one.
FDA OTC review — Where a claim or an active ingredient pushes a product out of “cosmetic” and into “drug”, we identify it and map the monograph route before the artwork is printed.
INCI naming — Korean ingredient decks rebuilt into INCI, in descending order of concentration, matched across the Korean and English artwork so the two never disagree.
Label compliance — Principal display panel and information panel built to federal rules, then checked against state-level requirements such as California’s reporting and warning regimes.
Customs clearance — Classification, entry documents, and a pre-shipment check so the container is not the place you discover a labeling problem.

What MoCRA actually requires

Most brands arrive believing MoCRA is a single registration. It is a standing set of obligations, and the ones that bite are usually the ones nobody assigned an owner to:

Facility registration, renewed on a recurring cycle — and it is the manufacturing facility that registers, which for most K-beauty brands means an ODM in Korea that has to cooperate.
Product listing for every marketed SKU, kept current as formulas and packaging change.
Safety substantiation — documentation on file supporting that the product is safe under its labeled conditions of use. This is a records requirement, not a submission, which is exactly why it gets skipped.
Adverse event records, with serious events reportable to the FDA inside a short statutory window. You need a process and an inbox before you need it, not after.
A Responsible Person on the label with a US contact point.

Some smaller sellers fall under exemptions from parts of the regime, but the exemptions are narrower than they look — they do not reach products used around the eye, products intended to be injected or taken internally, or products meant to change appearance for more than a day where removal is not part of ordinary use. Assume you are in scope until someone has actually checked your catalogue against the carve-out.

Two further pieces are still moving. The GMP regulation the statute directs the FDA to issue has slipped, and the fragrance-allergen labeling rule is coming. Neither is a reason to wait. Building to ISO 22716 now is the practical benchmark, and collecting allergen data from your Korean manufacturer while you are already asking them for ingredient breakdowns costs far less than reopening the conversation later.

Where filings go wrong

Almost none of the failures we are called in to fix are exotic. In order of how often we see them:

A claim written for the Korean market. Korean functional-cosmetic vocabulary translates into US drug claims with alarming ease. Whitening, anti-hair-loss and sun protection are the usual three.
Two ingredient lists that disagree. The Korean carton, the English carton and the listing submission were prepared by three different people at three different times.
The factory was never asked. The brand registered itself and assumed that covered the plant.
A Responsible Person who is a forwarding address. The role carries real recordkeeping duties; a mail drop does not discharge them.
The listing stopped matching the product. A reformulation shipped and nobody updated the filing — which is the failure that turns an ordinary customs question into a detention.

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.