By Vincent Cruz

Korean cosmetics are among the most imported beauty products in the United States – and every one of them sits under MoCRA. If your products are manufactured in Korea and sold in the U.S., your facility needs an FDA registration and a designated U.S. agent. Here is what that means for K-beauty brands specifically.

What MoCRA requires from Korean brands

Facility registration – the Korean manufacturing facility must be registered with FDA, with an FEI number.
U.S. agent – the foreign facility must designate a U.S. agent as its official FDA contact.
Product listing – each product must be listed by its responsible person (usually the brand owner).
Safety substantiation – documented evidence that each product is safe under its labeled use.
Adverse event reporting – serious adverse events reported within 15 business days.
Labeling – U.S. contact information for adverse event reports on the label.

Step by step for a Korean brand

1. Confirm your facility’s FEI status. If your manufacturer already exports to the U.S., it may have an FEI. Ask for it – and verify it. If not, request one early; it is the longest lead item (typically 7-10 business days per FDA guidance).

2. Appoint your U.S. agent. This must be a person or business physically present in the U.S. Your American importer or distributor does not fill this role automatically.

3. File the facility registration through FDA’s Cosmetics Direct portal, naming your U.S. agent.

4. File product listings as the responsible person (products with identical formulations — or differing only in color, fragrance, flavor, or quantity — may share a single listing).

5. Fix your labels so they carry compliant U.S. contact information.

Common K-beauty pitfalls

Assuming the importer handles it. Your U.S. distributor moves boxes; they are not your designated agent unless formally appointed.
Drug claims on brightening or anti-aging products. Claims about treating or preventing conditions can reclassify a cosmetic as a drug. See our guide on cosmetic vs. drug classification.
Amazon-only thinking. Selling exclusively on Amazon does not exempt the facility – the registration and agent requirements apply regardless of sales channel. See FDA requirements for selling cosmetics on Amazon.
Waiting until a shipment is detained. Registration after a detention is slower, more expensive, and puts inventory at risk.

Timeline and cost

Plan for roughly 3-6 weeks from a standing start: FEI request, document gathering, draft review, and filing. Our service is $450 one-time onboarding per facility plus $34.99/month for continuous representation, with biennial renewal filing included while you are subscribed. Full timeline: how long MoCRA registration takes.

Frequently asked questions

Do we need a U.S. agent if we sell only through Amazon?
Yes. The requirement attaches to the facility, not the sales channel.

Can our U.S. distributor be our agent?
Only if formally designated on your registration and willing to accept FDA correspondence duties. Most distributors decline.

We already have an agent but want to switch. Is that hard?
No – it is an amended registration. See our transfer guide.

Does our OEM/ODM factory’s registration cover our brand?
The facility registration covers the site. Your products still need their own listings under your responsible person.

We manufacture in Korea but are headquartered elsewhere. Which facility registers?
The physical manufacturing site registers – the Korean factory, with its own FEI – regardless of where the brand company sits.

US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. This article is for informational purposes only and is not legal advice.