FD&C Act §607 (MoCRA)

FDA U.S. Agent for cosmetic facilitys in South Korea

A cosmetic facility in South Korea that exports to the United States must register with FDA and name a U.S. Agent located in the U.S. (FD&C Act §607 (MoCRA)). In the 12 months from 2025-10 to 2026-09, FDA refused 1,347 import lines from South Korea, and 51 FDA import alerts list firms from South Korea.

FDA data for South Korea

Figures from FDA public data, retrieved 2026-10-21. Recall counts are by the recalling firm's country.

Import refusals, 2025-10 to 2026-09

Refused import lines	1,347
Refusals citing registration or listing problems	NOT LISTED-118 · 507 FRNMFGREG-3280 · 439

Most refused product industries

Code		Count
53	Cosmetics	260

Most common refusal charges

Code	Count
NOT LISTED-118 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information…	507
FRNMFGREG-3280 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on information available to FDA, i…	439
UNAPPROVED-75 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).	317
NO 510(K)-508 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantial…	206
NO PMA-237 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for prem…	201

Import alerts listing South Korea firms

Import alerts that list at least one firm in South Korea: 51. Recently updated:

Import Alert 16-39: Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes
Import Alert 20-07: Detention Without Physical Examination of Juice from Foreign Processors Not in Compliance with Juice HACCP Regulation
Import Alert 45-02: Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.
Import Alert 45-06: Detention without Physical Examination of Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts
Import Alert 99-05: Detention Without Physical Examination Of Raw Agricultural Products for Pesticides
Import Alert 99-08: Detention without Physical Examination of Processed Human and Animal Foods for Pesticides

What the rule requires

Under the Modernization of Cosmetics Regulation Act (MoCRA), foreign facilities that manufacture or process cosmetic products for U.S. distribution must register with FDA and include the name and contact details of a U.S. Agent. Registrations are renewed every two years, and product listings are updated every year.

Foreign facilities that manufacture or process cosmetic products distributed in the U.S.
Small businesses as defined in FD&C Act §612 may be exempt; check before assuming

Deadlines

Register new facilities within 60 days of starting to manufacture or process cosmetics for the U.S.
Renew every 2 years
Update product listings annually

Steps

Get a FEI number for the facility if you don't have one
Prepare facility, responsible person and product category data
Submit through FDA's Cosmetics Direct portal (or SPL)
Name the U.S. Agent with their contact details
Keep your facility registration number for product listings

Common mistakes

Confusing the "responsible person" (on the label) with the U.S. Agent
Missing the biennial renewal
Selling or buying "MoCRA certificates": FDA does not issue them

How US Agent Desk helps

We serve as your U.S. Agent, prepare the registration data in your language for your company's officer to submit, confirm the designation when FDA asks, and check FDA's public records for your company every morning. Prices start at $990 per year.

Check if you need a U.S. Agent See prices

Sources

Independent private service. Not affiliated with the U.S. FDA. Not legal advice.