FD&C Act §607 (MoCRA)

FDA U.S. Agent for cosmetic facilitys in United Kingdom

A cosmetic facility in United Kingdom 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 644 import lines from United Kingdom, and 38 FDA import alerts list firms from United Kingdom.

FDA data for United Kingdom

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	644
Refusals citing registration or listing problems	NOT LISTED-118 · 111

Most common refusal charges

Code	Count
UNSAFE COL-11 The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).	124
TP NO PMTA-3842 This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C …	116
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…	111
TP NO SE-3843 This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C A…	108
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).	99

Import alerts listing United Kingdom firms

Import alerts that list at least one firm in United Kingdom: 38. Recently updated:

Import Alert 16-39: Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes
Import Alert 45-02: Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.
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
Import Alert 99-19: Detention Without Physical Examination of Food Products Due to the Presence of Salmonella
Import Alert 89-04: Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements

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.