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FD&C Act §607 (MoCRA)

FDA US Agent for Foreign Cosmetic Facilities (MoCRA)

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.

Who needs a U.S. Agent

  • 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 to register

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

US Agent Desk prepares this data for your officer and serves as your U.S. Agent. Your company's own officer submits the registration in FDA's system.

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

By country

Cosmetic facility U.S. Agent for China · Cosmetic facility U.S. Agent for India · Cosmetic facility U.S. Agent for South Korea · Cosmetic facility U.S. Agent for Japan · Cosmetic facility U.S. Agent for Vietnam · Cosmetic facility U.S. Agent for Taiwan · Cosmetic facility U.S. Agent for Mexico · Cosmetic facility U.S. Agent for Italy · Cosmetic facility U.S. Agent for Germany · Cosmetic facility U.S. Agent for France · Cosmetic facility U.S. Agent for Spain · Cosmetic facility U.S. Agent for Turkey · Cosmetic facility U.S. Agent for Thailand · Cosmetic facility U.S. Agent for Indonesia · Cosmetic facility U.S. Agent for Brazil · Cosmetic facility U.S. Agent for Canada · Cosmetic facility U.S. Agent for United Kingdom · Cosmetic facility U.S. Agent for Israel · Cosmetic facility U.S. Agent for Malaysia · Cosmetic facility U.S. Agent for Pakistan

Check if your facility needs one See prices

Sources