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MoCRA Cosmetics U.S. Agent Services for Foreign Manufacturers

MoCRA U.S. Agent Overview

 

 

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, requires all foreign cosmetic facilities to designate a U.S. Agent as part of their FDA facility registration.

If your cosmetics manufacturing facility is located outside the United States and you export cosmetic products to the U.S. market, you are required to appoint a U.S. Agent under MoCRA. Your U.S. Agent acts as the official point of contact between your company and the U.S. Food & Drug Administration (FDA) for all cosmetic regulatory matters.

Without a designated U.S. Agent, your facility registration in the FDA's Facility Registration and Listing System (FURLS) will not be accepted, and your products may be denied entry into the United States.

MoCRA U.S. Agent Requirements

Under MoCRA, foreign cosmetic facilities must designate a U.S. Agent as part of FDA cosmetic facility registration and product listing requirements.

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Your MoCRA U.S. Agent must:

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  • Be physically located in the United States

  • Be available during normal U.S. business hours

  • Receive and respond to FDA communications related to your cosmetic facility

  • Forward FDA inspection notices, adverse event reports, and compliance correspondence

  • Assist FDA in communications with the foreign establishment

  • Be available for adverse event reporting as required under MoCRA Section 605

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Failure to designate a MoCRA U.S. Agent may prevent facility registration, product listing, and access to the U.S. cosmetics market.

Your Responsibilities

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  • Maintain accurate cosmetic facility registration with FDA

  • Submit product listings through FDA's electronic submission portal

  • Ensure compliance with MoCRA Good Manufacturing Practice (GMP) requirements

  • Maintain accurate product labeling per FDA regulations

  • Report serious adverse events to FDA within 15 business days

  • Maintain your own regulatory records, safety substantiation, and product formulations

Our Responsibilities as Your MoCRA U.S. Agent:

  • Serve as the official FDA point of contact for your cosmetic facility

  • Receive all FDA communications (notices, inquiries, inspection announcements, adverse event follow-ups)

  • Forward all FDA requests immediately to your designated contact

  • Acknowledge FDA inquiries as required under MoCRA

  • Maintain continuous availability during U.S. business hours

  • Support efficient, reliable communication between your company and FDA

  • Provide a secure U.S. mailing address for all compliance-related correspondence

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