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MoCRA US Agent for Cosmetic Facilities
Under MoCRA, every foreign facility that manufactures or processes cosmetics for the U.S. market must appoint a U.S.-based agent. The MoCRA US Agent acts as the official liaison between your facility and the FDA — handling communications, coordinating inspections, and ensuring your registration stays active. Cosmereg provides reliable, affordable MoCRA US Agent representation with transparent annual pricing.
✅ Official FDA-designated US Agent
✅ Facility registration and biennial renewal support
✅ Prompt FDA communication on your behalf
✅ Transparent annual fee
What Is a MoCRA US Agent?
A MoCRA US Agent is a person or entity located in the United States that is designated by a foreign cosmetic facility to serve as its point of contact with the FDA. This requirement was introduced under Section 607(a)(3) of the FD&C Act as amended by MoCRA. The US Agent must be physically present in the United States and available during regular business hours to communicate with the FDA. The MoCRA US Agent role is specific to cosmetic facilities. It is distinct from FDA US Agent requirements for food facilities, drug establishments, or medical device establishments — each of which has its own regulatory framework.
Key responsibilities of your MoCRA US Agent:
- Serve as your point of contact with the FDA
- Assist with facility registration and product listing
- Help coordinate FDA inspections
- Monitor and support adverse event reporting
- Provide ongoing regulatory updates
What Does a MoCRA US Agent Do?
Cosmereg, as your designated MoCRA US Agent, provides the following services. We act as the official intermediary for all FDA communication related to your cosmetic facility. We assist with and coordinate FDA inspections of your facility. We respond to FDA inquiries about your facility or products in a timely manner. We receive information from the FDA when the agency cannot reach your facility directly. We support facility registration and biennial renewal through the Cosmetics Direct portal. We provide ongoing annual representation and proactive regulatory communication.
Why Cosmereg:
- 10+ years of FDA compliance expertise
- 100% focused on cosmetics, food, and supplements
- Fast onboarding process
- Transparent annual fees with no hidden costs
How MoCRA US Agent Differs from the Responsible Person
While the Responsible Person holds legal responsibility for the product’s safety and compliance within those markets, the MoCRA US Agent plays a distinct yet equally critical role for the U.S. market. Under MoCRA, the US Agent acts as the official liaison between the foreign cosmetic manufacturer and the FDA facilitating communication, ensuring timely responses to FDA inquiries, and supporting regulatory compliance. Both roles are essential for maintaining smooth market access and meeting region-specific legal obligations.
Who Needs a MoCRA US Agent?
You must appoint a MoCRA US Agent if your facility is located outside the United States and manufactures, processes, packs, or holds cosmetic products distributed in the U.S. market. Each individual foreign facility must have its own designated US Agent. The US Agent requirement applies regardless of whether the facility is the brand owner, a contract manufacturer, or a private-label processor.
This applies to:
- Foreign cosmetic manufacturers
- Contract manufacturers outside the U.S.
- Brands selling online or via U.S. retailers
Appointing a U.S. Agent is not optional; it is a mandatory step for any non-U.S. entity seeking to maintain access to the American cosmetics market.
How to Appoint Cosmereg as Your MoCRA US Agent?
Step 1
Provide Facility Information:
Submit basic details about your facility, including company name, address, FEI number, and product categories.
Step 2
Registration and Agent Designation:
Cosmereg completes or updates your FDA cosmetic facility registration via Cosmetics Direct and is designated as your official US Agent.
Step 3
Ongoing Representation
Cosmereg remains your active US Agent for the year, handling FDA communications, biennial renewal, and any regulatory inquiries.
Why Choose Cosmereg as Your MoCRA US Agent?
Dedicated regulatory liaison with cosmetics expertise. Transparent pricing with no hidden costs. Experience supporting international brands from Europe, Asia, the Middle East, and Latin America. Responsive communication and proactive renewal management. Multilingual team fluent in English, Korean, French, Italian, Spanish, Turkish, and more.
Frequently Asked Questions About MoCRA US Agents
Yes. Every foreign facility that manufactures or processes cosmetics for U.S. distribution must designate a US-based agent under MoCRA.
While legally possible, many foreign companies prefer an independent regulatory representative to ensure consistent FDA communication and compliance oversight.
Yes. Each physical facility located outside the U.S. must have its own designated US Agent.
Foreign facilities without a valid US Agent cannot complete their FDA registration. Products from unregistered facilities may be subject to import holds and enforcement actions.
No. MoCRA US Agents are specific to cosmetic facilities under Section 607 of the FD&C Act. Food facility US Agents operate under a separate regulatory framework (21 CFR Part 1). Cosmereg provides US Agent services for both.
Cosmetic facility registration must be renewed every two years from the initial registration date. The first renewals are due in 2026. Cosmereg manages the renewal process as part of the annual US Agent service.
