MoCRA US Agent Services
With the enforcement of the Modernization of Cosmetics Regulation Act (MoCRA), all foreign cosmetic manufacturers are now required to designate a US Agent. Cosmereg serves as your official MoCRA US Agent, providing regulatory support and acting as your point of contact with the FDA. We ensure your cosmetic products remain compliant with all FDA requirements for distribution in the United States.
Why You Need a MoCRA US Agent
Foreign cosmetic facilities are required under MoCRA to appoint a US Agent for FDA correspondence, inspection coordination, and adverse event reporting.
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
Appointing Cosmereg as Your MoCRA US Agent
Choosing Cosmereg as your US Agent means partnering with a trusted regulatory leader. We help streamline your entry into the U.S. cosmetics market.
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 Must Appoint a US Agent?
Under the Modernization of Cosmetics Regulation Act (MoCRA), all foreign cosmetic manufacturers whose products are marketed in the United States are legally required to appoint a US Agent. 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.
Step-by-Step: How Cosmereg Supports US Agent Services
Step 1
Initial Compliance Review
We'll assess your cosmetic portfolio and identify MoCRA-specific obligations.
Step 2
US Agent Designation
We’ll issue your Letter of Authorization and submit to the FDA
Step 3
Ongoing Representation
We stay available year-round to support inspections, adverse event queries, and FDA communication.
Optional Add-ons
- Label and INCI formula review
- Cosmetic safety substantiation
- Monthly compliance reports
MoCRA US Agent and FDA Cosmetic Compliance
Yes, appointing a U.S. Agent is mandatory under MoCRA for all foreign cosmetic manufacturers.
The Modernization of Cosmetics Regulation Act (MoCRA), enforced by the U.S. Food and Drug Administration (FDA), requires every non-U.S. facility that manufactures or processes cosmetic products intended for the American market to designate a MoCRA-compliant U.S. Agent.
Yes, the MoCRA US Agent can assist with adverse event reporting—but only under specific conditions.
Under the Modernization of Cosmetics Regulation Act (MoCRA), the responsibility for serious adverse event reporting lies with the Responsible Person—typically the brand owner or the party whose name appears on the product label.
However, when the manufacturer is located outside the United States, and the Responsible Person is also based abroad, the designated MoCRA US Agent can act as the U.S.-based contact
No. The MoCRA US Agent is specific to cosmetics only.
Yes, a single MoCRA US Agent can represent multiple brands or companies as long as each relationship is formally documented and disclosed to the FDA.
Under MoCRA, the U.S. Agent is appointed on a per facility basis, meaning that if several cosmetic brands use the same foreign manufacturing facility, they may share the same U.S. Agent. Alternatively, a single regulatory firm, like Cosmereg—can serve as the MoCRA U.S. Agent for different companies and facilities, provided the required documentation is correctly submitted for each.
Yes. If you're unhappy with your current representative, Cosmereg can help you transition smoothly and file the necessary updates with the FDA.
Partner with Cosmereg – Your MoCRA US Agent for 2025 Compliance
Don't risk FDA delays or penalties. Appoint Cosmereg as your MoCRA US Agent and let our compliance experts guide your brand safely into the U.S. market.
