FDA U.S. Agent Service

Representation for Foreign Cosmetic Companies

According to FDA regulations, any foreign company that manufactures or distributes cosmetic products intended for the U.S. market must appoint a registered U.S. Agent.

This requirement is part of the agency’s efforts to ensure clear communication and accountability, especially under the updated MoCRA compliance framework.

To meet this critical requirement, we offer an FDA U.S. Agent service tailored to foreign cosmetic manufacturers.

We act as your official representative in the United States, managing communications with the FDA, responding to inquiries, and supporting regulatory processes.

How we support your company with an FDA U.S. Agent Appointment

Appointing a U.S. Agent is a key step toward maintaining compliant operations in the U.S. Our service includes:

Official representation: We serve as your legally appointed U.S. Agent, meeting all FDA requirements for foreign establishments;
Communication facilitation: Our team receives and responds to FDA inquiries on your behalf, including questions about your products imported or offered for import;
Regulatory backup: If the FDA is unable to contact your company directly, they may send documents or notices to us — which are legally considered delivered to you;

This representation helps you maintain FDA compliance and ensures there is always a reliable point of contact inside the U.S. One annual fee, regardless of how many cosmetic products you register.

Why do you need this service?

FDA requires a U.S.-based representative. Without one, your products cannot be registered or imported into the United States.

Quick and accurate responses to the FDA protect your company from compliance risks.

Representation ensures market continuity. You stay informed, responsive, and aligned with U.S. regulations — even from abroad.

For foreign cosmetic manufacturers, having a registered U.S. Agent is a legal requirement.

With Sobel as your U.S. Agent, you gain a reliable partner that keeps your business connected, compliant, and market-ready.

Need to Appoint a U.S. Agent for FDA Compliance?

We offer FDA U.S. Agent services for cosmetic companies without a U.S. presence. From communication handling to inspection coordination, we represent your business with the professionalism and reliability the FDA expects.

We can be your link to the FDA. Send a message and let us simplify your path to the U.S. cosmetics market.