Under MoCRA, a U.S. Agent is a person or company physically located in the United States who acts as the official point of contact between a foreign cosmetic facility and the FDA. The U.S. Agent receives FDA communications, inspection notices, and regulatory correspondence on behalf of the foreign facility.

All foreign cosmetic facilities that manufacture or process cosmetic products distributed in the United States are required to designate a U.S. Agent as part of their MoCRA facility registration. This applies to manufacturers, contract manufacturers, and processing facilities located outside the U.S.

Yes. MoCRA requires that the U.S. Agent be physically located in the United States and must be reachable during U.S. business hours. A P.O. box is not sufficient — the U.S. Agent must have a valid U.S. street address and a working U.S. phone number.

The U.S. Agent is named directly in the facility registration submission — FDA Form 5066 (Cosmetic Facility Registration). The U.S. Agent's name, U.S. address, and contact information must be provided at the time of registration and kept current throughout the registration period.

Failure to designate a U.S. Agent can result in rejection of the facility registration, import refusal for cosmetic products entering the U.S., and FDA enforcement action. A valid, reachable U.S. Agent is a mandatory requirement for all foreign cosmetic facilities under MoCRA.

No. The U.S. Agent must be physically located in the United States and cannot be the foreign facility itself. The U.S. Agent must be a separate person or company with a valid U.S. address, available to receive FDA communications on behalf of the foreign facility.

As your FDA-authorized U.S. Agent, FDA Registration Assistance receives all official FDA communications on your behalf — including FDA inspection notices, warning letters, and regulatory inquiries. We promptly notify your facility of any FDA contact and provide guidance on the appropriate response.

The U.S. Agent designation is filed as part of the MoCRA facility registration (Form FDA 5066) submitted through the FDA's Cosmetics Direct portal. When FDA Registration Assistance handles your facility registration, we simultaneously file our U.S. Agent designation — streamlining the entire process for your foreign facility.

Yes. The U.S. Agent designation is renewed as part of your annual MoCRA facility registration renewal. FDA Registration Assistance manages the full annual renewal process — keeping your U.S. Agent designation active and your facility registration current without any lapse in compliance.

If the FDA issues an inspection notice for your foreign cosmetic facility, the notice will be sent to your designated U.S. Agent. FDA Registration Assistance will immediately relay the inspection notice to your facility and provide guidance on the inspection process, documentation requirements, and preparation steps.

Yes. You can update your U.S. Agent information at any time by submitting an amendment to your MoCRA facility registration through the Cosmetics Direct portal. It is important to ensure your U.S. Agent information is always current — an unreachable or incorrect U.S. Agent can trigger FDA compliance issues.

Yes. In addition to facility registration and U.S. Agent designation, the responsible person (typically the brand owner or manufacturer) must submit a MoCRA product listing (Form FDA 5067) for each cosmetic product marketed in the United States. FDA Registration Assistance handles both facility registration and product listing as part of a comprehensive compliance service.

FDA Registration Assistance offers U.S. Agent services for $1,449 USD per year. This includes your official U.S. Agent designation filed with the FDA, receipt and relay of all FDA communications, and annual renewal management to keep your facility registration and U.S. Agent designation continuously active.

Yes. FDA Registration Assistance supports both domestic and foreign cosmetic facilities for MoCRA compliance. For domestic facilities, we handle facility registration, product listing, and annual renewals. For foreign facilities, we additionally serve as the FDA-authorized U.S. Agent — providing a complete, end-to-end compliance solution.

FDA Registration Assistance can establish U.S. Agent services and submit your MoCRA facility registration promptly after receiving your facility information. We review your submission, prepare the registration, and file with the FDA — typically completing the full process within a few business days of receiving your completed details.

To get started, you will need to provide your facility name and address, owner/operator information, facility contact details, the types of cosmetics manufactured or processed at your facility, and your DUNS number (required for FDA registration). FDA Registration Assistance guides you through every step and can assist with DUNS number acquisition if needed.