For a foreign cosmetic facility that is required to register under section 607 of the FD&C Act, the facility registration must include contact information for the facility's United States agent. FDA Form 5066 collects the U.S. Agent name, email, and phone number for foreign facilities.

Foreign cosmetic manufacturing or processing facilities that are required to register with FDA must provide U.S. Agent contact information as part of the facility registration. Certain small businesses and certain facilities or products subject to drug or device requirements may qualify for statutory exemptions, so the facility's actual activities and products should be reviewed.

FDA's current Form FDA 5066 instructions require the U.S. Agent's name, email, and phone number for a foreign facility. The current form does not list a U.S. Agent street address as a required field. Our service nevertheless provides a U.S.-based contact for the foreign facility.

The U.S. Agent information appears in Section III of Form FDA 5066 for foreign facilities. FDA requires the U.S. Agent name, email if available, phone number, and an optional phone extension.

Not simply because the responsible person is foreign. The U.S. Agent requirement addressed on Form FDA 5066 applies to a foreign cosmetic facility's facility registration. Product listing on Form FDA 5067 is a separate filing made by the responsible person.

Yes. Form FDA 5066 includes an Amended (Changes to Registration) document type that can be used to update registration information. If U.S. Agent contact information changes, the facility should keep its registration current.

We serve as the designated U.S. contact identified in the foreign facility's FDA registration, receive and relay FDA communications that are sent to us, help coordinate registration-related correspondence, and assist the facility with maintaining current registration information within the agreed service scope.

Our U.S. Agent engagement can be coordinated with MoCRA facility registration support. The exact scope depends on whether the facility is completing an initial registration, an amendment, or a biennial renewal and whether additional services such as FEI assistance or product listing are needed.

No. FDA requires covered cosmetic facility registrations to be renewed every two years. Our U.S. Agent service is billed annually so representation remains active between facility-registration renewal cycles.

FDA's current facility-registration framework does not describe a separate annual U.S. Agent renewal filing. U.S. Agent information is part of the foreign facility registration, which is renewed biennially and amended when registration information changes. Our professional U.S. Agent service renews annually.

The facility must submit a biennial renewal through FDA's cosmetic facility registration system. FDA's 2026 Cosmetics Direct updates display registration status and renewal date, and FDA sends automated reminders to contacts associated with the registration, including the U.S. Agent when applicable.

Not automatically. Cosmetic product listing is a separate MoCRA requirement assigned to the responsible person whose name appears on the cosmetic label. We can provide product-listing services separately when the responsible person needs assistance.

FDA Registration Assistance charges up to $849 USD per year for its cosmetic U.S. Agent service. The exact scope can include U.S. Agent representation and related facility-registration support as agreed in the engagement.

FDA's current MoCRA registration and listing materials do not identify a general government user fee simply to designate a U.S. Agent on Form FDA 5066. The $849 annual amount shown on this page is our professional service fee.

FDA's current Form FDA 5066 lists the facility DUNS number as optional information. The required cosmetic facility registration number is the FDA Establishment Identifier (FEI), which the owner or operator should obtain before submitting the facility registration.

Send us the foreign facility name and address, owner or operator information, facility email and phone, FEI if already assigned, brand names, responsible-person names, product categories, and any existing FDA registration details. We will review whether the facility is required to register and confirm the U.S. Agent service scope.