Resident US Agent

The Food and Drug Administration (FDA), requires that every foreign entity that registers with the FDA needs to appoint a US Agent to represent them. The US Agent must be a US Resident or maintain a place of business in the USA. If the Foreign Entity does not appoint a US Agent, the Registration Form will be rejected. The FDA considers the US Agent as the communications link between the FDA and the Foreign Entity. The FDA states that providing any information to the US Agent is the same as providing the information directly to the Foreign Entity. Its for this reason that the US Agent plays a vital and important role between the Foreign Entity and the FDA to provide all the information required by the FDA and to keep the Foreign Entity informed of all developments on a timely basis.

Who can be a US Agent?

1. A person that resides in the USA
2. A entity that maintains a place of business in the USA

GTH Solution

GTH executives are US Citizens and GTH maintains an office in the USA and qualifies to be a US Agent for the purpose of registration as established by the Bioterrorism Act. It is important to point out that GTH is closely involved in the food sector and can provide valuable services that other US Agents cannot provide.

Responsibility of a US Agent

1. The US Agent is responsible to provide the required information as a US Agent on the Registration Form.

2. Assume the responsibility of the US Agent representing the Foreign Entity before the Food and Drug Administration (FDA).

3. Constantly monitor for any changes or modifications of the law or regulations of the Bioterrorism Act, notify the Foreign Entity and take the necessary actions to stay in compliance with any changes.

4. Be vigilant on any notifications of the FDA.

5. Make the necessary changes or modification to the original Registration Form as required.

6. Be the communications link between the FDA and the Foreign Entity.

Can I appoint various US Resident Agents?

No, the FDA only permits one US Agent per Foreign Entity.

Estimated costs to appoint a US Resident Agent

Published in the US Federal Register Vol. 68, No. 22 / Monday, February 3, 2003 / Proposed Rules, Section vi. “Costs to a Foreign Entity to appoint a US Agent”, the FDA estimates that the annual costs to appoint a US Agent will be between $700.00 - $2,000.00 (Ref. 16 and 17). GTH is offering this valuable service far below what the FDA estimates other US Agents will charge, see costs.

Detention of your Product at the US Port

If there is a problem with your shipment and the FDA detains it at the Port to investigate it, the costs associated with storage, transport, inspection, administration and other related costs shall be paid by the owner of the Product, which most likely will be the exporter. If the Product is damaged in this process, there will be no claims allowed against the FDA. The FDA estimates that the majority of the time the causes for detention may be that the Prior Notification Form was not filled out correctly and will need to be investigated.