Who Should Register?

The Bioterrorism Act states that all food manufacturer, processor, packers, holders, exporters and transporters that sell food products destined for the USA for human or animal consumption, must comply with all the requirements of the new Bioterrorism Act which becomes effective on December 12th, 2003. Any entity that does not comply with the dispositions of the new law, will not be able to sell their products in the largest market in the world.

The law requires that all foreign entities must designate a US Agent to represent them. The Agent must be a US Resident or maintain an office in the USA.

All Forms must be in English and if you do not appoint an Agent to represent you, the Form will be rejected!

GTH Solution

GTH can help you comply with the Registration Form by submitting it electronically and representing you as your US Agent. We can help you translate the Form as required.

GTH has offices in the USA and qualifies to be your US Agent for the purposes of registration, as established by the FDA.

How and when to Register?

Between October 12th, and December 12th, 2003 is the period of registration. The FDA recommends that the registration be through electronic means, (the FDA will provide a website for registration which will be open 24 hours a day, 7 days a week), but you can send the Form via regular post. All information on the Form needs to be submitted in English and you will need to appoint a US Agent.

GTH is accepting Registration prior to October 12th, 2003. All Forms filled out prior to October 12th, will be placed in our Data Base and submitted to the FDA on October 12th. By registrating now, you will save money and avoid the rush to register.

Source: FDA