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Food and beverage compliance with US Bioterrorism Act regulations

Under Bioterrorism Act regulations, United States domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the United States Food and Drug Administration (FDA).

New Zealand exporters need to thoroughly understand these regulations. Exporters who do not comply will have their goods refused entry to the United States.

You need to register and provide prior notice of exports. Holding and warehousing facilities also need to be registered.

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Registration

Registration with the FDA is mandatory. It includes individuals authorised by owners, operators, or agents of food facilities.

Registration is required only once for each food facility.

As a part of registration, foreign facilities have to designate a United States agent (for example a facility's importer or broker) to acts as their domestic representative. New Zealand Trade and Enterprise in the United States cannot act as an agent. It needs to be an importer, distributor or broker.

There is no fee for registration or updates.

Prior notice

The FDA must receive prior notice before food is imported or offered for import into the United States. Without prior notice, the FDA may refuse entry.

Prior notice must be submitted, and the submission confirmed by FDA, no more than five days before arrival, except for food sent by international mail.

Information required for prior notice varies, depending on the type of entry, mode of transportation and whether the food is in its natural state.