When a food company wants to export food products to the United States, they must first register with the U.S. FDA. All food facilities that engage in manufacturing/processing, packing, or holding of food for human or animal consumption in the U.S. If food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted, the food will be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food. Trading companies that do not come into contact with the food do not need to be registered.

The FDA requires food facility registration, so they can identify where potential food safety issues occur in the food supply chain. Foreign food facilities must also identify a U.S. Agent during the registration process. The agent (1) must reside or maintain a place of business in the U.S. and (2) must be physically present in the U.S. The U.S. agent must be able to serve as the communication link between FDA and the foreign facility because FDA will contact the foreign facility’s U.S. agent for both routine registration matters and emergency situations.

This means that the U.S. agent must be accessible to FDA 24 hours a day, 7 days a week. If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf. A foreign facility’s U.S. agent may register the facility (21 CFR 1.230). Although foreign facilities can opt to register their facility, many foreign facilities hire a U.S. FDA specialist to take care of this process for them.

Once the facility is registered, you can send products and samples to the Unites States. Each time you ship, you need to notify US Customs and FDA by providing a Prior Notice. Often your shipper or freight forwarder will do that for you as part of their services, but we can also assist you with filing a Prior Notice.

As part of the new Foreign Supplier Verification Programs (FSVP), your US buyer/importer needs to be listed as the FSVP Importer. If you don’t have a buyer or importer at the moment your products are being imported, or if you don’t want to disclose sensitive manufacturing details with your U.S. importer, we can assist you as well.