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U.S. AGENT

All foreign businesses who import or offer to import food into the United States are required to register a U.S. Agent with the FDA (“U.S. Agent”). The U.S. Agent must be physically located in the United States, P.O. Boxes or answering services not allowed, and serves as the point of contact between the foreign business and the FDA.

Responsibilities of a U.S. Agent

The responsibilities of the U.S. Agent are as follows:

  • Assisting the FDA will all communications between FDA and the foreign business;
  • Responding to questions from the FDA regarding the products that are imported or offered for import into the United States;
  • Assisting FDA in scheduling inspections of the foreign business; and
  • If FDA is unable to contact the foreign business, FDA may provide the information and/or documents to the U.S. Agent, which serves as the equivalent to providing the same information and/or documents to the foreign business.

U.S. Agent Registration Process

All foreign businesses who import or offer to import foods must register with the FDA before the products enter the United States. If you do not register your foreign business, your products will not be allowed into the United States. Penalties may also apply.

Previously registered facilities are required to renew their registration, including U.S. Agent information, biennially (every other year) between October 1 and December 31 of each even-numbered year. (i.e. 2020, 2022, 2024, etc.)

How Much is the U.S. Agent Fee?

U.S. Agent fees are only $299.00 per year including the food facility registration.

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