FDA U.S. Agent
Foreign food facilities must designate a U.S. Agent when registering their food facility with the FDA. The U.S. Agent is a person or entity located within, or that maintains an office, in the United States. The U.S. Agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place.
The FDA AGENT acts as a communications link between US FDA and the food facility for both routine and emergency communications, unless the facility designates a different emergency contact.
- A foreign facility's U.S. agent must reside or maintain a place of business in the United States and must be physically present in the United States (21 CFR 1.227).
- FDA expects the facility management to contact the person and confirm that the person is willing and able to serve as the facility's U.S. agent. The facility should "designate" a person as the facility's U.S. agent only if the person has affirmatively agreed to serve in that capacity.
- FDA will verify that the person identified as the U.S. agent for the foreign facility has agreed to serve as the U.S. agent (see 21 CFR 1.231).
Which is the role of a U.S. Agent?
As established in 21 CFR 1.227, the U.S. agent acts as a communications link between FDA and a foreign facility for both routine and emergency communications. The U.S. agent will be the person FDA contacts when an emergency occurs, unless the registration specifies another emergency contact.
In functioning as the communications link with FDA, a U.S. agent may choose to initiate communications with FDA, and FDA may likewise choose to initiate communications with the U.S. agent.
Further, as stated in the definition for "U.S. agent" in 21 CFR 1.227, FDA will treat representations by the U.S. agent as those of the foreign facility, and will consider information or documents provided to the U.S. agent the equivalent of providing the information or documents to the foreign facility.
Why choose MAGNECO as your U.S. Agent?
When FDA determines a foreign food facility has not registered in accordance with section 415 of the FD&C Act because it does not provide a U.S. agent, FDA may hold shipments offered for import from that facility at the U.S. port of arrival until the facility amends their registration to list a U.S. agent who has affirmatively agreed to serve as such.
Do you have any questions or need to register?
Contact us now on (+1) 917-622-3409 or via email at register@magneco.us