Domestic or foreign facilities that manufacture, process, pack, or hold food for consumption in the U.S. are required to be registered with the U.S. Food and Drug Administration (FDA) in accordance with the federal Food, Drug, and Cosmetic Act (FDCA) and regulations promulgated thereunder. Foreign facilities must also include the name and contact information of a "United States Agent."
Failure to comply with the registration requirements could result in a food shipment from that facility being detained and refused admission into the United States.
To help you comply with certain aspects of the facility registration requirements, the NCA provides a service to its members with facilities located outside the U.S. Members in good standing may name the Association as their "United States Agent" when they register foreign facilities with the FDA.
The NCA will act as members' U.S. Agent for the sole purpose of serving as a communications link between the FDA and the Member. If you wish to take advantage of this U.S. Agent Service, just follow the steps below after reviewing the details of the Service Agreement. There is no fee associated with this U.S. Agent Service. Please read all steps thoroughly before proceeding:
Sign Agreement with the NCA
If you are currently a Member of the NCA and would like to designate the NCA as your "U.S. Agent" when registering your facilities with the FDA, you must accept the terms and conditions of the Service Agreement and follow the additional steps below. (If you just joined NCA on line, please wait for your e-mail acknowledgement before proceeding.) The signed Service Agreement should be emailed to email@example.com or faxed at (212) 766-5815.
For information on how to join the NCA, call (212) 766-4007 or e-mail firstname.lastname@example.org.
Provide Facilities’ Contact Information
Before you can designate the NCA as your "U.S. Agent" you must submit to NCA full and accurate contact information for each and every facility covered by the Agreement.
Register with the FDA
Once you have completed Steps 1 and 2, you may designate the NCA as your "U.S. Agent" when registering your foreign facility(ies) with the FDA. Please follow the electronic registration instructions on the FDA’s website.
Please understand that the NCA itself will NOT be registering your facility(ies) with the FDA, and it is up to you to fulfill the FDA’s registration requirements. Any questions regarding registering your facility(ies) should be directed to the FDA website; Help Desk Service at 1-800-216-7331 or 240-247-8804; or by email at email@example.com.
For further information about the nature and/or scope of the NCA’s U.S. Agent Service, please contact Terri Bartlett, Director of Member Relations, at firstname.lastname@example.org or at 646-924-4039.