U.S. Agent Service for NCA Members 

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:

Step 1

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  info@ncausa.org or faxed at (212) 766-5815.

For information on how to join the NCA, please contact us.

Step 2 

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.

Step 3

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 furls@fda.gov.

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 trbartlett@ncausa.org or at 646-924-4039. 

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The Bioterrorism Act of 2002, The Food Safety Modernization Act, and FDA Regulations

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) directed the FDA to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

The Bioterrorism Act added section 415 to the FDCA, which requires domestic and foreign facilities engaged in the manufacturing, processing, packing, or holding of food for consumption in the United States to register their facilities with the FDA.  In addition, the Bioterrorism Act and the regulations promulgated require:

• Foreign facilities to designate a U.S. Agent to serve as the communications link to the FDA, and,
• The FDA to be given prior notice of shipments of imported food.

In 2011, the FDA Food Safety Modernization Act (FSMA) was signed into law.  FSMA amended the facility registration requirements by requiring facilities to renew registrations on a biennial basis, to provide an email address for its U.S. Agent if it is a foreign facility, and adding new facility suspension provisions, among other things.  For more information on the FDA registration requirements, please review the FDA’s website, and review the FDA’s regulations at 21 C.F.R. Part 1, Subpart H.