Food facilities located in the United States and foreign facilities that intend to export product into the United States are required to register with the U.S. Food and Drug Administration (FDA) under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and Section 415 of the Federal Food, Drug, and Cosmetic Act. There is no fee for registration or renewal and registration can be submitted online, via mail or fax. Under the new FDA regulations arising out of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, most non-US food facilities shipping product to the U.S. must have an Agent based in the U.S. The Agent’s primary responsibility is to serve as a communications link between FDA and the foreign food facility. At the request of several non-U.S. members, IARW offers to provide this service to our members at no cost. We will serve as your U.S. Agent and be listed under Section 7 on the DHHS/FDA – Food Facility Registration Form.

This service is only available to active IARW Warehouse Members.

If you wish to designate IARW as your US Agent, you are authorized to provide FDA with the following information in Section 7:

  • Name of U.S. Agent: Lowell Randel
  • Title: Vice President of Government and Legal Affairs
  • Company: International Association of Refrigerated Warehouses
  • Address: 241 18th Street South, Suite 620
  • City: Arlington
  • State: Virginia
  • Zip Code: 22202
  • U.S. Agent Phone Number: 703-373-4300
  • Emergency Contact Phone Number: 703-373-4300
  • Fax Number: 703-373-4301
  • E-Mail Address: lrandel@gcca.org

If you wish to use IARW as your U.S. Agent, you must send us a copy of the complete registration form and tell us what registration number is assigned to you by FDA. We also urge you to show your own local emergency contact information under Section 5 of the registration form. For further information or questions, please contact Lowell Randel. If you do not wish to use IARW as your U.S. agent, there are many private companies that offer to  assist with registration forms and act as your U.S. Agent. However, there services can be costly and generally run several hundred dollars or more.

Liability

Should you choose to use IARW as your U.S. Agent, you agree that IARW shall not be liable for any incidental, consequential or punitive damages, whether foreseen or unforeseen, arising out of or related to, directly or indirectly, (a) any failure of the FDA to accept and approve the Form, (b) proceedings to terminate the IARW Member’s FDA Registration, or (c ) the failure of any product of IARW Member to be allowed entry into the United States.