FDA Import Regulations

What is the requirement?

Wineries, distilleries, food producers, warehousing facilities, retailers and everyone involved in the shipment of food and drink into the USA must comply with the terms of the “ Public Health Security and Bioterrorism Preparedness and Response Act of 2002”.

The Act stipulates that each foreign facility must appoint a US based agent. This will provide the FDA with a contact point in the USA for each registered facility. JF Hillebrand is able to act as an agent for its customers, wineries and other producers from countries outside the USA.

If you attempt to import beverages into the USA without registering, your goods may be detained at the US port, and the importer could be subject to penalties and/or barred from shipping goods into the USA.

Who must register?

The FDA defines a food facility as “any domestic or foreign establishment that manufactures, processes, packs or holds (warehouses) food for human or animal consumption in the United States.”

  • Owners, operators or agents in charge of such facilities are responsible for the registration.
  • A foreign facility must designate a US agent for purposes of registering the foreign facility (in this case JF Hillebrand USA may be appointed as the US agent).
  • Foreign facilities are exempt from registering if food from these facilities undergoes further processing or packaging by another facility outside the United States.
  • Farms, retail facilities, and restaurants are exempt; however, farms that pack for or sell product to consumers may not be exempt.

Renewal Requirements

The FDA requires all wineries, registered as food facilities to export into the USA to renew their registration every two years according to the Food Safety Modernization Act of 2012.  The renewal period starts October 1st, 2016 through December 31st, 2016.   
All facilities that have not renewed by this date will need to re-register.   
For more information about registering or electing JF Hillebrand as your US agent, please contact your local JF Hillebrand office or in the USA contact: 
Lydia Moya-Kiste
T +1 732 850 7639