The US Food and Drug Administration (FDA) requires that all manufacturers and producers of food or beverages intended for human or animal consumption in the US register their facilities with FDA. Warehouses and other facilities that store food or beverages are also required to register, if any of the products they store are exported to the US.
This “food facility registration” is normally done on-line, on the FDA website, by either:
* the food facility’s owner, operator, or agent in charge; or
* an individual authorized by the facility’s owner, operator, or agent in charge.
Users can create an account to use in registering their facilities, and log in to their account to file a new registration or update an existing one.
This user guide includes step-by-step instructions for food facility registration.
As part of its registration, each “food facility” that is not located in the US must designate a US agent, who serves as a communication link between the food facility and FDA. That agent must be a US resident. Many food facility operators who have a close relationship with a major customer located in the US make arrangements for that customer to serve as the food facility’s US agent, but this is not required. Also, the same person who is authorized to do a food facility’s registration on behalf of the facility’s owner, operator, or agent in charge may also be authorized by that facility to act as the facility’s US agent.
If all the necessary information is at hand, at the time a food facility is registered on the FDA website, the whole registration process can be done in as little as 15 minutes. When the registration is complete, FDA will automatically issue a “food facility registration number” to the facility. This is an eleven-digit number, which will serve to identify that food facility on any customs entry documentation that includes food or beverages from that facility.
Each food facility registration must be renewed every two years, during the period October 1 through December 31 of each even-numbered year. The registration renewal and renewal fact sheet are also available on the FDA website.
Naturally, clients who might find a “second opinion” useful are always welcome to contact TCB to discuss food facility registration, as well as other FDA issues.