Who Must Register?
Under the U.S. FDA Bioterrorism Act of 2002, all foreign and domestic facilities that manufacture, process, pack, or store food, beverages, and dietary supplements sold in the U.S. market are required to register with the FDA. This registration leads to the issuance of a Food Facility Registration (FFR) number. Furthermore, intermediary merchant companies, such as traders, importers, or distributors, must register with the FDA if they handle food in a holding facility or warehouse.
After registering, the FDA assigns an 11-digit registration number to the food facility. This number identifies the manufacturing or trading firm and is necessary for U.S. customs clearance. Due to the FDA’s confidentiality policy, food facility registration data remains private and is never published publicly. Consequently, the FDA’s initial registration or renewal notice, sent via an official FDA email, is the only proof that the registering firm will receive.
After registering, the FDA assigns an 11-digit registration number to the food facility. This number identifies the manufacturing or trading firm and is necessary for U.S. customs clearance. Due to the FDA’s confidentiality policy, food facility registration data remains private and is never published publicly. Consequently, the FDA’s initial registration or renewal notice, sent via an official FDA email, is the only proof that the registering firm will receive.
Required Information to Obtain an FFR
When applying for a food facility registration number, the following information is required:
● Unique Facility Identifier (9-digit DUNS number)● Facility name, address, and emergency contact● Information on the owner, operator, or agent in charge● General product categories and types of activities conducted● Any trade names (brand names)● U.S. Agent who has accepted the designation (for international facilities)
● Unique Facility Identifier (9-digit DUNS number)● Facility name, address, and emergency contact● Information on the owner, operator, or agent in charge● General product categories and types of activities conducted● Any trade names (brand names)● U.S. Agent who has accepted the designation (for international facilities)
Food, Beverage & Dietary Supplement FDA Facility Registration Process
Cost: $349
Step 1
Complete the inquiry form, and tell us about your facility
Step 2
We will send you a short and simple intake form to collect your company and facility details
Step 3
We prepare a draft for your review, and after receiving your approval, we submit it to the FDA
Step 4
We will work with the FDA to get your facility registered (1-3 days)
Step 5
Your facility will be FDA registered, and you will receive an FDA registration number and registration certificate issued by our company
Ready To Start Your Facility Registration? Share your name and email to receive the Facility Registration Intake Form
A Few Important Things To Note:- Our fee includes U.S. Agent services for foreign companies. We provide professional U.S. Agent representation to facilitate compliance and communication with the U.S. FDA. No additional fees required for U.S. Agent services.- Food facilities must renew their registrations every even-numbered year between October 1 and December 31. We work with you to manage this process to ensure your registration remains active and up to date, so we can avoid border issues.- The FDA requires foreign facilities to provide a D-U-N-S Number for registration. If you don’t have one, we can assist in obtaining it for an additional fee.