Navigating FDA Food Facility Registration and Renewal

• The FDA Food Facility Registration is a mandatory requirement for both domestic and foreign facilities involved in the manufacturing, processing, packing, or holding of food, beverages, or dietary supplements intended for consumption in the United States.

• The registration process helps the FDA quickly identify and locate food facilities during inspections, recalls, and emergencies, thereby enhancing food safety and security.

Food facility registration with FDA

• Registration Requirement: All domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the U.S. must register with the FDA. This includes dietary supplements, beverages, fruits, vegetables, and more, but excludes food contact substances and pesticides.

• Biennial Renewal: Registrations must be renewed every even-numbered year between October 1 and December 31. If a registration is not renewed by the deadline, it is considered expired and will be removed from the account.

• Initial Registration: Facilities must initially register before engaging in activities related to food for consumption in the U.S. This involves providing facility and contact information, and for foreign facilities, designating a U.S. agent.

• Renewal Process:

1. Log into the FDA Industry System (FIS) using your account credentials.

2. Navigate to the Food Facility Registration (FFRM) system.

3. Select the "Biennial Registration Renewal" option from the FFR main menu.

4. Review and update the registration information as necessary. Only sections with an edit button can be updated during the renewal process

5. Submit the changes to complete the renewal process.

• Unique Facility Identifier (UFI): A DUNS number, recognized as an acceptable UFI by the FDA, must be included with the registration submission. This number is managed by Dun & Bradstreet and must match the facility's contact information exactly.

What is the difference between initial registration and biennial renewal?

The difference between initial registration and biennial renewal for FDA food facility registration lies in their purpose and process:

Initial Registration

• The initial registration is required for any domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the U.S., unless exempted. This is the first step to legally operate such a facility.

• During initial registration, the facility is assigned an 11-digit registration number and a PIN. This registration must be completed before the facility begins operations

Biennial Renewal

• Biennial renewal is required to maintain the validity of the registration. It ensures that the FDA has up-to-date information about the facility and its operations.

• The biennial renewal occurs every two years during even-numbered years, between October 1 and December 31. During this process, the facility retains its existing registration number. The renewal involves confirming or updating the registration information to ensure it remains accurate and compliant

How do I update my facility's information if it has changed?

To update your facility's information with the FDA, follow these steps:

1. Log into the FDA Industry Systems: Access your Online Account Administration (OAA) account and select the "Food Facility Registration" (FFRM) system.

2. Select the Registration to Update: From the FFRM main menu, choose the "Update Facility Registration" option. You will see a list of all registrations associated with your account. Select the hyperlinked Registration Number for the facility you want to update.

3. Review and Edit Information: Review the current registration information. If changes are needed, indicate which section of the registration you want to update by clicking the "Edit" button next to the relevant section. Make the necessary updates.

4. Submit the Updates: After making the updates, navigate through all application sections and submit the changes. The system will display a confirmation message once the registration is successfully updated.

5. Compliance with Update Requirements: Ensure that you update the registration within 60 calendar days of any change to the information previously submitted, such as changes in the operator, agent in charge, or U.S. agent. If the facility has a new owner, the former owner must cancel the registration, and the new owner must submit a new registration.

Remember, all updates must be submitted electronically unless you have received a waiver from the FDA.

How do I obtain a unique facility identifier (UFI)?

To obtain a Unique Facility Identifier (UFI), you need to acquire a Data Universal Numbering System (DUNS) number, which is recognized by the FDA as the acceptable UFI for food facility registration. Here are the steps to obtain a DUNS number:

1. Visit the FDA D-U-N-S Portal: Go to the FDA D-U-N-S Portal to obtain or verify your D-U-N-S number.

2. Create an Account: If you are a new user, you will need to create an account on the portal to access the services.

3. Submit a Request: Once logged in, you can initiate an inquiry to obtain a D-U-N-S number. The portal provides user guides and instructions to assist you with the process.

4. Processing Time: Acquiring a DUNS number can take up to 45 days, so it is advisable to start the process well in advance of any deadlines.

The DUNS number is a unique nine-digit numeric identifier used to identify a facility and is managed by Dun & Bradstreet (D&B).

What happens if a food facility registration is not renewed by December 31 of the even-numbered year?

• If a food facility registration is not renewed by the deadline of December 31 in an even-numbered year, it leads to the expiration of the registration. Once expired, the registration is removed from your account and becomes inactive. This can result in the facility being unable to legally continue its operations, potentially disrupting business activities. 

• To avoid such complications, it's crucial for facilities to renew their registration prior to the year-end deadline to maintain compliance and uninterrupted operation. Failure to renew can also impact your relationships with partners and clients, as an expired registration may reflect poorly on your business's reliability and adherence to regulatory standards.

Summary of Food Facility Registration Fields

When registering or updating a food facility with regulatory authorities such as the FDA, you'll encounter numerous fields that require accurate information. Below is a detailed summary of the key fields typically included in food facility registration forms:

Alternate Trade Name (Section 6)

A trade name other than that listed in Section 2: Facility Name / Address Information. A facility trade name is the name or names under which the facility conducts business, or additional names by which the facility is known. A trade name is associated with a facility, and a brand name is associated with a product.

Area Code

The three-digit area code of a telephone or FAX number in the United States, Canada, and Caribbean Islands.

Are You The New Owner Of A Previously Registered Facility? (Section 1)

Select Yes if you are submitting a registration as a new owner of a previously registered facility.

Select No if you are submitting a registration for a facility never previously registered.

Assign Registration

Select this option to assign a registration to the account(s) selected in the Manage Registrations Among Accounts function.

AutoFill Address (Sections 3, 4, 5, 7, 13)

If this is the first facility registration entered by this account holder this session, this option will copy the company address data from your account information. Otherwise, this option will fill the address fields automatically using data in this section from the last registration entered this session. If you choose AutoFill, and decide the information is not what you wanted, you may choose Clear to undo and fill in the correct information manually.

Authorizing Individual Street Address (Section 13)

The address of the person who authorized you to submit this form, if applicable. This can be a physical/geographical location or other mailing address.

Check one box

Specify whether the owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, is submitting this form. Choose:

A. Owner, Operator, or Agent in Charge (Stop here, form is completed)

- or -

B. Individual Authorized to Submit the Registration (in Section 13) or Cancellation (in Cancel/Change Registration Status) (Fill in address below)

City

The city in which the facility (Section 2), preferred mailing address (Section 3), parent company (Section 4), U.S. Agent (Section 7), owner, operator, or agent in charge (Section 12), or authorizing individual (Section 13) is located.

City Code

The city code of a telephone or FAX number in a country/area other than the United States, Canada, and the Caribbean.

Company Name (Section 4)

The name of the company that owns the facility being registered, if different from facility name.

Company Name Suffix (Section 4)

The type of company, for example “Company,” “Corporation,” or “Limited.”

Confirm E-mail Address

An electronic mail address for the facility being registered (Section 2), parent company (Section 4), emergency contact (Section 5), U.S. Agent (Section 7), owner, operator, or agent in charge (Section 12), or authorizing individual (Section 13). Must match the E-Mail address entered.

Country/Area

The country/area in which the facility (Section 2), preferred mailing address (Section 3), parent company (Section 4), U.S. Agent (Section 7), owner, operator, or agent in charge (Section 12), or authorizing individual (Section 13) is located. Select a country/area from the pull-down menu. (For U.S. agent and domestic facility addresses, United States is filled in automatically.)

Country Code

For foreign registrations, the three-digit country code of a telephone number or FAX number.

Dates of Operation (Section 8)

The approximate dates during which this facility operates, if it operates on a seasonal basis.

Do you want to link this registration to your enterprise account? (Section 1)

If the account is a Subaccounts, then the user has the option of determining if their account will be automatically linked to this registration or not.

Do you want to re-register a facility that has passed the registration renewal deadline? (Section 1)

Indicates if the registration is for a previously registered facility that had passed the registration renewal deadline or a facility never previously registered.

E-mail Address

An electronic mail address for the facility being registered (Section 2), parent company (Section 4), emergency contact (Section 5), U.S. Agent (Section 7), owner, operator, or agent in charge (Section 12), or authorizing individual (Section 13).

Emergency Contact Phone

The telephone number of the person or entity (Section 5) or U.S. Agent (Section 7) that FDA can call 24 hours a day, 7 days a week, in case of emergency.

Extension

The telephone extension, if any, dialed after the telephone number.

Facility Location (Section 1)

Specifies whether the facility is located within or outside the United States of America.

Facility Name (Section 2)

The complete legal name of the facility being registered.

Facility Name Suffix (Section 2)

The type of company, for example, “company,” “corporation,” or “limited."

Facility Street Address

The physical location of the facility being registered. Normally, this is the street address of the facility, but may be some other geographical or physical location information such as used in some rural areas.

FAX Number

A telephone number of the FAX machine for the facility being registered (Section 2), preferred mailing address (Section 3), parent company (Section 4), U.S. Agent (Section 7), owner, operator, or agent in charge (Section 12), or authorizing individual (Section 13).

If information is the same as another section, check which section (Section 4)

"Specifies whether the parent company name/address information is identical to previously entered information. If you choose one of these and decide the information is not what you wanted, you may choose Clear to undo and fill in the correct information manually

Choose Section 2 if the parent company name/address is the same as the facility name/address entered in Section 2: Facility Name / Address Information.

- or -

Choose Section 3 if the parent company name/address is the same as the preferred mailing address entered in Section 3: Preferred Mailing Address Information.

- or -

Choose Clear if you need to clear Section 4."

Indicate who authorized you to submit the registration (Section 13) or cancellation (Cancel/Change Registration Status)

"Indicate who authorized you to submit the registration (Section 13) or cancellation (Cancel/Change Registration Status) If you checked Box B in Section 13 (Individual Authorized to Submit the Registration) or in Cancel/Change Registration Status (Individual Authorized to Submit the Cancellation) because you are not the owner, operator, or agent in charge, you need to identify the person who authorized you to submit this registration (Section 13) or cancellation (Cancel/Change Registration Status). Choose:

Owner, Operator, or Agent in Charge (Stop here, form is completed)

- or -

Fill in the Name of Individual who Authorized registration (Section 13) or cancellation (Cancel/Change Registration Status) on behalf of owner, operator, or agent in charge (Fill in address below)."

If information is the same as another section of the form, check which section (Section 12)

Specifies whether the owner, operator, or agent in charge name/address information is identical to previously entered information. If you choose one of these and decide the information is not what you wanted, you may choose Clear to undo and fill in the correct information manually.

Choose Section 2 if the owner, operator, or agent in charge address information is the same as the facility name/address entered in Section 2: Facility Name / Address Information.

- or -

Choose Section 3 if the owner, operator, or agent in charge address information is the same as the preferred mailing address entered in Section 3: Preferred Mailing Address Information.

- or -

Choose Section 4 if the owner, operator, or agent in charge address information is the same as the parent company address entered in Section 4: Parent Company Name / Address Information.

- or -

Choose Section 7 if the owner, operator, or agent in charge address information is the same as the U.S. Agent address entered in Section 7: United States Agent.

- or -

Choose Clear if you need to clear Section 12.

Individual's Name (Section 12)

The name of individual who authorized registration on behalf of owner, operator, or agent in charge.

Job Title (Section 5)

The title for the emergency contact, such as “Manager,” “CEO,” “President.”

Name (Section 3)

The name of the person or company where you wish to receive mail from FDA regarding this registration.

Name of Emergency Contact (Section 5)

The first name and last name (surname) of the person to contact in case of emergency for the facility being registered.

Name of Entity or Individual who is the Owner, Operator, or Agent in Charge (Section 12)

The name of the person or entity who is the owner, operator, or agent in charge of the facility being registered.

Name of U.S. Agent (Section 7)

The first name and last name (surname) of the person acting as U.S. Agent for the foreign facility being registered.

Name of Parent Company (Section 4)

The name of the company that owns the facility being registered, if different from the Facility Name.

Name of the Submitter (Section 12)

The first name and last name (surname) of the person submitting this form.

New Registration Status

When canceling a registration, the status to which you want to set the registration, i.e., Cancel.

Phone Number

The telephone number for the facility being registered (Section 2), preferred mailing address (Section 3), parent company (Section 4), emergency contact (Section 5), U.S. Agent (Section 7), owner, operator, or agent in charge (Section 12), or authorizing individual (Section 13).

PIN

The Personal Identification Number for this facility's registration. A mixed-case alphanumeric string that can contain special characters. This number will be assigned by FDA for each facility registration, and can be shared, if wanted, by account holders (or Subaccount holders) to allow multiple people access to a registration.

Previous Owner's Name (Section 1)

If you are a new owner of a previously registered facility, provide the name of the previous owner of the facility, if known.

Previous Owner's Registration Number (Section 1)

The Registration Number is assigned to a facility by FDA. If you are a new owner of a previously registered facility, provide the previous owner's registration number for this facility, if known. If the new owner provides the old registration number, FDA will send a notification to the former owner seeking confirmation and will cancel the former registration upon receipt of confirmation, or FDA's independent confirmation of a change in ownership, whichever occurs first. If the new owner does not provide the old registration number, FDA will keep the old registration in its database until it independently affirms that the facility is under new ownership.

Previous Owner’s Title (Section 1)

The title for the previous owner.

Receipt Code

A reference number assigned by FDA to a facility registration for purposes of confirming a Notification of Registration. If your registration number and PIN were sent to you by mail you were also sent a receipt code to send back to FDA to confirm that you received the information. If you use the online confirmation form, you do not have to send a confirmation by postal mail.

Registration Expiration Date

The date a facility’s registration expires.

Registration Number

The number assigned by FDA to this facility's registration.

State / Province / Territory

The state, province, or territory in which the facility (Section 2), preferred mailing address (Section 3), parent company (Section 4), U. S. Agent (Section 7), owner, operator, or agent in charge (Section 12), or authorizing individual (Section 13) is located. Select a state, province, or territory from the pull-down menu when applicable or select "Not applicable."

Street Address, Line 1

The address in which the facility (Section 2), preferred mailing address to receive FDA notices (Section 3), parent company (Section 4), U.S. Agent (Section 7), owner, operator, or agent in charge (Section 12), or authorizing individual (Section 13) is located. This can be a physical/geographical location or other mailing address.

Street Address, Line 2

The second street name and address number, if applicable. May also enter information such as Suite number.

Title

The title for the emergency contact (Section 5) or U.S. Agent (Section 7).

Type of Activity Conducted at the Facility

The type of activity that is performed at this facility regarding the manufacturing, processing, packing, or holding of food. Select a Type of Activity from the drop-down menu.

Type of Registration (Section 1)

Specifies whether the facility is located within or outside the United States of America. Choose one of the following two options:

Domestic Registration - to indicate that the facility is located in a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

- or -

Foreign Registration - to indicate a facility is not a domestic facility.

Note: The Type of Registration cannot be changed later in the application process. If you wish to change this selection, you must cancel the application and create a new registration.

Unassign Registration

Choose to unassign a registration to the account(s) selected in the Manage Registrations Among Accounts function.

Unique Facility Identifier

A Unique Facility Identifier (UFI) that allows users to identify the user’s facility through a unique number such as a DUNS number.

U.S. Agent (foreign countries only)

A person residing or maintaining a place of business in the United States whom a foreign facility designates as its agent for purposes of the registration regulation. A U.S. agent cannot be in the form of a mailbox, answering machine, or service, or other place where an individual acting as the foreign facility's agent is not physically present. The U.S. agent acts as a communications link between FDA and the foreign facility for both routine and emergency communications. The U.S. agent will be the person FDA contacts when an emergency occurs unless the registration specifies another emergency contact. FDA will treat representations provided by the U.S. agent as those of the foreign facility, and consider information provided to the U.S. agent as the equivalent of providing the same information or documents to the foreign food facility. Only one person can be designated as the “U.S. Agent”, but this does not preclude a facility from having multiple agents for other business purposes.

Zip Code (Postal Code)

The zip code (for domestic addresses) or postal code (for foreign addresses) for the facility being registered (Section 2), preferred mailing address (Section 3), parent company (Section 4), U.S. Agent (Section 7), owner, operator, or agent in charge (Section 12), or authorizing individual (Section 13).

Summary

Food facility registration renewals are required by the U.S. Food and Drug Administration (FDA) every two years during even-numbered years. The renewal period begins on October 1 and ends on December 31 of the same year. This requirement is mandated by Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] .

Key Points on Food Facility Registration Renewal

1. Renewal Period: The registration renewal must occur between October 1 and December 31 of each even-numbered year. If a facility fails to renew by the deadline, the registration is considered expired and will be removed from the FDA's account system.

2. Unique Facility Identifier (UFI): All facilities must include a UFI with their registration. The FDA recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI. This number must be associated with the physical location of the food facility.

3. Electronic Submission: All submissions must be electronic unless the facility has received a waiver. The FDA provides resources and guidance documents to assist facilities in understanding and completing the registration process.

4. Abbreviated Renewal Process: For facilities without changes in their registration information since the last submission, an abbreviated renewal process is available. This requires confirmation that no changes have been made and certification that the information is truthful and accurate

5. Importance of Registration: Registration helps the FDA identify the location and source of foodborne illness outbreaks or potential bioterrorism incidents. Non-compliance can result in the denial of imports into the U.S. and domestic exports.