FDA Food Facility Registration: A Comprehensive Guide for Manufacturers

If your company manufactures, processes, packs, or holds food or dietary supplements for U.S. consumption, you may be required to complete FDA Food Facility Registration (FFR).

This guide explains:

• Who must register

• How to obtain a DUNS (UFI)

• Domestic vs. foreign requirements

• U.S. Agent requirements

• Biennial renewal deadlines

• Common mistakes that cause delays

  
  

This article applies to food and dietary supplement facilities only. It does not apply to OTC drug registration or drug establishment listing.

What Is FDA Food Facility Registration?

Under the Federal Food, Drug, and Cosmetic Act (as amended by FSMA), domestic and foreign facilities that manufacture, process, pack, or hold food for U.S. consumption must register with FDA through the Food Facility Registration (FFR) system.

Dietary supplements are regulated as a category of food, so supplement manufacturers register under this same system.

Registration is mandatory — but it is not FDA approval.

Official FDA resource: FDA Food Facility Registration

Step-by-Step FDA Food Facility Registration Process

Step 1 — Confirm Your Product Is Not an OTC Drug

Before registering:

• Ensure your product does not make disease treatment or prevention claims.

• Ensure it does not contain drug active ingredients.

• Confirm it qualifies legally as food or a dietary supplement.

  
  

If your product meets the definition of a drug, you must follow drug establishment registration, not food facility registration.

Step 2 — Determine If Your Facility Must Register

Registration is required if your facility:

• Manufactures or processes food/supplements

• Packs or repacks food/supplements

• Holds food for U.S. distribution

  
  

This applies to:

• U.S. domestic facilities

• Foreign facilities exporting to the U.S.

• Contract manufacturers

• Warehouses storing food for U.S. commerce

  
  

Step 3 — Obtain a DUNS Number (UFI Requirement)

FDA requires a Unique Facility Identifier (UFI) for food facility registration. FDA currently recognizes the DUNS number as the UFI.

Important requirements:

• Each physical facility location must have its own DUNS.

• The facility name and address must exactly match the DUNS record.

• Mismatches can result in rejection or delay.

  
  

FDA reference: FDA Media

Step 4 — Determine Domestic vs. Foreign Requirements

Domestic Food Facility Registration

• Register through FDA Industry Systems (FIS).

• No U.S. Agent required.

  
  

Foreign Food Facility Registration

Foreign facilities must:

• Register in FIS/FFR.

• Designate a U.S. Agent.

• Ensure the U.S. Agent confirms agreement electronically.

  
  

The U.S. Agent must:

• Reside or maintain a place of business in the United States.

• Be available during normal business hours.

• Serve as FDA’s communication contact.

  
  

Step 5 — Create an FDA Industry Systems (FIS) Account

All registrations are submitted electronically through:

FDA Industry Systems (FIS) Module: Food Facility Registration (FFR)

Official portal: FDA Access

Paper submission is only permitted if FDA grants a waiver.

Step 6 — Submit the Food Facility Registration (FFR)

Information typically required:

• Facility legal name and physical address

• DUNS (UFI)

• Owner/operator information

• Emergency contact

• Activity type (manufacture, pack, hold)

• Food product categories

• U.S. Agent details (foreign facilities only)

  
  
  
  

Upon submission, FDA assigns a Food Facility Registration Number. This number confirms registration — not product approval.

FDA Food Facility Registration Renewal (Critical Compliance Requirement)

Food facility registrations must be renewed every even-numbered year between October 1 and December 31. This applies to both domestic and foreign facilities.

Example

If your facility first registers in 2025, you must renew between October 1 – December 31, 2026.

Renewal is tied to the even-year cycle, not your registration anniversary. Failure to renew by December 31 of the even year may result in:

• Expired registration

• Removal from FDA’s active database

• Potential import refusal (for foreign facilities)

  
  

FDA renewal guidance: FDA Renewal Guide

When Must You Update Your Registration?

You must update your registration if there are changes to:

• Facility name

• Address

• Ownership

• Contact information

• U.S. Agent (foreign facilities)

  
  

Updates must be submitted within the timeframe required by FDA regulations.

Common FDA Food Facility Registration Mistakes

• Using corporate headquarters DUNS instead of site-specific DUNS

• Address mismatch between DUNS record and FDA entry

• Missing the Oct–Dec renewal window

• Foreign facilities failing to secure U.S. Agent confirmation

• Confusing food facility registration with OTC drug establishment registration

  
  

Frequently Asked Questions

Is FDA food facility registration required for dietary supplements?

Yes. Dietary supplement facilities typically register under the Food Facility Registration (FFR) system because supplements are regulated as food.

If I register in 2025, do I renew in 2026?

Yes. Renewal occurs every even-numbered year, between October 1 and December 31.

Is there an FDA fee for food facility registration?

FDA does not charge a registration or renewal fee. Service providers may charge assistance fees.

Do foreign food facilities need a U.S. Agent?

Yes. A U.S. Agent is required for foreign food facility registration.

How Axentra Global Pharma Compliance Can Help

Axentra Global Pharma Compliance supports:

• FDA Food Facility Registration (FFR)

• DUNS/UFI coordination

• Foreign facility U.S. Agent services

• Biennial renewal management

• Compliance monitoring

  
  

For assistance with FDA Food Facility Registration or Renewal, visit: Axentra Compliance

Conclusion

Navigating the FDA Food Facility Registration process can be complex. However, understanding the requirements and following the steps outlined in this guide can simplify the process. If you have questions or need assistance, consider reaching out to professionals who specialize in FDA compliance. They can help ensure that your registration is completed accurately and on time, allowing you to focus on bringing your products to market confidently.