Quick Answer
FDA food facility registration is required for all domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Registration is free through FDA's online portal and must be renewed every two years during even-numbered years (October 1 - December 31).
2026 Biennial Renewal Year
The next biennial renewal window opens October 1, 2026. All food facility registrations must be renewed by December 31, 2026, or they will be automatically cancelled by FDA. Mark your calendar now.
Regulatory Authority: 21 CFR Part 1, Subpart H — Registration of Food Facilities
What Is FDA Food Facility Registration?
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ImmutableFDA food facility registration is a federal requirement under 21 CFR Part 1, Subpart H. All domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the FDA before beginning operations. Registration is free through FDA's online portal and must be renewed biennially (every two years during October 1 - December 31 of even-numbered years). You can register directly at the FDA Food Facility Registration page.
The requirement was established by the Bioterrorism Act of 2002 and enhanced by the FDA Food Safety Modernization Act (FSMA) of 2011. This mandatory registration system allows the FDA to quickly identify and locate food facilities in the event of a food safety emergency, such as a contamination outbreak or bioterrorism threat.
This requirement applies to both domestic U.S. facilities and foreign facilities that export food products to the United States. If you are importing food, you should also understand FSVP compliance requirements and Prior Notice filing procedures.
Registration provides the FDA with critical information about food facilities, including:
- Facility name, address, and contact information
- Type of food products handled
- Food product categories (using FDA food categories)
- Parent company information (if applicable)
- US Agent information (for foreign facilities)
- Emergency contact details
Important Note
Food facility registration is different from food product registration. The FDA does not require pre-market approval or registration for most food products themselves. However, facilities that make these products must be registered.
Who Must Register a Food Facility with the FDA?
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FDA food facility registration is required for any facility, domestic or foreign, that manufactures, processes, packs, or holds food for human or animal consumption in the United States. This includes a wide range of operations:
Domestic Facilities (U.S.-Based)
- Food manufacturers: Facilities that make food products from raw ingredients
- Food processors: Facilities that transform or modify food products
- Food packers: Facilities that package food products for distribution
- Food storage warehouses: Facilities that hold food products before distribution
- Pet food manufacturers: Facilities making animal food products
- Dietary supplement manufacturers: Facilities making supplements for human consumption
Foreign Facilities
Any foreign facility that manufactures, processes, packs, or holds food for export to the United States must register. This includes:
- Food manufacturers in other countries exporting to the US
- Foreign food processing plants
- Export-focused packaging facilities
- Foreign warehouses holding food destined for US import
Foreign facilities must also designate a US Agent who resides or maintains a place of business in the United States. The US Agent serves as the communication link between the foreign facility and the FDA. Learn more about US Agent services for food facilities.
Which Facilities Are Exempt from FDA Registration?
Certain facilities are exempt from FDA food facility registration requirements. Understanding these exemptions is crucial to ensure compliance without unnecessary registration.
Exempt Facilities Include:
- Farms: Facilities that grow, harvest, or raise animals for food (with some exceptions for mixed-type facilities)
- Retail food establishments: Restaurants, grocery stores, and other facilities that sell food directly to consumers
- Restaurants and food service: Establishments that prepare and serve food for immediate consumption
- Private residences: Home-based operations selling directly to consumers in limited quantities
- Fishing vessels: Boats that harvest and transport fish (but not process fish)
- Non-profit food establishments: Food banks and similar charitable food distribution organizations
- Facilities regulated exclusively by USDA: Meat, poultry, and egg product facilities under USDA jurisdiction
Mixed-Type Facilities
If your facility performs both exempt and non-exempt activities, registration may still be required. For example, a farm that also processes food beyond simple packing would need to register for those processing activities.
What Information Is Required for FDA Food Facility Registration?
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To complete FDA food facility registration, you'll need to gather specific information about your facility and operations. Having this information ready before starting the registration process will make it smoother and faster.
Required Information
Facility Information
- Facility name and physical address
- Mailing address (if different)
- Phone and fax numbers
- Email address
- Emergency contact information
- Facility type (manufacturer, warehouse, etc.)
Business Information
- Parent company name and address
- DUNS number (optional but recommended)
- Trade names used by facility
- Owner/operator contact details
Product Information
- FDA food product categories handled
- Types of activities performed
- General product descriptions
For Foreign Facilities
- US Agent name and contact
- US Agent address in United States
- US Agent phone and email
How Do I Register My Food Facility with the FDA?
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FDA food facility registration is completed online through the FDA's Food Facility Registration Module (FFRM). The registration is free and can be completed in approximately 20-30 minutes if you have all required information ready.
Create an FDA Account
Visit the FDA Industry Systems website, click "Create Account" and provide required information. Verify your email address and complete account setup with security questions.
Access the Food Facility Registration Module
Once logged in to your FDA account, navigate to the Food Facility Registration Module. Select "Register New Facility" to begin the registration process.
Enter Facility Information
Complete all required fields about your facility, including name, address, contact information, and facility type.
Select Food Product Categories
Choose all FDA food product categories that apply to your facility's operations. Be thorough — missing categories can trigger FDA inquiries.
Designate US Agent (Foreign Facilities Only)
If you're registering a foreign facility, you must designate a US Agent who resides or maintains a place of business in the United States.
Review and Submit
Carefully review all entered information for accuracy. Once submitted, you'll receive a unique FDA Registration Number immediately.
Registration Confirmation
Upon successful registration, you'll receive an 11-digit FDA Registration Number. Save this number — you'll need it for renewals, updates, and Prior Notice filings when importing food.
What Are the US Agent Requirements for Foreign Food Facilities?
Foreign food facilities exporting to the United States are required to designate a US Agent as part of their FDA registration.
US Agent Responsibilities
- Receive and respond to communications from FDA on behalf of the foreign facility
- Be available 24 hours a day, 7 days a week for emergency contact
- Assist the foreign facility with registration updates and renewals
- Help facilitate FDA inspections of the foreign facility
- Act as the facility's representative for all FDA-related matters
Choosing a US Agent
A US Agent can be any person or business located in the United States. Options include:
- A US-based subsidiary or affiliate of your company
- Your US importer or distributor
- A professional regulatory compliance service
- An attorney or consultant based in the US
Many foreign facilities choose professional compliance services like Assurentry for US Agent services, as we provide 24/7 availability, expertise in FDA communications, and comprehensive compliance support. See our FDA food facility registration service for full details, or explore our food import compliance page for importers.
When Is the FDA Food Facility Biennial Renewal?
FDA food facility registration is not a one-time requirement. Facilities must renew their registration during even-numbered years between October 1 and December 31. Use our Renewal Checker tool to see if your registration is due, or follow our step-by-step food facility renewal guide.
Biennial Renewal Period
October 1 - December 31 of even-numbered years
Next renewal periods: 2026, 2028, 2030, etc. Facilities that fail to renew during this period will have their registration cancelled and must re-register before resuming food-related activities.
Renewal Process
- Log in to your FDA Industry Systems account
- Access the Food Facility Registration Module
- Review all current registration information
- Update any information that has changed
- Submit the renewal
Updating Registration Information
You should update your registration within 60 days of any changes to:
- Facility name or address
- Contact information
- Product categories handled
- US Agent information (foreign facilities)
- Ownership or operational changes
What Are the Most Common FDA Registration Mistakes?
Based on our experience helping thousands of facilities with FDA registration, these are the most common mistakes:
Incomplete Product Category Selection
Risk: Missing product categories can trigger FDA inquiries and delay shipments
Fix: Review all categories carefully and select every category that applies to your operations
Incorrect US Agent Information
Risk: FDA cannot contact your facility, which can result in registration cancellation
Fix: Verify US Agent contact details and ensure 24/7 availability
Missing Biennial Renewal
Risk: Registration is cancelled, preventing legal import/export of food products
Fix: Set calendar reminders for renewal period (Oct-Dec of even years)
Not Updating Changed Information
Risk: Outdated information can cause communication failures and compliance issues
Fix: Update registration within 60 days of any changes
Registering Exempt Facilities
Risk: Unnecessary administrative burden and potential confusion
Fix: Review exemption criteria carefully before registering
What Are the Penalties for Not Registering a Food Facility?
Operating without proper FDA food facility registration can result in serious consequences:
Enforcement Actions
- Import refusal: Food products from unregistered facilities will be refused entry at US ports
- Product detention: Products may be held at the border pending registration verification
- Warning letters: FDA may issue formal warning letters requiring immediate corrective action
- Civil penalties: Fines up to $10,000 per violation, with higher penalties for subsequent violations
- Criminal prosecution: In severe cases, criminal charges may be filed
- Facility suspension: FDA can suspend a facility's registration if there's reason to believe food from the facility could cause serious adverse health consequences
Business Impact
Beyond FDA enforcement, non-compliance can severely impact your business through:
- Delayed shipments and lost sales
- Damaged relationships with importers and distributors
- Reputational harm in the marketplace
- Increased scrutiny on future shipments
- Higher compliance costs to remediate issues
Frequently Asked Questions
How long does FDA food facility registration take?
FDA food facility registration is typically processed within 1-5 business days after submission. Online self-registration takes approximately 20-30 minutes if you have all required information ready. You'll receive your FDA Registration Number upon successful submission.
Is FDA food facility registration free?
Yes, FDA charges no government fee for food facility registration. You can register directly through FDA's online portal at no cost. Assurentry charges $199 for professional registration assistance, which includes accuracy verification, product category optimization, and ongoing compliance support.
What is the biennial renewal deadline?
The biennial renewal period runs from October 1 through December 31 of even-numbered years (2026, 2028, 2030, etc.) per 21 CFR 1.230. FDA sends no reminder notices, so it is the registrant's responsibility to renew on time.
Do I need a DUNS number for FDA registration?
Yes, a DUNS (Data Universal Numbering System) number is required for FDA food facility registration. You can obtain a free DUNS number from Dun & Bradstreet. The DUNS number helps FDA identify and track registered facilities accurately.
What happens if I miss the biennial renewal?
If you miss the biennial renewal deadline (December 31 of even-numbered years), your registration is automatically cancelled by FDA. Products from unregistered facilities cannot legally enter US commerce, and shipments may be refused at ports of entry under 21 CFR Part 1, Subpart H.
Can one facility register for multiple product types?
Yes, a single facility can register under multiple FDA product categories. During registration, you select all applicable food product categories that your facility handles. This is common for facilities that manufacture, process, or store different types of food products.
What information do I need to register?
You need your facility name and physical address, DUNS number, owner/operator contact information, emergency contact details, all applicable FDA food product categories, and trade names. Foreign facilities also need US Agent information (name, US address, phone, and email) per 21 CFR 1.227.
Do dietary supplement facilities need to register?
Yes, dietary supplement manufacturing, processing, packing, and holding facilities must register as food facilities with the FDA under 21 CFR Part 1, Subpart H. Dietary supplements are regulated as a category of food, and all registration requirements including biennial renewal apply.
What happens if my US Agent changes?
You must update your registration within 60 days of any US Agent changes per 21 CFR 1.234. The new US Agent must confirm their appointment before the change is effective. Gaps in US Agent coverage can result in FDA enforcement action.
What if I have multiple facilities?
Each facility must be registered separately with its own unique 11-digit FDA Registration Number. If you have multiple locations that manufacture, process, pack, or hold food, each one needs its own registration and biennial renewal.
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