If your business manufactures, processes, packages, or holds food that will be served on American tables, FDA Food Facility Registration is mandatory. It is one of the key requirements of the Food Safety Modernization Act, and missing it can prevent your product from getting past the port of entry.This guide will explain the process and people who need to do the registration as well as where most of the exporters get stuck during this process. It is designed for exporters who need a practical guide to the regulation.
What Is the U.S. FDA Registration for Food Facilities?
U.S. FDA Registration of Food Facilities is a compulsory registration of any facility engaged in manufacture, processing, packing, or holding of foods for humans or animals in the market of the United States. This type of registration was enacted through the Bioterrorism Act of 2002 and further strengthened with the Food Safety Modernization Act (FSMA).
Registration does not mean that the facility is approved and compliant. All it means is that the facility is registered by the FDA to make sure that there is such a facility which manufactures food products to be used in the United States. All food facilities will have a specific FFR number. This FFR number is used by importers and customs brokers.
It can be viewed as a census rather than an inspection.
Does a Food Manufacturing Facility Need FDA Registration?
Indeed. If your facility is engaged in manufacturing, processing, packing, or holding any food that will be consumed in the United States, then you must register with the FDA irrespective of your physical location.
This holds true both for your facility located within the United States and those based abroad but supplying food to the United States.
Facilities That Typically Need to Register
- Food and Beverage Manufacturers
- Processors and Packers, Including Contract Packers
- Food Cold Storage and Warehousing Facilities
- Manufacturers of Animal Food and Pet Food
- Manufacturers of Dietary Supplements
Facilities That Are Usually Exempt
- Farm operations according to FSMA
- Food service and retail food establishments
- Vessels engaged in fishing activities but do not process
- Facilities controlled solely by USDA — meat, poultry, some egg products
- Non-profit food establishments which prepare or serve food directly to consumers
If you’re unsure whether your operation falls into an exempt category, it’s worth getting a facility-specific review rather than assuming either way.
FDA Registration Requirements for Food Manufacturers
FDA’s registration criteria for food manufacturers have two major aspects – what to provide and who should provide it. At least the facility should be registered with its address and contact person specified along with a U.S. Agent in case of foreign facility.
Core Information the FDA Requires
Manufacturers from abroad who export their products into the United States – a frequent case with Indian manufacturers of food processing industries, spices and packed goods – must be aware that having an authorized agent in the U.S. is of paramount importance.
How Do I Register a Food Facility with the FDA?
FDA’s Food Facility Registration Module (FFRM) is used by businesses for food facility registration on behalf of FDA’s FIS portal. This process can be completed within a few hours when you have all the necessary documents ready, and it is done online.
Step-by-Step Registration Process
- Register for an FDA Industry Systems account. This is the account login for FFRM and other FDA electronic submission programs.
- Collect facility and product information. Be sure to have your DUNS number, facility location, product categories, and contacts prepared prior to registration.
- Appoint a U.S. Agent. Required for all facilities situated outside the United States.
- Fill up Form 3537. This is the registration form to be completed and submitted electronically via FFRM.
- Submit and confirm. After approval, the FDA assigns a registration number unique to the facility.
- Keep a copy of your confirmation and registration number. This will be requested by customs brokers and importers during shipment processing.
- Renew during the biennial period. Registration is not a permanent process and must be renewed every two years.
Most delays happen at step two. Incomplete or mismatched facility details are the single biggest reason registrations get bounced back for correction.
The U.S. Agent Requirement for Foreign Food Facilities
All food establishments that are not based in the United States shall appoint a U.S. agent as part of the registration process. The U.S. agent is an individual or entity located in the United States who serves as the establishment’s contact point with the FDA.
A U.S. Agent’s Responsibilities Include
- Receipt of communications on behalf of the facility by the FDA
- Support during FDA inspections or facility audits
- Response to requests regarding recalls or safety issues
- Communication between the FDA and the foreign facility
No registration can be done without the appointment of a proper U.S. Agent, who must have agreed to the post willingly because FDA does check on this from time to time. Most exporters get the assistance of a compliance consultant or lawyer to act as their U.S. Agent.
FDA Registration and FSVP: How They’re Connected
FDA registration of facility and Foreign Supplier Verification Program (FSVP) are two different aspects but connected to each other. Registration of a facility involves identification of the facility, while FSVP makes the U.S. importer accountable for verification of the food being imported according to the safety standards of the U.S.
In case you are an Indian food producer exporting to the U.S., then the American importer will ask for your FDA registration number in connection with his FSVP due diligence. Non-registration or non-active registration may delay the process of FSVP compliance on the side of the importer despite the safety of your food being compliant with all safety norms.
Biennial Renewal: Don’t Let Your Registration Lapse
Every two years, a registration of an FDA food facility needs to be renewed in the period from October 1 to December 31 of even years. Outside of this period, the FDA will not accept any renewals but only registrations.
If a food facility fails to renew its registration within the stated period, then it will be automatically considered cancelled by the FDA from January 1 of the next year. This means that shipments may be delayed or blocked, because the facility would need time to register again.
Such a simple thing like putting a reminder in an office calendar in September of even years will solve the problem easily.
Common Mistakes During FDA Food Facility Registration
Most registration problems are avoidable. The FDA rejects or delays applications most often because of these recurring issues:
- Correct inconsistencies in the registration, transport and customs documents
- Absence of active DUNS numbers which are mandatory and sometimes go expired without anyone noticing
- Non-registration of the U.S. Agent, or having an agent without consent from him
- Incorrect categorization of the product, which might lead to misrepresentation of the product produced by the manufacturing facility
- Failure to complete the process of biennial renewal within the deadline
- Incorrect entity registration (registration of the trade facility instead of manufacturing facility)
Reviewing facility details against your export documentation before submission catches most of these before they become a problem.
FDA Registration vs. FDA Approval
The most common areas of misconception include the misunderstanding of FDA registration as being FDA approval. The two concepts are different, and there are implications in the way that you will market your product.
Labeling the food item as “FDA Approved” when it has only been registered presents labeling problems that must be avoided by exporters since it will attract attention for reasons unrelated to the safety history of the product.
Best Practices for Staying Compliant
- Keep facility and contact information current all year round, not just when renewing
- Make sure your U.S. Agent’s approval is still valid, particularly if you have changed compliance partners
- Check your product categories every year as your product line evolves
- Keep a copy of your registration verification with your export documentation
- Think of registration and FSVP as related procedures, not stand-alone tasks
Key Takeaways
- US FDA Registration for Food products is required by all facilities that manufacture, process, pack, or hold food for entry into the US market irrespective of their location.
- A foreign facility is required to appoint a consenting US Agent before registration can be done.
- Registration needs to be renewed every two years between October 1 and December 31 of even-numbered years; otherwise, it will lapse.
- FDA registration is a process of being registered administratively and not safety certified, and it shouldn’t be taken to mean FDA approval.
- The most common reasons for application rejections are address discrepancies, no DUNS number, or a non-confirmed US Agent.
Conclusion
Food Facilities Registration with the U.S. FDA is an example of something that may seem procedural at first until it becomes something that can stop a shipment from leaving because of an issue like late registration or an address mismatch. That’s why the first time needs to be perfect, and the renewal process needs to be included in your compliance schedule.
For manufacturers who’d rather have someone manage the registration, U.S. Agent designation, and renewal tracking end-to-end, Legal4sure works with food exporters on exactly this process. If you are a manufacturer looking to setup a business in dietary supplements, our article U.S. FDA Registration for Dietary Supplements provides clear and undesratble information on the same helping founders dig into a new emerging business category.
FAQs
Does a food manufacturing facility need FDA registration?
Yes, if a food manufacturing facility manufactures, processes, packs, and/or holds food for U.S. distribution irrespective of its location.
How do I register a food facility with the FDA?
Register online in FDA’s Food Facility Registration Module using Form 3537 after obtaining the DUNS Number and details of the facility.
Is U.S. FDA Registration for food manufacturing facilities a one-time process?
No, food manufacturing facilities registration should be renewed every two years from October 1 through December 31 during even years.
What happens if a facility misses the renewal window?
The registration will be canceled automatically from January 1 of next year.
Do foreign facilities need a U.S. Agent to register?
Yes, every facility located outside the U.S. must designate a consenting U.S. Agent as part of registration.
What are the FDA registration requirements for food manufacturers exporting from India?
Facilities exporting food products from India require valid information regarding the facility, DUNS number, proper product categories, and a U.S. Agent.
Is FDA registration the same as FDA approval?
No, FDA registration is not FDA approval.