In the FDA registration process, a crucial aspect is how to register an FDA food facility. This directly impacts the overall success of the registration process, making it an essential consideration. So, how can one proceed to register an FDA food facility, and what are the renewal timelines? Today’s article invites us to examine this alongside UCC!
1. Overview of Registering an FDA Food Facility
The Bioterrorism Act mandates that both domestic and foreign food facilities must register with the U.S. FDA if they produce, process, package, or store food intended for consumption by humans or animals in the United States. Furthermore, this requirement ensures that the FDA can effectively monitor and respond to potential food safety threats, thereby enhancing the overall safety of the food supply.
Registering food facilities and providing prior notice are crucial for ensuring food safety and integrity. This process enhances food safety and also improves traceability, which helps reduce foodborne illnesses. Additionally, it builds consumer confidence through compliance with safety standards, thereby reinforcing trust in the food supply chain. It also helps facilities avoid penalties, access U.S. markets, and participate in international trade, fostering a culture of preparedness in the food industry.
2. Who Needs To Register FDA Food Facility?
All owners, operators, or agents overseeing food facilities, whether domestic or foreign, are required to register their facilities with the FDA in the United States. Here are some notable examples:
- Food Facility: A unit that processes, packages, serves, stores, and distributes food for human consumption. This primarily occurs at the retail level, but it can also include wholesale food manufacturers. It’s important to note that food does not necessarily have to be consumed at the same facility.
- Supplemental Food Facility: Includes protein supplements, herbal supplements, and similar products.
- Canned Food Facility: Examples include canned corn, canned tomatoes, canned juice, etc.
3. FDA Food Facility Registration Steps and Costs
Food facility registration is conducted online through the FDA’s Unified Registration and Listing System (FURLS) by logging into the FDA Industry System (FIS). First, you need to create an account to begin the online registration process. Once your account is set up, you can proceed with the registration steps. Once the registration is completed and submitted, the FDA will review it and issue the FFR number.
The FDA does not issue certificates for food facility registration. Instead, they provide an FFR number associated with the registered facility. Furthermore, there is currently no public database available to search for information on food facility registrations.
3.1. FDA Food Facility Registration Steps
- Step 1. Designate a U.S. Agent
All foreign facilities must designate an FDA Managing Agent and a U.S Registration Agent to ensure compliance with agency regulations. - Step 2. DUNS Requirement
Before proceeding with registration, you need to provide a DUNS number (Data Universal Numbering System). This unique 9-digit number, issued by the FDA, is essential for identifying and verifying your business information. Furthermore, FDApals can assist you with this process; it typically takes 7 to 14 days to generate a DUNS number. Therefore, it’s important to factor in this timeline when planning your registration. - Step 3. Complete the Online Application and Authorize the U.S. Agent
You need to fill out the online application and authorize the U.S. Agent to represent you in the registration process. - Step 4. File the FDA registration application
UCC will assist you in submitting the FDA registration application, ensuring that all provided information is accurate and complete. - Step 5. FDA Food Facility Registration Number
Once your application is approved, you will receive an 11-digit food facility registration number. This number will be generated automatically and sent to the email address you provided. Furthermore, it is important to keep this registration number on file, as you will need it for future communications and compliance with FDA regulations. - Step 6. FDA Registration Certificate
The U.S. Agent will provide you with the FDA registration certificate, which is essential for you to present to business partners, suppliers, and potential customers. Additionally, detailed information regarding your registration will be kept confidential by the FDA. This confidentiality helps protect your business information while ensuring compliance with regulatory requirements.
3.2. Cost of FDA Food Facility Registration
Currently, the FDA does not impose any fees for food facility registration. However, if you enlist the help of a third party, such as a U.S. agent, you will incur associated costs. According to surveys, these fees may vary depending on the company. Therefore, it is advisable to thoroughly consider and research your options before selecting a partner.
UCC is committed to being a trusted partner for businesses in FDA registration services and related support. Moreover, with reasonable pricing and a strong emphasis on integrity, UCC is an excellent choice for your needs. Therefore, you can rely on UCC to provide the guidance and assistance necessary for successful registration and compliance.
3.3. Required Information
- Facility Information: The name, physical address, and phone number of the facility.
- Parent Company Information: The name, address, and phone number of the parent company, if applicable.
- Owner or Agent Information: Contact details for the owner or responsible agent.
- U.S. Agent: Foreign facilities must designate a U.S. agent residing here.
- Emergency Contact Information: Provide a 24-hour emergency contact phone number.
- Type of Operations: Facilities must disclose their activities, such as manufacturing, processing, or packaging.
- Food Product Categories: List the types of food products handled based on FDA categories.
4. Timeframe and Renewal Process
You must renew FDA food facility registration in even-numbered years, regardless of when you established the initial registration. Besides, you should complete the renewal between October 1 and December 31 of each even-numbered year. For example, if you establish the initial registration in 2025, you must renew it in 2026. Subsequently, in this example, the biannual renewal will continue in 2028, 2030, and in all subsequent even-numbered years. Therefore, it’s essential to keep track of these renewal dates to ensure compliance.
You can conduct the renewal process for food facility registration through the FDA Industry System website. To assist with the 2024 renewal period, the FDA has provided comprehensive user guidelines. Additionally, these guidelines offer step-by-step instructions to ensure a smooth renewal process, making it easier for facilities to remain compliant with regulations. Besides, facilities should be aware that “updating” registration is distinct from “renewing” registration. Specifically, during the renewal period, facilities will not find the “update” button within the Food Facility Registration Module. Moreover, if the registration is not renewed by December 31, the FDA will consider the registration expired and will remove it from the account.
If a food facility fails to complete the initial registration, the FDA will have two possible courses of action:
- First, for domestic facilities that are not registered, the FDA may take legal measures, including the imposition of fines and penalties.
- Second, for facilities based outside the United States, the FDA, in conjunction with the Customs and Border Protection agency, may detain products (with the costs of detention to be borne by the exporter until the food facility registration information is verified) or issue a destruction order for imported products.
5. Importance of the FDA Food Facility Registration
FDA Food Facility Registration is essential for ensuring food safety and compliance within the U.S. food system. It establishes a framework for monitoring and regulating food facilities, helping to protect public health. Below are five key points highlighting its importance:
- Regulatory Compliance: Registration ensures that food facilities adhere to U.S. laws and regulations, promoting safety standards.
- Public Health Protection: It helps monitor food safety, reducing the risk of foodborne illnesses by ensuring facilities follow proper practices.
- Traceability: Registered facilities allow for efficient tracking of food sources in case of contamination, enabling quicker responses and recalls.
- Facilitating Inspections: Registration subjects facilities to FDA inspections, ensuring adherence to good manufacturing practices and enhancing safety.
- International Trade Access: For foreign facilities, registration is essential for exporting to the U.S., showcasing adherence to safety regulations and a dedication to high standards.
For more information: Register FCE and SID Numbers: Everything You Need to Know
We hope that this article has provided you with a clear understanding of the important information regarding FDA food facility registration. We look forward to supporting you on your journey toward international integration in the future. Additionally, do not hesitate to contact UCC for dedicated advice for your business.
