What is FDA Registration?
FDA registration is a mandatory requirement for domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Under the Food Safety Modernization Act (FSMA), facilities must register with the FDA to ensure food safety and enable effective response to public health emergencies.
FDA registration provides the agency with information about your facility and the types of food you produce, helping to maintain the safety of the U.S. food supply.
Benefits of FDA Registration
- Legal Compliance: Meet federal requirements for food facility operations
- Market Access: Required to distribute food products in the United States
- Business Credibility: Demonstrates commitment to food safety standards
- Retailer Requirements: Many retailers require FDA registration for suppliers
- Import/Export: Facilitates international food trade
- Traceability: Enables rapid response during food safety incidents
Who Needs FDA Registration?
- Food manufacturing facilities
- Food processing plants
- Food packaging facilities
- Food storage and warehouse facilities
- Beverage production facilities
- Dietary supplement manufacturers
- Foreign facilities shipping food to the U.S.
- Pet food and animal feed manufacturers
Required Information for Registration
You will need to provide the following information:
- Facility Information: Name, physical address, and contact details
- Business Information: Owner/operator name and contact information
- Food Categories: Types of food products manufactured or stored
- Business Type: Domestic or foreign facility designation
- U.S. Agent: For foreign facilities, a designated U.S. representative
- Parent Company: If applicable, parent company information
- Emergency Contact: 24-hour emergency contact information
Biennial Renewal Requirement
FDA registration must be renewed every two years:
- Renewal period: October 1 through December 31 of even-numbered years
- Review and update all facility information
- Confirm food product categories are current
- Update emergency contact information
- No fee required for renewal
U.S. Agent Requirements (Foreign Facilities)
Foreign facilities must designate a U.S. Agent who:
- Resides or maintains a business in the United States
- Is physically present in the United States
- Serves as communication point between FDA and facility
- Can respond to emergency situations
- May assist FDA with inspections and communications
Exemptions from Registration
Certain facilities are exempt from FDA registration:
- Private residences of individuals
- Retail food establishments (restaurants, grocery stores)
- Fishing vessels not engaged in processing
- Farms (with some exceptions)
- Nonprofit food establishments
- Facilities regulated exclusively by USDA
Our FDA Registration Services
We provide comprehensive FDA registration assistance:
- Eligibility determination and consultation
- Complete registration application preparation
- Food product category identification
- U.S. Agent services for foreign facilities
- Online portal submission and management
- Registration number acquisition
- Biennial renewal reminders and assistance
- Updates and amendments processing
- FSMA compliance guidance