Dietary Supplement Facility Registration Services
Registration Program Implementation Based on 21 CFR 1.225–1.241, FSMA, and the Bioterrorism Act
To assist and maintain compliance for U.S. and foreign dietary supplement facilities, brand owners, and contract manufacturers through proper registration with the U.S. Food and Drug Administration (FDA), in accordance with the Food Safety Modernization Act (FSMA) and the Bioterrorism Act.
This service ensures lawful market entry, traceability readiness, and regulatory alignment for operations involving dietary supplements and supplement-related products intended for U.S. distribution.
Scope of Work
FDA Facility Registration for Dietary Supplements
Register new domestic and foreign dietary supplement facilities in accordance with 21 CFR 1.225–1.241 and FSMA. This includes:
• Initial FDA Dietary Supplement Facility Registration submission
• Biennial FDA Registration Renewal (every even-numbered year)
• U.S. Agent designation and representation for foreign facilities
• Management of registration updates (e.g., facility name, address, ownership, product categories)
• Support for maintaining active registration status and FDA compliance
• Initial FDA Dietary Supplement Facility Registration submission
• Biennial FDA Registration Renewal (every even-numbered year)
• U.S. Agent designation and representation for foreign facilities
• Management of registration updates (e.g., facility name, address, ownership, product categories)
• Support for maintaining active registration status and FDA compliance
U.S. Agent Services for Foreign Facilities
Designate a qualified U.S. Agent in accordance with 21 CFR 1.232(d). The U.S. Agent acts as the official FDA contact for:
• Facility registration matters
• Inspection notifications
• Regulatory communications and inquiries
• Ensuring uninterrupted market access
• Facility registration matters
• Inspection notifications
• Regulatory communications and inquiries
• Ensuring uninterrupted market access
Registration Compliance Monitoring and Renewal Support
Provide continuous support to monitor facility registration status, proactively manage biennial renewal obligations, and assist with registration updates to maintain full regulatory compliance.
Deliverables
• FDA Facility Registration or Biennial Renewal Confirmation for Dietary Supplements
• U.S. Agent Designation Letter (for foreign facilities)
• Optional: Certificate of FDA Registration (for client use only; not an official FDA endorsement)
• Facility Registration and Compliance Status Checklist
• Biennial Renewal and Monitoring Notifications
• U.S. Agent Designation Letter (for foreign facilities)
• Optional: Certificate of FDA Registration (for client use only; not an official FDA endorsement)
• Facility Registration and Compliance Status Checklist
• Biennial Renewal and Monitoring Notifications
Fees and Subscriptions
| Service | Fee (USD) |
|---|---|
| New FDA Food Facility Registration | $450 |
| Biennial FDA Registration Renewal | $350 |
| Certificate of FDA Registration | Included |
Pre-Requisites
• D-U-N-S® Number (for FDA account verification)
Ideal For:
• Foreign manufacturers, processors, packers, or holders of dietary supplements exporting to the United States
• U.S.-based or international companies establishing new dietary supplement facilities requiring FDA registration
• Brand owners utilizing contract manufacturers or co-packers for dietary supplements who must meet FDA registration requirements
• Foreign facilities needing ongoing U.S. Agent services to maintain FDA registration and compliance
• U.S.-based or international companies establishing new dietary supplement facilities requiring FDA registration
• Brand owners utilizing contract manufacturers or co-packers for dietary supplements who must meet FDA registration requirements
• Foreign facilities needing ongoing U.S. Agent services to maintain FDA registration and compliance
Additional Notes
• FDA facility registration is mandatory for all facilities involved in the manufacture, processing, packing, or holding of dietary supplements for U.S. consumption.
• Registrations must be renewed every two years between October 1 and December 31 of even-numbered years.
• Foreign dietary supplement facilities must designate a U.S. Agent at all times to maintain a valid registration.
• Failure to register or renew may result in detention, import refusal, or other FDA enforcement actions.
• Registrations must be renewed every two years between October 1 and December 31 of even-numbered years.
• Foreign dietary supplement facilities must designate a U.S. Agent at all times to maintain a valid registration.
• Failure to register or renew may result in detention, import refusal, or other FDA enforcement actions.