Dietary Supplement Facility Registration Services

Registration Program Implementation Based on Section 415 of the FD&C Act and 21 CFR Part 1, Subpart H (21 CFR 1.225–1.241)

This service assists U.S. and foreign dietary supplement manufacturers, packers, holders, and brand owners in completing required U.S. FDA Food Facility Registration obligations.

Services are administrative and facilitative in nature and support submission of registration data to the U.S. Food and Drug Administration (FDA) for facilities involved in the manufacture, processing, packing, or holding of dietary supplements intended for U.S. distribution.

This service does not transfer regulatory responsibility to the Service Provider and does not constitute legal representation, regulatory approval, or compliance certification.

Scope of Work

FDA Food Facility Registration Applicability Review

Review client-provided facility information to determine whether the operation falls under mandatory FDA Food Facility Registration requirements under Section 415 of the FD&C Act.

Includes identification of:

Initial registration obligation
Biennial renewal requirement
Update requirement
Cancellation requirement

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

U.S. Agent Services for Foreign Facilities

Collection and organization of facility registration data required by FDA Industry Systems (FIS), including:

Legal facility name and physical location
Parent company information (if applicable)
Trade names used in commerce
Owner, operator, or agent-in-charge information
Emergency contact details
Dietary supplement product category classification
Facility activity type (manufacture, process, pack, hold)
Seasonal operations (if applicable)
U.S. Agent information (provided by Client or separate agreement)
Unique Facility Identifier (D-U-N-S® Number)

Information is submitted exactly as provided by the Client. No independent verification or certification of accuracy is performed.

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

Registration Updates and Biennial Renewal Assistance (Optional Subscription)

Upon authorization and payment, assistance may include:

One-time update submission per year
Biennial renewal submission (even-numbered years)
Amendment of facility registration information

The Service Provider does not independently track renewal deadlines and proceeds only upon Client instruction.

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

Confirmation of FDA Food Facility
Registration submission
FDA-issued Registration Number (when assigned)
Submission activity records
Renewal or update submission confirmation (if applicable)
Optional: Client-use Registration
Certificate (non-FDA document)

• 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

Fees and Subscriptions

Service	Fee (USD)
FDA Food Facility Registration (Initial)	$250 per facility
Registration Update / Biennial Renewal Assistance	$199 per year per facility

Pre-Requisites (Must Be Provided by Client)

• U.S. Agent (or under separate agreement)
• D-U-N-S® Number

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

Foreign dietary supplement manufacturers exporting to the United States
Contract manufacturers producing supplements for U.S. brands
Brand owners using third-party supplement manufacturers
New supplement facilities requiring FDA registration submission assistance

Important Regulatory Notes

FDA registration is mandatory for facilities manufacturing, processing, packing, or holding dietary supplements for U.S. consumption
Registrations must be renewed every even-numbered year between October 1 – December 31
The facility owner/operator remains legally responsible for compliance with FDA regulations
Failure to register or renew may result in refusal of entry or enforcement action

• 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.