US FDA Food Establishment Registration and US Agent Service Fee
I3CGLOBAL, in association with LMG, assists with US FDA food facility registration and ensures compliance with FDA Bioterrorism Act requirements. We also provide US FDA Agent services for foreign food facilities. Below is the fee structure for US FDA Establishment Registration, covering the necessary services to help food and nutraceutical manufacturers and exporters comply with FDA requirements efficiently and affordably.
We offer fast and affordable Food Establishment Registration services, backed by over 20 years of experience and trusted by 8,000+ food exporters and manufacturers worldwide. With strong regulatory expertise and US Agent service capabilities, we ensure a smooth and compliant process. Check our competitive pricing below, submit the required forms and pay directly to get started.
Our Pricing
| # | Service | Fee (USD) |
|---|---|---|
| 1 | US FDA Food Facility / Establishment Registration (FSMA Compliance) | $100 |
| 2 | Annual US Agent Service (Mandatory for Foreign Manufacturers and Exporters Only) |
$350 |
| 3 | US FDA Registration Fee | Nil |
# We offer expedited service for all customers with a processing timeline of just 5 to 10 working days from June 2025
| # | Service | Fee (USD) |
|---|---|---|
| 1 | Food / Supplement – Primary / Secondary Label Review | $950 Per device (14 working days) |
| 2 | IFU Review for neutraceuticals | $1500 per device (30 working days) |
| # | Service | Fee (USD) |
|---|---|---|
| 1 | FCE – Food Canning Establishment Registration Assistance
SID – Process Filing Assistance |
$2500 |
| 2 | Prior Notice | $100 for each challan/item |
Frequently Asked Questions
What are Low-acid canned food
A low-acid canned food has a pH above 4.6, water activity over 0.85, is hermetically sealed, heat-treated for commercial sterility, and stored without refrigeration.
Do I need DUNS number to Register food Facility with FDA?
Yes, 21 CFR 1.232 (a)(2), released on Oct 1st 2023, all food facilities are required to provide a Unique Facility Identifier (UFI) when registering with FDA. DUNS number is the only acceptable UFI recognised by FDA for now.
Please visit DUNS official website https://www.dnb.com or contact the local DUNS office in the respective country for fast processing.