FDA Registration for Food Warehouses
This guide explains which food warehouse types must register, what "holds" means under FDA regulations, the exact exemptions that exist, activity codes, FSMA applicability, and how FDA Registration Assistance registers food warehouses in 24–48 hours.
Why "Holds" Means Your Warehouse Must Register
The most common misconception about FDA Food Facility Registration is that it only applies to manufacturers. It does not. Section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 350d) requires registration of any domestic or foreign facility that manufactures, processes, packs, or holds food for consumption in the United States.
"Holds" is explicitly defined at 21 CFR Part 1.227 as storing food. The definition is straightforward — a warehouse that stores food for U.S. distribution is performing the "holds" activity and is subject to registration requirements. The facility does not need to manufacture, cook, process, or transform the food in any way to trigger the obligation.
This means:
Cold Storage
Refrigerated and frozen food warehouses holding food for distribution must register. Temperature-controlled storage is still storage — it is the "holds" activity regardless of the temperature maintained.
3PL / Distribution
Third-party logistics providers storing food inventory for multiple clients must register the facility. Each tenant's food products are covered by the 3PL warehouse's single FDA registration under the "holds" activity code.
Fulfillment Centers
E-commerce food fulfillment warehouses holding packaged food, dietary supplements, or pet food for direct-to-consumer or B2B distribution must register. Amazon FBA food sellers may need registration for their own warehouses where food is prepared or held before sending to Amazon.
Which Food Warehouse Types Must Register — and Which Are Exempt
The exemptions under 21 U.S.C. § 350d(b) and 21 CFR Part 1.226 are narrow. Most commercial food storage and distribution operations do not qualify. Here is the full picture:
| Warehouse / Facility Type | Registration Required? | Notes |
|---|---|---|
| General food distribution warehouse | Required | Holds packaged food for U.S. distribution. Activity code: Hold. |
| Cold storage / refrigerated warehouse | Required | Holds refrigerated or frozen food. Temperature control does not exempt the facility. |
| Third-party logistics (3PL) provider | Required | Holds food inventory for multiple clients. Single facility registration covers all food tenants under "Hold" activity code. |
| E-commerce / fulfillment warehouse (food) | Required | Holds packaged food, supplements, or pet food for direct-to-consumer distribution. Includes food-holding warehouses that feed Amazon FBA. |
| Co-packing warehouse | Required | Holds and packs food. Activity codes: Hold + Pack. Additional FSMA Preventive Controls may apply to packing activities. |
| Dietary supplement warehouse | Required | Supplements are food products under the FDCA. Also subject to cGMP requirements under 21 CFR Part 111. |
| Pet food / animal food warehouse | Required | Animal food regulated same as human food for facility registration purposes under 21 CFR Part 1. |
| Foreign warehouse (exporting to U.S.) | Required + U.S. Agent | Foreign holding facilities must register and designate a U.S. Agent. Registration must be active before food shipments depart for the U.S. |
| Retail food establishment | Exempt | Grocery stores, restaurants, cafeterias that sell food directly to consumers. The retail exemption requires that at least 50% of food sales are directly to consumers. |
| Farm (raw agricultural commodities only) | Exempt | Farms that grow and store their own raw agricultural commodities prior to first processing are exempt. Does not cover commercial storage facilities that store produce for multiple farms. |
| Non-profit food establishment | Exempt | Non-profit food establishments are exempt under 21 U.S.C. § 350d(b). |
FDA Activity Codes for Warehouses & the Cost of Registration
Activity Codes — What They Are and Why They Matter
FDA Food Facility Registration requires selection of activity codes that accurately describe what operations are performed at the facility. For food warehouses, selecting the correct codes ensures the registration reflects your actual operations and that FDA categorizes your facility correctly in its regulatory systems.
Hold
Storage of food. The primary activity code for most food warehouses, cold storage facilities, and distribution centers.
Pack
Placing food into packaging. Required in addition to "Hold" for co-packing warehouses or fulfillment centers that repackage food products.
Manufacture / Process
Making or transforming food. Required if the warehouse also performs any food preparation, labeling, or processing activities beyond pure storage.
The Cost — $858 Complete Service
FDA charges $0 in government fees for Food Facility Registration. The cost you pay is the service fee to have the registration prepared, submitted, and managed correctly. FDA Registration Assistance charges $858 for the complete service:
For more detail on the cost breakdown and what's included, see the FDA Food Facility Registration Cost page.
FSMA Requirements for Food Warehouses
FDA Food Facility Registration is separate from — but related to — FSMA food safety compliance. Under FSMA's Preventive Controls for Human Food rule (21 CFR Part 117), food holding facilities are subject to specific requirements:
Holding Facilities — Modified Requirements
A facility that only holds packaged food in its original packaging from a registered facility is subject to modified FSMA requirements under 21 CFR Part 117. These modified requirements focus on temperature control for temperature-controlled foods, sanitation, pest control, and protection from contamination — without requiring a full written Food Safety Plan if no manufacturing or packing occurs.
Facilities That Also Pack or Process
If the warehouse also packs, relabels, or processes food in any way, it may be subject to the full FSMA Preventive Controls requirements — including a written Food Safety Plan with hazard analysis, preventive controls, corrective actions, and verification procedures. Co-packing warehouses and value-added distribution centers should evaluate their specific FSMA obligations based on their full range of activities.
Registration and FSMA compliance are both required but are separate systems. A warehouse must register AND meet applicable FSMA requirements. FDA Registration Assistance manages the registration component — and can advise on FSMA obligations and connect facilities with FSVP support for importers sourcing from foreign warehouses.
Register Your Food Warehouse with FDA
FDA Registration Assistance registers food warehouses, cold storage facilities, 3PL providers, and fulfillment centers — in 24–48 hours with the correct activity codes, DUNS Number, U.S. Agent designation for foreign facilities, and Biennial Renewal management. Complete service: $858. FDA charges $0.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. 1,000+ clients. 135+ countries. 15+ years of FDA regulatory experience.
Frequently Asked Questions — FDA Registration for Food Warehouses
1. Do food warehouses need FDA registration?
Yes, in most cases. Under 21 U.S.C. § 350d and 21 CFR Part 1, any facility that holds food for U.S. distribution must register with FDA. "Holds" is defined at 21 CFR 1.227 as storing food. Cold storage, 3PL, distribution centers, and fulfillment warehouses storing food for U.S. consumers are all covered.
2. What does "holds" mean under FDA food facility registration rules?
Under 21 CFR Part 1.227, "holds" means storing food. This is one of the four activities (manufacture, process, pack, hold) that trigger FDA Food Facility Registration under 21 U.S.C. § 350d. A facility does not need to manufacture or process food to be required to register — simply storing food for U.S. distribution is sufficient.
3. Are cold storage facilities required to register?
Yes. Cold storage warehouses holding refrigerated or frozen food products for U.S. distribution must register with FDA. Temperature-controlled storage is still the "holds" activity under 21 CFR 1.227. The facility must register under the "Hold" activity code, obtain a DUNS Number, and renew every two years.
4. Do 3PL warehouses need FDA registration?
Yes. 3PL warehouses storing food products for multiple clients must register with FDA. The single facility registration covers all food holding activities at the warehouse under the "Hold" activity code. 3PL providers storing imported food, packaged food products, dietary supplements, or pet food for U.S. distribution must register before holding any such products.
5. Does an Amazon FBA fulfillment warehouse need FDA registration?
Amazon's own FBA centers have their own registrations. However, food sellers using FBA may need registration for their own warehouses if food is repacked, relabeled, or held there before being sent to Amazon. Amazon also verifies FDA compliance documentation from food sellers. FDA Registration Assistance helps food brands establish correct FDA compliance for their supply chain.
6. What food warehouse types are exempt from FDA registration?
Exempt types under 21 U.S.C. § 350d(b) and 21 CFR Part 1.226: retail food establishments that sell food directly to consumers (at least 50% of sales direct to consumers); farms holding their own raw agricultural commodities prior to first processing; and non-profit food establishments. Commercial warehouses, 3PL providers, cold storage facilities, and distribution centers do not qualify for these exemptions.
7. What are FDA activity codes and how do they apply to warehouses?
Activity codes identify what operations are performed at the registered facility. For food warehouses, the primary code is Hold (storing food). Co-packing warehouses add Pack. Facilities performing any food preparation or transformation add Manufacture/Process. Correct activity codes ensure the registration accurately reflects operations and determines applicable FSMA compliance obligations.
8. Does a food warehouse need a DUNS Number for FDA registration?
Yes. FDA Food Facility Registration requires a DUNS Number (Unique Facility Identifier from Dun & Bradstreet). Warehouses without a DUNS Number must obtain one before registration. FDA Registration Assistance assists with DUNS Number procurement as part of the $858 complete registration service.
9. How much does FDA Food Facility Registration cost for a food warehouse?
FDA charges $0 in government fees. FDA Registration Assistance charges $858 for the complete service — registration preparation and submission, DUNS Number procurement, U.S. Agent designation for foreign facilities, and Biennial Renewal management. See the full cost breakdown.
10. Do foreign food warehouses need FDA registration and a U.S. Agent?
Yes. Foreign warehouses that hold food for importation into the United States must register with FDA and designate a U.S. Agent with a physical U.S. address under 21 CFR Part 1. Registration must be active before food shipments depart for the United States.
11. What is the Biennial Renewal and when must food warehouses renew?
FDA Food Facility Registration must be renewed every two years — October 1 through December 31 of every even-numbered year. Missing the window results in automatic cancellation and blocks all food shipments from that facility until re-registration is completed. FDA Registration Assistance manages Biennial Renewals for all registered warehouses.
12. Does FSMA apply to food warehouses?
Yes. Under FSMA's Preventive Controls for Human Food rule (21 CFR Part 117), food holding facilities are subject to modified requirements covering temperature control, sanitation, pest control, and contamination prevention. Facilities that also pack or process food may be subject to full Preventive Controls requirements including a written Food Safety Plan.
13. What happens if a food warehouse operates without FDA registration?
Operating without required registration is a prohibited act under 21 U.S.C. § 331. Consequences include shipment detention or refusal at U.S. ports; inability to file accurate FDA Prior Notice; potential Import Alert placement; and enforcement action. All food shipments from or associated with the unregistered warehouse can be affected.
14. Does storing dietary supplements require FDA warehouse registration?
Yes. Dietary supplements are regulated as food products. A warehouse holding supplements for U.S. distribution must register under 21 CFR Part 1. Supplement warehouses should also be aware of cGMP requirements under 21 CFR Part 111 for supplement manufacturing and holding facilities.
15. Does a pet food warehouse need FDA registration?
Yes. Pet food is animal food regulated under the Federal Food, Drug, and Cosmetic Act. Warehouses holding pet food for U.S. distribution must register with FDA under the same "holds" activity requirement that applies to human food warehouses.
16. How does FDA Food Facility Registration relate to Prior Notice for warehouses?
FDA Prior Notice for imported food shipments must include the FDA registration number of the manufacturing facility. When food is stored at a foreign warehouse before export to the United States, that warehouse's registration status may be relevant to the Prior Notice filing. An unregistered foreign warehouse in the supply chain can cause Prior Notice complications resulting in shipment holds at U.S. ports.
17. Can a food warehouse registration cover multiple tenants or clients?
Yes. FDA Food Facility Registration is per physical facility — not per tenant or client. A 3PL warehouse registers the facility under its own name and address. The registration covers all food holding activities at that facility regardless of how many brands or clients use the space under the "Hold" activity code.
18. Do co-packing warehouses need a different type of FDA registration?
Co-packing warehouses performing both storage and packing must register with both "Hold" and "Pack" activity codes, and may be subject to additional FSMA Preventive Controls requirements for packing operations. FDA Registration Assistance reviews co-packer activities to ensure the registration accurately reflects all operations performed at the facility.
19. Does the size of the warehouse determine whether FDA registration is required?
No. Registration requirements are based on activities performed — not facility size or food volume. A small cold storage warehouse has the same registration obligation as a large distribution center. Small businesses may qualify for modified FSMA compliance requirements, but these apply to Preventive Controls — not to the basic Food Facility Registration obligation.
20. Can FDA inspect a registered food warehouse?
Yes. FDA has authority to inspect registered food facilities, including food warehouses, under 21 U.S.C. § 374. FSMA increased FDA's inspection frequency for food facilities. Maintaining a current registration and accurate FSMA compliance records helps warehouses be inspection-ready at all times.
21. Is FDA registration required before the first food shipment arrives at the warehouse?
Yes. Food facilities must be registered before beginning to hold food for U.S. distribution. For foreign warehouses, registration must be complete before food shipments depart for the United States — the registration number is needed for accurate Prior Notice filing, which must be submitted before the shipment arrives at the U.S. port of entry.
22. What is the qualified facility exemption and does it apply to food warehouses?
The qualified facility exemption under 21 CFR Part 117.5(a) allows very small food businesses (average annual food sales of $1 million or less, with the majority of sales directly to consumers or nearby restaurants) to comply with modified FSMA Preventive Controls requirements. This exemption applies to food safety plan requirements only — not to the basic FDA Food Facility Registration obligation. Even qualified facilities must register with FDA.
23. Can FDA Registration Assistance take over management of an existing warehouse registration?
Yes. FDA Registration Assistance can transfer an existing Food Facility Registration from another U.S. Agent or manage a previously self-filed registration. The registration number stays the same — only the U.S. Agent or management contact is updated. Transfers are typically completed within 24–48 hours.
24. Does registering a food warehouse mean FDA has approved the facility?
No. FDA Food Facility Registration is not FDA approval or endorsement. It means the facility is in FDA's regulatory system as required by law. It enables FDA to identify the facility, schedule inspections, and monitor the food supply chain — it does not certify food safety practices.
25. How do I get started with FDA registration for my food warehouse?
Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Provide your warehouse name, address, the types of food stored, and whether the facility is domestic or foreign. FDA Registration Assistance confirms your obligation, obtains your DUNS Number, and completes the registration — typically within 24–48 hours. Complete service: $858.
