Quick answer: Foreign facilities that manufacture, process, pack or hold food for consumption in the United States must register with the US Food and Drug Administration (FDA). Registration must be renewed every two years, during the renewal period from October to December of each even-numbered year. Foreign facilities must name a US agent, provide a unique facility identifier and support other import steps such as prior notice for each shipment.
Key takeaways – Foreign food facilities supplying the US must register with FDA. – Registration is renewed every even-numbered year, October to December. – A US agent and a unique facility identifier are required. – Prior notice must be submitted before shipments arrive.
Who needs to register?
Facilities that manufacture, process, pack or hold food for people or animals in the US generally need to register. This includes foreign producers of ingredients such as coconut sugar. Some exemptions exist, such as for certain farms, but most food processors exporting to the US must register.
What information is required?
| Item | Explanation |
|---|---|
| Facility details | Name, address and contact information |
| Owner or operator | Responsible company information |
| Food categories | Types of food handled |
| US agent | A person or company in the US who acts as contact |
| Unique facility identifier | An identifier such as a DUNS number |
| Emergency contact | For urgent communication |
When must registration be renewed?
Registrations must be renewed every two years, between October 1 and December 31 of each even-numbered year. Registrations that are not renewed are considered expired, and food from that facility can be refused at the US border.
What is prior notice?
Before food arrives in the United States, FDA must receive prior notice of the shipment. This includes information about the product, the manufacturer, the shipper and the arrival details. Prior notice is usually submitted by the importer or their customs broker, using the registration number of the manufacturing facility.
What other US rules matter?
- Foreign Supplier Verification Program (FSVP): US importers must verify that foreign suppliers meet US safety standards.
- Preventive controls: food safety requirements for many facilities under the Food Safety Modernization Act.
- Labelling rules: for retail products sold in the US.
- Organic rules: for products sold as organic.
What should exporters do?
- Register the facility and keep the registration number available.
- Appoint a reliable US agent.
- Set reminders for the renewal period.
- Share registration information with importers when needed.
- Prepare food safety documentation for buyers’ supplier verification.
Why does this matter for buyers?
US importers depend on correct registration from their foreign suppliers. Missing or expired registrations can delay or block shipments. Buyers should confirm their suppliers’ registration status during approval.
Where does IMC fit?
PT Integral Mulia Cipta (IMC Group) exports organic coconut sugar from Central Java, Indonesia, to buyers in international markets, including the United States. Importers can contact our team for the documents needed for their supplier approval.
Frequently asked questions
Do foreign coconut sugar producers need FDA registration? Yes, if they manufacture, process, pack or hold food for the US market.
How often must registration be renewed? Every two years, from October to December of even-numbered years.
What is a US agent? A US-based contact who represents the foreign facility for FDA.
What is prior notice? Advance information FDA must receive before food shipments arrive.
IMC Group (PT Integral Mulia Cipta) supplies fine-granule organic coconut sugar from Central Java to food companies worldwide. Talk to our team: info@organic-coconut-sugar.com or WhatsApp +62 811 880 62273.
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