Service Description – FDA Prior Notice Submission
I provide FDA Prior Notice submission services for companies exporting food or dietary supplement products to the United States.
Under U.S. law, any food or dietary supplement sold, distributed, or imported into the U.S. market must have a Prior Notice submitted to the FDA before arrival. This requirement applies to commercial shipments, regardless of product size or shipment value.
Who needs FDA Prior Notice:
This service is mandatory for:
Companies exporting food products to the United States
Companies exporting dietary supplements to the United States
Importers, exporters, manufacturers or distributors shipping food or supplements into the U.S.
Without a valid Prior Notice, shipments may be held, delayed, refused or destroyed at the port of entry.
What this service includes:
FDA Prior Notice submission for one (1) shipment
Review of shipment and product information before submission
Accurate filing through the official FDA Prior Notice System Interface (PNSI)
Confirmation of Prior Notice submission
This service applies to food and dietary supplement products only.
Information required from the client:
To submit the Prior Notice, the client must provide:
Product name, batch, description and quantity of each product;
Product category (food or dietary supplement);
Manufacturer name and address;
FDA Facility Registration number of the manufacturer;
Importer information;
Shipper and consignee details;
Country of origin;
Mode of transportation;
Estimated arrival date and port of entry;
Tracklng number or Bill of Lading / Air Waybill;
Incomplete or incorrect information may result in submission delays or rejection.
Timeline:
Prior Notice must be submitted before the shipment arrives in the United States.
This service is typically completed within 1-3 business day, once all required and accurate information is provided by the client.
Important notes:
This service covers one (1) shipment per order (1-15 SKUs);
Prior Notice must be submitted for each shipment;
Submission of Prior Notice does not guarantee FDA clearance or release;
Regulatory decisions remain at the discretion of the FDA and U.S. Customs authorities.