FDA entry requirements vary by commodity and intended use. There is no single field set that applies to every FDA-regulated product.
Common data elements
Depending on the FDA program, a regulated line may require some or all of the following:
- Detailed product description and brand
- FDA Product Code
- Country of production/origin and country of shipment
- Manufacturer or producer information
- Shipper and importer information
- FDA quantity and unit of measure
- Intended Use Code (IUC)
- Program or processing information
- Prior Notice data for covered food shipments
- Facility registration, product listing, approval or other identifiers
- Affirmations of Compliance (A of C) where applicable
- FSVP importer information for covered foods
Accuracy matters at line level
FDA uses information from each line to evaluate the imported product. Products should not be grouped together when FDA data elements differ. FDA lists incorrect intended-use codes, incorrect product codes and incorrect grouping of line items among common submission problems.
Best practice for shippers
Create and maintain an FDA master record for each SKU before the first shipment. Do not ask operations teams to reconstruct FDA data from a commercial invoice at the time of dispatch.