ACE Transition | Changes To FDA Entry Filing
The U.S. Food and Drug Administration (FDA) has now completed its transition to the Automated Commercial Environment (ACE). As a result, all goods regulated by the FDA must be transmitted via ACE effective June 15, 2016 and will no longer be accepted in the previous Automated Commercial System (ACS). Additional information is now required when filing entries and corresponding entry summaries for FDA regulated goods.
What Additional Information Will Be Mandatory?
- Commodity details and intended use
- Description of how the commodity is processed
- Product state (i.e. fresh, frozen, shelf stable, etc.)
- FDA product code
- Country of production or source
- Full and detailed invoice description
- Full name and address of the:
- Manufacturer
- Shipper
- Importer
- Consignee
- Consolidator
- Farmer/grower (if applicable)
- Processing plant (if applicable)
- FDA registration number(s)
- Port of entry
- Quantity
- Weights (actual, rather than estimated)
- Packaging type
- Product line value
- Arrival date and time
Certain commodities may require additional information. Please contact Pacific Customs Brokers for additional details.
U.S. FDA Requirements For Regulated Goods
How Will This Affect My Entry?
Pacific Customs Brokers may contact importers to obtain any mandatory information required for the entry filing with ACE and FDA.
As CBP and FDA implement this mandatory filing requirement entry filing delays are to be expected. It is imperative to note that missing information will result in additional processing delays.
