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.

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About Author
Breanna Leininger
CCS, LCB

Breanna has been in the industry since 2004 and has dealt with clearances and compliance concerns for a multitude of commodities for all ports of entry and all modes of transportation. She has a Bachelors in Communications, Bachelors in Political Science & Government, is a Licensed Customs Broker as well as Certified Customs Specialist. Breanna has been asked to be the speaker as a variety of events including the BC Agriculture Show, Doing Business in the US seminar and has been a contributor to Smal Business BC publications She was recently nominated for the NCBFAA Government Affairs Conference Emerging Leaders and Mentors by the NBCBA. She participates in the Northern Border Customs Brokers Association and the NCBFAA annual conferences in Washington, DC. Breanna has a deep passion for politics, global affairs, and how communication shapes policy and international business relationships. She feels very fortunate to work in an industry that allows her to take part in how policy impacts the global economy and domestic businesses of all shapes and sizes.

While we strive for accuracy in all our communications, as the Importer of Record it is incumbent upon your company to ensure that you are aware of the requirements under the new regulations so that you maintain compliance as always.