FDA’s Import Trade Auxiliary Communication System (“ITACS”) Now Available
With an increased number of imports entering the United States, new enforcement initiatives under such programs as the Food Safety Modernization Act, decreasing budgets and a limited number of employees, complaints about the U.S. Food and Drug Administration (“FDA”) from the trade community have been on the rise. One particular sore spot for the Agency is communications. In an era of text messages, tweeting, and instant posting of documents on the internet, the FDA was still sending and receiving its messages to and from importers and brokers through fax machines and paper copies.
All of that is starting to change now.
On March 14, 2012, the FDA’s Division of Import Operations and Policy (“DIOP”) unveiled its Import Trade Auxiliary Communication System (“ITACS”) to members of the National Customs Brokers and Forwarders Association of America (“NCBFAA”). According to FDA, the new ITACS system is being implemented in order to improve communication between FDA and the import trade community.
ITACS is an internet portal with three critical functions for importers:
- The ability to check on the status of an entry/lines;
- The ability to submit entry documentation electronically; and
- The ability to submit goods availability information for targeted shipments electronically.
The importance of ITACS to the trade community cannot be understated. Using ITACS, importers and their brokers will no longer need to send or fax paper-versions of entry and goods availability documents to the FDA for their entries. This will reduce lost documents and help eliminate the uncertainty of importers as to whether their documents were ever received by the FDA. The automatic creation of an audit trail in ITACS means that the question of when a documents was sent and received by the FDA will no longer be in question.
ITACS is also beneficial to the trade community in that importers and brokers will be able to receive more detailed entry statuses than what are currently transmitted to filers via the U.S. Customs and Border Protection (“CBP”) Automated Broker Interface (“ABI”) system. This will reduce the need for phone calls to the FDA district offices to check on the status of entries. (Also, no more waiting for the FDA to return your call either.)
Finally, ITACS should reduce the confusion between importers/brokers and FDA about the date and location of shipment availability information.
The trade community is not alone in welcoming ITACS on the scene. The new system also benefits the FDA in that it:
- Enables FDA to focus its resources on expediting review of entries and focusing on completion of designated shipment examinations;
- Provides all FDA staff with easy access to entry documents via FDA’s Import system;
- Reduces the numbers of faxes, phone calls, and paper for FDA; and
- Eliminates the need to log information in FDA’s Import system;
In its presentation to the NBCFAA entitled “ITACS: Overview and Walkthrough of Functionality,” the FDA highlighted several important points about ITACS for the trade community to remember. First, the availability of goods for examination should not be submitted through ITACS until the shipment has been uploaded and is physically present for FDA staff to examine. Also, importers and filers with a current web browser and a valid CBP entry number may use ITACS. Finally, the FDA warned that there are currently some issues with file size capacity and that documents must be in PDF format to be uploaded. Also, ITACS will only display statuses for “open” entries. Therefore, if a final FDA admissibility decision has been made for all lines of an entry (e.g., a release), the entry will be considered “closed” in FDA’s import system and the importer or filer will need to check the ABI Messaging or Notices of FDA Action for the status.
We applaud the FDA’s move to improve communications between the Agency and the trade community. We are also looking forward to the future improvements to ITACS promised by the FDA, most notably, the direct, electronic transmission of Notices of Action to both the importer and its broker (versus the paper mailings and faxes that happen today) and the ability to perform online queries for FDA Firm Identifiers and Product Codes.
The link to ITACS can be found at https://itacs.fda.gov.
For more information about the ITACS system or for assistance with the importation or regulation of your food, drug, medical device or cosmetic product, please contact the Food & Drug Law practice group at Fuerst Ittleman at 305-350-5690 or email@example.com.