On November 29, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule that establishes requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) system and other authorized systems.
FDA, along with 46 other government agencies, is implementing ACE in collaboration with U.S. Customs and Border Protection (CBP). Some requirements established in the rule include:
- Clarification that FDA may reject an import filing for failure to provide required data elements
- Clarification that written notice can be provided electronically by FDA to owners or consignees of FDA actions to refuse and/or subject certain products to administrative destruction
- FDA is now allowed to provide notice of sampling directly to an owner or consignee
ACE is a “commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy.” ACE replaces the Automated Commercial System (ACS), the current commercial database used to submit data through CPB to FDA. FDA plans for ACE to be fully functional by December 29, 2016.
There are several benefits to ACE. FDA reports in the final rule that ACE has dramatically reduced the inspection and review times at U.S. ports for customs brokers and importers registered with the ACE system. The average processing time for manual review of ACS-submitted entries was about 28 hours in 2015, and that has been reduced to less than 2 hours in ACE. The automated “May Proceed” determination has been reduced from approximately 7.1 minutes in ACS to approximately 2 minutes in ACE. According to John Verbeten, Acting Director of Import Operations, “since July 23 when ACE became required for all FDA entries, ‘May Proceed’ determinations are now issued for 72% of entries, up from 50% before ACE.” ACE also provides cost savings to both the industry and FDA.
In June 2016, Registrar Corp published this blog to help importers and brokers avoid common errors made when filing in ACE. Brokers and importers may receive further assistance with ACE filings by e-mailing FDA at [email protected].
For more information on regulations for importing FDA-regulated products to the United States or how Registrar Corp can assist, contact us at
+1-757-224-0177. Live help is available 24-hours a day at www.registrarcorp.com/livehelp.