24/7 Live Chat Call Us

Filing in ACE for FDA: Compliance Dates and Common Errors

On June 9, 2016, the U.S. Customs and Border Protection (CBP) hosted a webinar on filing import entries through the Automated Commercial Environment (ACE) portal.  The webinar was organized by the U.S. Food and Drug Administration (FDA) and the National Customs Brokers and Forwarders Association of America (NCBFAA).

What is ACE?

Customs brokers and self-filing importers must file information with CBP and other agencies regarding products they import into the United States. CBP describes ACE as “the primary system through which the trade community will report imports and exports and the government will determine admissibility.” CBP and FDA, along with 46 other government agencies, have partnered to make ACE a single window for submitting all data required by the agencies.  ACE will replace ACS, the current commercial database used to submit data through CPB to FDA.

Compliance Dates

June 15, 2016 is the date when ACE is to become the sole filing system for the following FDA entry types:

  • 01 – Consumption – Free and Dutiable
  • 03 – Consumption – Antidumping/Countervailing Duty
  • 06 – Consumption – Foreign Trade Zone (FTZ)
  • 11 – Informal – Free and Dutiable
  • 23 – Temporary Importation Bond (TIB)
  • 51 – Defense Contract Administration Service Region (DCASR)
  • 52 – Government – Dutiable

While June 15 acts as the mandatory filing date for these FDA entry types, CBP is allowing a sort of learning period through July 23, 2016.  Entries filed through ACS after June 15 will likely be allowed, but the consequences will be decided on a case-by-case basis.  Users may receive a warning message.  CBP may also follow up with ACS filers to see why they are not filing through ACE and to determine how CBP can assist in the transition to ACE.  Come July 23, ACS will no longer be allowed as an alternate filing method.

Common Errors when Filing in ACE

During the webinar, FDA revealed some of the most common errors and causes for entry rejection made when filing entries through ACE.

  • Filers must provide a valid prior notice confirmation number for food and beverage shipments. Filers should only include the confirmation number and not the other FDA data required to file prior notice. Many filers submit invalid prior notice confirmation numbers.
  • Many filers fail to provide a valid FDA registration number. (Tip: FDA requires food facilities to renew their FDA registration between October 1 and December 31 of each even-numbered year. Registrations not renewed as required are considered expired by FDA.)
  • Many entries are rejected for a missing or invalid product code, affirmation of compliance code, or intended use code.
  • Many filers include mismatching entity IDs. For example, an entry for a processed food must list a manufacturer code (as opposed to a grower code) as the entity ID.
  • Many filers include mismatching source type codes. Entries for imports from growers or consolidators must list a country of growth, while entries for imports from manufacturers of processed foods must list a country ofproduction. Both types of entries must also include a country of shipment.
  • Many filers list a foreign country as the ultimate consignee for non-food items. This is incorrect, as the ultimate consignee is meant to represent the final destination where the product will be delivered within the United States.

These are but a few of the mistakes made when filing entries within ACE.  FDA offers assistance with ACE entries at[email protected]. FDA ACE support will be available 24/7 beginning sometime this month.  FDA also provides this chart for identifying required data elements for entries of FDA-regualated products.

If you notice a mistake in an ACE entry, you may submit corrections up to 5 days before a shipment’s expected arrival to the United States.  Once the shipment is within 5 days of its expected arrival, no corrections may be made unless FDA rejects the entry.

Speeding Up Your Imports

It’s prudent for brokers and importers to begin filing their entries through ACE as early as possible, as ACE provides the quickest entry. According to FDA, the agency is actively prioritizing ACE entries over those filed through ACS.  Entries filed through ACE are processed two times faster.

While DUNS and FEI numbers are not currently required for filing entries of most commodities in ACE, FDA noted that including this data may expedite the processing of an entry.  “Providing a DUNS number gives FDA a higher confidence level in looking at that data,” the agency said during the webinar regarding confirming the name and address of a product manufacturer.

How Registrar Corp can Assist

Registrar Corp offers a variety of services to help brokers obtain the information they need to file entries in ACE.  Registrar Corp can:

Registrar Corp’s FDA Compliance Monitor also acts as a valuable resource for custom brokers and importers.  The monitor provides detailed information on monitor facilities, such as a facility’s DUNS number (when available) and any FDA Warning Letters, Import Alerts, Import Refusals, and Inspection Classifications tied to the facility.

For more information on filing FDA-regulated entries in ACE, regulations for importing FDA-regulated products to the United States, or how Registrar Corp can assist, contact +1-757-224-0177.  Live help is available 24-hours a day at www.registrarcorp.com/livehelp.