ACE: FDA Import Compliance

Although the US Customs and Border Protection and US Food and Drug Administration (FDA) have not announced an official date, the Automated Commercial Environment (ACE) will be the mandatory means to electronically file FDA import data in 2016. At that time, additional electronic filing requirements may also be rolled out.

What’s Changing?
FDA data may no longer be filed via the Automated Commercial System, CBP’s legacy software. ACE will be the only acceptable means of filing data. The FDA will implement changes to their data requirements at that time, such as and requiring all involved parties to the transaction to register and report their Dun & Bradstreet D-U-N-S number or name and address. Supplying a name and address, in lieu of a D-U-N-S number, may lead to significant delays.

Based on the data transmitted to them, FDA creates a risk profile. In part, the risk profile is compiled by verifying names and addresses against databases for information, such as Food Facility Registration and Federal Canning Establishment numbers. If names and addresses are not an exact match, automated lookup processes may fail and require the manual intervention of an FDA officer. The FDA does not currently staff their resident posts on a 24 hour schedule; therefore, shipments requiring manual processing and arriving “after hours”, on weekends or holidays, may encounter additional delays.
    
The FDA will also give more consideration to government processing codes, which supplies the government with more information about the product’s category. Affirmations of Compliance will continue to be necessary to screen products, as well as intended use statements to identify products’ end-use or purpose.

To ensure automated “may proceed” messages from FDA, importers’ data needs to be accurate and complete.

Why Are There New Requirements?
The additional data provided to FDA will allow shipments to be expedited through FDA’s risk-based screening system, PREDICT. Shipments with lower risk will be granted “May Proceed” direction, possibly without FDA examination, while higher risk shipments may be subject to “FDA Review.”

Compliance Based Approach
CBP and FDA are defining the requirements and processes under ACE. Deringer will communicate and work with its customers to ensure import compliance under ACE. Please direct questions to compliance@anderinger.com.

**Deringer has compiled two templates (1. Medical Devices, and 2. Cosmetics, Food/Dietary Supplements & Food Related Items) to help importers and exporters of FDA regulated merchandise to understand the changes in data required by the FDA.