The FDA’s import rules get tougher for 2016. It is time to get familiarized with them.

The FDA has, in association with the Customs and Border Patrol Service (CBP), become more and more stringent of late with its insistence on the adherence to procedures and submission of information. Noncompliance with the FDA’s requirement could invite serious actions and severe penalties.

The FDA and the CBP have become so strict of late in their function that they could delay, detain or refuse shipment of firms that fail to properly implement the two agencies’ import and export program requirements. The legal and prior notice information requirements have to be complied with very strictly.


New rules for 2016

For 2016, a new layer of stringency has been added, what with the agencies demanding adherence to the Automated Commercial Environment (ACE) entry filing system for importers that enter American shores. Some of the consequences of not adhering to the ACE:

  • Any importer who fails to do this can have its shipment barred from entry
  • Such an importer could also face a monetary penalty of $10,000 for an offence
  • The ACE empowers the FDA to stop a ship even before it is loaded
  • The CBP can fine three times the value of the shipment if the FDA decides that the importer should bring the products back to the port of entry after it has received a release, but cannot find the product that has already been sold.

Understanding the rules for import

Are you an importer who faces issues with the FDA’s import rules? Do the new rules cause alarm in you? Are you looking for expert training on how to handle this aspect of the FDA? A two-day, in person seminar from GlobalCompliancePanel, a leading provider of professional trainings for the FDA-regulated industries, is the solution.

The Director of this seminar, Casper Uldriks, who has been an ex-FDA expert and a former Associate Center Director of CDRH, brings over three decades in handling all aspects of the FDA. This seminar, details of which can be had from, is the ideal leaning for importers who are muddled with the new rules from the FDA.

Uldriks will cover the following important areas during this session:

  • FDA Legal Authority Customs and Border Control (CBP) Import Process FDA Import Process Registration and documentation
  • Import Delays Import Alerts Detention Refusals
  • Foreign Inspections FDA 483 – Inspectional Observations
  • FDA Warning Letters and Automatic detention
  • Import Hypothetical FDA Import for Export Program FDA Export Program Export Hypothetical
  • FDA Export Program Special Import Issues


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