US Imports of Foodstuffs, Health Care Products Etc Subject to New Entry Procedures

US Imports of Foodstuffs, Health Care Products Etc Subject to New Entry Procedures

If you supply customers in the US with human and animal food, pharmaceuticals, medical devices, radiation devices and other goods subject to special clearance declarations and regulations, please take careful note of the following important new US import regulations.

The US Food and Drug Administration (FDA) has recently announced significant updates to its list of Affirmation of Compliance (AofC) codes. These codes are used for all imports liable to regulation by the FDA, and when entered on the FDA’s electronic systems significantly speed up the automatic screening of import declarations.

This in turn accelerates decisions concerning exactly which entries will receive the “May Proceed” status and those which will be subject to specific manual review by FDA personnel.

Other key aspects of the revised AofC regulations include the following:
* by using a valid AofC code the filer affirms that the details in the entry line on the FDA declaration fully meet all the requirements specific to that code
* while submission of the AofC code is entirely voluntary, it should be noted that an automated “May proceed” decision can only be obtained if the relevant AofC is correctly submitted
* failure to submit an appropriate AofC will automatically result in the import declaration becoming subject to manual review
* even if an automated “May proceed” status is not received, the presence of the AofC will still facilitate manual processing
* in consequence of these requirements, US importers may request their suppliers to include relevant data on their commercial invoices.

We strongly advise you to ensure that all your US customers identify the FDA AofC code(s) required for any commodities they plan to import, and also to check with them whether they want you to include this data on your commercial invoices.

Detailed information concerning the revised regulations - recently distributed by the US Customs and Border Protection (CBP) service in their CSMS message13-000234 of May 14 – are available in the FDA Affirmation of Compliance Quick Reference Guide and the FDA complete Reference Guide.