Contributing Lawyers

Canada

Cyndee Todgham Cherniak

United States

Susan Kohn Ross

Australia

Andrew Hudson



FDA Prior Notice - Common Errors

When filing Prior Notice in advance of the importation into the U.S. of food, FDA has identified the most common errors as:

1) Ultimate consignee is incomplete or wrong;

2) Manufacturer name and address is incomplete or wrong;

3) FDA product code does not match the actual product imported; and

4) The Prior Notice does not report all the food imported.

In terms of enforcement, FDA will elect among the following options:

A) Informed compliance;

B) Civil penalty;

C) Refused Admission; and

D) Injunction and/or debarment.

The rule of thumb is you need to break the product out and report it separately for Prior Notice purposes if there is a different product code, manufacturer or package size.

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