On December 11, 2003 the FDA and U.S. Customs issued a joint document outlining their plans for enforcement of the Prior Notice rules.

The document sets forth four implementation phases, during which enforcement becomes progressively more strict. FDA and Customs can refuse shipments or levy fines based on a number of factors including, but not limited to:

• the severity of the infraction;
• whether there is evidence of a threat of serious adverse health consequences or death to humans or animals;
• the importer’s history of violations; and
• whether or not the violation appears to be intentional or flagrant.

Importers should carefully read the full text of the Compliance Policy Guide.