Printable Version FDA Final Prior Notice rules define relevant food products and related import requirements

The US Food and Drug Administration (FDA) has published its final rule, effective from 6th May, regarding all its relevant Prior Notice requirements for food and foodstuffs to be imported into the US. 

The final rule replaces the previous interim rule that has been in effect since December 2003.  While the final rule contains some technical changes, the broad requirements of the relevant regulations remain largely unaltered.  A key and continuing element is that shipments imported into the US containing food for human or animal consumption without adequate Prior Notice may incur fines or penalties, and may also be refused entry to the US.

Customers should therefore note that FedEx will with immediate effect no longer be able to submit emergency Prior Notices to the FDA as they have done in the past on behalf of shippers submitting food shipments intended for import into the US.  All Prior Notice submissions must be submitted to the FDA no later than 4 hours before and no sooner than 15 days prior to the arrival of such shipments in the US.  Any food consignments arriving in the US without Prior Notice submissions having been made according to these requirements will either have to be returned  to the shippers concerned at their expense or else destroyed.  Fines and penalties may also apply if violations are deemed flagrant and the shipper has offended frequently. 

Shippers and importers should also note that the provision of Prior Notice information (which should always include the manufacturer’s name and the address of the place of production) while constituting formal acknowledgement of the preparation and submission of such information does not in itself guarantee formal clearance approval.

Shippers and importers should also especially note Section 201(f), which sets out relevant FDA definitions concerning food, articles used for food or drink for man or animals, chewing gum, and articles used as components of any such articles etc.  Examples of food according to such definitions include:

• Dietary supplements and dietary ingredients
• Infant formulae
• Beverages (including alcoholic beverages and bottled water)
• Fruits and vegetables
• Fish and seafood
• Dairy products and shell eggs
• Raw agricultural commodities for use as food or components of food
• Canned and frozen foods
• Bakery goods, snack food, and confectionery (candy), including chewing gum
• Live food animals
• Animal feeds and pet food
  
  

For more information, please contact FedEx Customer Service at 1802233.