FDA Prior Notice

Prior Notice refers to a US FDA requirement under which any food imported into the US must be notified to the FDA before it arrives. This helps the FDA protect the food supply from bioterrorism and other threats.

What Products Require Prior Notice?

  • Food and beverages for humans or animals.
  • Dietary supplements
  • Raw agricultural products intended for consumption
  • Food ingredients and additives

What foods do not require Prior Notice:

Homemade goods for personal use, or non-food items, don’t require prior notice.

What Must Be Included in the Prior Notice?

  • Identity of the food
  • Manufacturer FDA Registration
  • Shipper and country of origin
  • Estimated arrival date and time
  • Port of entry and carrier details
  • US recipient or importer

When Must It Be Submitted?

  • By land: At least 2 hours before arrival
  • By air: At least 4 hours before arrival
  • By sea: At least 8 hours before arrival
  • By international mail: Before the package is sent

Who can Submit Prior Notice

Anyone with information about the shipment.

What Happens If You Don’t File It?

  • Shipments may be refused entry, detained, or destroyed
  • The importer may face penalties or enforcement actions

Liberty Management Group Ltd can help facilities with FDA Registration & prior notice submissions.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us