Tag: Prior Notice

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

Why is Prior Notice important?

Prior Notice is a notification issued to FDA prior to the importation of an article of food for human or animal consumption into USA. This includes 50 US states, District of Columbia, Puerto Rico only. The US territories are not covered under this definition.

Food that is imported with inadequate Prior Notice is subject to refusal and detention at the port of entry.

For Prior Notice, food includes all foods for human or animal consumption, irrespective of intended use.

Prior Notices are considered inadequate:

  • When there is either no prior notice submitted, or
  • The information submitted in prior notice is inaccurate, or
  • The prior notice is not submitted in accordance with required timeframes.

The requirement for prior notice is not based on the requirement of FDA registration. FDA registration is required for facilities that are engaged in manufacturing, processing, packing or holding of food for consumption in USA. Prior Notice is required for articles of food imported into US.

There are two online systems available that may be used to file Prior Notices namely., FDA’s PNSI and CBP’s ABI/ACS. For a prior notice submitted via CBP’s ABI/ACS, you may not submit prior notice more than 30 calendar days before the anticipated date of arrival. For a prior notice submitted via the FDA’s PNSI, you may not submit prior notice more than 15 calendar days before the anticipated date of arrival.

The requirement of Prior Notice does not apply to:

  • Food for personal use that accompanies the individual.
  • Home made food sent as personal gift to another individual in US.
  • Food that is imported & then exported and doesn’t not leave the port of arrival.
  • Meat and Poultry food products regulated exclusively by USDA.
  • Food brought in diplomatic bags.

Any person with knowledge of the required information may submit prior notice for an article of food being imported.

Timeframes for submitting Prior Notice:

For foods arriving by international mail –

  • For foods arriving by road, 2 hours before arrival;
  • For foods arriving by rail or by air, 4 hours before arrival;
  • For foods arriving by water, 8 hours before arrival

For foods arriving by Express Couriers like FEDEX – before the food is sent

Liberty Management Group LTD  is one of the leading FDA consulting groups in the USA. LMG provides assistance with Prior Notice, FDA registration and other FDA regulations.  

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: February 06, 2019