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FDA Releases Draft Revisions to Prior Notice Guidance Document

The U.S. Food and Drug Administration (FDA) requires prior notice of food for both humans and animals to be submitted to FDA. In 2003, FDA issued a guidance document that addressed frequently asked questions about prior notice legal requirements to help the food industry and others comply with the Prior Notice rule.

In March 2014, FDA released a draft revision to the guidance document, “Guidance for Industry: Prior Notice of Imported Food and Questions and Answers (Edition 3).” The revised document includes simplified updates of previous answers and information on new requirements from the FDA Food Safety Modernization Act (FSMA). Prior notice submissions for imported food are now required to report the name of any country to which the article has been refused entry.

In addition to addressing the new FSMA requirements and updating answers to previously existing questions, the draft revision to the prior notice guidance document adds new questions and answers that were submitted after the second edition was released in 2004. These questions include:

  • 5.1 Is prior notice required for placebos that are imported for testing purposes?
  • 6.1 Is prior notice required for popcorn that is used as a packing material for shipping?
  • 9.1 Title 21 CFR 1.281 (a)(18), (b)(12), and (c)(19) requires the name of any country that has refused entry of the article of food to be reported through prior notice. Specifically, what types of entry refusals should be reported through prior notice?
  • 9.2 If an article of food is refused entry/admission upon arrival at a U.S. port, must the refusal be reported in subsequent prior notice(s) if the article is then offered for import at another U.S. port?
  • 9.3 Does ‘article’ refer to only the food in the specific shipment, or does it also refer to food from the same batch or lot numbers that was shipped to other countries?
  • 12.3 Is prior notice required for casings?
  • 15.5 While in Canada, I plan to buy animal food for my pets (such as, dog food, cat food, parakeet food, hay for my horses). Is prior notice required?
  • 15.6 I own a dairy farm in the U.S. and plan to go to Canada to buy a tractor trailer load of hay and bring the hay back to feed my cows. Is prior notice required for this hay?
  • 8.1 What name and address should be submitted as the ultimate consignee?

FDA’s response to most of these new questions is that if the product intends to be directed to a food use, can be construed as a food, or if it can be directed to a food use in the future, then the filing of a prior notice is required.

Registrar Corp is an FDA consulting firm that helps companies with U.S. FDA regulations. If you would like additional clarification regarding your specific food shipment circumstances, Registrar Corp can assist you.

Registrar Corp’s Prior Notice Express allows you to quickly file a Prior Notice with the U.S. FDA via fax or online and will help eliminate typical filing errors. For more information on Prior Notice requirements contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.