Background

The Food and Drug Administration has issued a final guidance revising a list of questions and answers on prior notice of imported food to include the following information.

- The existence of a systems recognition arrangement with or an equivalence determination of a foreign country does not exempt foods imported from that country from FDA prior notice requirements.

- Notification of prior notice refusals and holds will be communicated to U.S. Customs and Border Protection and provided to the relevant party (i.e., the submitter or transmitter of prior notice) upon arrival of the article (because advance notice could create incentives for bad actors who may attempt to reroute their entries to evade FDA requirements and import unsafe food).

- The five calendar day period within which certain parties may request reviews of prior notice refusals and holds begins when the FDA provides notice of the refusal or hold to the submitter or transmitter.
For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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