i- On October 13, FDA published the latest iteration of its “Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4).” This is the finalized version of the draft guidance we previously covered in September 2022. The updated guidance adds three questions regarding systems recognition or equivalency determinations and FDA’s notice of refusal for inadequate prior notice or a hold if the food is from an unregistered foreign facility. Because FDA did not receive comments on the draft guidance, it is published as drafted, with minor editorial changes to improve clarity.
- FDA published the final prior notice rule in November 2008, implementing section 801(m) of the Federal Food, Drug, and Cosmetic Act. Under the rule, FDA must receive prior notice of food imported into the United States. This guidance document answers frequently asked questions regarding the rule. The additional questions in the fourth edition clarify that prior notice refusals and holds will be communicated to U.S. Customs and Border Protection to prevent rerouted entries to evade FDA requirements. In addition, the updated guidance clarifies that the 5-calendar-day clock to request a review of the refusal or hold begins when FDA provides notice to the submitter or transmitter. Finally, the guidance clarifies that a Systems Recognition Arrangement or equivalence determination will not exempt a foreign country from prior notice requirements.
- The first edition of the guidance was published in 2003 and updated in 2004 and 2016. In addition to the new questions and answers, FDA made technical amendments such as updating links, contact information, and references to outdated systems.
FDA Publishes Updated Prior Notice of Imported Food Guidance Document
Monday, October 16, 2023
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