On October 13, 2023, the Food and Drug Administration (FDA) announced that the guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry,” originally released as draft guidance on September 13, 2022, has been made final. FDA received no comments on the draft guidance, and as a result, is publishing the guidance as drafted, with minor editorial changes to improve clarity. By finalizing the Fourth Edition of this Guidance, FDA is formally replacing the Third Edition, dated June 2016.
The guidance document updates the previous version by making a clarification about submitting prior notice to FDA and including three additional questions.
- The clarification to Question D.3.2 notes that prior notice must be submitted to FDA, and not both FDA and U.S. Customs and Border Protection (CBP). An authorized user of CBP’s ABI/AC/ITDS can submit prior notice to FDA through the ABI/ACE/IDTS interface or through FDA PNSI. Non-authorized users may arrange for prior notice submission by an authorized user or through FDA PNSI.
- Question C.1.4 explains that food imported from a country with which FDA has a Systems Recognition Arrangement (SRA) or equivalence determination is not exempt from prior notice.
- An SRA is a partnership between FDA and a foreign regulatory counterpart in which the agencies have concluded that they operate comparable regulatory programs for the purpose of sharing information and leveraging each other’s regulatory systems and activities to manage the safety of foods covered by the arrangement. The existence of an SRA with a country does not exempt food imported from that country from FDA prior notice requirements.
- An equivalence determination is the process of determining whether a country’s food safety controls achieve at least the same level of public health protection as measures required by U.S. law. Because a final equivalence determination is limited to a specific set of food safety controls in a foreign country, imported foods must still comply with all applicable U.S. requirements not covered by the scope of FDA’s equivalence determination. Since FDA’s prior notice requirements fall outside the scope of an equivalence determination, imported foods covered by a final equivalence determination are not exempt from FDA prior notice requirements.
- The other two questions, Questions E.1.6 and E.1.7, relate to FDA’s notice of a refusal under 801(m)(1) of the FD&C Act for inadequate prior notice or a hold under 801(l).
- Question E.1.6 states that if FDA determines that a food will be held or released under 801(l) or 801(m)(1) when the food arrives at the border, the notification of prior notice refusals and holds will be communicated first to CBP and then be provided to the relevant party (i.e., the submitter or transmitter of prior notice) upon arrival of the article. This clarification is made to avoid creating an incentive for bad actors to attempt to reroute their entries for the purpose of evading FDA requirements and importing unsafe food if given advanced notice of a refusal or hold.
- Question E.1.7 addresses the timeframe for making requests for FDA review of such a refusal or hold. The regulations state that the request must be submitted within 5 calendar days of the refusal or hold, and the Guidance clarifies that FDA considers the 5 calendar day clock to start at the time FDA provides notice of the refusal or hold to the relevant party who submitted the prior notice (i.e., submitter or transmitter) upon arrival of the article. Therefore, the time FDA provides notification of a refusal or hold, or a request for review is submitted, does not matter so long as it is within the 5 calendar day window.
Other helpful information and guidance on importing foods can be found on the FDA’s Importing Human Foods page. On September 29, 2023, the FDA posted a helpful video to this page about Importing FDA-Regulating Products: Human Foods. This video provides an overview of the steps to import, regulatory requirements, and tips for successful importation.
FDA will accept electronic or written comments on the updated guidance at any time.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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