FDA Prior Notice: When and How to Submit for Food Importers

FDA Prior Notice: When and How to Submit for Food Importers

Introduction

Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is imported into the United States. It ensures that the U.S. Food and Drug Administration (FDA) has the opportunity to evaluate the safety of a food shipment before it enters U.S. commerce and provides an opportunity for the FDA to inspect food products at their first port of arrival in the United States. In addition to protecting public health, prior notice allows FDA to reduce costs associated with detaining or refusing entry of potentially unsafe foods from entering U.S commerce

FDA prior notice food manufacturer importing

Submitting your FDA Prior Notice:

Prior Notice requires the submitter to provide certain information related to the food shipment to the FDA, including:

  • The name and address of the manufacturer, packer, or distributor
  • The name of the product
  • The quantity of each product being shipped
  • The anticipated arrival date of the shipment in the United States (or another applicable country)
  • Ports of entry through which the shipment will be imported into that country (e.g., “Port of Entry #1”) or another country relevant to a particular prior notice submission. This can be helpful if multiple countries are involved in your food importation process, and you wish to track your products as they move across borders—a very common situation for global brands selling products across continents!

Food Importers Submitting their FDA Prior Notice

The FDA has authority under section 801(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) to require that importers provide prior notice before the food product is imported into the United States.

  • The FDCA ensures that foods are safe for consumers by prohibiting adulterated foods from entering or being sold in interstate commerce, and by requiring all foods shipped in interstate commerce be labeled accurately.
  • The FDCA also requires that FDA inspects imported food products at ports of entry to ensure they are free from filth, pesticide residues, and natural or artificial poisonous or deleterious substances added after harvest but before such entry into the United States; do not contain any substance which renders it injurious to health; their labeling bears no false or misleading statement as defined in section 403(a)(1); have been processed in compliance with section 404; bear labeling information required by specific provisions of law set forth in 21 CFR 101-40.

Looking for help submitting your FDA prior notice or importing your food products?

When to Submit your FDA Prior Notices

Prior Notice submissions must be submitted at least 24 hours before the shipment arrives in the United States. The FDA allows Prior Notice submissions to be submitted any time after a transaction has been agreed upon but no later than two hours before the shipment arrives at its first port of arrival in the United States.

The FDA also requires that each shipment must be accompanied by a valid Prior Notice submission or it will be refused entry. Any importer or shipper can submit a prior notice on behalf of an importer, but they must have authorization from the foreign manufacturer or distributor and have access to certain information about their products, such as ingredient lists and country of origin. A complete list of the required information can be found in FDA’s guidance document which provides detailed instructions on submitting Prior Notice Submissions online through ACES (Automated Commercial Environment) via an eManifest system used by Customs & Border Protection (CBP).

How to Submit Prior Notice:

  • To submit a prior notice electronically, a submitter must use FDA’s Prior Notice System Interface (PNSi), which is available online. We recommend that you verify your submission information before submitting it to the FDA.

Can my Prior Notice Submissions be Refused?

If the FDA is not able to receive the information required by Prior Notice before a particular shipment of food arrives at its first port of arrival, the FDA may refuse entry of the food into the United States. It is important to note that in order for a submission to be considered “on-time,” the submission must be received by the FDA within 30 calendar days from when the product enters into U.S. commerce (i.e., when it is entered into any port).

Need Help Submitting your FDA Prior Notice?

In addition to webinars and videos, the FDA also offers a series of e-learning modules on Prior Notice for Human Food. The most recent module, “ePrior Notice for Human Food,” was released in 2017. The video explains what happens when a Prior Notice is missing and gives step-by-step instructions on how to file an effective Prior Notice submission. This includes providing details on how to create an electronic submission using the FDA’s eSubmitter tool and submitting it to the FDA through certain portals.

The video also covers common problems that are encountered when submitting a Prior Notice submission as well as ways to avoid them during submissions by giving best practices advice such as providing all required information upfront instead of waiting until after submission has been submitted before finding out missing data needs adding or updating later on down the road – something that could delay approvals unnecessarily due delays caused by rework efforts needed afterward!

Conclusion

In summary, the FDA expects a prior notice submission to be complete and accurate, as well as timely. This means submitting an appropriate quantity of information at the right time and in an approved format. If your company is required to submit a prior notice for food imports or exports and is not doing so consistently or accurately, you may be subject to enforcement action. Contact us today for more information!

How Quality Smart Solutions can help:

We hope this post helped you understand food additives and preservatives a little better. There are many different kinds, and they can have a big impact on your health.

Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labeling projects. Our specialists are here to help with the following services: Novel Food Notifications, SFCR License application, HACCP & PCP program, TMA License for Supplemented Foods, Nutrition Facts Table (NFT) Creation and label compliance!

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