FDA Seeks Public Input on Experiences with Export Certification in the Form of Lists (Export Lists) for Human Food Products
What's New
December 23, 2024
The U.S. Food and Drug Administration (FDA) is extending the comment period for the Request For Information on export lists for human food until February 21, 2025. The agency seeks public input on the listing requirements of other countries and the FDA’s approach to facilitating U.S. industry compliance with these requirements through the issuance of export certification for human food products. This extension provides additional time for interested parties to submit comments and share experiences with exporting human food products included on the export lists.
Submit electronic comments to https://www.regulations.gov to docket number FDA-2024-N-4776. Written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All written comments should identify the docket number FDA-2024-N-4776. Comments must be submitted on or before February 21, 2025. For more information about the Request for Information and specific instructions on how to submit comments, please refer to the Federal Register notice.
Original Constituent Update
November 7, 2024
The U.S. Food and Drug Administration (FDA) is seeking public input on its current approach to managing FDA certification for the export of human food products regulated by the agency.
Firms exporting products from the U.S. are often asked by foreign customers or governments to supply a “certification” for products regulated by the FDA. The agency’s export certification provides an official attestation concerning a product’s regulatory or marketing status, based on available information at the time FDA issues the certificate (including, as appropriate, attestations provided by the person seeking the certificate). To assist U.S. exporters the FDA provides necessary export certification in the form of certificates or export lists. A full description of the FDA’s process is available through the Request for Information (RFI).
This RFI is intended to gather input from all impacted stakeholders to help the FDA Human Food Program (HFP) ensure it is considering the full range of perspectives when planning and resourcing changes and/or improvements to the export list component of the Export Certification Program.
We invite comments on the challenges and experiences related to meeting the listing requirements of other countries and the FDA's certification processes for export lists. This feedback will be used to plan and resource our export certification program, including suggested approaches for implementing fees to offset the operational costs associated with maintaining a growing number of export lists and potential program enhancements.
Details on Submission: Comments can be submitted electronically via the Federal eRulemaking Portal or by mail. We encourage stakeholders to submit their feedback by January 7, 2025 to ensure it is considered in the ongoing development of our export list program.
Electronic Submissions:
- Visit Federal eRulemaking Portal
- Follow the instructions for submitting comments
Written/Paper Submissions:
- Send to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
Contact Information:
For more details including step-by-step instructions on how to apply in the ELM, visit Online Applications for Export Lists. Please contact the Export Certification Team at HFPExportCertification@fda.hhs.gov for any additional questions about the ELM.