FDA Seeks Public Input on Experiences with Export Certification in the Form of Lists (Export Lists) for Human Food Products

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.

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.

Additional Information

• Food Export Lists
• Food Export Library
• Online Application for Export Lists