FDA Issues New Export Certificates for Certain Foods

The U.S. Food and Drug Administration (FDA) is now accepting applications for new export certificatesfor certain foods. On August 31, 2018, the FDA announced its new export certification program for certain FDA-regulated food products and the fees it will assess for issuing new export certifications to U.S.-based exporters of these products. The new export certification and fees were authorized by the 2011 FDA Food Safety Modernization Act (FSMA) amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act), allowing the agency to collect up to $175 for export certification for food.

FDA issues different types of export certification for different food products. The “Certificate to a Foreign Government” and “Certificate of Exportability” are now available for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. The fee for these certificates is $175 for the first certificate, $155 for the second certificate for the same product(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request.

• The “Certificate to a Foreign Government” is available for conventional foods, food additives, food contact substances, and infant formula that meet the applicable requirements of the FD&C Act. This certificate certifies that a product (or products) may be marketed in and legally exported from the United States.
• The “Certificate of Exportability” is available for export-only conventional foods, food additives, food contact substances, and infant formula. This certificate certifies that a product (or products) meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported.

CFSAN will continue to issue a “Certificate of Free Sale” for dietary supplements, medical foods, and foods for special dietary use. FDA does not charge a fee for “Certificates of Free Sale”.

The FDA anticipates that the new certificates will help facilitate exports by assisting industry in fulfilling importing country requirements for certification by FDA of FDA-regulated food products. Additionally, the electronic form for the new certificates responds to numerous industry requests for additional flexibility regarding the information that is printed on export certificates.

Certificates can be requested through the CFSAN Export Certification Application and Tracking System (CFSAN eCATS). For more information, visit Online Applications for Export Certificates.

Please direct any questions to CFSANExportCertification@fda.hhs.gov.

For Additional Information

• Exporting Food Products from the United States
• Export Certification FAQs