August 31, 2018
The U.S. Food and Drug Administration (FDA) has published a Federal Register notice announcing the fees the agency will assess for issuing new export certification for certain foods. 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), which allow the agency to collect up to $175 for export certification for food.
On October 1, 2018, the agency plans to begin issuing and collecting fees for two new types of food certificates pursuant to this new FSMA authority, the “Certificate to a Foreign Government” and “Certificate of Exportability.” These certificates are currently available for other FDA-regulated products, such as drugs and medical devices. The certificate issued depends on the type of product being exported:
- The “Certificate to a Foreign Government” will be available for products that meet the applicable requirements of the FD&C Act and will certify that a product (or products) may be marketed in and legally exported from the United States.
- The “Certificate of Exportability” will be available for export only products and will certify that a product or products meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported.
Beginning October 1, 2018, the FDA will assess fees for issuing export certificates for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use.
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, announced January 2, 2018, responds to industry requests for additional flexibility regarding the information that is printed on export certificates.
Please direct any questions to CFSANExportCertification@fda.hhs.gov.
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