FDA’s export certification provides the agency’s 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). The fact that FDA issued an export certificate does not preclude FDA from taking appropriate regulatory action against a product covered by the certificate.
FDA issues different types of export certification for different food products. In limited circ*mstances, other federal agencies may issue export certificates for FDA-regulated food products, usually regarding compliance with foreign standards. It is the exporter’s responsibility to comply with the laws of the importing country, so you may wish to consult your importer or the relevant regulatory authorities in the importing country to determine what type of export certificate is required, if any. Please consult the lists below for descriptions of the types of export certificates offered by FDA and other federal agencies.
FDA-Issued Export Certificates
- 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 for marketing in the United States. This certificate states, among other things, that a product (or products) may be marketed in and legally exported from the United States. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(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. To request this certificate, please visit Online Applications for Export Certificates.
- The “Certificate of Exportability” is available for conventional foods, food additives, food contact substances, and infant formula products that cannot be legally marketed in the United States but that meet the requirements of section 801(e) of the FD&C Act and may be legally exported. This certificate states that a product (or products) meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(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. To request this certificate, please visit Online Applications for Export Certificates.
- The “Certificate of Free Sale” is available only for dietary supplements, medical foods, and foods for special dietary use. FDA does not charge a fee for this certificate. To request this certificate, please visit Online Applications for Export Certificates. Please note that products that contain N-acetyl-L-cysteine (NAC) do not meet the definition of “dietary supplement” and, therefore, should not be included in an application for a “Certificate of Free Sale.” However, NAC-containing products that are labeled as dietary supplements may be eligible for a different certificate to facilitate exports. To request a specific export certificate for products labeled as dietary supplements that contain NAC, please submit a CAP application (with only NAC containing products) to initiate the process. Once the application is submitted, ODSP will reach out to your company for next steps. If you have additional questions, please contact ODSP@fda.hhs.gov.
- The "Certificate for Cosmetics" is issued for products that meet the definition of a cosmetic under section 201(i) of the FD&C Act (21 U.S.C. 321(i)). We do not issue these certificates for products marketed with drug claims, such as cleansers with acne treatment claims. To request this certificate, please visit Online Applications for Export Certificates for Cosmetics.
- FDA also issues health certificates for collagen and gelatin products intended for export to the European Union (EU) and specified risk materials certificates for collagen and gelatin products intended for export to non-EU countries. FDA does not charge a fee for these certificates. Please note that exports of collagen and gelatin products to the European Union are also subject to importing country listing requirements for manufacturers/processors as a precondition for market access. Please visit Collagen and Gelatin Exports to the European Union for more information on collagen and gelatin export lists. To request these certificates, please send the following information to BulkCGExport-LM-OFS@fda.hhs.gov:
- Business name and address.
- Name, telephone number, and email address of contact person.
- List of products presently shipped to the country of destination and those intended to be shipped within the next 2 years.
- Name and address of the manufacturing and processing plant for each product
- Names and affiliations of any Federal, State, and local governmental agencies that inspect the plant, government assigned plant identifier, such as plant number and last date of inspection.
- A copy of the most recent (within 1 year of the date of application) inspection report issued by a State, local, or Federal public health regulatory agency and a copy of a recent laboratory analysis of the finished product as required by the foreign country.
- A copy of the label of the product that you are sending.
Examples of CFSAN-Issued Food Export Certificates
Export Certificates Issued by Other Federal Agencies
Dairy Products
The United States Department of Agriculture, Agricultural Marketing Service, Dairy Grading Branch (Dairy Grading Branch) offers certification services to assist in the export of dairy and related products. Please note that exports of dairy products to the European Union, China, and Chile are also subject to importing country listing requirements for manufacturers/processors as a precondition for market access. The Dairy Grading Branch will only provide export certification for firms on these lists. Please visit Dairy Exports to the European Union, China and Chile for more information on dairy export lists.
Seafood Products
The National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program certifies U.S. seafood products for export to any country requiring health certification. Please note that exports of seafood products to the European Union (EU) and China are also subject to importing country listing requirements for manufacturers/processors as a precondition for market access. NOAA will only provide export certification for firms on these lists. Please visit Seafood Exports to the European Union and China for more information on seafood export lists.
Honey Products
The United States Department of Agriculture, Specialty Crops Inspection Division offers certification of honey exports and related inspection services on a fee-for-service basis.
Egg Products
The United States Department of Agriculture, Agricultural Marketing Service offers certification services to assist in the export of processed eggs and egg product and composite foods containing egg products.
Alcoholic Beverages
You may consult the Alcohol and Tobacco Tax and Trade Bureau for information on Exporting Alcohol Beverages from the U.S.
Related Content
- Export Certificate FAQs
- Export Certification Contacts
- Online Applications for Export Certificates
