Do I Need an Export Certificate from the FDA?

Businesses that export food products, dietary supplements and other FDA-regulated products from the United States are not required to obtain a certificate from the FDA to legally export these products. However, many foreign countries and customers will request a “certificate” with every shipment. To help businesses meet these requests, the FDA will issue certain export certificates upon request.       

The FDA will issue one of three types of certificates (listed below), depending on the type of product being exported and the businesses’ need.  

Certification to a Foreign Government

•  The certification to a foreign government is available for exporting conventional foods, food additives, food contact substances, infant formula products, and seafood that meet the Federal Food Drug and Cosmetic Act’s (FDC Act) requirements for marketing in the U.S. and may be legally exported from the U.S.
• This certificate states that a product (or products) are under the jurisdiction of the FDA and may be marketed in, and legally exported from, the United States. 

Certificate of Exportability

• The certificate of exportability is available for conventional foods, food additives, food contact substances, infant formula products, and seafood that cannot be legally marketed in the U.S. but which meet the requirements of Section 801(e) of the FDC Act and may be legally exported from the U.S.
• Section 801(e) requires that the export: (1) meet the specifications of the foreign buyer; (2) is not in conflict with the laws of the country to which it is intended for export; (3) is labeled on the outside of the shipping package that it is intended for export; and (4) is not sold or offered for sale in domestic commerce.
• This certificate states that a product (or products) meet(s) the requirements of Section 801(e)(1) of the FDC Act and may be legally exported. 

Certificate of Free Sale

• The certificate of free sale is only available for dietary supplements, medical foods, and foods for dietary use that meet the requirements of the FDC Act, or if they cannot be legally marketed in the United States, meet the requirements of Section 801(e)(1) of the FDC Act.

There may be other certificates available for specific products or through other federal agencies that also regulate certain exported food products.  

US Imports can help your business apply for the applicable export certificate.