U.S. purveyors of foods, food additives, dietary supplements, and cosmetics for export are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA. Review of a certificate may be required by foreign countries as part of the process to import a product into those countries.
A Certificate of Free Sale (or Certificate of Export for Seafood) is a document prepared by CFSAN/FDA containing information about a product’s regulatory or marketing status A Certificate of Free Sale is issued for certain CFSAN-regulated products upon request by an exporter. However, a Certificate of Free Sale is not a CFSAN/FDA prerequisite for exporting to foreign countries.
Beginning February 20, 2017, certificates of free sale will be issued by CFSAN/FDA online as downloadable PDFs. The change from paper to PDF certificates should make the process of issuing a Certificate of Free Sale more efficient for both exporters and the agency. Advantages reasonably could include:
- Online submission of applications;
- Reduction in application processing time;
- Online receipt of certificates via PDF;
- Real-time status updates via email and online tracking; and
- Ability to copy, edit, and resubmit applications.
Online applications for a Certificate of Free Sale may be initiated at the FDA Industry Systems website, using (for food exports) the Food Export Certificate Application Step-by-Step Instructions.
A Certificate of Free Sale in PDF format will have a new look. Exporters will need to ensure that the printed certificates are clear and legible.
A Certificate of Free Sale issued directly to the applicant is considered an original certificate, and the U.S. Department of State is able to authenticate the certificate. For each certificate, FDA will provide a unique Certificate Identifier (ID). Foreign government officials authorized by the FDA will be able use this Certificate ID to verify the authenticity of the certificate.
Any questions or concern about the Certificate of Free Sale process may be submitted by e-mail to CFSANExportCertification@fda.hhs.gov, or by phone to 240-402-2307.