FDA recently published the guidance document “FDA Export Certification: Guidance for Industry,” which is intended to provide a general description of the FDA’s export certification to industry and foreign governments. Companies exporting products from the US are often asked by foreign customers or governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act and other statutes administered by the Agency.

FDA export certification provides information concerning a product and/or establishment’s regulatory or marketing status, based on available information at the time FDA issues the certification (including attestations provided by the person seeking the export certification). For some Agency Centers, if a product has received approval or clearance from FDA, it is indicated on the export certification and/or a copy of approved labeling is appended, as appropriate. FDA issues several types of export certificates, including “Certificate of Free Sale” for human food, animal food/drugs, and cosmetics, “Health Certificate,” “Certificate of a Pharmaceutical Product,” “Non-Clinical Research Use Only Certificate,” “Certificate to Foreign Government,” and “Certificate of Exportability.”

This guidance supersedes previous versions that were issued in July 2004, April 2005, and February 2019. The FDA is accepting comments on the guidance document electronically via docket ID: FDA-2013-S-0610.