- 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. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.