January 17, 2022

Volume XII, Number 17

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January 15, 2022

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January 14, 2022

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FDA Publishes Export Certification Guidance

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

© 2022 Keller and Heckman LLPNational Law Review, Volume XI, Number 237
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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