U.S – The United States Food and Drug Administration (FDA), has published a guidance document dabbed “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.

The move comes due to the constant questioning of companies exporting products from the U.S 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.

In many cases, foreign governments are seeking official assurance that products exported from the United States to their countries can be marketed in the U.S or meet specific U.S. regulations, for example, as applicable, current good manufacturing practice (CGMP) regulations.  A foreign government may also require export certification as part of the process to register or import a product into that country.

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.

Upon the request of external stakeholders, FDA might issue an export certification to facilitate export of FDA-regulated products from the United States.  

The exporter is responsible for ensuring that the export of the products to the intended destinations is in compliance with all other applicable U.S. statutes and regulations at the time of certification.

The fact that FDA has issued an export certification does not preclude FDA from taking appropriate regulatory action against an establishment or product covered by the certification.  For example, FDA might take regulatory action against an establishment or product covered by export certification if additional information about the regulatory or marketing status of the product becomes available.

Submitting false or misleading information in a request for certification, substituting a product under a certification, counterfeiting or altering a certificate, or fraudulently using a certification may violate federal law and subject those responsible to civil and/or criminal liability.

FDA issues several types of export certificates, including “Certificate of Free Sale” for human and animal food.

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.

The agency highlights that FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word ‘should’ in Agency guidance means that something is suggested or recommended, but not required.

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