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FDA Launches Accredited Third-Party Certification Website

In November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that established a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements. Subsequently, in December 2016, FDA issued a corresponding final guidance document to facilitate compliance with the rule.

On June 21, 2017, FDA announced that the Agency has launched a website where organizations can apply to be recognized as a Third-Party accreditation body. The launch of this website effectively implements the Accredited Third-Party Certification program. Foreign governments and agencies or private third-parties may apply to be recognized as an accreditation body. The process includes a web-based application and a user fee. For additional information click here.

Accreditation bodies recognized by FDA will have the ability to accredit third-party certification bodies, also known as third-party auditors. These accredited certification bodies will, in turn, conduct food safety audits of foreign food entities and are permitted – under the rule – to issue certifications of those entities and the foods for humans and animals that they produce.  Such certifications may be used to help establish eligibility for participation in FDA’s Voluntary Qualified Importer Program (VQIP) (also established by FSMA).  In addition, such certifications may be useful in those circumstances where FDA requires that an imported product be certified to prevent a potentially harmful food from entering the U.S.

© 2020 Keller and Heckman LLPNational Law Review, Volume VII, Number 173


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...