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FDA Issues Updated Guidance on Antimicrobial Agents Used in Food Applications

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The U.S. Food and Drug Administration (FDA) issued a new version of its Guidance for Industry: Microbiological Considerations for Antimicrobial Agents Used in Food Applications (September 2021). This guidance replaces a previous guidance on this topic that was issued in September 2007 and revised in June 2008. 

The updated guidance includes information on what data and information should be included in generally recognized as safe (GRAS) notices, in addition to food additive petitions (FAPs), food contact notifications (FCNs), and threshold of regulation (TOR) exemption requests to demonstrate that an antimicrobial agent achieves it intended technical effect in or on food or food contact articles. The reference to GRAS notifications was added to the most recent version of the guidance.

The guidance also addresses the statutory authority of FDA—and other agencies—with respect to antimicrobial agents used in food or in contact with food. A detailed discussion on the regulation of antimicrobials in food packaging, including a brief history and clarification of the jurisdictional divisions of the regulation of antimicrobials, can be found here.