FDA Animal Biotechnology Case Study Webinar for Investigational Food Use Authorizations of Animals with Investigational Intentional Genomic Alterations

The U.S. Food and Drug Administration is announcing the availability of a pre-recorded webinar for developers who are interested in learning more about the process of requesting an Investigational Food Use Authorization (IFUA) for animals with investigational intentional genomic alterations (IGAs). IGAs in animals are alterations to the animal’s genome that are made using genome editing or rDNA technologies.

An IFUA permits edible tissues (such as meat, milk, eggs, honey) from animal species treated with investigational products like new animal drugs, food additives, and IGAs in animals to be used for food. The FDA will issue a letter authorizing the food use of a specific set of animals after evaluating data to identify any potential food safety hazards and ways to avoid them to ensure the safety of the edible products entering the human food chain. IFUAs are helpful to developers because they allow animals (or their products) to be used for food instead of being wasted. 

The webinar covers what an IFUA is; when it is appropriate to make an IFUA request; the types of data and information the FDA reviews in support of an IFUA request; three case study examples that cover different types of scenarios where developers of IGAs in animals might request IFUAs; and administrative procedures that developers of IGAs in animals follow when submitting an IFUA request.

If those who have viewed the webinar have questions, they may submit the questions to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov by June 30, 2023.