The Animal Drug and Animal Generic Drug User Fee Amendments of 2018 and FDA’s Review and Approval Process for Animal Food Ingredients

By Riëtte van Laack — On August 17, FDA announced that the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 had been signed into law. As the name of the law suggests, it reauthorizes the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) programs administered by FDA. Not so obvious is that the amendment also impacts FDA’s review of animal feed ingredients. Specifically, section 360 concerns the review and approval process for animal food ingredients.  Among other things, the amendment removes Section 1002(a) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This section required FDA to establish ingredient standards and definitions with respect to pet food. Lacking a clear definition of pet food, FDA interpreted the provision broadly as to require ingredient standards and definitions for animal food ingredients. As discussed in a prior posting, FDA announced a strategy for the required…

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