60 Aafco Approval and Regulatory Process for Novel Ingredients

Abstract

Abstract In this presentation, we will explore different pathways in the regulatory approval process. There are three routes that individuals or companies can take to gain approval for an ingredient in a target species. The most common and rigorous of the three is the AAFCO Ingredient Definition process, which takes at least 18 months from start to finish. This process involves a six-month FDA review period of safety data generated in a target species, gathered after feeding a range of inclusions of the target ingredient. Additionally, manufacturing and analytical data are required for this process. After FDA review, there is a minimum of one year for review by the AAFCO ingredient definition committee and general membership. The second regulatory route we will discuss is Generally Recognized as Safe (GRAS). This route can be shorter but will require similar safety data and an assessment by an expert panel is recommended. FDA review of the GRAS panel findings is necessary for listing in the AAFCO original publication as GRAS. Finally, we will discuss the GRAS self-determined pathway. This does not require FDA review but entails state-by-state registration of products. This pathway will still require safety, analytical and efficacy data to support the product registration with each state.