There are many factors considered when commercializing a probiotic product. Market driven, innovative probiotic products are everywhere, focused on a variety of wellness benefits for many stages of life. Where does a regulatory strategy become implemented within the development process of these products? The answer to this question can truly determine the long-term possibilities of success of a probiotic product, especially as the scope of next-generation microbes and products progress to incorporate microbiome discoveries. Let’s discuss the appropriate regulatory considerations at each stage of product development and commercialization.