The aging population and skyrocketing medical costs are an urgent problem in some countries, which necessitates the prevention of diseases and postponement of disease progression with non-medical means. Functional foods are those that exhibit beneficial effects on human health and play a vital role in supporting part of normal diets. In order to produce functional foods with safe and effective active compounds, it is necessary to define functional foods and to identify the bioactive compounds, the mode(s) of action, and the proper daily dosage. Furthermore, functional foods should undergo a neutral evaluation by an independent organization to ensure only safe and effective products will be released to the market. Japans Foods for Specified Health Uses (FOSHU) approval system will be described in this review as an example in which individual functional foods are evaluated with numerous criteria by a governmental agency. Whilst the Food and Drug Administration (FDA) evaluates and authorizes health claim petitions, a definition of functional foods and a distinct functional food category are lacking in the U.S.. The Functional Food Center (FFC) has been supporting functional food scientists worldwide through research and the publishing of numerous educational materials on functional foods. Thus, the FFC and the Academic Society for Functional Foods and Bioactive Compounds (ASFFBC) can and are willing to help the FDA and other governmental agencies establish the category of functional foods and the field of functional food science, which needs to be highly collaborative and multidisciplinary. This review will also describe the current health claim authorization by the FDA and the FFCs vision on the definition of functional foods, bioactive compounds, and the establishment of functional food science that will eventually contribute to human health and well-being in the US and across the globe.