Functional Food Center’s vision on functional food definition and science in comparison to FDA’s health claim authorization and Japan’s Foods for Specified Health Uses

Abstract

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. Japan’s 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 FFC’s 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.Keywords: functional food definition, functional foods, FOSHU, bioactive compounds, functional food science, health claim, foods for specified health uses

The effect of amaranth oil on autoantibodies in lupus prone mice

“…It has also been shown to have hepatoprotective effects [65]. The Functional Food Center states a functional food should contain defined bioactive compounds and non-toxic dosages that provide a clinically proven and documented health benefit, utilizing specific biomarkers [66][67][68][69]. Resultantly, since our data are preliminary and based on a small sample size, we cannot definitively say whether amaranth or amaranth oil is a functional food in terms of lupus.…”

The effect of amaranth oil on proteinuria in lupus prone mice

“…In clinically proven and documented health benefit, utilizing specific biomarkers [80][81][82]. At this point, our data are preliminary, based on a very small sample size, and also clinically were not approved for lupus patients, so we are not able to claim amaranth/amaranth oil functionality in the case of lupus disease.…”

Japan’s health food industry: An analysis of the efficacy of the FOSHU system

“…FOSHU regulations have the potential to serve as a guide to the developing Food and Drug Administration (FDA) policies and give the United States the ability to carve out an official place for functional foods [2].…”

“…The process for identifying and approving a functional food according to the Functional Food Center is very similar to that of FOSHU with a few key differences (Figure 1): Mainly, the Functional Food Center believes in conducting epidemiological studies after a product is released in order to assess its effectiveness. This, along with more specific ratios and thorough instructions needed for a product and the addition of identification of biomarkers differentiates the FOSHU process from the Functional Food Center's process [2]. This can be especially important during times of pandemics when the public requires varied methods of staying healthy.…”

“…Food Center also created the Academic Society for Functional Foods and Bioactive Compounds (ASFFBC). The ASFFBC was established in order to unify the scientific and medical communityaround functional foods[2]. This is a critical step in the improvement of functional foods worldwide.CONCLUSIONSIn the past, the Functional Food Center has investigated how the FOSHU system operates in Japan, and how the Functional Food Center's vision of functional foods should be regulated in the US.However, this article dug deeper in discovering the efficacy of the FOSHU system in practice.…”