Abstract

Health claims and their regulations have been a contended topic globally with varying degrees of standardization. Japan is one of the most advanced countries in terms of their view on the regulation of health claims and their role in the food industry. With the introduction of functional foods in 1984, Japan put health claims to use by informing consumers of specific health benefits of food products marketed and sold to them, while also cutting down on inflated and false claims made by food manufacturers. This was done with the establishment of Foods for Specified Health Uses (FOSHU) a few years later. Although extremely strict and sometimes problematic, the FOSHU system has served as a model of what functional foods could be if given the chance. Regulations in the United States differ in their beliefs that health claims should be approved based on a disease-food relationship rather than on an individual product basis. This, along with the lack of definition for functional foods, leads to a poorly organized health food sector in the United States. FOSHU is highly regarded and well trusted in Japan; so much so that FOSHU products and packaging helps promote non-FOSHU products with similar appearance. Yet, despite the system’s tightly controlled mechanism, its efficacy and comprehensiveness to the average consumer has come under question. Due to tight regulations and the high costs and long wait times of developing FOSHU products, many small businesses find it difficult to apply for them. Subsequently, this trickles down to consumers and inhibits lower-income populations from purchasing these products. Additionally, the effectiveness of FOSHU products outside of a clinical setting has come into question from the scientific community. Factors including poor consumer education regarding FOSHU, as well as clinical settings that do not mimic the daily life of consumers have produced unsatisfactory results in the general public. Keywords: FOSHU, Health Claims, Functional foods, After market research, Clinical setting, functional/active ingredient, FOSHU seal

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