Background According to the Codex Alimentarius of the foods with health claims (FHCs), two major factors play a significant role in the ability for consumers to select functional foods and utilize them appropriately for health maintenance (Codex Alimentarius, 1997). These are: 1) food labeling based on scientific evidence that consumers are able to understand; and 2) standardized criteria for obtaining scientific evidence. Scope and approach We discuss the regulatory system for foods with health claims in the world and the need for consumer science and regulatory science research through reviewing the history and recent topics about the regulation on FHCs in Japan. Key findings and conclusions There are some differences in regulations on FHCs among countries participating in the Codex, which have been said sometimes to cause some troubles. These are: 1) despite of the lack of renewal system, Japan experienced the first revocation event regarding the approved Foods for Specified Health Uses category of FHCs in 2016; and 2) global export barriers. Therefore, the introduction of mutual recognition rules among countries has been desired in Japan for further international harmonization. However, its feasibility seems to be low because of the complexity caused by such differences on regulations among countries. When it happens, we expect that the global regulatory climates on FHCs may be better regulated by involving neutral academic researchers and the trained experts in the field of consumer and regulatory science of functional foods. As Japan is the first country to establish the FHCs regulatory system in the world, it should lead to discuss the introduction of mutual recognition rules with other countries immediately.
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