Current Status, Measures, and Issues in Ensuring the Safety of Health Foods: Focus on a Japan-US Comparison of Adverse Event Reporting Systems

Innovation, Health and Nutrition  ABSTRACT Objective: The increasing use of health foods has led to concerns about the possible health problems it could create. This review aims to clarify the current status and problems in ensuring the safety of health foods in Japan by comparing it with the measures prescribed for dietary supplement (DS) systems in the US. Methods: A literature review provided data on actual status, usage of products, and systems for collecting and evaluating adverse events. Information on the situation in the US was obtained by visiting the concerned department in charge. Results: The majority of severe adverse events suspected to be related to health foods was not attributed to the foods themselves, but to unapproved pharmaceutical ingredients added illegally to them. Minor to moderate cases involved discomforts such as gastrointestinal problems and allergies, which were not reported to the concerned authorities. Not enough action was taken on the reported adverse events owing to the small number of cases and the difficulty in determining the causal relationship of the symptom with the product. The US DS system and the Japanese system are similar in terms of safety measures, except for the mandatory GMP for products, compulsory reporting of severe adverse events to business operators, quick information collection using electronic media, and evaluation of information. Conclusions: Measures should be implemented to collect and evaluate as many cases of minor to moderate adverse events as possible, which have occurred post marketing of the health foods, to prevent recurrence of such