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

K. Umegaki, Hideko Ikeda, Kanako Yoshioka, Shiho Kito, Sumie Yamada, C. Nishijima, Takahiro Iwasaki, Koichi Shimizu
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Abstract

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
确保保健食品安全的现状、措施和问题:以日美不良事件报告制度比较为重点
摘要目的:保健食品的使用越来越多,人们对其可能造成的健康问题感到担忧。本文旨在通过与美国膳食补充剂(DS)制度的相关规定的比较,阐明日本保健食品安全保障的现状及存在的问题。方法:通过文献综述,提供了收集和评估不良事件的实际状况、产品使用情况和系统的数据。我们访问了有关主管部门,了解了美国的情况。结果:在怀疑与保健食品有关的严重不良事件中,大多数不是食品本身的问题,而是非法添加未经批准的药品成分的问题。轻微到中度的病例包括胃肠问题和过敏等不适,但没有向有关当局报告。由于病例数量少,而且难以确定症状与产品之间的因果关系,因此对报告的不良事件没有采取足够的行动。美国DS系统和日本系统在安全措施上是相似的,除了产品的强制性GMP,对经营者的严重不良事件的强制性报告,使用电子媒体的快速信息收集和信息评估。结论:应采取措施,尽可能多地收集和评价保健食品上市后发生的轻中度不良事件,防止此类事件再次发生
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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