Evaluation of Safety Information of the Foods with Function Claims Based on Adverse Event Reports in Information System on Safety and Effectiveness for Health Foods Database

Foods with Function Claims are allowed to label health claims based on scientific evidence evaluated by the manufacturers. To prevent health problems caused by inadequate use, the manufacturers should label proper safety information. To evaluate whether safety information is sufficiently provided, we conducted the adverse event review focused on popular functional ingredients using the database; Information system on safety and effectiveness for health food. The data suggested that causal factor of adverse events related to products containing soy isoflavone, ginkgo biloba extract and docosahexaenoic acid/eicosapentaenoic acid were overdose intake, concomitant use with certain medicines, and use by whom with an allergic predisposition. However, the safety information on the label was insufficient to prevent adverse events on each products' label. It is important not only to encourage food manufacturers to provide sufficient information based on safety review, but also to inform consumers about adverse events.