From 2012 to 2017, many adverse events, such as irregular vaginal bleeding and menstrual disorders, associated with the use of health foods containing Pueraria mirifica were reported in PIO-NET. Health foods containing P. mirifica claim mastogenic or body shaping effects, and it is for this reason that many women use these products. As a result, the Japanese government investigated and assessed the possibility of the occurrence of adverse effects associated with the use of other ingredients in health foods and labelled P. mirifica, Coleus forskohlii, black cohosh, and greater celandine as "designated ingredient, etc."The present study showed that recognition of "designated ingredient, etc." was 45.9% and that there was a difference between consumers and healthcare professionals. The prevalence of food containing P. mirifica use was 1.2%. Almost half of users experienced adverse events, such as irregular vaginal bleeding and menstrual disorder. Some subjects had a good perception towards "designated ingredient, etc.," such as "It seems effective"(32.7%) and "It seems good for health"(18.9%). After reading the descriptive text, their positive perceptions decreased.In conclusion, the recognition of "designated ingredient, etc." is insufficient. To avoid adverse events associated with "food containing designated ingredient, etc.," detailed information should be provided.
Keywords: Food Sanitation Act; Pueraria mirifica; adverse event; designated ingredient, etc.; health foods.