FFDA has revised “FFDA Guidelines for the Human Study on Functional Foods”, which was published to ensure the reliability of the human studies conducted to evaluate beneficial effects of testing functional foods by the name of “New FFDA Guidelines for the Human Study on Functional Foods”. The reason is to meet the governmental notice issued in 2014 that the two existing regulatory guidelines related to medical studies in humans be integrated into “Ethical Guidelines for Medical and Health Research Involving Human Subjects (New Ethical Guidelines; NEG)”. The aims of this amendment included: expanding the scope of covering human studies from clinical trials to epidemiological surveys; clarifying the research-related responsibility of the chief executive and principal investigator; concerned defining the role of the organization in collecting and providing specimens or information; making registration and publication of the research obligatory; strengthening the competence of the ethical review board; and others. With these backgrounds, “New FFDA Guidelines for the Human Study on Functional Foods” only covers those-human studies which evaluate efficacy of functional foods and intends to be helpful for designing and conducting appropriate and scientifically sound human studies.
Mangosteen (Garcinia mangostana L.) is cultivated in South-east Asia and people named as it ‘Queen of fruits.’ The mangosteen pericarp has been used as a traditional medicine for many years. We carried out repeated dietary dose toxicity study of the hot water extracts of mangosteen pericarp (Mangostin aqua) at dose of 0, 2, 4％ in SD rats to investigate the safety. No deaths occurred and there were no treatment related effects in clinical observation, body weights, food and water consumption, hematology, serum biochemistry and pathological examinations. Therefore, the NOAEL of mangosteen pericarp extract in the present study was assumed to be 4％ (3163 mg/kg/day for males and 3344 mg/kg/day for females).