Pharmaceutical products are intended to treat a person's disease and affect life, health directly. Therefore "Pharmaceutical Affairs Law" is established to prevent damage to health that is dripped by the use for the purpose of securing quality, the effectiveness of pharmaceutical products and safety.
"It is intended that we plan improvement of hygiene by this law performing necessary regulation for quality, effective and safe securing of pharmaceutical products, unregulated drug, cosmetics and medical equipment, and taking measures about regulation of designated drug, and the particularly need taking necessary measures for promotion of research and development of high pharmaceutical products and medical equipment in medical care." (Pharmaceutical Affairs Law Article 1)
In this law, it is set of pharmaceutical products as follows.
1.Thing which is put in Japanese Pharmacopoeia
2.Is thing intended that is used for diagnosis, treatment of illness of people or animal or the prevention, and machine appliance, dental material, medical care article and sanitary protection (say "machine appliances" as follows.) We do not appear (we remove unregulated drug.)
3.It is thing intended to have an influence on physical structure of people or animal or function and is not machine appliances (we remove unregulated drug and cosmetics.) (Pharmaceutical Affairs Law Article 2 Paragraph 1)
We correspond whether thing taken in from entrance is pharmaceutical products and which of food. Of these, only thing which does not correspond to pharmaceutical products is considered to be food. We set food in the food hygiene law as follows.
"Food means all food and drink. But pharmaceutical products prescribed in Pharmaceutical Affairs Law and unregulated drug do not include this." (food hygiene law Article 4 Paragraph 1)
Originally health food is not medicine. It is just food. It did not have to be aimed for treatment of illness. Health food has many things which assume things used as folk medicine raw materials, and we check effect, effect, dose and safety for a person's disease in detail, and there are none. There is person who worked well, but it is thought that psychological effect acts a lot. However, there is thing that thing which we can expect use of health of in bifidus bacteria and oligosaccharides, the eating habits including mineral understood recently. The nutrition improvement method was revised in 1990, and new category called new "food for specified health use" was established in that (we mention later in detail).
When we are going to show we are suitable for special uses such as the one for sick for expectant mothers for infant for baby/infant, permission of Ministry of Health, Labour and Welfare is necessary. It is street of figure 1 about classification of use food especially. Thing which received permission has mark that we showed in figure 2 each.
Because of food to offer for sale, person who is going to display that we are suitable for special uses such as the one for sick for expectant mothers for infant for baby/infant must receive permission of the Minister of Health, Labour and Welfare.
(Health Promotion Act Article 26 Paragraph 1)