III. Pharmaceuticals

3.Differentiation Between Foods and Pharmaceuticals


Q3-3

I am considering exporting a health drink made from Korean ginseng to Japan. Can I export this as a food? 

Answer

Products such as Korean ginseng, which is used as food as well as pharmaceuticals, can be subject to procedures as food under the condition that these products do not claim any drug efficacy.

(Pharmaceutical Affairs Law, Food Sanitation Law, Health Promotion Law)

1. Distinction between food and pharmaceuticals is made based on the following elements: properties of the ingredients, the purpose of use, drug efficacy, method of administration and dosage etc. indicated on its label, and an explanation made at the time of sale etc..
Products which give the impression of the thing whose purpose is drug to ordinary people are regarded as pharmaceuticals and subject to the Pharmaceutical Affairs Law.
When the products is labelled clearly as "food", shape of the product is not taken into account, in principle, when judging between food and pharmaceuticals.

2. Health drinks containing Korean ginseng are considered to be food because the ginseng may be used as food. If the label does not indicate any drug efficacy (for example, "helpful in nutritional enrichment, relief of fatigue, etc.") or method of administration or dosage (for example, "take 10 ml three times a day after meal"), it may be exported to Japan as food.