2nd Report of the Market Access Ombudsman Council (March 14, 1995)

2-(2) Abolition of handling health foods made from natural herbs as drugs

1. Complainant: American Chamber of Commerce in Japan

2. Ministry concerned: Ministry of Health and Welfare

3. Complaint:

Under Pharmaceutical Affairs Law, "drugs" are defined as:
* substances included in the Japanese Pharmacopoeia
* substances used for diagnosing, treating or preventing disease in humans or animals
* substances intended to have an effect on the bodily structure or function of humans or animals.
From the viewpoint of clearly distinguishing between drugs and foods and of controlling drugs not approved or permitted, the Director of the Ministry of Health and Welfare's Pharmaceutical Affairs Bureau has issued a list setting out standards for the scope of drugs and giving specific examples of ingredients.

In order to manufacture, import or sell substances classified as drugs, under the Pharmaceutical Affairs Law it is necessary to obtain approval to manufacture (import) and permission to manufacture (import and sell) these.

The complainant states that health foods made from 100% natural herbs which are sold in other countries as foods are regulated under the Pharmaceutical Affairs Law because they are handled as drugs in Japan and raises the following complaints because this in effect prevents their sale.

(1) That the scope of natural herbs which can be sold as foods be expanded

(2) That some natural herbs are handled as drugs when they are sold in capsule or tablet form even though they can be sold as foods in other cases, and that all such herbs, regardless of format, should be allowed to be sold as foods.

4. Results of deliberation:

The ministry concerned is undertaking a gradual review of its list concerning which substances should be classified as drugs, given changes in consumers' attitudes toward drugs caused by diversification of the daily diet, changes in the use of foods as drugs and others. Taking this complaint, which points out differences in the systems of other countries in terms of scope of drugs, into full consideration, access of products which are already distributed as foods in other countries to the Japanese market should be facilitated.

Doing this will necessitate decisions on all individual ingredients, and given the complaint received, views should be exchanged with the complainant at an early date, so that a solution satisfactory to the complainant concerning handling of the products, which the complainant will indicate, involved can be reached as quickly as possible.

Government decision (March 28, 1995)

2-(2) Review of the definition of the pharmaceuticals

As the daily diet has diversified and the use of herbal products as medication has changed, ordinary consumers' recognition for pharmaceuticals have changed. Based on these changes and taking differences in systems among countries into full consideration as well, the classification list of substances indicating whether to be treated as pharmaceuticals or not will be reviewed in turn.

Follow-up (May 27,1996)

2-(2) Abolition of handling health foods made from natural herbs as drugs

The current regulations on shape (dosage from) and labeling for herbs will be relaxed as much as possible in FY1997 so that products distributed and sold normally as food products will not be regulated as drugs but be allowed into the market as food products.