Provisional Translation
| OTO No. | 397 | Classification | MHW-193 |
|---|---|---|---|
| Date of Acceptance | February 7, 1990 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Korean firm | Exporting Countries | South Korea |
| Subject | Reconsideration of the regulation on the form (capsule) for health foods. | ||
| Details of Measures | Because this product (ginseng) is a health food resembling a pharmaceutical product, it cannot be imported and sold as a food product so long as it is in soft capsules, pills, or other form that might cause consumers to mistake it. This administrative judgment is also supported by case law, and even the Supreme Court has held that whether a product is considered a pharmaceutical or not is to be determined by "general recognition", with the shape and appearance being an important factor in such recognition (see the September 27, 1982, and December 17, 1979, decision of the Supreme Court and the October 19, 1989 decision of the Hiroshima District Court). It was further replied that such regulations are also compatible with international practice, as seen, for example, in the fact that F. R. Germany and Australia consider the pill form (shape) to be an important factor in determining whether or not a product is a pharmaceutical and in the fact that Switzerland forbids the use of capsules for food products. Finally, it was replied that it would be possible to import the product as a medical product (requiring the approval of the Ministry of Health and Welfare) if all the other active ingredients except the ginseng essence were eliminated and that, conversely, it would be possible to import it as a food product if it was packaged in a different-shaped, non-medical-looking container. |
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| Classification of Processing | D | Directions | I-b |
| Remarks | |||