Provisional Translation
| OTO No. | 635 | Classification | MHLW-(5) |
|---|---|---|---|
| Date of Acceptance | March 19, 2001 | Ministry/Agency Receiving Complaint | Cabinet Office |
| Responsible Ministries | Ministry of Health, Labour and Welfare | Related Laws | Pharmaceutical Affairs Law |
| Complainant | The Embassy of Switzerland (Proxy complaint) | Exporting Countries | Switzerland |
| Subject | Review of medical contents classification (L-carnitine) | ||
| Description of Complaint | The Swiss chemical manufacturers have been manufacturing and selling L-carnitine, which constitutes dietary supplements, infant foodstuffs, sport drinks, etc., in European countries and America. However, in Japan, L-carnitine is regulated as content that should be exclusively used as a form of medical supply under the Pharmaceutical Affairs Law. Thus, substances including L-carnitine fall under medical supplies. It is not allowed to use content that should be exclusively used as a form of medical supply for food, so food containing L-carnitine cannot be imported into Japan. The Ministry of Health, Labour and Welfare has proposed evaluation standards for medical contents classification in the "Handling of Essential Contents (Raw Materials) under Medical Contents Classification" in August 2000. At present, the ministry is examining the review of medical contents classification. In Japan, L-carnitine was approved as a cure for infants who have contracted congenital disease whereby L-carnitine cannot be produced within the body. In view of this development, there is a high possibility that L-carnitine will be treated as a form of medical supplies in the review as it has been originally intended. In terms of humans, however, L-carnitine is an in vivo substance produced mainly in the liver, which exists naturally. Therefore, looking at its medical status in foreign countries, L-carnitine is treated as food in many countries. For instance, in Switzerland, it is treated not as a medical supply but as a health food supplement though a maximum intake is specified. In Germany, L-carnitine contained in foodstuffs is considered as a natural substance, and no special regulation exists to regulate such foodstuffs. In view of this, it is suggested that L-carnitine is also treated as a form of foodstuffs in consideration of such foreign treatments. Furthermore, if the above suggestion is difficult to achieve, the complainant requests for the provision of scientific reasons for considering L-carnitine to be treated exclusively as a form of medical supply under the Pharmaceutical Affairs Law. |
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| Details of Measures | 1. The ministry replied as follows: Extracted or otherwise chemically treated L-carnitine cannot be classified as foodstuffs based on the following reasons. (1) Extracted or otherwise chemically treated L-carnitine has been treated as a form of medical supply based on the "medical classification standard" contained under the Pharmaceutical Affairs Bureau Notice No. 476 dated June 1, 1971, which is a standard for determining whether essential contents (raw materials) of products fall under a form of medical supply. (2) This time, public comments on the "medical classification standard" were solicited for one month starting from August 11, 2000, and based on these comments, various experts discussed the issue. As a result, the following reviews were made: whether an essential component of a product falls under a form of medical supply shall be determined based on 1) the actual condition of use in the form of medical supply and 2) its toxicity, narcotics or amphetamine contents (Pharmaceutical Affairs Bureau Notice No.243, March 27, 2001). (3) Even under the new standard, L-carnitine falls under "component exclusively used as a form of medical supply," in the same way as febrifuge or anodyne, hormones, antibiotics and digestive enzymes, and is treated as an "essential content (raw material) exclusively used as a form of medical supply" for the following reasons: 1) L-carnitine is an effective medical content approved in Japan, and its effectiveness and safety as a medical supply has been recognized based on scientific data (grounds) achieved through therapeutical trials on humans under the approval system based on the Japanese Pharmaceutical Affairs Law; 2) Its use as a medical stuff has been noted to cause digestive disorder (diarrhea, soft stool, etc.), face edema, bloody urine, anemia as well as other side effects; 3) Its actual use as a form of foodstuff has not been known in our country. (4) However, anything containing L-carnitine as a natural substance is not regulated as a medical supply. (5) Even if a substance is contained in food, the reason that the substance has originated from food should not be adopted to allow its extracted or otherwise chemically treated version to be taken in as food unlimitedly. (6) "The list of essential contents (raw materials) that are exclusively used forms of medical supplies" has been regularly reviewed based on scientific grounds including new views on safety. Additions and corrections to and eliminations from the list are implemented almost annually. We ask the complainant to submit scientific data (including epidemiological research data) on safety in consideration of reported side effects as specified in (3) 2). 2. Later Measures (1) The ministry received and examined the data as submitted by the complainant. (2) At its 31st meeting on November 11, 2002, the Market Access Ombudsman Council (MAOC) decided to deliberate on the "review of medical contents classification." (3) Under a notice by the Director of the Pharmaceutical Affairs Bureau on November 15, 2002, L-carnitine was eliminated from "the list of essential contents (raw materials) that are exclusively used forms of medical supplies" and added to "the list of essential contents (raw materials) that are not considered to be medical supplies unless their medical effect-efficacy is pursued." (Pharmaceutical Affairs Bureau Notice No.1115003, November 15, 2002, on "Partial Revision to Medical Classification Standard") (4) On November 26, 2002, the matter was deliberated on at the first meeting of MAOC experts for fiscal 2002. (5) Under a notice by the Director of the MHLW Food Safety Department Standards Division on December 25, 2002, L-carnitine was permitted to be distributed immediately without its designation as a food additive even if it was to be used as a food additive. (Food Safety Department Standards Division Notice No. 1225001 on "Revision to Treatment of List of Essential Contents (Raw Materials) That Are Not Considered to Be Medical Supplies Unless Their Medical Effect-efficacy Is Pursued") |
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| Classification of Processing | A | Directions | I-b |
| Remarks | A written reply was made on April 5, 2001. The matter was deliberated on at the first meeting of the MAOC experts for fiscal 2002 on November 26, 2002. |
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