| OTO No. | 636 | Classification | MHLW-(6) | |
|---|---|---|---|---|
| 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 | Domestic firm | Exporting Countries | USA | |
| Subject | Review of medical contents classification (L-carnitine) | |||
| Description of Complaint |
1. The complainant has intention to import health food supplies containing L-carnitine from the United States. However, as L-carnitine is treated as a content that should be exclusively used as a form of medical supply under the Pharmaceutical Affairs Law, it is not permitted to use the content for foodstuff, and the import of foodstuffs, which contain L-carnitine, cannot be made accordingly. However, L-carnitine is a natural nutrient found in milk, beef, asparagus, rice and others. Hence, to treat it exclusively as medical content is unacceptable. In view of this, the complainant requests that the L-carnitine also can be classified under a foodstuff category. Furthermore, if this 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. 2. The "extracted or otherwise chemically treated L-carnitine" mentioned in the reply of the Ministry of Health, Labour and Welfare means levocarnitine chloride, which is a substance made by artificially adding a base, or a compound artificially processed and combined. It is thus quite alien to L-carnitine, which is a natural nutrient. There is no scientific ground or rationality in disapproving the use of L-carnitine, which is a natural nutrient, for foodstuffs due to the reason that levocarnitine chloride has been approved as medical content and it has been reported as having side effects in use as medical content. L-carnitine is a natural nutrient that was found at the beginning of the 20th century. There has been no report in the world that any toxicity or side effect has been found in relation to the use of L-carnitine. Therefore, the Ministry of Health, Labour and Welfare's reply lacks scientific grounds, and is thus unacceptable. The complainant requests for the approval of using L-carnitine, which is a natural nutrient, as a foodstuff. |
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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 conventionally 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 the essential content (raw material) of product falls under medical supply. (2) This standard was reviewed in fiscal 2000 (Medical and Pharmaceutical Affairs Bureau Notice No. 243 on March 27, 2001), however, 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 "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 human 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. 2. (1) Extracted or otherwise chemically treated L-carnitine cannot be treated as foodstuffs due to reasons mentioned in the above 1 and below. However, this does not regulate foodstuffs that originally contain L-carnitine, such as milk, beef, asparagus and others, as medical supplies. 1) Extracted or otherwise chemically treated L-carnitine does not mean levocarnitine chloride. However, the complainant's opinion that the Ministry of Health, Labour and Welfare's reply lacks scientific grounds and rationality is not appropriate due to reasons mentioned in (2) 1) and 2) as well as the fact that levocarnitine chloride changes into an effective content, levocarnitine (substance identical with L-carnitine), and causes pharmacological action. 2) Under the new standard, regarding the "list of essential contents (raw materials) exclusively used as a form of medical supply," it has been determined to make additions, corrections and deletions based on scientific verification of new knowledge about safety, etc. However, the mere statement that "There has been no report in the world that any toxicity or side effect has been found in relation to the use of L-carnitine" is not considered to be a presentation of data on the safety of L-carnitine based on scientific verification (including epidemiological survey, etc.). In consideration of the reports on side effects mentioned in the above reply 1 (2) 2), it is not allowed to take L-carnitine as food without limit. (2) Therefore, the safety of L-carnitine, etc. will be considered when data based on scientific verification (including epidemiological survey, etc.) is submitted. |
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| Classification of Processing | D | Directions | I-b | |
| Remarks |
A written reply was made on April 5, 2001. An additional written reply was made on May 25, 2001. |
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