The Ministry of Health, Labour and Welfare (MHLW) held a closed working group on June 26, 2023, specifically focused on the "Drug List and Non-drug List." ChemLinked learned from its post-meeting documents that the MHLW is exploring regulatory requirements for melatonin and considering restructuring lists.
1) Concerns about Melatonin as a non-drug ingredient
Melatonin, a hormone, is used as a prescription pharmaceutical in Japan. In some other countries, there have been reports of health-related adverse effects potentially linked to nutritional supplements containing melatonin. Considering that it contains ingredients equivalent to prescription pharmaceuticals, it requires regulation from health and hygiene perspective. Therefore, it is deemed appropriate to primarily restrict its use to prescription drugs.
Additionally, reports on repetitive administration toxicity tests in rats have indicated occurrences of hepatomegaly and thyroid enlargement. Concerns were also discussed regarding the long-term effects of Melatonin transferring to non-drug use, impurities derived from the manufacturing process of melatonin, and potential chemical structures of decomposed byproducts expected to be present in the formulations, which may be mutagenic.
2) Listing method for non-drug ingredients (plant origin)
Currently, the non-drug list (plant origin) presents in the order of "name," "alias," "parts," and "remark." Due to the concerns regarding duplication of varieties and the confusion regarding the original plants, a proposal is put forth to enhance the clarity of varieties by adding the "scientific name" (Latin name) directly after the "name."
The "name" field indicates the Japanese name, while alias and herbal names are listed under "alias". However, for food ingredient whose herbal name is considered illegal, it should be marked with the plant name. If there is no Japanese name available, the scientific name in katakana will be used as the name. Additionally, in cases where the plants listed under "name" and "alias" refer to different plants, the MHLW proposes to separate and list them individually. For example:
Before | After | |||||||
Name | Alias | Part | Remark | Name | Scientific name | Alias | Part | Remark |
ブラッククミン | ニゲラ | Whole plant | / | ブラッククミン | Nigella sativa L. | ニオイクロタネソウ | Whole plant | / |
クロタネソウ | Nigella damasce na L. | ニゲラ | Whole plant | / | ||||
In Japan, oral products are divided into two categories: "pharmaceuticals" and "foods," with the key difference of the ingredients. Due to regulatory differences among countries, imported health supplements that contain pharmaceutical ingredients approved in Japan may be considered unapproved/unpermitted pharmaceutical products. Properly using the "Drug List and Non-drug List" can assist enterprises in entering the Japanese health supplement market more smoothly.
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