Provisional Translation

OTO No. 221 Classification MHW-128
Date of Acceptance October 5, 1985 Ministry/Agency Receiving Complaint Ministry of International Trade and Industry
Responsible Ministries Ministry of Health and Welfare Related Laws The Pharmaceutical Affairs Law
Complainant Domestic firm Exporting Countries Indonesia
Subject Approval of import of Kumis Kutjing leaves products as a food.
Details of Measures Reply was made as follows: The distinction between drugs and foodstuffs is made judging from their ingredients and general nature, and dosage forms as well as the purpose of use, indications and effect, directions and dosage, which are indicated on labels, package inserts, etc. of products.
Import of this product as a food cannot be approved, because it is made from a plant with urination effects. In addition, it is also handled as a drug in Indonesia.
Classification of Processing D Directions I-b
Remarks

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