Indonesia BPOM Mandates Risk Assessment for Raw Materials in Health Supplements

On October 3, 2025, Indonesia's National Agency of Drug and Food Control (BPOM) enacted Regulation No. 26 of 2025 on Risk Assessment for the Use of Raw Materials in Natural Ingredient Medicines, Health Supplements, Quasi-Drugs, and Certain Cosmetic Preparations. The regulation, which came into effect immediately, introduces a mandatory risk assessment framework to ensure the safety and quality of raw materials used in these products.

This move is a direct response to the tragic intoxication crisis linked to Ethylene Glycol (EG) and Diethylene Glycol (DEG) contamination in 2022. The incident led to a devastating spike in acute kidney injury cases and numerous deaths, highlighting the critical need for stricter controls over product ingredients.