A risk-based framework for identifying halal critical points in traditional medicines and health supplements

Abstract

Traditional medicines and health supplements combine ingredients, excipients, processing aids, and shared facilities whose origins and production histories can complicate halal assurance. This study aimed to identify halal critical points across the product life cycle and develop an expert-informed, risk-based verification framework. A qualitative descriptive design combined one semi-structured in-depth interview with each of five purposively and snowball-recruited experts during 2025 – 2026 with targeted document analysis. The team expanded written field notes into structured summaries. A retrospective inventory of the cited documentary corpus identified 18 substantive journal articles and 20 official documents; methodological references were classified separately. The document component supported triangulation and was not a systematic review. Reflexive thematic analysis identified five interdependent domains: material origin; process inputs and processing aids; formula and dosage form; facility and cleaning control; and evidence continuity and traceability. High-priority concerns included animal derivatives, dual-source glycerol and stearates, ethanol, fermentation inputs, capsule shells, compound formulations, uncontrolled alternatives, rework, and shared facilities. Informants emphasized that laboratory testing is question-specific and cannot replace supplier transparency, formula reconciliation, or batch traceability. The proposed framework distinguishes inherent from residual priority and directs verification toward gaps that could change halal status. It can inform halal-by-design, supplier approval, and change control while keeping halal decisions distinct from safety and quality assessment. Further validation is required before standardized application.

Keywords: Halal audit, Halal critical points, Health supplements, Traceability, Traditional medicine.