The Study of the Feasibility of Allowing the Shared Production Facilities for Dietary Supplements and Herbal Products in Thailand

Abstract

Background: The production industry for dietary supplements and herbal products in Thailand faced legal limitations regarding the co-use of manufacturing facilities. This led to increased production costs and a lack of business flexibility, particularly for small and medium-sized enterprises (SMEs) with capital constraints. Current legislation lacks clear guidelines for shared production facilities between food products and other health products, such as cosmetics, herbal products, or traditional medicines, creating uncertainty and restrictions on investment and business expansion. The strict separation of production facilities for each product type results in inefficient resource utilisation and misalignment with modern production trends that prioritise efficiency and cost reduction.

Objectives: This research aimed to define alternative models for the co-use of manufacturing facilities for dietary supplements, as regulated by the Food Act B.E. 2522 (1979), with herbal products in Thailand. It also seeks to evaluate their suitability and feasibility and to investigate regulatory approaches for such facilities to inform the development of post-licensing oversight measures.

Methods: This study was conducted between June 2024 and April 2025, utilising both documentary and qualitative research methods. Documentary research involved a comprehensive review of academic literature, domestic and international legal documents, and relevant regulations. Qualitative research included structured interviews with 11 operators of dietary supplement and herbal product manufacturing facilities who sought consultation on shared facility authorisation at the Thai FDA in July 2024. Additionally, interviews were conducted with three Thai FDA officers experienced in approving manufacturing facility layouts and overseeing post-market regulations for dietary supplements and herbal products.

Results: The study revealed that operators of dietary supplement and herbal product manufacturing facilities believed that shared production facilities for health products are feasible. This was predicated on considering the unique characteristics of each product and applying contamination prevention principles. Four main models were identified: Model 1: a shared production building with clearly separated production areas and distinct entrances/exits; Model 2: a shared production building utilising common conveyor systems but with separate production areas; Model 3: a shared building for storage, manufacturing and packaging but with separate machinery or production equipment; and Model 4: a shared building for storage, manufacturing, and packaging, including shared machinery and production equipment for food and other health products. Interviews with entrepreneurs seeking permission for shared facilities indicated that Models 3 and 4 can be implemented without increasing production costs. However, a risk assessment of the shared facility was essential to determine appropriate cross-contamination control measures. The majority of operators (72.73%) considered Model 4 to be the most suitable due to its potential for reducing costs associated with building construction, machinery, and equipment, as well as ease of maintenance and labour savings. However, Model 4 poses the highest risk of contamination, necessitating rigors risk assessment and the application of Hazard Analysis and Critical Control Points (HACCP) for dietary supplements and Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards for herbal products.

Conclusion: The authorisation of shared production facilities for dietary supplements and herbal products in Thailand was highly feasible both legally and practically, provided stringent and effective control measures are established to maintain product quality and safety. This was particularly crucial for Model 4, where storage, production, packaging areas, and machinery/equipment are shared. Operators must possess the readiness and knowledge to rigorously manage contamination risks. Therefore, clear manuals or guidelines, operator training, and pilot projects are recommended to test the effectiveness of the criteria. Furthermore, supporting the integration of licensing databases and post-licensing monitoring plans between relevant agencies is crucial for effective oversight and building consumer confidence.