Indonesia National Agency of Drug and Food Control (BPOM) issued Regulation Number 6 of 2025, which outlines new guidelines for stability testing of health supplements in Indonesia to ensure quality and protect public health. The regulation became effective on 20 March 2025.

This regulation is relevant to any company involved in the production, distribution, or export of health supplements within Indonesia. It aims to standardize and enforce quality control for health supplements through rigorous stability testing. The key points of the regulation include:

1. Purpose: Establishes guidelines for stability testing to confirm the shelf-life and quality of health supplements, protecting consumers from substandard products.

2. Definitions:

     a. Health Supplements are materials or preparations that are intended to complement nutritional needs, maintain, enhance, and/or improve health functions, have nutritional value and/or physiological effects, and contain one or more ingredients in the form of vitamins, minerals, amino acids,                   and/or other non-plant ingredients that can be combined with plants.

    b. Stability Testing is the testing of finished products of Health Supplements in accordance with the Stability Testing protocol to determine or confirm the shelf-life of finished products of Health Supplements.

    c. Business Actors are business entities, both incorporated and unincorporated, established and domiciled within the Unitary State of the Republic of Indonesia jurisdiction, both alone and together1 in organizing business activities in the Health Supplements sector.

3. Guidelines:

•  Serve as a reference for business actors to ensure product quality before distribution and for the National Agency of Drug and Food Control tin assessing the implementation of stability testing conducted by Business Actors as part of the health supplement registration process.
•  Cover stability testing design, evaluation, and labeling statements, detailed in an appendix.

4. Testing Facilities: Must be conducted in accredited laboratories or internal industry laboratory with good manufacturing practice certification.

5. Transition Period: Business actors conducting stability testing before the regulation must comply within one year of its promulgation.

6. Legal Continuity: Provisions from prior regulations (e.g., Regulation Number 32 of 2022, as amended) remain valid if not conflicting with this regulation.

To know more about the said regulation, please refer to this link (unofficial translation): https://bit.ly/Indonesia-GuidelinesForStabilityTestingofHealthSupplements

For questions and clarifications, please contact Philippine Trade and Investment Center-Jakarta at jakarta@dti.gov.ph and/or the DTI-EMB Market Division at marketdivision@dti.gov.ph.

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