The Indonesian Food and Drug Administration (BPOM) has introduced more stringent oversight of health supplements containing probiotics with new guidelines that require clinical trials for certain products and expanded documentation standards. BPOM Regulation No. 17 of 2025 replaces the previous 2021 regulation and establishes a comprehensive framework for evaluating probiotic strains used in health supplements.
Assessment Requirements
The new regulation expands the scope of assessment to include not only categorization and documentation but also technical procedures, strain classification, and clinical trial requirements. Unlike the previous regulation, which provided general guidance, the updated framework creates a comprehensive system for evaluating both registered probiotic strains and new or combined strains.
Manufacturers must now submit supporting documentation covering strain identification and functional characterization, safety, efficacy, and product quality. The previous regulation required documentation only on safety, efficacy, and quality.
Clinical Trials
One of the most significant changes is the requirement for clinical trials conducted in Indonesia for applications that include benefit claims other than maintaining digestive health, or where there are modifications to benefit claims. The regulation specifies that phase 1 trials must demonstrate safety, while phase 2 trials must validate efficacy using statistically valid methods such as double-blind, randomized, placebo-controlled studies). In addition, phase 3 and phase 4 trials may be required, and postmarket surveillance data must be submitted.
Technical Assessment Framework
Annex 4, a newly introduced section, establishes technical procedures for assessing health supplements containing probiotics in Indonesia. This comprehensive framework outlines criteria for evaluating new probiotic strains, including strain identification, functional characterization, safety, efficacy, and product quality.
The annex introduces a clear classification of claims for health supplement products containing probiotics:
- General claims(e.g., maintaining digestive health).
- Functional claims(e.g., normal biological function or activity in the body).
- Risk reduction claims(e.g., lowering disease risk).
The regulation restricts use of the term “probiotic” to products containing live microorganisms with proven health benefits, using specific strains at specific doses. BPOM has included algorithms for evaluating the safety and efficacy of new strains and combinations to help standardize the review process and ensure consistency across applications.
Labeling Requirements
Health supplements containing probiotics must include the following information on their labels:
- Genus, species, and strain identification clearly stated and presented according to proper nomenclature.
- Quantity of live probiotic strains declared and demonstrated to remain stable until the end of the product’s shelf life, expressed in colony-forming units (CFUs).
- Usage instructions based on clinical trial results.
- Storage conditions if storage at a certain temperature is required.
Implications for Industry Stakeholders
Manufacturers and importers of health supplements containing probiotics should now:
- Reassess their product portfolios against the new categorization and documentation standards.
- Prepare for mandatory clinical trials in Indonesia for new strains or advanced claims.
- Ensure compliance with updated labeling requirements, including strain identification and viable count declarations.
The heightened scientific and clinical standards under BPOM Regulation No. 17 of 2025 represent a fundamental shift in regulatory expectations. Given the complexity of the new requirements, early engagement with regulatory experts will be important for maintaining market access and avoiding potential delays in product approvals.
