Indonesia Updates Assessment Guidelines for Probiotic Health Supplements

On July 18, 2025, Indonesia's Food and Drug Authority (BPOM) promulgated Regulation No. 17 of 2025, a comprehensive new framework for the assessment of health supplements containing probiotics. The regulation, which replaces the previous 2021 guidelines, introduces more stringent requirements for scientific evidence, safety, and efficacy to align with rapid advancements in the field and provide greater consumer protection.

1. A Move to Modernize Standards 

The primary goal of the regulation is to provide a clear framework for both businesses and regulators. It serves as an official guide for business operators in the manufacturing and registration of probiotic health supplements and for BPOM in its evaluation process.

A key feature is a detailed flowchart in Annex 1 that helps classify whether a probiotic product should be categorized as a medicine, a health supplement, or processed food, based on its claims and formulation. This ensures products are regulated under the appropriate framework from the outset.

2. Rigorous Scrutiny for New Probiotic Strains 

The new regulation places a strong emphasis on the scientific validation of product registration. Besides, any business seeking to register a product with a new probiotic strain or a new combination of strains must first submit it for a detailed assessment by BPOM, which is illustrated in Annex 2.

The application for registration must be supported by extensive documentation covering four key areas:

• Identification and Characterization: This includes detailed data on the microorganism's genus, species, and strain, using both phenotypic and genotypic methods. Strains must also be deposited in a national or international culture collection.

• Safety: Comprehensive safety data is mandatory, including in vitro and in vivo tests. For many new strains, a Phase I clinical trial is also required to evaluate the safe dosage range and identify potential side effects.

• Efficacy: The health benefits of the probiotic must be substantiated. This requires evidence from either a full clinical trial report or a study published in a peer-reviewed scientific journal.

• Quality: Documentation must prove the product meets all quality specifications, including the total viable count of live microorganisms through the end of its shelf life.

3. Emphasis on Clinical Evidence for Health Claims 

The guidelines establish a clear assessment pathway, distinguishing between supplements using existing, registered probiotic strains and those introducing new strains or combinations. For products introducing new strains or making health claims beyond general digestive maintenance, the regulation mandates a formal review process that can take up to 85 working days, as outlined in Article 9.

Notably, Article 10 stipulates that clinical trials must be conducted in Indonesia if a company wishes to make a new health claim or if existing clinical data is deemed insufficient for the local population. This underscores a commitment to ensuring that product benefits are verified within the context of the Indonesian public.

4. Stricter Rules for Labeling and Claims 

To enhance transparency and protect consumers, the regulation enforces strict labeling requirements for all probiotic health supplements. The product packaging must clearly state:

• The full nomenclature of the probiotic, including its genus, species, and specific strain.

• The total number of live microorganisms in Colony Forming Units (CFU) that is guaranteed to be present until the product's expiration date.

• Specific storage conditions, such as refrigeration, if required to maintain the product's stability and viability.

The new regulation took effect immediately, though existing product licenses issued under the 2021 rule will remain valid until their expiration date.