You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

October 15, 2025

Indonesia Strengthens Guidelines for Health Supplements Containing Probiotics

Subscribe to Updates

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.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

December 9, 2024
Cambodia’s Law on Seed Management and Plant Breeder’s Rights was enacted in 2008, but it was not until recently that new plant varieties could successfully be registered for protection in the country. Although the law has been in place for some time, recent developments confirmed the application process and a schedule of charges for the registration of new plant varieties. With these developments, breeders have been able to register their new plant varieties in Cambodia since March 1, 2024. Applicants for new plant variety protection must be Cambodian nationals, foreign nationals domiciled in Cambodia, or permanent residents of either a country that is a contracting party to the International Union for the Protection of New Varieties of Plants (UPOV) Convention or a country with which Cambodia has signed a memorandum of understanding on plant variety protection. Applicants can also claim a priority date from the first application for the same plant variety filed in any contracting party of the UPOV Convention within 12 months of the earliest application’s filing date. To be eligible for protection, new plant varieties must satisfy the following criteria: Novelty: A variety is considered “new” if, at the date of filing the application for new plant variety protection, it has not been sold, marketed, or otherwise disposed of others—by or with the consent of the breeder—for more than: One year for any plant variety in Cambodia; Six years for trees and vines or four years for all other plant varieties in countries besides Cambodia. Distinctiveness: A variety must be clearly distinguishable from any other existing varieties. Uniformity: A variety must be sufficiently uniform in its relevant characteristics. Stability: A variety must remain unchanged in its essential characteristics at the end of each cycle of propagation and in each generation. The last three criteria are often
Read More
December 4, 2024
On October 28, 2024, Indonesia officially amended its existing Patent Law when the president ratified Law Number 65 of 2024. This comprehensive update—the third such amendment in the history of Indonesia’s Patent Law—introduces several key changes that will significantly impact patent protection and application processes in Indonesia. Key highlights and changes are outlined below. Definition of Invention The new law broadens the definition of “invention” to explicitly include systems, methods, and uses. Additionally, the law introduces formal definitions for traditional knowledge and genetic resources. Patentability Criteria Notable changes include: Computer programs are now excluded, with an exception for computer-implemented inventions. Theories and methods in science and mathematics are added to the list of excluded inventions. Previous restrictions on new uses of existing products are removed. Grace Periods The grace periods for some patent-related actions have been adjusted: The grace period for disclosures has been extended to 12 months (from 6 months previously), providing inventors with more flexibility in filing patent applications after initial disclosure. A newly introduced item is the grace period for a conventional patent application claiming priority rights, which is 4 months after the 12-month filing deadline under the Paris Convention. The grace period for annuity payments is 6 months (from 12 months previously) with a fine for late payments of 100% of the annual fee payable. Patent Holder Rights and Obligations Patent holders can now grant permissions to enforce patents. There is a new requirement for patent holders to submit annual statements on patent implementation in Indonesia. Compulsory Licensing Significant changes to compulsory licensing include: Establishment of licenses based on the principle of expediency. Limitations on license scope and transferability. Prioritization of domestic market needs. New provisions for technical improvements and economic significance. Government Patent Exploitation The new law contains specific provisions for the government’s implementation
Read More
December 4, 2024
Thailand Legal Basics, a valuable primer for foreign investors, explores all aspects of living and doing business in Thailand. Written by specialists at Tilleke & Gibbins in Bangkok, it is the only comprehensive English-language guide to the Thai legal system with a focus on the concerns of foreign business and investment.
Read More
December 2, 2024
Kratom (Mitragyna speciosa) was once listed as a prohibited substance under the Narcotics Act. Kratom was then removed from the narcotics list in 2021 and is now regulated under the Kratom Plant Act B.E. 2565 (2022), which allows the trading, use, import, and export of kratom. Furthermore, the Ministry of Public Health has allowed the use of kratom in food and drink, food supplements, and herbal products. Anyone who wishes to launch kratom food or herbal products must first obtain a product license from the Thai Food and Drug Administration (FDA). On September 4, 2024, the Thai FDA announced guidelines specifically for powdered kratom leaves and kratom leaf extracts (using water or ethanol as solvents) as ingredients in food supplements. These guidelines aim to provide business operators with a clear framework for launching kratom-based food products in Thailand. Key points from these guidelines include: Raw material specifications and standards: Powdered kratom leaves and kratom leaf extracts must contain at least the prescribed amount of mitragynine (one of the primary active compounds in kratom) as a marker of quality. For example, mitragynine must account for at least 1% by mass for powdered kratom leaves. Food supplement specification and standards: Food supplements containing powdered kratom leaves or kratom leaf extracts must not have a dosage of over 0.2 mg/day of mitragynine (including 7-hydroxymitraglynine, which may occur naturally), or 1 mg/day for food supplements containing kratom extracts that use water as a solvent. Addition of 7-hydroxymitraglynine to food supplements is prohibited. Mitragynine content in food supplement products must not exceed the specified dosage limit. Additionally, the food supplement product must be in a ready-to-eat form (e.g., liquid, gel, tablet, or capsule). If powdered kratom leaves or kratom leaf extracts are to be used as ingredients in food categories other than food supplements,
Read More