Tightening Supervision, BPOM Issues New Rules For Probiotic Supplements

Head of BPOM, Cadet Ikrar (Photo: Doc. BPOM)

JAKARTA - The Food and Drug Supervisory Agency (BPOM) officially issued BPOM Regulation Number 17 of 2025 concerning Guidelines for Assessment of Health Supplement Products Containing Probiotics (PerBPOM 17/2025).

This regulation is stipulated on June 23, 2025 by the Head of BPOM, Ikrar Cadets, and at the same time revokes the BPOM Regulation Number 17 of 2021 which previously regulated the same thing.

The issuance of this new regulation is a form of BPOM's commitment to present adaptive regulations for the development of science and technology.

The Head of BPOM, Taruna Ikrar, explained that this regulation was prepared to provide clearer technical guidance for business actors and BPOM evaluators in assessing probiotic-based health supplement products before being given a distribution permit.

Probiotics themselves are health supplements with different characteristics of products in general, because they contain active ingredients in the form of living microorganisms.

"We see an increasing trend of probiotic use in health supplements. Therefore, relevant and implementative regulations are needed. This regulation is a more targeted guideline to ensure the safety, benefits, and quality of products," said Taruna, quoted from the official BPOM website.

Probiotics are defined as living microorganisms which, when consumed in adequate quantities, can provide health benefits for consumers.

Therefore, its use in supplements, especially to maintain digestive health, must go through a strict assessment. The assessment includes the identification of strains, safety tests, test benefits, and fulfillment of quality standards.

Business actors are required to conduct an independent assessment of the products to be registered. This applies to either the use of registered probiotic strains or new strains or new combinations.

If using a new strain, business actors need to apply for a review by attaching supporting documents, including clinical trial results data, especially if product benefit claims exceed digestive health care.

"BPOM is a strategic partner of industry players. With this guideline, the registration process becomes more structured, efficient, and still prioritizes consumer protection. We not only supervise, but also encourage the growth of a healthy and responsible supplementary industry," said Taruna.

This new regulation also provides space for BPOM to reassess products that already have a distribution permit, if there is a development of science that has an impact on safety or benefit. However, products that have obtained distribution permits before this rule is valid will still be recognized until the expiration date ends.

Taruna Ikrar emphasized that this regulation is part of BPOM's strategy in building a science-based surveillance system and encouraging the competitiveness of domestic health supplement products.

"We want to build an industrial ecosystem that is able to compete at the global level, without neglecting the quality and protection of public health," he said.

With the implementation of PerBPOM 17/2025, BPOM hopes that the industry can more easily understand the product registration and evaluation path. The distribution permit process is expected to run more efficiently without ignoring consumer protection aspects.

"This regulation provides a more definite direction for business actors in developing probiotic-based health supplement products. On the other hand, the community also gets assurances for the safety and benefits of the products consumed." he continued.

BPOM urges all business actors to immediately adjust the registration process according to the latest provisions and ensure that all products in circulation meet the established standards.