BPOM Stability Testing for Health Supplements: What Businesses Must Know

The Indonesian Food and Drug Authority (BPOM) has taken a decisive step to improve the quality assurance of health supplements by issuing BPOM Regulation No. 6 of 2025. This new regulation mandates that all health supplement products undergo stability testing before being distributed, ensuring their safety and efficacy throughout the declared shelf life.

This regulation aligns Indonesia’s standards with the ASEAN Guideline on Stability Study and Shelf-life of Health Supplements (Annexe V). It’s a significant move for manufacturers and distributors, signalling that compliance is not optional—it’s essential.

Key Takeaways

1. BPOM Regulation No. 6/2025 mandates stability testing for all health supplements.
2. Shelf-life must be scientifically validated and tested under ASEAN-standard conditions.
3. A 1-year transition period applies to products tested before the new regulation.
4. Businesses risk losing distribution permits or facing legal sanctions if they fail to comply.

What the Guideline Covers

BPOM’s regulation provides detailed technical instructions for businesses, focusing on three key areas:

• Stability Testing Design: Clear protocols for long-term (real-time) and accelerated studies, specifically under ASEAN climate zone IV B conditions (30ºC / 75% RH).
• Result Evaluation: Scientific analysis of stability data to validate the shelf life.
• Labelling: Ensuring shelf-life claims on product packaging match tested stability.

Testing must be performed at:

• An officially accredited facility, or
• An internal industry lab certified with Good Manufacturing Practice (GMP).

If testing occurs in different conditions (e.g., 30ºC / 65% RH), scientific justification is required to support the declared shelf life.

Adjustment & Transition Period

If companies previously conducted stability tests under older guidelines, they must adjust their procedures to comply with BPOM Regulation No. 6/2025. This adjustment must occur within one year of the regulation’s issuance on 20 March 2025.

Notably, Article 8 of BPOM Regulation No. 32 of 2022 (as amended by Regulation No. 15 of 2024) remains valid unless it contradicts the new regulation.

Why This Matters for the Industry

The Indonesian health supplement market is booming:

1. As of April 2025, 6,173 products have active distribution permits.
2. In 2024 alone, BPOM issued 957 new permits.
3. In Q1 2025, 262 new products were approved—up from 240 in Q1 2024.

This surge reflects a global shift toward preventive health behaviours. However, as the market grows, so does the need for regulatory compliance. This regulation ensures that businesses don’t just ride the trend; they build trust through verified product quality.

Penalties for Non-Compliance

BPOM has outlined clear sanctions for businesses that fail to comply:

1. Administrative Sanctions:
   • Written warnings
   • Formal notifications
   • Revocation of distribution permits
2. Criminal Sanctions:
   • Fines or imprisonment based on Article 435–436 of Law No. 36 of 2009 on Health.

These penalties underscore the serious consequences of skipping mandatory testing and highlight the importance of getting compliance right from the start.

How Permitindo Can Help

Navigating technical regulations like BPOM’s stability testing requirements can be challenging. Permitindo offers legal and product registration services tailored for health supplement businesses.

With a deep understanding of local compliance standards and processes, we assist clients in adapting their documentation, registration approach, and product testing strategy, ensuring alignment with current regulations and a smooth path to market entry.