December 26, 2025

The Indonesian nutraceutical market is undergoing remarkable growth, fueled by an increasing focus on health, wellness, and preventive nutrition. With rising consumer awareness and an expanding middle class, Indonesia has become one of the most dynamic nutraceutical markets in Southeast Asia.

However, navigating the country’s complex regulatory framework under the National Agency of Drug and Food Control (NADFC/BPOM) requires an in-depth understanding of product classification, dossier submission, safety evaluation, and labeling requirements.

In this comprehensive guide, Maven Regulatory Solutions provides expert insights into the latest NADFC and BPOM nutraceutical regulations (updated for 2025) helping global and domestic companies ensure compliance, accelerate approvals, and maintain market access in Indonesia.

Regulatory Authority: NADFC / BPOM Overview

The National Agency of Drug and Food Control (NADFC), also known as Badan Pengawas Obat dan Makanan (BPOM), is the primary regulatory authority overseeing the registration, importation, safety, and labeling of nutraceuticals, health supplements, and functional foods in Indonesia.

Established on January 31, 2001, BPOM operates directly under the President of Indonesia, ensuring product safety, quality, and efficacy through a stringent pre-market and post-market control system.

Key Regulatory Framework Governing Nutraceuticals in Indonesia

The regulatory foundation for nutraceuticals and health supplements is defined through several key legislative instruments:

Major Laws and BPOM Regulations

  • Law No. 18 of 2012 on Food — governs all food products, including functional foods, nutraceuticals, and dietary supplements, ensuring safety, quality, and proper labeling.
  • BPOM Regulation No. 27, 2017 — covers the registration, labeling, advertising, and safety of food supplements.
  • BPOM Regulation No. 31 of 2018 — Outlines comprehensive processed food-labeling standards.
  • BPOM Regulation No. 12 of 2020 — defines the processed food registration process, including submission procedures and dossier validation.
  • BPOM Regulation No. 31 of 2022 — the cornerstone regulation for health supplement registration, integrating ASEAN harmonization standards.
  • Minister of Health Regulation No. 86 of 2019 — Governs importation and market authorization of drugs and food products, including nutraceuticals.

Local Representation Requirement for Foreign Companies

Foreign manufacturers intending to market nutraceuticals in Indonesia must appoint a locally authorized representative (local agent).

Key Requirements:

  • Must be a legally registered Indonesian entity.
  • Must possess a valid import license (API) and authorization to submit BPOM dossiers.
  • Acts as the official applicant and liaison with BPOM.
  • Responsible for compliance, safety reporting, and renewal applications.

NADFC Classification of Nutraceuticals and Supplements

Product classification determines applicable regulations and dossier requirements. BPOM categorizes nutraceuticals into several groups:

  1. Food Supplements – Contain vitamins, minerals, amino acids, or botanical extracts intended to supplement the diet.
  2. Functional Foods – Provide health benefits beyond nutrition (e.g., probiotics, and prebiotics).
  3. Traditional Medicines (Jamu) – Based on herbal or natural ingredients with traditional claims.
  4. Fortified Foods – Enhanced with additional nutrients to improve public health outcomes.
  5. Novel Foods – Contain new bioactive compounds not traditionally consumed in Indonesia.
  6. Health Supplements – Support health and wellness, covered under BPOM Regulation No. 31 of 2022.

BPOM Registration Process for Nutraceuticals in Indonesia

To legally market nutraceuticals in Indonesia, BPOM registration is mandatory.

Systematic Process:

  1. Product Classification & Ingredient Verification
  2. Compliance Check (GMP, Raw Materials, Claims)
  3. Dossier Preparation & Submission via BPOM e-Registration Portal
  4. Payment of Regulatory Fees
  5. BPOM Scientific and Safety Evaluation
  6. Laboratory Testing (if applicable)
  7. Issuance of Product Approval and Registration Number (ML Number)
  8. Post-Market Surveillance & Adverse Event Reporting
  9. Renewal Before Expiration (5-Year Validity)

BPOM Dossier Requirements for Nutraceutical Registration

A complete dossier ensures a smooth approval process and must include:

  • Product Composition: Full list of ingredients, quantities, and sources.
  • Manufacturing Information: GMP certification, facility accreditation, and process details.
  • Scientific Evidence: Safety and efficacy of data, clinical studies, or bibliographic evidence.
  • Stability and Shelf-Life Data: Supporting storage and expiration claims.
  • Labeling Samples: Indonesian-language labels with accurate information.

BPOM Labeling & Language Requirements

All nutraceutical labels must be:

  • Written in Bahasa Indonesia.
  • Include product name, ingredient list, usage instructions, expiry date, manufacturer/distributor details, and BPOM registration number.
  • Avoid misleading or unsubstantiated health claims.
  • Include Halal certification and alcohol content disclosure, if applicable.

Import and Market Access Requirements

For foreign nutraceuticals:

  • Import License (API) is required.
  • Certificate of Free Sale (CFS) and Certificate of Analysis (CoA) from the country of origin.
  • Products subject to customs inspection and BPOM laboratory testing prior to market release.

License Validity, Renewal, and Transfer

  • Registration validity: 5 years.
  • Renewal: Must include updated stability data, post-market reports, and safety updates.
  • License Transfer: Requires BPOM approval and notarized ownership documentation.

Post-Market Obligations & Surveillance

Companies must monitor their products in-market and report:

  • Adverse events or product complaints to BPOM.
  • Periodic safety and quality data.
  • Changes in formulation, labeling, or packaging for re-approval.

BPOM conducts random inspections, sampling, and testing to ensure ongoing compliance.

Harmonization with ASEAN Guidelines (2025 Update)

Indonesia continues aligning its health supplement and nutraceutical regulations with ASEAN Harmonized Regulatory Framework (AHSRF), facilitating regional trade and faster approvals across ASEAN member states.

This harmonization includes:

  • Unified ingredient lists
  • Standardized claim categories
  • Consistent GMP and labeling requirements

Key Challenges for Nutraceutical Companies in Indonesia

  • Complex BPOM documentation and frequent regulatory updates.
  • Need for local representation and distribution network.
  • Archipelagic logistics across 17,000 islands.
  • Consumer education and awareness gaps in rural regions.

Why Choose Maven Regulatory Solutions

Maven Regulatory Solutions offers end-to-end support for BPOM nutraceutical and health supplement registration, including:

  • Regulatory strategy and product classification
  • Dossier compilation and submission
  • Local representation coordination
  • Compliance audits and gap analysis
  • Labeling and claim validation
  • Post-market monitoring

Ensure your nutraceuticals meet Indonesia’s NADFC/BPOM compliance standards with Maven’s expertise guiding every step.