Indonesia: Health Supplements 2025 Agenda

    BPOM (the Indonesian Food and Drug Agency) has published its Regulatory Roadmap for 2025, identifying Health Supplements as a key focus area.

    Some of the key areas addressed are:

        • Labelling: companies are required to disclose the source of their ingredients on the product label

        • Safety: clear guidelines will be introduced to assess the safety of ingredients.

        • Post-market controls: measures will be implemented to ensure a quicker response to safety issues. This includes oversight of online sales, management of product recalls, and procedures for product destruction.

        • e-commerce: existing regulations will be reviewed to ensure that digital platforms adhere to the same safety standards as traditional sales channels.

    Additionally, BPOM released new Guidelines on Stability Testing of Health Supplements.

    These guidelines stipulate that:

       • All Health Supplements must undergo stability testing.

       • Testing should be conducted in accredited laboratories or in-house facilities with a valid Good Manufacturing Practice (GMP) certificate.

       • Requirements are established for the design and evaluation of testing results.

       • Defines clear labelling on storage conditions and expiry.

Philippines: Vitamins and Mineral Limits Aligned with ASEAN Guidelines

    The Philippines FDA has updated its maximum nutrient levels based on the ASEAN Guidelines, aligning the country within the region.

    These Guidelines apply only to adults; products designed for pregnant/lactating women or children will continue to follow nutrient levels based on the Philippine Dietary Reference Intakes (PDRI) and associated standards.

    In summary, and for adults only:

        • Nutrients must provide at least 15% of the Recommended Nutrient Intake (RNI) to be recognised as a source.

        • Products must remain below the maximum levels set by ASEAN.

        • For vitamins and minerals not listed in the ASEAN Guidelines, the default maximum level will be 150% of the RNI for water-soluble vitamins and 105% for fat-soluble vitamins.

    The following transition period will apply:

        • Products undergoing reformulation must apply for registration before their current Certificate of Product Registration (CPR) expires.

        • CPRs that will expire in less than 1 year may be renewed for an additional 2 years.

        • Label stock exhaustion may be permitted for up to 12 months (upon request and approval).

Vietnam: Review of the Regulations for Food Supplements

    As a consequence of a large-scale counterfeit Health Supplements scheme, the government is revising the regulations governing Food Supplements.

    The latest draft made available includes a requirement for clinical, in vitro or in vivo, studies on finished products. It was also understood that the current version of the decree doesn’t provide a transition period: all existing product licences would be revoked once the new regulation takes place.

Brazil: Creatine – New Upper Limit in Force

    ANVISA published and officialised this week that the new maximum limit for Creatine for Food Supplements is now 5000 mg/day.

    This new limit will apply only to Food Supplements for adults.

This is a developing narrative; we will update it as new information emerges.