» Vietnam: Changes in Quality Control for Health Supplements Starting August 1, 2025

    Last year, Vietnam’s Ministry of Health issued Circular 12 (Circular 12/2024/TT-BYT), which regulates the limits for contaminants in Health Supplements/Dietary Supplements. Circular 12 will take effect on August 1, 2025.

    The new Circular, in which Vietnam shows greater alignment with the ASEAN guidelines, is the first for Health Supplements. It is expected to significantly impact the quality control of health supplements in Vietnam.

    Key contents of the Circular include:

     –  Maximum limits for heavy metals (arsenic, cadmium, lead, and mercury).

      – Maximum limits for microorganisms, including those for products containing probiotics.

      – Sampling and testing methods.

      – Requirements for product management, including labelling and product registration.

      – Responsibilities for entities involved in the manufacturing and trading of supplements.

    Transitional Provisions

      – Before August 1, 2025

            Health supplements that hold a registration certificate and were manufactured before this date may continue to be imported, traded, and circulated until their expiration date.

            Applications for registration of health supplements submitted before August 1 will still be processed according to the regulations in place at the time of submission.

      – After August 1st, 2025

            For any health supplement that holds a registration certificate but is produced according to manufacturer standards that do not comply with Circular 12, the responsible entity for manufacturing or trading the product must adjust the standards to align with Circular 12 and notify the authorities of these adjustments.