You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

July 31, 2024

Vietnam Issues First National Technical Regulation for Health Supplements

On July 18. 2024, Vietnam’s Ministry of Health issued Circular No. 12/2024/TT-BYT promulgating National Technical Regulation QCVN 20-1:2024/BYT on the limits of contaminants for health supplements (“Circular 12”). The new national technical regulation is the very first relating to health supplements, and is expected to have a great impact on the control of health supplement quality in Vietnam. Circular 12 will take effect on August 1, 2025.

Contents of Circular 12

The new circular prescribes limits of contaminants (heavy metals and microorganisms), testing samples and testing methods, management requirements, and responsibilities of entities manufacturing and trading in health supplements.

Supplemented alcohol products which are declared as health supplements are notably excluded from the scope of the regulation.

Transitional Provisions

Health supplements which (i) have been granted a declaration registration certificate, and (ii) are manufactured before August 1, 2025, are allowed to continue to be imported, traded, and circulated until the expiry date of the product, even if it is not aligned with Circular 12, except when there is food safety warning.

Declaration registration dossiers for health supplements submitted before August 1, 2025, will continue to be handled in accordance with the prevailing regulations at the time of submission.

From August 1, 2025, if a health supplement with a granted declaration registration certificate has a manufacturer’s standard that does not comply with Circular 12, the party manufacturing/trading in the product must adjust the product standard to conform to Circular 12 and notify the authority of this adjustment.

RELATED INSIGHTS​ 

November 25, 2025
Food safety incidents can emerge without warning, requiring businesses to act swiftly to protect consumers and comply with regulatory obligations. Across Southeast Asia, Thailand, Vietnam, and Indonesia have each developed comprehensive food recall frameworks designed to ensure rapid removal of unsafe products from the market while holding businesses accountable for compliance failures. While these three jurisdictions share common objectives—protecting public health and ensuring food safety—each has crafted distinct regulatory approaches reflecting their unique administrative structures, enforcement priorities, and legal traditions. Understanding these differences is essential for food businesses operating in the region, as recall procedures, timelines, reporting requirements, and penalties vary significantly across borders. This guide, available through the button below, examines the food recall regulations in Indonesia, Thailand, and Vietnam, providing practical guidance on legal requirements, procedural steps, and compliance obligations in each market.
October 15, 2025
The Indonesian Food and Drug Administration (BPOM) has introduced more stringent oversight of health supplements containing probiotics with new guidelines that require clinical trials for certain products and expanded documentation standards. BPOM Regulation No. 17 of 2025 replaces the previous 2021 regulation and establishes a comprehensive framework for evaluating probiotic strains used in health supplements. Assessment Requirements The new regulation expands the scope of assessment to include not only categorization and documentation but also technical procedures, strain classification, and clinical trial requirements. Unlike the previous regulation, which provided general guidance, the updated framework creates a comprehensive system for evaluating both registered probiotic strains and new or combined strains. Manufacturers must now submit supporting documentation covering strain identification and functional characterization, safety, efficacy, and product quality. The previous regulation required documentation only on safety, efficacy, and quality. Clinical Trials One of the most significant changes is the requirement for clinical trials conducted in Indonesia for applications that include benefit claims other than maintaining digestive health, or where there are modifications to benefit claims. The regulation specifies that phase 1 trials must demonstrate safety, while phase 2 trials must validate efficacy using statistically valid methods such as double-blind, randomized, placebo-controlled studies). In addition, phase 3 and phase 4 trials may be required, and postmarket surveillance data must be submitted. Technical Assessment Framework Annex 4, a newly introduced section, establishes technical procedures for assessing health supplements containing probiotics in Indonesia. This comprehensive framework outlines criteria for evaluating new probiotic strains, including strain identification, functional characterization, safety, efficacy, and product quality. The annex introduces a clear classification of claims for health supplement products containing probiotics: General claims(e.g., maintaining digestive health). Functional claims(e.g., normal biological function or activity in the body). Risk reduction claims(e.g., lowering disease risk). The regulation restricts use of the term
October 3, 2025
On September 26, 2025, the Contract Committee under Thailand’s Consumer Protection Board issued a regulation that aims to standardize contracts and enhance consumer protection within the beauty and wellness industry. The Notification on Prescribing the Beauty Service Business as a Contract-Controlled Business B.E. 2568 (2025), which takes effect on January 24, 2026, requires business operators to use a prescribed standard contract in Thai and adhere to strict mandatory provisions and prohibitions. These regulations apply to operators across all in-person and online service channels, including via digital platforms. “Beauty services business” is defined as the provision of services under an agreement allowing consumers to receive a series of treatments, either over a set number of sessions or within a set period. This includes massage, spa, other methods for cleanliness, beauty, or care of facial or body skin, and weight control and body shaping—including services offered electronically. The law excludes surgery, liposuction, and medical treatments performed by licensed practitioners. The notification establishes the following key requirements: Mandatory contract and formatting. All contracts with consumers must use the standard contract form, in Thai, with clear, readable text (minimum font size of 2 millimeters, no more than 11 characters per inch), and include all essential terms from the annexed form. Contract execution. Contracts must be made in duplicate, with one copy given to the consumer at signing. For agreements concluded through electronic channels, the process must comply with the Electronic Transactions Act and use the same required terms. Digital platforms. Business operators who provide services facilitated through a digital platform as an intermediary are ultimately responsible for ensuring the consumer receives a compliant contract. Prohibited clauses. The law prohibits clauses that limit or exclude liability for damages to life, body, health, mind, or property resulting from breach of contract or a wrongful act;