Attorneys in Tilleke & Gibbins’ regulatory affairs team have produced the Cannabis and Hemp Business Guide – Thailand, a primer on the rapidly developing cannabis industry in Thailand.

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

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;

Since Thailand formally removed Mitragyna speciosa (kratom) from the list of narcotic drugs, the country has progressed from outright prohibition to a structured, license-based regime. While the Ministry of Public Health oversees cannabis plant regulation, the Ministry of Justice (MOJ) is the regulatory authority overseeing kratom plants. For the avoidance of doubt, separate Ministry of Public Health notifications prohibit the use of kratom as a food ingredient unless a food safety evaluation has been conducted; however, this restriction does not affect trade in unprocessed leaves per se. For businesses in Thailand dealing exclusively in kratom leaves, the most consequential development is the Ministerial Regulation on the Application for Permits and Notifications for the Importation and Exportation of Kratom Leaves B.E. 2568 (2025), a bylaw of the Kratom Plant Act 2022. The ministerial regulation establishes the following notable definitions: “Kratom leaves”: Fresh or dried leaves in their natural, unprocessed state (no extracts, concentrates, or infused products). “Import/Export”: Any act of bringing kratom leaves into or out of Thailand, whether for commercial sale, industrial processing abroad, or research. Import/Export Licensing Under the Kratom Plant Act, a license is mandatory for importing or exporting kratom leaves. Individuals, juristic persons, community enterprises, and state agencies in Thailand are eligible to obtain a license to import (or a license to export) kratom leaves. Licenses are available to qualified individuals and juristic persons. Individuals must satisfy the following qualifications to be eligible for a license: Thai nationality, ≥ 20 years old, resident in Thailand. Not incompetent, quasi-incompetent, or under legal guardianship. No license suspension currently in force under the Kratom Act or Narcotics Code. No license revocation in the previous two years. No conviction under the Kratom Act or Narcotics Code within the previous two years (unless fully released from punishment). Juristic persons must satisfy