Thailand is a member state of the ASEAN Economic Community, and next year, it is expected that the ASEAN Harmonization of Traditional Medicines and Health Supplements will be signed by the economic minister of each ASEAN country. Following ratification, the ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements will become the standard guidelines in the region, and various implementation efforts and instruments will follow. These guidelines cover a wide range of medicines and supplements; however, it is not possible to cover all herbal products. There are three types of health supplement claims: nutritional claims, functional claims, and disease risk reduction claims. Examples of the three types of claims include the following: Nutritional claims: supplements nutrition, nourishes the body, supports healthy growth and development, etc. Functional claims: maintains healthy joints, supports immunity, maintains liver function, etc. Disease risk reduction claims: helps to reduce risk of dyslipidemia, helps to reduce risk of osteoporosis, etc. The degree of evidence required for substantiating disease risk reduction claims is higher than for functional claims and nutritional claims. Functional claims and disease risk reduction claims must be substantiated by efficacy studies and the relevant toxicity data. It is the responsibility of the health supplement company to provide the required evidence in order to comply with the criteria for making such claims. Tips on Health Claims for Health Supplements 1. Nutritional Claims For essential nutrients such as vitamins and minerals, as listed by the Thai Food and Drug Administration (FDA), the amount included in a supplement must be between 15% and 100% of the Thai Recommended Daily Intake (RDI) values. Rules for specific kinds of nutritional claims are provided in the Notification of the Thai FDA RE: Nutrient Function Claims. For example, the nutrients that can be claimed as boosting the

When your company suffers a data breach, taking prudent, careful action can limit and perhaps even rectify some of the damage. First of all, it is important to document everything, starting with the time the data breach was discovered. Secure the data systems and preserve all evidence so that investigators can determine what happened, and begin following the protocol that all companies handling personal data should have in place to guide their data breach response. It is also crucial to seek timely legal assistance to ensure that every aspect of the response is planned and carried out according to the law. While applicable legal advice for each situation can only be obtained by consulting a legal advisor, this guide gives an overview of what companies in Southeast Asian jurisdictions can expect if they suffer a data breach. This guide from Tilleke & Gibbins is a quick-reference resource covering key regulatory issues regarding data breach responses in Cambodia, Laos, Myanmar, Thailand, and Vietnam. The full guide can be downloaded through the button below.

Laos’ Ministry of Health (MOH) has promulgated a regulation detailing registration and notification protocols for medical devices. Decision on the Registration and Notification of Medical Devices No. 1470/MOH will come into force 60 days after both the signing of the regulation (which already occurred in July) and publication in the Official Gazette, which has not yet been specified by the government. Registration of medical devices in Laos is mentioned in the country’s Law on Drugs and Medical Products No. 07/NA, dated December 21, 2011, but a registration procedure has not been put in place. There was only a separate requirement to furnish certain required documents when importing medical devices. Now, the decision outlines the registration and notification process for medical devices through the Ministry of Health’s Food and Drug Department (FDD), in line with the regulatory principles in the ASEAN Medical Device Directive of 2015, which Laos has ratified. Medical Devices in Laos The decision defines medical devices as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended for any of the following uses in humans: Diagnosis, prevention, monitoring, recovery from, or alleviation or treatment of a disease; Diagnosis, monitoring, recovery from, or alleviation of or compensation for an injury; Replacement, modification, or support of anatomy or a physiological process; Supporting and sustaining life; Controlling or assisting in conception; or Disinfection and sterilization of tools and medical devices. Medical devices in Laos are given one of four classifications based on their level of risk: Class A – Low risk (e.g., rubber belts, cotton for medical purposes, nonwoven swabs, adhesive bandages) Class B – Low-moderate risk (e.g., neonatal suction equipment, surgical gloves, gastro-catheters) Class C – Moderate-high risk (e.g., endoscopic surgical equipment, anesthesia equipment, peritoneal dialysis equipment) Class

Since the June 9, 2022, delisting of all parts of the cannabis plant according to the Narcotics Code, there has been an explosion of cannabis dispensaries operating in Thailand. The Department of Thai Traditional and Alternative Medicine (DTTAM) has issued more than 12,000 cannabis dispensary licenses to businesses in Thailand. A license allows a dispensary to sell cannabis flowers legally. In addition, the DTTAM requests the cooperation of dispensaries in submitting monthly reports about the sourcing, selling, and inventory of cannabis flowers. The DTTAM may suspend the selling license of dispensaries that fail to submit these reports. Apart from the enforcement duties and administrative acts of the DTTAM, the enactment of the laws and regulations pertaining to cannabis seemed to be drastically winding down. One of the reasons was that Thailand had delays in the process of forming a new government following the general election of May 14, 2023. These delays dampened Thailand’s thriving cannabis industry. In particular, the industry has concerns about the uncertainty of the nascent cannabis law. On August 11, 2023, the Narcotics Control Division of the Thai Food and Drug Administration (FDA) posted the Draft Regulation Re: Application for Approval and Approval for Manufacture, Importation, Exportation, Distribution or Possession of Narcotics under Category 5 (Extracts from Cannabis or Hemp Plants Only). This may be the first regulation that the newly formed government implements with regard to cannabis extracts. Unlike the DTTAM’s enforcement activities, the Thai FDA requests that a domestic manufacturer, importer, exporter, or seller of cannabis extracts apply for a license. The Thai FDA, as the authority, will consider granting a license only in the following cases: For medical benefits; For commercial or industrial benefits; For the benefit of medical or scientific analysis or research; and For use by the government for preventing and