During the first quarter of 2022, Thailand’s Securities and Exchange Commission (SEC) announced a series of notifications aiming to strengthen the regulatory regime for digital assets while safeguarding investors’ interests. The updated rules and conditions apply to digital asset business operators licensed by the SEC. The key features of the new notifications, which took effect in March and April 2022, are summarized below. Custody of customers’ assets (effective March 1, 2022) As custodians of their customers’ assets, digital asset business operators must: Segregate customers’ assets in their custody so that the operators can clearly identify which assets belong to which investors. If customers’ digital assets are to be deposited with a third party, the operators must inform the customers accordingly. Refrain from seeking benefits from customers’ assets in any manner other than the purpose for which the assets are held. This includes refraining from using customers’ assets to provide benefits to others or to the customers themselves, and from depositing customers’ digital assets with a custodian that intends to lend out the digital assets (but does not include giving the customer’s assets to a licensed digital asset fund manager for investment in digital assets). Reconcile customers’ assets and keep evidentiary documentation for a period of at least five years. Privacy coin services (effective April 1, 2022) Digital asset business operators are prohibited from providing privacy coin services that can conceal (or allow the concealing of) specific transactional information, such as data about the transferor, the transferee, and the transfer amount. Digital asset business operators that provided privacy coin services to customers before the effective date of these new regulations may continue to provide such services, but they must arrange for their customers to disclose at least the required transactional information or agree not to engage in information concealment. Digital assets as a means of payment (effective April 1, 2022) Digital asset business operators are prohibited from using digital assets as a means of payment and must not provide any services or undertake any activities that encourage or promote the use of digital assets to pay for goods or services. This includes: Representing to any customer (through an advertisement, etc.) that the business operator will accept payment for goods or services using digital assets; Establishing a system or tool facilitating the use of digital assets to pay for goods or services; Providing e-wallets for the purpose of using digital assets as a means of payment; Providing a service for transferring THB-denominated funds from a customer’s account to third-party accounts; Providing a service for transferring digital assets from a customer’s account to third party accounts in order to pay for goods or services; and Providing any other services that support the use of digital assets to pay for goods or services. Business operators must take action (e.g., warnings, account suspension or termination, etc.) against customers who fail to comply with service terms and conditions. Providing customers with activity reports (effective March 30, 2022) The SEC now requires digital asset operators to provide their customers with a report, within one business day of a transaction, containing specific information about the customers’ digital asset trading, exchanging, and investment activity. Operators must retain the disclosed information for at least 18 months. Although the requirement came into effect on March 30, there is an initial implementation stage until April 30, 2022, during which operators only need to provide reports to their customers within a reasonable period of time upon request. The reporting requirement will be fully implemented from May 1, 2022, onward. For more information on the latest SEC rules and regulations for digital assets, or on any aspect of digital asset business or cryptocurrency in Thailand, please contact Kobkit Thienpreecha at [email protected], Onunya Chanpen at [email protected], Sorawit Partomtanasarn at [email protected], or Napassorn Lertussavavivat at [email protected]

New technologies and production processes in the food industry have led to novel foods becoming increasingly important to both food manufacturers and the consuming public worldwide. This is very much the case across a number of jurisdictions in Southeast Asia. “Novel foods” refer to new food production processes, foods, and ingredients that have not yet been commonly used for human consumption, so these innovative foods require safety assessments before companies can produce and market them. While rules for these safety assessments are already part of novel food regulations in several other jurisdictions—such as the novel food regulations in the United Kingdom and European Union adopted in 2003, and the major reform of food safety laws in the United States passed in 2011 under the Food Modernization Act—similar rules governing the assessment of novel foods are relatively new or yet to be introduced in many parts of Asia. Nevertheless, it is important to understand the laws and practices that apply to safety assessments and the process of bringing novel foods to market in jurisdictions in the region. This article provides some clarity in this regard by summarizing important practical information on novel foods and the relevant required safety assessments in Indonesia, Thailand, and Vietnam.   Indonesia Regulator National Agency for Drug and Food Control (NADFC); frequently referred to as BPOM (Badan Pengawas Obat dan Makanan). Relevant Measures BPOM Regulation No. 27 Year 2018 concerning Public Service Standards in BPOM; Decision of the Director of Processed Food Standardization No. HK.02.02.51.511.06.21.21 Year 2021 concerning Public Service Standard Directorate Processed Food Standardization Definitions General “food ingredients” are basic fresh or processed ingredients that can be used to produce food; novel food is any food ingredient not listed in BPOM’s positive list of ingredients. Official Fees None   Process and Timeline Before submitting an application for novel food safety assessment, the applicant or a representative should first consult with BPOM’s Directorate of Processed Food Standardization. This consultation can help the applicant identify the data requirements for submission. For obtaining approval of novel foods, applicants must submit the required items through the directorate’s online submission system. BPOM will then check the application to verify its completeness, and will contact the applicant within five working days either to confirm that the submission is complete or to direct the applicant to rectify any shortcomings. Once all requirements have been fulfilled, BPOM is to assess the application within 85 working days—or around 4–6 months in practice.   Required Documents The application requirements differ depending on the category of novel food. There are two main categories: Novel food substances, mixtures of substances, mixtures of food ingredients, or other ingredients Novel foods sourced from plants or animals Ingredient name(s) Ingredient specification Physicochemical properties Composition Production process Certificate of analysis Toxicity data Potential allergenicity Regulation or distribution in other countries Name of type of processed food (final food product) Purpose of adding ingredients Amount of ingredients added Composition of processed food Processed food production process Use or application of processed food Suggested consumption (if any) Ingredient name(s) Parts of plant or animal used Chemical and/or nutritional content of ingredients Ingredient specifications and composition Production process Certificate of analysis History of use as food Toxicity data Potential allergenicity Regulation or distribution in other countries Name of type of processed food (final food product) Purpose of adding ingredients Amount of ingredients added Composition of processed food Processed food production process Use or application of processed food Suggested consumption (if any) Thailand Regulator Food and Drug Administration (FDA) Relevant Measures Notification of the Ministry of Public Health (No. 376) B.E. 2559 (2016) Re: Novel Food Definitions “Novel food” is any substance used as food or food ingredients that either has been used widely for human consumption for less than 15 years based on scientific or reliable evidence, or has undergone a production process not currently used, where that process gives rise to significant changes in the composition or structure of the food that affect their nutritional value, metabolism, or level of undesirable substance Official Fees THB 3,000 (approx. USD 90)   Process and Timeline Seeking approval for novel foods consists of two stages. Novel food safety assessment registration In this stage, the applicant submits safety data to one of four safety assessment organizations accepted by the FDA. The maximum or estimated duration of this step depends on the organization: Bureau of Quality and Safety of Food, Ministry of Public Health – 95 business days; National Food Institute, Ministry of Industry – 93 business days Thailand Risk Assessment Center (TRAC), Mahidol University – 90 business days National Center for Genetic Engineering and Biotechnology (BIOTEC) – 7–12 months Novel foods that contain any ingredient derived from a genetically modified organism (GMO) must undergo a BIOTEC review. Novel food safety assessment registration considered by the FDA To apply for the FDA’s approval of a novel food, the applicant must submit the letter from the safety assessment organization, along with other relevant documents, to the FDA via their online system. The FDA will consider the application and make a determination within 40 business days.   Required Documents General product and ingredient information Information on history of consumption as food Finished product and ingredient specifications Certificate of analysis Storage Production process, synthesis, or extraction method Basic information on chemical substances used in production Characteristics and recommendations for consumption Safety information, usually including three toxicology studies: 90-day subchronic toxicity study using rats Test for induction of gene mutations in bacteria (Ames Test, OECD Guidelines 471) In vitro assay to detect chromosomal aberrations (OECD Guideline 473), in vitro micronucleus assay (OECD Guidelines 487), or mouse lymphoma TK assay with colony sizing (OECD Guidelines 476) Nutritional data Results of safety assessments by international agencies or recognized countries.   Vietnam Regulator Vietnam Food Administration (VFA) Relevant Measures No specific regulations or guidance on novel foods and ingredients; however, both imported and domestically produced food products must comply with the Law on Food Safety as well as the following measures on genetically modified organisms

Since the onset of the COVID-19 pandemic and the ensuing safety measures, many Thai retailers have shifted their sales toward online platforms. Unsurprisingly, counterfeiters have followed suit. The online sale of counterfeit healthcare and other life sciences products (e.g., food, cosmetics, and medical devices) is an area of significant concern, as it is particularly prevalent, damaging, and complex in relation to Thailand’s laws. This article outlines this type of counterfeiting activity in Thailand and explains some important tools brand owners have for fighting it. Counterfeiting Operations Although illicit operations seek to avoid being identified by authorities and brand owners, investigations by law enforcement and Tilleke & Gibbins on behalf of clients have yielded some insights into how these illegitimate sellers typically operate. Often, consumers are first exposed to these counterfeit life sciences products by paid social media advertisements that link to social media accounts set up by sellers impersonating brand owners. This brand impersonation may include unauthorized use of a trademark or trade name as part of the account name, and unauthorized reproduction of official advertisement artwork or product descriptions, taken directly from the official social media account. From the fake social media account, consumers are usually directed to a merchant website that contains consumer reviews, which are entirely fabricated. While not every counterfeiting operation follows this exact blueprint, employing some variation of these methods lends counterfeiting platforms the ability to proliferate through multiple iterations, as well as believability in the eyes of consumers. How Brand Owners Can Take Action Life sciences brand owners often discover that their products have been targeted by counterfeiters when a counterfeit item injures or negatively impacts a consumer. Thinking that the product is genuine, the consumer may then complain to the brand owner, or worse, file a complaint with the authorities. Many times this has resulted in brand owners being surprised by an inquiry from Thailand’s Food and Drug Administration (FDA) or police looking to investigate a case by interrogating the brand owner and other relevant parties. Once they are aware of the counterfeiting situation, brand owners can fight the counterfeiting operation via a number of legal pathways. The typical methods that counterfeiting operations employ (as described above) likely violate provisions of many different laws. Furthermore, in most cases, the counterfeit items are produced in or imported into Thailand without marketing approval from the Thai FDA, which is an offense under the FDA laws for different product classes, such as the Food Act, Cosmetics Act, or Medical Device Act. Aside from producing or importing, the marketing of unsafe products amounts to an even more serious offense under these laws, punishable by fines and imprisonment. Additionally, unauthorized use of a registered trademark is trademark infringement under the Trademark Act, while unauthorized use of an unregistered trademark may violate the Penal Code. Unauthorized reproduction of an advertisement image or a product description may be enforced under the Copyright Act. Thailand’s intellectual property laws are enforced through the Department of Intellectual Property (DIP) and the Economic Crime Suppression Division of the Royal Thai Police. Furthermore, infringement online may trigger the Computer Crime Act, which can lead to website blocking by court order. Petitions under the Computer Crime Act must be filed with the Ministry of Digital Economy and Society through the review of the IPR Enforcement Affairs Office of the DIP. Brand owners tend to view the variety of relevant laws and enforcement authorities differently. Some may appreciate the freedom to strategize using the enforcement options the laws provide; others may find those options simply overwhelming. However, experienced advisors in Thailand will be able to help in either scenario—either by executing the selected strategy efficiently and effectively, or by helping brand owners sort through their options and recommending the method with the highest likelihood of success. Key Takeaways for Brand Owners First, brand owners can be confident that the Thai authorities take their anticounterfeiting duties seriously. This is shown most clearly by the frequent Thai FDA and police press conferences declaring successful raids and apprehension of suspects. The press conferences are reported almost weekly, with one of the most recent (March 18, 2022) involving THB 70 million worth of allegedly infringing cosmetic products. Second, cooperation with the authorities is always wise. The authorities expect to be provided with any helpful information that the brand owner can give, including identification of the counterfeit products and further witness statements. Besides helping authorities in their enforcement activities, cooperation is also the best way to establish the brand owner’s non-involvement with the allegedly defective or counterfeit products. Finally, participating in enforcement, either through cooperation with authorities or through private actions, is encouraged. Although online infringers are elusive, making instant success unlikely, continuous enforcement sends a strong message to the market, contributes to a good reputation among consumers, and raises infringers’ risks and costs (e.g., the risk that the paid ads may be taken down). With vigilance and persistent action, the fight against counterfeiters of healthcare and life sciences products is a battle of attrition that will prove beneficial in the long run.

Indonesia’s National Agency of Drug and Food Control (BPOM) has recently issued several new regulations governing advertisements for cosmetic products in the country. The main regulation—BPOM Regulation No. 32 of 2021 concerning Cosmetics Advertising—took effect on December 13, 2021, and revokes previous regulations regarding cosmetics advertising from 2016. The key aspects of the new regulation are outlined below. Cosmetic Claims The list of prohibited claims for cosmetic products is no longer included with the regulation. Instead, BPOM issued a stand-alone regulation on cosmetic claims as Regulation No. 3 of 2022, which was enacted on January 7, 2022. This regulation on cosmetic claims contains nonexhaustive lists of prohibited and allowed claims for cosmetic products. The new regulation states that published cosmetics advertisements must correspond to the information on the cosmetic product notification. This differs from the previous regulation, which only stated that published cosmetics advertisements were acceptable as long as they were in accordance with the Technical Guidelines for Cosmetics Advertising. Nonetheless, advertisements for cosmetics still do not have to be approved by BPOM prior to their publication. Publication Media Unlike the previous regulation, which only listed electronic, printed, or outdoor media for publishing advertisements for cosmetic products, the new regulation details six main types of advertising media: Printed media: Gazettes, magazines, tabloids, newspapers, bulletins, posters or flyers, leaflets, stickers, booklets, pamphlets, yellow pages, catalogs, and any other printed media  targeting a limited audience in a certain sector, industry, entity, or profession (i.e., non-mass media). Broadcast media: Television (including running-text classifieds, superimposed ads, and “built-in” ads displayed during a television program), radio, and cinema. Online media: Activities (such as searches of websites and webpages), e-commerce, games, social media (e.g., Instagram, Facebook, Twitter), applications, publications, transportation on demand, display ads, video ads, and entertainment, in various possible formats (such as video, audio, and banner). Outdoor media: Advertising boards, billboards, decorative lights/neon boxes, nameplates, hot air balloons, tire covers, panels at the airport or other public places, printed advertisements stuck/hung outdoors, banners, transit ads (ads placed on moving objects), gimmicks, and backdrops. Face-to-face communication: Talk shows and sales promoters. Warning Statements The new regulation shortens the list of cosmetic products for which a warning statement must be placed on the advertisement. According to the new regulation, a statement (in Indonesian) advising the consumer to read the usage directions and accompanying warnings must be placed on: Hair coloring and straightener; Permanent wave products; Depilatories; Sunblock; Sunbathing products; Aerosols; and Tooth whitener. This means that a warning statement is no longer required in advertisements for the following cosmetic products: Deodorants and antiperspirants; Aerosols; Exfoliating cosmetic products containing alpha hydroxy acid (AHA); and Cosmetic products applied or supervised by a professional. Research Data and Statistics While the previous regulation on cosmetics advertising does not address the age of product sales data used in an advertisement, the new regulation states that such data may not be more than two years old. Commercial Actors While the use of commercial actors in advertisements for cosmetic products was already subject to restrictions, the new regulation provides the following additional restrictions: Healthcare professionals may not be commercial actors in cosmetics advertisements. Actors may not play healthcare professionals in cosmetics advertisements. Religious figures cannot act in cosmetics advertisements. For more information on these new advertising rules, or on any aspect of cosmetics regulations in Indonesia, please contact Tilleke & Gibbins at [email protected]