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

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

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,

Attorneys from Tilleke & Gibbins’ offices in Vietnam have contributed the Vietnam chapter to Pharmaceutical Advertising 2022 from Chambers & Partners. Pharmaceutical Advertising 2022—the fifth annual edition of this practice guide—provides information on pharmaceutical advertising regulations in 18 jurisdictions around the world. The guidance is especially useful for pharmaceutical manufacturers looking to share their products and innovations with the public in a responsible, transparent way that is compliant with local laws. The Vietnam chapter specifically the following topics: Regulatory Framework for pharmaceutical advertising Scope of advertising and general principles Advertising of unauthorized medicines or unauthorized indications Advertising pharmaceuticals to the general public Advertising to healthcare professionals Vetting requirements and internal verification compliance Advertising of medicinal products on the internet Inducement and antibribery Gifts, hospitality, congresses and related payments Transparency considerations for pharmaceutical companies Enforcement of pharmaceutical advertising rules Tilleke & Gibbins also provided the Thailand chapter to this guide. Chambers & Partners’ Global Practice Guides provide in-house counsel with expert legal commentary focusing on practical legal issues affecting business, and enable readers to compare legislation and relevant procedures across a range of key jurisdictions. The full Pharmaceutical Advertising 2022 guide—including the Vietnam chapter—is available for free on the Chambers and Partners website. The Vietnam chapter is also available as a PDF through the button below.