Thailand FDA — Proposed Food Labelling Rules for Prepackaged Foods

The Ministry of Public Health Notification No. 450 B.E. 2567 (2024) (“MOPH Notification No. 450”), issued pursuant to the Food Act B.E. 2522 (1979), constitutes Thailand’s current regulatory framework governing the labelling of food in sealed containers. Certain aspects of the existing regime, however, are no longer fully aligned with prevailing international standards or evolving market practices — particularly with respect to allergen disclosure, food additive labelling, exemptions from labelling requirements, and the absence of mechanisms for digital labelling.

In response, the Ministry of Public Health has issued a draft notification on the labelling of food in sealed containers (the “Draft Notification”), which introduces a series of targeted amendments designed to strengthen consumer protection and modernize the applicable regulatory requirements. The Draft Notification is currently open for public consultation from 18 March to 16 April 2026.

Key Proposed Amendment

The Draft Notification introduces several substantive amendments, which may be broadly categorized into four key areas, as summarized below.

1.  Revision of Exemptions from Labelling Requirements

Under MOPH Notification No. 450, certain foods sold directly by manufacturers to consumers are exempt from labelling requirements, provided that the manufacturer is able to convey the relevant information to consumers directly.

The Draft Notification narrows this exemption by introducing nine categories of food that must bear labels in all circumstances, irrespective of the method of sale or whether information can be communicated directly to consumers. These categories are as follows:

• food additives;
• infant formula and infant formula for special medical purposes;
• follow-on formula for infants (6–12 months) and young children;
• supplementary food for infants and young children;
• foods intended for special dietary purposes;
• dietary supplements;
• foods containing added extracts, nutrients, or synthetic substances;
• foods subject to specific warning requirements under other applicable notifications; and
• foods subject to specific manufacturing or storage requirements under applicable regulations.

This amendment reflects a risk-based regulatory approach, ensuring that higher-risk food categories remain subject to mandatory labelling requirements in all cases.

2.  Enhancement of Allergen Labelling Requirements

The Draft Notification revises allergen labelling requirements to improve clarity and achieve greater alignment with international standards. Key changes include:

• Expansion of the allergen list:
• the addition of sesame as a priority allergen; and
• the inclusion of celery, mustard, and lupin as national and regional allergens.
• Clarification of tree nut categories, with specific identification of almond, cashew, hazelnut, pecan, pistachio, walnut, Brazil nut, macadamia, and pine nut (and their derived products).
• Removal of lactose from the allergen list, on the basis that lactose intolerance is not classified as an allergenic reaction under applicable scientific and regulatory frameworks.

These amendments are designed to enhance transparency for consumers and to bring Thailand’s allergen labelling regime into closer conformity with international best practice.

3.  Revision of Food Additive Labelling Requirements

The Draft Notification further refines the requirements governing food additive disclosure, with a view to better reflecting actual manufacturing practices. In particular, it permits additives that serve multiple technological functions to declare additional relevant functions, provided that their use is consistent with those functions.

At the same time, certain functions are no longer required to be declared on labels, specifically:

• carriers; and
• packaging gases.

These revisions seek to strike an appropriate balance between technical accuracy and regulatory practicability, reducing unnecessary complexity in labelling while maintaining an adequate level of transparency for consumers.

4.  Introduction of Digital Labelling

A significant development under the Draft Notification is the formal introduction of optional digital labelling — a mechanism not currently permitted under the existing framework. Digital labelling may be implemented through formats such as QR codes, NFC technology, or barcodes, and will be available for most food categories, with the exception of certain higher-risk products such as infant foods and foods intended for special dietary purposes.

Importantly, digital labelling is not intended to replace physical labels in their entirety. The following core information must continue to appear on the physical packaging:

• product name;
• food registration number;
• net content;
• list of ingredients;
• allergen information;
• warnings; and
• expiry date or best-before date.

This approach reflects a broader shift towards technology-enabled regulatory compliance, while ensuring that essential information remains immediately accessible to consumers at the point of sale.

Current Status

The Draft Notification preserves the core regulatory framework established under the Food Act B.E. 2522 (1979). Several points of clarification are noteworthy:

• Pre-approval requirements are maintained for specific higher-risk food categories — including infant formula and foods intended for special dietary purposes — given the potential consequences of inaccurate labelling for consumer health and safety.
• No dedicated committee mechanism is introduced under the Draft Notification.
• The Draft Notification does not itself prescribe criminal penalties; however, non-compliance remains subject to sanctions under the Food Act.
• Regulatory authorities retain discretionary powers in reviewing labelling content, including the authority to prohibit the use of certain wording were considered appropriate.

Key Takeaway

• Thailand is transitioning towards a more risk-based and internationally aligned food labelling regime.
• Labelling exemptions will be significantly narrowed, with particular focus on higher-risk product categories.
• Allergen disclosure requirements will become more comprehensive and precise.
• Food additive labelling rules are being streamlined to better reflect prevailing industry practice.
• Digital labelling is being formally recognized, marking an important step towards modern and flexible compliance tools.

Author: Panisa Suwanmatajarn, Managing Partner.

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FDA: Food and Drug Administration Proposes Revised Food Advertising Notification

The Thai Food and Drug Administration (“FDA”) has issued a draft notification on food advertising (B.E. ….) (the “Draft Notification”), which proposes a comprehensive modernization of Thailand’s food advertising regulations. The existing framework, governed by the FDA Notification on Food Advertising B.E. 2564 (2021) (the “2021 Notification”), has been in effect since 31 March 2021. The Draft Notification is currently open for public consultation until 16 April 2026.

This initiative seeks to address practical challenges that have arisen since the implementation of the 2021 Notification. Key issues include the framework’s limited adaptability to evolving digital marketing practices, shifting consumer expectations, and the emergence of new product categories such as hemp-, cannabis-, and kratom-based items. The proposed revisions aim to resolve ambiguities faced by businesses, particularly concerning advertising claims and sustainability-related communications, while strengthening protections against misleading advertisements.

The Draft Notification introduces targeted amendments across five principal areas to enhance regulatory clarity, close existing gaps, and provide greater operational flexibility without compromising consumer safeguards.

Introduction of Product-Specific Advertising Rules:

The Draft Notification establishes dedicated advertising standards for specific food categories that were not adequately addressed under the current regime. These include:

• Food supplements containing kratom; and
• Food products incorporating hemp seeds, hemp oil, hemp protein, cannabis, or cannabidiol (CBD).

These provisions are designed to ensure appropriate oversight of these sensitive and increasingly prevalent product categories.

Revision of Prohibited Claims (Annex 1):

Annex 1, which lists prohibited claims regarding the quality, benefits, or properties of food, has been substantially revised. The previous fixed list of prohibited expressions is replaced by a broader, principle-based standard. Prohibited claims are now defined as those that create exaggerated or misleading expectations concerning the quality, benefits, or properties of food.

Specific examples that remain expressly prohibited include:

• Terms such as “miraculous” or “extraordinary”;
• Claims implying a cure, guaranteed results, or the absence of side effects; and
• Statements suggesting endorsement or approval by the FDA.

The revised approach emphasizes the overall impression conveyed by the advertisement, enabling a more nuanced, case-by-case evaluation by regulators.

Expansion of Advertising Not Requiring Prior Approval (Annex 2):

The scope of advertising exempt from prior FDA approval has been broadened to better accommodate contemporary marketing practices. Permitted content now includes:

• Expanded use of descriptive expressions related to taste, texture, and sensory attributes; and
• Sustainability-related messaging, such as recycling symbols, carbon footprint indicators, and green certifications, provided they satisfy applicable conditions.

These updates facilitate more flexible communication while preserving safeguards against misleading practices.

Clarification of Advertising Requiring Prior Approval (Annex 3):

The Draft Notification provides clearer criteria for advertising that necessitate prior FDA approval, specifically claims relating to quality, benefits, or functional properties. Examples include:

• Functional claims (e.g., those concerning probiotics);
• “Free-from” claims (e.g., gluten-free); and
• References to FDA-related awards or quality marks.

This clarification is expected to reduce uncertainty and promote greater consistency in regulatory application.

Revision of Warning Requirements in Advertising (Annex 4):

The framework for mandatory warning statements in advertisements has been updated to focus on relevance to specific advertising media. Additional warning obligations have been introduced for products involving kratom, cannabis, and hemp. The revised wording aims to enhance clarity and consistency across different media formats.

Regulatory Position:

The core elements of the existing regulatory framework remain intact:

• Advertising concerning the quality, benefits, or properties of food continues to require prior FDA approval;
• No new criminal penalties are introduced;
• Non-compliance remains subject to penalties under the Food Act B.E. 2522 (1979); and
• Regulatory authorities retain broad discretion in assessing whether advertisements are misleading or non-compliant.

Key Takeaways:

The Draft Notification represents a significant modernization of Thailand’s food advertising regime. Principal changes include:

• Introduction of product-specific rules for emerging categories such as kratom-, hemp-, and cannabis-based products;
• Transition to a principle-based approach for evaluating misleading claims;
• Greater flexibility for descriptive and sustainability-related advertising;
• Enhanced guidance on claims requiring prior approval; and
• Updated warning requirements tailored to advertising media.

These amendments collectively promote a more structured, transparent, and market-responsive regulatory environment. As the Draft Notification remains subject to public consultation and has not yet been finalized, businesses are advised to monitor subsequent developments closely. It is recommended that affected entities evaluate the potential implications for their advertising strategies, internal review processes, and overall compliance frameworks.

Author: Panisa Suwanmatajarn, Managing Partner.

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Thailand’s New FDA Notification on Controlled Health Products: Streamlining Import and Export Processes

Thailand’s Food and Drug Administration (FDA) is set to introduce a new notification regarding the control of health products, in collaboration with the Thai Customs Department. This initiative aims to modernize and streamline the processes for importing and exporting controlled health products, addressing current regulatory challenges and improving efficiency for all stakeholders.

The cornerstone of this new approach is the National Single Window (NSW) system, which will serve as a centralized database for controlled health products. The NSW is designed to facilitate data collection and exchange, reduce procedural complexities, enhance transparency, and ultimately save time and costs for both government agencies and business operators.

The draft notification, titled “Notification of the Food and Drug Administration on the Control of Health Products under the List of Controlled Goods Database of the Customs Department,” seeks to replace outdated regulations with a more comprehensive framework. Key objectives include updating current laws and regulations, reducing unnecessary burdens on businesses whose products are not classified as health products, and minimizing excessive bureaucratic processes and discretionary decision-making by officials.

One of the most significant changes in the draft notification is the introduction and expansion of exemption codes. The new “EXEMPT2” category covers various scenarios, including:

1. Drugs intended for use in science laboratories, analysis, or verification of diseases not directly related to human use.
2. Specific chemical compounds such as Lithium, Carbonate, Mannitol, Corn Starch, and Dextrin.
3. Materials intended for use in sports and entertainment.
4. Materials intended to produce dangerous household products.
5. Materials with specifications for industrial use outside of health product manufacturing.

The draft notification also introduces the “EXEMPT100” code, which is reserved for situations where system failures prevent the issuance of standard permits or licenses per invoice documentation.

Furthermore, the draft notification expands the existing “EXEMPT99” category to encompass a broader range of medical instruments and related items. This expanded exemption now includes components, materials, and spare parts of medical devices. Additionally, it covers materials intended for use in herbal products, as well as instruments or software designated for research purposes only.

These detailed exemption categories demonstrate the FDA’s efforts to create a more nuanced and flexible regulatory framework. By providing clearer guidelines on what products fall under various exemptions, the notification aims to reduce confusion and streamline the import/export process for businesses dealing with products that may have previously occupied regulatory grey areas.

The proposed notification demonstrates a more nuanced approach to regulating health products, acknowledging the diverse needs of different industries while maintaining necessary controls. It covers both import and export processes, providing a more holistic regulatory framework for the sector.

As part of the legislative process, the draft notification is currently open for public consultation until 30 July 2024. Following this period, it will undergo further review by the Thai Customs Committee and the Import and Export Division of the Food and Drug Administration.

This initiative represents a significant step forward in Thailand’s efforts to modernize its regulatory environment for health products. By leveraging technology and refining regulatory categories, the Thai FDA aims to create a more efficient, transparent, and business-friendly ecosystem while maintaining robust health and safety standards. The new system is expected to benefit a wide range of stakeholders, from pharmaceutical companies and medical device manufacturers to importers of specialized industrial materials and research institutions.

Key Takeaways:

1. The Thai Food and Drug Administration (FDA) and Customs Department are collaborating to implement a new system for managing controlled health products.
2. The National Single Window (NSW) system will be used to collect and exchange data on controlled health products, enhancing efficiency and transparency.
3. The draft notification aims to update regulations, reduce burdens on businesses, and streamline processes for both operators and officials.
4. The draft notification introduces new exemption codes (EXEMPT2 and EXEMPT100) and expands the EXEMPT99 category to cover more scenarios.
5. The draft notification covers both import and export processes, providing more comprehensive guidance for stakeholders.
6. Public hearings on the draft notification will be open until 30 July 2024, followed by internal discussions within relevant government bodies.

Author: Panisa Suwanmatajarn, Managing Partner.

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Thailand Streamlines Regulatory Processes for Food, Medical Devices, and Cosmetics to Enhance Business Operations

Recently, the Chairperson of Regulatory Reform for Ease of Doing Business convened with the Prime Minister to discuss the progress of legal reforms aimed at aligning business regulations with the evolving economic and social landscape. The meeting was attended by key stakeholders, and the Secretary-General of the Food and Drug Administration (FDA), to highlight the tangible benefits arising from these reforms.

The FDA, as a pivotal authority in implementing the government’s policy to streamline public access to governmental services and permits, has introduced several significant improvements to expedite the importation of food, medical devices, cosmetics, and medicines:

1. Expedited Medicine Registration: The FDA has substantially reduced the registration period for new medicines from 310 days to 90 days, based on evaluations from the World Health Organization Collaborative Registration Procedure (WHO CRP).
2. Rapid Import Processing: A new fast-track channel has been established within the e-submission system, enabling product import approvals within 24 hours.
3. Simplified Licensing Procedures: The process for license renewal has been streamlined to a straightforward fee payment procedure.
4. Accelerated Approval for Low-Risk Foods: Reporting and registration timelines for 28 categories of low-risk foods eligible for automatic permission (Auto E-Permission) have been significantly shortened, facilitating quicker market entry.
5. Enhanced Support for Thai Food Manufacturers: Under the Ignite Thailand initiative, approval processes for popular Thai food items such as Tom Yum Goong and Pad Thai have been expedited, reducing processing times from 78 to 44 business days.
6. Streamlined Medical Device Registration: Procedures for registering low-risk medical devices and equipment have been optimized, reducing registration timelines to 30 business days for both manufacturers and importers.

Furthermore, for foreign enterprises approved by the European Union (EU), Canada, and the World Health Organization (WHO), the FDA has markedly reduced operational processing times from 180 days to approximately 80-90 days. This initiative is complemented by the nationwide implementation of paperless transactions using a single identification card, effective from 1 May 2023.

These comprehensive reforms underscore Thailand’s commitment to enhancing its business environment, fostering innovation, and promoting economic growth through streamlined regulatory processes and improved governmental service delivery.

Author: Panisa Suwanmatajarn, Managing Partner.

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Controlling over Young Child Food Marketing Promotion

The Department of Health under the Ministry of Public Health has initiated a campaign to encourage mothers of 6 months and below infants to be fed with breast milk and 6 months and above infants to be fed with breast milk continuously along with appropriate food until 2 years old or longer as per the guidelines of the International Code of Marketing of Breast-Milk Substitutes (Milk Code) of World Health Organization. It is aimed to support mothers to breastfeed as much as possible, and ensure that consumers, particularly mothers who are unable to fully breastfeed, receive accurate information regarding infant and young child food.  

As of such campaign, the Ministry of Public Health has enacted the Control of Marketing of Infant and Young Child Food Act B.E.2560 (2017) (Act) to promote and support the guidelines of the Milk Code. The Act has been introduced with a strict definition regarding the marketing promotion of Infant Food. However, the specific definition specifying Young Child food marketing promotion has yet to be enacted resulting in ineffective control over marketing communications of young child’s food especially the provisions regarding the prohibition of advertisement and product labels.

The Ministry of Public Health, therefore, has proposed the draft Notification regarding the Determination of the Marketing Promotion of Young Child Food Being Controlled B.E. …. (Draft Notification) stating that “Young Child Food” specifies in section 3 of the Act includes milk or any other product used as food.  The Draft Notification also specifies statements being able to be used for feeding young child and communication or marketing communication in a manner associating with or causing the understanding that it is infant food or suitable for feeding infants. 

The statements being able to be used are as follows:

1. Contain a message on the product label that is used for feeding young child. 
2. Contain a message on the product label or in marketing communication in a manner associated with young child.
3. Contain the message, name, or ingredients of nutrients that are appropriate and sufficient for feeding young child on the product label or in marketing communication. 
4. Present the nutritional value of young child Food on the product label or marketing communication. 
5. Present the span of age number of young child on the product labels or in marketing communication.

The Draft Notification was opened for public hearing from 23 April to 7 May 2024, after which it will be presented to the Minister of Public Health for consideration and signing before being published in the Royal Gazette. The Draft Notification will become effective 180 days after its publication date.

Author: Panisa Suwanmatajarn, Managing Partner.

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Thailand’s FDA Proposes Amendments to Streamline GMP Certification for Foreign Drug Manufacturers

Thailand’s Food and Drug Administration (FDA) has proposed draft amendment to the Announcement on Criteria, Procedures, and Conditions for Applying, Issuing, and Renewing Certificates of Good Manufacturing Practice (GMP) for Pharmaceutical Products from Foreign Manufacturing Facilities B.E. …. (3rd amendment) (“Draft Announcement”). After a public hearing period ending on 1 May 2024, the Draft Announcement will be presented to the Minister of the Ministry of Public Health for consideration and approval before being published in the Royal Gazette.

The proposed revisions aim to update and simplify the requirements outlined in the previous 2nd Issue of the announcement, which has been enforced since 24 March 2023. The key goals are to reduce administrative burdens for drug importers in preparing application documents, while also enabling a more streamlined and efficient evaluation process by FDA officials. This will allow more effective regulatory oversight of imported drug product quality based on current industry practices.

Key proposed changes to the certification criteria include:

1. Importers bringing in medicines from foreign facilities classified as an ASEAN Listed Inspection Service or as a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) can submit alternative documents demonstrating GMP compliance instead of a GMP Certificate or Certificate of Pharmaceutical Product (CPP) when applying for new certifications or renewals. Additionally, for PIC/S members, importers may not need to provide Corrective and Preventive Action plans when applying for new certifications.
2. For orphan drugs, veterinary medicines, and medicines from other foreign facilities not covered above, the FDA proposes to categorize document requirements based on the specific medicine type. This risk-based approach aims to facilitate more focused inspections while reducing unnecessary documentation demands.
3. In evaluating whether a foreign facility meets GMP standards, the FDA can consider alternative documents providing evidence of GMP compliance as acceptable instead of only accepting official GMP Certificates or CPPs.

The Draft Announcement allows for a more flexible, risk-based approach to verifying current good manufacturing practices at foreign facilities based on available documentation from trusted regulatory authorities. Highly regulated facilities under PIC/S would have streamlined certification renewals, while foreign sites producing orphan drugs or veterinary medicines would follow requirements commensurate with their risk profiles.

Overall, these proposed changes aim to increase efficiency for both FDA regulators and the industry while maintaining strict oversight of drug product quality, safety, and efficacy standards for imported pharmaceutical products in Thailand. The streamlined certification framework reduces administrative burdens while focusing inspection resources based on risk.

If approved, the Draft Announcement will provide an updated regulatory system better adapted to current pharmaceutical manufacturing practices and global regulatory collaboration on GMP inspections. Both importers and the Thai FDA could benefit from a more modern, agile system for ensuring public health protection.

Author: Panisa Suwanmatajarn, Managing Partner.

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