In July 2025, the Indonesian National Agency of Drug and Food Control (BPOM) issued Regulation No. 18 of 2025 on Tobacco Product Surveillance (PerBPOM 18/2025), which introduces a more comprehensive framework for overseeing tobacco products in Indonesia. This new regulation extends the obligations of business actors in the tobacco sector, outlining specific requirements for the disclosure of ingredients, prohibition of harmful substances unless proven safe, and stricter rules for health warnings on tobacco product packaging.

PerBPOM 18/2025 is a key component in Indonesia’s evolving public health framework, operating in tandem with the Health Law No. 17 of 2023 and Government Regulation No. 28 of 2024 (“PP 28/2024”). These laws collectively govern the country’s national health services and provide a robust control mechanism for the regulation of tobacco and electronic cigarette (e-cigarette) products. BPOM (the Indonesian National Agency of Drug and Food Control) is entrusted with the critical responsibility of overseeing and enforcing compliance with these regulations, ensuring that businesses adhere to strict health and safety standards for tobacco-related products.

With the introduction of PerBPOM 18/2025, there is a marked departure from the previous regulatory framework established under PerkaBPOM 41/2013. The earlier regulation, while pioneering in its approach, primarily focused on regulating key aspects such as nicotine and tar content in tobacco products, as well as mandating the placement of health warnings. However, PerBPOM 18/2025 introduces a far more comprehensive and updated structure designed to address emerging concerns and challenges in the tobacco and e-cigarette sectors. This regulation now includes provisions for the oversight of additives used in tobacco products and extends its reach to cover electronic cigarettes (e-cigarettes), an increasingly prevalent segment in the market.

The expansion of the surveillance framework under PerBPOM 18/2025 reflects a growing recognition of the need for more stringent oversight as the market for both traditional and alternative tobacco products (such as e-cigarettes) continues to evolve. With these updates, BPOM’s regulatory scope has been broadened to encompass not only the chemical composition of tobacco products but also the broader health implications posed by additives, flavorings, and other substances that may be introduced into the product during the manufacturing process.

E-Cigarettes are now directly under BPOM’s jurisdiction, requiring manufacturers to adhere to new labeling, health warning, and content disclosure guidelines. The regulation mandates that these products are tested for safety, with specific provisions on the disclosure of nicotine levels, production dates, and producer details. This move to regulate e-cigarettes alongside traditional tobacco products is a strategic step to protect public health and address growing concerns regarding the safety of these newer products.

Furthermore, PerBPOM 18/2025 strengthens the requirements surrounding the placement of health warnings on tobacco product packaging, emphasizing the need for more prominent and detailed information regarding the health risks associated with tobacco use. This includes the addition of specific language and imagery on the packaging, designed to inform consumers of the potential dangers of smoking and the harmful effects of nicotine and other substances found in tobacco products. The regulation now mandates that health warnings cover a larger portion of the product packaging—up to 50% of the front and back of the packaging—ensuring that the message is visible and accessible to all consumers.

One of the most significant updates under PerBPOM 18/2025 is the inclusion of new requirements related to the use of additives in tobacco products. The regulation now mandates that all additives used in tobacco products must be disclosed, and any new additives must undergo thorough scientific testing to ensure that they are not harmful to health. This requirement places an additional burden on tobacco manufacturers to ensure the safety and transparency of the substances they incorporate into their products.

These updates are part of a broader effort by the Indonesian government to align with international best practices in tobacco product regulation, as well as to respond to changing public health needs. With PerBPOM 18/2025, Indonesia takes a significant step forward in regulating the tobacco and e-cigarette industries more comprehensively. The regulation emphasizes consumer protection, public health safety, and corporate transparency, ensuring that all stakeholders—manufacturers, importers, distributors, and consumers—are well informed about the risks associated with tobacco and e-cigarette products.

For businesses in the tobacco industry, the implications of PerBPOM 18/2025 are far-reaching. Manufacturers, importers, and distributors will need to implement robust internal procedures for compliance with the new labeling, ingredient disclosure, and testing requirements. Ensuring that products meet these updated regulations will be essential for maintaining legal market access and avoiding potential sanctions or penalties from BPOM.

Ultimately, the introduction of PerBPOM 18/2025 is a clear signal that Indonesia is committed to enhancing public health through stricter oversight and regulation of the tobacco and e-cigarette sectors. As the regulatory landscape evolves, it is crucial for all businesses involved in these industries to stay ahead of the changes and ensure full compliance with the new rules to protect both consumer health and their operational interests.

Key Areas of PerBPOM 18/2025: Expanded Surveillance Coverage and New Obligations

The PerBPOM 18/2025 regulation introduces significant changes to the regulatory framework governing tobacco and e-cigarette products in Indonesia, focusing on expanded surveillance, increased transparency, and enhanced safety standards. These updates emphasize BPOM’s enhanced role in overseeing the composition, production, and distribution of tobacco products. Below are the key areas that this new regulation covers:

A. Expanded Surveillance Coverage

The inclusion of ingredient and additive disclosure is part of a larger effort to ensure transparency in the tobacco industry. PerBPOM 18/2025 places a premium on accountability by requiring businesses to openly share critical data with the regulatory authorities. This transparency allows BPOM to monitor the market more effectively and ensures that any changes in product composition are subject to review and approval.

By enforcing these stringent guidelines, PerBPOM 18/2025 not only aims to protect consumers but also encourages businesses to adopt ethical production practices and maintain higher standards of product safety. Manufacturers who comply with these requirements will be better positioned in the market, benefiting from a reputation for trustworthiness and responsibility.

PerBPOM 18/2025 significantly expands the scope of BPOM’s regulatory authority over tobacco and e-cigarette products. This expansion ensures that the surveillance is not just limited to nicotine and tar content but includes a wider range of factors affecting public health and safety. The new regulation covers the following critical components:

1. Ingredient Disclosure: For the first time, tobacco product manufacturers and distributors are required to disclose the full list of ingredients used in their products. This includes all chemical compounds, flavorings, and other substances. The regulation mandates that any substances added to the tobacco product be reported transparently to BPOM. This change is designed to improve consumer awareness and enhance the overall safety of tobacco products in the market.
   • Rationale: The goal of ingredient disclosure is to provide consumers with the necessary information about what they are consuming, ensuring that the substances in tobacco products are not only legal but also scientifically proven to be safe for human health. It is also designed to facilitate better regulatory oversight, allowing BPOM to trace the components of tobacco products more effectively.
2. Health and Safety Compliance: PerBPOM 18/2025 emphasizes the importance of adherence to strict health and safety standards. Tobacco manufacturers, importers, and distributors must now comply with specific limits on the nicotine and tar content in their products. These limits have been established to protect public health by minimizing the harmful effects of tobacco consumption.
   • Regular Testing Requirement: In addition to complying with the maximum permissible nicotine and tar levels, businesses must also conduct regular testing on each product variant. This ensures that the composition of each tobacco product remains within the safety limits and helps monitor any potential deviations that could harm public health.
   • Testing Protocols: The regulation requires manufacturers to provide regular testing reports to BPOM, which will monitor whether the nicotine and tar content remain within the prescribed limits. These reports must be submitted for every new product variant, as well as for continuous batches of existing products, ensuring that tobacco products remain compliant with the safety standards.
3. Additives and Substances: One of the most significant updates in PerBPOM 18/2025 is the stringent regulation of additives used in tobacco products. While additives have been common in tobacco products for years, this regulation introduces new compliance measures.
   • Safety Testing of Additives: The regulation stipulates that any additives used in tobacco products must undergo scientific testing to prove that they do not pose a threat to human health. The additives must be subject to testing before distribution and throughout the distribution process. This includes testing for any chemical reactions, harmful emissions, or side effects that the additives might introduce.
   • Accredited Laboratories: All testing related to additives must be conducted in accredited laboratories that meet specific standards for health and safety. This ensures the reliability and accuracy of the results, allowing BPOM to trust the findings and take necessary action if a product violates safety standards. Manufacturers must submit the results of these tests to BPOM for evaluation and approval.
   • Continuous Monitoring and Compliance: The regulation also mandates that these tests be conducted periodically to ensure ongoing compliance. If a new batch of tobacco products is found to contain unsafe additives or chemicals, BPOM has the authority to take action, including issuing recalls or imposing fines on non-compliant manufacturers.

B. Transparency and Accountability

The inclusion of ingredient and additive disclosure is part of a larger effort to ensure transparency in the tobacco industry. PerBPOM 18/2025 places a premium on accountability by requiring businesses to openly share critical data with the regulatory authorities. This transparency allows BPOM to monitor the market more effectively and ensures that any changes in product composition are subject to review and approval.

By enforcing these stringent guidelines, PerBPOM 18/2025 not only aims to protect consumers but also encourages businesses to adopt ethical production practices and maintain higher standards of product safety. Manufacturers who comply with these requirements will be better positioned in the market, benefiting from a reputation for trustworthiness and responsibility.

C. Implications for Manufacturers, Importers, and Distributors under PerBPOM 18/2025

The expanded surveillance and new obligations under PerBPOM 18/2025 represent a significant shift in how tobacco products are regulated in Indonesia. Manufacturers, importers, and distributors of tobacco products must now undertake a proactive approach to ensure compliance with these updated regulations. Key implications for businesses include:

1. Updated Testing and Reporting Procedures: Businesses will need to implement new testing protocols for nicotine, tar content, and additives. This will require collaboration with accredited laboratories and the development of a robust internal process for submitting compliance reports to BPOM.
2. Increased Product Transparency: With the mandatory disclosure of ingredients and additives, businesses will need to establish a system for managing and reporting detailed product compositions. This might require revising product formulations to meet safety standards.
3. Legal and Financial Risks: Non-compliance with PerBPOM 18/2025 could result in legal actions, fines, and product recalls. Companies that fail to meet these new obligations risk losing their market access and facing damage to their reputation.
4. Consumer Trust: On the positive side, adhering to these regulations may enhance consumer trust in tobacco products. With clearer product labeling and safer formulations, manufacturers can present their products as safer, more transparent, and more responsible, potentially leading to higher consumer loyalty and market share.

Conclusion

The introduction of PerBPOM 18/2025 marks a pivotal moment in the regulation of tobacco and e-cigarette products in Indonesia. With its expanded surveillance, stricter health and safety standards, and increased transparency requirements, this regulation aims to better protect public health and enhance consumer confidence in the tobacco industry. By broadening BPOM’s regulatory scope to include not only traditional tobacco products but also e-cigarettes and their additives, the government seeks to address emerging health concerns while aligning with international best practices in tobacco control.

For manufacturers, importers, and distributors, PerBPOM 18/2025 introduces significant operational challenges, from the need for more rigorous testing and reporting procedures to ensuring full disclosure of ingredients and additives. However, these changes also present valuable opportunities for businesses that are proactive in adopting transparent, ethical practices. Companies that comply with the updated regulations can differentiate themselves in the market, gaining trust from consumers who are increasingly conscious of the health implications of tobacco and e-cigarette products.

Moreover, businesses in the tobacco sector must meet essential compliance requirements under PerBPOM 18/2025:

1. Obtaining Relevant Business Permits:
   Companies must secure the necessary business licenses to legally operate in the tobacco industry.
2. Complying with Nicotine and Tar Limits:
   Manufacturers must ensure their products do not exceed the maximum permissible levels for nicotine and tar.
3. Testing Nicotine and Tar Content:
   It is mandatory to conduct regular testing on every tobacco product variant to ensure that the nicotine and tar levels are within the approved limits.
4. Submitting Test Results to BPOM:
   All testing results must be reported to the Head of BPOM, ensuring continuous oversight and compliance with the regulation.

Ultimately, PerBPOM 18/2025 is a crucial step toward enhancing public health protections and establishing a more transparent, accountable tobacco industry in Indonesia. By staying ahead of the regulatory changes and ensuring compliance, businesses can continue to operate successfully while contributing to a healthier, more informed society.

ET Consultant is here to help guide you through the complexities of these regulatory changes. Our team of experts can assist you with securing the necessary permits, ensuring compliance with testing requirements, and facilitating transparent reporting to BPOM. We provide comprehensive services to ensure that your tobacco or e-cigarette products meet the highest standards, helping you stay ahead in a competitive and regulated market.

Contact ET Consultant today to get the expert support you need to navigate PerBPOM 18/2025 and ensure your business stays compliant while securing long-term success in Indonesia’s evolving tobacco market.

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ET Consultant is a Business Consultant and Legal Consultant Expert that provides support for local and multinational clients to start and manage their business operations in Indonesia. ET Consultant specializes in Business Incorporation, Licensing & Legal, Accounting & Taxes, Immigration, and Advisory Services.

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