Despite the landmark passage of the 1938 Federal Food, Drug, and Cosmetic Act...
Legal consequences of selling products in Indonesia without obtaining BPOM ML registration
2026-05-12
As the largest economy in Southeast Asia, Indonesia has a strict regulatory system for market access of food, pharmaceuticals and cosmetics.BPOM（Food and Drug Monitoring Agency）The Indonesian Food and Drug Regulatory Agency (BFDA) is the core enforcement agency responsible for pre-market approval and post-market surveillance of products. Any product sold in Indonesia without a BPOM ML (Makanan Luar Negeri/Imported Processed Food) registration number is illegal and faces multi-layered legal risks, ranging from administrative penalties to criminal prosecution.
Core legal basis
Indonesia's regulation of unregistered products is not based on a single regulation, but rather on a comprehensive system comprised of multiple laws:
1. Food Law No. 18 of 2012 (Undang-Undang No. 18 Tahun 2012 tentang Pangan)
This is the fundamental law for Indonesia's food sector, covering the entire regulatory chain from production and import to sales. Article 142 of the law clearly stipulates that anyone who intentionally sells unregistered processed food within the country will face severe sanctions.
2. Health Law No. 17 of 2023 (Undang-Undang No. 17 Tahun 2023 tentang Kesehatan)
The law was promulgated in 2023, replacing the Health Law No. 36 of 2009, and further strengthened the control over the circulation of medicines and food.Article 435It is one of the most frequently cited provisions in BPOM enforcement in recent years, and is used in conjunction with Section 138 to constitute the basis for criminal prosecution of violators.
3. Consumer Protection Act No. 8 of 1999
Article 19 of the law prohibits businesses from making false or misleading statements about their products, while Articles 60 to 63 stipulate administrative and criminal penalties, respectively.
4. BPOM Ordinance No. 27/2017 and Ordinance No. 14/2024
Regulation 27 of 2017 detailed the specific requirements for BPOM registration, while Regulation 14 of 2024 specifically addresses...Online (electronic system) circulationThe products have been fully updated, the scope of supervision has been expanded, and the procedures for removing and withdrawing products after online verification have been clarified.
Administrative penalty (Sanksi Administratif)
For first-time or minor violations of unregistered products, the BPOM may impose administrative penalties in accordance with the law. According to BPOM Regulation No. 19/2025 regarding the follow-up processing of regulatory results, the types of administrative penalties include:
Written warning (Peringatan Tertulis)—Those who violate the rules are required to rectify the situation within a specified period.
Activities or product distribution suspended (Penghentian Sementara Kegiatan atau Peredaran)— Immediately freeze the sale and distribution of the products in question.
Product recall and destruction order (Perintah Penarikan dan Pemusnahan Produk)—Force the recall and destruction of products from all distribution channels
Freezing or revoking registration number/circulation license (Pembekuan atau Pencabutan Sertifikat dan Izin Edar)—This completely destroys the product's legitimate market position.
It is recommended to revoke the business license (Rekomendasi Pencabutan Izin Usaha).—By coordinating with the industry and commerce departments, the operating qualifications of non-compliant enterprises can be terminated at the root.
It is important to note that administrative penalties do not equate to exemption from criminal liability. BPOM has the authority to transfer a case to criminal investigation proceedings simultaneously with imposing administrative penalties.
Criminal punishment (Sanksi Pidana)
According to Article 142 of the Food Law
According to Article 142 of the Food Law No. 18 of 2012,Individuals or businesses that intentionally sell processed food without obtaining a distribution licenseHe may be sentenced to:
Maximum 2 years imprisonment
A fine of up to 4,000,000,000 Indonesian Rupiah (approximately 4 billion Indonesian Rupiah / approximately 1.8 million RMB) is possible.
Former BPOM Director Penny once publicly stated regarding the seizure of illegal beverages, "Unregistered food cannot guarantee its safety, quality, and nutritional value, and producers may add any substance to it—this is a criminal act that endangers human health."
According to Article 435 of the Health Law
Articles 435 and 138 of the Health Law (No. 17 of 2023) provide a stronger basis for criminal prosecution:
Maximum 12 years imprisonment
A fine of up to 5,000,000,000 Indonesian Rupiah (approximately 5 billion Indonesian Rupiah / approximately 2.25 million RMB) is possible.
This clause primarily applies to cases involving health hazards or aggravating circumstances. In July 2025, BPOM targeted unregistered Australian health supplements sold on e-commerce platforms.Blackmores Super Magnesium+In one case, this provision was invoked to pursue criminal charges against the relevant distributors. BPOM explicitly warned that distributing unregistered health products could lead to criminal charges under Section 435.
According to Articles 61-62 of the Consumer Protection Law
Article 62 of the Consumer Protection Law (No. 8 of 1999) stipulates:
Maximum 5 years imprisonment
A fine of up to 2,000,000,000 Indonesian Rupiah.
In practice, when a product is not only unregistered but also contains harmful ingredients, law enforcement agencies can take action against violators based on multiple legal provisions.Superimposed penaltiesFor example, violating both Article 142 of the Food Law regarding unlicensed distribution and Article 435 of the Health Law concerning health hazards will result in penalties for both offenses.
Corporate criminal liability (Korporasi)
Indonesian legal system recognizesCorporate criminal liability capacityAccording to relevant laws and regulations, when the violator is a legal entity (company):
Additional finesThe maximum fine that can be imposed on an individual can be imposed on a company.3 times
Additional penalties：
Revoke specific rights
Court judgment announcement (causing devastating damage to the company's reputation)
Company dissolution
This means that not only could the company's executives go to jail, but the company itself could also face the most serious consequence of being ordered to dissolve.
New regulations in 2024: Upgraded supervision of online circulation.
In 2024, BPOM was released.Ordinance No. 14/2024(PerBPOM No. 14 Tahun 2024), replacing the previous Regulation No. 8/2020, imposes stricter regulations on products distributed online:
Expand coverageAll medicines and food sold through electronic systems (e-commerce platforms, social media, self-built websites, etc.) are subject to regulation.
Online verification obligationThe platform must verify the authenticity of the BPOM registration number uploaded by the merchant.
Quick removal mechanismOnce it is confirmed that a product is not registered, BPOM can request the platform to remove the product link within a specified time.
Coordinated law enforcementBPOM establishes joint law enforcement channel with the Ministry of Communications and Digital Affairs (Kemenkomdigi)
This means that even foreign brands that sell only on e-commerce platforms and have no physical stores cannot bypass BPOM ML registration.
BPOM ML Registration: An Inviolable Legal Bottom Line
Indonesian BPOM ML registration is not an optional compliance program, but rather...The legal bottom line for the legal sale of imported processed foods in the Indonesian marketFrom written warnings to up to 12 years imprisonment and fines of up to 5 billion Indonesian Rupiahs, Indonesian law has constructed a comprehensive network of penalties covering administrative, civil, and criminal offenses. New regulations in 2024 and continuously upgraded e-commerce supervision have further squeezed out the gray areas.
For any foreign brand that wishes to cultivate the Indonesian market long-term"Register first, then sell" is not a suggestion, but a legal obligation that must be followed.The costs of violating regulations—whether financial losses, damage to brand reputation, or personal freedom—far outweigh the investment in compliance itself.