https://dinastires.
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DOI: https://doi.
org/10.
38035/jlph.
https://creativecommons.
org/licenses/by/4.
Withdrawal of Processed Food And Cosmetic Products Without Bpom Distribution Permits Shelomita Putri Amelia1*.
Dwi Desi Yayi Tarina2 Faculty of Law.
Universitas Pembangunan Nasional AuVeteranAy Jakarta.
Jakarta.
Indonesia, 2210611205@mahasiswa.
Faculty of Law.
Universitas Pembangunan Nasional AuVeteranAy Jakarta.
Jakarta.
Indonesia, dwidesiyayitarina@upnvj.
Corresponding Author: 2210611205@mahasiswa.
Abstract: The circulation of processed foods and cosmetics without distribution permits from the Food and Drug Supervisory Agency (BPOM) continues to increase in line with high market This situation poses problems because products that have not undergone an evaluation process may contain hazardous ingredients and do not meet established safety and quality This study aims to analyze the mechanism for recalling unlicensed foreign products and the legal implications of recalling unlicensed processed food and cosmetic products from Normative legal research using a legislative, case, and conceptual approach is the methodology employed.
Research data was obtained through a literature study using p rimary, secondary, and tertiary legal materials.
The study's findings demonstrate that BPOM uses premarket and post-market oversight as part of a systematic supervisory mechanism.
Product recalls are carried out in layers, starting from administrative sanctions to legal action in the event of repeated violations.
The legal implications can take the form of technical guidance from BPOM and/or administrative sanctions such as warnings.
In conclusion.
BPOM's mechanism for recalling products without distribution permits emphasizes the importance of business actors' compliance with licensing regulations.
Keyword: BPOM.
Distribution Permit.
Product Recall INTRODUCTION In Indonesia, the circulation of processed foods and cosmetics without distribution permits from the Food and Drug Supervisory Agency (BPOM) is becoming increasingly troubling as public demand for them is rising.
This situation has created an opportunity for irresponsible businesses to market products without going through the quality, safety, and halal evaluation procedures mandated by regulations.
The presence of these unlicensed products carries the risk of containing hazardous ingredients, pathogenic bacteria, or untested chemicals that can cause allergic reactions, poisoning, and even long-term hormonal disorders.
Therefore, all products sold in Indonesia and abroad must be registered to obtain a distribution license number issued by BPOM.
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A distribution permit is an official approval issued by BPOM to a product after undergoing a process of safety, quality, and benefit evaluation.
Products that have obtained a distribution permit are declared fit for legal marketing in Indonesia.
Various products, ranging from processed foods, cosmetics, to medicines and supplements, can be approved through this licensing process (Rifda, 2.
According to a 2025 report by BPOM, between February 24 and March 19, 1,190 processed food distribution facilities throughout Indonesia were inspected.
As a result.
BPOM found that 68.
4% of the facilities complied with regulations, while the rest did not.
The BPOM conducted cyber patrols, in addition to offline inspections, to monitor the distribution of processed food products on digital platforms that did not meet the requirements, including ecommerce.
As a result.
BPOM found 4,374 links selling TIE food products, with the majority of products originating from abroad, such as Malaysia.
Japan.
Nigeria.
Singapore.
Australia, and Belgium (BPOM, 2025.
As for cosmetics.
BPOM officers found 205,133 pieces of illegal cosmetics .
,334 items/variant.
from 91 brands in circulation.
These findings consisted of 9% cosmetics without distribution permits, 17.
4% containing prohibited/hazardous ingredients, including blue-labeled skincare products that did not comply with regulations, 6% expired cosmetics, and 0.
1% injection cosmetics (BPOM, 2025.
Processed foods that do not have distribution permits indicate that they have not undergone food safety testing, meaning that their quality is not guaranteed and their contents cannot be accounted for.
Article 91.
of Law No.
18 of 2012 on food (Indonesian: UndangUndang Panga.
stipulates that a permit is required to distribute processed food.
The aim of this legal regulation is to ensure that food sold to consumers is of high quality, nutritionally safe, and has an appropriate nutrient content.
Meanwhile, for cosmetics.
Article 4 .
, of BPOM Regulation No.
21 specifies that authorization must be obtained in order to distribute (Indonesian: Peraturan BPOM tentang Tata Cara Pengajuan Notifikasi Kosmetik.
, which explicitly states that in order to ensure that cosmetics distributed in Indonesia meet the criteria, business operators are required to distribute cosmetics that have obtained a distribution permit in the form of a notification.
Once a commercial operator has satisfied the necessary conditions to apply for a cosmetics distribution permit, the notification becomes an authorization granted by the director of the Food and Drug Supervisory Agency (BPOM) for that operator to distribute cosmetics in Indonesia.
The criteria that must be met to obtain a distribution permit are specified in Article 2 of BPOM Regulation No.
21 of 2022 concerning Procedures for Submitting Cosmetic Notifications (Indonesian:
Peraturan BPOM tentang Tata Cara Pengajuan Notifikasi Kosmetik.
, namely criteria for safety, efficacy, quality, labeling, and claims.
The National Drug and Food Control Agency (BPOM) oversees food and drug control in Indonesia.
It is dispersed throughout all provinces to allow for regional oversight.
In its capacity as an organization authorized to carry out drug and food supervision in Indonesia.
BPOM seeks to enhance its role, efficacy, and efficiency.
BPOM legally able to supervise products that are in circulation across Indonesia by enforcing and creating restrictions on food and pharmaceuticals (Antasia & Tarina, 2.
The BPOM, which is the Food and Drug Supervisory Agency, has the obligation to controlling the supply, distribution, and trade of food and drugs in Indonesia.
BPOM not only supervises drugs, but also food, cosmetics, and raw materials used in production.
The existence of BPOM is very important to ensure that goods sold on the market have undergone a rigorous testing and approval process.
According to Article 3.
letter d of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Supervisory Agency (Indonesian: Peraturan Presiden tentang BPOM).
The BPOM can carry out its duty of overseeing medicines and food by undertaking pre-market and post-market 558 | P a g e https://dinastires.
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Subsequently, pursuant to Article 4 of Presidential Regulation No.
80 of 2017 on the Food and Drug Supervisory Agency (Indonesian: Peraturan Presiden tentang BPOM).
BPOM has several tasks related to drug and food supervision, namely: .
issue permits and certificates for the distribution of products in accordance with safety, quality, and efficacy/benefit standards and requirements, in addition to conducting food and drug testing in accordance with regulatory standards and laws.
performing investigative activities related to drug and food supervision as mandated by prevailing laws and regulations.
enforcing administrative penalties as stipulated by applicable laws and regulations.
Products that do not have BPOM distribution permits pose significant risks because they have not undergone safety and efficacy evaluations in accordance with established Without official permits, the composition of ingredients in these products is not guaranteed to comply with regulations, thereby posing potential health risks ranging from skin irritation to long-term consequences that can be fatal (Ayang, 2.
Previous research conducted by (Gundokesumo & Amir, 2.
shows that supervision has a multidimensional and complex scope, requiring a holistic supervisory approach from the production stage to the distribution of products to the public.
Furthermore, it points out that the government has the legal authority to impose administrative and criminal penalties for any detected violations.
The current BPOM monitoring mechanism can be said to be reactive in Based on the findings of a study carried out by (Marchella et al.
, 2.
, monitoring of the distribution of illegal products in the rapidly changing digital space has not been handled optimally, because the BPOM mechanism is still more reactive in nature.
Although regulations have established criminal and administrative sanctions, the practice of marketing and selling illegal cosmetics continues to grow rapidly.
This study emphasizes the urgency of transforming the BPOM's oversight model from a conventional, passive approach to a more proactive system, through consumer education efforts and building strategic collaborations with digital platform providers.
Previous research by (Rahmawati et al.
, 2.
mentions weaknesses in the food risk classification system, the Import Certificate (SKI) mechanism that only emphasizes administrative aspects, and weak distribution of supervision in the field.
Administrative efforts undertaken by BPOM, such as product recalls, suspension of distribution permits, and inspection of distribution facilities, are considered to be reactive in nature and have not had a strong preventive effect.
This situation has opened the door for some businesses to continue distributing products without distribution permits.
Even though the requirement to obtain distribution permits for processed foods and cosmetics is clearly outlined in laws and regulations, in the case of Court Decision No.
179/Pid.
Sus/2024/PN Sbs (Indonesian: Putusan Pengadila.
, a business operator named Ferry Sukmawan, owner of Toko Aneka Sembako, was found guilty of producing or distributing pharmaceutical preparations and processed foods without distribution permits or business licenses.
To provide a clearer picture of the tests, below is one of the products found at Toko Aneka Sembako that did not have distribution authorization from the Indonesian Food and Drug Agency (BPOM).
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Source: .
MAGGI .
, .
Dove .
ize 10, cente.
Figure 1.
one of the processed foods without distribution permits .
one of the cosmetics without distribution permits Taking into account the aforementioned background, this study is undertaken to conduct a legal analysis under the title AuWithdrawal Of Processed Food And Cosmetic Products Without Bpom Distribution Permits.
Ay This study will discuss the mechanism for recalling processed food and cosmetic products without BPOM distribution permits and the legal implications of recalling processed food and cosmetic products without BPOM distribution permits.
METHOD
This research is a type of legal normative research, which means that its focus is on analyzing the implementation of norms or rules in positive law (Efendi & Ibrahim, 2.
This type of research is conducted through the study of formal legal tools, such as legal theories, laws, court rulings, and the views of prominent jurists.
These are then combined with the issues that are the focus of the debate.
The approaches adopted in this research to examine the issues consist of the case approach, the conceptual approach, and the statutory approach.
The legal instruments employed in this study comprise Law No.
18 of 2012 on Food (Indonesian:
Undang-Undang Panga.
Law No.
17 of 2023 on Health (Indonesian: Undang-Undang Kesehata.
BPOM Regulation No.
19 of 2020 concerning Guidelines for the Follow-up Supervision of Drugs and Drug Substances (Indonesian: Peraturan BPOM tentang Pedoman Tindak Lanjut Pengawasan Obat dan Bahan Obat.
) along with other relevant regulatory The case used is based on Court Decision Number 179/Pid.
Sus/2024/PN Sbs (Indonesian: Putusan Pengadila.
This study draws upon secondary data, consisting of three categories of legal materials, with primary legal materials covering statutes and regulatory secondary legal materials, which are sources that explain primary legal materials such as textbooks, journals, expert opinions, and jurisprudence, with an example used in this study being Court Decision Number 179/Pid.
Sus/2024/PN Sbs (Indonesian: Putusan Pengadila.
and tertiary legal materials serve as supplementary references that offer clarification and guidance in interpreting both primary and secondary legal sources.
These include resources such as the Kamus Besar Bahasa Indonesia (Great Dictionary of the Indonesian Languag.
, legal dictionaries, and various internet-based media.
This research also used a data collection method based on bibliographic research, which involved searching for different related legal works, such as legal theories, legislation, and court rulings.
RESULTS AND DISCUSSION
Mechanism for Withdrawing Processed Food and Cosmetic Products Without BPOM Distribution Permits BPOM's supervisory mechanism is implemented through Pre-Market and Post-Market These procedures aim to assess whether products on the market are safe, provide the claimed benefits, and do not harm consumers.
Pre-Market supervision is carried out when 560 | P a g e https://dinastires.
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manufacturers, importers, or traders register with BPOM and during the verification of integrity and verification of documents and goods at the main port or airport, which is carried out by customs officers.
For processed foods, in carrying out its duty to supervise the distribution of food.
BPOM issued BPOM Head Regulation Number HK.
145 (Indonesian:
Peraturan Kepala BPOM) concerning Supervision of Processed Food Imports.
After the inspection period is complete, applicants will be given a distribution permit by BPOM with an Overseas Food (ML) code and an Import Certificate (SKI).
This section must answer the problems or research hypotheses that have been formulated previously (Hera Natalia & Prasetyo, 2.
For cosmetics.
Law No.
36 of 2009 on health regulates (Indonesian: Undang-Undang Kesehata.
this pre-market approach in Article 106.
Section 1.
This law establishes that pharmaceutical and healthcare products are only permitted to be distributed if they have marketing authorization.
Based on BPOM Regulation No.
23 of 2019 concerning Technical Criteria For Cosmetics (Indonesian: Peraturan BPOM tentang Kriteria Teknikal Kosmeti.
, every claim of benefit on cosmetic products must be proven with adequate scientific data.
Additionally, all cosmetic products distributed in Indonesia must have a BPOM Notification as a pre-distribution permit, in accordance with the mandate of Regulation No.
1176/MENKES/PER/Vi/2010 of the Minister of Health (Marchella et al.
, 2.
Subsequently, post-market surveillance is implemented once a product has been granted a distribution permit, with the objective of ensuring continued compliance with the established safety and quality standards (Suyudi et al.
, 2.
The inspection of imported food products is conducted in the same manner as that of domestically produced food.
The National Agency for Drug and Food Control (BPOM) takes samples of product labels and food items to determine their quality during these regular inspections.
In relation to cosmetics, inspections encompass not only the evaluation of product composition but also the accuracy and completeness of labeling, in order to prevent the dissemination of misleading information to consumers.
The format of the notification of the permit number for distributing cosmetics.
The notification itself is NX 12345678901.
X is a letter from A to E, which represents the continent of origin of the cosmetics, such as A for Asia.
B for Australia.
C for Europe.
D for Africa, and E for America, followed by eleven digits.
Meanwhile.
MD/ML 123456789012 is the license number for distributing processed foods.
MD refers to the distribution authorization number for domestic processed foods, and ML is the distribution authorization number for foreign processed foods.
In Case No.
179/Pid.
Sus/2024/PN Sbs (Indonesian: Putusan Pengadila.
, a business owner named Ferry Sukmawan, owner of Toko Aneka Sembako, was found to be selling processed food and cosmetic products without a distribution permit.
After officials from the Food and Drug Control Agency (BBPOM) in Pontianak.
Indonesia, obtained the information, this was discovered.
The Enforcement Team from BBPOM Pontianak visited the store and conducted inspections inside the premises and the warehouse of Toko Aneka Sembako.
This was not the first time the business owner had been inspected.
he had previously been inspected and issued a warning.
Nine types of pharmaceutical products and twenty types of processed foods were found, all of them originating from Malaysia and without authorization for distribution by the Indonesian Food and Drug Control Agency (BPOM).
The details of the seized products can be seen in the following table:
Table 1.
List of Cosmetics and Processed Food Products Without BPOM Distribution Permits No.
Nama Produk Kelompok Produk Minyak Masak Tigab Gula Pasir PRIAI Garam CYK Pangan Pangan Pangan 561 | P a g e https://dinastires.
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Popo MARUKU Ikan Pangan Pop MARUKU Ikan (Peda.
Pangan Dairy Champ (Krimer Mani.
500 gr Pangan Dairy Champ (Krimer Mani.
1 kg Pangan Mie Maggi Rasa Ayam Pangan Mie Maggi Rasa Kari Pangan Gula Pasir Super Pangan Pico Stix Pangan Milo 200 gr Pangan Milo 400 gr Pangan Milo 1 kg Pangan Double Lion Rasa Sarsi Pangan Double Lion Rasa Mangga Pangan Double Lion Rasa Tebu Pangan Sosis Valey Fresh Frankvurter Pangan Minyak Masak BZ Pangan Minyak Masak Cap Gold Palm Oil Pangan Summer Naturale Royal Jely Kosmetik Summer Naturale GoatAos Milk Kosmetik Summer Naturale Green Tea Kosmetik Summer Naturale Rose Kosmetik Summer Naturale Pamelo Kosmetik Armoni Naturale Green Tea Aloevera Kosmetik Armoni Naturale Rose Corn Flower Kosmetik Dove Beauty Cream Kosmetik Message Oil Sunflower Kosmetik Source: Court Decision Number 179/Pid.
Sus/2024/PN Sbs (Indonesian: Putusan Pengadila.
Based on an interview with one of the sources from the Pontianak POM Center, the first step taken in withdrawing unauthorized foreign products is for the supervisory team to conduct routine field inspections to ensure that the products in circulation comply with distribution permit requirements.
If violations are found, the initial step taken is to impose administrative sanctions in the form of warning letters.
If the business operator ignores the sanction and continues to repeat the violation.
BPOM can escalate its actions to a more decisive stage, namely legal action.
This action is no longer limited to administrative sanctions, but continues to the judicial process as a form of law enforcement for distribution permit violations.
Aspects that are taken into consideration during the inspection process include compliance with product labeling requirements, distribution permits, expiration dates, and In Case No.
179/Pid.
Sus/2024/PN Sbs (Indonesian: Putusan Pengadila.
, the labeling requirements were not met.
Labeling is comprehensive information regarding efficacy, safety, and usage instructions, as well as other information related to the product, which is included on the label and/or brochure attached to the packaging.
For cosmetics.
Article 5.
of Food and Drug Supervisory Agency Regulation Number 30 of 2020 concerning Technical Requirements for Cosmetic Labeling (Indonesian: Undang Ae Undang tentang Persyaratan Teknis Penandaan Kosmeti.
stipulates that the information on cosmetic labeling must at least include details regarding: .
the name of the cosmetic.
its benefits/uses.
how to use it.
its composition.
the country where the product is manufactured.
name and complete address of the notification number holder.
the batch identification number.
the dimensions, content, or net weight.
expiration date.
notification number.
2D barcode.
any necessary warnings and/or precautionary statements.
For processed foods.
According to Article 5.
of Food and Drug Administration Regulation No.
20 of 2021, amending Regulation No.
31 of 2018 on Processed Food Labels (Indonesian: Undang Ae Undang tentang Label Pangan Olaha.
, the label referred to must 562 | P a g e https://dinastires.
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contain at least the following information: .
the name of the product.
a specification of the ingredients utilized.
the net weight or volume.
the identity and address of the manufacturer or importer.
halal certification where required.
the production date and corresponding batch code.
expiration date.
distribution permit number.
the source of particular food The information in letters a, c, d, e, g, and h must be placed on the label in a location that is easy to see and read.
It was found that processed food and cosmetic products sold at Toko Aneka Sambas did not comply with the labeling requirements stipulated by law.
According to the findings of the review conducted by the Pontianak BBPOM, the packaging of these cosmetic items did not contain the name and address of the notification number owner, the number itself, or the distribution license, nor did it include a 2D barcode.
Meanwhile, the manufacturer's or importer's name and address, halal certification .
f require.
, and distribution permission number were not included on processed food product packaging.
Accordingly, this product recall is categorized as a Class i action pursuant to Article 12.
of BPOM Regulation No.
22 of 2025 on the Recall and Destruction of Processed Food (Indonesian: Peraturan BPOM tentang Penarikan dan Pemusnahan Pangan Olaha.
This classification denotes a scenario in which the food product in question presents no adverse health effects, but fails to comply with specific legislative stipulations that are not covered under the purview of Class I or Class II Consequently.
Pre-Market and Post-Market supervision is used to create procedures that enable BPOM to withdraw cosmetic products and processed foods that do not have distribution Administrative sanctions are applied first if violations are found, and if the violations continue to be ignored, the case can be brought to court.
This process demonstrates how BPOM supervision is carried out in a gradual and systematic manner to ensure that all products on the market meet the applicable marketing authorization standards.
Legal Implications of Withdrawing Processed Food and Cosmetic Products Without BPOM Distribution Permits All processed foods manufactured domestically or imported and sold in retail packaging must meet safety, quality, nutrition, and labeling standards as established by law.
This is stipulated in Article 2.
of BPOM Regulation No.
23 of 2023, which refers to the registration of processed foods .
n Indonesian: Peraturan BPOM tentang Registrasi Pangan Olaha.
Meanwhile, for cosmetics.
Article 1.
of Law No.
36 of 2009 concerning Health (Indonesian:
Undang - Undang Kesehata.
states that cosmetics are classified as pharmaceutical preparations, meaning that cosmetic products can only be distributed if they have obtained an authorization for distribution issued by the Food and Drug Supervisory Agency (BPOM) in accordance with BPOM Regulation Number 44 of 2013 and have met the requirements stipulated in Article 106 of Law Number 36 of 2009 concerning Health (Indonesian: Undang Ae Undang Kesehata.
, which states that .
Medical devices and pharmaceutical preparations may only be distributed after authorization to do so has been obtained.
The information and labeling of medical devices and pharmaceutical preparations must not be misleading, and must be comprehensive and objective.
The government possesses the competence to withdraw circulation licenses and mandate the recall of medical devices and pharmaceutical products which, although previously authorized, fail to comply with established standards of efficacy, safety, or quality.
In such circumstances, the products may be subject to seizure and destruction in accordance with prevailing legal provisions.
After a violation committed by a business operator is discovered, it may be subject to technical guidance and/or administrative sanctions.
The provisions in Article 5.
of BPOM Regulation Number 19 of 2020 concerning Guidelines for Follow-up on Drug and Drug Ingredient Supervision (Indonesian: Peraturan BPOM tentang Pedoman Tindak Lanjut 563 | P a g e https://dinastires.
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Pengawasan Obat dan Bahan Oba.
state that technical guidance is an action carried out by officers in the context of guidance on improving the management of drugs and drug ingredients at production facilities.
Distribution Facilities.
Pharmaceutical Service Facilities, and PSE/PSEF, and if based on the results of supervision, violations are found that fall into the minor category and/or less than 6 .
findings that fall into the major category.
Article 6.
of BPOM Regulation No.
19 of 2020 establishes administrative sanctions related to guidelines for follow-up on the supervision of drugs and active ingredients (Indonesian: Peraturan BPOM tentang Pedoman Tindak Lanjut Pengawasan Obat dan Bahan Oba.
, which states that administrative sanctions include .
stern warnings.
temporary suspension of activities.
suspension of CPOB Certificates.
revocation of the CPOB Certificate.
recommendation to freeze the pharmaceutical industry license.
freezing of the distribution license.
revocation of the distribution license.
recommendation to close or block the Electronic System used for online Drug Distribution.
recommendation to revoke the pharmaceutical industry license.
recommendation to revoke the Distribution Facility license/recognition.
revocation of the CDOB Certificate.
recommendation for revocation of the Pharmaceutical Service Facility license.
and/or .
temporary distribution ban and/or order for the recall of Drugs or Drug Ingredients from distribution.
Continued in Article 7 of BPOM Regulation Number 19 of 2020 concerning Guidelines for Follow-up on Drug and Drug Ingredient Supervision (Indonesian: Peraturan BPOM tentang Pedoman Tindak Lanjut Pengawasan Obat dan Bahan Oba.
, article 6 mentions the application of administrative sanctions, but that does not mean that civil and/or criminal sanctions cannot be imposed in conformity with the stipulations set forth in statutory and regulatory provisions.
In Case No.
179/Pid.
Sus/2024/PN Sbs (Indonesian: Putusan Pengadila.
, the business operator was subjected to criminal sanctions because in 2022 guidance had already been provided by the Pontianak Food and Drug Supervisory Agency (BBPOM).
At that time, the operator was proven to have produced, stored, and distributed pharmaceutical preparations without the required distribution permit.
Despite receiving warnings and opportunities to improve business management, no effort was made to fulfill legal obligations, including the submission of a business license application in accordance with prevailing regulations at both the central government and Sambas regency levels.
This pattern of repeated non-compliance indicates that administrative sanctions were no longer effective in ensuring adherence to the Therefore, law enforcement authorities escalated the matter to the criminal domain as a repressive legal measure, intended to create a deterrent effect and to emphasize the obligation of business operators to comply with licensing requirements for pharmaceutical and food Thus, the legal consequences of removing processed foods and cosmetic products from the country without a circulation license show that the Food and Drug Supervisory Agency (BPOM) has extensive authority, which includes not only providing technical advice and imposing administrative penalties, but also taking cases to court to apply criminal penalties if violations are committed on a regular basis.
This confirms that the recall of products without distribution permits is not merely a routine administrative action, but has real and serious legal The existence of this legal mechanism implies that business actors are required to always comply with applicable licensing provisions, as non-compliance will result in more severe legal risks.
In addition, the application of criminal sanctions also serves as a repressive instrument intended to provide a deterrent effect and ensure that business practices are in line with national safety, quality, and regulatory standards.
Thus, this regulation not only protects product distribution governance but also affirms the strategic role of BPOM in enforcing legal certainty in the food and cosmetics sector.
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CONCLUSION
A methodical and progressive supervisory system is put in place by the Food and Drug Supervisory Agency (BPOM).
This mechanism consists of Pre-Market supervision, which is carried out through product feasibility verification before distribution permits are granted, and Post-Market supervision, to ensure that products that have been distributed continue to meet safety, quality, and labeling requirements.
In the context of law enforcement, when violations such as the distribution of products without a license are found.
BPOM applies tiered measures starting with administrative sanctions.
These sanctions can escalate to criminal charges if the business operator shows non-compliance and repeats the violation.
The legal implications for business actors who distribute products without a distribution permit are clearly regulated in various laws and regulations, including the Indonesian Health Law (Law No.
36 of 2.
, the Food Law (Law No.
18 of 2.
, as well as the Food and Drug Administration Regulation No.
19 of 2020 on Guidelines for the Follow-up Supervision of Medicines and Pharmaceutical Substances, and a number of other BPOM regulations.
These regulations mandate various sanctions, ranging from administrative to criminal sanctions.
reflected in Court Decision Number 179/Pid.
Sus/2024/PN Sbs, business actors who have received prior guidance but continue to commit violations can be subject to criminal sanctions.
Thus, the applicable legal framework not only emphasizes the imperative of compliance with licensing and product standards but also reinforces BPOM's strategic role in protecting consumers through progressive and firm law enforcement instruments.
REFERENCE