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INDONESIA
Eruditio : Indonesia Journal of Food and Drug Safety
Published by Badan Pengawas Obat dan Makanan
ISSN : 27472493     EISSN : 28076222     DOI : https://doi.org/10.54384
Core Subject : Health, Science, Agriculture,
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemistry Medicine & Pharmacology Public Health
Eruditio : Indonesia Journal of Food and Drug Safety adalah jurnal yang diterbitkan oleh Pusat Pengembangan Sumber Daya Manusia Pengawasan Obat dan Makanan (PPSDM POM), Indonesia. Jurnal ini memuat hasil kajian dan kajian literatur di bidang keamanan Obat dan Makanan.
Arjuna Subject : Pharmacology, Toxicology and Pharmaceutics - Ilmu Farmasi
Articles 86 Documents
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Studi Stabilitas Baku Pembanding Glukosamin Hidroklorida: Penerapan ISO 17034:2016 dalam Memastikan Kualitas dan Validitas Pengujian Farmasi Neni Isnaeni
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 2 (2025): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i2.205

Abstract

Reference standards are essential in drug and food control to ensure the quality and validity of test results. According to ISO 17034:2016, the Center for National Quality Control Laboratory of Drugs and Food (PPPOMN), as a producer of reference materials, must evaluate and monitor the stability of the standards it produces. Stability testing is critical to maintain product quality during storage and use. However, PPPOMN-developed reference standards had not undergone stability testing to determine shelf life. This study therefore conducted a stability assessment of the Glucosamine hydrochloride reference standard to ensure stability during transportation, distribution, and storage. Long-term stability tests were conducted at 4–8°C at 0 months (control), 72 months, and 144 months. Short-term stability tests were performed at 25°C and 60°C for 72, 120, 168, and 240 hours, with 0 hours as the control. Stability analysis was performed using validated High-Performance Liquid Chromatography (HPLC), and analyte stability was assessed using a t-test. Results indicated that the Glucosamine hydrochloride secondary reference standard remained stable under recommended storage conditions for 144 months and at distribution temperatures up to 60°C for 240 hours (t-count = 0.976). These findings demonstrate that the reference standard maintains its quality under specified conditions, ensuring the reliability and validity of pharmaceutical testing. The study concludes that the glucosamine hydrochloride reference standard has guaranteed quality and can be used as long as it is stored under the recommended conditions and shelf life. Information regarding storage conditions and shelf life can be included on the reference standard label.
Profile of Natural Medicine Registration Document Compliance for Stunting Prevention in 2021–2023 Rima Dwi Pratiwi; Erna Rahmawati
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 2 (2025): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i2.219

Abstract

Stunting is one of the indicators of social and economic problems in a country. As part of efforts to prevent stunting, one of the strategies that can be implemented is the use of herbal medicines. This study examines the registration process for herbal medicines aimed at preventing stunting, submitted to the Indonesian Food and Drug Authority (Badan POM) between 2021 and 2023. A total of 900 products have been registered with an increasing annual trend, indicating high interest from businesses in producing and registering these products. Although awareness of the importance of product registration to ensure safety and quality has increased, there are still significant issues related to the incompleteness of the necessary documents. This research showed that, on average, 77% of product submissions were still incomplete, particularly from the UKOT group, which accounted for 90%. This analysis found that aspects of quality and labeling often failed to meet the standards set by Badan POM Regulation No. 25 of 2023. The study suggests that simplifying the registration procedures and more targeted interventions, such as the provision of educational materials and more intensive training, can help address these issues. Additionally, the research recommends further surveys to specifically identify the obstacles faced by businesses, which will assist in the design of more effective policies to support the improvement of quality and speed in the product registration process in the future.
Analysis of Trends in Cosmetics Supervision Cases in Indonesia in 2021-2024 Mohamad Kashuri; Taruna Ikrar; Gunawan Indrayanto
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 2 (2025): Edisi Juni
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i2.235

Abstract

This study offers a comprehensive analysis of cosmetic product regulation in Indonesia from 2021 to 2024, examining enforcement trends, patterns of regulatory non-compliance, and the evolving oversight role of the Indonesian Food and Drug Authority (BPOM). Data were obtained from BPOM’s annual inspection and enforcement reports and analyzed descriptively to identify changes in regulatory compliance over time. The results reveal that the majority of violations originated from Small and Medium-Sized Enterprises (SMEs), accounting for 1–2% of total cases, while larger industries reported slightly higher rates (2.7–6.9%). A significant 165% surge in products without distribution permits was recorded from 2021 to 2022, followed by substantial reductions in 2023 (85%) and 2024 (32%). Adherence to Good Cosmetic Manufacturing Practices (GCMP) showed a consistent improvement from 2022 onwards. Violations involving labeling, advertising, and product claims also declined, though more than 1,500 cases are still reported annually. Public education campaigns have played a crucial role in enhancing consumer awareness and minimizing exposure to unsafe products. Enforcement data further demonstrate a reduction in formal sanctions and warnings, reflecting BPOM’s strategic pivot toward a more preventive and facilitative regulatory approach. Looking ahead, BPOM needs to strengthen industry compliance by expanding its technical assistance initiatives through both direct consultations and digital platforms, supporting a more risk-based and innovation-friendly regulatory environment.
Studi Kandungan Residu Antibiotik Kloramfenikol pada Produk Pangan Olahan Madu, Udang, dan Ikan di Sulawesi dan Maluku Ma'rifah Ebtasari; Alifah Nur Aini
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.157

Abstract

Antibiotic residues in food products can cause significant public health problems. Using antibiotics in livestock farming can potentially cause antibiotic residues in animal-based foods. We conducted this study to determine the results of chloramphenicol residue testing in processed honey, shrimp, and fish food products in the Sulawesi and Maluku regions. This study can determine the distribution of test results based on business type. This study is expected to produce recommendations to stakeholders to minimize the use of chloramphenicol, which is not covered by the provisions. The research samples came from processed honey, shrimp, and fish food products distributed in the Central Sulawesi, Ambon, Sofifi, Mamuju, Morotai, and Tanimbar regions in 2021-2022. Testing was carried out at the laboratory of the Indonesian Food and Drug Authority Regional Office in Palu according to the analysis method of PPPOMN 071/PA/17 concerning the Determination of Chloramphenicol Residue Levels in Shrimp by ELISA and MA PPPOMN 11/PA/09 concerning the Determination of Chloramphenicol Residue Levels in Honey by ELISA. Based on the test results, processed honey, shrimp, and fish food products were found to contain chloramphenicol residues. Of the total 92 samples tested, there were 15 honey products, four processed shrimp food products, and seven processed fish food products that did not meet the requirements (TMS). Chloramphenicol residue levels ranged from 0.01 to 0.09 ppb. The number of TMS samples in honey and fish food products with PIRT distribution permits was more significant in percentage when compared to products with MD/ML distribution permits. The rate of TMS in honey and processed fish food products with PIRT distribution permits was 53% and 21%, respectively. Further research on the source of chloramphenicol residues and the origin of honey, shrimp, and fish-producing areas needs to be conducted by relevant institutions or academics. In addition, it is necessary to conduct socialization and education among the public regarding the use of chloramphenicol antibiotics according to the provisions for both the treatment of diseases and livestock practices to minimize the presence of chloramphenicol residues in processed food products.
Implementasi Regulatory Sandbox dalam Konteks Pengawasan Pangan Olahan di Indonesia Yulian Dwi Anggraeni Puspa Handoko; Andi Wibowo; Yovia Rizki Arrahman; Pepi Fauziah; Yuliani
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.172

Abstract

The enhancement of innovation in processed food products in Indonesia faces regulatory challenges that often limit the speed and flexibility of development, particularly for high-risk products. The recent implementation of the Omnibus Law has brought significant changes to the food oversight framework, including the exemption of criminal sanctions for low to medium-risk business activities and the transition of distribution permits into business licenses. However, these regulations have not fully addressed the barriers to innovation in processed food development. The concept of a regulatory sandbox has been identified as a promising prospective approach to overcoming these challenges, providing a controlled testing environment for businesses to develop innovative products within a more adaptive ecosystem. This article explores the potential of a regulatory sandbox as a creative tool for overseeing high-risk processed food products through a qualitative literature review method. The study indicates that the success of implementing a sandbox depends on several key factors: collecting robust experimental data to assess product safety and efficacy, developing adaptive procedures responsive to industry feedback, and granting limited yet flexible authorization for testing new technologies. Other factors, such as limitations on the duration, scope, and use of the sandbox, must be established to avoid consumer safety risks. As a recommendation, The Indonesian Food and Drug Authority (BPOM) may consider adopting a regulatory sandbox as a strategic framework to support the oversight of processed food products with a dynamic approach, accelerating innovation while maintaining a balance between consumer safety and industry growth.
Deteksi Salmonella spp pada pakan hewan laboratorium berbentuk pelet menggunakan Real Time Polymerase Chain Reaction (qPCR) dan Loop Mediated Isothermal Amplification (LAMP) Fitra Yovita Delviona P; Puspita Dewi Fortuna; Nur Aini
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.194

Abstract

Salmonella spp. contamination in animal feed is challenging for the commercial feed industry and laboratory animal facilities. Salmonellosis is a term used for Salmonella infection. Salmonellosis is a zoonosis directly transmitted to humans through contaminated feed, food, water, or infected animals. Nevertheless, infection in animals is mainly caused by contaminated feed. Since it provokes a significantly high economic loss due to its high mortality, accurate and rapid Salmonella detection methods are necessary for monitoring the quality of animal feed. The standard method for Salmonella detection in animal feed, which refers to ISO 6579, is based on the culture method, which takes about 5-7 days. Thus, an alternative method is required to give valid results faster. This study aims to develop alternative methods for Salmonella spp. detection in animal feed using Loop isothermal Amplification (LAMP) and Real-time Polymerase Chain Reaction (PCR) methods. Salmonella detection has been carried out on animal feed pellets artificially inoculated with Salmonella Typhimurium ATCC 14028 at three concentration levels, namely 1, 3, and 9 cfu per test portion (25-gram samples). e-LOD range values between the LAMP method and Real PCR are compared with the culture method and analyzed descriptively. Salmonella detection method using LAMP and Real-Time PCR showed the value e-LOD50 at 0.62 cfu/portion in mouse feed and e-LOD50 at 0.37 cfu/portion in rabbit feed. Compared to the LOD of the culture method, the e-LOD of LAMP and PCR showed similarity. This e-LOD value is the same as the e-LOD culture method. Related laboratories can utilize the results of this study to monitor the quality of animal feed.
Pengembangan Metode Analisis Penetapan Kadar Deksklorfeniramin Maleat Sediaan Tablet Secara Kromatografi Cair Kinerja Tinggi Detektor UV Lilik Budiati; Nurul Ilmiyati
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.203

Abstract

Dexchlorpheniramine maleate, an antihistamine for allergy treatment, is traditionally tested in tablet form using the UV spectrophotometric method referenced in United States Pharmacopeia (USP), NF 43. However, this method struggles to separate the active compound from other tablet components, such as dyes, necessitating an extraction process. Extraction has several drawbacks, including high waste production, extensive use of costly pure solvents, prolonged preparation times, and reliance on hazardous volatile solvents. This study aims to develop a safer, more efficient, and effective method using high-performance liquid chromatography (HPLC), modified from the USP, NF 43 standard. The experimental approach involves method development and validation, focusing on selectivity, precision, accuracy, linearity, and robustness. The selectivity test demonstrated a resolution value 19.6 between dexchlorpheniramine and maleic acid peaks. The specificity test confirmed identical retention times and spectra between standard and sample peaks. Precision testing yielded a relative standard deviation (RSD) below 0.37%. Accuracy tests at 80%, 100%, and 120% levels achieved an average recovery of 99% within the 97%–103% acceptance range. Linearity testing resulted in a correlation coefficient (r) 1.00 and Vx0 of 0.1. ANOVA test results on Robustness testing revealed no significant differences with column modification but identified sensitivity to pH and mobile phase composition changes. In conclusion, the developed HPLC method meets validation parameters, providing a reliable alternative for analyzing dexchlorpheniramine maleate tablets, with attention to pH and mobile phase suitability.
Audit Komunikasi Program Intervensi Keamanan Pangan Jajanan Anak Sekolah Balai Besar Pengawas Obat dan Makanan di Yogyakarta Wulandari Wulandari; Basuki Agus Suparno; Prayudi Prayudi
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.206

Abstract

Unsafe school children's snacks (PJAS) pose health risks and can cause various diseases. To address this, the PJAS Safety Intervention Program was introduced. The COVID-19 pandemic brought changes to the definition of PJAS and altered communication patterns in program delivery. This study evaluates the success of the program implemented by the Indonesian Food and Drug Authority Regional Office in Yogyakarta during the pandemic. It identifies factors inhibiting its effectiveness through a communication audit. The research used an evaluative qualitative method involving interviews with informants to assess planning and preparation and surveys with school community respondents to evaluate program communication. The study followed the General Guidelines for Communication Audits in Government Agencies. Results indicate that the program was effectively implemented and can be enhanced by improving communication dimensions. Key strategies include strengthening message delivery through direct engagement with policymakers, expanding media use by adding hardcopy materials, improving message clarity with comprehensive posters detailing program stages, and fostering public feedback through information sharing and participation mechanisms, particularly at junior and senior high school levels. Additionally, expanding promotional media can further optimize program outreach. The communication audit concluded that the PJAS Safety Intervention Program successfully met its objectives through effective management with minor, manageable obstacles. These findings suggest that the program can continue with improved communication strategies to enhance its impact.
Analisis Hasil Pengawasan Iklan Produk Pangan Olahan di Provinsi DKI Jakarta pada tahun 2021-2023 Umar Saifudin; Tenri Noviardani
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.208

Abstract

Food is a fundamental need in society, and advertising significantly influences the consumption of processed food products. Advertising introduces products for businesses and provides product-related information for consumers. However, some advertisements violate regulations. Supervising processed food advertisements is one of the Indonesian Food and Drug Authority's (FDA) roles. This study analyzes processed food advertisement supervision in DKI Jakarta from 2021 to 2023, focusing on media types, violation types, and food categories most frequently violating regulations. Secondary data from supervision reports collected by the Jakarta FDA Office during this period were analyzed descriptively. Results show that 1468 (77.7%) of the 1890 advertisements evaluated did not meet regulatory requirements. Most violations occurred in online media (1424 ads, 97%), followed by outdoor media (39 ads, 2.7%) and print media (5 ads, 0.3%). The most common violations included health claims not complying with provisions (1110 ads, 75.7%), misleading advertisements (175 ads, 11.9%), prohibited advertising in non-health media (160 ads, 10.9%), superlative statements (21 ads, 1.4%), and norm violations (1 ad, 0.1%). Violations based on food categories were highest in beverages (category 14) with 1149 ads (78.3%), milk products (category 1) with 66 ads (4.5%), and sugar products and sweeteners (category 11) with 49 ads (3.3%). These findings highlight the need for stricter oversight and public awareness of advertising regulations.
Kajian Kepatuhan Sarana Produksi Minyak Goreng Sawit di Wilayah Kerja BBPOM di Bandung dan BBPOM di Surabaya dalam Melakukan Fortifikasi Vitamin A Setyo Utami; Dinny Andriany
Eruditio : Indonesia Journal of Food and Drug Safety Vol 5 No 1 (2024): Edisi Desember
Publisher : Badan Pengawas Obat dan Makanan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54384/eruditio.v5i1.214

Abstract

Vitamin A deficiency (VAD) remains a public health issue in many countries, including Indonesia. To address this, the government has mandated vitamin A fortification in food, with cooking oil being a key target. The policy is outlined in SNI 7709-2019 through Minister of Industry Regulation Number 46 of 2019, requiring producers to achieve a minimum vitamin A level of 45 IU/g in fortified cooking oil. Samples of palm cooking oil were collected from producers and packers for evaluation. This study examines the compliance of palm cooking oil production facilities within the Bandung and Surabaya catchment areas under the supervision of THE INDONESIAN FDA REGIONAL OFFICE. Using a descriptive qualitative method, data were collected from sampling and testing conducted between 2021 and 2023, following the Guidelines for Sampling and Testing of Drugs and Food. The results indicate that 31.58% of production facilities failed to meet fortification requirements due to a lack of commitment from producers and limited availability of vitamin A as a fortifier. Non-compliance was linked to facility type, with relaxation of regulations during rising cooking oil prices contributing to the issue. Notably, the fortification program was temporarily paused in January 2022 due to these challenges. To ensure public health benefits, it is essential to reinstate and enforce the vitamin A fortification program for palm cooking oil, emphasizing producer accountability and stable raw material supply.

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