Regulatory Oversight Research Articles

The necessity of artificial intelligence in fintech for SupTech and RegTech supervisory in banks and financial organizations

In the rapidly evolving financial landscape, the integration of Artificial Intelligence (AI) into Supervisory Technology (SupTech) and Regulatory Technology (RegTech) has become increasingly vital. As banks and financial organizations grapple with the complexities of compliance, risk management, and regulatory oversight, AI offers transformative capabilities that enhance efficiency, accuracy, and resilience. This paper explores the critical need for AI in Fintech for SupTech and RegTech, focusing on its role in supervisory functions within the banking sector. A case study on AI-driven anti-money laundering systems is presented, along with a discussion of authentic laboratory research and survey results. The paper concludes by illustrating the potential impact of AI on financial supervision with graphs and data, underscoring its necessity in modern financial governance.

The effect of hydropower bidding strategy on the iberian day-ahead electricity market

In 2021, the Iberian Electricity Market, which includes Portugal and Spain, experienced a significant increase in electricity prices. On average, prices tripled compared to pre-pandemic levels in 2019, despite stable demand. This trend, though less pronounced in other European markets, has raised concerns about the efficiency and competitiveness of wholesale electricity markets. This study investigates the bidding behavior of non-pumped hydropower plants in the Iberian market, employing a merit order model based on real data from 2019 to 2021. The analysis reveals a clear mismatch between hydropower bid prices and actual production costs. Although this practice is legal, it conflicts with the European Union's goal of promoting fair competition within the internal electricity market.Our findings suggest that aligning hydropower bid prices with 2019 levels could have reduced annual market costs by approximately 2324 million euros under a moderate scenario. This indicates substantial potential for cost savings and improved integration of hydropower. However, this strategy also benefits companies that own these hydropower plants, as they often possess large portfolios and can capitalize on increased market prices through other plants, particularly renewable energy units, which offer electricity at very low prices and have a high likelihood of being dispatched.Furthermore, the study highlights regulatory gaps allowing hydropower plants to price low-cost energy similarly to thermal plants, raising consumer costs and distorting market dynamics. These findings emphasize the need for stronger regulatory oversight and reforms to prevent excessive price inflation by hydropower, which plays a critical role in renewable energy integration and grid stability. Policymakers must ensure fair pricing while compensating hydropower plants for their flexibility and essential contributions to the energy system.

Assessment of Lead and Iron Concentration in Cosmetics Traded in the AL-Ajilat City Market

This study examined the concentrations of heavy metals, namely lead (Pb) and iron (Fe), in lipsticks, foundations, and face powders to ensure compliance with international safety standards and assess potential health risks. Using atomic absorption spectroscopy (AAS), samples were analyzed for heavy metal content and compared to WHO, FDA, and Health Canada guidelines. Results included that lead levels in lipsticks ranged from 0.03 to 6.15 ppm, with one sample exceeding the WHO limit of 0.01 ppm, raising safety concerns. Iron levels were alarmingly high, with a maximum of 2,566 ppm, well above the WHO guideline of 0.3 ppm. Baseline samples consistently showed low levels of lead at 0.03 ppm, but iron concentrations reached 5,735 ppm, indicating significant safety deviations. Lead concentrations in the face powders ranged from 0.03 to 2.14 ppm, with some exceeding the WHO limit, while iron levels averaged 2,613 ppm, well above acceptable limits. The study concluded that high iron levels in these cosmetic products pose health risks, stressing the need for stricter regulatory oversight and quality control in the cosmetics industry.

Gaps in the Global Regulatory Frameworks for the Use of Artificial Intelligence (AI) in the Healthcare Services Sector and Key Recommendations.

Artificial Intelligence (AI) has shown remarkable potential to revolutionise healthcare by enhancing diagnostics, improving treatment outcomes, and streamlining administrative processes. In the global regulatory landscape, several countries are working on regulating AI in healthcare. There are five key regulatory issues that need to be addressed: (i) data security and protection-measures to cover the "digital health footprints" left unknowingly by patients when they access AI in health services; (ii) data quality-availability of safe and secure data and more open database sources for AI, algorithms, and datasets to ensure equity and prevent demographic bias; (iii) validation of algorithms-mapping of the explainability and causability of the AI system; (iv) accountability-whether this lies with the healthcare professional, healthcare organisation, or the personified AI algorithm; (v) ethics and equitable access-whether fundamental rights of people are met in an ethical manner. Policymakers may need to consider the entire life cycle of AI in healthcare services and the databases that were used for the training of the AI system, along with requirements for their risk assessments to be publicly accessible for effective regulatory oversight. AI services that enhance their functionality over time need to undergo repeated algorithmic impact assessment and must also demonstrate real-time performance. Harmonising regulatory frameworks at the international level would help to resolve cross-border issues of AI in healthcare services.

Pediatric Neem powder poisoning: a report of two cases and a review of toxicity mechanisms

Neem (Azadirachta indica) is a plant known for its wide array of therapeutic properties, derived from its diverse phytochemical makeup. Despite its medicinal benefits, neem can pose significant toxicity risks, especially in children. This report presents two pediatric cases of neem powder poisoning. The first case involves a two-year-old boy who ingested neem powder with milk, resulting in seizures and fatal cardiac arrest. The second case describes a six-year-old boy who experienced vomiting after consuming neem powder with milk. Prompt medical intervention, including gastric lavage and supportive care, led to his stabilization and discharge. Neem’s toxicity is attributed to compounds like azadirachtin, which disrupt mitochondrial function, leading to symptoms such as seizures, vomiting, and hepatic stress. These cases highlight the importance of recognizing the potential dangers of neem and underscore the need for public health education and regulatory oversight to prevent such adverse outcomes in pediatric populations.

Pharmacy Compounding Regulation in the German Pharmaceutical Market. Part 2. Organisational Features (Review)

INTRODUCTION. The Russian Federation has decided to restore the system of compounding pharmacies as an element of the critical national healthcare infrastructure and pharmaceutical supply chain. To improve Russian regulatory practices, develop novel advanced approaches to pharmacy compounding and quality control, and implement these approaches, it is necessary to study relevant good compounding practices applied in healthcare systems of other countries.AIM. The study aimed to analyse the German experience in the organisation and regulation of pharmaceutical compounding to suggest recommendations for the development and implementation of Russian guidelines on good compounding and dispensing practices.DISCUSSION. This work continues a comprehensive study that delves into the current provisions of German legislation governing the system of good compounding practices. This article examines the differences between approaches to compounding by medical and pharmaceutical specialists. According to the findings, compounding by medical specialists is guided by the “free practice of medicine” principle and is subject to minimal regulatory oversight. All pharmacy organisations operate as compounding pharmacies, thereby enhancing the physical accessibility of compounded medicinal products to the population. The authors highlight the features of a process-based quality assurance system encompassing production process controls and quality control methods for compounded medicinal products. Additionally, the authors discuss the applicability of rapid test methods to compounding. In accordance with the German concept of good pharmacy practices, a compounding pharmacy may use the available validation, qualification, and verification tools in the pharmaceutical development of compounded medicinal products and may outsource its internal quality control function. Using the concept of risk ranking, compounding pharmacies may design their own sampling programmes. The article describes approaches to and requirements for organising the evaluation of compounding prescriptions. In Germany, compounding pharmacies may independently assign shelf lives to the compounded medicinal products they produce.CONCLUSIONS. Some German solutions are of considerable practical importance and are applicable to the development and implementation of Russian guidelines on good compounding and dispensing practices. In particular, pharmacy organisations may outsource the quality control of their compounded medicinal products. Additionally, pharmacies can conduct the full-scale pharmaceutical development of compounding technologies and quality control methods (including rapid test methods) using the validation, qualification, and verification tools available to drug manufacturers. Moreover, pharmacy organisations may independently assign shelf lives to the compounded medicinal products they produce. Finally, pharmacy organisations may design their individual sampling programmes.

Drivers of Pharmaceutical Compounding: Regional Experience Analysis Using Irkutsk Pharmacy Organisations as a Case Study

INTRODUCTION. National pharmacy compounding is a priority for providing the population with medicinal products, particularly the medicinal products lacking in the Russian Federation. Investigating opportunities to improve the operation of compounding pharmacies in the Russian Federation remains essential, especially in the context of the developing personalised approach to treatment, growing practice of orphan drug development, and import substitution needs.AIM. This study aimed to identify the factors driving the development of compounding pharmacies under the current conditions.MATERIALS AND METHODS. The study focused on the Russian regulatory framework for pharmacy compounding, as well as the range of dosage forms and administration routes of the medicinal products that had been produced and packaged by the compounding pharmacies in Irkutsk in 2021–2023.RESULTS. This study showed a demand for compounded medicinal products among both healthcare providers and patients. These medicinal products covered a traditional range of compounded medicines, including custom formulae, medicines for paediatrics and geriatrics, stock preparations, and pharmacy-packaged items. In 2021–2023, the mean annual production of Irkutsk pharmacy organisations amounted to ~500,000 units of compounded medicinal products, with a variety of doses and dosage forms. The medicinal products were compounded using ~100 different active substances and over 20 approved medicinal products. This study examined the evolution of Russian pharmacy compounding legislation. The key aspects included the establishment of a pharmaceutical quality system for compounded medicinal products, the extension of shelf life for specific dosage forms, and the authorisation to use medicinal products approved in the Eurasian Economic Union in compounding. The study showed that the main factors driving the operation of compounding pharmacies were the ongoing regulatory framework transformation and the transition from standardised treatment to personalised medicine. The main impediments for compounding pharmacies included the lack of state support, the ban on compounding medicinal products produced by pharmaceutical companies, the shortage of skilled staff, the inadequate supply of equipment (first of all, production machinery), the poor availability of active substances and excipients in small packages, and the challenges associated with regulatory control and oversight over the quality of compounded medicinal products.CONCLUSIONS. Further stimulation of the active development of compounding pharmacies requires further investigation into their operation in other regions, which will help to develop legal arrangements for the federal and regional state support of compounding pharmacies, procure up-to-date materials and equipment, and train the staff for compounding pharmacies.

Drug providers’ perspectives on antibiotic misuse practices in eastern Ethiopia: a qualitative study

ObjectiveAntibiotic misuse includes using them to treat colds and influenza, obtaining them without a prescription, not finishing the prescribed course and sharing them with others. Although drug providers are well...

Regenerative Aesthetics: A Genuine Frontier or Just a Facet of Regenerative Medicine: A Systematic Review.

Regenerative aesthetics claims to enhance cosmetic outcomes through advanced biological interventions like Stem cell and Exosome therapy, Polydeoxyribonucleotide (PDRN), Photobiomodulation, bioactive peptides and treatment for cellular senescence yet lacks substantial scientific and regulatory validation. To evaluate the scientific and clinical foundations of regenerative medicine techniques in non-surgical aesthetics and assess the legitimacy of regenerative aesthetics as a medical specialty. A systematic review was conducted according to PRISMA guidelines, searching databases including PubMed, Scopus, and Web of Science for studies published in the last ten years. We included 19 studies, comprising 14 randomized controlled trials (RCTs) and 5 prospective studies, focusing on interventions that purportedly use regenerative medicine principles in aesthetic applications. The review highlights a prevalent gap in molecular and clinical evidence supporting the efficacy and safety of regenerative aesthetics. Despite the robust design of the included RCTs and prospective studies, there remains a significant lack of consistent, high-quality evidence proving the effectiveness of these interventions. Issues such as inadequate reporting, unclear molecular mechanisms, and absence of long-term safety data were common. The field of regenerative aesthetics lacks the necessary scientific rigour and regulatory compliance to be recognized as a legitimate medical specialty. This review underscores the need for stringent scientific validation and regulatory oversight to ensure patient safety and treatment efficacy before these techniques can be recommended for clinical use. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Margin Rules and Margin Trading: Past, Present, and Implications

AbstractMargin—collateral or funds that investors deposit with their counterparties—is a crucial component of the practice of borrowing money to fund investment. While margin offers the potential for enhanced returns, it also exposes investors to the risk of escalated losses, thereby necessitating stringent regulatory oversight. Delving into the regulatory framework governing margin trading, we provide historical insights into the origins and dynamics of various margin requirements, and we review academic studies that illuminate the implications of these regulations for asset pricing, financial stability, and the design of margin rules. With an eye to the future, we also outline recent advancements in the evolving landscape of margin rules, such as portfolio margin and central clearing.

1-Benzhydryl-piperazine: Isolation, structure determination, and in silico studies for a novel potential narcotic agent detected in sports supplements

Adulteration of sports supplements poses significant health risks, necessitating stringent regulatory oversight. This study investigates deceptive practices by manufacturers, including concealment of formulations and manipulation of label information, impacting a wide demographic beyond elite athletes. Cinnarizine (CIN), and its degradation product, 1-benzhydryl-piperazine (BHP), which has amphetamine-like effects, are detected for the first time in 8 out of 41 sports supplements. An HPTLC method was developed to quantify CIN, and validated with specificity, linearity, the limit of detection (LOD), the limit of quantification (LOQ), accuracy, and precision studies. The linear range was between 50–800 ng spot−1. LOD and LOQ were 15 and 50 ng spot−1, respectively. The average recovery was calculated as 88.32 %, and %RSD values were less than 4 %. CIN’s degradation products were detected using GC-MS. CIN's decomposition into BHP also was confirmed via NMR analysis. Molecular docking studies revealed BHP's superior binding affinity and stability compared to 1-benzyl-piperazine (BZP), a prohibited narcotic agent, for dopamine and serotonin receptors, indicating potent psychoactive effects. Molecular dynamics simulations further elucidated interaction patterns, highlighting BHP's robust binding and potential for abuse, necessitating regulatory scrutiny and potential reevaluation of its legal status. It is also the first in silico study to compare BHP with BZP in terms of receptor interactions, which makes it pioneering. This study emphasizes the critical need for regulatory vigilance in the sports supplement industry to ensure consumer safety. Methodologies developed here for detecting adulterants provide foundational tools for future research aimed at enhancing public health protections against adulterated supplements. Regulatory collaboration and enhanced quality controls are essential to mitigate risks associated with deceptive practices and ensure the well-being of consumers.

Ethical considerations in surgical research conducted in African LMICs: A comprehensive narrative review

Introduction: Surgical research has revolutionized healthcare by improving the efficacy, safety, and efficiency of surgical interventions. This research has the potential to significantly impact healthcare delivery in Africa, where surgical diseases pose a major public health burden. Studies suggest surgery alone could reduce the global disease burden by 11%, with a substantial portion stemming from conditions prevalent in sub-Saharan Africa like traumatic injuries, childbirth complications, and surgical infections. However, conducting surgical research in Africa presents unique ethical challenges. The continent’s diverse socio-economic environments and rich cultural contexts necessitate careful consideration of ethical principles. Traditional research models often don’t translate well to African settings, raising concerns about informed consent, community engagement, and benefit-sharing. Aim: This review aims to shed light on various ethical dilemmas posed within surgical research, conducted in African countries. Further, standard practices and recommendations that involve a multi-pronged approach to mitigate said issues were explored. Materials and Methods: A meticulous analysis of the existing literature pertaining to the ethical issues proffered in Africa was performed. Databases employed comprised PubMed/MEDLINE, Embase, Scopus, and EBSCOhost. Pertinent case studies were also reviewed to comprehend said issues, providing comprehensive recommendations. Results: In addressing the ethical challenges in the research, the importance of resource limitation, sociocultural factors, informed consent barriers, technological obsolescence, training deficits, power dynamics, vulnerable populations, regulatory oversight, and compliance was highlighted. The proposed approaches include conducting focused research lectures and practical workshops on surgery, organizing surgical boot camps for medical students, interns, and residents, promoting research in related fields such as anesthesia, radiology, and pathology, ensuring the presence of on-site surgeons as needed, and arranging outreach surgical and educational camps for patients. Conclusion: Promoting community engagement and training local researchers and surgeons are crucial for navigating the unique ethical landscape in Africa. By prioritizing ethical considerations, surgical research can contribute to improved healthcare outcomes and a more equitable healthcare system across the continent.

Exploring self-care choices: a qualitative study of self-medication insights among university students in Lira City, Northern Uganda

BackgroundSelf-medication, the practice of treating health issues without professional medical guidance, is a widespread phenomenon among students globally, raising concerns about potential consequences. This study investigates perceptions and knowledge of...

Occurrence, persistence, and removal of contaminants of emerging concern through drinking water treatment processes – A case study in South Africa

The presence of contaminants of emerging concern (CECs) in drinking water is a global issue of concern. Evidence galore of the potential impacts of CECs on human health, yet there are no concrete guidelines or regulatory oversight to effectively tackle CECs exposure from drinking water. As a result, CECs concentrations can be well-above the suggested thresholds, particularly in low and middle-income countries (LMICs) due to undeveloped or underdeveloped (waste)water treatment infrastructure and/or substandard treatment practices. Yet, CECs occurrence and particularly their persistence during drinking water treatment is not well-documented in such settings. For this reason, here, the occurrence of 19 CECs was monitored across the different treatment steps (coagulation, sedimentation, sand filtration, and chlorination) of a typical water treatment plant in South Africa using UPLC-MS/MS. The most dominant CEC was, by and large, efavirenz (1103.9 ± 743.1 ng/L in raw water) tracing back to antiretroviral treatment for the human immunodeficiency virus (HIV) and revealing unpleasant realities about the HIV epidemic crisis in Sub-Sahara Africa (Global South) and possible drug abuse for illicit drug (whoonga/nyaope) manufacturing. For the other examined CECs, their concentrations in drinking water were, from higher to lower score: 1,7 dimethylxanthine (403.3 ± 244.2 ng/L) ≥ emtricitabine (358.4 ± 250.8 ng/L) ≥ atrazine (227.0 ± 61.0 ng/L) ≥ caffeine (194.1 ± 216.5 ng/L) ≥ tramadol (189.5 ± 112.4 ng/L) ≥ carbamazepine (122.9 ± 24.5 ng/L) ≥ sulfamethoxazole (107.8 ± 55.1 ng/L) ≥ methaqualone (72.2 ± 20.5 ng/L) ≥ benzotriazole (61.2 ± 18.8 ng/L) ≥ trimethoprim (59.1 ± 30.4 ng/L) ≥ cetirizine (33.7 ± 19.6 ng/L) ≥ codeine (26.7 ± 57.2 ng/L) ≥ naproxen (25.7 ± 11.3 ng/L) ≥ venlafaxine (21.6 ± 16.3 ng/L) ≥ acetaminophen (17.7 ± 25.8 ng/L) ≥ benzoylecgonine (9.6 ± 5.1 ng/L) ≥ methamphetamine (8.6 ± 6.4 ng/L) ≥ diclofenac (5.2 ± 7.9 ng/L). The large standard deviations indicate the high temporal variations in CECs releases in freshwater. The silver lining is that in the final drinking water, CECs concentrations are greatly reduced, with percentage removals in the range of 9 % (diclofenac) to 75 % (efavirenz). Nonetheless, in LMICs tangible limits and regulatory frameworks for the effective removal of CECs from drinking water, along with more robust polishing techniques such as activated carbon treatment, are missing and should be introduced to avoid the worst effects of CECs exposure.

Testosterone and male contraception.

Rates of unintended pregnancy have remained relatively stagnant for many years, despite a broad array of female contraceptive options. Recent restrictions on access to abortion in some countries have increased the urgency for expanding contraceptive options. Increasing data suggest men are keen to utilize novel reversible male contraceptives. Despite decades of clinical research in male contraception, no reversible hormonal product currently exists. Nestorone/testosterone, among other novel androgens, shows promise to finally move to pivotal Phase 3 studies and introduction to the marketplace. Hormonal male contraception utilizes androgens or androgen-progestin combinations to exploit negative feedback that regulates the hypothalamic-pituitary-testicular axis. By suppressing release of gonadotropins, these agents markedly decrease endogenous testosterone production, lower intratesticular testosterone and suppress spermatogenesis. The addition of a progestin enhances the degree and speed of sperm suppression. The androgen component preserves a state of symptomatic eugonadism in the male. There is growing demand and acceptance of male contraceptive options in various forms. As these formulations progress through stages of drug development, regulatory oversight and communication with developers around safety and efficacy standards and garnering industry support for advancing the production of male contraceptives will be imperative.

The platform policy matrix: Promotion and regulation

AbstractThis study provides a comprehensive analysis of policy measures adopted by countries in response to the rapid growth of digital platforms, which significantly impact various sectors and national economies. It examines the delicate balance between regulation and innovation, offering nuanced policy recommendations. Central to this study is the introduction of the “Platform Policy Matrix,” a strategic framework that explores the relationship between innovation encouragement and regulatory stringency in platform economies. The matrix is divided into four quadrants: “Regulatory Innovation,” “Accelerated Innovation,” “Laissez‐Faire,” and “Stringent Regulation.” This framework aims to guide policymakers in achieving a balance that protects consumers while fostering a competitive and innovative environment. The study advocates for a multifaceted approach that recognizes the unique characteristics of digital platforms. It underscores the necessity for policies that simultaneously promote innovation and enforce necessary regulations in rapidly evolving platform ecosystems. This approach ensures that innovation thrives while maintaining essential regulatory oversight, adapting policy frameworks to the dynamic nature of digital platforms.

Use of Artificial Intelligence in Medical Devices for Post-Market Surveillance

Artificial intelligence (AI) has emerged as a transformative tool in post-market surveillance (PMS) for monitoring the safety and performance of medical products. This article explores the role of AI in optimizing PMS practices, focusing on its applications in signal detection, risk assessment, and regulatory compliance. By harnessing machine learning algorithms and big data analytics, AI facilitates the automated analysis of real-world evidence, including patient outcomes data, adverse event reports, and electronic health records. Through pattern recognition and anomaly detection, AI algorithms enable the early identification of potential safety issues and facilitate timely interventions to mitigate risks. Moreover, AI-driven PMS systems enhance regulatory oversight by providing regulators with comprehensive and actionable insights into product safety profiles and emerging trends. However, concerns regarding data privacy, algorithm bias, and interpretability underscore the need for transparent and ethically responsible AI deployment in PMS frameworks.

Legal Aspects in Developing Security Systems to Counter Fraud and Manipulation Threats in Online Gambling

Online gambling emerges as an endeavor characterized by pecuniary stakes, wherein the operational mechanics and wagering parameters are established by entities overseeing online gambling activities. Facilitated by electronic media and internet connectivity, this milieu offers a platform for the engagement of such pursuits. Supplementing the legal underpinning provided by the Indonesian Criminal Code, Law Number 7 of 1974 concerning the Regulation of Gambling furnishes supplementary provisions governing the conduct of gambling activities. The aim of this reseach is to address the legal aspects in the development of security systems to combat fraud and manipulation threats in online gambling. The process of criminalization ensues with the promulgation of statutes designating certain behaviors, akin to or resembling individual conduct, as proscribed actions subject to punitive reprisals. The research method using normative method legal research. This legislative trajectory culminates in the promulgation of laws prescribing penal sanctions for transgressions. Furthermore, the realm of gambling is subject to regulatory oversight within the purview of Law Number 11 of 2008 about Information and Electronic Transactions (ITE Law). Article 27 paragraph (2) of the aforementioned legislation proffers legal recourse against individuals who, with intent and sans entitlement, disseminate, transmit, or render accessible electronic informational and documentary material imbued with gambling content. Concomitantly, the legal strictures delineated in Article 303 of the Indonesian Criminal Code (KUHP) proscribe gambling activities, imposing penal sanctions that may encompass custodial sentences not exceeding ten

The Alzheimer's Disease Neuroimaging Initiative Clinical Core.

The Alzheimer's Disease Neuroimaging Initiative (ADNI) Clinical Core is responsible for coordination of all clinical activities at the ADNI sites, including project management, regulatory oversight, and site management and monitoring, as well as the collection of all clinical data and management of all study data. The Clinical Core is also charged with determining the clinical classifications and criteria for enrollment in evolving AD trials and enabling the ongoing characterization of the cross-sectional features and longitudinal trajectories of the ADNI cohorts with application of these findings to optimal clinical trial designs. More than 2400 individuals have been enrolled in the cohorts since the inception of ADNI, facilitating refinement of our understanding of the AD trajectory and allowing academic and industry investigators to model therapeutic trials across the disease spectrum from the presymptomatic stage through dementia. HIGHLIGHTS: Since 2004, the Alzheimer's Disease Neuroimaging Initiative (ADNI) Clinical Core has overseen the enrollment of > 2400 participants with mild cognitive impairment, mild Alzheimer's disease (AD) dementia, and normal cognition. The longitudinal dataset has elucidated the full cognitive and clinical trajectory of AD from its presymptomatic stage through the onset of dementia. The ADNI data have supported the design of most major trials in the field.

Challenges in herbal-induced liver injury identification and prevention.

Herbal and dietary supplements (HDS) are being used worldwide at an increasing rate. Mirroring this trend, HDS-induced liver injury, also known as HDS-induced liver injury (HILI), has increased significantly over the past three decades in the Drug-Induced Liver Injury Network (DILIN), now accounting for 20% of cases of drug-induced liver injury (DILI). There are significant challenges in the identification and prevention of HILI due to varying presentations, ability to make clear diagnosis, identification of the responsible ingredient, lack of treatment, and lack of regulatory oversight of HDS products to confirm their ingredients and ensure safety. The major implicated agents include anabolic steroids, green tea extract, garcinia cambogia, kratom, ashwagandha, turmeric and multi-ingredient nutritional supplements. Fortunately, with the formation of major DILI consortiums across the world, the last decade has seen advances in the identification of at-risk genetic phenotypes, the use of chemical analysis on multi-ingredient nutritional supplements, and the publication of data/injury patterns of potentially risky HDS.