The Food and Agriculture Organization of the United Nations (FAO) has identified personalised nutrition as a transformative opportunity in nutritional science, with potential to optimise health through tailored dietary interventions and functional foods (Di Martino, 2025). This shift from population-based recommendations to individualised approaches creates major opportunities for innovation and market growth, yet progress depends on robust food safety frameworks.
Current regulatory fragmentation – such as melatonin being sold as a food supplement in the EU and US but classified as a prescription drug in Australia (Dwyer et al., 2018) – underscores the urgent need for harmonised international standards. The FAO report shows that consumer confidence and regulatory clarity are critical foundations for sustainable development, enabling innovation while ensuring public health protection.
Methodology
The FAO report (Di Martino, 2025) adopted a systematic methodology to assess the food safety implications of supplements and functional foods, combining literature review, regulatory assessment, and consumer behaviour analysis across regions.
Search strategy and data collection
Publications were retrieved from open-access databases including PubMed and Google Scholar, utilising keywords such as ‘personalised nutrition’, ‘food safety’, ‘food supplements’, ‘dietary supplements’, ‘nutraceuticals’, and ‘functional foods’ (Di Martino, 2025).
The review incorporated data from scientific articles, regulatory reports, and national authority websites to ensure comprehensive coverage of safety assessment protocols and regulatory practices.
Regulatory framework analysis
The study examined regulatory landscapes across multiple jurisdictions, including Argentina, Australia, Brazil, Canada, China, Egypt, Europe, India, Japan, Nigeria, South Africa, the United Arab Emirates, and the United States.
This comparative analysis was conducted in consultation with Codex Alimentarius focal points from each country to ensure accuracy and alignment with specific regulatory requirements and practices (Di Martino, 2025).
Scope and limitations
The analysis focused specifically on food supplements and functional foods, excluding medical foods defined by Codex as ‘foods for special medical purposes‘. The study did not assess efficacy of these products but concentrated on safety implications and regulatory challenges associated with their use in personalised nutrition contexts.
The transformative potential of personalised nutrition
Scientific innovation and therapeutic opportunities
Personalised nutrition represents a paradigmatic revolution in the field of nutritional science, promising to radically transform the approach to health through dietary interventions tailored to individual characteristics. This innovative approach is based on the understanding that physiological responses to food vary significantly between individuals (Di Martino, 2025).
The convergence of scientific advances in genomics, microbiome research, food biotechnology, and precision medicine has created unprecedented opportunities to optimise individual health through targeted nutritional strategies.
The applicative potential extends well beyond simple supplementation, embracing the prevention and management of chronic diseases, optimisation of physical and cognitive performance, and improvement of quality of life through evidence-based nutritional interventions.
Market development and regulatory frameworks
Technological developments in artificial intelligence, advanced genetic analysis, and continuous biometric monitoring are enabling the creation of increasingly precise nutritional profiles, supporting economic growth in the sector that according to projections will reach multibillion-dollar global dimensions in the coming decades. However, the realisation of the full potential of personalised nutrition depends critically on the availability of safe, effective, and adequately regulated products.
Food supplements and functional foods represent essential tools in this context, but their success requires a delicate balance between scientific innovation and rigorous safety standards. The FAO report emphasises how this expansion must be guided by principles of scientific sustainability and social responsibility, highlighting the necessity for harmonised regulatory frameworks that can support sustainable market development while protecting public health.
Food safety issues
Drug-food interactions
One of the most significant safety concerns identified involves potential interactions between food supplements and pharmaceutical medications. The analysis revealed that approximately 80% of globally available food supplements are likely to interact with cytochrome P450 (CYP) enzymes in the human body, which play crucial roles in drug metabolism (Di Martino, 2025; Zarowitz, 2010).
These interactions can manifest through multiple mechanisms, including enzyme induction or inhibition, affecting drug efficacy and potentially leading to adverse effects. For instance, St John’s wort (Hypericum perforatum) has been documented to interact with numerous medications, including immunosuppressants, anticancer drugs, and oral contraceptives, potentially reducing their effectiveness (Australian Government, 2000).
Bioactive ingredient concentration and safety
The report highlighted significant safety challenges associated with highly concentrated or chemically modified bioactive ingredients. Whilst compounds like curcumin and catechins are generally regarded as safe in their natural food forms, their safety profiles can change substantially when consumed in concentrated forms or altered through processing (Di Martino, 2025).
The European Food Safety Authority (EFSA) has specifically noted concerns regarding green tea extracts containing high concentrations of epigallocatechin gallate (EGCG), which have been associated with hepatotoxicity when consumed on an empty stomach (EFSA, 2018).
This illustrates the importance of considering bioavailability enhancement technologies and their potential impact on safety.
Contamination and adulteration
Contamination issues represent a critical safety concern, encompassing both unintentional contamination and deliberate adulteration. The analysis documented various forms of contamination, including heavy metals, mycotoxins, pesticide residues, and the presence of undisclosed active pharmaceutical ingredients (APIs) (Di Martino, 2025).
Particularly concerning is the practice of ‘spiking’ supplements with APIs to enhance perceived efficacy. Studies from the Netherlands revealed that 264 out of 416 examined supplements contained pharmacologically active substances, often at doses exceeding safe levels (Biesterbos et al., 2019). This practice poses significant health risks, particularly when consumers are unaware of these undisclosed ingredients.
Overdose and toxicity risks
The potential for overdose and toxicity emerged as a significant concern, particularly with vitamin and mineral supplements. The analysis identified several factors contributing to overconsumption, including appealing marketing strategies, inadequate dosage information, and the use of proprietary blends that obscure specific ingredient quantities (Di Martino, 2025).
Notable cases include vitamin D toxicity leading to hypercalcemia and, in extreme cases, death (BBC News, 2024). The marketing strategies employed, such as gummy formulations designed to appeal to children, can inadvertently encourage overconsumption and increase toxicity risks.
Allergenic ingredients and labelling issues
The presence of unexpected allergenic ingredients poses additional safety challenges. Many consumers may not scrutinise supplement labels with the same rigour applied to conventional foods, potentially exposing themselves to allergens. For instance, glucosamine supplements, often derived from shellfish, can trigger allergic reactions in sensitive individuals (Di Martino, 2025; Xu et al., 2018).
Regulatory framework analysis
Global regulatory diversity
The analysis revealed significant regulatory variations across jurisdictions, with products classified differently depending on local frameworks. A substance considered a food supplement in one country may be regulated as a pharmaceutical in another, creating complex compliance challenges for manufacturers and potential safety concerns for consumers (Di Martino, 2025).
Terminology and classification
The lack of harmonised terminology presents substantial challenges. Different countries employ varying terms for similar products – ‘dietary supplements’ in the United States, ‘food supplements’ in the European Union, ‘complementary medicines’ in Australia, and ‘natural health products’ in Canada – each with distinct regulatory requirements and oversight mechanisms.
Market entry requirements
Regulatory approaches range from notification-based systems, such as those employed in the European Union, to registration-based systems requiring comprehensive safety data, as implemented in Argentina. Some jurisdictions, including the United States for established dietary ingredients, require minimal premarket oversight, relying primarily on post-market surveillance (Di Martino, 2025).
Challenges in novel ingredient assessment
The introduction of novel ingredients involves several regulatory challenges. Substances lacking a well-established history of safe consumption must undergo thorough assessments before they can be placed on the market.
However, the evaluation criteria and the required scientific evidence differ considerably across jurisdictions, from the proportionate GRAS system in the United States to the complex and costly procedures for the authorisation of novel foods in the European Union.
Consumer behaviour and perceptions
Motivations for use
The analysis identified multiple consumer motivations for supplement use, including health consciousness, media influence, recommendations from healthcare professionals, and symbolic cultural beliefs. Particularly concerning is the ‘compensatory behaviour’ phenomenon, where individuals use supplements to offset perceived dietary inadequacies without addressing underlying nutritional issues (Di Martino, 2025).
Social and cultural Influences
Traditional medicine systems, including Traditional Chinese Medicine and Ayurveda, significantly influence consumer perceptions of supplement safety and efficacy. This cultural context can foster assumptions of safety based on traditional use, without accounting for how modern processing and higher concentrations may alter the risk profile.
Misconceptions about safety
A critical finding involves widespread consumer misconceptions regarding the safety of ‘natural’ products compared to synthetic pharmaceuticals. This ‘natural fallacy’ can lead to inappropriate self-medication and delayed medical treatment for serious conditions (Di Martino, 2025). The blurred line between food supplements and medicines contributes to these misperceptions, particularly when health claims suggest therapeutic benefits.
Discussion and implications
Technological innovation and safety assessment
The rapid advancement of bioavailability enhancement technologies, including nanoencapsulation and microemulsions, presents both opportunities and challenges for safety assessment. Whilst these technologies can improve the therapeutic potential of bioactive compounds, they may also alter absorption patterns and increase the risk of adverse effects (Di Martino, 2025).
Current safety assessment protocols may not adequately address these technological innovations, necessitating updated evaluation frameworks that consider novel delivery mechanisms and their impact on bioavailability and toxicity.
Regulatory harmonisation needs
The analysis reveals substantial regulatory fragmentation that creates significant challenges for both industry compliance and consumer protection in the global food supplements market. This fragmentation manifests across multiple dimensions, from fundamental definitional inconsistencies to divergent safety assessment protocols, creating a complex web of regulatory obstacles that potentially compromise public health outcomes (Di Martino, 2025).
Definitional and classification disparities
The most fundamental challenge lies in the absence of harmonised definitions for basic product categories. A striking example of this regulatory divergence involves melatonin, which is regulated as a food supplement in both the European Union and United States, yet classified as a prescription medication in Australia (Dwyer et al., 2018). Similarly, vitamin D at 5,000 International Units constitutes a pharmaceutical product under European Union regulations whilst remaining classified as a dietary supplement in the United States. These classification inconsistencies create substantial barriers to international trade and may result in products with identical compositions receiving vastly different levels of regulatory scrutiny depending on their market destination.
The terminology employed across jurisdictions further exacerbates these challenges. Products described as ‘dietary supplements’ in the United States, ‘food supplements’ in the European Union, ‘complementary medicines’ in Australia, ‘natural health products’ in Canada, and ‘health supplements’ in various other jurisdictions may contain identical active ingredients yet face entirely different regulatory pathways and safety requirements (Di Martino, 2025). This linguistic fragmentation reflects deeper differences in how jurisdictions conceptualise the boundary between functional food, food supplement and medicine (Chanda, 2025).
Regulatory shopping and market distortions
The regulatory inconsistencies identified create opportunities for ‘regulatory shopping‘, whereby manufacturers strategically locate production or registration activities in jurisdictions with more permissive regulatory frameworks. This phenomenon poses significant risks to consumer safety, as products may enter global supply chains having undergone less rigorous safety assessment than would be required in more stringent regulatory environments. The analysis documented instances where products prohibited or restricted in one jurisdiction continue to be available through online channels originating from less regulated markets (Di Martino, 2025).
This regulatory arbitrage not only compromises consumer protection but also creates unfair competitive advantages for manufacturers willing to operate under less stringent standards. Companies investing in comprehensive safety testing and quality assurance measures may find themselves disadvantaged compared to competitors operating in jurisdictions with minimal oversight requirements.
International standardisation efforts and limitations
The Codex Alimentarius Commission has established foundational guidelines for vitamin and mineral supplements and nutrition and health claims, representing significant progress towards international harmonisation (FAO & WHO, 2005). However, these guidelines possess limited scope, addressing only basic categories of supplements whilst leaving substantial gaps in areas such as botanical extracts, novel ingredients, and emerging technologies for bioavailability enhancement.
The adoption rates and implementation approaches for existing Codex guidelines vary considerably across jurisdictions. Some countries have incorporated these standards directly into national legislation, whilst others have developed parallel frameworks that may diverge significantly from international recommendations. This selective adoption undermines the potential benefits of international standardisation efforts and perpetuates regulatory fragmentation.
Technological innovation and regulatory adaptation
The rapid pace of technological innovation in supplement formulation and delivery presents additional challenges for regulatory harmonisation. Advanced techniques such as nanoencapsulation, targeted delivery systems, and personalised formulations require sophisticated safety assessment methodologies that many regulatory systems have not yet developed.
Furthermore, the integration of artificial intelligence and genetic testing into personalised nutrition recommendations introduces novel regulatory considerations that existing frameworks may not adequately address. The development of harmonised approaches to regulating these emerging technologies will require unprecedented levels of international cooperation and technical expertise sharing.
Cultural and traditional medicine integration
Regulatory harmonisation efforts must navigate the complex challenge of integrating traditional medicine systems with modern safety standards whilst respecting cultural diversity and traditional knowledge. Many supplements derive from traditional medicinal practices that have extensive historical use records but may not meet contemporary evidence standards for safety and efficacy claims. Different cultures place varying emphasis on traditional knowledge versus scientific validation, creating tensions in developing universally acceptable regulatory standards.
The economic implications of these cultural considerations are substantial, as traditional medicine represents significant commercial interests in many regions. Harmonisation efforts that inadequately address traditional medicine may face resistance from stakeholders whose livelihoods depend on these products, whilst frameworks that rely too heavily on traditional use may not provide adequate consumer protection in modern commercial contexts.
Practical implementation challenges
Achieving meaningful regulatory harmonisation faces numerous practical obstacles beyond technical and scientific considerations. Jurisdictional sovereignty issues mean that countries may resist adopting international standards that conflict with domestic priorities or established regulatory philosophies. The resource requirements for implementing harmonised standards may exceed the capacity of some regulatory authorities, particularly in developing nations, creating potential implementation gaps.
The establishment of mutual recognition agreements between jurisdictions represents one potential pathway towards harmonisation, allowing products approved under one regulatory system to gain market access in partner jurisdictions. However, such agreements require substantial confidence in partner regulatory systems and may face political obstacles related to trade policy and national sovereignty concerns.
Economic and trade implications
The current regulatory fragmentation imposes substantial economic costs on both industry and consumers. Manufacturers face duplicative registration requirements, varying documentation standards, and the need to reformulate products for different markets, costs that are ultimately passed to consumers.
These barriers particularly disadvantage smaller manufacturers who may lack the resources to navigate multiple regulatory systems, potentially reducing market competition and innovation.
Future directions for harmonisation
The development of effective harmonisation strategies will require unprecedented levels of international cooperation, technical expertise sharing, and political commitment. Priority areas for harmonisation include establishing common safety assessment protocols for novel ingredients, developing standardised approaches to evaluating emerging delivery technologies, and creating mutual recognition frameworks for regulatory decisions.
The digital transformation of regulatory processes offers opportunities to facilitate harmonisation through shared databases, standardised electronic submission formats, and collaborative assessment platforms. However, realising these opportunities will require significant investments in technological infrastructure and cybersecurity measures to protect confidential commercial information.
Success in regulatory harmonisation will ultimately depend on balancing the competing demands of consumer safety, innovation promotion, trade facilitation, and respect for national sovereignty and cultural diversity. The complexity of these challenges suggests that harmonisation will likely proceed incrementally, focusing initially on areas of broad consensus before addressing more contentious issues related to traditional medicine and emerging technologies.
Public health implications
The findings highlight significant public health implications, particularly regarding vulnerable populations such as elderly individuals, pregnant women, and those with chronic medical conditions. These groups may be more susceptible to adverse effects from supplements while simultaneously being more likely to use them for health management (Di Martino, 2025).
The potential for drug-supplement interactions in these populations is particularly concerning, as they are more likely to be taking multiple medications. Healthcare professionals play a crucial role in identifying and preventing these interactions, yet many consumers do not disclose supplement use to their healthcare providers.
Conclusions and recommendations
Primary conclusions
The FAO analysis demonstrates that while food supplements and functional foods offer potential benefits within personalised nutrition frameworks, they present complex safety challenges that require comprehensive regulatory attention. The multifaceted nature of these challenges – spanning technological innovation, regulatory inconsistency, and consumer behaviour – necessitates coordinated international responses.
Critical safety priorities
The most pressing safety concerns include drug-supplement interactions, contamination and adulteration, inappropriate dosing, and inadequate safety assessment of novel ingredients and delivery technologies. These issues are compounded by consumer misconceptions about supplement safety and the lack of harmonised international regulatory standards.
Regulatory recommendations
The comprehensive analysis of food safety challenges in personalised nutrition necessitates a multifaceted regulatory approach that addresses both immediate safety concerns and long-term systemic improvements. These recommendations emerge from documented evidence of regulatory gaps, safety incidents, and the evolving complexity of the supplements market. Implementation of these measures requires coordinated efforts between regulatory authorities, industry stakeholders, and international organisations to ensure comprehensive consumer protection whilst supporting legitimate innovation (Di Martino, 2025).
Enhanced labelling and information requirements
The most immediate regulatory priority involves implementing comprehensive labelling requirements that provide consumers with essential safety information currently absent from many products. Enhanced labelling must explicitly detail potential drug interactions, particularly for supplements containing bioactive compounds known to affect cytochrome P450 enzymes or P-glycoprotein transporters.
Contraindications for vulnerable populations require prominent display on product labels, including specific warnings for pregnant and lactating women, children, elderly individuals, and those with chronic medical conditions.
Dosage information must extend beyond simple recommended daily amounts to include maximum safe limits, interaction with concurrent supplement use, and clear instructions regarding timing relative to meals and medications.
The implementation of standardised supplement facts panels, similar to those required in the United States, provides a framework for consistent information presentation across jurisdictions (U.S. FDA, 2024). However, these panels require enhancement to include interaction warnings and contraindication information not currently mandated.
Standardised safety assessment protocols
The development of harmonised safety assessment protocols represents a critical need for addressing gaps in current evaluation methodologies. These protocols must specifically address concentrated bioactive ingredients, novel delivery technologies, and traditional ingredients used in non-traditional forms or concentrations. The European Food Safety Authority’s approach to evaluating green tea catechins provides a model for risk assessment of concentrated botanical compounds, considering factors such as consumption patterns, bioavailability, and vulnerable population exposure (EFSA, 2018).
Novel delivery technologies require specialised assessment protocols that evaluate how nanoencapsulation, targeted delivery systems, and bioavailability enhancers may alter traditional toxicological profiles. Current safety assessment frameworks, designed for conventional food ingredients, may inadequately address these technological innovations. The development of nanotechnology-specific guidance documents, as implemented by some regulatory authorities for pharmaceutical applications, offers a pathway for addressing these assessment gaps (Bleeker et al., 2013).
Traditional ingredient evaluation requires protocols that balance respect for historical use with modern safety standards. The WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants provide foundational principles, but require expansion to address commercial processing methods that may concentrate or chemically modify traditional ingredients (WHO, 2003). Assessment protocols must consider plant-to-extract ratios, extraction methodologies, and standardisation practices that may significantly alter safety profiles compared to traditional preparations.
Robust post-market surveillance systems
Current post-market surveillance systems demonstrate significant limitations in detecting and responding to emerging safety concerns, particularly for products distributed through online channels or across international borders. Enhanced surveillance requires integration of multiple data sources, including adverse event reporting systems, laboratory testing programmes, and digital monitoring of online marketplaces (Biesterbos et al., 2019).
Adverse event reporting systems require standardisation across jurisdictions to enable effective signal detection and international cooperation. The implementation of compatible reporting formats, similar to those developed for pharmaceutical products, would facilitate data sharing and collaborative analysis of safety signals. The Singapore model, which documented over 600 adverse events related to complementary health products, demonstrates the value of systematic adverse event collection and analysis (Xu et al., 2018).
Laboratory surveillance programmes must expand beyond traditional contaminant testing to include systematic screening for undisclosed pharmaceutical ingredients, novel psychoactive substances, and emerging adulterants. The Netherlands’ comprehensive testing programme, which identified pharmacologically active substances in 264 of 416 examined supplements, illustrates the scope of adulteration issues and the need for systematic surveillance (Biesterbos et al., 2019).
Digital surveillance capabilities require development to monitor online sales channels, social media marketing claims, and cross-border commerce in supplements. Current regulatory oversight often fails to address products sold through international e-commerce platforms, creating significant enforcement gaps. Implementation of automated monitoring systems, utilising artificial intelligence and natural language processing, could enhance detection of non-compliant products and misleading marketing claims.
International regulatory harmonisation mechanisms
Harmonisation efforts must address both technical standards and procedural mechanisms to achieve meaningful convergence in regulatory approaches. The establishment of mutual recognition agreements between jurisdictions with comparable regulatory standards offers a practical pathway for reducing duplicative assessments whilst maintaining safety standards.
Technical working groups should be established under international organisations such as Codex Alimentarius to develop detailed guidance on emerging issues including novel ingredients, personalised nutrition products, and traditional medicine integration. These groups must include representation from diverse regulatory philosophies and cultural perspectives to ensure broad acceptability of resulting standards.
Capacity building programmes require implementation to support regulatory authorities in developing nations in adopting harmonised standards and implementing effective oversight systems. The WHO’s traditional medicine strategy provides a framework for technical assistance and knowledge transfer that could be adapted for supplements regulation (WHO, 2019). Such programmes must address both technical capabilities and infrastructure requirements for effective regulatory implementation.
Innovation-responsive regulatory frameworks
Adaptive regulation mechanisms must be developed to address the rapid pace of innovation in personalised nutrition whilst maintaining appropriate safety oversight. Regulatory sandboxes, successfully implemented in financial services regulation, offer a model for allowing controlled testing of innovative products under relaxed regulatory requirements whilst gathering safety and efficacy data (Zetzsche et al., 2017).
Fast-track approval pathways for products addressing significant public health needs, combined with enhanced post-market monitoring requirements, could accelerate access to beneficial innovations whilst maintaining safety oversight. The FDA’s breakthrough therapy designation for pharmaceuticals provides a precedent for prioritised review processes that could be adapted for supplements addressing specific health conditions.
Risk-based regulation approaches must be implemented to focus regulatory resources on products and manufacturers presenting the highest consumer risks. This includes enhanced oversight of online retailers, products making therapeutic claims, and manufacturers with histories of non-compliance. The implementation of manufacturer licensing systems, as employed in several jurisdictions, provides mechanisms for ensuring ongoing compliance with safety standards.
Consumer protection and education initiatives
Public education programmes require development to address widespread misconceptions about supplement safety, appropriate use, and potential interactions with medications. These programmes must target both consumers and healthcare professionals, addressing gaps in knowledge about supplement safety and interaction management. The integration of supplement education into medical and pharmacy curricula represents a critical component of professional education enhancement.
Healthcare provider resources must be developed to support identification and management of supplement-related health issues. This includes training programmes on supplement-drug interactions, adverse event recognition, and appropriate patient counselling regarding supplement use. The development of clinical decision support tools and interaction databases could enhance healthcare providers’ ability to manage supplement-related risks.
Vulnerable population protections require specific regulatory attention, including enhanced safety requirements for products marketed to children, pregnant women, elderly individuals, and those with chronic medical conditions. Age-appropriate formulations, dosing restrictions, and mandatory healthcare provider consultation requirements for certain products could reduce risks in these populations.
Industry accountability and quality assurance
Good manufacturing practice (GMP) requirements must be harmonised and strengthened across jurisdictions to ensure consistent product quality and safety. Current GMP standards vary significantly between countries, creating opportunities for substandard products to enter global supply chains. The implementation of international GMP standards could enhance product quality and safety.
Supply chain transparency requirements should be implemented to enable traceability of ingredients from source to final product. This includes mandatory documentation of ingredient sourcing, processing methods, and quality control testing results. Blockchain technology offers potential solutions for creating tamper-resistant supply chain documentation systems.
Manufacturer liability frameworks require enhancement to ensure appropriate accountability for product safety and quality. This includes mandatory insurance requirements, financial responsibility provisions for product recalls, and enhanced penalties for non-compliance with safety standards. The implementation of strict liability provisions for adulterated or mislabelled products could provide additional incentives for quality assurance.
Future directions
As personalised nutrition continues to evolve, regulatory frameworks must adapt to address emerging challenges whilst supporting innovation. This includes developing risk assessment methodologies appropriate for individualised nutrition products and establishing clear pathways for evaluating the safety of traditional ingredients in modern formulations.
The integration of artificial intelligence and genetic testing into personalised nutrition will likely create additional regulatory challenges that require proactive consideration. Ensuring that these technological advances enhance rather than compromise safety will be crucial for the continued development of the field.
The FAO’s analysis represents a significant contribution to understanding the complex safety landscape of supplements and functional foods in personalised nutrition. Through coordinated efforts to establish harmonised international standards, the personalised nutrition sector can achieve sustainable growth serving both public health objectives and commercial interests.
Dario Dongo
Cover image from FAO report (Di Martino, 2025)
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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
