Fluoride and caries prevention: a scoping review of public health policies.

Background: Dental caries is the most common infectious disease, affecting approximately 60 to 90% of the world population, especially young children, and disadvantaged communities. Due to the extremely high prevalence and the significant negative impact on general health, well-being, and quality of life it is considered a global public health problem. Despite the improvement of policies to promote oral health care in the past decades, dental caries is still a healthcare challenge, characterized by increasing disparities among different social groups between and within countries. Fluoride-based prevention of dental caries is a cost-effective approach, that has been implemented since 1940's. It includes systemic and topical administrations, through community-based or individual programs. Preventive interventions should be tailored to individual and community caries risk assessment and estimate of cumulative fluoride intake, in order to maximize the preventive effect and avoid the risk of potential adverse effects associated with excessive fluoride exposure. Regulation of public health policies plays a major role in this context. Study design: Scoping review. Methods: The aim of this scoping review was to report an overview of current guidelines regarding fluoride-based preventive strategies for dental caries and relevant policies on the matter, as well as to address current issues related to public health aspects of dental caries prevention. We searched for the relevant literature on the matter, focusing on policy documents, such as recommendations, position papers and guidelines, issued from the major scientific and regulatory institutions involved in oral health promotion and on publications concerning relevant aspects of public health law. Results: Prevention of dental caries through fluoride can rely on topical fluorides for home-use (toothpastes and mouthrinses), professionally applied topical fluorides (gels, varnishes, silver diamine fluoride, fluoride-releasing restorative materials and sealants), fluoride supplements (tablets and drops), and community-based strategies (community water fluoridation, fluoridated salt and milk). Current relevant guidelines for all these preventive aids are outlined in the paper. A significantly greater preventive effect of topical fluorides has been widely established in the recent past, as compared to systemic effects. Furthermore, increasing concerns have emerged on potential adverse effects on general health associated with early and excessive systemic exposure to fluoride, especially for children, supported by recent meta-analyses. Also, community water fluoridation has raised significant aspects of relevance for health law and policies. In a public health perspective, healthcare policymakers should tackle social iniquities by promoting information and oral health literacy, through community and school-based programs, ensuring access to early dental visits and basic dental care and improving availability and affordability of fluoride topical products. Conclusions. Fluoride-based prevention can provide a simple and cost-effective approach to reduce the incidence of dental caries and the associated social burden. Among fluoride-based preventive strategies, systemic community-based administration of fluoride should be considered with great caution, due to the unfavorable risk-benefit ratio currently established. Topical fluoridated pro-ducts are generally preferred, given the optimal risk-benefit ratio. Further efforts must be made to identify and tackle the barriers to dental caries prevention and related social iniquities from a public health perspective. Policies and laws on oral health should promote access to caries prevention with targeted comprehensive strategies.

Water fluoridation between public health and public law: an assessment of regulations across countries and their preventive medicine implications.

Background: Among health professionals and health policymakers concern is growing as to the difficulty of balancing the prevention of dental caries through cost-effective interventions and the need to limit unnecessary exposure of the population, and especially children, to environmental chemicals. In this respect, the use of water fluoridation to prevent tooth decay epitomizes the dilemma by raising questions relevant to both public health and public law, ranging from the balance of public health and medical self-determination, the division of powers between local or national authorities over water fluoridation, and the need to avoid the adverse effects of socioeconomic inequalities as well as both under- and over-exposure. Study design: We carried out a narrative review by searching the relevant literature about the laws and rules related to drinking water fluoridation at the community level in the US, UK, and Europe, in order to discuss how the issue is handled from both a public health and public law perspective. Methods: Sources of data for this review were the biomedical and legal literature retrieved by searching online databases, and websites of public health and legal institutions. Results and Conclusions: We found that water fluoridation is still largely adopted throughout the US, while in the UK and particularly in the European Union only a minor part of the population is subject to it. In addition, the recommended and maximum allowed amounts of fluoride in drinking water are being adapted to the public health recommendations and the new regulations, within an evolving evaluation of the epidemiologic evidence and the risk assessment currently in progress by two major regulatory agencies, the US National Toxicology Program - NTP and the European Food Safety Authority - EFSA. Under a comparative public law perspective, the three investigated legislations are facing a reassessment of their policies and regulations, to allow for effective and safe public health measures in the field of water fluoridation and more generally for a preferred use of topical fluoride for caries prevention. A consistent trend across these legislations is the choice to centralize at the national level regulatory and management issues related to water fluoridation, and to carefully balance benefits for dental caries prevention in children and the potential risks of systemic overexposure associated with excess fluoride intake, by promptly responding to the evolving indications by the scientific community and the public health professionals.

The role of statistical significance testing in public law and health risk assessment.

Following a fundamental statement made in 2016 by the American Statistical Associations and broad and consistent changes in data analysis and interpretation methodology in public health and other sciences, statistical significance/null hypothesis testing is being increasingly criticized and abandoned in the reporting and interpretation of the results of biomedical research. This shift in favor of a more comprehensive and non-dichotomous approach in the assessment of causal relationships may have a major impact on human health risk assessment. It is interesting to see, however, that authoritative opinions by the Supreme Court of the United States and European regulatory agencies have somehow anticipated this tide of criticism of statistical significance testing, thus providing additional support to its demise. Current methodological evidence further warrants abandoning this approach in both the biomedical and public law contexts, in favor of a more comprehensive and flexible method of assessing the effects of toxicological exposure on human and environmental health.

Revising the legislation of Ethics Committees to ease biomedical research in humans across the world: lessons from the COVID-19 emergency.

As a legislative domain that considerably influences implementation of biomedical research, the need to improve the legal rules surrounding the organization and functioning of Ethics Committees in public health, toxicology, and clinical medicine is widely recognized within and outside the European Union. Given the often-heard complaints by researchers about the complexity and length of both the application and the review process by Ethics Committees in the authorization of new studies, adjustments to their legislation appears to be warranted. Within the European Union this seems also all the timelier, given the upcoming new regulation of clinical trials to become effective in early 2022. For this process, valuable lessons can be gleaned from the COVID-19 pandemic and the changes in the functioning of Ethics Committees that were adopted to cope with the exceptional circumstances imposed by the health emergency. The pandemic experience clearly indicates that a more responsive and practical system of applications' review by the Ethics Committees can be squared with acceptable levels of transparency and reliability in ethical accountability. For this reason, countries like Italy should consider undertaking a significant revision of the public law rules that govern the review processes of Ethics Committees in light of the pandemic experience. (www.actabiomedica.it).

Leveraging artificial intelligence to advance the understanding of chemical neurotoxicity.

Neurotoxicology is a specialty that aims to understand and explain the impact of chemicals, xenobiotics and physical conditions on nervous system function throughout the life span. Herein, we point to the need for integration of novel translational bioinformatics and chemo-informatics approaches, such as machine learning (ML) and artificial intelligence (AI) to the discipline. Specifically, we advance the notion that AI and ML will be helpful in identifying neurotoxic signatures, provide reliable data in predicting neurotoxicity in the context of genetic variability, and improve the understanding of neurotoxic outcomes associated with exposures to mixtures, to name a few.

Updating the European Union's regulation on classification, labelling and packaging of substances and mixtures (CLP): A key opportunity for consumers, workers and stakeholders with interests in the legislation and toxicology of hazardous chemicals.

Recent advancements in toxicology and the European Union's Green Deal, with its Chemicals Strategy for Sustainability, have paved the way for major changes in EU legislation on the control of environmental chemicals for a cleaner and safer environment. Another substantial legislative advancement underway is the update of the "Regulation on Classification, Labelling and Packaging of Substances and Mixtures (CLP)," an ambitious piece of EU legislation with exceptional scientific toxicological background in identifying a hazard, aiming at better protecting its citizens and the environment from the risk of chemical substances and products, the occupational settings included. Update of CLP legislation additionally aims at facilitating the free exchange of chemicals in the European Internal Market, provided that proper labelling and packaging processes are implemented. Participation in the ongoing online public consultation on these issues, ending on November 15, 2021, is of key relevance to ensure a transparent and effective definition of such an important piece of legislation, fully compliant with current EU priorities in terms of human and environmental protection and animal welfare.

Italian National Recovery and Resilience Plan: a Healthcare Renaissance after the COVID-19 crisis?

Proposed for the first time by European Commission in May 2020, the "NextGenerationEU" (NGEU) program is the European Union's most important effort to address key issues relating to public health and healthcare, digital and technological innovation, climate change, sustainable mobility, and key sociocultural aspects. In addition, the NGEU represents a response to the COVID-19 crisis through an extremely powerful financial intervention (over 800 billion euros). Italy is one of the main recipients of the NGEU plan's resources with almost 200 billion euros received in grants and loans. Implementation of the NGEU in Italy will take place through the National Recovery and Resilience Plan (NRRP). The NRRP not only describes how the NGEU resources will be used, but it singles out crucial public law reforms in national legislation and organization. Unsurprisingly, public health intervention represents a major component of the NRRP. Here we summarize and discuss the rules, regulations and perspective envisaged by the NRRP to foster effective healthcare and to reshape the Italian National Health System through the redesigning of primary care, enhanced communication between hospital and community healthcare, and stronger implementation of digital technologies in public health. (www.actabiomedica.it).

COVID-19 Compulsory Vaccination and the European Court of Human Rights.

Between August and September 2021, the European Court of Human Rights rejected three requests for interim measures against France and Greece's compulsory vaccination statutes against COVID-19. Due to the procedural nature of the interim measures, however, the status of vaccine mandates against SARS-CoV-2 under the European Convention of Human Rights has not been addressed. The paper argues that COVID-19 compulsory vaccination is consistent with both the text and the original understanding of Article 8 of the Convention. Moreover, considering pertinent case law on medical mandatory treatments, COVID-19 vaccine mandates should also square with the European Court of Human Right's "living instrument" doctrine. For this reason, it is expected that the European Court of Human rights will uphold COVID-19 vaccination programs. At the same time, it would be beneficial if more Council of Europe member states triggered Article 15 derogation mechanism in order to make an even stronger case for fast-track developed vaccines and contrast vaccine hesitancy.