Legal and regulatory instruments for NCD prevention: a scoping review and descriptive analysis of evaluations in OECD countries.

CONTEXT: Public health law is an important tool in non-communicable disease (NCD) prevention. There are different approaches available for achieving policy objectives, including government, co-, quasi- and self-regulation. However, it is often unclear what legal design features drive successes or failures in particular contexts. This scoping review undertakes a descriptive analysis, exploring the design characteristics of legal instruments that have been used for NCD prevention and implemented and evaluated in OECD countries. METHODS: A scoping review was conducted across four health and legal databases (Scopus, EMBASE, MEDLINE, HeinOnline), identifying study characteristics, legal characteristics and regulatory approaches, and reported outcomes. Included studies focused on regulation of tobacco, alcohol, unhealthy foods and beverages, and environmental pollutants. FINDINGS: We identified 111 relevant studies evaluating 126 legal instruments. Evaluation measures most commonly assessed implementation, compliance and changes to the built and lived environment. Few studies evaluated health or economic outcomes. When examining the design and governance mechanisms of the included legal instruments, government regulation was most commonly evaluated (n = 90) and most likely to be reported effective (64%). Self-regulation (n = 27) and quasi-regulation (n = 5) were almost always reported to be ineffective (93% and 100% respectively). There were few co-regulated instruments evaluated (n = 4) with mixed effectiveness. When examining public health risks, food and beverages including alcohol were more likely to be self- or quasi-regulated and reported as ineffective more often. In comparison, tobacco and environmental pollutants were more likely to have government mandated regulation. Many evaluations lacked critical information on regulatory design. Monitoring and enforcement of regulations was inconsistently reported, making it difficult to draw linkages to outcomes and reported effectiveness. CONCLUSIONS: Food and alcohol regulation has tended to be less successful in part due to the strong reliance on self- and quasi-regulation. More work should be done in understanding how government regulation can be extended to these areas. Public health law evaluations are important for supporting government decision-making but must provide more detail of the design and implementation features of the instruments being evaluated - critical information for policy-makers.

POLICY POINTS: Government regulation is reported as more effective than co-regulation, quasi-regulation or self-regulation. Voluntary approaches, including voluntary government regulation, are reported less effective due to low uptake and limited accountability. In public health law mandated government regulation should be strived for.Food and alcohol sectors are more likely to adopt self- or quasi-regulation and are frequently reported as ineffective. More work should be done to support government regulation in these areas.Many public health law evaluations are lacking critical design information for policy makers. This may make it difficult to learn from successes or failures and replicate interventions in other jurisdictions.

Banning Engineered Stone: A Landmark Australian Public Health Law Reform.

Union activism, medical lobbying and occupational health and safety prosecutions led to a major public health initiative in Australia - the banning from 1 July 2024 of work with engineered/artificial stone, including manufacturing, supplying, processing and installing it. This editorial contextualises within the history of regulation of workers' exposure to risks of contracting silicosis the growing international awareness of the dangers posed by working with engineered stone, particularly in relation to making and installing kitchen and bathroom benchtops made from engineered stone. It argues that the Australian initiative is an important public health decision that has a sound justification, is likely to save many lives and should be emulated internationally.

COVID-19 and the law in Uganda: a case study on development and application of the public health act from 2020 to 2021.

BACKGROUND: Despite the discovery of vaccines, the control, and prevention of Coronavirus disease 2019 (COVID-19) relied on non-pharmaceutical interventions (NPIs). This article describes the development and application of the Public Health Act to implement NPIs for COVID-19 pandemic control in Uganda. METHODS: This is a case study of Uganda's experience with enacting COVID-19 Rules under the Public Health Act Cap. 281. The study assessed how and what Rules were developed, their influence on the outbreak progress, and litigation. The data sources reviewed were applicable laws and policies, Presidential speeches, Cabinet resolutions, statutory instruments, COVID-19 situation reports, and the registry of court cases that contributed to a triangulated analysis. RESULTS: Uganda applied four COVID-19 broad Rules for the period March 2020 to October 2021. The Minister of Health enacted the Rules, which response teams, enforcement agencies, and the general population followed. The Presidential speeches, their expiry period and progress of the pandemic curve led to amendment of the Rules twenty one (21) times. The Uganda Peoples Defense Forces Act No. 7 of 2005, the Public Finance Management Act No. 3 of 2015, and the National Policy for Disaster Preparedness and Management supplemented the enacted COVID-19 Rules. However, these Rules attracted specific litigation due to perceived infringement on certain human rights provisions. CONCLUSIONS: Countries can enact supportive legislation within the course of an outbreak. The balance of enforcing public health interventions and human rights infringements is an important consideration in future. We recommend public sensitization about legislative provisions and reforms to guide public health responses in future outbreaks or pandemics.

The Legal Needs of People Living with a Sexually Transmissible Infection or Blood-Borne Virus: Perspectives From a Sample of the Australian Sexual Health and Blood Borne Virus Workforce.

Law and the legal environment are important factors in the epidemiology and prevention of sexually transmissible infections (STIs) and blood-borne viruses (BBVs). However, there has been no sustained effort to monitor the legal environment surrounding STIs and BBVs. This article presents the first data on the incidence and impacts of unmet legal needs for those affected by an STI or BBV in Australia using a survey administered to a sample of the Australian sexual health and BBV workforce. Migration, Housing, Money/Debt, Health (including complaints about health services), and Crime (accused/offender) were reported as the five most common legal need areas, with 60% of respondents describing these legal problems as generating a "severe" impact on health. These results indicate that unmet legal needs generate significant negative impacts in terms of individual health, on public health, and the ability to provide sustainable services such as testing and treatment to those facing unmet legal needs.

Sociodemographic characteristics associated with a higher wish to complain about health care.

OBJECTIVES: Previous research has shown that patients who are older, less educated, or have lower income are less likely to lodge complaints about health care. This variation may reflect less wish to complain or inequitable access to complaint channels or remedies. We aimed to investigate associations between sociodemographic characteristics and health users' wish to complain. STUDY DESIGN: This was a randomized case vignette survey among 6756 Danish men aged 45-70 years (30% response rate). METHODS: Assuming they received the care in vignettes about prostate cancer (prostate-specific antigen) testing, participants rated their wish to complain on a 5-point Likert scale. Information on sociodemographic characteristics was obtained through self-reports and municipality-level information from national registries. RESULTS: Lower education was associated with an increased wish to complain (mean Likert difference 0.44 [95% CI 0.36-0.51]; P < .001). The wish to complain was higher among unemployed men (difference 0.16 [95% CI 0.04-0.28]; P < .011) and those with a chronic illness (difference 0.06 [95% CI 0.02-0.10]; P < .004). Given the same healthcare scenarios, there was no difference in wish to complain among health users who were retired, living rurally, or from lower income groups. CONCLUSIONS: Health users who are less educated, lower income, elderly, or from rural or minority communities appear to be as likely, or more likely, to wish to complain about health care as others. Yet, younger, well-educated, and higher income citizens are overrepresented in actual complaint statistics. The finding suggests persisting inequalities in the suitability or accessibility of complaint processes for some groups of patients.

Progress, challenges and the need to set concrete goals in the global tobacco endgame.

The tobacco endgame is rapidly moving from aspirational and theoretical toward a concrete and achievable goal and, in some cases, enacted policy. Endgame policies differ from traditional tobacco control measures by explicitly aiming to permanently end, rather than simply minimize, tobacco use. The purpose of this paper is to outline recent progress made in the tobacco endgame, its relationship to existing tobacco control policies, the challenges and how endgame planning can be adapted to different tobacco control contexts. Examples of implemented policies in three cities in the United States and national policies in the Netherlands and New Zealand are outlined, as well as recent endgame planning developments in Europe. Justifications for integrating endgame targets into tobacco control policy and the need to set concrete time frames are discussed, including planning for ending the sale of tobacco products. Tobacco endgame planning must consider the jurisdiction-specific tobacco control context, including the current prevalence of tobacco use, existing policies, implementation of the World Health Organization's Framework Convention on Tobacco Control, and public support. However, the current tobacco control context should not determine whether endgame planning should happen, but rather how and when different endgame approaches can occur. Potential challenges include legal challenges, the contested role of e-cigarettes and the tobacco industry's attempt to co-opt the rhetoric of smoke-free policies. While acknowledging the different views regarding e-cigarettes and other products, we argue for a contractionary approach to the tobacco product market. The tobacco control community should capitalize on the growing theoretical and empirical evidence, political will and public support for the tobacco endgame, and set concrete goals for finally ending the tobacco epidemic.

La fase final para poner fin al consumo de tabaco está rápidamente dejando de ser una aspiración y una teoría y se está convirtiendo en un objetivo concreto y alcanzable y, en algunos casos, una política promulgada. Las políticas para poner fin al consumo de tabaco difieren de las medidas tradicionales de control porque están dirigidas explícitamente a poner fin al consumo de tabaco de forma permanente, en lugar de solo minimizarlo. El propósito de este artículo es describir los progresos recientes en la fase final para poner fin al consumo de tabaco, su relación con las políticas existentes de control del tabaco, los desafíos que se enfrentan y cómo la planificación de la fase final se puede adaptar a los diferentes contextos de control del tabaco. Se describen ejemplos de políticas implementadas en tres ciudades de los Estados Unidos y de políticas nacionales en los Países Bajos y Nueva Zelanda, así como los progresos recientes en la planificación de la fase final en Europa. Se abordan las justificaciones para integrar los objetivos de fase final en las políticas de control del tabaco y la necesidad de establecer plazos concretos, incluida la planificación para poner fin a la venta de productos de tabaco. La planificación de la fase final para poner fin al consumo de tabaco debe considerar el contexto de control del tabaco específico según la jurisdicción, así como la prevalencia actual del consumo, las políticas existentes, la aplicación del Convenio Marco de la Organización Mundial de la Salud para el Control del Tabaco y el apoyo público. Sin embargo, el contexto actual no debe determinar si se debe realizar la planificación de la fase final, sino más bien cómo y cuándo pueden desarrollarse los diferentes planteamientos de la fase. Entre los posibles desafíos se encuentran los legales, el controvertido papel de los cigarrillos electrónicos y el intento de la industria tabacalera de incorporarse a la retórica de las políticas libres de humo. Si bien reconocemos las diferentes opiniones con respecto a los cigarrillos electrónicos y otros productos, abogamos por un enfoque restrictivo con respecto al mercado de productos de tabaco. La comunidad que trabaja por el control del tabaco debe capitalizar la creciente evidencia teórica y empírica, la voluntad política y el apoyo público para lograr la fase final para poner fin al consumo de tabaco, y establecer objetivos concretos para acabar finalmente con la epidemia de tabaquismo.

A erradicação do tabaco está passando rapidamente de uma aspiração teórica para um objetivo concreto e alcançável e, em alguns casos, está se tornando política em vigor. As políticas de erradicação diferem das medidas tradicionais de controle do tabagismo pois visam explicitamente ao fim permanente do consumo de tabaco, ao invés de simplesmente minimizá-lo. O objetivo deste artigo é delinear os avanços recentes rumo à erradicação do tabaco, sua relação com as políticas existentes de controle do tabaco, os desafios e como o planejamento da erradicação pode ser adaptado aos diferentes contextos de controle do tabaco. São apresentados exemplos de políticas implementadas em três cidades nos Estados Unidos e políticas nacionais na Holanda e Nova Zelândia, assim como desdobramentos recentes do planejamento da erradicação na Europa. São discutidas justificativas para integrar metas de erradicação nas políticas de controle do tabaco e a necessidade de estabelecer prazos concretos, incluindo o planejamento para encerrar a venda de produtos de tabaco. O planejamento da erradicação do tabaco deve considerar o contexto do controle do tabaco específico a cada jurisdição, incluindo a prevalência atual do consumo de tabaco, as políticas existentes, a implementação da Convenção-Quadro para o Controle do Tabaco da Organização Mundial da Saúde e o apoio do público. Porém, o contexto atual de controle do tabaco não deve determinar se o planejamento da erradicação deve acontecer, mas sim, como e quando diferentes abordagens à erradicação podem ocorrer. Os desafios potenciais incluem recursos judiciais, o papel polêmico dos cigarros eletrônicos e a tentativa da indústria do tabaco de cooptar a retórica das políticas antitabagistas. Embora reconhecendo os diferentes pontos de vista em relação aos cigarros eletrônicos e outros produtos, defendemos uma abordagem contracionista ao mercado de produtos de tabaco. A comunidade de controle do tabaco deve aproveitar as crescentes evidências teóricas e empíricas, a vontade política e o apoio do público à erradicação do tabaco para estabelecer metas concretas e, finalmente, pôr fim à epidemia de tabagismo.

Sexual and Reproductive Health Advocacy Successes, Failures, and Needs in the United States: Perspectives From Key Stakeholders.

Physician advocates for sexual and reproductive health (SRH) care have been active in the United States for decades. Despite such activism, access to SRH services has been fraught with persistent restrictions, particularly for abortion care. We sought the perspectives of key stakeholders on what makes for an effective SRH physician advocate and thoughts about the successes, failures, and needs of the abortion advocacy movement. We interviewed 15 SRH key informants (KIs) in sectors with expertise in organizational policy and advocacy (n = 6); clinical leadership and education (n = 3), media (n = 3), and reproductive justice (n = 3). The analytic team coded repeating ideas and conducted a thematic analysis, organizing findings within KI perspectives on the role of physician advocates in the field of abortion and contraception; successes, failures, and needs in abortion and contraception advocacy; and recommendations on the composition and components of an ideal clinician advocacy training program. KIs relayed that skill building related to communication, developing relationships with changemakers, and understanding political systems was critical for effective advocacy. They felt clinician advocacy training programs should include providers other than physicians and be designed for trainees to build relationships with one another over time. KI perspectives can be valuable in informing advocacy training programs and for contributing strategic approaches to increasing equitable and widespread access to SRH services.

Shattering the Mirage: The FDA's Early COVID-19 Pandemic Response Demonstrates a Need for Reform to Restore Agency Credibility.

The power afforded to the administrative state is heavily reliant on public trust and the perception of evidence-based agency decision-making. Organizational reputation is key to preserving regulatory power. However, recent investigations reveal that existing scientific integrity policies may not be sufficient to preserve the credibility of many federal agencies. In fact, a significant number of career scientists across various entities - including the FDA - have observed unreported incidents of political interference. While political influence exerted by the executive branch to set policy goals and determine agency priorities can be beneficial, political pressures must not undermine public trust in scientific agencies. Recently, public perception regarding the FDA's COVID-19 response threatened to weaken the agency's longstanding reputation as the gold standard of review. The COVID-19 pandemic publicized vulnerabilities that exist across agencies, as well as those that are unique to the FDA. The FDA's evolution as an increasingly public health-focused agency that must function in the landscape of politicized science exposes the agency to a greater risk of political interference. After all, the FDA's involvement in public health requires increased participation in non-ideal, value-based decision-making. Throughout its history, the FDA has managed to maintain its reputation through its firm responses to scandal. The COVID-19 pandemic provides a platform for the FDA to - once again - look introspectively and institute safeguards addressing vulnerabilities that plagued the agency's pandemic response. This Article examines the FDA's early COVID-19 response to propose reforms that promote meaningful transparency, public accountability, and scientific integrity.

Vaccinating Children: The COVID-19 Family Law Jurisprudence.

Australian, New Zealand, English and Canadian courts have made a number of orders, often in the context of parenting disputes, requiring children to be vaccinated. Complementary therapy options have generally not been permitted as an alternative to mainstream vaccination. Debates about parental entitlements to make decisions about such matters have taken place in the context of contested family law litigation during the COVID-19 era. However, by contrast with Ontario Superior Court of Justice decisions in 2022, a series of Australian decisions, including the judgment of Sutherland CJ in Clay & Dallas [2022] FCWA 18, have developed the law further, having regard to both the capacity of a minor to consent to vaccination and reviewing a variety of factors going to children's best interests at different junctures during the pandemic, finding it generally to be in the best interests of children to receive COVID-19 vaccinations. This is likely to flow back into curial decision-making about vaccinations more broadly, as well as cognate matters.

The Legal Status of General Practitioners at the dawn of the New Primary Care in Italy.

Abstract: A debate is developing in Italy on the reform of the employment status of general practitioners. The dispute was prompted by the extraordinary resources the European Union has allocated to Italy on the condition of several structural reforms, among which lies the renewal of the primary care system. One of the most debated questions is whether general practitioners should become civil servants or remain autonomous workers. The issue is not only relevant to the quality and efficiency of primary care but is propitious for improving the legal certainty of this "hybrid figure" in Italian health law. The commentary suggests that, from a public law point of view, the employment status of civil servants better agrees with the foreseeable conditions of general practitioners working in Community Houses. In any case, national and regional policymakers must take into consideration possible controversies and litigation arising from an inappropriate qualification of the legal status of general practitioners in building the new system of Italian primary care.

The legal determinants of health (in)justice.

The mutual influences of social epidemiology and ideas of justice, each on the other, have been seminal in the development of public health ethics and law over the past two decades, and to the prominence that these fields give to health inequalities and the social-including commercial, political, and legal-determinants of health. General and political recognition of injustices in systematised health inequalities have further increased given the crushingly unequal impacts of the COVID-19 pandemic; including impacts of the legal and policy responses to it. However, despite apparent attention from successive UK governments to injustices concerning avoidable inequalities in health opportunities and outcomes, significant challenges impede the creation of health laws and policy that are both effective and ethically rigorous. This article critically explores these points. It addresses deficiencies in a UK health law landscape where health care contexts and medico-ethical assumptions predominate, to the great exclusion of broader social and governmental influences on health. The article explains how a public health framing better serves analysis, and engages with a framework of justice-oriented questions that must be asked if we are to understand the proper place and roles of law and regulation for the public's health.

Involuntary Patient Assessment in Australia: A Mental Health or Public Health Response?

Involuntary assessment relates to detaining and transporting a person at risk of harming themselves or others, and without their consent, to hospital for examination and treatment. State and Territory statutory authorities generally allow police, paramedics and/or health practitioners to initiate involuntary assessment. Because of the stigma attached to mental illness, and to protect people from harming themselves or others in broader circumstances than mental illness alone, the Queensland government changed involuntary assessment powers. Instead of mental health legislation governing involuntary assessment in Queensland, this is now a public health function. Despite the best intentions, the public health legislation does not address some of the practical challenges of involuntary assessment for health practitioners. This article explores the evolution of involuntary assessment powers in Australia and considers the impacts of it becoming a public health power in Queensland.

Chasing Immunity: How Viable Is a Mandatory COVID-19 Vaccination Scheme for Australia?

When he first announced Australia's acquisition strategy for the COVID-19 vaccine, Prime Minister Scott Morrison alluded to the possibility of a mandatory vaccination scheme. The statement was met with significant backlash and Mr Morrison promptly rescinded the statement focusing instead on his desire to reach high levels of voluntary vaccine coverage. Nevertheless, interesting legal questions about the possibility of mandatory COVID-19 vaccination arose. This article explores the possible legal frameworks for implementing a mandatory vaccination scheme in Australia as well as the associated ethical dilemmas. Furthermore, it argues that a mandatory vaccination scheme, while possible and arguably ethical, would have undesirable implications resulting in popular opposition and decreased compliance with other voluntary vaccines such as childhood vaccination and seasonal influenza. Consequently, a voluntary scheme based on incentives and transparent provision of information is much more likely to achieve the desired uptake.

COVID-19: Public Health Emergency Powers and Accountability Mechanisms in Australia.

During the COVID-19 pandemic in Australia, governments in all jurisdictions (except New South Wales) have declared states of emergency and exercised powers under their public health emergency legislation. Highly restrictive measures have been introduced pursuant to the exercise of such powers. Extraordinary government action demands strong accountability. This section piece reviews the public health emergency legislation in all Australian jurisdictions and finds that inadequate accountability mechanisms are embedded in the statutes. This section piece demonstrates that there is insufficient transparency around the decisions being made by the Executive under the public health emergency powers. The section piece also reveals that there are very few options built into the public health emergency legislation for review of executive action for its legality, meritoriousness and fairness.

The Political Determinants of China'S New Health Constitution.

The Basic Healthcare and Health Promotion Law 2019 became the new constitution of China's health system in June 2020, giving legal effect to ambitious health reform programmes like Healthy China 2030. The concurrent outbreak of coronavirus disease 2019 must not distract us from appreciating the fact that this Law will comprehensively overhaul the health regulatory framework of the world's most populous country during the coming decade, if not beyond. This article offers an original evaluation of the Law in its political context. The Law commendably promises to safeguard the right to health, assist citizens to live a 'complete cycle of life', and promote health using the resources of the public health system. However, it is also deeply politicised, guaranteeing extensive and penetrative political control in health campaigns, digitalised health data, the governance of health institutions, and the resolution of medical disputes. This can be explained by the consequential roles played by epidemics in China's historical dynastic cycles, but even more so by powerful tendencies of centralisation on the part of the Leninist Party-state. The Law's potential is thus subject to the overriding caveat that the Party-state's existence and influence over law and public health must be secured.

Compulsory medical intervention versus external constraint in pandemic control.

Would compulsory treatment or vaccination for COVID-19 be justified? In England, there would be significant legal barriers to it. However, we offer a conditional ethical argument in favour of allowing compulsory treatment and vaccination, drawing on an ethical comparison with external constraints-such as quarantine, isolation and 'lockdown'-that have already been authorised to control the pandemic in this jurisdiction. We argue that, if the permissive English approach to external constraints for COVID-19 has been justified, then there is a case for a similarly permissive approach to compulsory medical interventions.

[Subnational population health monitoring and reporting: public health at the grassroots level]. / Gesundheitsberichterstattung in Ländern und Kommunen: Public Health an der Basis.

Population health monitoring and reporting provides regular and up-to-date information on health outcomes and its determinants. The outputs of population health monitoring aim to inform policymakers and other stakeholders to develop fact-based decisions. Population health monitoring is located at the national, but also federal state and county level. This paper describes the legal basis for population health monitoring in the federal states' public health acts as well as current challenges and possibilities for further development from a federal state and county perspective on population health monitoring.A legal basis for population health monitoring on the federal state and county level exists for almost all federal states in Germany. The level of detail of these laws varies in terms of responsibility, periodicity of population health monitoring and reporting, content, and designated use. Population health monitoring needs to respond to challenges in the areas of population health monitoring resources, data sources, (intersectoral) reporting, and impact. Practical examples illustrate how the challenges can be handled and further development can take place.Based on its solid legal basis, being a routine task, and its close link to the living conditions of the population, population health monitoring on the federal state and county level has the possibility for cocreating public health at the grassroots level and to be a pioneer for health equity.

COVID-19 Curfews: Kenyan and Australian Litigation and Pandemic Protection.

Historically and etymologically, curfews are public health measures imposed to guard against risks to health and safety. On occasion they have been deployed oppressively, disproportionately and without proper regard to their ramifications. It is important that they not be used during a pandemic unless there is sufficient medico-scientific reason to conclude that they will serve a constructive purpose and that they are the least restrictive available governmental response. Inevitably, they impact adversely on a variety of human rights, particularly freedom of movement. They isolate and inhibit human connection. However, in the context of a worldwide pandemic causing terrible loss of life, there are occasions where they may be a necessary adjunct to these restrictions. This article identifies a variety of scenarios in which curfews have been imposed on different populations and identifies legal challenges that have been made to them. In the context of the COVID-19 pandemic it reviews the Kenyan judgment of Law Society of Kenya v Mutyambai [2020] eKLR and the Victorian Supreme Court judgment of Loielo v Giles [2020] VSC 722. It contends that the carefully reasoned decisions in each instance constitute an important reassurance that decision-making about a lengthy curfew in order to reduce the spread of the COVID-19 virus was reasoned, rights-aware and suitably responsive to the risks posed.

International Access to Public Health Data: An Important Brazilian Legal Precedent.

Accurate, up-to-date data are the bedrock of effective public health responses, including in the context of the suffering caused by COVID-19. Any action to inhibit the compilation of such data has ramifications locally, nationally and internationally, and risks impairing the global capacity to respond to the virus. This article contextualises the decision of the government of President Bolsonaro of Brazil to reduce the accessibility of contemporary data about COVID-19 infections in Brazil within his views about, and responses to, the virus. It identifies the nature of actions taken to suppress such data by the Brazilian Ministry of Health and then scrutinises a decision by De Moraes J of Brazil's High Court in Sustainability Network v The President of the Republic of Brazil (ADPF 690 MC/DF, 8 June 2020), which quashed the attempted suppression of public health data. The article hails the decision as an important public health law precedent.

Ten Years of FDA Tobacco Regulation: Lessons for Public Health Stakeholders.

In the 10 years that the U.S. Food and Drug Administration (FDA) has been regulating tobacco products, the agency has been plagued with setbacks, some of its own making, and some the result of outside forces. What has been consistently true is that the public health community has not had as much of a voice as it should have until public health groups began filing lawsuits against the FDA. This article examines four areas of FDA regulation over the last decade in an attempt to qualitatively describe the work of the Center for Tobacco Products and identify opportunities for public health groups to have greater advocacy success in the future.