Enforcement Priorities Research Articles

FDA Warning Letter Trends: A 15-Year Analysis

The U.S. Food and Drug Administration (FDA) plays a crucial role in safeguarding public health by regulating pharmaceutical and medical device industries. Warning letters issued by the FDA serve as a critical tool for enforcing regulatory compliance and highlighting significant violations that require prompt correction. Aim: The article analyzes trends in FDA warning letters issued to pharmaceutical companies from 2005 to 2021, identifying common violations, geographic distribution of recipients, and emerging regulatory concerns. The research is driven by the critical need to understand evolving FDA enforcement priorities and persistent industry challenges. Study Design: Retrospective analysis of publicly available FDA warning letters and related literature. Methodology: We reviewed 13 studies analyzing FDA warning letters, covering a total of 1,569 warning letters issued during the study period. Data were extracted on the frequency of warning letters, types of violations, geographic distribution of recipients, and emerging trends. Quantitative and qualitative analyses were performed to identify patterns and changes over time. Results: The annual number of warning letters increased significantly from an average of 17 in the early 2000s to 304 in 2020. Quality system issues were the most common violation, accounting for 34% of all citations from 2014-2016. Data integrity breaches emerged as a major concern, rising from negligible levels pre-2014 to 24% of violations by 2016. The proportion of warning letters issued to foreign manufacturers increased from 22.9% in 2019 to 33% in 2020. COVID-19 related violations accounted for 42.1% of all warning letters in 2020. Conclusion: FDA enforcement actions have intensified over the study period, with a shift towards systemic quality issues and data integrity concerns. The globalization of pharmaceutical manufacturing has led to increased scrutiny of foreign facilities. These trends highlight the need for robust quality management systems and proactive compliance strategies in the pharmaceutical industry. By synthesizing data from various periods and studies, this paper offers a longitudinal perspective on regulatory compliance issues to prioritize areas for improvement in quality management systems.

Internal investigations into regulatory misconduct: Key issues for individuals

This paper will address key issues for individuals in respect of internal investigations prompted by significant, non-criminal, financial regulatory issues. For the purposes of the paper, the authors will focus on firms authorised and regulated by the Financial Conduct Authority (FCA) and internal investigations conducted as a result of a breach or suspected breach of FCA rules. The paper will cover matters relevant to individuals such as: (i) duty to participate, (ii) rights and obligations, (iii) access to materials, (iv) legal advice and (v) costs/the availability of insurance coverage. The analysis will be framed in the context of current FCA enforcement trends and priorities regarding both entities and individuals.

The Days of Captive Audience Meetings May Be Numbered. But Does It Matter?

Four states, including Minnesota, Connecticut, Maine, and New York, have recently passed legislation that limits or prohibits the use of captive audience speeches with employees. Other states, such as California and Vermont, are expected to follow suit shortly. These state‐level efforts mirror the enforcement priorities of the NLRB's General Counsel, Jennifer Abruzzo, which plainly articulate a desire to find a test case to challenge the continued lawfulness of captive audience meetings under federal law.

Collective or Collusive Agreements?

The world of work, and indeed the Treaty itself, has changed considerably since the Court first examined the issue of competition law and collective bargaining agreements in the Albany decision. Exempting only those categorised as employees from the scope of Article 101 is no longer adequate to address the imbalance of bargaining power recognised by the Court. Although recognition of the ‘false self-employed’ in FNV went some way towards acknowledging the atypical position of some workers, confusion also stemmed from this intermediary category, which led to inconsistent approaches across Member States. The combination of the COVID-19 pandemic, the increased digitisation of the world of work, and a prominent decision at international level finally prompted the Commission to take action to remedy the uncertainty, by introducing Guidelines on the application of Article 101 to collective agreements regarding the working conditions of solo self-employed persons. The purpose of this paper is thus to critically analyse the likely effectiveness of these Guidelines, focusing on their substance and form respectively, while also exploring potential avenues for the Commission and the Court to provide increased legal certainty for solo self-employed persons seeking to collectively bargain, against the backdrop of an increasingly social understanding of the Treaties. Collective bargaining, Solo self-employed, Albany exception, Interpretative guidelines, Enforcement priorities, Non-competition concerns

E-Cigarette Tobacco Flavors, Public Health, and Toxicity: Narrative Review.

Recently, the US Food and Drug Administration implemented enforcement priorities against all flavored, cartridge-based e-cigarettes other than menthol and tobacco flavors. This ban undermined the products' appeal to vapers, so e-cigarette manufacturers added flavorants of other attractive flavors into tobacco-flavored e-cigarettes and reestablished appeal. This review aims to analyze the impact of the addition of other flavorants in tobacco-flavored e-cigarettes on both human and public health issues and to propose further research as well as potential interventions. Searches for relevant literature published between 2018 and 2023 were performed. Cited articles about the toxicity of e-cigarette chemicals included those published before 2018, and governmental websites and documents were also included for crucial information. Both the sales of e-cigarettes and posts on social media suggested that the manufacturers' strategy was successful. The reestablished appeal causes not only a public health issue but also threats to the health of individual vapers. Research has shown an increase in toxicity associated with the flavorants commonly used in flavored e-cigarettes, which are likely added to tobacco-flavored e-cigarettes based on tobacco-derived and synthetic tobacco-free nicotine, and these other flavors are associated with higher clinical symptoms not often induced solely by natural, traditional tobacco flavors. The additional health risks posed by the flavorants are pronounced even without considering the toxicological interactions of the different tobacco flavorants, and more research should be done to understand the health risks thoroughly and to take proper actions accordingly for the regulation of these emerging products.

Youth Use of e-Cigarette Flavor and Device Combinations and Brands Before vs After FDA Enforcement

The US Food and Drug Administration's Center for Tobacco Products (CTP) prioritized its enforcement efforts against nontobacco, nonmenthol (ie, sweet)-flavored cartridge e-cigarettes in February 2020. Within-person e-cigarette initiation, continuation, and switching behaviors among youth are unknown following CTP's prioritized enforcement efforts. To describe transitions in youths' e-cigarette flavor/device combination use, brand use, nicotine use, and frequency of use following CTP's e-cigarette enforcement prioritization. The US population-based, nationally representative Population Assessment of Tobacco and Health cohort study included data collected in 2019 and 2021 from youth aged 12 to 17 years. The data were analyzed from February to June 2023. e-cigarette use (past 30 days), flavor/device combination used, brand used, nicotine use, and frequency of use. Transitions in e-cigarette use, flavor/device combination used, brand used, nicotine use, and frequency of use between 2019 and 2021 among 9088 youth aged 12 to 17 years in 2019; prevalence of e-cigarette use, flavor/device combination used, and brand used in 2019 (n = 8771) and 2021 (n = 5574) among youth aged 14 to 17 years in each year. The 2019 sample included 8771 youth. The population of those aged 12 to 17 years was 49.0% female (95% CI, 48.7%-49.3%) and 51.0% male (95% CI, 50.8%-51.3%). Participants were 15.4% Black (95% CI, 15.0%-15.7%), 24.1% Hispanic (95% CI, 23.9%-24.4%), 75.9% non-Hispanic (95% CI, 75.6%-76.1%), 69.1% White (95% CI, 68.5%-69.8%), and 15.5% another race (95% CI, 14.9%-16.1%). Among youth ages 12 to 17 years who did not use e-cigarettes in 2019, 531 (6.5%) initiated use in 2021 (95% CI, 5.9%-7.1%); among them, 415 (76.8%) initiated with a combination other than a sweet cartridge (95% CI, 72.2%-80.8%). Among youth ages 12 to 17 who used e-cigarettes in 2019, 360 (47.8%) continued use in 2021 (95% CI, 44.0%-51.1%). Continuation rates were similar for those who used sweet-cartridge e-cigarettes (144 [51.5%]; 95% CI, 45.7%-57.3%) and those who used other combinations (204 [47.6%]; 95% CI, 42.8%-52.4%) in 2019. Among those who continued e-cigarette use in 2021, 121 (84.0%) of those who used sweet-cartridge e-cigarettes in 2019 switched to a different combination (95% CI, 77.0%-89.2%). Overall, among youth who used e-cigarettes in 2021, 177 (53%) used a sweet-disposable combination, 32 (11%) used a sweet-cartridge, and no individual brand was used by more than 10%. The results of this longitudinal cohort study of youth in the US suggest that most youth who initiated or continued e-cigarette use in 2021 used flavor/device combinations that were excluded from CTP's enforcement priorities. Restrictions and enforcement efforts that only cover a subset of products may be ineffective at preventing youth flavored e-cigarette use.

Analysis Juridical Restoration of Justice Against Perpetrator follow Criminal Corruption

Justice , obstacles and solutions taken when the Restorative justice done . Known barriers _ is obstacle from internal Police in the form of there is a sense of fear and ways long thought , meanwhile from external Police namely the ego sense of the litigants , as well from party government that is No exists issued rules _ about implementation of the Restorative justice . Because deep enforcement priority law _ is a sense of justice Good from the victim as well from party perpetrator , so mediation between party it is very influential big in settlement case . In implementation of Restorative Justice or mediation only can held of the legal process carried out by children as perpetrator ( below age ) with term Diversion, however For case criminal other general yet There is the rules that govern it . The application of restorative justice that can done in situation the that is with carry out mediation between second split the party poured in letter agreement together witnessed by religious leaders or _ figure public as base in implementation title case termination investigation.

The complex relationship between Web2 giants and Web3 projects

Web2 giants and Web3 projects entertain a complex relationship. They cooperate to maximize their chances of survival, yet they also compete through a combination of dynamic factors and anti-competitive strategies. The present contribution untangles Web2 and Web3’s relationship, explores their distinct value propositions, and outlines what may be one of tomorrow’s enforcement priorities for antitrust agencies.

The US Immigration Courts, Dumping Ground for the Nation’s Systemic Immigration Failures: The Causes, Composition, and Politically Difficult Solutions to the Court Backlog

The US immigration court system seeks to “fairly, expeditiously, and uniformly administer and interpret US immigration laws” (DOJ 2022a). It represents the first exposure of many immigrants to due process and the rule of law in the United States, and occupies an integral role in the larger US immigration system. Yet it labors under a massive backlog of pending cases that undermines its core goals and objectives. The backlog reached 1.87 million cases in the first quarter of FY 2023 (Straut-Eppsteiner 2023, 6). This paper attributes the backlog to systemic failures in the broader immigration system that negatively affect the immigration courts, such as: Visa backlogs, United States Citizen and Immigration Services (USCIS) application processing delays, and other bottlenecks in legal immigration processes. The immense disparity in funding between the court system and the Department of Homeland Security (DHS) agencies that feed cases into the courts. The failure of Congress to pass broad immigration reform legislation that could ease pressure on the enforcement and court systems. The lack of standard judicial authorities vested in Immigration Judges (IJs), limiting their ability to close cases; pressure parties to “settle” cases; and manage their dockets. The absence of a statute of limitations for civil immigration offenses. Past DHS failures to establish and adhere to enforcement priorities and to exercise prosecutorial discretion (PD) throughout the removal adjudication process, including in initial decisions to prosecute. The location of the Executive Office for Immigration Review (EOIR), which oversees US immigration courts, within the nation’s preeminent law enforcement agency, the Department of Justice (DOJ). The misconception of many policymakers that the court system should primarily serve as an adjunct to DHS. A past record of temporary judge reassignments and government shutdowns. The paper supports a well-resourced and independent immigration court system devoted to producing the right decisions under the law. Following a short introduction, a long section on “Causes and Solutions to the Backlog” examines the multi-faceted causes of the backlog, and offers an integrated, wide-ranging set of recommendations to reverse and ultimately eliminate the backlog. The “Conclusion” summarizes the paper’s topline findings and policy proposals.

Decency Norms in Law Enforcement to Online Prostitution in Indonesia: An Islamic Law Perspective

This study aims to describe Islamic law norms as living Law are offered decency norms for law enforcers against online prostitution as Article 27 of Information and Electronic Transaction (IET) law, and the factors that prevent the enforcement of the decency norms under Article 27 against the massive development of online prostitution. This research was conducted in four provinces: Jakarta, West Java, East Java, and South Sulawesi. The interviewees are investigators from the Indonesian National Police and District Court judges in four cities of four provinces. The method used is a qualitative approach.The research subjects were selected by purposive sampling, and the data were analysed using descriptive analysis. The findings of this study show Islamic Law as decency norms or living law can be a priority for law enforcement to online prostitution by using Article 27 of the IET Law, where decency norms can be imposed on perpetrators, pimps, sex workers, and buyers. Sex services, as well as intermediaries. This study also shows the reluctance of law enforcers at the investigation and court levels to enforce Article 27 more strictly and maximally because it is not a cybercrime priority that must be enforced to prevent the massive development of online prostitution.

Lasting change in competition law and policy

Abstract This is a time of passionate debate on the fundamental goals of competition law. Should there be a single overarching goal for all competition law and policy? Should that goal be framed in purely economic terms? Should antitrust focus on protecting the competitive process, preventing unfair market conduct, or the abuse of superior bargaining position? Should antitrust promote and protect democracy, address social and racial injustice, or address climate change and sustainability? How should multiple goals be administered, weighed, and traded off in enforcement priorities and litigation? There is a progressive turn in the USA at the moment. But regardless of the nature and direction of the desired change, there is the equally important issue of how to achieve lasting change that survives the inevitable change in enforcement personnel and political leaders over time. In this essay, I focus on how to achieve that lasting change regardless of the goals and direction of change that any particular jurisdiction seeks to adopt. Most of the specific examples come from current developments in the USA, but are illustrative of the process of lasting change in competition. Enforcement agencies are key players in this process, but are constrained by the constitutions, treaties, legislation, and court decisions of their jurisdictions. Any campaign for change therefore depends on the wise use of the full substantive and procedural powers assigned to them by the political branches of the government. Successfully achieving substantial change rarely happens by accident, and most often requires a combination of such factors as: (i) creatively using the full statutory powers assigned to the agencies, (ii) striving for a unified whole-of-government approach to competition policy and (iii) deeply engaging the general public.

How does environmental policy uncertainty influence corporate green investments?

Although environmental policy uncertainty is becoming prominent in emerging economies, such as China, the existing literature ignores its effect. In this study, we divided environmental policy uncertainty into policy content uncertainty (PCU) and policy enforcement uncertainty (PEU) and examined the influence of environmental policy uncertainty on corporate green investments based on survey data from Zhejiang Province, China. The results show that environmental policy uncertainty, regardless of PCU or PEU, can significantly inhibit corporate green investments. We found that executives' environmental awareness could not increase corporate green investments but significantly moderated the relationship between PEU and corporate green investments. We conclude that the government should keep environmental policies stable and enhance the capacity to develop policy enforcement priorities to ease PEU and improve the effectiveness of environmental policies.

Alcohol Enforcement in the United States From 2010 to 2019.

Despite the important role of enforcement in reducing alcohol-related harms, few studies have assessed alcohol enforcement efforts, particularly over time. We assessed the prevalence of alcohol law enforcement strategies at two time points. Of a random sample of U.S. local law enforcement agencies (i.e., police, sheriff) surveyed in 2010, 1,028 were resurveyed in 2019 (742/1,028 [72%] response rate). We assessed changes in alcohol enforcement strategies and priorities within three domains: (a) alcohol-impaired driving, (b) alcohol sales to obviously intoxicated patrons (i.e., overservice), and (c) underage drinking. Agencies reported placing higher priority on enforcement of alcohol-impaired driving and overservice in 2019 versus 2010. For alcohol-impaired driving enforcement strategies, we found increases over time in use of saturation patrols and in enforcing laws prohibiting open containers of alcohol in motor vehicles, but not in use of sobriety checkpoints. Approximately 25% of agencies conducted overservice enforcement in both years. For all strategies directed at underage drinking, enforcement decreased over time with more agencies using strategies aimed at underage drinkers versus alcohol suppliers (alcohol outlets, adults) in both years. Agencies reported continued low levels or declines in enforcement across most strategies despite reported increases in prioritizing alcohol enforcement. More agencies could adopt alcohol control enforcement strategies, including an increased focus on suppliers of alcohol to youth rather than on underage drinkers, and increased awareness and enforcement of selling alcohol to obviously intoxicated patrons. Use of these strategies has the potential to reduce health and safety consequences of excessive alcohol use.

In search of a European economic imaginary of competition: fifty years of the Commission’s annual reports

AbstractThe term ‘competition’ is a core notion for social and economic thinking and the organisation of markets. Nevertheless, this paper shows that there is no single acceptable economic imaginary ascribed to the notion in Europe. The search for the meaning of competition is an ongoing journey, from the EU’s very inception 60 years ago to the present day, which is inherently tied to the objectives, scope, and boundaries of EU (competition) law and to socio-economic transformations.The paper first reviews the history of the notion in both common-usage language and in legal-economic thinking. It exposes the emergence of three parallel, partly conflicting, imaginaries influencing the notion in EU competition law: Keynesian, ordoliberal, and neoliberal. After demonstrating that no single imaginary was adopted by EU primary, secondary, or soft laws, it applies Critical Discourse Analysis to the Commission’s annual reports on competition (1971–2020) in search for the meaning of competition. The paper reveals that the notion of competition had acquired one meaning in ‘hard’ contexts of the enforcement (scope of the prohibition of competition; exceptions or justifications for allowing otherwise anti-competitive behaviour), and another meaning in ‘softer’ contexts (mandates of the competition rules, and to a lesser extent – selection of enforcement priorities). While the ‘hard’ contexts have experienced a transformation from Keynesian and ordoliberal imaginary of competition to a neoliberal notion; the ‘soft’ contexts still invoke a broader notion reflecting influences from all three theories.Finally, the paper argues that although the lack of a clear definition for competition undoubtedly raises challenges relating to the rule of law, legal certainty, and uniformity, its ambiguity also serves as a powerful tool in safeguarding the durability and legitimacy of competition as an economic imaginary. It allows tailoring the notion of competition to changing legal, economic, and social conditions without a Treaty amendment.

Alcohol-impaired driving enforcement priorities and strategies in a nationwide sample of U.S. law enforcement agencies

Objective Excessive alcohol consumption leads to a range of public health problems and social and financial burdens. Traffic crashes resulting from alcohol-involved driving are a major contributor to the overall health consequences of alcohol. Various laws and enforcement strategies aim to prevent alcohol-involved driving. The extent to which law enforcement agencies prioritize enforcement of alcohol-impaired driving laws can help to reduce alcohol-impaired driving. Among law enforcement agencies in the US, we examined prioritization of alcohol-impaired driving enforcement and how it is associated with use of specific enforcement strategies, as well as agency and community characteristics. Methods We conducted a survey of a national sample of 1,024 US police and sheriff agencies in 2019. We assessed prioritization of alcohol-impaired driving enforcement, use of specific enforcement strategies (saturation patrols, sobriety checkpoints, open container law enforcement, training field officers to identify driving impairment), and agency and jurisdiction characteristics. We assessed how priority of enforcement (high vs. low) was associated with use of specific strategies, and agency and jurisdiction characteristics using regression models that accounted for agencies nesting within states. Results A majority of agencies (68%) placed a high priority on alcohol-impaired driving enforcement. Almost all agencies (93%) reported performing at least one alcohol-impaired driving enforcement strategy and the most common strategy used was saturation patrols. Agencies that prioritized alcohol-impaired driving enforcement were more likely to use sobriety checkpoints and saturation patrols, conduct enforcement of open container laws and train field officers in identifying driving impairment (p < 0.05). They were also more likely to have an officer assigned primarily to alcohol enforcement, have an alcohol division, and serve jurisdictions that had fewer Black residents (p < 0.05). Conclusions Many law enforcement agencies utilize strategies to address alcohol-impaired driving, however, some strategies are underutilized and an opportunity exists for agencies to incorporate additional strategies to help prevent alcohol-impaired driving. Agencies that made alcohol-impaired driving enforcement a priority were more likely to conduct related enforcement strategies. Encouraging police and sheriff agencies to prioritize alcohol-impaired driving enforcement may be an effective approach for preventing alcohol-related harms.

Electronic nicotine delivery systems (ENDS) flavours and devices used by adults before and after the 2020 US FDA ENDS enforcement priority: findings from the 2018 and 2020 US ITC Smoking and Vaping Surveys

BackgroundIn February 2020, the US Food and Drug Administration (FDA) prioritised enforcement efforts against flavoured prefilled cartridge/pod electronic nicotine delivery systems (ENDS), with the exception of tobacco and menthol. This...

POLICING FORENSIC EVIDENCE

POLICING FORENSIC EVIDENCE

Entrepreneurial Strategies in Extractive Environments

Entrepreneurs operating outside of developed markets often face heightened risks of expropriation. However, the strategies by which they can reduce said risk remained under-examined and undertheorized. This abductive study attempts to address this void through the analysis of a novel historical dataset— 2734 cases of individuals who were prosecuted as “speculators and profiteers” in Maoist China. With this data, we show that, even in the most extreme of contexts, entrepreneurs can effectively reduce the severity of expropriation by either embedding themselves in political institutions or availing themselves of incongruencies in enforcement priorities across different levels of government. These findings have broader implications for understanding the relationship between entrepreneurs and the state, as well as strategic decision-making in emerging market and authoritarian contexts.

Law Enforcement and Community Participation in Combating Illegal Logging and Deforestation in Indonesia

Purpose: This study attempts to analyze the reconstruction of law enforcement on illegal logging based on community participation and the values embodied in Pancasila as a national philosophy in Indonesia. Methodologies: This study was conducted using a normative empirical method, by employing data-driven approaches. Principal results: The results revealed that combating deforestation and illegal logging can be achieved by participatory measures with the implementation in the grassroots through community participation being taken as an important consideration to instill the principles of sustainable forest management. To obtain optimal and equitable benefits of forest resources, local community empowerment is carried out, through capacity building and providing access in order to improve their welfare. Major conclusions: The prevention and eradication of deforestation should pay attention to the principles of sustainable forest management by the government and regulatory agencies with involving grassroot level to obtain sustainable and optimal benefits of forest management. Contribution to the field: This study contributes to the intertwined relationship between law enforcement in developing forest management and social participation through a series of mechanisms and practices based on local wisdom. Important aspect of the study: The findings highlight social forestry as a sustainable forest management practice in balancing natural sustainability and social justice as law enforcement priorities. Research limitations/implications: The theoretical scope is specific to the idea of natural sustainability in the context of social justice. This has theoretical implications for further studies to provide empirical and practical justification for the implementation of social forestry in Indonesia. Practical implications: The findings practically underline the need for social forestry activities through efforts to provide legal access to local communities in the forms of forest management, business permits, plantation, partnerships, recognition and protection and customary law for community welfare and forest resource conservation. Social implications: The principles and practices of community involvement in social forestry are required to reduce poverty, unemployment and inequality in the management/utilization of forest areas.

Asset Recovery as a Fundamental Principal in Law Enforcement of Corruption by Corporations

Corruption is one of the most widespread and chronic crimes in Indonesia. Therefore, handling corruption is a very important priority for law enforcement. Perpetrators of corruption are not only individuals but also corporations. The crime is done for the benefit of the corporation itself. Today corruption committed by corporations have started to be a concern of law enforcement officials even though the implementation is not yet optimal. This paper discusses the assets recovery as a fundamental principal in criminal punishment against a corrupt corporation. This research is using a dogmatic legal method by analyzing legal materials. From the research conducted it can be concluded that law enforcement of criminal acts of corruption carried out by corporations should be prioritized in the asset recovery principal and not only aiming to punish criminal offenders. So it is recommended to law enforcement officials to use asset recovery approach in handling corruption cases committed by corporations, including in pairing the indictment with money laundering regime.