Food and Drug Law Commons^™

The Safe Drinking Water / Food Law Nexus, Margot J. Pollans

Pace Environmental Law Review

At 2 AM on August 2, 2014, the Ohio Environmental Protection Agency issued the following warning to the citizens of Toledo: “Do Not Drink.” The Ohio City's tap water was contaminated with microcystin, a toxin that can cause diarrhea, vomiting, and abnormal liver function. The source was an algal bloom in Lake Erie resulting from high levels of agricultural fertilizers and animal waste. For three days, Toledo residents drank only bottled water.

This is just one of many similar examples of agricultural contamination of urban drinking water supplies. Creating a physical connection between urban and rural communities, this pollution highlights …

An International Sos (Save Our Sharks): How The International Legal Framework Should Be Used To Save Our Sharks, Crystal Green

Pace International Law Review

The purpose of this Article is to shed light on the plight on sharks in international and domestic waters. An estimated 100 million sharks are killed every year. The cruel and wasteful practice of shark finning is responsible for a large portion of those killings. Shark fins are the most valuable part of the shark, because they are used as the key ingredient – and namesake – in an Asian delicacy known as “shark fin soup.” This Article opens with background information on the dire situation sharks are facing in our oceans, and how the depletion of these top predators …

New York City Rules! Regulatory Models For Environmental And Public Health, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Scholars have become increasingly interested in facilitating improvement in environmental and public health at the local level. Over the last few years, former New York City Mayor Michael Bloomberg and the New York City Council have proposed and adopted numerous environmental and public health initiatives, providing a useful case study for analyzing the development and success (or failure) of various regulatory tools, and offering larger lessons about regulation that can be extrapolated to other substantive areas. This Article, first, seeks to categorize and evaluate these “New York Rules,” creating a new taxonomy to understand different types of regulation. These “New …

Regulating Farming: Balancing Food Safety And Environmental Protection In A Cooperative Governance Regime, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

After providing a brief overview of regulation in each area, Part I of this Article identifies three types of discordance between produce safety and environmental protection on farms. First, because of limited resources, farmers will have to choose between implementing food safety practices and implementing environmental practices. Second, indirect trade-offs between the two regulatory goals result in damaging collateral consequences for the environment. Food safety regulation may exacerbate a range of existing environmental harms. Third, there is at least one direct clash that may make compliance with food safety law incompatible with participation in certain environmental programs. Part I also …

Rethinking The Childhood-Adult Divide: Meeting The Mental Health Needs Of Emerging Adults, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

Part I of this article describes ADHD and explores the extent of ADHD medication abuse, especially among young adults. Part II discusses the characteristics of emerging adults, who may be more likely than their older counterparts to make unwise decisions about medications and other life choices.34 While we protect minors by requiring parental consent for their medical treatments, emerging adults are effectively able to obtain any drug on the market if they convince the doctor that they have the requisite diagnosis. Part III explores HIPAA, the medical malpractice standard of care and the challenges associated with a society that is …

Creating Order Amidst Food Eco-Label Chaos, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Eco-labels, certifications, and seals of approval serve a variety of functions including communicating to businesses and consumers the environmental attributes of a particular product and incentivizing improvements in production. Eco-labels also provide a basis for companies to set measurable sustainability goals for sourcing, improvements, and transparency. As they gain greater traction in the marketplace, however, there has been a massive proliferation of labels, certifications, and green seals of approval. This has led to consumer confusion, inaccurate and misleading claims, and inconsistent standards. A 2009 survey identified about 600 labels that denote some definition of “environmentally friendly” worldwide, including more than …

Greenwashing And Self-Declared Seafood Ecolabels, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

The credibility and veracity of an environmental claim depends on a high degree of transparency, clarity, and trust. Businesses that utilize ecolabels to market the environmental performance of their seafood products often turn to third-party certifications to minimize the potential for greenwashing and provide a level of verification and independence. Others rely on a riskier approach by developing their own self-declared or first-party ecolabels. Seafood retailers and suppliers considering the creation and use of an ecolabel, certification, or seal to be used in the marketing of seafood products should ensure compliance with applicable Food and Drug Administration and United States …

Eating Invaders: Managing Biological Invasions With Fork And Knife?, Joshua Ulan Galperin, Sara Kuebbing

Elisabeth Haub School of Law Faculty Publications

As the public, academy, government, and private sector all turn increased attention to food systems, new ideas constantly emerge for healthy, sustainable, and just innovations in growing, marketing, and eating food. “Invasivory” — eating invasive species — is one such idea. Biological invasions occur when humans transport an organism from its ecosystem of origin into a new ecosystem and that organism adapts to its new location, spreading widely from the site of introduction. Invasive species can cause significant ecological, economic, and public health damage. Crops, homes, and native species are all at risk. “Invasivores,” as the proponents of invasivory are …

Food Court, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This article, focusing on produce and grain, discusses the environmental and climate change impacts of food production, processing, packaging, and distribution, which ultimately contribute to both economic and social costs. The article addresses environmental energy costs in the food supply. Figure 1 shows, for example, the significant amount of energy used in various aspects of food production, transportation, and processing.

Much of this article's focus will be on commodity crops. Along with wheat and rice, corn and soybeans constitute the world's most popular planted and consumed crops. The United States is the leading producer of corn, growing nearly 40 percent …

Fair Or Foul: When Does Media Accusation Of Performance Enhancing Drug Use Become Tortious?, Richard T. Ward Iii

Pace Intellectual Property, Sports & Entertainment Law Forum

The Steroids Era in baseball refers to the recent period in the MLB where many players and trainers have been found guilty or been implicated in the use of performance enhancing drugs which leads to sharp increases in player talent. The stigma associated with PED use, and also any other form of cheating, has proven to be a fast track to shame in the world of Major League Baseball. This article addresses the current state of defamation law in New York and the Federal Courts by analyzing the recent statement made by Skip Bayless concerning use of Performance Enhancing Drugs …

Harmony With Nature And Genetically Modified Seeds: A Contradictory Concept In The United States And Brazil?, Heather Leibowitz

Pace Environmental Law Review

Looking at the differing regulatory frameworks for genetically modified organisms (GMOs) in the United States and Brazil, this Article will help demonstrate how a lack of scientifically objective standards has allowed regulatory agencies to circumvent environmentally protective and sustainable policies. Additionally, this analysis will help illuminate what corrective steps can be taken.

Is Sugar The New Tobacco? How To Regulate Toxic Foods, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

This article explores the health risks associated with added sugar. It then examines how, if at all, sugar should be regulated, by considering tobacco regulation as a possible model. Part I identifies the health risks of sugar consumption. Part II examines the reasons why sugar is added to so much of our food supply. Part III provides an overview of tobacco regulation, including educational initiatives, warning labels, advertising restrictions, age limitations, and taxes. Finally, Part IV provides a framework for sugar regulation, suggesting that most of the foregoing laws designed to discourage tobacco use should, with the exception of age …

Global Environmental Law: Food Safety & China, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This article makes the case for food security law and policy as a component of global environmental law in recognition of the global economy, trade liberalization, and concerns for food safety and environmental harm. It further describes rule of law as a significant force in mitigating food safety concerns and pollution in China. Part II explores global food safety concerns in the context of United States-China relations, while Part III discusses the U.S. Food & Drug Administration's on-the-ground presence in China as an example of the emergence of cooperative agreements in global environmental governance. Part IV shows how increased rule …

Hot, Crowded, And Legal: A Look At Industrial Agriculture In The United States And Brazil, David N. Cassuto

Elisabeth Haub School of Law Faculty Publications

Over the last sixty years, industrial agriculture has expanded in the United States and throughout the world, including in Brazil. Any benefit this expansion has brought comes at significant environmental and social costs. Industrial agriculture is a leading contributor to global climate change, air and water pollution, deforestation, and dangers in the workplace. This Article discusses the impact of industrial animal agriculture in the U.S. and Brazil. It also examines the laws pertaining to industrial agriculture in both countries and provides a comparative analysis of the two legal regimes. Finally, this Article concludes with the observation that although the price …

Food, Law & The Environment: Informational And Structural Changes For A Sustainable Food System, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This Article considers legal, theoretical, and practical steps to a more sustainable food model. Part I discusses the underlying reasons for problems in the current food system, including those manifested in law, and the perceived benefits of creating a new agricultural paradigm. Part II discusses the major agricultural and food programs that have become more common in shaping a different food system model, specifically focusing on direct marketing (for example, farmers markets and community-supported agriculture) and the organic movement as it relates to small farmers. Part III argues that in order to change modern American food consumption, two changes must …

The Future Of Food Eco-Labeling: Organic, Carbon Footprint, And Environmental Life-Cycle Analysis, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This Article discusses public and private efforts to inform consumers about environmentally preferable food choices. Part II describes the environmental consequences of the modern food system. Part III describes existing public and private eco-labeling regimes, including organic labeling, carbon footprint labeling, and country of origin labeling.

Rethinking Addiction: Drugs, Deterrence, And The Neuroscience Revolution, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This article connects the debate about addiction with the fundamental criminal law principle of deterrence. It seeks to bridge the gap between the competing medical and criminal justice approaches by exploring addiction in light of recent research about the brain, gender differences, and what works best from both a treatment and justice perspective. To sharpen the issues, the article deliberately focuses on the emotionally freighted subject of pregnant drug users. This approach will illuminate prevailing assumptions about how biological, genetic, cultural, and other environmental factors shape human behavior and challenge conventional understandings of deterrence in light of new research on …

Reclaiming The Right To Food As A Normative Response To The Global Food Crisis, Smita Narula

Elisabeth Haub School of Law Faculty Publications

In 2009, the number of hungry in the world crossed the one billion mark, a dubious milestone that has been attributed in large part to consecutive food and economic crises. Over ninety-eight percent of these individuals live in the developing world. Ironically, a great majority are involved in food production as small-scale independent food producers or agricultural laborers. These facts and figures signal a definitive blow to efforts to reduce global hunger and lift the world's poorest from abject and dehumanizing poverty. They also bring to light the deep imbalance of power in a fundamentally flawed food system. Responses to …

We Can Work It Out: Co-Op Compulsory Licensing As The Way Forward In Improving Access To Anti-Retroviral Drugs, Horace E. Anderson

Elisabeth Haub School of Law Faculty Publications

This Article explores the social and developmental underpinnings of the access problem and describes the legal framework that provides the backdrop for the Waiver's licensing scheme. Part III examines the various lenses, humanitarian, economic, and political, through which the underutilization problem may be viewed and explained. Part IV sets out the structural heart of the Waiver scheme's deficiencies: the notion of the “compulsory” license itself. Part V posits a co-op scheme of licensing that aligns the concerns, goals, and incentives of IP owners, importers, exporters, and consumers. Finally, the Article relates the proposed scheme to more general trends in thinking …

Bundling Public And Private Goods: The Market For Sustainable Organics, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

Modern agriculture has vast environmental externalities. The pesticides, fertilizers, and sediments in irrigation runoff pollute surface and groundwater; single-crop farms destroy biodiversity; and massive amounts of fossil fuels are burned in agricultural production, post-harvest processing, and shipping. Nevertheless, farming operations have largely escaped the post-1970 expansion of federal environmental regulation. Compounding the problem, federal farm policy has encouraged the very farming practices that most cause this degradation.

In 1990, Congress passed the Organic Foods Production Act (OFPA), which created an organic food certification and labeling system. While OFPA's primary purposes are to facilitate the growth of the organic sector and …

Owning What You Eat: The Discourse Of Food, David N. Cassuto

Elisabeth Haub School of Law Faculty Publications

This essay examines the role of communication in the formation of law and social norms and the implications of that role for animal law and ethics. Part III contextualizes animal law within contemporary risk society. Part IV looks at how efficiency has transformed from an economic concept into a normative guideline and discusses how that transformation has affected animals and agriculture. It tracks the rise of industrial agriculture and ties it to this fundamental misunderstanding of the concept of efficiency. The essay concludes with some thoughts on how to reformulate contemporary notions of efficiency and ethics to account for the …

Marketing Mothers' Milk: The Commodification Of Breastfeeding And The New Markets For Breast Milk And Infant Formula, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This paper explores the commodification of women and biological processes, the confusion of scientific evidence with social agendas, and the conflict between marketing and public health. I assert that key actors in the healthcare marketplace - government, businesses, and doctors – have acted to enable weak medical and scientific evidence to be manipulated by ideological and profit-making partisans in a poorly regulated market. I focus on the unique role of the medical profession, which has acted with government and the private sector to shape the markets in human milk and infant formula. In a striking parallel to the pharmaceutical industry, …

Obesity, Public Health, And The Food Supply, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

This Article proposes a three-part approach to improve the food supply. Specifically, it explores government taxing and spending, two traditional public health tools, and suggests that both of these governmental powers can be used to make healthier foods more readily reasonable prices, while increasing the cost of less healthy alternatives. Finally, it proposes that we promote a true “food democracy” through the creation of an education and awareness campaign. This campaign would not only better educate Americans about proper nutrition but would also focus on how we can change our entire relationship with food. It would encourage consumption of locally …

The Right To Food: Holding Global Actors Accountable Under International Law, Smita Narula

Elisabeth Haub School of Law Faculty Publications

Economic globalization represents both an unmet opportunity and a significant challenge for the fulfillment of social and economic rights, including the right to food. While corporate sector accountability and the responsibility of international financial institutions (IFIs) to ensure social and economic rights are now at the forefront of the globalization discourse, greater attention must be paid to how these actors can be held accountable under international law. The existing human rights legal framework is ill-equipped to deal with violations committed by non-state actors, such as transnational corporations (TNCs), and multi-state actors, such as IFIs. Using the right to food as …

Internet Pharmacies And The Need For A New Federalism: Protecting Consumers While Increasing Access To Prescription Drugs, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

In this article I will argue that Internet pharmacies pose a significant public health problem, as they raise the classic eternal triangle of health care issues--access, quality, and financing--in a new technological context. Part II describes the phenomena of Internet pharmacies, and Part III reviews the present regulatory scheme. Part IV explains why the current legal framework is inadequate to address the public health and safety problems posed by Internet pharmacies, focusing particularly on the jurisdictional, constitutional, and practical obstacles to effective state oversight of Internet pharmacies. Part V argues that comprehensive federal oversight of Internet prescribing and dispensing is …