Law Commons^™

Veggiecation: A Novel Approach To Improve Vegetable Consumption Among School-Aged Children, Yeon Bai, Lisa Suriano, Shahla M. Wunderlich

Department of Nutrition and Food Studies Scholarship and Creative Works

Children's general preference for sweeter foods and aversion to bitter vegetables is explained partly by fear of new food and social and cultural influences. Reluctance to eat new foods is related to unfavorable facial expressions and is often learned from the child's family, social circle, and culture.1 Researchers report that the fruit and vegetable consumption of children 6–12 years of age is associated with the accessibility and availability.2 School-based interventions that combine classroom curricula, parental, and nutrition service components show the greatest promise for fruit and vegetable promotion among children.

New York: Public Health Implications Of The 'Soda Ban' Ruling, Andrew Geltman

Homeland Security Publications

No abstract provided.

Food Deprivation: A Basis For Refugee Status?, James C. Hathaway

Articles

It is commonplace to speak of those in flight from famine, or otherwise migrating in search of food, as “refugees.” Over the past decade alone, millions of persons have abandoned their homes in countries such as North Korea, Sudan, Ethiopia, Congo, and Somalia, hoping that by moving they could find the nourishment needed to survive. In a colloquial sense, these people are refugees: they are on the move not by choice, but rather because their own desperation compels them to pursue a survival strategy away from the desperation confronting their home communities.

The question addressed here is whether persons in …

E-Cigarettes, Vaping, And Youth, Lawrence O. Gostin, Aliza Y. Glasner

Georgetown Law Faculty Publications and Other Works

E-cigarettes, a relatively new product, storming the tobacco industry are causing a massive stir among public health advocates. While e-cigarettes have the potential to serve as an effective harm reduction tool for existing smokers, they also may present an equally tempting pathway to first time smoking, particularly among youth. Many fear that e-cigarettes will revive the popular smoking culture that has taken decades to dismantle.

In April 2014, the FDA issued proposed rules to “deem” or extend its authority over tobacco products to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and orally ingested dissolvable tobacco products. …

Food Labeling Litigation: Exposing Gaps In The Fda's Resources And Regulatory Authority, Nicole Negowetti

Law Faculty Publications

No abstract provided.

A Case Study Of The Regulations Imposed Upon Massachusetts' Prescription Monitoring Program, Meredith Rodman

Public Affairs Capstones Collection

This case study focuses on the effectiveness of the recent regulations imposed upon Massachusetts’s prescription monitoring program. Abuse and/or misuse of prescription opioids is becoming increasingly problematic within the United States and as a result many policy makers are looking for ways to combat the problem. In Massachusetts, the OxyContin and Heroin Commission was established to investigate the impact of both OxyContin and heroin on the state. The Commission delivered recommendations that eventually led the state legislature to make changes to Massachusetts’s prescription monitoring program. This study targeted five major stakeholder groups and asked a series of questions through interviews …

The End Of Sustainability, Melinda Harm Benson, Robin Kundis Craig

Publications

No abstract provided.

The End Of Sustainability, Melinda Harm Benson, Robin Kundis Craig

Publications

It is time to move past the concept of sustainability. The realities of the Anthropocene warrant this conclusion. They include unprecedented and irreversible rates of human-induced biodiversity loss, exponential increases in per-capita resource consumption, and global climate change. These factors combine to create an increasing likelihood of rapid, nonlinear, social and ecological regime changes. The recent failure of the Rio +20 provides an opportunity to collectively reexamine--and ultimately move past--the concept of sustainability as an environmental goal. We must face the impossibility of defining--let alone pursuing--a goal of "sustainability" in a world characterized by such extreme complexity, radical uncertainty and …

Managing Complex Water Resource Systems For Ecological Integrity: Evaluating Tradeoffs And Uncertainty, Richard Morrison

Publications

Water resource systems often contain numerous components that are intertwined or even contradictory, such as power production, water delivery, recreation, and environmental needs. This complexity makes it difficult to holistically assess management alternatives. In addition, hydro climatic and ecological uncertainties complicate efforts to evaluate the impacts of management scenarios. We need new tools that are able to inform managers and researchers of the tradeoffs or consequences associated with flow alternatives, while also explicitly incorporating sources of uncertainty. My research addresses this limitation using two modeling approaches: stochastic system dynamics modeling and Bayesian network modeling. I developed a stochastic system dynamics …

Spring 2014 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Pharmacy Compounding After The Drug Quality And Security Act, Erika Lietzan

Faculty Publications

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act ("DQSA"), which amends the Federal Food, Drug, and Cosmetic Act ("FDCA") to add statutory provisions addressing drug compounding and supply chain issues. This article discusses Title I of this legislation, known as the Compounding Quality Act, and draft compounding guidances subsequently issued by the Food and Drug Administration ("FDA"). Section I provides a brief history of FDA's regulation of compounding activities before the Compounding Quality Act's enactment. Section II reviews the Compounding Quality Act and FDA's new draft guidances. Section III considers some of the …

Developing The Law Of The River: The Integration Of Law And Policy Into Hydrologic And Socio-Economic Modeling Efforts In The Willamette River Basin, Adell Louise Amos

Publications

A legal and policy infrastructure -- referred to as a "law of the river" -- exists for every river basin in the U.S. an can be as important as natural processes in terms of managing the future of the resource. Because of the way that water law and policy have evolved in the U.S., this infrastructure involves a matrix of state and federal law that governs the choices that policymakers, end users, and agencies make. This "law of the river" provides the context in which decisions are made and not made. It also draws the boundaries within which decision makers …

Jump In Before It's Too Late: Protecting And Increasing Streamflows In New Mexico, Sharon Wirth

Publications

Freshwater ecosystems need adequate streamflow to supply clean water for humans and maintain healthy habitat for wildlife. Over-appropriation, overuse, climate change, and drought plague New Mexico's rivers, taxing many rivers beyond sustainability. Despite the myriad of problems caused by little or no water in our rivers, policies and procedures to protect and increase streamflows in New Mexico are limited. While most Western states have made demonstrable progress in alleviating various legal and technical barriers to protecting and increasing streamflows, New Mexico has made only limited, recent progress towards solutions for our drying rivers. This article takes a critical look at …

Water Governance Challenges In New Mexico's Middle Rio Grande Valley: A Resilience Assessment, Melina Harm Benson, Dagmar Llewellyn, Ryan Morrison, Mark Stone

Publications

No abstract provided.

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

The Rise Of Transnational Private Meta-Regulators, Paul Verbruggen, Tetty Havinga

Transnational Business Governance Interactions Working Papers

In recent years scholars from various disciplines have turned their attention to transnational regimes of regulation that are chiefly developed outside state-driven frameworks. The rise of such "transnational private regulation" has also led to the emergence of private meta-regulation. The term 'meta-regulation' commonly refers to processes through which a regulatory body oversees another and sets standards for its activities or performance of regulation. In the public domain, meta-regulation has been associated with the devolution of regulatory activities by a statutory body to private actors with the view to enhance voluntary rule compliance, awareness of responsibilities among the regulated and reduce …

The Farmer In Chief: Obama's Local Food Legacy, Sarah J. Morath

Akron Law Faculty Publications

As criticism over America’s food policy has grown, many scholars have offered suggestions for reform. Complementing this body of scholarship, The Farmer In Chief identifies and assesses recent changes to federal laws and policies as they affect ‘local food’ and describes local farmers’ awareness of and reaction to these changes. These changes and the farmers’ responses show greater recognition of local food by the President and federal government in three ways: increased inclusion of local food in legislation and policy discussions; increased awareness of the benefits of local food production and consumption; and increased consumer access to local food. But …

A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan

Faculty Publications

Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation …

The Presumption Against Expensive Health Care Consumption, Christopher Robertson

Faculty Scholarship

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate particular uses of medical technologies on the basis of their cost-benefit ratios. Nonetheless, this essay argues in favor of a general regulatory presumption against consumption for the most expensive medical technology usages, which drive most of aggregate healthcare spending. This essay synthesizes twelve facts about the ways in which medical technologies are produced, regulated, studied, and consumed to suggest that it is quite unlikely that the most expensive usages of …

A Continuing Plague: Faceless Transactions And The Coincident Rise Of Food Adulteration And Legal Regulation Of Quality, Denis Stearns

Faculty Articles

Over two decades ago, the Jack in the Box E. coli outbreak, in which five victims died, and hundreds more were seriously injured, dramatically changed the way the world looked at food and food safety. Although deemed “trivial” by tort scholars, who nonetheless used legal doctrines first developed in food cases to justify the extension of strict liability to all products, this article uses the Jack in the Box outbreak as a point of departure for exploring not only the relationship between food, being, and knowledge, but to posit that commerce in food, and the inevitability of profit-motivated food adulteration, …

Fraud In The Market, Samuel R. Wiseman

Scholarly Publications

No abstract provided.

Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann

Law Faculty Scholarship

There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely, while pharmaceutical drugs must undergo years of costly pre-market testing, most supplements, like foods, can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (FDA) remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as supplements tend to be most perceived for their apparent medicinal qualities. This philosophy of waiting for a …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Ignorance, Harm, And The Regulation Of Performance-Enhancing Substances, Lisa Milot

Scholarly Works

There is a disconnect between how legal and sporting authorities, on the one hand, and many elite athletes, on the other, view the use of performance-enhancing substances. While official and popular narratives portray the use of these substances as isolated examples of deviant behavior, to the elite athletes who daily push their bodies beyond societally normal limits of pain and risk, enhancement is oftentimes an accepted part of the job. As a result, efforts to regulate and detect athletes’ use of these substances have consistently captured only a small fraction of the use that exists.

This Article describes the ways …

Excluding Patentability Of Therapeutic Methods, Including Methods Using Pharmaceuticals, For The Treatment Of Humans Under Trade Related Aspects Of Intellectual Property Rights Article 27(3)(A), Michael Henry Davis

Law Faculty Articles and Essays

The Agreement on Trade Related Aspects of Intellectual Property Rights ("TRIPS"), the General Agreement on Tariffs and Trade ("GATT"), and the World Trade Organization ("WTO") debacle has radically altered the traditional ability of nations to adopt whatever patent regime seems appropriate to them. Instead, TRIPS requires all member nations, even those which never thought it appropriate to grant such state monopolies, to afford patent protection to areas which had never been granted before-most dramatically in the area of health related innovations and, most expensively, pharmaceuticals. Until TRIPS, most -- or at least a number approaching half -- countries simply did …

Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane

Articles

The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …

A System Of Men And Not Of Laws: What Due Process Tells Us About The Deficiencies In Institutional Review Boards, Greer Donley

Articles

Governmental regulation of human subjects research involves unique agency action. It delegates power to non-expert committees, Institutional Review Boards, to decide whether research protocols are "ethical" according to vague federal regulations. Without IRB approval, the protocol cannot be investigated. The empirical evidence regarding this system demonstrates that IRBs render deeply inconsistent and inaccurate outcomes. This Article argues that the lack of due process in the IRB system is to blame for such arbitrary agency action. By juxtaposing the levels of process required for IRB approval or research with FDA new drug approval--agency action involving similar interests--this Article highlights that IRBs …

A Response To Professor Leff’S Tax Planning 'Olive Branch' For Marijuana Dealers, Philip Hackney

Articles

Professor Benjamin Leff argues in a forthcoming article entitled Tax Planning for Marijuana Dealers that a tax-exempt social welfare organization described in Internal Revenue Code section 501(c)(4) may sell medical marijuana without putting its exempt status in jeopardy. He argues that (1) the “public policy” doctrine applicable to charitable organizations under section 501(c)(3) does not apply to social welfare organizations, and (2) a social welfare organization may consider “community” law and ignore federal law in considering whether its activity meets the idea of social welfare. I argue that Leff is wrong and that the public policy doctrine applicable to charitable …

Prosser’S Bait-And-Switch: How Food Safety Was Sacrificed In The Battle For Tort’S Empire, Denis Stearns

Faculty Articles

In this article, Professor Stearns discusses the legal history of the development of the rules that govern liability for selling unsafe food.