Law Commons^™

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Maryland Law Review Online

No abstract provided.

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Faculty Scholarship

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Joe M Stell Ombudsman Program - Taos Settlement Technical Work, Peggy Barroll

Publications

No abstract provided.

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 …

Farm To Institution, Harvard Law School Food Law And Policy Clinic, Harvard Law School Mississippi Delta Project

Delta Directions: Publications

In a state with rich agricultural resources and a long farming tradition, why are Mississippi’s institutions serving fruits and vegetables mostly shipped from other states and countries? Connecting Mississippi growers with institutions within the state offers a promising way to increase fruit and vegetable consumption while improving the economic viability of local farms. This step-by-step guide aims to help growers in Mississippi start to sell locally grown foods to be served in meals at institutions around the state, such as hospitals, schools, prisons, and state and local government agencies.

Groundwater Challenges In Spain: Lessons From The Western Mancha Aquifer, Pedro Martinez-Santos

Publications

No abstract provided.

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 …

Fda And The Rise Of The Empowered Consumer, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

This Article traces the still-evolving view of consumers of FDA-regulated products as capable, rational, and rights-bearing decision makers. It also examines the corresponding diminution of FDA’s role as a paternalistic gatekeeper collaborating with medical and scientific experts to prevent products and manufacturer-provided information from reaching the public. Compared with their 1960s counterparts, today’s consumers of food and drugs have far greater freedom to make unmediated choices among a wider variety of products, guided by a relative deluge of labeling and advertising information. Moreover, food and drug regulation, once the exclusive domain of bureaucrats and experts, has become a focus of …

Advancing An Adaptive Standard Of Strict Scrutiny For Content-Based Commercial Speech Regulation, Nat Stern, Mark Joseph Stern

Scholarly Publications

No abstract provided.

Food Defense Among Meat Processing And Food Service Establishments In Kentucky, Morgan Webb-Yeates

Masters Theses & Specialist Projects

Agroterrorism is the deliberate introduction of a plant or animal disease with the
goal of causing fear, economic instability, illness, or death. After the 2002 terrorist
attacks on the World Trade Center, the security of the food supply is of increasing
concern to the United States. A major incidence of agroterrorism or food tampering would have far reaching impacts on the economy and public health. The first objective of this project was to determine knowledge and concern of agroterrorism in meat processing facilities in Kentucky, and to determine knowledge and concern of food tampering and food defense in food service …

Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley

Georgetown Law Faculty Publications and Other Works

Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to …

What Is The Best Way For Manufacturers And Physicians To Apply Sunscreen To Avoid Being Burned By The Final Sunshine Act Regulations?, Abraham Gitterman

Student Articles and Papers

This [article] explains the requirements under the Patient Protection and Affordable Health Care Act’s Physician Payment Sunshine Act that all medical product manufacturers report to Health and Human Services (HHS) any payment or transfer of value made to physicians and teaching hospitals. Author Abraham Gitterman ... warns that manufacturers may face adverse consequences of public access to payment data, including fraud and abuse investigations and private litigation actions. He recommends that manufacturers begin training employees to ensure compliance with the statute and reduce the likelihood of further investigations. He further suggests that the Center for Medicare & Medicaid Services (CMS) …

Winter 2013 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Frameworks For Amending Reservoir Water Management, Ethan Mower, Leandro E. Miranda

Publications

Managing water storage and withdrawals in many reservoirs requires establishing seasonal targets for water levels (i.e., rule curves) that are influenced by regional precipitation and diverse water demands. Rule curves are established as an attempt to balance various water needs such as flood control, irrigation, and environmental benefits such as fish and wildlife management. The processes and challenges associated with amending rule curves to balance multiuse needs are complicated and mostly unfamiliar to non-US Army Corps of Engineers (USACE) natural resource managers and to the public. To inform natural resource managers and the public we describe the policies and process …

A Water Rights Manual For Mutual Domestic Water Consumers Associations, Utton Center, University Of New Mexico - School Of Law, Zachary Carpenter, Gregory Chakalian, Darcy S. Bushnell

Publications

The Utton Center prepared this Water Rights Manual to assist Mutual Domestic Water Consumers Associations (MDWCAs) with the development, protection and management of their water rights.

This manual provides an introduction to and defines Water Rights in New Mexico, as well as to acquire and have recognized Water Rights. This document also covers water management and planning, and provides additional resources.

Public-Private Regime Interactions In Global Food Safety Governance, Ching-Fu Lin

Transnational Business Governance Interactions Working Papers

In response to an apparent decline in global food safety, numerous public and private regulatory initiatives have emerged to restore public confidence. This trend has been particularly marked by the growing influence of private regulators such as multinational food companies, supermarket chains and non-governmental organizations (NGOs), who employ private standards, certification protocols, third-party auditing, and transnational contracting practices. This paper explores how the structure and processes of private food safety governance interact with traditional public governance regimes, focusing on Global Good Agricultural Practices (GlobalGAP) as a primary example of the former. Due to the inefficiency and ineffectiveness of public regulation …

A National "Natural" Standard For Food Labeling, Nicole E. Negowetti

Law Faculty Publications

No abstract provided.

Shame, Blame, And The Emerging Law Of Obesity Control, Lindsay Wiley

Articles in Law Reviews & Other Academic Journals

In using law as a tool to combat the obesity epidemic, legal scholars and policymakers are drawing heavily on the lessons of tobacco control. This Article describes the resulting emergence of "obesity control law" and argues for a radical reorientation of it from a "denormalization" strategy based on the tobacco control experience to a "destigmatization" strategy based on the HIV prevention experience. The war on obesity is nearing a political crossroads. Subsidies and food industry regulations aimed at making our environment more conducive to physical activity and healthy eating are in danger of losing out to cheaper and more politically …

The U.S. Department Of Agriculture As A Public Health Agency, Lindsay Wiley

Articles in Law Reviews & Other Academic Journals

Introduction: The "war on obesity" is now well into its second decade.' What began as an effort to encourage medical doctors to screen and treat patients whose weight put them at risk for health problems has transformed into a much broader public health campaign to address the root causes of obesity. A growing number of state, territorial and local health departments are currently exploring new ways to promote healthy eating and physical activity. At the federal level, the U.S. Centers for Disease Control and Prevention (CDC) has made "nutrition, physical activity and obesity" a top priority.

Who’S Your Nanny, Lindsay Wiley

Articles in Law Reviews & Other Academic Journals

INTRODUCTION: In June 2012, New York City Mayor Michael Bloomberg announced his plans for a ban on the sale of sugary beverages in containers larger than 16 ounces. Shortly thereafter, the Center for Consumer Freedom took out a full-page ad in the New York Times featuring Bloomberg photo-shopped into a matronly dress with the tag line "New Yorkers need a Mayor, not a Nanny."1 On television, the CATO Institute's Michael Cannon declared, "This is the most ridiculous sort of nanny state-ism; [ilt's none of the mayor's business how much soda people are drinking." And in news- papers around the country, …

The American Public’S Perception Of Illegal Steroid Use: A National Survey, 2013, Gary Siperstein, Neil Romano, Gizem Iskenderoglu, Anthony Roman, Floyd J. Fowler Jr., Max Drascher

Center for Social Development and Education Publications

Through the surge of news about doping scandals in the media, it is expected that the public is aware of the magnitude of the problem among professional athletes; however, it is uncertain whether the public is aware that the problem often starts when athletes are younger. To this end, the National Baseball Hall of Fame and Museum, the Taylor Hooton Foundation, and the Professional Baseball Athletic Trainers Society partnered with the Center for Social Development and Education and the Center for Survey Research at the University of Massachusetts Boston to conduct the most comprehensive national opinion survey to date to …

Christopher V. Smithkline Beecham Corporation: An Unsurprising Loss For Pharmaceutical Sales Representatives And An Erosion Of Power For Administrative Agencies, Anna Johnston

Proxy

No abstract provided.

Insights In Enforcement, Litigation & Compliance For Pharmaceutical And Medical Device Manufacturers At Fdli's Enforcement, Litigation And Compliance Conference, December 12-13, 2012, Thomas Sullivan, Abraham Gitterman

Student Articles and Papers

No abstract provided.

Preemption Under The Controlled Substances Act, Robert A. Mikos

Vanderbilt Law School Faculty Publications

States are conducting increasingly bold experiments with their marijuana laws, but questions linger over their authority to deviate from the federal Controlled Substances Act. The CSA bans marijuana outright, and commentators have assumed that Congress sought to preempt all state laws that might somehow conflict with the CSA. Under the preemption rule now in vogue, state marijuana reforms are preempted if they either require someone to violate the CSA or, more controversially, if they pose an obstacle to Congress’s objective of eradicating marijuana. Seeking to avoid such conflicts, government officials have scuttled a number of important state marijuana reforms. This …

Taxing The Platypygous, James J. White

Articles

This Article maintains that obesity in the United States is an enormous public health issue that causes the health care costs of the obese Americans greatly to exceed those of citizens of normal weight. Recognizing that that much of that cost will be born by publicly financed programs and that the taxes supporting those programs will constitute an externality that the fat impose on the thin, the Article proposes a tax on high calorie food-but only when that food is purchased by the obese. The Article addresses many of the administrative, moral and other objections to a tax aimed at …

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Faculty Publications

The past several decades have seen the creation of transformative new technologies that are being used to design innovative consumer product ingredients never seen before in nature. Examples include the use of nanotechnology and genetic modification, and, right around the corner, cloning and lab grown meat. These innovative technologies are harbingers of more pioneering consumer product ingredients to come. The remarkable pace of the development of ground-breaking new technologies means that the population is being steadily exposed to novel ingredients with unknown health risks.

Optimally, the Food & Drug Administration ("FDA") should be regulating these innovative, novel ingredients in consumer …

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 …

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 …

When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder

Articles, Book Chapters, & Popular Press

Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …

Regulating Prescription Drugs For Patient Safety: Does Bill C-17 Go Far Enough?, Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, Barbara Mintzes

Articles, Book Chapters, & Popular Press

Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962. However, most of the drug’s distribution was in the form of free samples to medical professionals, which the directorate had no legal authority to control. Therefore, to avoid similar situations in the future and to stop sales of thalidomide, on Dec. 4, 1962, the Parliament of Canada amended the Food and Drugs …