Food and Drug Law Commons^™

Jurisdiction Of The Food And Drug Administration To Regulate Tobacco Products Under The Food, Drug, And Cosmetic Act: Food And Drug Administration V. Brown & Williamson Tobacco Corporation Et Al., Alison J. Lezak

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

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.

Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork

Michigan Telecommunications & Technology Law Review

Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …

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

Publications

No abstract provided.

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

Undue Process At The Fda, Lisa Heinzerling

Georgetown Law Faculty Publications and Other Works

For over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the FDA …

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 …

Archival: A Water Rights Manual For Mutual Domestic Water Consumers Associations, Utton Center, University Of New Mexico - School Of Law, Zackeriah 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.

Selected Bibliography On Adjudications And New Mexico Water Management, Carol Romero-Wirth, Susan Kelly, Ernesto Longa

Publications

No abstract provided.

The Special Supplemental Nutrition Program For Women, Infants, And Children (Wic) And The Supplemental Nutrition Assistance Program (Snap): Comparing Policies And Suggesting Changes, Regina T. Cucurullo

Journal of Food Law & Policy

National concerns, such as obesity, should be addressed through national efforts. Considering the national reach of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) and the Supplemental Nutrition Assistance Program (SNAP) and their ability to influence the diets of a significant amount of the nation's population, changes to these programs should be made to encourage healthy nutrition.

Food And Agricultural Security Strategy And Its Implementation Under Public Health Security And Bioterrorism Preparedness And Response Act Of 2002, Vivek V. Nemane

Journal of Food Law & Policy

The U.S. agricultural system can be described as concentrated, specialized and industrialized. A typical food chain generally involves agricultural production, storage, processing and distribution. In the U.S. agricultural and food system, most production, distribution and processing is done in a consolidated and centralized manner.

Water Rights Management In New Mexico And Along The Middle Rio Grande: Is Awrm Sufficient?, Carol Romero-Wirth, Susan Kelly

Publications

No abstract provided.

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

Fall 2012 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Groundwater In New Mexico, Darcy Bushnell

Publications

No abstract provided.

Kirtland Afb - Bulk Fuels Facility Spill: Regulatory Authority Under Rcra And History, New Mexico Environment Department, University Of New Mexico - School Of Law

Publications

No abstract provided.

A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus

University of Michigan Journal of Law Reform

To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.

Summer 2012 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

American Indian Water Right Settlements, Darcy Bushnell

Publications

No abstract provided.

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of the developments in Canadian food law and policy in 2011. This update considers the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm.

New Mexico Ex Rel. State Engineer V. Aamodt, No. 66cv6639 (D.N.M.), New Mexico State Engineer

Publications

No abstract provided.

Regulating By Repute, David Zaring

Michigan Law Review

Is regulation a hopeless cause? Many thoughtful observers spend a lot of time enumerating all of the reasons why it is doomed to fail. The entire field of public choice, with impeccable logic, posits the likely corruption of every bureaucrat. And if corruption cannot explain the failure of regulation, the atrophy that comes from lack of competition-there is just one government, after all, and it does not have a profit motive-may be just as rich a vein to mine. It could also be that the legal system itself, with its myriad complexities, checks, and procedural requirements, may ossify to the …

The Tragedy Of The Horse, American Icon, Tim Opitz

Journal of Food Law & Policy

Whether a prohibition on slaughter improves the welfare of the American horse population is the focus of this article. At the time it was written, winter of 2010-2011, a confluence of Federal and State legislative action had ended domestic slaughter. These actions are detailed in the body of this article. Since 2007, the legal status of horse slaughter remained static. Just as Sir Isaac Newton's first law of motion explained, an object at rest tends to stay at rest. Legislative inertia is the perspective from which this article was originally written. However, Newton's first law also stated that the object …

United States Food Law Update: Moving Toward A More Balanced Food Regulatory Regime, A. Bryan Endres, Nicholas R. Johnson

Journal of Food Law & Policy

For decades, the federal government has played a significant role in promoting healthy eating. In the early 1900s, the United States Department of Agriculture (USDA) promoted a foundational diet of milk, proteins, fruits and vegetables, and grains. Most Americans are at least somewhat familiar, although perhaps confused, with the more nuanced healthy eating recommendations contained in the food pyramid - first employed in 1992. And virtually every American has experienced the federally supported school lunch program. In the first half of 2011, these two iconic programs underwent significant change as part of a stepped-up effort to improve the health of …

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

Greenwashing The Organic Label: Abusive Green Marketing In An Increasingly Eco-Friendly Marketplace, Greg Northen

Journal of Food Law & Policy

The green wave of environmental advertising among organic food producers, distributors, and retailers begun during the 1990s has become an all-out green tsunami. The organic food market is the fastest growing segment of the American food industry. Consumers are increasingly becoming aware of the impact their purchases have on several environmental issues. As a result, those consumers are becoming more aware of their spending power and are willingly altering their buying practices to purchase from companies that emphasize environmental responsibility. In fact, some retailers' inventory is already being scanned for alternative green products by their customers' iPhones because, guess what, …

Food Entrepreneurs And Food Safety Regulation, Nina W. Tarr

Journal of Food Law & Policy

It is a bucolic scene: local food growers and producers chatting with consumers who come back each week to participate in a direct and continuing conversation about food with someone they know, and to engage in commerce. This illusion of simplicity masks the ever-growing morass of conflicting, complicated, and expensive regulatory oversight that undermines the local food movement by creating barriers between producers and consumers. Those creating and implementing food policy in the United States are facing a fundamental dilemma of how to reconcile the local food movement with regulations designed to address concerns about food safety.

This article will …

The History And Future Of Genetically Modified Crops: Frankenfoods, Superweeds, And The Developing World, Brooke Glass-O'Shea

Journal of Food Law & Policy

In a 1992 letter to the New York Times, a man named Paul Lewis referred to genetically modified (GM) crops as "Frankenfood," and wryly suggested it might be "time to gather the villagers, light some torches and head to the castle." Little did Lewis know that his neologism would become the rallying cry for activists around the world protesting the dangers of genetic engineering. The environmental activist group Greenpeace made great use of the "Frankenfood" epithet in their anti-GM campaigns of the 1990s, though they have since backed away from the word and the hardline stance it represents. But genetically …