Food and Drug Law Commons^™

Forging Careers In Food Law And Policy: Challenges And Opportunities For Law Schools, Allison Condra

Journal of Food Law & Policy

Food Law and Policy (FL&P) is a quickly growing field of legal practice that offers many exciting career opportunities for law students. As national awareness of food and agricultural issues increases, particularly the way laws and policies influence our food system, more law students are demanding that their law schools offer courses, internships, and clinical experiences in this field. Law schools across the country have an opportunity to satisfy this student demand, while at the same time providing students with skills and knowledge that will equip them to engage with the many complex, dynamic, and important issues related to the …

Trademarks, Gis, And Commercial Aspects Of Wine Distribution Agreements, Sarah A. Hinchliffe

Journal of Food Law & Policy

The marketing of goods under geographical names has always been common. In addition to introducing commercial facets of wine distribution agreements, this article discusses the justifications, principles and, policies that lie behind the protection of geographical indications (GIs) for wine on an international level as well as in the Old World and, to a lesser degree, in the New World. The scope and shape of the GI system will then be scrutinized in light of its own justifications and in the light of its impact on international trade, intellectual property, and agricultural policy.

A Cost-Benefit Analysis Of Sugary Drink Regulation In New York City, Shi-Ling Hsu

Journal of Food Law & Policy

New York City Mayor Bill de Blasio spent much of his time during his successful 2013 campaign positioning himself as the populist candidate, pointedly contrasting himself with the outgoing mayor, billionaire Michael Bloomberg. There is one Bloomberg initiative, however, that de Blasio has committed to carry forward: the city-wide size restriction on sales of "sugary drinks," most commonly, carbonated sodas. On city public health issues such as the sugary drink policy, the populist de Blasio and the billionaire Bloomberg would appear to have much in common. "People are dying every day, this is not a joke," remarked Bloomberg in striking …

Health And Welfare Preempted: How National Meat Association V. Harris Undermines Federalism, Food Safety, And Animal Protection, Marya Torrez

Journal of Food Law & Policy

In 2008, the Humane Society of the United States (HSUS) released an undercover video filmed at the Hallmark Meat Packing Company and Westland Meat Company (Hallmark/Westland) in Chino, California. "The footage depicted nonambulatory cows being kicked, dragged, electrocuted, jammed with forklifts and sprayed in the nostrils with water to simulate drowning - in an effort to get them to stand up and walk to their slaughter." At least five inspectors from the U.S. Department of Agriculture (USDA) - the federal agency tasked with ensuring that food safety and animal welfare guidelines are followed - were present at the time. The …

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

Publications

No abstract provided.

Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino

University of Richmond Law Review

No abstract provided.

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 …

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 …

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 …

Failing To Warn In The Context Of Rare Side Effects, Morris Dweck

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

Depicting The Graphic Truth: The Heated Controversy Over Cigarette Warning Labels And The Boundaries Of First Amendment Protection, Brian Fedele

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

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

Publications

No abstract provided.

Unequal Protection Under The Law: Why Fda Should Use Negotiated Rulemaking To Reform The Regulation Of Generic Drugs, Marie Boyd

Cardozo Law Review

The duty to ensure the safety of drug products, through adequate warnings or other means, should ultimately rest with the drug's manufacturer regardless of whether the drug is a generic drug or a brand-name drug. Recent U.S. Supreme Court holdings, however, suggest that while the manufacturer of a brand-name drug is always responsible for its label's content, this is not the case for generic drugs. In addition, by holding that failure-to-warn claims against generic drug manufacturers based on state law are preempted, the Court has removed the protections and compensation that state tort law can provide consumers of generic drugs …

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 …

"Natural" Food Labeling: False Advertising And The First Amendment

Marquette Elder's Advisor

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 …

Squashing The Superbugs: A Proposed Multifaceted Approach To Combatting Antibiotic-Resistant Bacteria , Lauren Orrico

Journal of Law and Health

Section II of this Note will provide background on the practices of the United States farming system, which fosters the creation of antibiotic-resistant bacteria. This section will also provide background on the detrimental effects that antibiotic resistance has on human health and will briefly describe the legal history of food and drug regulations. After establishing an informational foundation, Part III will elaborate on current laws and describe the legal authority of key players, before pointing out the shortcomings in current animal feed policy and recommending the development of further regulation in this area. Additionally, Part III will propose new legislation …

Food Art: Protecting "Food Presentation" Under U.S. Intellectual Property Law, 14 J. Marshall Rev. Intell. Prop. L. 1 (2014), Cathay Smith

UIC Review of Intellectual Property Law

In 2006, a scandal broke in the culinary world. It was alleged that Robin Wickens, chef at (now closed) Interlude restaurant in Melbourne, Australia, had copied dishes by renowned American chefs Wylie Dufresne, Jose Andres, and Grant Achatz. It is not uncommon for chefs to borrow recipes from other chefs, and there has been a long culture of sharing in the cuisine industry. However, what made Wickens’ actions scandalous was that he had purportedly copied the artistic presentation and plating of other chefs’ dishes, not just their recipes.

This Article examines whether chefs can protect the artistic presentation or plating …