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Food and Drug Law Commons

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One False Move: The History Of Organic Agriculture And Consequences Of Non-Compliance With The Governing Laws And Regulations, Sara N. Pasquinelli 2010 Golden Gate University School of Law

One False Move: The History Of Organic Agriculture And Consequences Of Non-Compliance With The Governing Laws And Regulations, Sara N. Pasquinelli

Golden Gate University Environmental Law Journal

This Article provides an overview of the types of factors that may lead to the decertification of organic products, and the current regulatory scheme to evaluate and adjudicate potential violations. The underlying rationale for the enforcement of the Organic Foods Production Act of 1990 may lie in protection of the integrity of the product, as well as protection of the environmental system that is integral to its production. However, the risk factors for transitioning the U.S. food economy to a larger market share in order for organic food to reach a broader population could be an unintended disincentive. Part ...


Different Endings: Lethal Injection, Animal Euthanasia, Humane Slaughter, And Unregulated Slaugter, Jeff Welty 2010 Golden Gate University School of Law

Different Endings: Lethal Injection, Animal Euthanasia, Humane Slaughter, And Unregulated Slaugter, Jeff Welty

Golden Gate University Environmental Law Journal

This Article compares the laws and regulations that govern the termination of life in several contexts: lethal injection of condemned inmates; the euthanasia of companion animals; the slaughter of farmed animals covered by the Humane Methods of Slaughter Act; and the slaughter of farmed and other animals not covered by the Act.


An Evaluation Of Lead In Imported Candies Within Clark County, Nevada, Usa, Lee Reuben Ibarra 2010 University of Nevada Las Vegas

An Evaluation Of Lead In Imported Candies Within Clark County, Nevada, Usa, Lee Reuben Ibarra

UNLV Theses, Dissertations, Professional Papers, and Capstones

Imported candies from Latin America pose a danger to children because of the potential for those candies to contain harmful levels of lead. This study sought to identify characteristics of imported candies that typically display higher concentrations of lead. This study also explored the Integrated Exposure Uptake Biokinetic model developed by the EPA. Using lead exposure data specific to Clark County, Nevada, the IEUBK model was used to estimate the amounts of candy a child would have to consume in order to raise his blood lead level to over 10µg/dL (the federal allowable limit).

The results showed that candies ...


A Reconsideration Of Agricultural Law: A Call For The Law Of Food, Farming, And Sustainability, Susan A. Schneider 2010 College of William & Mary Law School

A Reconsideration Of Agricultural Law: A Call For The Law Of Food, Farming, And Sustainability, Susan A. Schneider

William & Mary Environmental Law and Policy Review

American agricultural policy has evolved from its early focus on agricultural development and expansion to its current focus on economic and political support for the agricultural sector. Agricultural law as a discipline has tracked this policy, with agricultural law scholars debating the origins and the validity of the special treatment of agriculture under the law. This article reviews these debates and calls for a reconsideration of agricultural law and policy to address the unique aspects of agricultural production, the fragility of the environment, and the fundamental need for healthy food. Transforming the special law of agriculture to a new more ...


Against Freewheeling, Extratextual Obstacle Preemption: Is Justice Thomas The Lone Principled Federalist?, Catherine M. Sharkey 2010 NYU School of Law

Against Freewheeling, Extratextual Obstacle Preemption: Is Justice Thomas The Lone Principled Federalist?, Catherine M. Sharkey

New York University Public Law and Legal Theory Working Papers

The assessment of Justice Clarence Thomas as the lone principled federalist - supported on its face by his concurrence in Wyeth v. Levine, which solidifies his rejection of implied obstacle preemption, coupled with his resolute rejection of the dormant Commerce Clause - is far more complicated, due to the chimerical nature of abstract federalism arguments in preemption and statutory interpretation cases.

Preemption jurisprudence is notably variegated. One dimension of the analysis is akin to statutory interpretation - how best to read and interpret the precise words used or implied by Congress in the statutes it enacts. Another layer consists of federalism-based presumptions, driven ...


A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski 2010 Louisiana State Univ. Law Center

A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.


Keeping Agriculture Alive In The Shadow Of A Uranium Mine: Potential Effects And Regulatory Solutions For Virginia, Maggy J. Lewis 2010 College of William & Mary Law School

Keeping Agriculture Alive In The Shadow Of A Uranium Mine: Potential Effects And Regulatory Solutions For Virginia, Maggy J. Lewis

William & Mary Environmental Law and Policy Review

No abstract provided.


Re-Stocking The Shelves: Policies And Programs Growing In Food Deserts, Tess Feldman 2010 Loyola University Chicago, School of Law

Re-Stocking The Shelves: Policies And Programs Growing In Food Deserts, Tess Feldman

Public Interest Law Reporter

No abstract provided.


Thoughts On Preemption In The Wake Of The Levine Decision, Erika Lietzan, Sarah E. Pitlyk 2010 University of Missouri School of Law

Thoughts On Preemption In The Wake Of The Levine Decision, Erika Lietzan, Sarah E. Pitlyk

Faculty Publications

This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s decision in Wyeth v. Levine. Part I describes the Levine decision. Part II examines the majority’s holding as it relates to impossibility preemption and considers the future of the doctrine in failure-to-warn suits after Levine. We argue that the announced standard for impossibility preemption — the clear evidence standard — should be interpreted reasonably and not in a manner that effectively eviscerates the doctrine. We also describe other instances of impossibility in the food and drug regulatory context that were not presented to the Court ...


Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan 2010 University of Missouri School of Law

Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan

Faculty Publications

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from ...


Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa 2010 University of Richmond

Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa

Richmond Journal of Law and the Public Interest

Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally strengthen their warning without prior FDA approval under current regulations to head off any state tort claims for failure to warn. If the FDA ultimately determines not to approve the strengthened label, under explicit authority granted by Congress in the FDCA, drug makers have a strong argument that implicit conflict preemption now applies. As another avenue, drug makers may include a potential warning amounting to a prohibition of the drug's use or method of delivery when seeking initial approval of the warning label ...


Livestock Animal Cloning: This Steak Is Giving Me Déjà Vu, Blake M. Mensing 2010 American University Washington College of Law

Livestock Animal Cloning: This Steak Is Giving Me Déjà Vu, Blake M. Mensing

Sustainable Development Law & Policy

No abstract provided.


Medical Rights For Same-Sex Couples And Rainbow Families, Anisa Mohanty 2010 SelectedWorks

Medical Rights For Same-Sex Couples And Rainbow Families, Anisa Mohanty

Anisa Mohanty

No abstract provided.


The “California Effect” & The Future Of American Food: How California’S Growing Crackdown On Food & Agriculture Harms The State & The Nation, Baylen J. Linnekin 2010 George Mason University Law School

The “California Effect” & The Future Of American Food: How California’S Growing Crackdown On Food & Agriculture Harms The State & The Nation, Baylen J. Linnekin

Baylen J. Linnekin

For several decades, California has served as the epicenter of the American food scene. California produces one-third of the nation’s food, is home to one in eight American consumers, and boasts a staggering 90,000 restaurants. California is also where eating trends are born, and where fast food, organic food, and Napa Valley wines became durable icons of American culinary culture.

The state’s place atop the national food chain, though, is in jeopardy. In recent years, California legislators have pursued regulations that negatively impact many important agricultural and culinary trends. State and local governments have banned or severely ...


Emerging Law Addressing Climate Change And Water, Prof. Elizabeth Burleson 2010 SelectedWorks

Emerging Law Addressing Climate Change And Water, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

The World Economic Forum recognizes that while restrictions on energy affect water systems and vice versa, energy and water policy are rarely coordinated. The International Panel on Climate Change predicts that wet places will become wetter and dry places will become dryer. Transboundary water, energy and climate coordination can occur through international consensus building.


Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova McCabe 2010 University of New Hampshire School of Law

Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova Mccabe

Law Faculty Scholarship

In 2009, gluten-free foods were not only "hot" in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term "gluten-free." The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers.


Obama Administration Withholds Funds For Drug War In Mexico Pending Human Rights Reform, Christina McMahon 2010 Loyola University Chicago, School of Law

Obama Administration Withholds Funds For Drug War In Mexico Pending Human Rights Reform, Christina Mcmahon

Public Interest Law Reporter

No abstract provided.


The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness 2010 University of Kentucky College of Law

The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness

Law Faculty Scholarly Articles

On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription ...


Regulating Tobacco Advertising And Promotion: A "Commerce Clause" Overview For State And Local Governments, Kathleen Dachille 2010 University of Maryland School of Law

Regulating Tobacco Advertising And Promotion: A "Commerce Clause" Overview For State And Local Governments, Kathleen Dachille

Faculty Scholarship

On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, giving the U.S. Food and Drug Administration (FDA) comprehensive authority to regulate the manufacturing, marketing, and sale of tobacco products. The new law represents the most sweeping action taken to date to reduce what remains the leading preventable cause of death in the United States.

To help you understand the potential ways in which state and local regulation of tobacco product marketing and promotion might be limited by the U.S. Constitution’s Commerce Clause, the Tobacco Control Legal Consortium, a ...


Between Starvation And Globalization: Realizing The Right To Food In India, Lauren Birchfield, Jessica Corsi 2010 Harvard Law School

Between Starvation And Globalization: Realizing The Right To Food In India, Lauren Birchfield, Jessica Corsi

Michigan Journal of International Law

This Article evaluates People's Union for Civil Liberties v. Union of India & Others (PUCL) through multiple lenses, examining: (1) the necessary factors that contributed to the success of the Public Interest Litigation (PIL) and its enforcement and (2) both the implications and limitations of PUCL as it relates to India's larger economic policy framework. We argue that the development and success of the PUCL litigation have depended in part on provisions of the Indian Constitution amenable to the incorporation and promotion of economic and social rights as well as on a unique relationship between civil society and judicial ...


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