Food and Drug Law Commons^™

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Killing Us Sweetly: How To Take Industry Out Of The Fda, Jason Iuliano

Journal of Food Law & Policy

For more than a century, the Food and Drug Administration has claimed to protect the public health. During that time, it has actually been placing corporate profits above consumer safety. Nowhere is this corruption more evident than in the approval of artificial sweeteners. FDA leaders' close ties to the very industry they were supposed to be regulating present a startling picture. Ignoring warnings from both independent scientists and their own review panels, FDA decision makers let greed guide their actions. They approved carcinogenic sweeteners such as saccharin, aspartame, and sucralose while simultaneously banning the natural herb stevia because it would …

Splitting Scales: Conflicting National And Regional Attempts To Manage Commercial Aquaculture In The Exclusive Economic Zone, Brandee Ketchum

Journal of Food Law & Policy

Like other environmental resources subject to public use, various interest groups struggle over joint management of scarce fisheries resources. Further, differing goals for resource management, such as financial goals versus conservation goals, frequently pit regional groups against one another. In some cases, regional interests may conflict with overall national interests. As goes the water and the air, so go the fish.

Journal Of Food Law & Policy - Spring 2010, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Not Cool: The Consequences Of Mandatory Country Of Origin Labeling, Matt Mullins

Journal of Food Law & Policy

The much anticipated and hotly debated Country-of-Origin Labeling (COOL) provision of the 2002 Farm Bill went into effect on September 30, 2008. The interim final rule published on August 1, 2008 finally put into law a provision first passed in the 2002 farm bill. This provision requires grocery stores and other retailers who sell food products to the private consumer to label certain meats, vegetables, fruits, and nuts with their country of origin. Foods that must be labeled are identified in the bill as "covered commodities." But, for all of the covered commodities, there exists a substantial list of products …

United States Food Law Update: Initial Food Safety Restructuring Efforts, Poultry Production Contract Reforms And Genetically Engineered Rice Litigation, A. Bryan Endres, Michaela N. Tarr

Journal of Food Law & Policy

This edition of the food law update will address recent events that may serve as bellwether signs that significant, long sought changes to the food and agricultural production system may be on the horizon. The first section of the update focuses on several general food safety initiatives. These efforts may, in the near term, coalesce into comprehensive food safety legislation. The second section analyzes two food safety actions relating to specific product categories: oysters and eggs. Section three provides a brief overview of poultry production contracts that may signal a broader restructuring of the legal relationships between farmers and the …

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 with …

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 …

Water Law In The Western United States, Susan Kelly

Publications

No abstract provided.

The E-Flow Challenge In An Acequia Irrigation System With Storage - Environmental Flow Workshop, Harold Trujillo

Publications

No abstract provided.

Status Of New Mexico's Rivers - Existing Data Panel, Stephanie Carman, James Hogan

Publications

No abstract provided.

Some Municipal Programs To Develop And/Or Sustain Living Rivers In New Mexico, Claudia Borchert

Publications

No abstract provided.

Climate Change, Streamflows, And Water Management Implications In The Upper Rio Grande Watershed, Brian H. Hurd

Publications

No abstract provided.

Colorado's Instream Flow Program: History And Current Activities, The Colorado Water Conservation Board

Publications

No abstract provided.

Environmental Flow Issues & Science, Tom Annear

Publications

No abstract provided.

Environmental Flows In Elephant Butte Irrigation District, Gary Esslinger

Publications

No abstract provided.

Environmental Flows Allocation Process In Texas, Kevin Mayes

Publications

No abstract provided.

Riparian Area And Upper Watershed Condition, Mary Steuver

Publications

No abstract provided.

Geomorphic Condition And Shallow Aquifers, Shann Stringer

Publications

No abstract provided.

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.

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 collaborative network of …

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.

A Bitter Pill To Swallow: Canadian Drug Regulation, Michael Duncan Taylor

LLM Theses

This thesis assesses the current status of Canadian prescription drug regulation and the policy drivers that guide this process. This analysis is accomplished by first providing a general survey of the steps, law, and institutional players involved in the full life-cycle of a drug. Next the evolution of current clinical trials and the gaps that the present legal regime creates in the scientific standards employed in clinical research is reviewed. This is followed by a discussion of how commercialization (innovation) and speed of approval (market access) are slowly becoming the dominant policy drivers for the Canadian regime. Finally a discussion …

Volume 10 Issue 3, Sustainable Development Law & Policy

Sustainable Development Law & Policy

No abstract provided.

Are You Covered? The Need For Improvement In Insurance Coverage For Autism Spectrum Disorder, 44 J. Marshall L. Rev. 291 (2010), Marissa Mazza

UIC Law Review

No abstract provided.

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. …

It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü

Michigan Telecommunications & Technology Law Review

Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …

How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette

Michigan Telecommunications & Technology Law Review

As described by Professors Dan Burk and Mark Lemley, drugs are[...] special because of the low number of patents per product: "In some industries, such as chemistry and pharmaceuticals, a single patent normally covers a single product. Much conventional wisdom in the patent system is built on the unstated assumption of such a one-to-one correspondence." Although many have repeated this one-patent, one-drug assumption, there has been little empirical analysis of how many patents actually protect each drug. In fact, most small-molecule drugs are protected by multiple patents. The average was nearly 3.5 patents per drug in 2005, with over five …

Regression By Progression Unleveling The Classroom Playing Field Through Cosmetic Neurology, Helia Garrido Hull

Faculty Scholarship

No abstract provided.

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

Sustainable Development Law & Policy

No abstract provided.