Food and Drug Law Commons^™

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …

Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled

Faculty Publications By Year

No abstract provided.

Keeping Up With New Legal Titles, Franklin L. Runge

Law Faculty Scholarly Articles

In this book review, Franklin L. Runge discusses In Food We Trust: The Politics of Purity in American Food Regulation by Courtney I. P. Thomas.

On The Permanence Of Permanent Law: An Argument For The Continued Presence Of The Permanent Law Provisions In The Farm Bill, Kate Giessel

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

The 2014 Farm Bill: Farm Subsidies And Food Oppression, Andrea Freeman

Seattle University Law Review

The 2014 Farm Bill ushered in some significant and surprising changes. One of these was that it rendered the identity of all the recipients of farm subsidies secret. Representative Larry Combest, who is now a lobbyist for agribusiness, first introduced a secrecy provision into the bill in 2000. The provision, however, only applied to subsidies made in the form of crop insurance. Until 2014, the majority of subsidies were direct payments and the identity of the people who received them was public information. In fact, the Environmental Working Group’s release of the list of recipients led to a series of …

Take Me To Your Liter: Politics, Power, And Public-Private Partnerships With The Sugar-Sweetened Beverage Industry In The Post-2015 Development Agenda, Craig W. Moscetti, Allyn L. Taylor

Washington International Law Journal

Today, non-communicable diseases (“NCDs”) are widely recognized as a global public health crisis and a foreign policy priority. The international community was slow to identify and respond to the crisis of NCDs in the later part of the twentieth century. However, in 2011 the United Nations High Level Meeting on NCDs recognized NCDs as one of the greatest threats to health and development in the twenty-first century, and a major topic for the post-2015 development agenda. Notably, many experts, national governments, and global leaders have rallied for an inclusive, “whole-of-government” and “whole-of-society” approach, situating public-private partnerships (“PPPs”) with some of …

Regulating Ambiguous Risks: The Less Than Rational Regulation Of Pharmaceuticals, W. Kip Viscusi, Richard J. Zeckhauser

Vanderbilt Law School Faculty Publications

The US Food and Drug Administration (FDA) balances risks and benefits before approving pharmaceuticals. But powerful behavioral biases that lead to the mishandling of uncertainty also influence its approval process. The FDA places inordinate emphasis on errors of commission versus those of omission, a bias that is compounded by its desire to avoid blame should risks eventuate. Despite extensive testing, uncertainties inevitably remain. We often learn about the risks of drugs after they are on the market. And there are off-label uses of drugs, which are not part of the initial testing. The FDA shows a strong aversion to ambiguous …

The Beginnings Of The Journal Of Food Law & Policy, Michael T. Roberts

Journal of Food Law & Policy

In the first sentence of the introduction to the inaugural edition of the Journal for Food Law & Policy, Margie Alsbrook, the founding Editor-in-Chief, and I, the founding faculty advisor, stated: "It is with great pride and pleasure that we present the inaugural issue of the Journal for Food Law & Policy." In celebration of the Journal's tenth anniversary, I am inclined to echo the same sentiment, but with the added proviso: "surprised!" I confess being gravely concerned ten years ago over the Journal's survivability. Food law and policy was then barely in its formative stage. The nascent, social food …

Predicting The Future: Our Food System In 2025, Susan A. Schneider

Journal of Food Law & Policy

It has been inspiring participate in the development of food law and policy as a recognized discipline. Over the last ten years, the Journal of Food Law & Policy and the LL.M. Program in Agricultural & Food Law have each played a significant role in that development. And, the landscape continues to evolve. The impact of changing attitudes toward our food system, environmental challenges, public health concerns and other integrated influences are certain to cause a continued evolution in our food system and the legal system that frames it. My task with this essay is to consider our food system …

Putting A Gag On Farm Whistleblowers: The Right To Lie And The Right To Remain Silent Confront State Agricultural Protectionism, Rita-Marie Cain Reid, Amber L. Kingery

Journal of Food Law & Policy

Whistleblowers play an important role in filling gaps in government food safety systems. Unfortunately, several dominant food-producing states have pursued legislative initiatives that punish farm whistleblowers and silence investigative tactics. First, this research describes various state legislative initiatives that curb criticism of agriculture. The work analyzes the federal food safety system and how these protections limiting agricultural criticism contravene that food safety net. Further, the research analyzes the free speech concerns in the newest protectionist laws. The analysis recommends strategies and future research to improve agriculture safety and protect free speech in an evolving food safety landscape.

Tribal Food Sovereignty In The American Southwest, Julia Guarino

Journal of Food Law & Policy

Food is an issue that implicates tribal sovereignty for historical, cultural, and public health reasons. This article undertakes a policy analysis of the importance of food to tribal sovereignty, and suggests that tribes, many of which have begun to do so already, make robust use of the concept of "food sovereignty" as part of their overarching project of protecting and promoting tribal sovereignty in general. This article sets the stage for understanding the importance of food sovereignty to tribes by exploring the history of food and culture in the American Southwest, where the public health consequences of changes in diet …

Setting The Table For Feast Or Famine: How Education Will Play A Deciding Role In The Future Of Precision Agriculture, Lauren Manning

Journal of Food Law & Policy

Precision agriculture has many names including satellite farming, or site-specific crop management. Early forms of precision agriculture involved creating fertilizer maps, yield measurements, grid sampling, and soil pH content monitoring. Roughly 25 years ago, the advent of global positioning systems, commonly known as GPS, enabled farmers to make more informed decisions about where to plant seed and how much seed to plant. Precision agriculture technologies typically utilize sensors that are placed on tractors, combines, and other farm equipment, and which measure various conditions including seeding rates, soil conditions, and other indicators of production. Over time, this technology has been expanded …

From The Lab To The Supermarket: In Vitro Meat As A Viable Alternative To Traditional Meat Production, Trae Norton

Journal of Food Law & Policy

In 1932, Winston Churchill predicted that 50 years in the future "we shall escape the absurdity of growing a whole chicken in order to eat the breast or wing by growing these parts separately under a suitable medium." Although Churchill's prediction is about 30 years off, in August of 2013, the first ever meat patty grown in vitro was consumed in London, England. With this historic scientific achievement, many are predicting that in vitro meat will be a viable solution to the problems associated with industrial meat production, such as animal cruelty, inefficient natural resource consumption, and pollution. Analysts predict …

Keeping The Farm And Farmer In Food Policy And Law, Neil D. Hamilton

Journal of Food Law & Policy

Thank you for the opportunity to be with you, it is always a pleasure to return to the University of Arkansas Law School where I began my teaching career in the fall of 1981. We are pleased Drake University Law School and the University of Arkansas College of Law have built and maintained a partnership on teaching and research that stretches back over three decades. I am especially pleased to be with you as we celebrate the 10th Anniversary of the Journal of Food Law and Policy, another part of the University's pioneering work in the area of food policy …

Battle Of The Streets: Food Cart Edition, Ninna Mendoza

Tredway Library Prize for First-Year Research

Through this paper, I wanted to highlight the unique struggle of food carts in Chicago, IL. Unlike other major cities in America, in Chicago, it is illegal to sell freshly prepared food from a cart. However, given the unique characteristics of food carts, legalizing this practice could greatly benefit the city and its people.

Proving Personal Use: The Admissibility Of Evidence Negating Intent To Distribute Marijuana, Stephen Mayer

Michigan Law Review

Against the backdrop of escalating state efforts to decriminalize marijuana, U.S. Attorneys’ Offices continue to bring drug-trafficking prosecutions against defendants carrying small amounts of marijuana that are permitted under state law. Federal district courts have repeatedly barred defendants from introducing evidence that they possessed this marijuana for their own personal use. This Note argues that district courts should not exclude three increasingly common kinds of “personal use evidence” under Federal Rules of Evidence 402 and 403 when that evidence is offered to negate intent to distribute marijuana. Three types of personal use evidence are discussed in this Note: (1) a …

Dissecting The Contents Of Law Of Indonesia On Halal Product Assurance, Aal Lukmanul Hakim

Indonesia Law Review

Indonesia with its majority Moslem population and even the biggest Moslem nation in the world has obligations to its citizens to assurance the halal products (halal) for consumption and/or used as a constitutional obligation to be enforceable and applicable. The constitutional obligation is granted in the form of legal certainty covering the halalness of all products either to those useable, consumed and/or utilized by the society. Upon the legalization and enactment of Law of the Republic of Indonesia Number 33 year 2014 regarding Halal Product Assurance is the evidence of constitutionally protection commitment. Having this Halal Product Assurance Law, the …

Requiem For A Remedy: The Law And Economics Of Mutual Pharmaceutical V. Bartlett’S Over-Preemption, Robert C. Baker Iii

Maryland Law Review Online

No abstract provided.

The “Legal” Marijuana Industry’S Challenge For Business Entity Law, Luke Scheuer

William & Mary Business Law Review

In recent years, many states have legalized the use and sale of marijuana for medical or even recreational purposes. This has led to the booming growth of a “legal” marijuana industry. Businesses openly growing and selling marijuana products to the consuming public face some unusual legal hurdles. Significantly, although the sale of marijuana may be legal at the state level, it is still illegal under federal law. This Article explores the conflict between state and federal marijuana laws from a business entity law perspective. For example, managers owe a fiduciary duty of good faith to their businesses and equity holders. …

Man Made Organs: Technology Made It Possible But Can The Fda Keep Up?, Amanda Chatman

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

No More Drugs! What Will North Carolina Do When Its Supplier Stops Supplying?, Cynthia D. Dixon

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

The Cost Of Evidence: Examining The Fda's Treatment Of Critically-Needed Drugs From An Ex Ante Perspective, Julie Dorais J.D., M.P.H.

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Optimizing Reservoir Operations To Adapt To 21st Century Expectations Of Climate And Social Change In The Willamette River Basin, Oregon, Kathleen M. Moore

Publications

Reservoir systems in the western US are managed to serve two main competing purposes: to reduce flooding during the winter and spring, and to provide water supply for multiple uses during the summer. Because the storage capacity of a reservoir cannot be used for both flood damage reduction and water storage at the same time, these two uses are traded off as the reservoir fills during the transition from the wet to the dry season. Climate change, population growth, and development in the western US may exacerbate dry season water scarcity and increase winter flood risk, creating a need to …

Carrots And Sticks: Safer Fresh Produce In The United States Through British Style Supermarket Co-Regulation, Victoria Tokar

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

Spring 2015 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Marijuana Localism, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The states have wrested control of marijuana policy from the federal government, but they risk losing some of their newfound power to another player: local governments. Hundreds of local communities are now seeking to establish their own marijuana policies, from legalization to prohibition and a variety of idiosyncratic regulatory schemes in between. These local efforts raise one of the most important and unresolved questions surrounding marijuana law and policy: What authority, if any, should states give local governments to regulate marijuana? This Article provides some guidance on this question. It starts by identifying two competing considerations that help determine whether …

Scouting For Approval: Lessons On Medical Device Regulation In An Era Of Crowdfunding From Scanadu’S “Scout”, Colleen Smith

Student Award Winning Papers

This Article will argue that medical device companies should be able to utilize crowdfunding to raise the necessary capital to develop a product. However, because of the risks medical devices pose, any solution that allows medical device companies to employ crowdfunding should ensure the continuing commitment to consumer safety that is at the core of FDA regulation. This Article uses the Scanadu Scout as an example and a staring point for evaluating the use of crowdfunding in the medical device industry. This Article explains how and why Scanadu broke the law when it moved the Scout, an “adulterated or misbranded” …

An Fda For Financial Innovation: Applying The Insurable Interest Doctrine To Twenty-First-Century Financial Markets, Eric A. Posner, E. Glen Weyl

Northwestern University Law Review

The financial crisis of 2008 was caused in part by speculative investment in complex derivatives. In enacting the Dodd–Frank Act, Congress sought to address the problem of speculative investment, but it merely transferred that authority to various agencies, which have not yet found a solution. We propose that when firms invent new financial products, they be forbidden to sell them until they receive approval from a government agency designed along the lines of the FDA, which screens pharmaceutical innovations. The agency would approve financial products if they satisfy a test for social utility that focuses on whether the product will …

Opening The Barnyard Door: Transparency And The Resurgence Of Ag-Gag & Veggie Libel Laws, Nicole Negowetti

Law Faculty Publications

Over the past several decades, as the agricultural system became increasingly industrialized and the steps from farm to plate multiplied, consumers became farther removed from the sources of their food. Until recently, most consumers in America were content to eat their processed, cheap, and filling foods without giving a second thought to how these foods were produced. The tides are changing. Increasingly, consumers are calling for more transparency in the food system. Repulsed by images of animal cruelty and shocked by unsavory food production practices, consumers want the food industry’s veil lifted and are demanding changes in food production. The …

The Executioners‘ Dilemmas, Eric Berger

Nebraska College of Law: Faculty Publications

When people learn that I study lethal injection, they are usual-ly curious to know more (or at least they are polite enough to ask questions). Interestingly, the question that arises most often—from lawyers, law students, and laypeople—is why states behave as they do. In the wake of botched executions and ample evidence of lethal injection‘s dangers, why do states fail to address their execution procedures‘ systemic risks? Similarly, why do states so vigorously resist requests to disclose their execution procedures‘ details? This symposium essay takes a stab at answering these ques-tions. In the interest of full disclosure, I should admit …