Food and Drug Law Commons^™

Engaging Health Insurers In The War On Prescription Painkillers, Valarie K. Blake

Law Faculty Scholarship

No abstract provided.

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Tribal Sovereignty And Tobacco Control In State-Tribe Cigarette Compacts, Arielle Sloan

BYU Law Review

Compacts are powerful legal tools that states and tribes can use to negotiate agreements. One of the most interesting examples of state-tribe compacts is the cigarette compact, which is useful in combating the illicit cigarette trade. This Note argues that tribal leaders and states can more effectively reach this goal by (1) recognizing tribal sovereignty in and (2) keeping tobacco control at the heart of compact discussions.

Circling The Drain: Regulating Nutrient Pollution From Agricultural Sources, William Gutermuth

Journal of Law and Health

The 2014 Toledo, Ohio tap water ban has, at least temporarily, put a spotlight on United States water supplies. Consequently, many Americans have begun to take a closer look at the quality of the fresh water bodies being used to supply tap water to their homes. Therefore, this Note analyzes the problems currently threatening the lakes, rivers, and other surface waters that are the source of fresh drinking water for huge populations in the United States. Part II examines the problem of nutrient pollution and explains the harmful effects it has on human health. Part III provides an overview of …

Weird Science: Frankenstein Foods And States As Laboratories Of Democracy, Jennifer Mcgee

Journal of Law and Health

The National Bioengineered Food Disclosure Standard (the 'National Standard') was signed into law July 29, 2016. This Article analyzes the National Standard and posits that Vermont’s Act 120 was a more effective labeling law because it safeguarded consumer sovereignty. The State regulatory scheme in place prior to the passage of the National Standard satisfied consumer demand for disclosure while allowing for necessary experimentation with GMO labeling. Part I provides an overview of the current federal scheme regulating GMOs. Part II analyzes of the conflict surrounding GMOs and labeling. Given that analysis, Part III compares the disclosure requirement of the National …

Beyond The War: The Evolving Nature Of The U.S. Approach To Drugs, Don Stemen

Criminal Justice & Criminology: Faculty Publications & Other Works

Over the last forty years, perhaps no issue has affected the United States’s criminal justice system as profoundly as has drug policy. Since President Nixon declared drug abuse “America’s public enemy number one,”1 concerns about the manufacture, distribution, and possession of drugs have remained at the fore of criminal justice policy discussions.2 President Reagan’s subsequent pronouncement of drugs as “an especially vicious virus of crime” set a course for national drug policy that emphasized enforcement and punishment over treatment to “win the war on drugs.”3 Throughout the 1980s, increasing public concern about the effects of drug abuse4 further pressured policymakers …

Preventing A Risk/Risk Trade-Off: An Analysis Of The Measures Necessary To Increase U.S. Pollinator Numbers, Camila Acchiardo Vallejo

Pace Environmental Law Review

This Note will proceed in four parts. Part II will discuss the importance of pollinators and the possible reasons for their declining numbers. Part III will delve into the current and proposed actions to increase pollinator populations that are taking place in the United States. Part IV will then discuss the generally desired and widely accepted solution: a ban on neonicotinoids. This Part will introduce the implementation and results of a neonicotinoid ban in the European Union, and the risk/risk trade-off presented by a neonicotinoid ban. Finally, Part V will compile the solutions discussed in Parts III and IV, and …

Public Conservation Policies On Private Land: A Case Study Of The Brazilian Forest Code And Implications For The Agro-Industry Sector, Rayane Aguiar, Jody M. Endres, Caroline Taylor, Samuel Evans

Pace Environmental Law Review

The objectives of this paper are to discuss (1) a brief history of the Brazilian Forest Code (FC); (2) key aspects of the 2012 FC revisions; (3) the status of implementation, including institutional and field-level challenges, as well as economic incentives to ease compliance; and (4) the importance of the FC for the Brazilian agro-industrial sector.

A Window Of Opportunity For Gmo Regulation: Achieving Food Integrity Through Cap-And-Trade Models From Climate Policy For Gmo Regulation, Gabriela Steier

Pace Environmental Law Review

GMOs are the links of our centralized food system, largely dependent on international trade. GMOs are inherently unsustainable because they reduce biodiversity, harm the environment, and empower positive feedback loops between monocultures, industrial agriculture, and biodiversity depletion, thereby jeopardizing food safety, security, and sovereignty. Conglomerates of multi-national companies, in short BigAg, shape multi-lateral food trade and flood international markets with their small array and enormous volumes of crops, while controlling large aspects of agriculture and food production world-wide. Zooming in on the trans-Atlantic dispute about GE crops, this paper uses comparative law to explore how a cap-and-trade model borrowed from …

Appellations And Adaptations: Geographical Indication, Viticulture, And Climate Change, Raz Barnea

Washington International Law Journal

Fine wine as we know it is a relatively modern innovation. But French wine culture presents a mythology of a stable and venerable tradition dating back centuries. Central to this mythology is the concept of terroir: the notion that the place—both the land and the people—defines the product. In the early Twentieth Century, France adopted laws giving local producers of wine exclusive rights to name the wine for the region of its origin. These regions, called appellations, have come to stand for the type and quality of wine produced within them—Champagne and Bordeaux are two well-known examples. The appellation regime …

From Pay-For-Delay To Product Hopping: The Limited Utility Of Antitrust Law In The Pharmaceutical Industry, Joseph Fielding

Cardozo Law Review

The note examines the intersection of patent law and antitrust policy, particularly in the context of pharmaceutical drug competition. It argues that while antitrust enforcement is an effective solution to address "pay-for-delay" agreements, it is less suitable for resolving "product-hopping" issues. Instead, the article contends that closing regulatory loopholes in the Hatch-Waxman framework would be a more effective approach to curbing anticompetitive product-hopping practices. The analysis focuses on two key cases—Federal Trade Commission v. Actavis, Inc. and Schneiderman v. Actavis LLC—to illustrate the legal and economic implications of these strategies.

Illegal Marijuana Cultivation On Public Lands: Our Federalism On A Very Bad Trip, Hope M. Babcock

Georgetown Law Faculty Publications and Other Works

Fueled by increasing demand for marijuana, illegal cultivation of the drug on public lands is causing massive environmental harm. The federal government lacks the resources to wage what would be a difficult and costly campaign to eradicate these illegal grow sites and instead focuses its limited resources on enforcing the federal marijuana ban. Marijuana decriminalization might allow legally grown marijuana to squeeze out its illegal counterpart, but the political likelihood of decriminalization is low. The key is reducing demand for the illegal drug by changing public buying preferences. However, doing this depends on an available legal alternative. This Article discusses …

Taxing Marijuana: Earmarking Tax Revenue From Legalized Marijuana, Armikka R. Bryant

Georgia State University Law Review

This Article provides an overview of the legal, political, and societal landscapes in states that have legalized marijuana and imposed taxes on its sale. The article begins by summarizing the War on Drugs’ origins, its fiscal expenditures, and the social policies that ultimately led to its failure.

Part I briefly details the history of marijuana regulation starting from the early twentieth century up to the Obama administration’s decision to permit recreational marijuana laws to stand in Washington state and Colorado. Part II dives deeper into the social costs of the War on Drugs and outlines the hardships faced by those …

Do Desperate Times Really Call For Desperate Measures? The Ethical Dilemma Behind The Regulation And Use Of Experimental Drugs, Lauren Kuehn

Notre Dame Journal of International & Comparative Law

This Note will argue that, unlike what many patients believe, the U.S. Food and Drug Administration (FDA) plays an invaluable and imperative role in seeking the efficacy and safety of new treatment options and drugs. The balance of interests between those who are terminally ill, who wish to see increased access to unapproved medicines; the general public, who has an interest in preserving the drug approval process; and the FDA, who has been mandated by law to safeguard the safety of the general public, creates a tension that will continue to go unresolved. Thus, the patients who continue to advocate …

“Safe Harbor” On The Rocks: Ttb Label Approval For Beer, Wine, And Spirits, And The Uncertain Status Of The “Safe Harbor” Defense, Michael Mercurio

Notre Dame Journal of International & Comparative Law

This Note examines the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB)’s label review process and the judicial split regarding the “safe harbor” doctrine in the context of alcoholic beverage labels. This Note observes that the judicial split is a result of the tension between two conflicting priorities stemming from the TTB’s purpose and identity: on one hand, courts apply Chevron deference to the TTB as a federal agency enforcing federal law, but on the other hand, courts aim to uphold the central purpose of the Federal Alcohol Administration (FAA) Act—protecting consumers from misinformation. Ultimately, this Note, by examining …

Selling The Footlong Short: How Consumers Inch Toward Satisfaction In Costly Food Class Action Litigation, Erica A. Burgos

Seventh Circuit Review

Food and beverage class action litigation has increased tremendously over the last five years. While many have ridiculed these lawsuits as ploys to extort money from wealthy food producers, plaintiff consumers maintain that the surge of food litigation suits evidence their growing desire for transparency. Many food-based class actions allege companies are purposefully deceiving consumers with misleading marketing campaigns. Defendants argue that a reasonable consumer should know better than to take their advertising at face value. Even still, defendants are often eager to resolve conflicts without admitting liability and, in turn, rush to settle the matter. Courts are then faced …

Journal Of Food Law & Policy - Spring 2017, Journal Editors

Journal of Food Law & Policy

After Donald Trump’s victory last November, we put out a call for brief essays examining what happened, what’s likely to happen, and what policymakers and advocates can do to keep pushing forward. The response was extraordinary. We received thought provoking submissions on a number of important topics, including antitrust, trade policy, food safety, and labor, among others. Instead of running a standard issue comprised of legal articles—with essays as an accompaniment—we decided to reverse the format and devote the bulk of this issue to these essays. The result is a penetrating and timely look at the state of food law …

Implementing The National Bioengineered Food Disclosure Standard, Lesley K. Mcallister

Journal of Food Law & Policy

In July 2016, the National Bioengineered Food Disclosure Law was passed to establish a mandatory national system for disclosing the presence of genetically-engineered material in food (GMOs). The federal law preempts state and local initiatives to create labeling systems. This essay first analyzes the benefits and drawbacks of having a national GMO law rather than a patchwork of state laws. Then it provides commentary on how the USDA can create an effective and accessible labeling system, using scannable Quick Response (QR) codes.. The essay envisions a retail food system in which all consumers can easily and usefully obtain reliable information …

Aldf V. Otter: What Does It Mean For Other State’S “Ag-Gag” Laws?, Jacob Coleman

Journal of Food Law & Policy

Across the nation, states have enacted “Ag-gag” laws that criminalize various types of investigations into animal cruelty and worker abuses in the chain of animal agriculture. This article divides the types of “ag-gag” statutes into four waves with varying degrees of protection for farmers and corporations engaged in animal agriculture. Next, this article analyzes Animal Legal Defense Fund v. Otter, in which an Idaho judge struck down an “ag-gag” statute, and applies its holding to the various waves of “ag-gag” statutes.

Comment: Prison For You. Profit For Me. Systemic Racism Effectively Bars Blacks From Participation In Newly-Legal Marijuana Industry, Elizabeth Danquah-Brobby

University of Baltimore Law Review

Historically, blacks have been prosecuted and convicted across the United States at significantly higher rates when compared to whites for marijuana-related crimes, despite the fact that studies indicate marijuana use by whites and blacks is relatively equal. Further, individuals with lower economic means were dually susceptible to conviction as a result of less vigorous legal representation.

Now, laws have legalized marijuana for medicinal purposes in twenty-six states, along with a small portion of states (seven) legalizing marijuana for recreational use. Yet retroactive ameliorative relief is not widely available to those who were convicted under circumstances that are now legal, and …