Food and Drug Law Commons^™

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 …

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Foreword, Journal Editors

Journal of Food Law & Policy

No abstract provided.

A Call To Action: The New Academy Of Food Law & Policy, Emily M. Broad Leib, Susan A. Schneider

Journal of Food Law & Policy

The food system is affected by unique and complex laws. These laws call for a new generation of legal practitioners and scholars. This essay announces the creation of the Academy of Food Law and Policy. The Academy creates a network of law professors researching, teaching, and mentoring in food law and policy.

The Butz Stops Here: Why The Food Movement Needs To Rethink Agricultural History, Nathan A. Rosenberg, Bryce Wilson Stucki

Journal of Food Law & Policy

From the 1890s to the 1930s, rural Americans played a vital role in radical leftist politics. While specialists know this history well, the public tends to know a folk history, written by figures associated with contemporary food movements. This folk history rests on several key myths, which cover different periods of modern history from the New Deal to the present. This essay challenges these myths to reveal the causes and extent of the suffering endured by rural families in the 20th century, which in turn, decimated the populist left. A reconsideration of the history of agricultural policy will help food-system …

After The White House Garden: Food Justice In The Age Of Trump, Garrett M. Broad

Journal of Food Law & Policy

It’s debatable whether President and First Lady Obama’s White House garden was a positive or negative symbol to the community food justice movement—but it did send a signal. This essay speculates what, if anything, the Trump administration will signal to these community food justice activists. It also recommends a potential strategy for grassroots food justice advocates fighting for already limited resources.

Food Justice In The Trump Age: Priorities For Urban Food Advocates, Nevin Cohen, Janet Poppendieck, Nicholas Freudenberg

Journal of Food Law & Policy

This essay outlines priorities for food advocates following the election of President Donald Trump. Specifically, this essay advocates for: 1. preservation of snap, 2. prevention of industry deregulation, and 3. sustainment of regional food systems. In its analysis, this essay examines each of the potential conservative-back counter proposals for these priorities.

Possibilities For Farm Policy In A Trump Era, Stephen Carpenter, Kirsten Valentine Cadieux

Journal of Food Law & Policy

This essay addresses options for the Trump administration in promoting a modern, sustainable, and inclusive agricultural system. This essay considers what might be achieved while the Trump administration stays committed to its goals, espoused throughout the Trump campaign. The particularly relevant goals affecting the administration’s agricultural policy are shrinking government, decreasing the number of illegal immigrants, and renegotiating free trade.

Will The Trump Administration Support Farmers Facing Fsma Compliance?, Sophia Kruszewski

Journal of Food Law & Policy

In keeping with Donald Trump’s campaign promises of cutting burdensome regulations, this essay recommends two Food Safety Modernization Act (FSMA) regulations that should be removed or altered. The two regulations are for irrigation water quality standards and third-party audits. This essay argues that these regulations are unnecessary in keeping with the goals of FSMA and are burdensome for farmers of all scales, but especially small and very small scale farmers.

Food Labor And The Trump Administration: A Grim Prognosis, Erik Loomis

Journal of Food Law & Policy

Farm laborers made few gains under the Obama administration; however, food workers received some benefit under the Obama’s Secretary of Labor, Tom Perez. Unfortunately, any gains for food workers will likely be rolled back under the Trump administration through both his cabinet appointments and judicial appointments. This essay predicts a strengthening of “ag-gag” bills and a weakening of Occupational Safety and Health Agency (OSHA). President Trump’s attacks on immigration and regulations also signal fewer workers’ rights in the fields and less accountability of exploitative employers.

Editorial Board, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Myth Making In The Heartland – Did Agriculture Elect The New President?, Neil D. Hamilton

Journal of Food Law & Policy

This essay addresses the role of America’s farmers in electing President Donald Trump. This role may not have been as large as the agricultural community and others have suggested. Additionally, this essay cautions the agricultural community against taking too much credit for the election of a politician and party whose interests are often at odds with agricultural interests.

Fomenting Democracy: The Case For Federal – Local Cooperation, Marilyn Sinkewicz, Jess Gilbert, Calvin Head

Journal of Food Law & Policy

This essay profiles a program in a rural, black Mississippi community called Youth-in-Agriculture. This case study of Mileston, Mississippi depicts the collaborative efforts of the federal government and community organizations through nearly a century. This essay also describes the ways in which the Trump administration could most support agricultural communities like Mileston, MS.

Farming And Eating, Margot J. Pollans

Journal of Food Law & Policy

There has long been tension between rural and urban communities, often referred to as the urban-rural divide. Donald Trump’s presidential campaign has exacerbated this divide. However, urban and rural groups rely on each other; farmers need eaters in densely populated areas for markets and eaters need farmers for food. In recognition of this codependency, this essay proposes a coalition of farmers, food consumers, and environmentalists to lead agricultural policy and stop the divide between farming and eating.

Organic Agriculture Under The Trump Administration, Marne Coit

Journal of Food Law & Policy

This essay will examine the implications of the policies of the upcoming Trump administration on the integrity of the National Organic Program (NOP), the regulations promulgated under the Organic Foods Production Act (OFPA). Advocates fears of weakening organic standards are likely to become reality under the Trump administration. Support for organic may be dependent on high returns for large agricultural producers. However, there is a negative correlation between larger agri-businesses entering the organic market and the erosion of the organic standards. The Trump administration will likely continue down the path of supporting larger agribusinesses—to the detriment of not only smaller, …

Eating Is Not Political Action, Joshua Galperin, Graham Downey, D. Lee Miller

Journal of Food Law & Policy

To create policy at the interface of the centrally important and overlapping American ideals of agriculture and the environment, there are two options. Passive governance fosters markets in which participants make individual choices that aggregate into inadvertent collective action. In contrast, assertive governance allows the public, mediated through elected officials, to enact intentional, goal-oriented policy. This essay contends that the latter option, assertive governance, is the only appropriate means of creating harmony between agriculture and the environment it depends upon.

An Interview With Outgoing Secretary Of Agriculture Tom Vilsack: Reflections On His Legacy & Challenges Facing A New Era In American Agriculture Policy, Lauren Manning

Journal of Food Law & Policy

In a special interview with Lauren Manning, former Secretary of Agricultural Tom Vilsack reflects on his eight-year tenure at the Department of Agriculture (USDA). Sec. Vilsack discusses such issues as the farm bill, opportunities for beginning and disadvantaged farmers, and trade. In addition to recounting the successes of the Obama administration’s USDA, Sec. Vilsack explains his hopes for the incoming Secretary of Agriculture and the Trump administration.

Farmers Market Rules And Policies: Content And Design Suggestions (From A Lawyer), Jay A. Mitchell

Journal of Food Law & Policy

Farmers market rules and policies can set out what products can be sold, how vendors are selected, what’s expected of vendors from growing practices to signage to paperwork, and how vendors are disciplined or removed from the market. Rules and policies can do even more, adding to their length and complexity. The landscape gets even more complex when the rules are accompanied by separate vendor applications, hold-harmless agreements, membership materials, and the market has a website providing additional information. All this can put a quite a reading burden on vendors and quite a management burden on the market. This article …

Trump’S New Trade Policy: Risks For North American Food And Farms, Karen Hansen Kuhn

Journal of Food Law & Policy

In his presidential campaign, Trump promised to build a “great, great wall”, and he promised to renegotiate the terms of the North American Free Trade Agreement (NAFTA), leaving open the possibility of pulling out entirely. There are many concerns with NAFTA as it currently exists and there are many areas in which renegotiation would be welcome. This essay argues, however, the Trump administration’s loyalties to big business could hinder positive change. If NAFTA is significantly renegotiated, it should be with farmer and consumer interests in mind, not those of multinational corporations.

Antitrust In Food And Farming Under President Trump, Leah Douglas

Journal of Food Law & Policy

Corporate powers are proposing mega mergers in almost every sector of agriculture. This essay explores how President Trump can keep his campaign promises to protect rural voters by strengthening the weakening enforcement of antitrust doctrines; specifically through the Grain Inspection, Packers and Stockyards Administration (GIPSA) and reinstating the Country of Origin Labeling (CoOL) of meat products.