Food and Drug Law Commons^™

Litigating Together: Social, Moral, And Legal Obligations, Elizabeth Chamblee Burch

Scholarly Works

In a post-Class Action Fairness Act world, the modern mass-tort class action is disappearing. Indeed, multi-district litigation and private aggregation through contracts with plaintiffs’ law firms are the new mass-tort frontier. But something’s amiss with this “nonclass aggregation.” These new procedures involve a fundamentally different dynamic than class actions: plaintiffs have names, faces, and something deeply personal at stake. Their claims are independently economically viable, which gives them autonomy expectations about being able to control the course of their litigation. Yet, they participate in a familiar, collective effort to establish the defendant’s liability. They litigate from both a personal and …

Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez

Faculty Journal Articles and Book Chapters

This Article considers whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.

I examine the tests and factors courts claim they use when making this threshold distinction, then identify the various …

Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

Enough Rope: Why United States V. White Plume Was Wrong On Hemp And Treaty Rights, And What It Could Cost The Federal Government, Lori Murphy

American Indian Law Review

No abstract provided.

Is Usda Organic A Seal Of Deceit: The Pitfalls Of Usda Certified Organics Produced In The United States, China And Beyond, Chenglin Liu

Faculty Articles

American consumers' appetite for organic foods (organics) has dramatically increased since Congress passed the Organic Foods Production Act (OFPA) in 1990. Because the domestic organic food industry has been unable to meet the growing demand for these products, U.S. groceries have increasingly relied on imported organics. Studies show that 40% of organic foods consumed in the United States are imported from over 100 foreign countries.

To regulate organic food production, the United States Department of Agriculture (USDA) accredits certifying agents, which in turn certify organic farms and handlers according to U.S. organic standards. Certifying agents can be state agencies or …

Memory And Punishment, O. Carter Snead

Journal Articles

This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish are inextricably intertwined with how a crime is remembered - by the offender, by the sentencing authority, …

Legislative And Regulatory Recommendations To Allow Home-Processing Of Low-Risk Foods In Mississippi, Harvard Law School Mississippi Delta Project

Delta Directions: Publications

With the recent growth in farmers markets and the demand for local, fresh foods there has been a push to allow individuals to produce and sell foods made in their homes. This report will explain why Mississippi should follow the trend set by over 30 states to allow in-home production and sale of certain low-risk or non-potentially hazardous foods like baked goods, jams, jellies, and dried herbs. This report will lay out current Mississippi law regarding the processing of such non-potentially hazardous foods in home kitchens; compare Mississippi law to the laws employed in other states; and make recommendations for …

Cheaters Shouldn't Prosper And Consumers Shouldn't Suffer: The Need For Government Enforcement Against Economic Adulteration Of 100% Pomegranate Juice And Other Imported Food Products, Michael T. Roberts

Journal of Food Law & Policy

In the modern global food system - marked by the trade flow of a variety of food products and ingredients from multiple locations in the world - economically motivated adulteration has emerged as a growing menace that threatens the health and wellbeing of consumers, the economic livelihoods of honest purveyors of food in the global marketplace, and the integrity and viability of national food regulatory systems. Economic adulteration is a form of cheating that includes the padding, diluting, and substituting of food product. Although this cheating is rooted in past food systems, the new paradigm for economic adulteration - a …

The Quest To End Hunger In Our Time: Can Political Will Catch Up With Our Core Values?, David P. Lambert

Journal of Food Law & Policy

David Lambert a nationall recognized advocate to end hunger speaks about his work and the impact it has had on Arkansas, the USA and the world.

A Bittersweet Deal For Consumers: The Unnatural Application Of Preemption To High Fructose Corn Syrup Labeling Claims, Josh Ashley

Journal of Food Law & Policy

The recent rise of consumer consciousness regarding the health qualities of foods and beverages has become something akin to common knowledge. Reflecting this rise, studies reveal that labels regarding the health qualities of a food are more likely to increase sales. And among the health labels consumers prefer, labels describing the product as natural top the list. One website reports that according to a recent study, 31.3-percent of respondents thought that "100% natural" was the best description to read on a label, compared with only 14.2-percent who thought that "100% organic" was the best description. "All natural ingredients" was the …

Produce Exceptionalism: Examining The Leafy Greens Marketing Agreement And Its Ability To Improve Food Safety, Varun Shekhar

Journal of Food Law & Policy

Isolated food safety crises are not uncommon occurrences in the United States. Indeed, the history of public scares indicates a pattern of deficiencies in the safety of the American food supply. In the early 20th century, the public learned of the squalid conditions of meatpacking facilities through muckraking publications such as Upton Sinclair's The Jungle. In the 1980s, a 60 Minutes report documented research finding carcinogenic properties of a widespread pesticide, traces of which were commonly found in apple-based products. In the 1990s, widespread media reports of beef tainted with E. coli led to both product recalls unprecedented in scope …

What Is The Impact Of Liquor Licensing Laws On Portland’S Entertainment Venues? A Case Study, Will Etheridge

Muskie School Capstones and Dissertations

In January 2009, Port City Music Hall in Portland, Maine was preparing to open its doors to the public for the first time. With a capacity for nearly six hundred attendees, Port City Music Hall was designed to attract national touring acts to Portland too big for the bar scene, but not suited for the Merrill Auditorium or Cumberland Civic Center. With the State Theatre still shuttered at the time, this new venue hoped to fill an important niche in the city’s creative economy, bringing a diverse array of performers that would not otherwise be able to find a viable …

Reconsidering Federalism And The Farm: Toward Including Local, State And Regional Voices In America's Food System, Margaret Sova Mccabe

Journal of Food Law & Policy

Why is the relationship between our food system and federalism important to American law and health? It is important simply because federal law controls the American food system. This essay considers how federal law came to structure our food system, and suggests that though food is an essential part of our national economy, the dominating role of the federal government alienates citizens from their food system. It does so by characterizing food as a primarily economic issue, rather than one that has ethical, health, and cultural components. However, state and local governments have much to offer in terms of broadening …

United States Food Law Update: Health Care Reform, Preemption, Labeling Claims And Unpaid Interns: The Latest Battles In Food Law, A. Bryan Endres, Nicholas R. Johnson, Michaela N. Tarr

Journal of Food Law & Policy

This edition of the Food Law Update explores four legal issues arising in the first half of 2010 reflective of the diverse nature of the food law specialist. As the national debate surrounding the merits of health care reform dominated the legislative agenda, this article first will discuss the food labeling rules embedded within section 4205 of the Patient Protection and Affordable Care Act of 2010. The authors then analyze the preemptive reach of the Federal Food, Drug, and Cosmetic Act and the Meat Inspection Act with respect to three separate California statutes regarding animal welfare standards, retail labels on …

European Union Food Law Update, Emilie H. Leibovitch

Journal of Food Law & Policy

This EU Food Law Update will focus on the recent developments in the areas of genetically modified organisms, novel foods, feed safety, transmissible spongiform encephalopathy, salmonella and food borne diseases, food additives, organic farming, food contact materials, and labeling.

Foodshed Foundations: Law's Role In Shaping Our Food System's Future, Margaret Sova Mccabe

Law Faculty Scholarship

[. . .] This symposium Article analyzes how we can rethink the architecture of law based on a foodshed model to provide a greater role for local, state, and regional government in the American food system. In turn, greater roles for different levels of government may help America achieve greater efficiencies in domestic food safety, nutrition and related public health issues, sustainability, and international trade.

Americans need a greater voice in the food system. The foodshed model is a powerful vehicle that allows us to conceptualize change, allowing greater citizen participation and a more nuanced approach to food policy. The …

Bridging The Gap: How United States V. Munn Correctly Interprets The Legislative Intent Of Amendment 706 Addressing The Disparity Between Crack And Cocaine Offenses, Alyn Goodson

North Carolina Central Law Review

No abstract provided.

A Conflict By Any Other Name Would Smell As Foul: A Comment On The Appointment Of A Vice-President Of Pfizer To The Cihr Governing Council, Jocelyn Downie

Articles, Book Chapters, & Popular Press

If one had to pick the pharmaceutical company most associated with unethical and illegal conduct this past year, it would likely be Pfizer. So it seems reasonable to respond with disbelief and outrage to the federal government’s October 5, 2009 appointment of Dr. Bernard Prigent – Vice President, Medical Director and registered lobbyist for Pfizer Canada – to the Canadian Institutes of Health Research Governing Council (CIHR GC). This is the body that sets the strategic direction for most federally funded health research in Canada. A senior executive from a for-profit pharmaceutical company should not be given a seat at …

Pharmaceutical Patent Bargains: The Brazilian Experience, Bruno Salama, Daniel Benoliel

Cardozo Journal of International and Comparative Law

In the backdrop of the strict patent regime flatly adopted by the World Trade Organization (WTO) for all countries, a few countries constantly challenge this system through aggressive patent bargains. Within the pharmaceutical sector, noticeably, some countries now threaten to issue or otherwise actually issue compulsory licenses that may sway large pharmaceutical companies into selling drugs with large discounts or into granting voluntary licenses domestically. That is conspicuously the negotiation strategy adopted by Brazil in its negotiations with big international pharmaceutical companies.

This paper explains Brazil's aggressive bargaining approach based on an analysis of two aspects of its political economy. …

Voices From The Field: An Inter-Professional Approach To Managing Critical Information

Cardozo Law Review

No abstract provided.