Food and Drug Law Commons^™

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Are Food Subsidies Making Our Kids Fat? Tensions Between The Healthy Hunger-Free Kids Act And The Farm Bill, Melissa D. Mortazavi

Washington and Lee Law Review

On December 15, 2010, President Obama signed the Healthy Hunger- Free Kids Act of 2010 (HHFKA)1 into law. It was hailed as a bipartisan success and a significant reform of childhood nutrition policy. Indeed, on its surface the law appears to make a significant shift away from the food paradigm of the past. However, upon closer examination, it fails to unwind the tangled connections between domestic eating habits and longstanding farm subsidies. This Article breaks new ground in several ways: First, it is one of the first essays in the emerging and underexplored field of food law, a crosssection of …

Creating A More Efficient And Effective Food Safety System In Memphis And Shelby County, Harvard Law School Mississippi Delta Project

Delta Directions: Publications

The taste of a fresh-picked peach on a warm summer day is one of life’s simple joys. A store-bought peach can never truly replicate the experience. But in Memphis, getting that peach from the farmer’s tree into the customer’s hand is not as simple as one would assume. The fruit cannot be simply picked from the tree and then sold from the back of a produce truck. Instead, someone wanting to sell these fruits from his truck must obtain a permit and conform to outdated rules, such as the requirement for the truck to remain in motion at all times …

Patents, Genetically Modified Foods, And Ip Overreaching, Elizabeth A. Rowe

UF Law Faculty Publications

Genetically engineered plants and animals have become and will continue to constitute a large part of the food we consume. The United States is the world's largest producer of genetically modified foods, making American consumers the most exposed population to these products. Agricultural biotechnology patents spur and support innovation. Accordingly, patent law is one of the main contributors to this phenomenon that has changed not only the kinds of food we eat, but the nature of the agri-business industry that produces these foods. This Article takes on an area of concern involving the patenting of food that has remained unexplored: …

International Drug Trafficking: A Global Problem With A Domestic Solution, Matthew S. Jenner

Indiana Journal of Global Legal Studies

Forty years ago, the world declared war on drugs. Today, after decades of failing to adequately control drug consumption, an even graver problem has emerged: violent drug traffickers have taken the industry hostage and will stop at nothing to preserve their power. Governments have instituted dozens of programs to dismantle the illicit drug industry, but they have seen only marginal success. One strategy, however, has yet to be fully tested: universal legalization. Universal legalization of all drugs would attack the illicit drug market head-on, destroying the profit incentive for drug traffickers and placing control of the industry in the hands …

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

Drinking Motives Of College Students At A Hbcu In Oklahoma, Yasmeen Shumate

McCabe Thesis Collection

The use of alcohol can be found throughout colleges across the nation (O'Malley and Johnston, 2002). Whether the college is a 2 year institution or a 4 year institution, private of public, there have been multiple studies conducted over alcohol use in various settings. College students consistently report higher levels of alcohol use than their non-college counterparts (O'Malley and Johnston, 2002). In addition, specific demographic characteristics, such as gender, ethnicity, and age, have been studied in relation to college drinking. It's been proven that college men are found to drink more than college females (Humara and Sherman, 2004). Non- White …

Getting Into The Field, Jay A. Mitchell

Journal of Food Law & Policy

A group of students enrolled in a law school clinic wanders through a large farmers' market. They stop to chat with the proprietors of a farm that has sold vegetables at the market for many years. They visit with a cheesemaker and an apple grower. A second group learns about the economic costs of organic production from a farmer and talks with an olive oil producer. Both sets of students seem unusually attentive to their surroundings. That may be because the first group helped the sponsor of the market rework the market's rules and regulations, and the second developed a …

Greenwashing The Organic Label: Abusive Green Marketing In An Increasingly Eco-Friendly Marketplace, Greg Northen

Journal of Food Law & Policy

The green wave of environmental advertising among organic food producers, distributors, and retailers begun during the 1990s has become an all-out green tsunami. The organic food market is the fastest growing segment of the American food industry. Consumers are increasingly becoming aware of the impact their purchases have on several environmental issues. As a result, those consumers are becoming more aware of their spending power and are willingly altering their buying practices to purchase from companies that emphasize environmental responsibility. In fact, some retailers' inventory is already being scanned for alternative green products by their customers' iPhones because, guess what, …

Journal Of Food Law & Policy - Spring 2011, Journal Editors

Journal of Food Law & Policy

No abstract provided.

European Food Law Update, Emilie H. Leibovitch

Journal of Food Law & Policy

This EU Food Law Update will focus on the developments that occurred since October 2010 in the areas of genetically modified organisms, novel foods, contaminants, food quality, and labeling.

Food Entrepreneurs And Food Safety Regulation, Nina W. Tarr

Journal of Food Law & Policy

It is a bucolic scene: local food growers and producers chatting with consumers who come back each week to participate in a direct and continuing conversation about food with someone they know, and to engage in commerce. This illusion of simplicity masks the ever-growing morass of conflicting, complicated, and expensive regulatory oversight that undermines the local food movement by creating barriers between producers and consumers. Those creating and implementing food policy in the United States are facing a fundamental dilemma of how to reconcile the local food movement with regulations designed to address concerns about food safety.

This article will …

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

The History And Future Of Genetically Modified Crops: Frankenfoods, Superweeds, And The Developing World, Brooke Glass-O'Shea

Journal of Food Law & Policy

In a 1992 letter to the New York Times, a man named Paul Lewis referred to genetically modified (GM) crops as "Frankenfood," and wryly suggested it might be "time to gather the villagers, light some torches and head to the castle." Little did Lewis know that his neologism would become the rallying cry for activists around the world protesting the dangers of genetic engineering. The environmental activist group Greenpeace made great use of the "Frankenfood" epithet in their anti-GM campaigns of the 1990s, though they have since backed away from the word and the hardline stance it represents. But genetically …

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of developments in Canadian food law and policy in 2010. This update primarily analyzes the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm.

United States Food Law Update: The Fda Food Safety Modernization Act, Obesity And Deceptive Labeling Enforcement, A. Bryan Endres, Nicholas R. Johnson

Journal of Food Law & Policy

The long-awaited enactment of the FDA Food Safety Modernization Act (FSMA), the most significant amendment to the Federal Food, Drug, and Cosmetic Act in several decades, provides the Food and Drug Administration (FDA) with significantly enhanced jurisdiction to close some of the gaps in the domestic food safety system. The enhanced FDA authority, however, will have little impact on the shared governance system at the federal level that involves multiple agencies, as the Act does not address the U.S. General Accounting Office's (GAO) repeated calls for consolidation of the fragmented federal food safety system. Rather, the Act perpetuates the division …

Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang

University of Michigan Journal of Law Reform

Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …

Breaking Patents, Daniel R. Cahoy

Michigan Journal of International Law

In the 1970s and 1980s, the Boeing aircraft company worked to address the rising cost of jet fuel by inventing lighter metal alloys for use in aerospace materials. Among its discoveries was a method of producing aluminum-lithium alloys with high "fracture toughness," and in 1989, Boeing received a patent for the process. Five years later, another aerospace company working as a National Aeronautics and Space Administration (NASA) contractor, Lockheed Martin, was attempting to solve a similar problem related to materials used in the space shuttle. Lighter materials were necessary for future shuttle missions to transport components of the International Space …

Community Growth And Land Use, Susan Kelly

Publications

No abstract provided.

Dynamic Patent Governance In Europe And The United States: The Myriad Example, Kali Murray, Esther Van Zimmeren

Cardozo Journal of International and Comparative Law

This Article examines the emerging elements of a new model for patent governance. It is divided into four parts. In Section One, we develop a model of dynamic patent governance. This model extends the theoretical framework of network governance, to explain the emergence of networks in the decisionmaking infrastructure for the public and private actors in the patent system. Dynamic patent governance widens this theoretical framework in two key ways. First, dynamic patent governance, within its formal dimensions, is based on the idea that heterogeneous administrative actors regulate the grant and enforcement of patents. This challenges a perspective that sees …