Food and Drug Law Commons^™

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 …

Beer, Liquor, Or A Little Bit Of Both? Getting To The Bottom Of Properly Classifying Flavored Malt Beverages In The United States And Australia, Bryan A. Schivera

Georgia Journal of International & Comparative Law

No abstract provided.

Let My Brewers Go! A Look At Home Brewing In The U.S., Hannah Jeppsen

Journal of Food Law & Policy

In mid-August of 2012, a group of Americans stormed the White House, demanding transparency on a subject many Americans may find surprising: beer. More specifically, Americans requested White House home brew recipes, a presidential secret until Barack Obama's administration released them on September 1, 2012. Not only does Obama enjoy a good home brew, he is also the first president to brew in the White House and even take beer on the campaign trail. However, it was the August petition that garnered home brewing national media attention.

Trademarks, Gis, And Commercial Aspects Of Wine Distribution Agreements, Sarah A. Hinchliffe

Journal of Food Law & Policy

The marketing of goods under geographical names has always been common. In addition to introducing commercial facets of wine distribution agreements, this article discusses the justifications, principles and, policies that lie behind the protection of geographical indications (GIs) for wine on an international level as well as in the Old World and, to a lesser degree, in the New World. The scope and shape of the GI system will then be scrutinized in light of its own justifications and in the light of its impact on international trade, intellectual property, and agricultural policy.

Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane

Articles

The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …

Fair Or Foul? Major League Baseball's Use Of A Tortious Interference Lawsuit As A Means Of Investigation, Michael S. Beck

Cardozo Arts & Entertainment Law Journal

No abstract provided.

United States Food Law Update: Shrouded By Election-Year Politics, State Initiatives And Private Lawsuits Fill In The Gaps Created By Congressional And Agency Ossification, A. Bryan Endres, Lisa R. Schlessinger, Rachel Armstrong

Journal of Food Law & Policy

Observers of food law in the 2012 presidential election year witnessed a dramatic slowing of federal initiatives-perhaps arising from a desire by both Congress and the administration to avoid upsetting critical constituent groups during a year seemingly dominated by campaigns and endless talking points. For example, Congress failed to take action on a unique compromise between what some had considered mortal enemies-the Humane Society of the United States and United Egg Producers-that would implement a federal animal welfare standard for laying hens in return for abandoning ballot measures in various states. Similarly, the FDA waited until the early days of …

Check Please: Using Legal Liability To Inform Food Safety Regulation, Alexia Brunet Marks

Publications

Food safety is a hotly debated issue. While food nourishes, sustains, and enriches our lives, it can also kill us. At any given meal, our menu comes from a dozen different sources. Without proper incentives to encourage food safety, microbial pathogens can, and do enter the food source--so much so that according to the Centers for Disease Control and Prevention (CDC), each year roughly one in six Americans (or forty-eight million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. What is the optimal way to prevent unsafe foods from entering the marketplace?

Safety in the food …

Cornography: Perverse Incentives And The United States Corn Subsidy, Anthony Kammer

Journal of Food Law & Policy

Among the most important functions we have afforded to the U.S. Congress is the power to reshape social and economic incentive structures through legislation. Proceeding from the enumerated powers under the Constitution and using a complex toolbox of legislative and regulatory innovations, the federal legislature has enormous power to transform the types of behavior that people will perceive as self-interested throughout our economy and thus how those same people are likely to act. Congress can, among other things, create new forms of criminal and civil liability, establish entitlement systems, subsidize industries, encourage behavior through the tax code, regulate interactions among …

Misappropriation And Patenting Of Traditional Ethnobotanical Knowledge And Genetic Resources, Maxim V. Gubarev

Journal of Food Law & Policy

Four-fifths of all pharmaceuticals have been developed from natural plant resources, and native plant resources similarly play a significant role in the development of new and improved crops.

Put A Cork In It: The Use Of H.R. 161 To End Direct Wine Shipping Throughout The States Once And For All, Victoria H. Jones

Journal of Food Law & Policy

Due to Congress' recent agenda, oenophiles throughout the country are up in arms about the possible threat to their beloved wine. Wine lovers and other alcohol enthusiasts face the very real fear that access to their favorite products may soon be heavily restricted. This is in large part attributed to the fact that House Resolution 1161 would effectively change the ways in which states regulate alcohol shipment. The possible implications of this bill range from the forced shutdown of many wineries and distilleries due to lack of funding, to the smaller effects of regulation such as the inability of customers …

European Union Food Law Update, Emilie Majster

Journal of Food Law & Policy

Nutrition is increasingly important in both the European Union (EU) and in global food-related policy making. Governments, which up until recently have focused on regulating food products based on a food safety perspective, are now turning to regulate from a nutritional aspect.

Cows V. Capitalists: Visions Of A Post-Carbon Economy, Alison Peck

Journal of Food Law & Policy

I was tempted to entitle this book review something like, "Why the Farm Bill Is the Key to Our Energy Future (Hint: It's Not About Ethanol, Methane Emissions, or Carbon Sinks)." But in addition to being too long to fit across the header of a law review page, such a title would have been slightly misleading. Actually, in Simon Fairlie's view, our future is about ethanol, methane emissions, and carbon sinks - but not in the way our current agricultural policies understand and deal with these subjects.

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of the developments in Canadian food law and policy in 2011. This update considers 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: Moving Toward A More Balanced Food Regulatory Regime, A. Bryan Endres, Nicholas R. Johnson

Journal of Food Law & Policy

For decades, the federal government has played a significant role in promoting healthy eating. In the early 1900s, the United States Department of Agriculture (USDA) promoted a foundational diet of milk, proteins, fruits and vegetables, and grains. Most Americans are at least somewhat familiar, although perhaps confused, with the more nuanced healthy eating recommendations contained in the food pyramid - first employed in 1992. And virtually every American has experienced the federally supported school lunch program. In the first half of 2011, these two iconic programs underwent significant change as part of a stepped-up effort to improve the health of …

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 …

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 …

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 …

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 …

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.

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 …

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 …

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 …

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 …

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 …

Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman

Faculty Works

Much like tort reform, the debate over recently enacted legislation on biotech drugs — and particularly regulatory supplements to patent protection — has taken on a significance that dwarfs its impact on prescription drug expenditures. Under the Health Care Reform legislation, Congress enacted two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics (FOBs), which are the analogues of generics for biotech drugs. Second, establishment of a twelve-year “data exclusivity” period in which clinical testing data collected by brand-name innovators cannot be used by producers of FOBs to satisfy FDA testing requirements. …

The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang

Michigan Telecommunications & Technology Law Review

China's pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the world by the year 2050. However, entry to the market remains difficult for many international pharmaceutical manufacturers due to the country's costly and complicated regulatory licensing requirements. This Article provides an overview of the regulatory licensing regime for pharmaceutical products in China. Then, the Article evaluates three key features of the regulatory licensing regime through a law and economics approach. These features include the use of licensing, as contrasted with alternative regulatory and non-regulatory mechanisms; the standards to be met …

Marketing Mothers' Milk: The Commodification Of Breastfeeding And The New Markets For Breast Milk And Infant Formula, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This paper explores the commodification of women and biological processes, the confusion of scientific evidence with social agendas, and the conflict between marketing and public health. I assert that key actors in the healthcare marketplace - government, businesses, and doctors – have acted to enable weak medical and scientific evidence to be manipulated by ideological and profit-making partisans in a poorly regulated market. I focus on the unique role of the medical profession, which has acted with government and the private sector to shape the markets in human milk and infant formula. In a striking parallel to the pharmaceutical industry, …

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Scholarly Articles in Law Reviews & Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …