Food and Drug Law Commons^™

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 …

Splitting Scales: Conflicting National And Regional Attempts To Manage Commercial Aquaculture In The Exclusive Economic Zone, Brandee Ketchum

Journal of Food Law & Policy

Like other environmental resources subject to public use, various interest groups struggle over joint management of scarce fisheries resources. Further, differing goals for resource management, such as financial goals versus conservation goals, frequently pit regional groups against one another. In some cases, regional interests may conflict with overall national interests. As goes the water and the air, so go the fish.

Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova Mccabe

Law Faculty Scholarship

In 2009, gluten-free foods were not only "hot" in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term "gluten-free." The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers.

"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane

Reviews

Congratulations to Mike on a very fine book. I will confine my comments to Mike's chapter on patent settlements (Chapter 15), which I understand will also be coming out as an article in the Michigan Law Review. Patent settlements involving "reverse payments" are a huge topic on which I and many others have spilled much ink already. Representative Bobby Rush (President Obama's erstwhile nemesis from Chicago's South Side) has just introduced legislation that would ban reverse payments.' I will not regurgitate my entire spiel on patent settlements here, but instead just try to highlight my essential disagreement with Mike …

A Healthy Diet Of Preemption: The Power Of The Fda And The Battle Over Restricting High Fructose Corn Syrup From Food And Beverages Labeled 'Natural', Adam C. Schlosser

Journal of Food Law & Policy

America is unhealthy. America faces an obesity epidemic. The food consumed by Americans is making them fat. Americans, bombarded every single day by negative headlines like these, are becoming more and more health conscious. This newfound commitment to health is reflected in the food and beverages Americans purchase.

Labeling Of Credence Attributes In Livestock Production: Verifying Attributes Which Are More Than "Meet The Eye", Nicole J. Olynk, Christopher A. Wolf, Glynn T. Tonsor

Journal of Food Law & Policy

Americans are increasingly sensitive to the conditions under which the foods they purchase and consume are produced. It is becoming commonplace for consumers to incorporate perceived environmental impacts, animal welfare concerns, and other process attributes into food purchase decisions. Increased interest in production practices and technologies employed in food production has been seen in the U.S. specifically concerning irradiation, antibiotics, and hormone and pesticide use. Perhaps one of the most controversial technologies employed in food production today is the use of genetic engineering. Not surprisingly, consumers are particularly sensitive about practices employed or technologies used in foods produced specifically for …

Dietary Supplements And Structure-Function Claims: The Dysfunctional Structure Of Current Regulation, Matthew W. Lindsey

Journal of Food Law & Policy

Twenty percent of Americans report using one of the more than thirty thousand dietary supplement products generated by an estimated one thousand manufacturers, contributing to an industry exceeding twenty billion dollars globally. Fueled by increasing public interest in individual health, dietary supplement manufacturers in the United States (U.S.) continue to exploit the weaknesses in the way the Food and Drug Administration (FDA) regulates these products. Dietary supplement manufacturers perpetuate the perceived safety of supplements through the advertisement of structure-function claims, which many consumers mistakenly assume to be the same as FDA-regulated health claims.

United States Food Law Update: Food Allergy Labels, Reaching Organic Equivalence, Misbranding Litigation And Regulatory Takings, A. Bryan Endres, Michaela N. Tarr

Journal of Food Law & Policy

The start of 2009 found the nation transitioning to a new presidential administration, speculating on the impact new appointees to the executive branch may have on regulatory priorities and monitoring a bill' making its way through Congress that seeks a substantial overhaul of the food regulatory system. This version of the Food Law Update will analyze two major developments in food allergy labeling: finalization of rules requiring the labeling of Cochineal extract/ carmine and an analysis of the proposed "gluten-free" product labels. The update next discusses the execution of an equivalency agreement between the United States and Canada with respect …

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …

United States Food Law Update: Pasteurized Almonds And Country Of Origin Labeling, A. Bryan Endres

Journal of Food Law & Policy

The last six months of 2008 found the nation occupied with a heated presidential election campaign and the transition to a new party's control of the executive branch. The outgoing president, as is often the case in the waning months of an administration's time in office, attempted to finalize several policy initiatives. This version of the Food Law Update will discuss two major developments with significant long-term impact on the law of food: the implementation of mandatory country of origin labeling (COOL) for most unprocessed agricultural commodities; and the increasing use of the United States Department of Agriculture's (USDA) Agricultural …

Whatever Happened To Old Mac Donald's Farm… Concentrated Animal Feeding Operation, Factory Farming And The Safety Of The Nation's Food Supply, Julie Follmer, Roseann B. Termini

Journal of Food Law & Policy

Today, livestock farming is a far stretch from the nostalgic notion of animals grazing in green pastures, roaming free in the fresh country air and returning at the end of the day to a cozy barn. Simply stated, livestock farming is a large scale business, where tens of thousands of animals are swiftly raised industrial-style for maximum profit. Under the "factory farm" model, large corporate owned operations grow quantities of animals for slaughter for human consumption as food. In fact, livestock farms now raise 40% of all animals in the United States.

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, …

Peru's Too Expensive - I'Ll Get My Cheese From Chile: The Agricultural Market Access Provisions Of The U.S.-Chile Fta And The U.S.-Peru Tpa, Guillermo Gabriel Zorogastua

Florida State University Journal of Transnational Law & Policy

No abstract provided.

Outsourcing Drug Investigations To India: A Comment On U.S., Indian, And International Regulation Of Clinical Trials In Cross-Border Pharmaceutical Research, James Cekola

Northwestern Journal of International Law & Business

The traditional research and development model of large pharmaceutical companies is arguably unsustainable in current times. For example, estimated research and development costs increased as much as twelve percent over the last year while pharmaceutical sales grew only seven percent over the same period. Current estimates put the price to develop a new drug and bring it to market between $800 million and $1.5 billion per drug. These costs are increasing, driving large pharmaceutical companies to find more cost-effective research and development models. One cost-saving initiative is to globalize the system. In particular, companies have increasingly outsourced the required investigational …

To Achieve Closure Of The Hatch-Waxman Act's Loopholes, Legislative Action Is Unnecessary; Generic Manufacturers Are Able To Hold Their Own, Yana Pechersky

Cardozo Arts & Entertainment Law Journal

No abstract provided.

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy

ExpressO

Trade, economists and trade theorists advise, is a mutually beneficial exercise. Among this group, a particular set of advocates, claim that “Free Trade” is in the interest of all parties. As will be demonstrated, Free Trade is not truly “free” but an exercise of foreign policy and the implementation of policies favouring wealthy corporate interest groups. Free Trade is controlled by wealthy nations who have stacked the rules in favour of themselves, and in particular their corporate interests, and against the poor producers in poor nations. This control is used contrary to fairness, economic and ecological logic. Fair trade, by …

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Suppression Of Innovation Or Collaborative Efficiencies?: An Antitrust Analysis Of A Research & Development Collaboration That Led To The Shelving Of A Promising Drug, 5 J. Marshall Rev. Intell. Prop. L. 348 (2006), Saami Zain

UIC Review of Intellectual Property Law

This article discusses antitrust issues present in research and development collaborations between competitors. In particular, it illustrates that, although often very beneficial, these collaborations may have the potential for considerable harm via suppression of innovation. The article examines a recent case involving a collaboration to develop drugs, which arguably resulted in the suppression of a promising drug.

Paying For Delay: Pharmaceutical Patent Settlement As A Regulatory Design Problem, C. Scott Hemphill

Center for Contract and Economic Organization

Over the past decade, drug makers have settled patent litigation by making large payments to potential rivals who, in turn, abandon suits that (if successful) would increase competition. Because such "pay-for-delay" settlements postpone the possibility of competitive entry, they have attracted the attention of antitrust enforcement authorities, courts, and commentators. Pay-for-delay settlements not only constitute a problem of immense practical importance in antitrust enforcement, but also pose a general dilemma about the proper balance between innovation and consumer access.

This Article examines the pay-for-delay dilemma as a problem in regulatory design. A full analysis of the relevant industry-specific regulatory statute, …

Do Reverse Payment Settlements Violate The Antitrust Laws, Christopher M. Holman

Faculty Works

The term "reverse payment" has been used as shorthand to characterize a variety of diverse agreements between patent owners and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. Reverse payment settlements are particularly associated with drug patent challenges mounted by generic drug companies under the Hatch-Waxman Act. Many, including the Federal Trade Commission, would characterize these agreements as antitrust violations. However, courts have generally declined to find these agreements in violation of the antitrust laws based solely on the presence of a reverse payment.

This article begins in Section II with an …

Deadly Discounts: How Reimportation Jeopardizes The Safety Of The U.S. Pharmaceutical Drug Supply Under The Federal Trade Commission Amendment, Nicole C. Bates

ExpressO

The amendment to a Federal Trade Commission (FTC) reauthorization bill, previously introduced as Senate Bill 334 (S.334) Pharmaceutical Market Access and Drug Safety Act of 2005 allows for the reimportation of prescription drugs into the United States from approximately 25 countries, including Canada via Internet pharmacies. There are no guarantees that the internet websites advertising as Canadian pharmacies are legitimate. The shipping of pharmaceutical drugs occurs through importation, which refers to drugs produced abroad then later shipped to the U.S., or re-importation, a term applied when drugs are produced in the U.S. and exported for sale to foreign countries and …

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

Traceability And Labeling Of Genetically Modified Crops, Food, And Feed In The European Union, Margaret Rosso Grossman

Journal of Food Law & Policy

In the last several years, European Union (E.U.) policy has encouraged development of biotechnology, including genetically modified (GM) (that is, bioengineered) agricultural crops. The E.U. developed a strategy for life sciences and biotechnology, directed toward improving the competitiveness of the European biotechnology sector and the general situation for European biotechnology. E.U. documents have acknowledged the potential significance of genetically modified crops-for example, the conclusion in a recent report that "the potential of plant genomics and biotechnology to deliver major advances in our lifestyles and prosperity is enormous. [Biotechnology] can also maintain and enhance the competitiveness of E.U. farmers and food …

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

The purpose of this update is to present the main events that have taken place each six months in the food law sector in the European Union (E.U.). This presentation will cover June through December 2004, but is not exhaustive. This update will not include detailed discussions of regulations, such as authorizations of new additives for animal feed or registrations of new geographic names. Instead it will concentrate on fundamental topics and focus on food, which excludes from our scope questions regarding the management of agricultural products (Common Agricultural Policy, or CAP). However, some questions which legally pertain to the …