Food and Drug Law Commons^™

The Renewed Concern Over Soil Erosion: The Current Federal Programs And Proposals, Linda A. Malone

Linda A. Malone

Because soil erosion affects the quantity and quality of farmland, it is a matter of great concern for both the government and the farm industry. Whereas in the past concern was over the potential damage to productivity, concern is now being voiced over off-site damage and water pollution. There are numerous federal programs set up to fight soil erosion, but they are all voluntary, thereby making it difficult for the government to target funds. The author reviews the seriousness of the problem, looks at the numerous government programs, and then analyzes the Food Security Act of 1985—the first act to …

A Historical Essay On The Conservation Provisions Of The 1985 Farm Bill: Sodbustin, Swampbusting, And The Conservation Reserve, Linda A. Malone

Linda A. Malone

No abstract provided.

The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan

Srividhya Ragavan

This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents o n life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, …

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Srividhya Ragavan

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication

Fda Flip-Flops On Antibiotic Hazard, David A. Wirth

David A. Wirth

No abstract provided.

Fda On Food Additives And Salt, David A. Wirth

David A. Wirth

No abstract provided.

Reconciling The Lanham Act And The Fdca: A Comment On Chris Hurley’S Note, Christopher B. Seaman

Christopher B. Seaman

No abstract provided.

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more …

Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa

Ryan B. Stoa

The United States and Canada may be friends and allies, but the two countries' approaches to the regulation of marijuana agriculture have not evolved in tandem. On the contrary, their respective paths toward legalization and regulation of marijuana agriculture are remarkably divergent. In the United States, where marijuana remains a federally prohibited and tightly-controlled substance, legalization and regulation have remained the province of state legislatures and their administrative agencies for decades. In Canada, a succession of court cases paving the way toward medicinal marijuana use has prompted the federal government to develop a national framework committed to "legalize, regulate, and …

Marijuana Appellations: The Case For Cannabicultural Designations Of Origin, Ryan Stoa

Ryan B. Stoa

An appellation is a certified designation of origin that may also require that certain quality or stylistic standards be met. Appellations are most commonly associated with the wine industry, but they can be applied to any agricultural product for which the geographic origin carries importance. The MMRSA [California Medical Marijuana Regulation and Safety Act] … may have far-ranging effects on the marijuana industry in the United States. [A provision of the act permits the state Bureau of Medical Marijuana Regulation to ‘establish appellations of origin for marijuana grown in California.’] As the most populous state in the Union and the …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system …

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory …

Direct-To-Consumer Genetic Testing: Learning From The Past And Looking Toward The Future, Stephanie Bair

Stephanie Bair

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. These tests have been subject to only minimal regulation, despite the fact that scientists and policymakers have serious concerns about both the clinical effectiveness of the tests and the safety of releasing certain types of health information to the public without the supervision of a health care professional. Proponents of minimal regulation argue that the tests allow for patient autonomy and privacy of genetic information, …

Adjustments, Extensions, Disclaimers, And Continuations: When Do Patent Term Adjustments Make Sense?, Stephanie Plamondon Bair

Stephanie Bair

The United States patent system represents a measured trade-off between two competing policy considerations: providing sufficient incentives to encourage the innovation and development of new and socially useful inventions; and ensuring that such inventions are readily available to the public at an affordable price. Although the default patent term is now twenty years from filing, various features of, and changes to, the patent system over the years have allowed patent owners to extend the duration of their patent monopolies, sometimes for several years. Such extensions, though seemingly insignificant when compared to the full patent term, have an enormous impact on …

Impacts Of The Food Safety Modernization Act On On-Farm Food Safety Practices For Small And Sustainable Produce Growers, Aaron Adalja, Erik Lichtenberg

Aaron Adalja

We use data from a national survey of fruit and vegetable growers to examine the current prevalence and cost burden of food safety practices required in the proposed Produce Rule implementing the Food Safety Modernization Act. In particular, we analyze the influence of farm size and farming practices on the probability of adopting food safety measures that would be required by the Produce Rule; and we analyze how the costs of using those food safety practices vary by farm size and farm practices. Majorities of our respondents currently employ most of the food safety practices that would be required under …

Adoption And Coexistence Of Ge, Conventional Non-Ge, And Organic Crops, Aaron Adalja, Catherine Greene, James Hanson, Robert Ebel, Michael Barron

Aaron Adalja

The adoption of genetically engineered (GE) crop varieties by U.S. farmers is widespread for major crops—94 percent of planted acres for soybeans, and 88 percent for corn in 2012 (USDA-NASS 2012). The potential exists for GE crop production to impose costs on organic and conventional non-GE production via unintended presence of GE material along the supply chain through: • Contamination of seed stock • Accidental cross-pollination • Accidental co-mingling during planting, harvesting, handling, and storing of crops (Bullock and Desquilbet 2002). Maintaining the integrity of GE-differentiated product markets relies on segregation protocols such as: • Hybrid selection and seed purity …

Introduction: Marijuana Laws And Federalism, Erwin Chemerinsky

Erwin Chemerinsky

No abstract provided.

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Joanna K Sax

No abstract provided.

Memory And Punishment, O. Carter Snead

O. Carter Snead

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, …

The Current Scientific And Legal Status Of Alternative Methods To The Ld50 Test For Botulinum Neurotoxin Potency Testing, Sarah Adler, Gerd Bicker, Hans Bigalke, Christopher Bishop, Jörg Blümel, Dirk Dressler, Joan Fitzgerald, Frank Gessler, Heide Heuschen, Birgit Kegel, Andreas Luch, Catherine Milne, Andrew Pickett, Heidemarie Ratsch, Irmela Ruhdel, Dorothea Sesardic, Martin Stephens, Gerhard Stiens, Peter D. Thornton, René Thürmer, Martin Vey, Horst Spielmann, Barbara Grune, Manfred Liebsch

Martin Stephens, PhD

No abstract provided.

Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa D. Mortazavi

Melissa Mortazavi

No abstract provided.

Geographical Indications, Food Safety, And Sustainability Challenges And Opportunities, David A. Wirth

David A. Wirth

Incumbent Landscapes, Disruptive Uses: Perspectives On Marijuana-Related Land Use Control, Donald J. Kochan

Donald J. Kochan

Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled

Yaniv Heled

No abstract provided.

European Court Of Justice Rules In Favour Of Greater Transparency In Accessing Efsa Data, Luis González Vaqué

Luis González Vaqué

This commentary looks at an interesting judgment by the European Court of Justice (ECJ) on 16 July. The judgment relates to plant protection products, but as it seeks to achieve levels of transparency capable of overcoming the lack of trust towards the European Food Safety Authority (EFSA) - often accused of being biased for using experts with vested interests because of their industry associations - it may also be relevant to the food sector, given that the EFSA deals with many authorization procedures, opinions, etc. related to food products.

Resumen de la conferencia pronunciada el 10.11.2015 en San Cugat del …

Legal Risk Management In Online Sales Of Food And Wine, Dan Svantesson

Dan Svantesson

Most businesses have an online presence, but an online presence brings a legal risk exposure. The extent and type of risks that businesses expose themselves to vary depending on the industry as well as how they structure their online presence. This article examines a selection of legal risks facing businesses engaging in online sales and marketing of food and wine products. It also presents strategies for managing those risks.

The Jurisprudence Of Nature: The Importance Of Defining What Is "Natural", Jill M. Fraley

Jill M. Fraley

Informal regulations defining nature, natural, and organic have proliferated across diverse fields of law from patents to agriculture, from taxation to gemstones. The unwritten jurisprudence of defining nature is primarily a story of the struggle to isolate mankind’s manipulations and interventions, creating a man-nature dichotomy that frustrates more than it explicates. This failure to define nature continues with the Supreme Court’s recent Myriad decision, which struggles to define the law of nature exception to patentability, highlighting the challenge of measuring levels of human intervention and manipulation. Our dichotomous definitions do not generate neat, binary answers, but rather complicated scales of …

Regulatory Competitive Shelters, Yaniv Heled

Yaniv Heled

This Article identifies an array of seemingly disparate federal exclusivity regimes as belonging to an increasingly prevalent and relatively new class of highly valuable government benefits, which it names “regulatory competitive shelters” (RCSs). It characterizes RCSs and distinguishes them from other, more traditional kinds of government-instituted properties. The Article then proceeds to describe a particular brand of RCSs established in federal statutory frameworks whose aim—much like patents—is to create incentives for technological innovation. Identifying several common motifs of such RCS regimes, the Article offers a taxonomy of these RCSs and describes the mechanisms by which RCSs instituted under such regimes …