Food and Drug Law Commons^™

An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao

Brooklyn Journal of International Law

In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …

High Time For A Change: How The Relationship Between Signatory Countries And The United Nations Conventions Governing Narcotic Drugs Must Adapt To Foster A Global Shift In Cannabis Law, Alexander Clementi

Brooklyn Journal of International Law

Since the early 1970’s, the inclusion of cannabis and its byproducts in the United Nations Single Convention on Narcotic Drugs has mandated a strict prohibition on cultivation and use of the substance, which has led to a largely global practice of criminalization and imprisonment of anyone found to be in its possession. Yet recently, mostly in response to growing public health concerns, countries like Uruguay, Portugal, The Netherlands, Canada, and the United States have enacted laws which seek to decriminalize or even legalize cannabis use and possession. Yet, cannabis remains classified as a Schedule IV narcotic under the Single Convention, …

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.

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 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.

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.

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 …

2016 China Food Law Update, Michael T. Roberts, Ching-Fu Lin

Journal of Food Law & Policy

This update of China food law builds on a unique feature for the Journal of Food Law .& Policy that has been provided since the Journal's inception - separate food law updates for both the United States and European Union. "Recognizing the globalness of the modem food system, these updates have served an invaluable role in keeping scholars and practitioners abreast of the world's leading food regulatory systems." China's emergence as a developed, modem food regulatory system with the potential of being a leading food regulatory system makes sense given its position as a world economic powerhouse. China's role in …

Moving Towards Harmonization Of The Food Safety Standards: Role Of The Tpp And Ttip Agreements, Ksenia A. Petrovets

Journal of Food Law & Policy

We are now less dependent on locally available food resources that we have ever been. The continuing industrialization of food production, the advancement in technologies and the rapid development of supply chains granted us the luxury of immediate access to a variety of products originating from local supermarkets all over the world. This, along with the greater level of food production industrialization, inevitably comes the rise of related food safety risks. Because of the enlargement of producing operations, an emerging safety threat in one place may result in a foodborne illness outbreak thousands of miles away from its place of …

A Paper Tiger? Prosecutorial Regulators In China’S Civil Environmental Public Interest Litigations, Chunyan Ding, Huina Xiao

Fordham Environmental Law Review

In July 2015, China’s national legislature brought in prosecutor-led civil environmental public interest litigation (“EPIL”) for thirteen selected provincial areas of the country. After a two-year legal experiment, this prosecutor-led civil EPIL system was then established nationwide in July 2017. Yet, can it be said that prosecutorial regulators in China are in fact a paper tiger? Drawing upon content analysis of the 655 prosecutor-led civil EPILs and in-depth interviews with twelve frontline prosecutors and judges, this article examines the dynamics of regulatory practice and the motivation of the Chinese prosecutorial organs to engage in environmental regulation through litigation. Based upon …

Environmental Racism: Using Environmental Planning To Lift People Out Of Poverty, And Re-Shape The Effects Of Climate Change & Pollution In Communities Of Color,, William C.C. Kemp-Neal

Fordham Environmental Law Review

In the mid-1900s the United States began to see a rise in concern for environmental awareness issues. In the early days the movement focused on things like clean air, water and pollution but by the 1970s-1990s many prominent environmental awareness groups began to form focused on the idea that in order to avert climate change the principal goal needed to be to reduce global greenhouse gas emissions. In 1987 a report was released called Toxic Waste and Race, which outlined an intimate link between the placement of environmental hazardous waste sites in communities of color, and greater instances of polluted …

Squaring The Cercla: Superfund And The Superfund Task Force, Manny Marcos

Fordham Environmental Law Review

The Superfund Task Force recently released its final report on the implementation of its recommendations for improving the Superfund program. The Task Force was given five goals for improving the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (“CERCLA’s”), implementation. These goals are to expedite cleanup and remediation, re-invigorate responsible party cleanup and reuse, encourage foreign investment, promote redevelopment and community revitalization, and engage with partners and stakeholders. While the Task Force’s recommendations have improved CERCLA’s implementation, many of CERCLA’s structural flaws remain intact. Specifically, CERCLA still has a severe shortage of funding, an unfair liability scheme, perverse incentives, …

The Yoga Analogy: Scaling-Up The U.S.’S Renewable Energy Sector Mindfully With New Technologies, Evolving Standards, Public Buy-In, Data Sharing, And Innovation Clusters, Kimberly E. Diamond

Fordham Environmental Law Review

This paper focuses on innovative renewable energy devices, exploring how scientifically-based industry standards that continuously evolve with engineering design technology, the public’s buy-in and feeling of connectedness with groundbreaking devices, and innovation clusters that accelerate device development through data sharing and public-private partnerships can all help advance the U.S.’s domestic renewable energy industry.

Part I analyzes challenges inherent to scaling- up novel renewable energy technologies while simultaneously developing the industry standards regulating them. Part II uses the Block Island Wind Farm, an offshore wind demonstration project, and Pavegen’s globally-deployed arrays of piezoelectric smart flooring tiles as examples illustrating the importance …

Climate Change, Competition & Conflict Along The River Nile: The Great Ethiopian Renaissance Dam & Shifting Customary International Water Law, Salma Shitia

Fordham Environmental Law Review

Decade-long negotiations between the Arab Republic of Egypt and the Federal Democratic Republic of Ethiopia surround the decision to build the hydroelectric power plant along the River Nile. For much of Ethiopia, the Grand Ethiopian Renaissance Dam represents a beacon of prosperity. For countless Egyptians, the structure embodies a potential catastrophe. Grounded in threats of displacement for Egyptian agricultural communities, some have compared the Grand Ethiopian Renaissance Dam crisis to disasters culminating in mass migration.

This battle for natural resource access has intensified as climate change exacerbates the region’s dire conditions. Specifically, exhaustible resource allocation amid climate change indicates that …

Beyond Equity: Shared Natural Resources And Human Rights, Criminal Law, And The Use Of Force, Eian Katz

Fordham Environmental Law Review

Transboundary resource disputes are often analyzed by reference to two nebulous and conflicting principles that have emerged in international environmental law: “equitable and reasonable utilization” and “no significant harm.” Frequently overlooked in this context is the potential value of other canons of international law—especially human rights law, criminal law, and the rules governing the use of force—in adding definition to the muddled contours of these foundational precepts. This Article therefore undertakes an assessment of sovereign rights and obligations regarding shared natural resources which arise from these other bodies of law. In doing so, it offers new lenses through which to …

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 …

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 …

Revising Seed Purity Laws To Account For The Adventitious Presence Of Genetically Modified Varieties: A First Step Towards Coexistence, A. Bryan Endres

Journal of Food Law & Policy

Adoption of genetically modified (GM) seed varieties in the United States, Canada, and South America continues to expand, with GM crops comprising almost 76 million hectares and over 93 percent of the total biotech cropland worldwide. As an increasing number of farmers plant GM varieties, the potential for adventitious mixture of genetically modified DNA with products produced via organic and conventional (non-GM) methods also increases. Many consumers of organic and identity-preserved products, however, object to the adventitious presence of genetically modified DNA at even low levels. Accordingly, the ability of farmers to choose between conventional, organic, or GM crop production …

Do European Union Non-Tariff Barriers Create Economic Nuisances In The United States?, Thomas P. Redick, Michael J. Adrian

Journal of Food Law & Policy

The European Union's new traceability system for biotech crops will lead to the proliferation of non-tariff barriers affecting biotech crops. This, in turn, will lead to economic dislocation and attendant liability in the United States, which is losing billions of dollars in export trade. A chain of complex legal problems will arise for United States-based companies as they strive to trace particular genetically modified (GM) events and avoid commingling. The European Union (E. U) tracing law for biotech crops applies at each stage of commodity commerce, from grain shippers leading back through elevators, growers, and seed companies. Warranty liability could …

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 …

Trademarks, Gis, And Commercial Aspects Of Wine Distrubtion 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.

The U.S. Dairy Industry In The 20th And 21st Century, George B. Frisvold

Journal of Food Law & Policy

At the beginning of the 20th Century, the U.S. dairy industry was comprised of millions of small-scale operations producing for their own or for very local consumption. By the end of the 20th Century, the industry was dominated by large-scale producers marketing products via large cooperatives. Improvements in transportation, advances in animal breeding and feeding technologies, and scale economies have allowed the industry to be more competitive on global markets, where there is now active international trade in dairy products. Major government programs to support dairy farm income date back to Depression-era problems facing the industry. Federal programs to support …

Covid-19 Impacts: How A Global Pandemic Amid The Sunsets Of The Ptc And Itc Made The U.S. Wind And Solar Industries More Resilient, Kimberly E. Diamond

Fordham Environmental Law Review

A cataclysmic event is sometimes the necessary catalyst for companies within certain industries to re- examine, radically shift, and replace their standard practices with technologically-advanced alternatives. In the United States, the occurrence of the Coronavirus pandemic (“COVID-19”) during the sunsets of the Production Tax Credit (“PTC”) and the Investment Tax Credit (“ITC”) created a unique confluence of factors that produced a perfect storm tantamount to such a cataclysmic event for companies in the wind and solar industries, particularly developers. Over the years, the domestic utility-scale wind industry has come to rely heavily upon the PTC, while the domestic utility- scale …

Illegal Discharge: Exploring The History Of The Criminal Enforcement Of The U.S. Clean Water Act, Dr. Joshua Ozymy, Dr. Melisssa L. Jarrell

Fordham Environmental Law Review

The criminal prosecution of defendants that violate federal clean water laws has been ongoing for roughly four decades. Yet, we continue to have a poor understanding of how federal prosecutors use the U.S. Clean Water Act (“CWA”) to charge and prosecute criminals and the outcomes of those prosecutions. We use content analysis to analyze 2,588 federal criminal prosecution case summaries, 1983-2019, to gain a better historical understanding of how the CWA has been used as a prosecutorial tool, to bring out the major themes in the prosecutions, and quantify sentencing outcomes. Findings from the 828 CWA prosecutions undertaken during this …

Red Tide: A Blooming Concern For Florida Manatees, Shannon Price Esq.

Fordham Environmental Law Review

Although red tides are a common and natural occurrence around the coast of Florida, within the last few decades they have intensified and become much more deadly. Several identifiable human-caused factors exacerbate the size, concentration, and duration of the harmful algae bloom and disturb the environment’s natural balance. The Florida Gulf Coast provides all the algae’s necessary requirements for survival, the perfect storm to create a resilient super bloom that annihilates its host ecosystem.

This article explains the plight of Florida manatees who, like other marine animals and plants, are being injured or killed by this algae crisis. It also …

"Eco" Your Own Way: An Argument For State-Specific Climate Change Legislation, Amanda Voeller

Fordham Environmental Law Review

The consequences of climate change seriously and immediately threaten the American way of life, but proposed federal legislation like the Green New Deal is overly broad, unrealistic, and inefficient. The most effective way for the United States to combat climate change is not with a one-size-fits-all plan like the Green New Deal, but with federal legislation that incentivizes states and cities to enact and enforce individualized, local climate legislation. Different states and cities have different climates, available energy sources, and transportation needs, so the federal government should use financial incentives to encourage states and cities to pass tailor-made bills and …

The Use Of Regular Militaries For Natural Disasters After A Major Event Where The Military Was Seen As A Failure - The Somalia Effect In The Age Of Black Lives Matters And Covid-19, Donald D.A. Schaefer

Fordham Environmental Law Review

This is written as a continuation of Dr. Schaefer’s recent article entitled, “The Use of the Regular Militaries for Natural Disaster Assistance: Climate Change and the Increasing Need for Changes to the Laws in the United States, China, Japan, the Philippines, and Other Countries.” 2 Perhaps few other areas have affected so many people than the Covid-19 pandemic. Coupled with this has been the struggle over the use of force by the military and police in the age of “black lives matters” and the movements that have been transpired as a result. With the increased global warming likely to continue …

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

On March 31, 2006, the European Commission published Council Regulation (EC) No. 510/2006 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs. This new regulation repealed Council Regulation (EEC) No. 2081/92 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs mainly to bring Community law into conformity with the World Trade Organization (WTO) agreements and the findings of a recent WTO panel. Under the new Regulation, persons in third countries (non-European Union members) are entitled to address applications for the protection of geographic names and statements of objection …

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.

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 2008. This update primarily analyzes regulatory and policy developments by the federal government. This focus reflects the significance of federal activities in the food policy realm. As this is the first Canadian update to appear in the Journal of Food Law & Policy, it is appropriate to include a brief summary of the Canadian regulatory framework for food. The regulatory framework provides the necessary context to identify trends driving recent changes in Canadian food law and policy.