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Food and Drug Law

2018

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The Carbon Tax Vacuum And The Debate About Climate Change Impacts: Emission Taxation Of Commodity Crop Production In Food System Regulation, Gabriela Steier Dec 2018

The Carbon Tax Vacuum And The Debate About Climate Change Impacts: Emission Taxation Of Commodity Crop Production In Food System Regulation, Gabriela Steier

Pace Environmental Law Review

The scientific consensus on climate change is far ahead of U.S. policy on point. In fact, the U.S. has a legal vacuum of carbon taxation while climate change continues to impact the codependence of agriculture and the environment. As this Article shows, carbon taxes follow the polluter-pays model, levying taxes on the highest greenhouse gas (“GHG”) emissions—and contributions to climate change. But this is not only unsustainable; it would also undermine agricultural production and, thus, food security. This Article describes how the law can regulate climate change contributions and promote adaptation and mitigation supported through carbon taxes in the agricultural …


Food Sustainability In The Age Of Complex, Global Supply Chains, Steph Tai Dec 2018

Food Sustainability In The Age Of Complex, Global Supply Chains, Steph Tai

Arkansas Law Review

Food production has become more complex over time. Moreover, we are producing food in an increasingly global, rather than local, manner. How can demands for sustainability be reinforced in this age of complex, global supply chains? This essay focuses on three key features of the modern food supply chain: the variety of components, the complexity of the chain itself, and diversity of “enforcement” mechanisms in food production supply chains. These features suggest that traditional governmental tools (such as command and control measures) and contractual tools (such as performance standards) may not be sufficient to ensure sustainable production methods.


Tying The Knot: An Interdisciplinary Approach To Understanding The Human Right To Adequate Nutrition, Jessica Fanzo, Kaitlin Y. Cordes, Elizabeth F. Fox, Anna Bulman Dec 2018

Tying The Knot: An Interdisciplinary Approach To Understanding The Human Right To Adequate Nutrition, Jessica Fanzo, Kaitlin Y. Cordes, Elizabeth F. Fox, Anna Bulman

Columbia Center on Sustainable Investment Staff Publications

Malnutrition is alarmingly prevalent, affecting one in three people worldwide. In this Article, we argue that a key reason the global community has been unsuccessful in combating malnutrition is a lack of clarity outside the field of nutrition regarding the true meaning of “nutrition.” In particular, this has limited the effectiveness of international human rights law as a mechanism for addressing malnutrition.

In this interdisciplinary Article, which draws from both the legal and nutrition fields, we unpack the meaning of nutrition and demonstrate that a standalone right to adequate nutrition does indeed exist in international human rights law as a …


Selling Fish To Restaurants And The Public: A Fisher's Guide, Marine Affairs Institute, Roger Williams University School Of Law, Brynae Riggins Dec 2018

Selling Fish To Restaurants And The Public: A Fisher's Guide, Marine Affairs Institute, Roger Williams University School Of Law, Brynae Riggins

Sea Grant Law Fellow Publications

No abstract provided.


Ethical Cannabis Lawyering In California, Francis J. Mootz Iii Dec 2018

Ethical Cannabis Lawyering In California, Francis J. Mootz Iii

St. Mary's Journal on Legal Malpractice & Ethics

Cannabis has a long history in the United States. Originally, doctors and pharmacists used cannabis for a variety of purposes. After the Mexican Revolution led to widespread migration from Mexico to the United States, many Americans responded by associating this influx of foreigners with the use of cannabis, and thereby racializing and stigmatizing the drug. After the collapse of prohibition, the federal government repurposed its enormous enforcement bureaucracy to address the perceived problem of cannabis, despite the opposition of the American Medical Association to this new prohibition. Ultimately, both the states and the federal government classified cannabis as a dangerous …


Sb 17 - Alcoholic Beverages, Lauren A. Newman, Erin N. Winn Dec 2018

Sb 17 - Alcoholic Beverages, Lauren A. Newman, Erin N. Winn

Georgia State University Law Review

Georgia law previously allowed counties and municipalities to permit the sale of alcoholic beverages on Sundays from 12:30 P.M. until 11:30 P.M. This Act, deemed “the Brunch Bill,” authorizes the counties and municipalities that have affirmatively voted by referendum to sell alcoholic beverages on Sundays to sell them earlier, at 11:00 A.M., if approved by a second referendum vote. This change applies to restaurants that make at least 50% of their revenue from the sale of food and hotels, and Georgia wineries.


Unrealistic Expectations: The Federal Government's Unachievable Mandate For State Cannabis Regulation, Rebecca Sweeney Dec 2018

Unrealistic Expectations: The Federal Government's Unachievable Mandate For State Cannabis Regulation, Rebecca Sweeney

Washington Law Review

The states that have legalized cannabis maintain a complicated relationship with the federal government. Since the Ogden Memorandum was issued in 2009, the federal government has left regulation of cannabis to the discretion of the states. That policy has recently shifted. In 2018, former U.S. Attorney General Jeff Sessions issued a new memorandum that rescinded guidance for states about how to structure the legalization of cannabis. The federal government’s current position is now ideologically aligned with that of states like Nebraska and Oklahoma. These states chose not to legalize cannabis and instead adhere to the Controlled Substances Act’s classification of …


The Crazy Maze Of Food Labeling And Food Claims Laws, Patrick Meyer Nov 2018

The Crazy Maze Of Food Labeling And Food Claims Laws, Patrick Meyer

St. John's Law Review

(Excerpt)

This Article critiques the role of the FDA in providing consumers with accurate and relevant food label information, identifies impediments in the pursuit of its mission, and offers solutions to those impediments.

Part I of this Article traces the history of U.S. food labeling and health claims laws. Current food laws and their regulation have developed over time. The first federal legislation was passed in the early 1900s. The food laws of today have certainly been influenced by past food laws, which were largely a reaction to societal events. A brief summary of the historical development of our nation’s …


The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan Nov 2018

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, …


Peacebuilding Through Food Recovery, Angela Hackstadt Nov 2018

Peacebuilding Through Food Recovery, Angela Hackstadt

University Libraries Faculty Scholarship

The United States wastes approximately 133 billion pounds of food annually while 15 million American households are food insecure. Current and proposed U.S. legislation attempts to encourage food recovery efforts to address both of these problems by incentivizing donation of surplus foods by businesses to charitable organizations, yet legislation has failed to deliver. Food insecure individuals who use food banks or other safety net programs are often required to provide personal information and are subject to scrutiny in the process of acquiring food. Information can be leveraged in different ways to stigmatize or marginalize those in need. This presentation discusses …


The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski Oct 2018

The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski

Faculty Scholarship

No abstract provided.


The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy Oct 2018

The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy

Michigan Business & Entrepreneurial Law Review

In this Article, I argue that drug companies have created a highly profitable but dangerous business model by employing the same legal tactics as the nineteenth-century “robber barons,” the group of financiers who orchestrated corporate law’s infamous race to the bottom. Like these historical financiers, drug company executives have captured the legal apparatus and regulatory bodies that oversee them. In so doing, they have transformed the law from a system of governance into a set of enabling doctrines. The pharmaceutical industry has turned legislation intended to protect the public into a legal justification for marketing ineffective and unsafe prescription drugs. …


Life Cycle Costing And Food Systems: Concepts, Trends, And Challenges Of Impact Valuation, Katherine Fiedler, Steven Lord, Jason J. Czarnezki Oct 2018

Life Cycle Costing And Food Systems: Concepts, Trends, And Challenges Of Impact Valuation, Katherine Fiedler, Steven Lord, Jason J. Czarnezki

Michigan Journal of Environmental & Administrative Law

Our global food systems create pervasive environmental, social, and health impacts. Impact valuation is an emerging concept that aims to quantify all environmental, social, and health costs of food systems in an attempt to make the true cost of food more transparent. It also is designed to facilitate the transformation of global food systems. The concept of impact valuation is emerging at the same time as, and partly as a response to, calls for the development of legal mechanisms to address environmental, social, and health concerns. Information has long been understood both as a necessary precursor for regulation and as …


Agricultural Investments Under International Investment Law, Jesse Coleman, Sarah Brewin, Thierry Berger Oct 2018

Agricultural Investments Under International Investment Law, Jesse Coleman, Sarah Brewin, Thierry Berger

Columbia Center on Sustainable Investment Staff Publications

International investment law, based primarily on international investment treaties, plays an important role in the governance of investment in agriculture, forestry, and fishing. The obligations established by these treaties, and enforced by means of investor–state arbitration, can present challenges for policy-makers and others seeking to ensure that investments are sustainable, including by affecting the ways in which the costs and benefits of investments are distributed among different actors.

CCSI partnered with the International Institute for Environment and Development (IIED) and the International Institute for Sustainable Development (IISD) to produce a briefing note on agricultural investments under international investment law. The …


Life Cycle Costing And Food Systems: Concepts, Trends, And Challenges Of Impact Valuation, Jason J. Czarnezki Oct 2018

Life Cycle Costing And Food Systems: Concepts, Trends, And Challenges Of Impact Valuation, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Our global food systems create pervasive environmental, social, and health impacts. Impact valuation is an emerging concept that aims to quantify all environmental, social, and health costs of food systems in an attempt to make the true cost of food more transparent. It also is designed to facilitate the transformation of global food systems. The concept of impact valuation is emerging at the same time as, and partly as a response to, calls for the development of legal mechanisms to address environmental, social, and health concerns. Information has long been understood both as a necessary precursor for regulation and as …


Paper Promises For Drug Innovation, Erika Lietzan Oct 2018

Paper Promises For Drug Innovation, Erika Lietzan

Faculty Publications

Innovation does not stop when a new medicine is launched. Development of new uses for already approved drugs, in particular, can make profound contributions to the public health. Whether a new use is suspected during the initial premarket trials, identified through focused research after approval, or discovered serendipitously by physicians treating patients, however, it requires extensive clinical testing before it can be approved by FDA. This testing takes time and money — three to five years on average, and as much as $300 million. This Article considers the incentives that federal law offers to companies to make this investment: patent …


Swimming Upstream: The Need To Resolve Inconsistency In The Fda's Fishy Regulatory Scheme, Kelsie Kelly Oct 2018

Swimming Upstream: The Need To Resolve Inconsistency In The Fda's Fishy Regulatory Scheme, Kelsie Kelly

Journal of Law and Policy

The citizens of the United States rely on the federal government to maintain the safety of their food through effective regulation. As the technology used to develop food has advanced, the outermost limits of the current regulatory framework are being tested. The result has been a circuitous and ineffective attempt to regulate transgenic organisms, intended for human consumption, using multiple agencies and a patchwork of laws. The ability to incorporate DNA from nearly any organism into the genome of another provides immense potential for innovative new food products, but may also allow for unintended health and environmental consequences. Proper regulation …


Reversal Of Fortune: Moving Pharmaceuticals From Over-The-Counter To Prescription Status?, Lars Noah Oct 2018

Reversal Of Fortune: Moving Pharmaceuticals From Over-The-Counter To Prescription Status?, Lars Noah

Villanova Law Review

No abstract provided.


Preventing Drug-Related Deaths At Music Festivals: Why The "Rave" Act Should Be Amended To Provide An Exception For Harm Reduction Services, Robin Mohr Sep 2018

Preventing Drug-Related Deaths At Music Festivals: Why The "Rave" Act Should Be Amended To Provide An Exception For Harm Reduction Services, Robin Mohr

Chicago-Kent Law Review

No abstract provided.


Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs Sep 2018

Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs

Articles

Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.


A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch Sep 2018

A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch

Seattle University Law Review

The patent system in the United States was forever changed with the introduction of the Leahy-Smith America Invents Act (AIA) in September of 2011. The AIA brought sweeping changes to American patent law in order to align the U.S. with much of the rest of the world by changing the invention priority from a “first to invent” to a “first to file” system. The first section of this note will provide a brief overview of the substance of inter partes reviews and some of the most critical negatives that have become apparent since 2013. The second section of this Note …


It Is Not About The Drugs: A Comparative And Contextual Analysis Of Singapore And European Approach To Drug Issues, Rathna N. Korman Sep 2018

It Is Not About The Drugs: A Comparative And Contextual Analysis Of Singapore And European Approach To Drug Issues, Rathna N. Korman

Research Collection Yong Pung How School Of Law

This article aims to establish that Singapore’s drug policy and approach though not in tandem, is consistent with the elements espoused in the harm reduction approach advocated by the Global Commission on drug policies. The Commission takes the position that drug control nationally has to be aligned with the sustainable development goals agenda approved by the member states in 2015. It has recommended abolishing death penalty for all drug related offences, decriminalizing drug possession and cultivation for personal consumption, implementing non-penal sanctions for all low level drug offenders, and exploring non-penal regulatory models following decriminalization. There is a paradigm shift …


Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 4, Richard Thompson Ainsworth, Brendan Magauran Aug 2018

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 4, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

This is the fourth of a five-part series dealing with the rescission by U.S. Attorney General Jeff Sessions of the Obama-era policy that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases.

This article focuses on retail-level frauds. It proposes a limited purpose crypto currency. At the retail level the MJ Freeway or METRC software essentially functions as a marijuana-industry-specific point of sale (POS) system. It is common in retail for different industry sectors (restaurants, hotels, convenience stores, or gasoline stations) to have market-specific POS systems that are molded to fit the unique characteristics of …


Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 2, Richard Thompson Ainsworth, Brendan Magauran Aug 2018

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 2, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

Legalization of marijuana burdens the States with the responsibility of (a) monitoring the physical flows of marijuana through the supply chain (making sure the marijuana does not enter inter-state commerce; making sure it stays out of the hands of minors, etc.), and (b) monitoring the fiscal flows (making sure the proceeds of marijuana production do not end up in criminal hands).

The type of controls favored by the states are track and trace (TAT), or seed-to-sale (STS) systems. These systems are reasonably complex, as well as technology-intensive. Nevertheless, there are questions about whether they are adequate to the enforcement needs. …


Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 5, Richard Thompson Ainsworth, Brendan Magauran Aug 2018

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 5, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

This is the fifth part of a five-part series dealing with the rescission by U.S. Attorney General Jeff Sessions of the Obama-era policy that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases.

This article focuses on the back-end leakage in the state’s obligation to control both the physical flows of legalized marijuana, as well as the related fiscal flows (the proceeds of legalized marijuana sales). These flows intersect dramatically in retail-level frauds.

There are very few new proposals on how to solve the physical flow problems with consumer re-sales into the black market. Traditional …


Commentary On The Investigation: The April 20, 2001 Peruvian Shootdown Accident, Ibpp Editor Aug 2018

Commentary On The Investigation: The April 20, 2001 Peruvian Shootdown Accident, Ibpp Editor

International Bulletin of Political Psychology

This article critiques an investigative report officially intended (1) to establish the facts and circumstances contributing to the April 20, 2001 interdiction of a United States (US) missionary floatplane and the death of two US citizens and (2) to make recommendations to minimize another such accident. The report was issued by the US Department of State Bureau for International Narcotics and Law Enforcement Affairs.


Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 1, Richard Thompson Ainsworth, Brendan Magauran Aug 2018

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 1, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

On January 4, 2018, the Trump Administration through Attorney General Sessions rescinded an Obama-era policy1 that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases under the federal Controlled Substances Act,2 as well as under the Bank Secrecy Act.3 Federal law is at odds with state law in the majority of states on the legalization and subsequent state taxation of marijuana.4 Twenty-eight states and the District of Columbia have at least partially legalized marijuana. Eight of these states have legalized both medicinal and recreational use.5 With limited exceptions, legalized sales of marijuana are taxed.

We …


The Overdose/Homicide Epidemic, Valena E. Beety Aug 2018

The Overdose/Homicide Epidemic, Valena E. Beety

Georgia State University Law Review

This Article explores the lack of regulation of coroners, concerns within the forensic science community on the reliability of coroner determinations, and ultimately, how elected laypeople serving as coroners may influence the rise in drug-induced homicide prosecutions in the midst of the opioid epidemic.

This Article proposes that the manner of death determination contributes to overdoses being differently prosecuted; that coroners in rural counties are more likely to determine the manner of death for an illicit substance overdose is homicide; and that coroners are provided with insufficient training on interacting with the criminal justice system, particularly on overdose deaths. Death …


Drug Approval In A Learning Health System, W. Nicholson Price Jul 2018

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …


The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan Jul 2018

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

Faculty Scholarship

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, …