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Full-Text Articles in Food and Drug Law

A “Natural” Stand Off Between The Food And Drug Administration And The Courts: The Rise In Food-Labeling Litigation & The Need For Regulatory Reform, Amy-Lee Goodman Jan 2019

A “Natural” Stand Off Between The Food And Drug Administration And The Courts: The Rise In Food-Labeling Litigation & The Need For Regulatory Reform, Amy-Lee Goodman

Boston College Law Review

Faced with the health and financial toll from escalating rates of chronic disease, consumers are demanding healthier food products and increased transparency regarding the ingredients in their food. Food labels provide the primary means for businesses to communicate with customers about their food products. In response to consumer demand, food companies are stocking grocery store shelves with products claiming to be wholesome, “natural” and healthy. Yet, many of these products are not as healthy or natural as purported. Although both consumers and food manufacturers place importance on the term “natural,” the Food and Drug Administration has refused to define the ...


Advancing The Aquaculture Industry Through The Federal Crop Insurance Program, Matthew H. Bowen Jan 2019

Advancing The Aquaculture Industry Through The Federal Crop Insurance Program, Matthew H. Bowen

Ocean and Coastal Law Journal

In recent times, the aquaculture industry has experienced dramatic growth. The growth of the industry is a direct result of an increase in demand for seafood, and a decrease in supply from wild fisheries. The industry, however, is also experiencing growing pains. Aquaculture species, compared to their wild counterparts, are at a higher risk of catastrophic loss from a variety of different perils. These perils make investment in the aquaculture industry significantly risky. The federal crop insurance program could be a tool that mitigates these risks, but the program was designed around terrestrial agriculture, and while aquaculture may be covered ...


Pacta Sunt Servanda State Legalization Of Marijuana And Subnational Violations Of International Treaties: A Historical Perspective, Brian M. Blumenfeld Jan 2019

Pacta Sunt Servanda State Legalization Of Marijuana And Subnational Violations Of International Treaties: A Historical Perspective, Brian M. Blumenfeld

Pepperdine Law Review

In November 2012, voters in the states of Colorado and Washington passed ballot initiatives to legalize recreational marijuana industries. Since then, eight additional states and the District of Columbia have followed suit, and many more have seen legalization debates in their legislative halls and among their electorates. Over twenty bills recently introduced in Congress have sought to break federal marijuana laws away from prohibition. Although the national debate is indeed a vibrant one, it has neglected to address how legalization may be jeopardizing the compliance status of the United States under international drug treaties, and what the consequences may be ...


Rohrabacher-Blumenauer Amendment, Case Law And The Department Of Justice: Who Prevails In The Medical Marijuana Legalization Debate?, Florence Shu-Acquaye Dec 2018

Rohrabacher-Blumenauer Amendment, Case Law And The Department Of Justice: Who Prevails In The Medical Marijuana Legalization Debate?, Florence Shu-Acquaye

Florence Shu-Acquaye

No abstract provided.


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 ...


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.


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 ...


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 ...


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.


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.


The Uneasy Case For Patent Law, Rachel E. Sachs Dec 2018

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study ...


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 ...


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.


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 ...


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.


Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams Oct 2018

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid ...


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

Pace 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 ...


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.


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 ...


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 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 ...


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

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


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 ...


Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak Jul 2018

Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak

Pace Environmental Law Review

The FDA does not conduct pre-market review of chemicals contained in cosmetics—which encompasses not only makeup but also numerous personal care products including shampoo, lotion, perfume, aftershave, and shaving cream. Every day, consumers use cosmetic products that contain a variety of synthetic ingredients, none of which the FDA has approved for safety but each of which are being ingested, absorbed, and inhaled into our bodies and accumulating in our tissue. Many of these products contain endocrine disrupting chemicals (“EDCs”), which emerging research links to an increased risk of cancer as well as immune and neurological dysfunction. This Article examines ...


Food Localization: Empowering Community Food Systemsthrough The Farm Bill, Brian Albert Fink, Alexandra Oakley Schluntz, Joshua Ulan Galperin Jul 2018

Food Localization: Empowering Community Food Systemsthrough The Farm Bill, Brian Albert Fink, Alexandra Oakley Schluntz, Joshua Ulan Galperin

Journal of Food Law & Policy

More diverse and value-driven public engagement has transformed the American food system. This engagement has changed the behavior of industries, consumers, policymakers, and communities. At the heart of this change is the drive among countless individuals and organizations to promote a wider variety of food choices and shape the food system in harmony with their values. Despite the local and sovereign nature of this engagement, federal food and agricultural policies have contributed substantially to this transformation of the American food system. In isolation, many of these policies support discrete programs and individuals. In the aggregate, these policies strengthen different facets ...


The End Of The Ramen Diet:Higher Education Students And Snap Benefits, Erika M. Dunyak Jul 2018

The End Of The Ramen Diet:Higher Education Students And Snap Benefits, Erika M. Dunyak

Journal of Food Law & Policy

Americans joke that college students have so little money that they subsist on 10 cent packs of ramen. Statistically, college students face much higher rates of food insecurity than the general population and the situation is particularly dire for students of color. Much has been written on this area in recent months and years and many commentators are seeking to denormalize poverty, hunger, and the “freshman 15” on campuses. This article will look to a solution for this hungry and often neglected population. In 2010, the Health, Hunger-Free Kids Act (HHFKA) reauthorized the Federal School Lunch Program. HHFKA contained several ...


Strengthening The National Organic Program With Stateorganic Programs, Kelly Damewood Jul 2018

Strengthening The National Organic Program With Stateorganic Programs, Kelly Damewood

Journal of Food Law & Policy

With an increasing amount of organic imports and steady growth in the organic sector, the U.S. Department of Agriculture’s (USDA) National Organic Program (NOP) needs additional enforcement resources to oversee a growing and evolving organic marketplace. California has the most efficient, robust organic enforcement in the U.S. because it has a state-administered organic enforcement program, the California State Organic Program (SOP). Based on the costs and benefits of the SOP, additional state organic programs are a viable means to increasing NOP enforcement resources when they are established in states where additional enforcement adds value to the state ...


The Snap Sugar-Sweetened Beverage Debate: Restrictingpurchases To Improve Health Outcomes Of Low-Incomeamericans, Nicole E. Negowetti Jul 2018

The Snap Sugar-Sweetened Beverage Debate: Restrictingpurchases To Improve Health Outcomes Of Low-Incomeamericans, Nicole E. Negowetti

Journal of Food Law & Policy

The Supplemental Nutrition Assistance Program (SNAP) is a highly effective government program that reduces poverty and improves food security for millions of our country’s most vulnerable families. Amid threats of budget cuts to this critical program in the 2018 Farm Bill, advocates representing various interests have banded together in support of this vital program. However, the issue of restricting the purchase of sugar-sweetened beverages (SSB) with SNAP benefits has divided anti-hunger and public health advocates. While public health and medical officials support the idea of restrictions on junk food, arguing that SNAP should improve health and nutrition, not contribute ...


Proactive Policies: Building The Farm Bill Of The Futurethrough New Collaborations And Perspectives, Jennifer Zwagerman Jul 2018

Proactive Policies: Building The Farm Bill Of The Futurethrough New Collaborations And Perspectives, Jennifer Zwagerman

Journal of Food Law & Policy

The Farm Bill highlights both one of the great divides in our political process, as well as one of the most beneficial partnerships in politics. Historically, partnerships between rural and urban have been key to successful passage of the Farm Bill. However, calls to divide nutrition support and agricultural support programs continue, and there are increasingly diverse viewpoints regarding agricultural programs. To build the Farm Bill of the future, one that is comprehensive and addresses the needs of not just producers, but ultimately everyone impacted by this Bill, there needs to be a broader coalition of partnerships and voices involved ...


Insuring A Future For Small Farms, Mary Beth Miller, D. Lee Miller Jul 2018

Insuring A Future For Small Farms, Mary Beth Miller, D. Lee Miller

Journal of Food Law & Policy

Congress created Whole Farm Revenue Protection (WFRP) in the 2014 Farm Bill to provide small, diversified, and organic operations with an insurance product tailored to their unique needs. The program stands out from other federal crop insurance programs with its blend of features that, inter alia, incentivize risk management through crop/animal diversification, increase premium subsidies for beginning producers, allow organic price elections, and recognize on-farm processing expenses. For the farmers who use it, WFRP provides more than peace of mind in the face of unpredictable weather and prices. It provides a revenue guarantee that opens up critical financing channels ...