Food and Drug Law Commons^™

Endnotes, David Hunter

Sustainable Development Law & Policy

No abstract provided.

Nothing Shellfish About It: Why The Fad Needs To Update The Seafood List To Require Geographic Origin And Species-Specific Shrimp Labeling, Bree Evans

Sustainable Development Law & Policy

Introduction

Imagine you are seated at a nice restaurant down by the wharf where you live. You are celebrating a job offer, out for a romantic night with your partner, or just craving some salt air and a great meal. You would expect the shrimp tacos brought to your table to be fresh and local—the fishing boats are docked just across the boardwalk. But the seafood brought to your table seems off somehow, not quite the same as you remembered it. Unfortunately, this experience is more common than you might think, and it’s getting harder to know how fresh and …

A Silver Bullet: Could Data Linking Urban Heat Islands To Housing Discrimination Curtail Environmental Racism?, Russell Armstrong

Sustainable Development Law & Policy

“[A]ll things share the same breath— the beast, the tree, the man …the air shares its spirit with all the life it supports.”

Google “Chief Seattle” and you will likely find that quote. We now know it is a work of fiction after several misinterpretations and fabrications of Dr. Henry Smith’s original translation. We also know now that all people, particularly Black Americans, do not all breathe the same air. Instead, Black Americans and other underrepresented minorities are subjected to the toxic effects of climate change at increasingly disproportionate rates. Controlling for income, studies find racial identity is the most …

Manufacturers Beware Of Right To Repair: An Analysis Of The Resurgence Of Right To Repair & The Legal Consequences Of Third-Party Access To Embedded Software In The ‘Internet Of Things’ Era, Lindsey Barringto

Sustainable Development Law & Policy

On March 18, 2019 California became the twentieth state to introduce Right to Repair legislation in one year. The policy objectives for Right to Repair are straightforward: advocate for federal and state laws that make it easier for owners of consumer goods to ix a device when it breaks rather than relying on the Apple store. However, since 2014, small farmers have joined the Right to Repair movement because major manufacturers, such as John Deere, have consolidated dealer networks in response to the consolidation of farming in the past decade.

While proponents for Right to Repair legislation argue that consumers …

Climate Gentrification: An Imminent Threat To Oceanfront Cities, Marcel Apple

Sustainable Development Law & Policy

Overview

Traditionally, gentrification occurs when real estate prices appreciate, leading to significant cultural change in low-income communities and involuntary displacement of low-income residents. In recent years, Miami, Florida is beginning to feel the impacts of “climate gentrification.” High-income buyers, who historically develop property close to the ocean, are affected by rising sea levels and increasingly look inland to develop areas on higher ground. The influx of real estate investments in these is expected to lead to spiking home prices and property taxes, forcing many longtime community members to abandon their homes.

Homeowners in these communities already report approaches from developers …

Canada’S Arctic Policy Framework: Governance Transformation In Nunavut, C. Mark Macneill

Sustainable Development Law & Policy

On August 28, 2017 Canada’s Prime Minister, Justin Trudeau committed to a renewed relationship with Indigenous Peoples based on the recognition of rights, respect, co-operation and partnership. To accomplish this mission, major structural changes in how the Government of Canada engages and relates with Indigenous peoples across the country were co-developed with indigenous, territorial and provincial partners to form a new Arctic Policy Framework (APF). This has had major implications of departmental transformation, particularly for the former Department of Indigenous and Northern Affairs (INAC), Nunavut. Regional Office (NRO), its staff, programs, and operations.

Splitting Canada’S Northern Strategy: Is It Polar Mania?, C. Mark Macneill

Sustainable Development Law & Policy

On July 15, 2019, Prime Minister Justin Trudeau’s legislation splitting Indigenous and Northern Affairs Canada (INAC) into two new departments and dissolving INAC came into effect. The same legislation also formally established the mandates of the two new departments, Crown-Indigenous Relations and Northern Affairs (CIRNAC) and Indigenous Services Canada (ISC). The Government of Canada passed the legislation to develop deeper relations and higher levels of collaboration with Canada’s Indigenous people to build stronger and healthier northern communities. Dovetailing with the splitting of INC, Prime Minister Justin Trudeau announce the Arctic Policy Framework (APF). The APF was co-developed with indigenous, territorial, …

Transboundary Air Pollution In Northeast Asia: Two Pathways Forward For China And South Korea, Yeeun Uhm, Creighton Barry

Sustainable Development Law & Policy

Simply put, air pollution kills. Each year, more than 5.5 million people die from illnesses caused by breathing polluted air worldwide. In 2013 alone, one in ten deaths globally were associated with air pollution. Such alarming statistics ought to provide governments a strong incentive to combat air pollution, but toxic air unrelentingly blankets places like New Delhi, Seoul, and Bangkok. Fundamentally, this may be because humans take the atmosphere for granted as a place to dump industrial waste. This article will discuss two alternative pathways to addressing transboundary air pollution between China and South Korea. One involves binding international dispute …

Sdlp After 20: Sustainable Development In The Anthropocene, David Hunter

Sustainable Development Law & Policy

This volume marks the 20th anniversary of Sustainable Development Law and Policy (SDLP) published by the students of American University’s Washington College of Law. SDLP was founded to explore the legal and policy dimensions of sustainable development (i.e. the simultaneous pursuit, or integration, of economic development, environmental protection, and social welfare). During its twenty years, SDLP has provided a forum for scholars, practitioners, and students to analyze the complex challenges to achieving economic and social justice within the constraints of our planet’s natural environment. From its first volume addressing liability for carbon trading, the regulation of genetically modified organisms, and …

About Page, Sustainable Development Law And Policy Brief

Sustainable Development Law & Policy

The Sustainable Development Law & Policy Brief (ISSN 1552-3721) is a student-run initiative at American University Washington College of Law that is published twice each academic year. The Brief embraces an interdisciplinary focus to provide a broad view of current legal, political, and social developments. It was founded to provide a forum for those interested in promoting sustainable economic development, conservation, environmental justice, and biodiversity throughout the world.

Because our publication focuses on reconciling the tensions found within our ecosystem, it spans a broad range of environmental issues such as sustainable development; trade; renewable energy; environmental justice; air, water, and …

Editor's Note, Brianna Delduca, Hannah Gardenswartz

Sustainable Development Law & Policy

Dear Readers,

This issue is a celebration of Sustainable Development Law & Policy Brief’s (SDLP’s) twentieth anniversary. It has been a privilege to oversee SDLP during this tumultuous time. Now more than ever, we need to focus on global ramifications of the human environment. Over the past twenty years, SDLP has discussed developing theories in international environmental law. While we are living in strange times, SDLP continues to be a place to discuss how humans interact with the environment.

For this issue, we are celebrating twenty years by publishing articles and features that look at where the law of sustainable …

Endnotes, Joan F. Chu

Sustainable Development Law & Policy

Underserved Communities Trashed by Plastic; Continued

And Endnotes

Underserved Communities Trashed By Plastic: Slowing The Proliferation Of Petroleum Based Products Through Stewardship Laws And Enhanced Back-End Regulatory Solutions, Joan F. Chu

Sustainable Development Law & Policy

Introduction

Plastic pollution has attracted a tremendous amount of attention and press coverage in early 2021 as evidenced in news stories; an episode of John Oliver’s show, “Last Week Tonight”; and a viral tweet from Greta Thunberg highlighting a study linking plastic pollution to human penises shrinking. These eye-catching pieces stemmed from Dr. Shanna H. Swan’s work that culminated in her book, Count Down: How Our Modern World Is Threatening Sperm Counts, Altering Male and Female Reproductive Development, and Imperiling the Future of the Human Race. Other articles have highlighted plastic pollution’s impact on polar bears, which causes their penis …

Bison, Tribes, And Brucellosis In The Interagency Bison Management Plan, Bailey Nickoloff

Sustainable Development Law & Policy

Introduction

It would be in the best interest of the Interagency Bison Management Plan (“IBMP”) and its affiliated agencies to allow Tribal governments and Tribal members to hunt bison within Yellowstone National Park (“YNP”). This would help to reduce the spread of brucellosis, reduce the environmental impacts from bison in YNP, and honor the treaties signed between the United States and Tribal governments. These agencies can accomplish this by implementing treaty hunting rights in a new Environmental Impact Statement (“EIS”) and within an existing legal framework.

Paving A Path To Independent Tiny Living: An Introduction To Roadblocks, Jaclyn Troutner

Sustainable Development Law & Policy

“Tiny living” is a growing trend in which small-scale, ecoconscious housing is used as an alternative means for homeownership. Tiny homes are smaller than the average detached home with the appearance and character of a traditional freestanding residential home. They are one-story, single-occupant dwellings and usually constructed on a trailer base for towing. State-of-the-art building techniques provide a lower environmental burden and utility cost per square foot. Due to their smaller size, tiny homes are cheaper with an average price of $52,000, opening a wider door to home ownership. The typical design is to include all the standard amenities and …

Rulemaking Doubletake: An Opportunity To Repair And Strengthen The National Environmental Policy Act, Rachel Keylon

Sustainable Development Law & Policy

Introduction

In the middle of the twentieth century, there was a turning point in the United States and around the world in the understanding of the human relationship with the natural environment and natural resources. It was a shift from a perspective of natural resources endlessly available for exploitation to a perspective that natural resources are finite, and conservation and preservation are necessary to ensure that these resources are available for future generations. The accumulation of chronic environmental degradation, such as the unchecked proliferation of pesticides and other toxic chemicals, pollution to the nation’s waters, loss of land to erosion, …

About Sdlp

Sustainable Development Law & Policy

The Sustainable Development Law & Policy Brief (ISSN 1552-3721) is a student-run initiative at American University Washington College of Law that is published twice each academic year. The Brief embraces an interdisciplinary focus to provide a broad view of current legal, political, and social developments. It was founded to provide a forum for those interested in promoting sustainable economic development, conservation, environmental justice, and biodiversity throughout the world.

Because our publication focuses on reconciling the tensions found within our ecosystem, it spans a broad range of environmental issues such as sustainable development; trade; renewable energy; environmental justice; air, water, and …

Editor's Note, Juliette Jackson, Bailey Nickoloff

Sustainable Development Law & Policy

Dear Readers,

For more than two decades, the Sustainable Development Law and Policy Brief (SDLP) remains true to its mission of providing innovative solutions to some of the most important legal issues related to environmental law, energy law, and natural resources law. We are honored to be the Editors-in-Chief during these unprecedented times in our history, as we witnessed a historical presidential election and now enter the third year of the COVID-19 global pandemic. Despite these unparalleled times, the SDLP staff brought our readership another great issue.

In this issue, our authors provide an in-depth analysis into current regulations and …

Costly Gadgets: Barriers To Market Entry And Price Competition For Generic Drug-Device Combinations In The United States, Michael S. Sinha

Minnesota Journal of Law, Science & Technology

No abstract provided.

How Public Health Informed Lawmaking Would Address The Rising Synthetic Opioid Death Toll, Jennifer S. Bard

Brooklyn Law Review

The sharply rising deaths associated with use of synthetic opioids in the United States highlight the failure of a legislative strategy focused on reducing the availability of prescription opioids. However, since synthetic opioids prescribed for pain relief have never been a major contributor to either developing opioid dependence or dying from opioid use, it is not surprising that these measures have not only failed to reduce deaths, but have also caused considerable harm to people in need of pain relief. Yet reversing them and taking a public health approach focused on preventing the most serious harms associated with synthetic opioids …

Eaters, Powerless By Design, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

Food law, including traditional food safety regulation, antihunger programs, and food system worker protections, has received increased attention in recent years as a distinct field of study. Bringing together these disparate areas of law under a single lens provides an opportunity to understand the role of law in shaping what we eat (what food is produced and where it is distributed), how much we eat, and how we think about food. The food system is rife with problems--endemic hunger, worker exploitation, massive environmental externalities, and diet-related disease. Looked at in a piecemeal fashion, elements of food law appear responsive to …

Eaters, Powerless By Design, Margot J. Pollans

Michigan Law Review

Food law, including traditional food safety regulation, antihunger programs, and food system worker protections, has received increased attention in recent years as a distinct field of study. Bringing together these disparate areas of law under a single lens provides an opportunity to understand the role of law in shaping what we eat (what food is produced and where it is distributed), how much we eat, and how we think about food. The food system is rife with problems— endemic hunger, worker exploitation, massive environmental externalities, and diet-related disease. Looked at in a piecemeal fashion, elements of food law appear responsive …

It’S About Lyme: Why Congress Must Enact Medical Insurance Coverage Laws For Lyme Disease Patients Now, Jennifer Barrett

Seattle University Law Review Online

The Centers for Disease Control and Prevention (CDC) estimates approximately 476,000 people are diagnosed with Lyme disease in the United States each year. While many will recover with a short course of antibiotics, up to 35% will suffer from persistent symptoms after initial treatment. Despite scientific evidence showing the infection can persist long after initial treatment, most insurance companies restrict access to treatment beyond twenty-eight days, leaving patients to bear much of the financial burden. To limit crippling out-of-pocket expenses, Congress must enact legislation mandating coverage for the treatment of clinically diagnosed Lyme disease and co-infections based on the International …

Learning From South Korea’S Covid-19 Response: Why Centralizing The United States Public Health System Is Essential For Future Pandemic Responses, Meghan Ricci

Seattle Journal of Technology, Environmental, & Innovation Law

The COVID-19 pandemic revealed stark differences in governmental preparedness across the globe. The United States, once thought of as a global leader in public health, had the theoretical skill and efficiency to handle the pandemic but failed to utilize those skills and resources during an actual health crisis. In the spring of 2020, everyone watched the U.S.’s reaction to the unfolding of the COVID-19 pandemic due to its historic placeholder as a global leader and innovator. However, the performance of the U.S. in response to the global pandemic disappointed both global commentators and U.S. citizens. This paper will compare the …

The War On Drugs And Its Legal Effects On Black Americans, Alexia L. Howard-Mullins

2022 Symposium

The differences in treatment between Black and white Americans in the past fifty years has been a topic of thought in the minds of political and sociological scholars since the inception of the War on Drugs in 1971. These differences in treatment may lead to discrimination legally, resulting in longer prison sentences and a higher proportion of Black Americans in prison. This study analyzes the results of the War on Drugs that led to disproportionate imprisonment of Black Americans, including mandatory sentencing laws, drug classifications, and discrimination within law enforcement and the legal system. This study will use primary sources …

Food And Drug Regulation: Statutory And Regulatory Supplement (2022 ), Adam I. Muchmore

Books

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than comprehensive.

The Federally Regulated Decline, Rebirth, And Decline Of The United States Hemp Industry, Henry Webb, Patrick R. Baker, Paula H. Moore, Karen Scanlon

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

"Thank You For Your Sacrifice": Off-Label Drug Regulation Strategies After The Misuse Of Hydroxychloroquine For Covid-19, Erin Mccluan

Duquesne Law Review

In March 2020, BuzzFeed News reported that a 45-year-old patient with systemic lupus erythematosus ("SLE") was denied her long-standing hydroxychloroquine ("HCQ") prescription due to the COVID-19 pandemic.¹ Her healthcare network, Kaiser Permanente, informed her that this was necessary to "conserve[] the current supply for those who are critically ill with COVID-19."² Disturbingly, Kaiser wrote to the patient, "Thank you for the sacrifice you will be making for the sake of those that are critically ill; your sacrifice may actually save lives." ³

The patient, Dale, who asked only to be identified by her first name, told BuzzFeed News, …

U.S. Drug Reform: A Cultural Shift, Leionah J. Noah

St. Thomas Law Review

When a human body ingests a lethal dose of heroin, the body goes through an enormous physiological transformation. The functions of the central nervous system begin to depress, breathing is shallowed, the pulse is weakened, and the skin turns blue or gray with dark lips and fingernails. An alert person must quickly administer naloxone, an opioid antagonist, to reverse the effects of a heroin overdose, as symptoms typically begin after ten minutes. For many, however, their lives end with an overdose, despite this outcome being preventable. This paper will establish that drug overdose deaths are preventable for an entirely different …

A Hot Topic: Is The Fda’S Approach To Sunscreen Regulation Failing Consumers?, Haley Westman

Seattle University Law Review

This Note suggests a better balance between allowing sunscreen innovation and protecting the public from unsafe products. Part I of this Note will review the factual background of the public’s attention to sunscreen, explain the current sunscreen issues in the news, and highlight the different actors involved in the growing discourse surrounding sunscreen. Part I will also show that the actors involved in the sunscreen industry—scientific researchers, social media influencers, and the public at large—have considerable influence on consumers’ trust in sunscreen, their buying habits, and the FDA’s approach to sunscreen regulation. Part II of this Note will outline the …