Food and Drug Law Commons^™

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 …