Food and Drug Law Commons^™

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

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 …

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 …

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 …

The Regulation Of Lab-Grown Meat Under Existing Jurisdictional Authority, Kate Sollee

Journal of Health Care Law and Policy

No abstract provided.

Genetically Engineered Food, Food Security, And Climate Change, Joanna K. Sax

Faculty Scholarship

Malnutrition is the leading cause of death and disease worldwide. Climate change is an existential crisis. We need to feed people and address the role of agriculture in climate change – at the same time. This is problematic, as agriculture inherently creates issues that contributes to climate change. Utilizing science, through genetically engineered crops, is one way to close the harm gap between food security and climate change. This essay addresses the controversial issue of genetically engineered crops with the complicated issues of food security and climate change by analyzing three main issues: (1) how the science of genetically engineered …

Why Can't I Get Pliny The Elder? Beer Distribution Law In Michigan, Kincaid C. Brown

Law Librarian Scholarship

If you are a craft beer drinker, you have noticed that there are many beers brewed in the United States that you cannot buy in Michigan, like California-based Pliny the Elder. You will have also noticed that there are many craft beers brewed in Michigan that you cannot buy at your local grocery store or bottle shop. Why is that the case? The short answer is because Michigan law mandates that beer pass through what’s known as a three-tier distribution system. This article outlines what a three-tier distribution is, what it means for Michigan brewers and beer drinkers,

Cannabis Receiverships: The Alternative For State Legal Cannabis Businesses Seeking Financial Rehabilitation Locked Out Of Bankruptcy Court By The Controlled Substances Act, Ryan C. Griffith

Seattle University Law Review

This article explores how cannabis businesses suffer by being unable to utilize federal bankruptcy and explore state law receiverships as an alternative remedy to help cannabis businesses weather financial storms.

Part I explores the limitations and differences between a receivership and a bankruptcy. Part II discusses how state legal cannabis companies cannot seek financial rehabilitation in bankruptcy court due to cannabis being listed as a schedule I drug federally. Part III explores how receivership be used to help cannabis companies that cannot seek bankruptcy protection to financially rehabilitate themselves. Part IV details how a receiver can help a cannabis company …

Let’S Get Crafty: The Evolution And Challenges Of Beer In The Southeast, Kennedy Weathers

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The Legal Role In Building Sustainable Public Health (Symposium Transcript), Joanna K. Sax

Faculty Scholarship

The article presents a discussion of food as a public health issue, beginning with why science matters and utilizing science to solve food as a public health issue, especially as it relates to sustainability and climate change. Consumer misperceptions of the risk created by new scientific technologies (e.g., GMOs), or even older scientific technologies, may thwart use of such technologies to solve sustainability problems. The talk addresses why consumers might inappropriately assign risk to certain scientific applications and ways that we might want to think about resolving that issue or closing the divide between consumer misperception of risk and evidence-based …

Table Of Contents

Seattle University Law Review

Table of Contents

Where's The Beef? Meat Shortages, Farmer Needs, And Long-Term Recovery Policies In A Pandemic Era, Kim Vu-Dinh

Faculty Scholarship

COVID-19 not only affected every hospital bed in the nation--if not the world; it also affected nearly every dinner table in America and beyond. Supply chain disruptions caused by the pandemic highlighted deep-seated problems with how we get our meat, and how difficult we make it for American farmers to sell to the family next door. Within a few months of the first reported case in the US, hundreds of workers from just two meat-processing plants on American shores became infected with COVID-19, and imports from around the world came to a standstill as factories and shipping companies were forced …

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …