Food and Drug Law Commons^™

Rewriting The Playbook: The X’S And O’S Of The House Settlement And The Future Of Student-Athletes’ Voice In Their Compensation, Matthew K.V. Glazer

Seattle University Law Review

Since the formation of the National Collegiate Athletic Association (NCAA) in the 1900s, collegiate athletes (student-athletes) have been prohibited from using their own name, image and likeness (NIL) for profit. But on July 1, 2021, the NCAA changed course and began allowing student-athletes to profit from their own NIL. In the past few years, U.S. college athletics have undergone significant changes, most notably introducing monetary compensation for student-athletes’ NIL. While these changes were long overdue and ultimately beneficial, they have significantly disrupted the landscape of college sports, giving rise to numerous challenges that some experts have compared to the “Wild …

Mr. Trump Goes To Washington Part Ii: A Review Of Richard Delgado's 2025, Kevin Johnson

Seattle University Law Review

Richard Delgado’s The Rodrigo Chronicles have captivated a generation of law students and legal scholars.  Mapping the terrain of race, racism, and Critical Race Theory (CRT), the skillful, and long-running narrative series stands as a testament to Delgado’s dedication to justice for all.

The Rodrigo Chronicles are simply one of Delgado’s many intellectual contributions and part of an unparalleled scholarly legacy.  As one of the founders of CRT, he produced a landmark body of scholarship –authoring the field's primary text,  making the argument for the regulation of hate speech,  forcefully challenging the Black/white binary of civil rights that long dominated …

With All The Strings Attached: Analyzing Participation Of Disempowered Groups In Structuring New York’S Social Equity Cannabis Investment Fund, Nicholas Schuermann

Journal of Law and Policy

For decades, New York’s selective enforcement of cannabis prohibition has disproportionately targeted low-income Black and brown communities, resulting in mass incarceration, decimated economic opportunity, and entrenched generational harm. In 2021, New York enacted the Marihuana Regulation and Taxation Act (“MRTA”) with an explicit reparative mandate: to redress these harms by lowering barriers to enter the new recreational cannabis market for those severely impacted by prohibition. Central to this effort is the Cannabis Social Equity Investment Fund, a $200 million program designed to provide justice-impacted entrepreneurs with turnkey retail locations, low-interest loans, and business support. In practice, however, the Fund has …

The Martha Wright-Reed Act: How The Fcc Took One Step Forward For Communication Equality For Deaf Individuals In Correctional Facilities And How It Could Be Expanded, Ashley Seebold

Seattle University Law Review

For decades, phone companies preyed on incarcerated individuals and their loved ones due to the lack of regulation of jail phone calls.2 In 2021, the average cost of a fifteen-minute jail phone call was about $3.3 In 2022, the average cost rose to $5.74, while some individuals faced an extreme charge of $24.82 for the same amount of time.4 In the early 2000s, consumer advocate and concerned grandmother Martha Wright-Reed called upon the Federal Communications Commission (FCC) to fix the imbalance so she could speak to her incarcerated grandson.5 Eventually, in 2023, the FCC answered her call to action and …

Molecules And Monoclonals: The Two-Tiered Patent System, Candi L. Lasarge Ph.D.

The University of Cincinnati Intellectual Property and Computer Law Journal

No abstract provided.

Reckitt-Benckiser And Buprenorphine: Opioid Addiction Treatment, Drug Monopolies, And Consumer Implications, Peri G. Heyen

Theses/Capstones/Creative Projects

The opioid crisis in the United States is a deadly epidemic that demands fair and accessible treatment for those affected. The introduction of buprenorphine for opioid addiction disorder in 2002 allowed for the first treatment of the disorder beyond the time intensive and stigmatized practices of methadone clinics, which proved to be revolutionary. Reckitt-Benckiser (“Reckitt”) and former subsidiary Indivior were able to gain a legal monopoly of buprenorphine through their orphan drug exclusivity designation on Suboxone tablets that was approved by the FDA. Once orphan drug exclusivity was near expiration and generic competition began to prepare to enter the market, …

Red 40 Riot: An Interdisciplinary Perspective On The Fight For Food Additive Regulation, Margaret Q. Gray

Honors Theses

This paper explores the chemical, business, and governmental influences that impact the perception and future of Red 40. This inquiry was inspired by the increasing trends towards health-conscious consumer preferences and the 2025 Red 3 ban. This thesis examines foundational research, modern sources, and public-facing articles to create a comprehensive understanding of both sides of the argument in support of and against regulation. The paper concludes that a three-pronged approach would be ideal to target each key perspective included: chemistry, business, government. The approaches include confirming chemical research method validity, encouraging governmental regulation, and corporate accountability and enforcement. The paper …

From Tech To Table: Moving Sustainable Proteins Beyond Marketplace Bottlenecks, Andy Fitch, Cynthia Hanawalt

Sabin Center for Climate Change Law

Climate advocates may hope to see dramatic commercial breakthroughs over the next several decades that reshape emissions-intensive components of our everyday lives, such as our dietary choices, household energy use, and transportation habits. Yet transforming these consumer sectors will require not only scientific ingenuity and entrepreneurial ambition, but also nimble competition policy to address complex market dynamics.

Sustainable food production likely necessitates substantial departure from traditional livestock-management practices. Agricultural production currently generates about one-third of global greenhouse gas emissions (“GHGs”). Animal livestock account for the largest share, while occupying roughly 40% of the Earth’s habitable land, much of which could …

The Retreat Of Federal Power And The Rise Of Post-Supremacy Federalism, Victoria Grace Litman

Cleveland State Law Review

This Article introduces the theory of post-supremacy federalism to describe a structural condition in which federal law remains formally binding, but enforcement has durably receded or collapsed. Unlike frameworks grounded in intergovernmental friction or negotiated cooperation, this account begins from federal retreat—the cumulative erosion of enforcement capacity across judicial, administrative, legislative, and executive institutions. Post-supremacy federalism arises when three conditions are met: (1) federal law remains intact; (2) enforcement retreats; and (3) no formal devolution occurs. In this vacuum, states are not merely filling gaps. They are governing by default—under laws that still bind but no longer structure governance in …

"The Silence Of The Farms": Suppressing Speech And Trampling Transparency To Shield Big Ag, Erin Okuno

Texas A&M Law Review

Do you really know where your last meal came from and whether it was safe to eat? Most people are not aware of the often appalling conditions at agricultural production facilities (aptly known as “factory farms”), including worker injuries and abuse, contaminated food, and environmental pollution, as well as the horrific ways in which the animals are kept, raised, and slaughtered. In the face of these concerning conditions and alarmingly frequent food recalls—including millions of pounds of contaminated meat—it would seem prudent to increase transparency at factory farms, but historically, they have operated behind a shield of secrecy due to …

When The Weeds Strike Back: Rethinking Aphis's Regulation Of Genetically Engineered Plants Post-National Family Farm Coalition V. Vilsack, Reagan Powers

Celebrating WCL Student Authors

No abstract provided.

Drawing Lines In The Substance: Questioning The Inconsistent Application Of West Virginia's Recidivist Statute In Cases Involving Controlled Substance Violations, Patrick Hassen

West Virginia Law Review

For decades, West Virginia’s recidivist statute required courts to sentence repeat felony offenders to life in prison even if their offenses were not violent. Over the years, the statute mandated life sentences for triggering offenses as minor as writing a bad check or failing to register a new phone number with the police. Unsurprisingly, the statute has come under its fair share of constitutional attack for violating the state Constitution’s proportionality principle. In 1981 the Supreme Court of Appeals of West Virginia held the state’s proportionality principle requires a strict interpretation of the recidivist statute in favor of the defendant. …

Drug War Repair Guarantees, Amber Baylor

Washington and Lee Law Review

Drug legalization, especially cannabis legalization, is a critical step forward in states’ willingness to address systemic disparities, privacy intrusions, violence, and other harms of the drug war. Yet, reforms center on legalization and repair through a narrow lens, focused on changes to the penal code. The public has found that narrow forms of legalization cannot serve their purported reparative purpose. Narrowly drawn legalization is illusory. Drug war harms and punishment for legalized substance use continue. Legalization reforms are vulnerable to political trends, resulting in rollback and retrenchment of drug war operations.

Legalization cannot deliver on its reparative terms without guarantees. …

Birthdate Phaseout To A Nicotine Free Generation, Katharine Silbaugh

University of Richmond Law Review

This Article explores the Nicotine Free Generation (“NFG”) policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: prohibition or a legal age-gate, such as twenty-one, for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the twenty-one …

Probing The Prevalence Of Pharmaceutical Corruption, Marc A. Rodwin

Suffolk University Law School Faculty Works

This article reviews the history and current evidence of systematic pharmaceutical industry corruption.  It draws on studies by the OECD on international corruption; reports of the Securities and Exchange Commission; studies of the Public Citizen health Research Group of settlement agreements between federal and state authorities and pharmaceutical firm; the history of the Medicare and Medicaid Anti-Kickback Act; professional and industry codes of ethics; the literature on institutional corruption; and studies of conflicts of interest.  These sources support findings of systemic corruption since the mid-20th century. The paper also explores the relationship between classic corruption, institutional corruption and conflicts of …

Birthdate Phaseout To A Nicotine Free Generation, Katharine B. Silbaugh

Faculty Scholarship

This Article explores the Nicotine Free Generation ("NFG") policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: prohibition or a legal age-gate, such as twenty-one, for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the twenty-one …

Preempting Pre-Approval: Clarifying Preemption Doctrine For Product-Liability Suits Against Brand-Name Drug Manufacturers, Nicholas G. Wallenburg

Vanderbilt Law Review

One of the most important issues for product-liability lawsuits against drug manufacturers today is federal preemption. Plaintiffs injured by prescription drugs regularly turn to state tort law for a remedy. Defendants in these cases—often brand-name drug manufacturers—frequently invoke preemption doctrine to argue that the Food and Drug Administration’s (“FDA”) rigorous approval process for prescription drugs has displaced state causes of action. While the text of the Food, Drug, and Cosmetics Act does not clearly address this issue, the U.S. Supreme Court has relied on a so-called “impossibility” theory of preemption: When a drug manufacturer cannot comply with the duties imposed …

Trust, Transparency, And The Fragile Promise Of Data Governance In The Era Of Modernization, Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William M. Sage, Cason Daniel Schmit

Faculty Scholarship

Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust — a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial …

Ayahuasca And Religious Freedom, Andrew C. Michaels

Pepperdine Law Review

Ayahuasca is an ancient and powerful psychedelic brew that has been used for many centuries in the Amazon rainforest, and over past decades has been gaining popularity in western countries such as the United States. The ayahuasca brew contains dimethyltryptamine (DMT) and accordingly is banned by the Controlled Substances Act (CSA). But some groups working with ayahuasca have applied for exemptions under the Religious Freedom Restoration Act (RFRA), and so far, at least five such groups have received exemptions, either via court decision or via agreement with the Drug Enforcement Administration (DEA). However, the factors that courts and the DEA …

Unveiling The Patent Landscape Of Biologic Drugs, Michael D. Frakes, Melissa F. Wasserman

Northwestern University Law Review

It is undeniable that the escalating price of biopharmaceuticals is a critical issue, as high prices limit patients’ access to life-saving medications and strain our healthcare system. Biologics, or large-molecule drugs, which are revolutionizing modern healthcare, are significantly contributing to the escalating cost of prescription drugs. While biologic drugs represent only 2% of all U.S. prescriptions, they comprise close to 50% of net drug spending.

Policymakers have proposed a series of interventions to decrease drug prices that target the patent practices of pharmaceutical firms. Yet due to differences in law, we have a robust source of patenting information for small-molecule …

The New Red Scare: The Shocking Truth Behind The Fda's Unethical Regulation Of Red 40 And Other Synthetic Food Dyes, Angelica Martuscello

Pace Law Review

For decades, the U.S. Food and Drug Administration (FDA) has allowed synthetic food dyes to remain in the American food supply, despite evidence linking them to cancer and behavioral issues in children. These additives offer no nutritional value yet remain common in everyday products. This essay scrutinizes the FDA’s failure to enforce its own legal obligations, particularly its continued approval of synthetic dyes, which were later found to be harmful to human health. Harmful dyes have been kept on the market due to weak oversight, outdated science, and industry lobbying. In 2025, the FDA finally announced a plan to phase …

Frankenstein’S Drugs: Did Gilead Sciences’ Bahamas Tax Caper Create A Multibillion-Dollar Periodic Adjustment?, Stephen L. Curtis, Reuven S. Avi-Yonah

Articles

With about 182 million infections worldwide at the time, the potential value of a cure for the hepatitis C virus (HCV) was staggering.2 The company behind this drug, Pharmasset Inc., was a startup in Princeton, New Jersey, with 42 researchers and $127 million in the bank, churning through $66 million per year with no commercialized products and no codevelopment or commercialization partners. The “Pharmasset combo” was an extremely effective nucleotide analog that could treat HCV-infected individuals across genotypes, known as PSI-7977 (later renamed GS-7977), also called sofosbuvir, the active pharmaceutical ingredient (API) found in multiple current drugs used to treat …

Outbound Investment Restrictions And International Law’S Challenge, Harlan Grant Cohen

Seattle University Law Review

The Outbound Investment Rule, restricting U.S. investment in certain Chinese advanced technology sectors, has largely been portrayed as an incremental measure, a modest extension to fill loopholes in the existing investment screening regime. But while perhaps the logical next step in the securitization of the economy, the Outbound Investment Rule actually reflects a momentous shift in the relationship between governments and business, one playing out in the United States and around the world and worth attention. Unlike traditional investment screening, the Outbound Investment Rule operates like a sanctions regime, designed not to protect the U.S. economy, but to hamper the …

Resilient Dispute Resolution Systems For International Energy Conflicts, Guillermo J. Garcia Sanchez

Seattle University Law Review

Energy-related conflicts are on the rise, spanning diverse issues such as the impacts of rare mineral mining on local communities, the impacts of sanctions on energy investments due to the Russia-Ukraine war, and the impacts of expanded subsidies on the electric vehicle and solar panel industries. Increasingly, companies, communities, and governments are clashing over the challenges of pursuing disparate and sometimes competing energy policies. This Article argues that dispute resolution mechanisms in the energy investment sector must be fundamentally rethought. Traditional semi-adjudicatory models, which focus on winners and losers, fail to accommodate the complex and multifaceted nature of contemporary energy …

Restricting Data Flows Is A Sign Of Weakness, Nikolas Guggenberger

Seattle University Law Review

There has been a seismic shift in American attitudes toward the free flow of data across borders.  In less than a decade, the United States has transitioned from condemning barriers to digital trade to constructing a digital fortress of its own. It passed legislation requiring TikTok’s parent company to divest its U.S. operations or face a nationwide ban affecting 170 million U.S. users, citing national security concerns about its ties to China and the potential for data surveillance and content manipulation. Upon legal challenge by TikTok on First Amendment grounds, the Supreme Court affirmed the ban’s constitutionality. Recent federal legislation …

Product Nationality And Corporate Identity, Trang (Mae) Nguyen

Seattle University Law Review

Global supply chains have long depended on a deceptively technical device: the attribution of a “nationality” to goods. A trade law principle, rules of origin assign products an “economic passport” that governs how they are treated at the border, including what markets they may enter and which tariff rates apply. In recent years, however, product nationality has taken on a new and far more ambitious role. As U.S. trade policy increasingly intersects with national security and human rights policy, policymakers rely on nationality-based measures to police supply chain linkages, curb geopolitical issues, and discipline firms for their links to forced …

Global Supply Chain Resilience In Emerging Technologies: A Case Study Of Bitcoin Mining, Kishanthi Parella, Carla L. Reyes

Seattle University Law Review

The United States has put into motion bold plans in critical and emerging technologies to bolster its national and economic security.  For example, the federal government created a national bitcoin strategic reserve and a stockpile of other cryptocurrency; while several states have committed to or are considering similar goals.  However, the security of these reserves is dependent on two types of supply chains within the Bitcoin mining industry: analogue supply chains, relating to the physical components needed for Bitcoin mining, and data supply chains, relating to the complex and layered logistical network of actors that create input into the software …

Third-Party Funding: Balancing Transparency, National Security, And Access To Justice, Victoria Shannon Sahani

Seattle University Law Review

Many lawmakers who have recently become aware of the multi-billion-dollar global third-party funding industry are raising new national security concerns that further complicate preexisting, longstanding debates about transparency, disclosure, access to justice, and the best way to regulate third-party funding. In response, this Article briefly asserts three main points relating to the question of how best to regulate third-party funding. First, this Article explains the third-party funding industry, including its global regulatory landscape and how it serves three distinct populations: consumers, businesses, and law firms. Second, this Article explains that third-party funding is one tool that can help expand access …

The Field Of International Business Transactions Law, Kathleen Claussen

Seattle University Law Review

This Article studies the evolution of the scholarly subfield referred to as the law of “international business transactions” (IBT). It reviews data on academic articles, courses, textbooks and other signifiers of the growth of this research area. Beginning around 1960, scholars began to use the term “international business transactions” and by the 1980s, several law schools were offering a course by that title. A handful of dedicated textbooks soon followed. These data reflect a gradual increase in research on the topic of IBT, particularly in the United States, but also considerable diversity of subject matters covered by those works. The …

Kim Gyeong-Seok And The Origins Of Northeast Asia’S Corporate Accountability Movement For War And Colonialism, Timothy Webster

Seattle University Law Review

For the past three decades, a transnational reparations movement has unfolded across Northeast Asia. Hundreds of victims—assisted by attorneys, academics, and activists—seek remedies from Japan for various atrocities committed during World War II, colonialism, and other historical injustices.  They press their claims in street protests, legislative hearings, dramatic performances, and other fora.  The “comfort women” are the best known of these claimants; their global redress campaign ex-tends from noisy protests outside of Japan’s embassy in Seoul, to mute statues in raucous boroughs of Berlin.  More obscure, though larger in number, were the roughly one million Koreans who performed forced labor …