Food and Drug Law Commons^™

The Gap: Addressing The Missing Piece In HawaiʻI’S Anti-Discrimination Laws On Credit And Lending, Wendy Mun

Seattle University Law Review

This author addresses the significant gap in Hawaiʻi’s anti-discrimination laws, specifically the lack of explicit protections for LGBTQ+ individuals against credit and lending discrimination. Although federal laws like the Equal Credit Opportunity Act (ECOA) and recent interpretations by the Consumer Financial Protection Bureau (CFPB) extend some protections, they remain vulnerable to shifting federal priorities and interpretations. The author explores how other states, particularly California and Washington, have enacted robust statutory protections that clearly prohibit credit discrimination based on sexual orientation and gender identity. They argue that Hawaiʻi, despite its large LGBTQ+ population, must amend its credit protection laws to reflect …

The U.S. Drug Policy Hamster Wheel: A Critical Discourse Analysis Of Seattle’S New Drug Ordinance, Hallie Conyers-Tucker

Seattle University Law Review

The author critically examines Seattle’s new drug ordinance using Critical Discourse Analysis (CDA) to reveal how legislative language influences the policy's actual effect. Although the ordinance claims to prioritize diversion and community health, the use of permissive language such as “may” and “shall” grants broad discretionary power to law enforcement and undermines the stated intent. The author situates the ordinance within a broader historical context, highlighting how drug policy in the United States has consistently been shaped by racialized and stigmatizing narratives. Additionally, the author argues that meaningful reform requires reframing the discourse around substance use to support public health …

Something Concrete: How Labor Advocates Can Best Respond To The Ambiguity Of Glacier Northwest, Ateş Serifsoy

Seattle University Law Review

The Supreme Court’s much-anticipated decision in Glacier North-west, Inc. v. International Brotherhood of Teamsters Local No. 174 (Glacier) marked a critical moment for workers’ rights under the National Labor Relations Act (NLRA) and the longstanding practice of Garmon preemption. Yet, initial fears of a significant rollback of workers’ rights, driven by sensational headlines, were met with an unexpectedly narrow Court opinion. This Comment examines Glacier’s implications for Gar-mon preemption and the right to strike. It offers the historical background of the doctrine of labor law preemption before Glacier; presents a detailed analysis of Glacier itself, including its …

Table Of Contents

Seattle University Law Review

Table of Contents

Can The Law Protect My Craft? How Gaps In Copyright Of Knitting Patterns Symbolize A Greater Struggle For Protecting Traditionally Feminine Forms Of Intellectual Property, Kysa Walzer

Seattle University Law Review

The purpose of this article is to demonstrate the application of intel-lectual property rights within the context of copyright protection of knit-ting patterns. The article will discuss the underutilization of copyright pro-tection for knitters and crafters and its larger impact upon craft and indus-try traditionally comprised of women. Part I introduces knitting patterns and a short history of copyright protections. Part II discusses the specific areas within knitting patterns and the knitting community which give rise to legal grey areas for copyright protection. Part III discusses the larger implications of copyright and intellectual property in spaces where women traditionally make …

A New Exclusionary Rule To Protect Bodily Integrity And Discourage Pretext Stops, Josephine Ross

Seattle University Law Review

The author proposes a novel state-level exclusionary rule to reduce racial profiling and protect bodily autonomy during police encounters. The current Fourth Amendment jurisprudence fails to deter pretextual stops and frisks because the exclusionary rule often turns on officer fault and "good faith," allowing racially motivated practices to go unchecked. As federal rollbacks on diversity and data collection hinder efforts to track racial bias, the author argues for a statutory evidentiary rule that automatically excludes drug evidence found during (1) traffic stops, (2) pat-downs for weapons, and (3) consent searches, regardless of an officer’s intent or the legality of the …

Navahine V. HawaiʻI Dept. Of Transportation: The Keiki Will Lead Us, Catherine Smith

Seattle University Law Review

The author analyzes the landmark case Navahine v. Hawaiʻi Department of Transportation, which culminated in the world’s first constitutional climate settlement. Catherine Smith, serving as an expert for the youth plaintiffs, situates the case within Hawaiʻi’s legal tradition of prioritizing children’s rights and intergenerational equity. She explores the evolution of children’s constitutional protections, contrasting Hawaiʻi’s progressive jurisprudence with the dominant adult-centric legal framework on the mainland. She critiques four recurring analytical missteps in U.S. courts that marginalize children’s interests and highlights Hawaiʻi’s public trust doctrine and cultural values, such as the Aloha Spirit, as models for addressing climate-related harms. …

Constitutional Futurism As Pedagogy, Jeremiah Chin

Seattle University Law Review

Constitutional Law has transformed from a course on history to a discussion of current events. Cases like Students for Fair Admissions v. Harvard College, Dobbs v. Jackson Women’s Health Organization, and Loper Bright Enterprises v. Raimondo reveal that the study of constitutional law is not a static, or even linear, discussion of constitutional text and history. Law is a shifting, changing enterprise that reflects social constructions of power, authority, and identity. How do we teach, learn, and understand constitutional law that is so laden with history, riddled with theories of consistency and adherence to precedent, but ultimately subject …

For The Greater Good: Civil Commitment For Addiction Amid The Overdose Epidemic, Steven P. Meerschaert

Cleveland State Law Review

America is facing a reckoning born of its own duality. Our society is gradually embracing an increasingly permissive stance on recreational drug use, while at the same time we lament the human costs of addiction. What the media has dubbed the “opioid epidemic” has seen increases in drug addiction diagnoses and opioid-involved overdose deaths nearly every year since 1999. In a rush to designate guilty parties and to crown a “gold standard” for treatment options, we have focused on theoretically flawed approaches that fail to follow the science precisely. At the same time, we dismiss validated treatment modalities in their …

The Indian Pharmacopoeia: Enabling Open Access And Crafting A ‘Sovereign Function Exception’ For Government Works, Aparajita Lath

National Law School Journal

Standardisation of drugs and access to such standards are important levers for effective drug regulation. The Indian Pharmacopoeia, the official book of standards for drugs in the country prescribed by the Union government under the Drugs and Cosmetics Act 1940, are legally binding and enforceable. Not only do the standards have the force of law but are also government-created. The Indian Pharmacopoeia Commission (IPC), a division of the Union Department of Health and Family Welfare, has a legal monopoly over creating and publishing this compendium. Though it is legally binding, the Indian Pharmacopoeia is neither in the public domain …

Examining Pricing And Availability For Neglected Tropical Disease Therapies In The Us, Maple Goh, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Background

Neglected tropical diseases primarily affect vulnerable populations in low-resource settings worldwide. In the US, neglected tropical diseases such as Chagas, soil-transmitted helminthiases, and other infections historically impacted immigrants but are increasingly relevant for US residents with climate change. We examined the pricing, prescribing rates, and supply of therapies used to treat neglected tropical diseases in the US and their implications for accessibility and patient care. Methods

A retrospective analysis of prescription rates, wholesale acquisition costs, and shortages was conducted for 11 treatment products from 2019 to 2024, aggregating data from Symphony Metys, First Databank, NAVLIN, Red Book, and the …

Expanding Equity And Innovation In Pharmaceutical Law And Drug Development: Paying Clinical Trial Participants For Their Data, Steve Calandrillo, Bernadette Tosti, Jefferson Smith, Jamison Koeman

Articles

Bringing a drug to market is exceedingly expensive and exposes pharmaceutical manufacturers to significant legal risk. But when companies are successful, their profits make the PowerBall jackpot look like petty cash. Staggering rewards measure in the billions or millions for the firms, CEOs, pharmacies, drug benefit managers, data brokers, and many more actors in the pharmaceutical-to-patient pipeline. The only individuals who don’t get paid handsomely are the clinical trial participants, whose voluntary participation and data helped make those successes possible. It is long past time that we reform the legal and regulatory roadblocks to paying clinical trial participants in the …

Beneath The Label - Evaluating The Fda Approval Of Copenhagen Classic Snuff As A Modified Risk Tobacco Product, Yisroel Grabie, Tafani Chowdhury, Sudeep Acharya

HCA Healthcare Journal of Medicine

In this review, we critically evaluate the Food and Drug Administration's modified risk tobacco product (MRTP) status granted to a smokeless tobacco product (March 2023), Copenhagen Classic Snuff (CCS). This new status necessitates an assessment of the product CCS use and its public health impacts. We assess the impact of CCS as it relates to the reduction of lung cancer risk and the potential increased risk for nasopharyngeal cancer, chronic rhinitis, nicotine dependence, and other health hazards. Concerns persist regarding nicotine's harm and public misperception due to risk reclassification, and caution should be maintained to discourage novel snuff users. Advocating …

Purdue’S Side Effects: Using Due Process To Realign Mass Tort Bankruptcies, William A. Organek

BYU Law Review

In Harrington v. Purdue Pharma, the United States Supreme Court held that victims of the opioid crisis could not be forced to release their independent claims against the Sacklers, who owned and controlled Purdue, without the victims’ consent. Such releases had become a controversial mainstay of mass tort bankruptcy filings. Yet Purdue was decided on narrow, textualist grounds, leaving as a side effect many seemingly disparate and difficult questions unanswered. This Article argues that Purdue and its open issues should be analyzed through a broader due process lens in tension with some aspects of current bankruptcy practice but consistent with …

The Opioid Crisis: How The United States And Countries Abroad Are Making Strides, Maura Mcginnity

DePaul Journal of Health Care Law

The opioid epidemic has been an ongoing problem in the United States since the 1980s. The United States has had a very negative attitude towards individuals suffering from addiction. This attitude is clearly shown through the United States’ handling of the opioid crisis. Hundreds of thousands of individuals have died due to opioids. In the forty years since this epidemic became prevalent, the United States has still failed to implement a country-wide solution to combat the crisis. Certain states, like New York and Illinois, have made strides toward helping individuals suffering from opioid use disorder, but nationally, the country is …

محددات الحقوق البيئية بالمغرب وواقع ممارستها, Mansour Ennaama

Journal of the Association of Arab Universities for Research in Higher Education مجلة اتحاد الجامعات العربية للبحوث في التعليم العالي

استعرض المقال الإطار النظري والقانوني للتشريع البيئي في المغرب، بالإضافة إلى تحليل التحديات التي تعترض تطبيقه وآفاق تحسينه. وتبرز الدراسة وجود فجوة بين النصوص القانونية البيئية وواقع الممارسة في المغرب مما يقلل من فعالية هذه التشريعات في حماية البيئة. كما تعيق التحديات المؤسسية والإدارية والمالية التطبيق الفعال لهذه التشريعات، إذ تواجه المؤسسات المعنية بحماية البيئة تحديات كبيرة تتعلق بنقص التنسيق والتداخل في الصلاحيات، مما يؤدي إلى ضعف في التنفيذ والمراقبة، حيث تعاني الجهات المسؤولة عن حماية البيئة من نقص في التمويل، مما يؤثر سلباً على قدرتها على تنفيذ البرامج البيئية وصيانة البنية التحتية البيئية. كما أن هناك حاجة ملحة لتعزيز …

Consumer (Mis)Understanding Of Dietary Supplement Labels, Jason Iuliano, Madison Kilbride

Texas A&M Law Review

“Helps lower cholesterol levels” and “helps promote healthy cholesterol levels.” Both of these claims are found on pharmacy products. And to ordinary consumers, the message is the same: take this pill and improve your cholesterol. Nevertheless, Congress has placed these statements in two very different regulatory categories. The former is classified as a disease claim, and the latter as a structure/function claim. Whereas products making disease claims require years of clinical trials and analyses before regulatory approval can be granted, products making structure/function claims do not even require governmental review before they can be sold to consumers. This bifurcated regulatory …

The National Bioengineered Foods Disclosure Standard & Absence Claims: The Cost Of The Butterfly, Cahlen Cheatham

Texas A&M Law Review

The National Bioengineered Foods Disclosure Standard (“NBFDS”) is a step in the right direction in providing a uniform labeling standard for genetically engineered organisms (“GEOs”) that meet the statutory definition of “bioengineered.” Importantly, the law provides a consensus that GEOs are safe and that labeling standards should be uniform across the United States. However, the law largely fails to settle the broader debate and the issues associated with GEO labeling. Namely, the NBFDS’s use of the term “bioengineered” causes additional confusion, and terms like “genetic modification” and “genetic engineering” remain ambiguous. Furthermore, the Final Rule promulgated by the U.S. Department …

When Poison Is On The Menu: Proposing The Adoption Of Ireland’S Stricter Allergen Regulations In America’S Food Establishments, Katherine Fitzgerald

Journal of Law and Policy

In the modern era, a growing number of children and adults have been diagnosed with deadly food allergies. For the approximately 33 million Americans who have at least one food allergy, restaurants, aside from the home, are the most likely place where deadly reactions could occur. In order to adapt to this expanding and sensitive population, the federal government should pass legislation that protects these citizens from suffering a preventable, untimely death. Luckily, the legislators of the European Union, and specifically Ireland, have already put food labeling legislation in place that serves to protect those with food allergies. This Irish …

The Ethics Of Advertising Unhealthy Food To Children: A Study On Potential Advertising Policy Restrictions And Their Effects On Children Of Disadvantaged Minority Groups, Riley M. O'Neal

Honors Theses

According to the Centers for Diseases Control and Prevention, one in five children in America have obesity. Black and Hispanic children experience obesity at higher rates than children of other racial groups. With obesity rates increasing, what should be done to stop this increase? One partial solution is to restrict the advertisements of foods high in sugar fat, and/or refined grains directed towards children. Advertisements may be restricted in their mode (i.e., the media through which they are viewed) or their content (i.e., the substance of the advertisement or product packaging). While these restrictions on advertising may help lower overall …

No Lawyer, No Jail: A Critical Case Study Of Pragmatism And The Flaws Of “Purposeful” Decision Making In Argersinger V. Hamlin, Alisa Smith, Sarah K. Stice

Seattle University Law Review

By releasing conference notes and internal communications, Supreme Court Justices provide insight into the otherwise private decisionmaking process, shedding light on how case outcomes and legal reasoning are framed and negotiated. The watershed case of Argersinger v. Hamlin (1972) extended the constitutional right to counsel to some, but not all, misdemeanor defendants. The case was argued twice, and the Court relied on empirical and authoritative sources to answer complex and practical questions about requiring counsel. This case study employs critical discourse analysis to uncover what influenced the Justices’ decisions and how they framed, shaped, and constructed social realities to foreground …

The Race To Erase: Destruction Of Government Documents Undermines Freedom-Of-Information Laws, Frank D. Lomonte

Seattle University Law Review

In August 2019, reporters with Chattanooga’s daily newspaper, the Times Free Press, filed what seemed to be a routine request for access to emails and other public records held by their local county government. The seemingly unremarkable request set the newspaper’s staff on a months-long journey of unpleasant surprises. The first was a demand to pay the county $717 in advance before being allowed to inspect the documents. The second was that—during prolonged haggling over the fee assessment— the county attorney’s office simply destroyed almost all of the disputed records. Third, and most glaringly, the journalists discovered that Tennessee law …

When You’Re Arrested For A Felony In Seattle, You’Ll Meet Me., Austin Field

Seattle University Law Review

In this Essay, Austin Field, a practicing public defender, uses a first-person perspective to describe what it is like to meet a criminal defendant for the first time. He explains the process from start to finish, detailing everything from the way he introduces himself to how bail works.

"I’ll ask you for your name. Most of the time, you tell me. I check your name against my list. On any given day I’m supposed to interview between five and fifteen people. I have a lot of questions for you. We only have about ten minutes."

The Public Square In A Private-Property Obsessed Country: What New York City’S Pops Regulations Get Right And Why Other Cities Should (Mostly) Copy Them, Carson Mcgregor

Seattle University Law Review

When New York City (NYC) was first becoming the metropolitan monolith it is today, it had a problem: the city streets were chock full of skyscrapers, and sunlight, air, and usable open space were at a premium. In response, the City promulgated its first Privately Owned Public Spaces (POPS) regulations, which allowed developers to build skyward in exchange for providing public space on the street level. Unfortunately, in July of 2023, the New York Times (NYT) discovered that New Yorkers received only a fraction of what they were promised. Building owners received billions of dollars’ worth of added floor space, …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Defining Deference: Impacts Of Abandoning Chevron On Emerging Technology Governance And Administrative Law, R. Aubrey Davis Iii

Seattle University Law Review

Emerging technologies, particularly Artificial Intelligence (AI), often lead to unforeseen legal outcomes. Notable abuses in areas such as facial recognition, employment bias, and housing discrimination are well known. However, legislative responses to these issues either have been largely reactive or there has been no legislative response at all. In lieu of legislation, agencies have sought to fill the gap. For example, the Federal Communications Commission (FCC) recently proposed a rule mandating voter notification for all AI-generated political phone calls citing the Telephone Consumer Protection Act (TCPA) of 1991 as authority. However, the TCPA was originally passed to curtail telemarketing, not …

Intellectual Property Or Modern Folklore? The Problem With Open Gaming Licenses In Tabletop Gaming, Rosie Midget

Seattle University Law Review

This Note addresses how courts and legislatures should address “Open Gaming Licenses” commonly attached to tabletop roleplaying games (TTRPGs), which game publishers use to promote a false image of accessibility—misleading consumers and building goodwill from the misunderstanding. Part I discusses what TTRPGs are, including the defining features of the hobby and culture surrounding it, as well as the unique interplay between publishers and players. Part II explores the question of which elements in a TTRPG system may be subject to copyright protection. Part III examines these elements in practice using Wizards of the Coast’s Dungeons and Dragons TTRPG as a …

Modern Day Colonialism Through HawaiʻI’S Quiet Title And Partition Laws, Cheyann Fujii

Seattle University Law Review

This Note will attempt to highlight important aspects of Hawaiian history to provide readers with a clear picture on how Native Hawaiians are still impacted by colonialism, specifically when plaintiffs bring a quiet title or partition action against Native Hawaiian owners of kuleana lands. Before colonization, the concept of private land ownership did not exist in Hawai‘i, and Native Hawaiians adopted a feudal system by dividing land into geographical areas. Missionaries and businessmen brought Western ideas to Hawai‘i and influenced legislation such as the Great Māhele and the Kuleana Land Act of 1850, which solidified the concept of private property. …

Data Advantage And Merger Review: Can Entrenchment Theory Reform Antitrust Enforcement?, Shin-Ru Cheng

Seattle University Law Review

A merger involving giant digital companies is likely to dampen competition, as it allows those companies to combine and control data access, enabling them to entrench their dominant positions in relevant markets and extend those positions into related markets. While competition law in many jurisdictions aims to prohibit mergers that may substantially lessen competition or create a monopoly, arguably the review of digital mergers is failing because antitrust agencies lack an effective approach to identify data-generated anticompetitive harms. This Article demonstrates that entrenchment theory, recently reintroduced in the 2023 U.S. Merger Guidelines, would help reform the process of antitrust enforcement. …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents