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 …

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 …

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 …

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 …

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. …

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 …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Caution: Potholes In E-Scooter Data Collection, Dakota Rakestraw

Seattle University Law Review

Lime scooters keep ending up in major waterways in Washington state metro areas, a testament to the ubiquity of e-scooters in the metropolitan landscape. How they get there is unclear. Why they get there is even murkier. Perhaps the answer lies in the implications of modern geolocation data collection through e-scooters and gaps in current data collection regulation curbing individual liberties.

Since September 2020, electric scooters have run Seattle’s streets and have dramatically overtaken ridesharing bike trips. For example, from September 2020 to September 2021, there were about 1.4 million scooter and bike trips with September 2021 seeing 300,000 scooter …

Machinists Preemption In The New Administrative Law, Andrew J. Ziaja

Seattle University Law Review

This Article assesses Machinists preemption—a labor-specific form of implied field preemption—while freshly considering implications both for and of new developments in administrative law. The radical transformation of administrative law in the Supreme Court, particularly its newfound emphasis on clear-statement rules, provides opportunities to reconsider the Machinists rationale. Aligning with scholars who have called to question the doctrine’s “ossifying” influence on labor and employment policy, it argues that the modern-day version of Machinists preemption clashes with the Supreme Court’s newly constrained view of delegated power and its differing conceptions of the major questions doctrine.

On the other hand, Machinists preemption might …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

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, …

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 …

Cultivating Legal Protection: Replacing Wine Labeling Regulations With Regional Certification Marks, David Corasaniti

Washington and Lee Law Review Online

While wine labeling in the United States is currently governed by a complex regulatory framework administered by the Alcohol and Tobacco Tax and Trade Bureau (“TTB”), intellectual property (“IP”) rights for wine producing regions could serve this core function of protecting consumers better and more efficiently. Regulating wine labeling through IP would more closely mirror the system used by the European Union, which recognizes Geographical Indications, such as Champagne, Rioja, and Bordeaux, as a unique form of IP. By deregulating American wine labeling, and encouraging wine producing regions to assert their IP rights in the form of collectively held certification …

The Incremental Development Of An Extra-Statutory System Of Regulation: A Critique Of Food And Drug Administration Regulation Of Added Poisonous And Deleterious Substances, James David Poliquin

Maine Law Review

Federal regulation of added poisonous and deleterious substances in food by the Food and Drug Administration has become an administrative quagmire. Although responsibility for this situation evades precise assignment, FDA regulatory problems typically arise through the operation of three factors. First, the applicable statutory provisions are highly ambiguous, far exceeding the level of ambiguity traditionally viewed as necessary to administrative flexibility and efficiency. Even resort to the legislative history of these provisions often leaves many questions unanswered. Second, the perpetual amendment of the original Federal Food, Drug, and Cosmetic Act without the simultaneous repeal of all the inapplicable and inconsistent …

Meat, The Future: The Role Of Regulators In The Lab-Grown Revolution, Joseph B. Davault, Michael S. Sinha

All Faculty Scholarship

The United States is one of the largest consumers of meat globally. The production of meat contributes substantially to climate change due to the levels of greenhouse gasses emitted and the amount of land, water, feed, and other natural resources required to raise animals used for meat. Traditional meat production is another major source for the emergence of zoonotic diseases and antimicrobial-resistant pathogens. Nevertheless, Americans consume more meat now than at any time in the nation’s history.

Advocates for policy change aimed at addressing the risks associated with meat production have typically focused on reducing meat consumption, alternatives to meat, …

Let The Sunshine In: Crafting Constitutional Transparency Regulations For Content Moderation, Caitlin Ring Carlson

Seattle University Law Review

In response to public concern about the impact of social media, legislators in some U.S. states have developed laws to regulate the process of content moderation. Many include mandatory transparency and disclosure requirements, some of which courts have already deemed an unconstitutional infringement on social media platforms’ right to free expression. This article explores the parameters for crafting constitutional social media transparency regulations using existing U.S. media policy and insights from recent legal challenges. The resulting analysis identifies content neutral transparency requirements that mandate the disclosure of purely factual, non-controversial information as those most likely to withstand judicial scrutiny. Specifically, …

This Is Not A Game: The Addictive Allure Of Digital Companions, Nizan Geslevich Packin, Karni Chagal-Feferkorn

Seattle University Law Review

Artificial Intelligence (AI) agents have become an inescapable part of modern childhood, reshaping education, leisure activities, entertainment, and social interaction. From AI-powered tutors that adapt to individual learning styles to emotionally responsive chatbots that simulate human companionship, these systems promise unprecedented personalization, cognitive stimulation, and social support. However, these benefits mask significant risks that remain unregulated and inadequately addressed.

Although adults are also susceptible to forming deep emotional bonds with AI companions—often trusting them as if they possessed genuine understanding and empathy—children are particularly vulnerable. Their misplaced trust can more severely distort social development, weaken critical thinking, and foster unhealthy …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Re-Imagining Tomorrow: A Technology, Innovation Law, And Ethics Symposium On Addictive Technology And Children, Margaret Chon

Seattle University Law Review

In this Foreword, Professor Margaret Chon introduces Seattle University's Technology, Innovation Law, and Ethics (TILE) program, the 2024 TILE Symposium, and Dr. Gaia Bernstein’s Unwired: Gaining Control Over Addictive Technologies.

Keynote Address: The Movement To Protect Kids From Addictive Technologies, Gaia Bernstein

Seattle University Law Review

In this keynote address, I describe my personal journey starting with a school outreach program I created in 2017 to address technology overuse among kids. While I initially advocated for self-help methods, I grew to recognize that the tech industry bore responsibility. This realization led me to write Unwired: Gaining Control over Addictive Technologies, which focused on collective action to pressure the tech industry to redesign its addictive products.

I then describe the movement to control addictive technologies and protect kids, which has gained momentum since the end of the pandemic. This movement combines grassroots parent activism with legal-political action. …

Moral Panic Or Public Health Crisis? Lessons From Drugs And Gambling For “Addictive” Design, Matthew B. Lawrence, Haomin (Kevin) Yan

Seattle University Law Review

Alcohol, automobiles, guns, lottery, loot boxes, meat, music, opioid painkillers, processed foods, prop bets, slot machines, television, tobacco, violent video games. Over the last century each of these has been subject to concerns—some might even say “moral panics”—from parents and policymakers about avoidable harms to kids and adults. In some cases we look back with the benefit of hindsight and dismiss those concerns as naïve or moralistic. In others we look back at them as justified or as having come too late to check an expanding industry before it did unfathomable harm while growing so powerful that it became all …

Responding To Digital Addiction, Ned Snow

Seattle University Law Review

In Unwired: Gaining Control over Addictive Technologies, Professor Gaia Bernstein calls our attention to the growing problem of digital addiction. Digital addiction may sound like something out of a science-fiction novel or something that does not raise the same sort of real-life practical concerns as are present in a physical health crisis or an economic decline. But as Bernstein presents the evidence, we learn that the consequences of digital addiction can be just as harmful as a serious disease or a financial depression. Cognitive development disorders, anxiety, emotional depression, social isolation, and other mental health ills can be debilitating—as much …

The Ai Doppelgänger Dilemma: Cloned Voices In The Music Industry, Elizabeth Shields

Seattle University Law Review

With the rise of generative artificial intelligence (AI), there has been an influx of “voice clones”—deep-learning algorithms that create synthetic speech to realistically mimic human voices. Celebrities and, in particular, music artists, have been subjected to the proliferation of AI voice clones on social media platforms like TikTok and streaming platforms such as Spotify. Despite music utilizing AI voice clones having amassed much popularity, this technology can be harmful and highly invasive to musicians whose livelihoods often depend on their distinct voices. While legal scholars have attempted to articulate various rights that could protect a person’s voice, individuals are largely …

The End Of Fda Exceptionalism? Dissecting Deference To The Fda In Drug Disputes, Anjali Deshmukh

Cardozo Law Review

On April 7, 2023, a federal judge issued a nationwide stay on the United States Food and Drug Administration (FDA) approval of the abortifacient medication mifepristone. It was instantly a landmark case, decried as the first time in over one-hundred years that a federal court nullified an FDA drug approval. A few hours later, a second federal district court enjoined FDA restrictions on mifepristone. Two federal courts substantively evaluating FDA drug approval data in one day is unprecedented. It begs the question: will courts overturn FDA drug approvals again?

Conventional wisdom says no. Abortion exceptionalism, the trend of legislatures and …

Public Patent Powers, Laura E. Dolbow

Michigan Law Review

Congress has created multiple structures for agencies to control how patents are used, but that institutional design choice has received little academic attention. This Article provides the first comprehensive survey of existing laws that expressly authorize agencies to control patents. I locate 113 express conditions across 68 laws that expressly authorize executive actors to make some form of decision about patents. These powers, which I refer to as “public patent powers,” allow the government to use patented inventions, to obtain patents, to authorize third parties to use patented inventions, and to regulate how patents are used. Agencies have used many …