Food and Drug Law Commons^™

Magic Mushrooms As Medicine: What The United States Can Learn From Jamaica’S Unregulated Psilocybin Industry As Fda Approval Nears, Kyle Spohn

University of Miami Inter-American Law Review

In 1970, Congress passed the Controlled Substances Act and swiftly placed psilocybin (the active chemical in “magic mushrooms”) under Schedule I—the strictest level of regulation withheld for substances with “no currently accepted medical use.” While the United States has maintained this rigid framework, Jamaica has taken the opposite approach. Psilocybin was never listed under Jamaica’s Dangerous Drugs Act, and remains unregulated. In recent decades, research has shown that psilocybin, when administered in controlled settings, can effectively treat depression, anxiety, and other psychiatric conditions. In response, the Jamaican government has not only preserved psilocybin’s legality but has encouraged research and industry …

Oh, Oh, No Ozempic: The Dangers Of Ozempic’S Direct-To-Consumer Advertisements, Taylor Blicht

Journal of Law and Policy

On average, viewers are exposed to about nine drug advertisements a day. Direct-to-consumer pharmaceutical advertising (“DTCPA”) is when pharmaceutical companies market their prescription drugs straight to consumers. Ozempic is a weekly injection of semaglutide, developed by the pharmaceutical company Novo Nordisk in 2017 for adults with Type-2 diabetes. After people started to show signs of weight loss on Ozempic, Novo Nordisk created Wegovy in June 2021, targeting towards people with obesity. Due to the exploding weight-loss effect of Wegovy, celebrities and social media influencers started taking the medication and sharing their weight loss journeys. DTCPA can be harmful to consumers …

Leveling The Playing Field? Exploring The Moral Ambiguity Of The Private Attorney General Model, Nathan Heastie

Washington and Lee Law Review Online

Johnson & Johnson’s market cap is twice the GDP of Oklahoma. So, when Oklahoma hauled Johnson & Johnson and other behemoth pharmaceutical companies into state court for their participation in the opioid epidemic, Big Pharma’s resources created a David v. Goliath situation. Against all odds, Oklahoma stood toe-to-toe with Big Pharma and brought home more than $650 million in settlement funds.

Oklahoma’s success would be otherwise impossible without the assistance of three private law firms serving the role of “private attorneys general.” The State signed contingency fee arrangements with the firms, transferring the financial burden of litigation from the State …

Investigating The Relationship Between Noun Classes And Plant Folk Taxonomy In Chasu Language Of Kilimanjaro Region In Tanzania, Peter Rabson Mziray

Journal of Humanities and Social Sciences

The current study investigates the relationship between noun classes and plant folk taxonomy in Chasu (G 22). The study focuses on two objectives: the first objective is to describe the plant folk taxonomy in Chasu and the second objective is to determine the relationship between noun classes and plant folk taxonomy in Chasu. Data were collected from rural villages in Same and Mwanga districts by using free listing, field interviews (jungle-walk-and-identify), and written texts containing Chasu plant names. The findings reveal that Chasu folk taxonomy reflects different ethnobotanical categories; including a unique beginner which is mmea/mimea ‘plant(s)’, and three life …

Living Property, Joseph William Singer

Seattle University Law Review

The Supreme Court has increasingly defined property rights that are per se exempt from regulation in the absence of compensation, most recently in Cedar Point Nursery v. Hassid (2021) and Tyler v. Hennepin County (2023). The Court claims that it can identify property rights that are categorically protected from regulation by reference to history, tradition, and precedent. Yet this approach is oddly ahistorical; it is inconsistent with the fact that property law changed dramatically over U.S. history, as well as varying tremendously among the states. It is also inconsistent with the historical context of the Founding era. At that time, …

Table Of Contents

Seattle University Law Review

Table of Contents

The Roots Of Credit Inequality, Andrea Freeman

Seattle University Law Review

Debt oppression began before the United States became a country. Settlers enslaved Africans and Indigenous people, treating them as property that they could buy and sell for their economic and personal benefit. When enslavement became illegal, new economic systems and laws that included sharecropping, Black Codes, and Jim Crow kept Black people in servitude. Laws that prohibited enslaved people from owning property or selling goods to white people evolved into restrictions on Black people’s occupations and market participation, both formal and informal. When Black entrepreneurs overcame these obstacles and built wealth within Black business enclaves, white people enforced their racist …

“A Plain Denial”: Reclaiming Equal Protection In American Juvenile Law, Addie C. Rolnick, David S. Tanenhaus, Justin Iverson, Danielle L. Silvestri

Seattle University Law Review

Juvenile courts are based on the premise that children are different from adults and should therefore be treated differently. Children may be treated more informally by courts, punished for different purposes, and brought before the court for different behaviors. Since In re Gault, the Supreme Court has been clear that there are limits to how different juvenile courts can be. Juveniles are entitled to many of the same procedural protections as adult criminal defendants, although the Court has preserved some procedural differences where it has determined that their benefit is outweighed by the need to preserve the informality, flexibility, …

Mandating Fluoride: A Constitutional Exercise Of Police Power, Anita Jahangiri

Seattle University Law Review

This Note addresses the ongoing debate over fluoridation: the regulation of fluoride levels in public water systems. Extensive research indicates fluoridation, when regulated at the recommended concentration, is both safe and highly effective in preventing dental caries. Better known as cavities, dental caries is a preventable yet widespread health issue that disproportionately affects low-income populations. Reducing dental health disparities among economic classes is a pressing public health issue. Fluoridation is not merely a policy option, but a critical, proven tool to address such disparities and uphold the collective welfare of Washingtonians. This Note focuses on fluoridation as a public health …

Neurodiversity In The Courtroom: Expanding Jury Service Accessibility Beyond Physical Disability, Samantha L. Mabe

Seattle University Law Review

The Americans with Disabilities Act has required equal access to jury service for decades; however, efforts to accommodate jurors with disabilities have been slow to develop beyond some minor accommodations for physical disabilities. While neurodivergent people frequently struggle to navigate a world catered toward neurotypical people, jury service remains inaccessible for many neurodivergent people who need accommodations to attend trial and engage in jury deliberations. If courts and advocates do not consider how to develop accommodations to secure the service of neurodivergent jurors, they will miss out on the unique skillsets that neurodivergent people can bring to resolving disputes.

Disabled …

Redefining Section 230 Immunity, Lucas Dini

Seattle University Law Review

Section 230 of the Communications Decency Act has provided broad immunity to online platforms for third-party content which was the foundation for the internet's growth. However, the rise in the use of artificial intelligence (AI) to produce algorithms to curate content to users of online services has blurred the line between being a passive host of third party content and active editorial control. This Note examines the legal, policy, and constitutional implications of applying Section 230 immunity to platforms that use AI to curate and promote third-party content. This analysis argues that algorithmic promotion of third-party content constitutes a platform's …

Overcrowding The System: Rethinking Juvenile Justice In Washington State, Mckenna White

Seattle University Law Review

The recent crisis at Green Hill School highlights the detrimental consequences of severe overcrowding in Washington State’s Juvenile Rehabilitation system—a problem exacerbated by the implementation of the JR to 25 legislation. This Note argues that the juvenile rehabilitation system, which is currently struggling to manage a wide age range of offenders, necessitates a fundamental rethinking of juvenile justice practices. By examining neurological research indicating continued brain development into the mid-twenties, along with the high prevalence of trauma among justice-involved youth, this Note proposes the creation of a dedicated third system of care within the Department of Children, Youth, and Families …

Addressing The Root Of Housing Insecurity: Washington Should Divest From “Crime-Free” Housing Programs, Sarah Cerdena

Seattle University Law Review

Crime-Free Rental Housing Properties (CFRHPs) have proven to be an ineffective and inequitable approach to public safety. Often, tenants in these properties are evicted—at times, extrajudicially—as a result of conduct that does not rise to violations of their lease provisions, much less criminal behavior. By placing extraordinary power in the hands of local law enforcement to carry out these ordinances, CFRHPs predictably pose significant harm to Black and Latinx communities, survivors of domestic violence, disabled tenants, and low-income tenants generally. Recently, the Washington State Supreme Court grappled with the tensions arising between CFRHPs and the enforcement of Washington landlord-tenant law. …

Volume 49 Masthead

Seattle University Law Review

Volume 49 Masthead

Esg Investing Breaches Erisa Fiduciary Duties? A Closer Look At Spence V. American Airlines, Inc., Eric Chin-Ru Chang

Seattle University Law Review

In Spence v. American Airlines, Inc., the U.S. District Court for the Northern District of Texas found that American Airlines breached its fiduciary duties due to BlackRock’s ESG investing practices. Contrary to some reports suggesting that the ruling prohibits ESG investing under ERISA, a closer look at the ruling shows that the court only targeted American Airlines’ failure to manage conflicts of interest appropriately, rather than the legality of ESG investing itself. In light of the intensifying ESG backlash in the United States, this Article cautions against further restrictive measures on ESG investing. Such measures would exacerbate the widening …

Pardon Me Please: Evaluating Clemency For Marijuana Offenders, Mitchell F. Crusto

Washington and Lee Law Review Online

Since 2012, several states and municipalities have decriminalized the non-violent use and possession of small amounts of recreational marijuana by adults. These criminal law reforms raise the issue of whether individuals who were convicted in the past should be exonerated retroactively by way of pardons or clemency. Consequently, many past marijuana offenders remain in state prisons for committing acts that are no longer deemed illegal in many states. Furthermore, these prisoners, as well as persons who were formerly accused or imprisoned, suffer from the stigma and negative collateral consequences of their alleged criminality. In response to these injustices, many governors …

“Contains: Gluten” And “Gluten Free”; Fda, It’S A No-Grainer!, Elizabeth Bulat

Cardozo Law Review

Reading food, drug, and cosmetic labels is a frequent practice for all individuals with allergies. However, unlike those who are allergic to peanuts, dairy, or another major food allergen, individuals with celiac disease (“celiac consumers”) are not offered a bold, capitalized statement clearly identifying the allergen they seek to avoid. Instead, celiac consumers are tasked with studying a list of ingredients and relying on their own ability to catch any sources of gluten. This Note considers the authority provided by Congress to the Federal Food and Drug Administration (FDA) to remedy this rash regime. Then, this Note proposes that the …

Venturing Into Health, Rachel E. Sachs

Fordham Law Review

In recent years, the landscape of venture capital (VC) investment in healthcare technologies has been altered by the introduction of new types of VC firms: those that have emerged from hospital systems and health insurers. However, the legal literature has not yet analyzed these new VC firms, the role they may play in healthcare innovation, and how innovation law and policy ought to consider their involvement. Hospital system and health insurer VC firms operate very differently than traditional VC firms, even those that have historically developed healthcare specializations. Instead of simply investing capital into start-up firms, hospital system and health …

Double Dosing: How Brand-Name Pharmaceutical Manufacturers Manipulate Patent Rules To Extend Market Exclusivity, Elizabeth Hertzberg

Washington and Lee Law Review

A robust patent system is important for spurring innovation, but it is not without risk. Because a patent owner has exclusivity over the patented subject matter for a specific term, there is incentive to extend that monopoly however possible. Identical subject matter is unpatentable, but obvious variants of an existing patent may be allowed if the applicant agrees to the same expiration date for both patents. This agreement is called a terminal disclaimer. While patents tied together with terminal disclaimers may not necessarily lead to unjust patent term extensions, an army of terminal disclaimers directed at one invention presents a …

When Executions Don't Kill: The Stories Of Eight People Who Survived Their Date With Death, Austin Sarat, Julia Morgan-Canales, Aidan Gemme

Cardozo Journal of Equal Rights & Social Justice

This Article focuses on the eight people who have survived execution attempts in the last 100 years. Some of them faced a second attempt to carry out the sentence. Others escaped that fate only to die in prison; one reached an agreement with the state to allow them to remain in prison for the rest oftheir life, and the fate of another is up in the air.

By examining what went wrong in their executions and the accounts of those events offered by defense lawyers, state officials, and judges, this Article suggests that these executions fall into distinct genres. Each …

The Ethics Of Industry-Funded Speakers’ Bureaus—How They Disseminate Innovation And Could Corrupt Medicine, Jennifer E. Miller, Christopher Robertson

Faculty Scholarship

It is often said that a business without marketing is dead. But when a medical product is marketed irresponsibly, it is patients who may pay with their lives. In this context, Wieberdink et al¹ examine participation in industry-sponsored speakers’ bureaus by academic clinical faculty, conceptualizing the practice as a form of conflicted and irresponsible pharmaceutical marketing. Reviewing 129 US allopathic medical school conflict-of-interest (COI) policies, they found that less than 40% prohibit industry speakers’ bureau participation outright, while 19% impose conditional restrictions, such as requiring that faculty retain control over presentation content. Wieberdink et al¹ advocate for a …

Wine Unwelcome: The Constitutional Contours Of Wine Regulation, Alexander Fallone

Brooklyn Journal of Corporate, Financial & Commercial Law

Wine retail shops face a dizzying labyrinth of state laws that severely restrict their ability to ship wine to out-of-state consumers. While the dormant Commerce Clause would normally strike down laws that impose restrictions on interstate commerce, wine (and alcoholic beverages) must contend with Section Two of the Twenty-first Amendment, which gives the states control over the importation and distribution of wine intending to be consumed within their borders. Court of Appeals cases interpreting Supreme Court precedent on the tension between the dormant Commerce Clause and Section Two have practically stripped the dormant Commerce Clause of any power. This Note …

Are Ai-Assisted Drug Technologies Addressing Or Aggravating The Opioid Crisis In The United States?, Abby O'Hern

West Virginia Law Review

The opioid crisis is a significant public health emergency, intensified by the rise of synthetic opioids such as fentanyl. Lawmakers have described fentanyl as “terroristic in nature” due to its often-fatal properties. According to the Center for Disease Control (“CDC”), an estimated 107,543 people died from drug overdoses in the United States in 2023. As fentanyl use has surged, it has increasingly shaped public health policy through harm reduction initiatives, expanded addiction treatment resources, and legislative reforms aimed at curbing overdose deaths. Artificial Intelligence (“AI”) now plays a dual role in this evolving crisis. While AI technologies offer valuable tools …

Rethinking Aquaculture Regulation In A Post-Chevron World, Kamaile A. N. Turčan

Fordham Environmental Law Review

After the Supreme Court overruled Chevron deference in Loper Bright v. Raimondo, commentators warned of the detriment to federal agencies resulting from the loss of judicial deference to agencies’ interpretations of the statutes they administer. This Essay takes a different approach and examines how advocates for agency authority can use this shift away from judicial deference to their advantage—by refocusing litigation strategy toward congressional delegations. Statutory interpretation arguments need no longer focus on whether an agency is intruding on the judicial prerogative to interpret the law and can now focus instead on whether a court is intruding on the …

Agricultural Biotechnology In The Courts: Judicial Opinions And Commentary, Drew L. Kershen

Faculty Articles

Seven jurisdictions from around the world have issued judicial opinions that address fundamental issues about the governance and regulatory systems of agricultural biotechnology. This article summarizes these legal proceedings and describes their impact upon agricultural biotechnology. The article then provides a commentary and critique of the legal proceedings and resulting judicial opinions.

Redressing The Harm Of Accelerated Approval, Laura Karas

Articles

The accelerated approval pathway of the United States Food and Drug Administration (FDA) enables drugs to come to market more quickly than would be possible under a traditional FDA approval pathway. Accelerated approval is based upon the agency's determination that changes in a surrogate or intermediate clinical endpoint are "reasonably likely" to predict a clinical benefit meaningful for patients. In essence, the pathway affords sick patients earlier access to potentially beneficial drugs while trials to confirm clinical benefit continue. Accelerated approval has been likened to a social compromise in which promising drugs enter the market sooner in exchange for a …

Volume 48 Masthead

Seattle University Law Review

Volume 48 Masthead

Keynote Address: Community Over Constitution, Riddhi Mukhopadhyay

Seattle University Law Review

In this keynote address, Riddhi Mukhopadhyay challenges the veneration of the U.S. Constitution by highlighting its origins in exclusion and its continued failure to protect marginalized communities. Drawing from her experience in civil legal aid and gender justice, she argues that the Constitution was drafted to consolidate power among white, wealthy men and continues to reflect that legacy through racial, gender, and class-based inequities. While acknowledging the significance of constitutional amendments and landmark cases, Mukhopadhyay emphasizes that meaningful change has always come from community-led action, not top-down reform. Additionally, Mukhopadhyay calls on lawyers and legal advocates to center community, practice …

The Lost Child: A Critique On Transracial Adoption Rhetoric, Hallie Conyers-Tucker

Seattle University Law Review

Transracial adoption in the United States reflects a deeply rooted history of colonialism, cultural assimilation, and racial hierarchy, masked by rhetoric focused on the “best interest of the child.” The author critiques that rhetoric and traces how adoption practices and policies, both domestic and international, have evolved to reinforce systemic inequities. Through historical analysis of the forced adoption of Native American, Black, and Asian children, it reveals how the best interest standard has been wielded not to protect children but to uphold political and racial ideologies. The author argues that the prevailing adoption framework relies on child-saving and color-blind narratives …

A Global Reconstruction: Black Internationalism And The Human Rights Regime, Britta Redwood

Seattle University Law Review

Black American advocates for civil, political, and economic rights have long taken an internationalist approach and fostered connections with international organizations and transnational movements. This engagement has also been a generative force and played role in shaping international law. Beginning in the early years of the twentieth century, Black intellectuals and leaders, spearheaded by the NAACP and the UNIA, focused on human rights as a means for addressing and repairing the harms wrought by slavery, Jim Crow, and racism. From the Paris Peace Conference of 1919 through the Universal Declaration of Human Rights, the Genocide Convention, and the drafting of …