Food and Drug Law Commons^™

Debts And Desertion: Bankruptcy Law And The Orphan Well Crisis

Fordham Environmental Law Review

The issue of orphan wells—unplugged and unproductive oil and

gas wells with no responsible operator—poses a significant

environmental and public health threat in the United States. The scale

of this crisis is alarming: there are over 120,000 documented orphan

wells and potentially millions more undocumented. These wells are

often significant sources of methane emissions and other toxins that

exacerbate climate change and endanger the health of surrounding

communities. This paper examines the orphan well crisis, exploring

how wells become orphaned and the environmental and health

impacts associated with them. Furthermore, it delves into how the

situation is likely to worsen …

The Federal Future Of Medication Abortion, Michelle S. Simon

Elisabeth Haub School of Law Faculty Publications

A majority of Americans believe that there should be a right to abortion, at least in some cases. Yet a vocal and determined minority has its sights set on a complete ban on all abortions everywhere in the United States. In many states, these anti-abortion activists have achieved their goal through new laws and limitations enacted in the wake of the Supreme Court's 2022 decision in Dobbs. Anti-abortion advocates are also challenging the Food and Drug Administration's regulatory approval of mifepristone, one of the drugs used in medication abortion (also known as medical abortion). The FDA had initially approved mifepristone …

Identifying Youth Appeals In Alcohol Alternative Social Media Content Through Framing, Melina Oneal

West Chester University Master’s Theses

Proposed regulations for alcohol advertising prevent beverage companies from targeting people under the legal drinking age. However, similar regulations for alcohol alternative beverages are less explored, which could allow alcohol alternative products to create awareness for alcoholic beverages among youth. Alcohol alternatives beverages, including no-alcohol and low-alcohol products, are increasing in popularity and can function as compliments to alcoholic products to decrease the total alcohol volume consumed or as substitutes for alcoholic products. Framing theory can be operationalized through the Content Appealing to Youth Index, an index of content elements found in research literature to be appealing to youth, to …

Ductus Exemplo: A Model Municipal Executive Order On Food Waste Reduction, Linda Breggin, Darby Hoover, Jessica Sugarman

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Petition Power, Erika Lietzan

Faculty Publications

The law cannot be kept secret. We cannot comply with rules that we do not know. Nor can we question their legitimacy, which is both our right and our duty as citizens. And yet, a substantial body of law applied in this country is difficult for anyone but federal agency insiders to piece together. Rather than publishing regulations that lay out standards of conduct for the future, many agencies interpret the law, and articulate and implement new policies, as they go. Those subject to the law they implement are left to piece the rules together by studying whatever information is …

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …

The Need For Corporate Guardrails In U.S. Industrial Policy, Lenore Palladino

Seattle University Law Review

U.S. politicians are actively “marketcrafting”: the passage of the Bipartisan Infrastructure Law, the CHIPS and Science Act, and the Inflation Reduction Act collectively mark a new moment of robust industrial policy. However, these policies are necessarily layered on top of decades of shareholder primacy in corporate governance, in which corporate and financial leaders have prioritized using corporate profits to increase the wealth of shareholders. The Administration and Congress have an opportunity to use industrial policy to encourage a broader reorientation of U.S. businesses away from extractive shareholder primacy and toward innovation and productivity. This Article examines discrete opportunities within the …

Securities Regulation And Administrative Deference In The Roberts Court, Eric C. Chaffee

Seattle University Law Review

In A History of Securities Law in the Supreme Court, A.C. Pritchard and Robert B. Thompson write, “Securities law offers an illuminating window into the Supreme Court’s administrative law jurisprudence over the last century. The securities cases provide one of the most accessible illustrations of key transitions of American law.” A main reason for this is that the U.S. Securities and Exchange Commission (SEC) is a bellwether among administrative agencies, and as a result, A History of Securities Law in the Supreme Court is a history of administrative law in the Supreme Court of the United States as well.

Delegated Corporate Voting And The Deliberative Franchise, Sarah C. Haan

Seattle University Law Review

Starting in the 1930s with the earliest version of the proxy rules, the Securities and Exchange Commission (SEC) has gradually increased the proportion of “instructed” votes on the shareholder’s proxy card until, for the first time in 2022, it required a fully instructed proxy card. This evolution effectively shifted the exercise of the shareholder’s vote from the shareholders’ meeting to the vote delegation that occurs when the share-holder fills out the proxy card. The point in the electoral process when the binding voting choice is communicated is now the execution of the proxy card (assuming the shareholder completes the card …

Capitalism Stakeholderism, Christina Parajon Skinner

Seattle University Law Review

Today’s corporate governance debates are replete with discussion of how best to operationalize so-called stakeholder capitalism—that is, a version of capitalism that considers the interests of employees, communities, suppliers, and the environment alongside (if not before) a company’s shareholders. So much focus has been dedicated to the question of capitalism’s reform that few have questioned a key underlying premise of stakeholder capitalism: that is, that competitive capitalism does not serve these various constituencies and groups. This Essay presents a different view and argues that capitalism is, in fact, the ultimate form of stakeholderism. As such, the Essay urges that the …

The Esg Information System, Stavros Gadinis, Amelia Miazad

Seattle University Law Review

The mounting focus on ESG has forced internal corporate decision-making into the spotlight. Investors are eager to support companies in innovative “green” technologies and scrutinize companies’ transition plans. Activists are targeting boards whose decisions appear too timid or insufficiently explained. Consumers and employees are incorporating companies sustainability credentials in their purchasing and employment decisions. These actors are asking companies for better information, higher quality reports, and granular data. In response, companies are producing lengthy sustainability reports, adopting ambitious purpose statements, and touting their sustainability credentials. Understandably, concerns about greenwashing and accountability abound, and policymakers are preparing for action.

In this …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

The Marijuana Insurgency: Federalism And Social Reframing In Policy Reform, Matthew P. Cavedon

Seattle University Law Review

After fifty years of federal prohibition, marijuana reform efforts have won political and legal success. These victories hold lessons for anyone seeking to resist federal law without being able to directly affect it.

Victory can come from reframing an issue. For marijuana reform, social reframing—not formal legal analysis or material factors—provides the best explanation for how advocates achieved change. Their unconventional political tactics, akin to those used by insurgents in wartime, undercut federal prohibition by winning hearts and minds.

This is an analysis of the sociology of legal change. It is also the story of how ordinary Americans retook personal …

What Is In Your Tampon? Increasing Transparency In Menstrual Products, Elianna Spitzer

Seattle University Law Review

The average person who menstruates will bleed for an average of five days, every twenty-four to thirty-eight days, over several decades and could use thousands of disposable menstrual products in their lifetime. Menstrual products line retail shelves. They can be found in homes, bags, and bodies—but until 2021, manufacturers were not required to disclose the ingredients used to make these products to consumers at all. In fact, they still are not federally required to disclose menstrual product ingredients on product packaging. Instead, in recent years, changes to menstrual product labels have largely been the result of state legislation. In 2019, …

Intersectionality Matters In Food And Drug Law, Colleen Campbell

University of Colorado Law Review

Feminist scholars critique food and drug law as a site of gender bias and regulatory neglect. The historical exclusion of women from clinical trials by the FDA prioritized male bodies as the object of clinical research and therapies. Likewise, the FDA’s prior restriction on access to contraceptive birth control illustrates how patriarchal and paternalistic attitudes within the Agency can harm women’s reproductive health. However, there is little analysis of how race and gender intersect in this domain. This Article uses the regulation of skin-lightening cosmetics products to illustrate why and how intersectionality matters in food and drug law. While the …

Preempting Red State Restrictions On The Use Of Fda-Approved Drugs In Gender-Affirming Care?, Lars Noah

UF Law Faculty Publications

Some observers recently have wondered whether actions by the U.S. Food and Drug Administration (“FDA”) could federally preempt increasingly common state restrictions on gender-affirming care, particularly prohibitions on the use of puberty blockers and cross-sex hormones in adolescent patients. In theory, such a legal strategy might sidestep the need to lodge increasingly unsuccessful challenges under the Fourteenth Amendment. The Supremacy Clause offers little assistance, however, in attempting to get around these state laws. Indeed, even if the FDA eventually approved such uses for currently marketed drugs, implied preemption doctrine as currently configured probably would not do the trick, though securing …

Legal Pressure To Attend Substance Abuse Treatment, Angelicia Courteau

AUCTUS: The Journal of Undergraduate Research and Creative Scholarship

This paper was written to bring awareness of how the legal system does not take into consideration those who suffer from substance use disorder, as well as ACEs. Brian Luke Burijon’s battle with addiction while incarcerated was used as an example of how the legal system’s one-size-fits-all approach is flawed. Mr. Burijon opted for a treatment he did not feel was ideal for him because the alternative was to remain incarcerated for a long period. Mr. Burijon was unable to tolerate the treatment at the facility and left early, which resulted in his overdose death.

Conjuring The Flag: The Problem Of Implied Government Endorsements, Michael Mattioli

Articles by Maurer Faculty

This Article exposes a harmful form of advertising that exploits government actions like patent issuances, FDA authorizations, and trademark registrations. By calling upon the symbolic power of such regulatory approvals—i.e., “conjuring the flag”—marketers deceive consumers, distort competition, and undermine administrative agencies. Using machine-learning techniques to analyze hundreds of ads across multiple media formats, this Article offers the first comprehensive analysis of this pervasive practice. The study reveals that it is especially prevalent in industry settings where consumers are likely to seek reassurance that a product is safe and effective. Specifically, the examples examined show that patents are mentioned frequently in …

Shareholder Primacy Versus Shareholder Accountability, William W. Bratton

Seattle University Law Review

When corporations inflict injuries in the course of business, shareholders wielding environmental, social, and governance (“ESG”) principles can, and now sometimes do, intervene to correct the matter. In the emerging fact pattern, corporate social accountability expands out of its historic collectivized frame to become an internal subject matter—a corporate governance topic. As a result, shareholder accountability surfaces as a policy question for the first time. The Big Three index fund managers, BlackRock, Vanguard, and State Street, responded to the accountability question with ESG activism. In so doing, they defected against corporate legal theory’s central tenet, shareholder primacy. Shareholder primacy builds …

Verses Turned To Verdicts: Ysl Rico Case Sets A High-Watermark For The Legal Pseudo-Censorship Of Rap Music, Nabil Yousfi

Seattle University Law Review

Whichever way you spin the record, rap music and courtrooms don’t mix. On one side, rap records are well known for their unapologetic lyrical composition, often expressing a blatant disregard for legal institutions and authorities. On the other, court records reflect a Van Gogh’s ear for rap music, frequently allowing rap lyrics—but not similar lyrics from other genres—to be used as criminal evidence against the defendants who authored them. Over the last thirty years, this immiscibility has engendered a legal landscape where prosecutors wield rap lyrics as potent instruments for criminal prosecution. In such cases, color-blind courts neglect that rap …

Time To Abolish The Dea: Evaluating The Agency’S Failures And Calling For Community Investments, Ifetayo Harvey

Fordham Law Review

No abstract provided.

Enhancing 21 U.S.C. §§ 355, 356, And 360 To Encompass Artificial Intelligence-Based Drug Design And Manufacturing Methods, Aj Tsang

Michigan Technology Law Review

Despite newfound attention to how artificial intelligence (AI) may accelerate pharmaceutical development, federal regulators may find that current statutes are ambiguous or silent about their applicability to AI-based drug design and manufacturing methods. This poses a serious problem in the era of Loper Bright and the Major Questions Doctrine. As federal agencies struggle to adjust to courts’ growing demand for Congress to craft clear, explicit, and express delegations of authority, this note develops a statutory framework in which the Food and Drug Administration (FDA) would have more flexibility to regulate the use of AI in advanced drug manufacturing. Guided by …

Beyond Traditional Ip: Addressing Regulatory Barriers, Cynthia M. Ho

Faculty Publications & Other Works

The chapter begins with the genesis of relevant regulatory protections and their general parameters before discussing their prevalence among countries. It then turns to discussion of proposed and actual modification of TRIPS requirements for COVID and how that intersects with these regulatory barriers. The chapter concludes with recommendations.

From Streets To Stats: A Statistical Analysis Of The Quantity Of Illegal Narcotics Seized In The United States, Zachary T. Strickland

Tenor of Our Times

This study aims to determine how seven different variables affect the total quantity of illegal narcotics seized. These seven variables include four dichotomous and three continuous variables, each striving to teach readers how they relate to the quantity of narcotics seized across specific states. My goal for this project is to figure out if there is any relationship to help law enforcement fight the war on drugs. With the continuing apparent rise of this war, this study is crucial in determining potential relationships between a state's characteristics and the quantity of illegal narcotics they forcibly take possession of. I further …

Expecting Medication Surveillance, Jennifer D. Oliva

Fordham Law Review

In response to federal financial incentives and mandates, all fifty states, the District of Columbia, and three U.S. territories administer electronic prescription drug monitoring programs (PDMPs). Federal and state policymakers justified the implementation and enhancement of ubiquitous prescription drug monitoring by contending that expansive state drug surveillance was a necessary weapon in the war against the American drug overdose crisis. As is often the case with tools designed for law enforcement surveillance, however, PDMPs have proven susceptible to mission creep. Although pioneer PDMPs were paper-based systems that limited their surveillance to a narrow class of heavily regulated controlled substances, modern …

We Shall Overcome: The Evolution Of Quotas In The Land Of The Free And The Home Of Samba, Stella Emery Santana

Seattle University Law Review

When were voices given to the voiceless? When will education be permitted to all? When will we need to protest no more? It’s the twenty-first century, and the fight for equity in higher education remains a challenge to peoples all over the world. While students in the United States must deal with the increase in loans, in Brazil, only around 20% of youth between the ages of twenty-five and thirty-four have a higher education degree.

The primary objective of this Article is to conduct an in-depth comparative analysis of the development, implementation, and legal adjudication of educational quota systems within …

Pacific Islands And The U.S. Military: The Legal Borderlands Of The Environmental Movement, Sonia Lei

Seattle University Law Review

Climate change remains an urgent, ongoing global issue that requires critical examination of institutional polluters. This includes the world’s largest institutional consumer of petroleum: the United States military. The Department of Defense (DoD) is a massive institution with little oversight, a carbon footprint spanning the globe, a budget greater than the next ten largest nations combined, and overly generous exemptions to environmental regulations and carbon reduction targets. This Comment examines how this lack of accountability and oversight plays out in the context of three Pacific islands that have hosted U.S. military bases for decades. By considering the environmental impact of …

Petition Power, Erika Lietzan

American University Law Review

The law cannot be kept secret. We cannot comply with rules that we do not know. Nor can we question their legitimacy, which is both our right and our duty as citizens. And yet, a substantial body of law applied in this country is difficult for anyone but federal agency insiders to piece together. Rather than publishing regulations that lay out standards of conduct for the future, many agencies interpret the law, and articulate and implement new policies, as they go. Those subject to the law they implement are left to piece the rules together by studying whatever information is …

Defining "Healthy" On Food Labels: One Step Forward, Two Steps Back, Alexia Brunet Marks

Publications

Few definitions of the mid-twentieth century have survived into the twenty-first century. It is worth asking, then, why the definition of "health," articulated seventy-five years ago by the World Health Organization, has endured into the present. The 1948 definition reads as follows: "[h]ealth is a state of complete physical, mental[,] and social well-being and not merely the absence of disease or infirmity." Aspirational in tone, the definition resonates with the surge among consumers towards healthier foods and overall well-being. However, in addition to wartime and pandemic concerns, today's threats to achieving "health" include climate change and a rise in diet-related …

Weed Like Our Money Back: Amending Pennsylvania’S Medical Cannabis Law For Insolvent Cannabusinesses, Nikolajs V. Gaikis

Dickinson Law Review (2017-Present)

In 2016, Pennsylvania joined what is now 37 states and the District of Columbia in legalizing medical cannabis. The Commonwealth’s cannabusinesses share in a struggle that is common in other legal jurisdictions: operating within the confines of the Controlled Substances Act and the Bankruptcy Code. Insolvent individuals and businesses that profit from cannabis or hold cannabis assets cannot declare bankruptcy because cannabis is a Schedule I drug. Under state law, other insolvency alternatives like an assignment for the benefit of creditors, receiverships, and compositions with creditors exist as potential alternatives.

Pennsylvania’s insolvent cannabusinesses are in a uniquely poor position because …