Food and Drug Law Commons^™

Seeding A Movement: Indigenous Food Sovereignty, Mariaelena Huambachano

University of Miami Law Review

For many Indigenous peoples, well-being is bound up with and inseparable from the natural world. But since colonialism, Indigenous traditions and access to traditional foods or foodways have been disrupted, imperiling their health and well-being. In this Article, I discuss the role of Indigenous cosmovision/worldview and Indigenous Food Sovereignty in achieving environmental justice. Specifically, in this Article, I discuss that despite, or perhaps because of, efforts to deny Indigenous peoples’ access to healthy and culturally appropriate foods, Indigenous Food Sovereignty took a rise of preciousness in informing natural regenerative food systems, and ultimately, “holistic/collective well-being.”

U.S. Food & Drug Administration V. Alliance For Hippocratic Medicine: Brief For Food And Drug Law Scholars And Professors As Amici Curiae Supporting Petitioners And Reversal, Rebecca S. Eisenberg

Appellate Briefs

Amici curiae are U.S. food and drug law scholars and professors from academic institutions across the United States. A full list of amici is included as an Appendix to this brief. Amici have expertise in food and drug law, including the drug approval process and regulation of pharmaceuticals under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. Amici submit this brief to address important issues raised by this case concerning the authority of the U.S. Food & Drug Administration (FDA or the Agency) to regulate prescription drugs.

The Federal Food, Drug, and Cosmetic Act …

Cracking Down On Egg Law: Legal Discrepancies Impacting Sales Of Ungraded Eggs In Texas, Parker Benton

St. Mary's Law Journal

No abstract provided.

Legal, Policy, And Environmental Scholars Discuss Global Food Systems At Indiana Law Symposium, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

The Indiana University Maurer School of Law and its Indiana Journal of Global Legal Studies are hosting scholars from around the country Friday and Saturday (Jan. 19-20) for an interdisciplinary discussion on one of the world’s most prevalent problems—food insecurity.

Data from the World Bank estimate more than 780 million people around the world suffered from chronic hunger in 2022. As climate change affects agricultural production and water accessibility, the problem could worsen in coming years.

“A Fragile Framework: How Global Food Systems Intersect with the International Legal Order, the Environment, and the World’s Populations” will bring together legal, policy, …

National Pork Producers Council V. Ross: Reining In The Dormant Commerce Clause, Pushing The Limits Of State Sovereignty, Jessica Kowalski

Loyola University Chicago Law Journal

The dormant Commerce Clause is one of the oldest constitutional doctrines in the United States and is essential in maintaining equal sovereignty among the states. While the doctrine has been substantially refined since it was first recognized, it had gone largely unchanged in recent years, until a controversial California law required further clarification of its scope.

In National Pork Producers Council v. Ross, the Supreme Court considered whether a California law prohibiting the in-state sale of pork produced in cruel conditions was constitutional under the dormant Commerce Clause. The Court ultimately upheld the California law, holding that a regulation …

A History Of Corporate Law Federalism In The Twentieth Century, William W. Bratton

Seattle University Law Review

This Article describes the emergence of corporate law federalism across a long twentieth century. The period begins with New Jersey’s successful initiation of charter competition in 1888 and ends with the enactment of the Sarbanes-Oxley Act in 2002. The federalism in question describes the interrelation of state and federal regulation of corporate internal affairs. This Article takes a positive approach, pursuing no normative bottom line. It makes six observations: (1) the federalism describes a division of subject matter, with internal affairs regulated by the states and securities issuance and trading regulated by the federal government; (2) the federalism is an …

Stakeholder Capitalism’S Greatest Challenge: Reshaping A Public Consensus To Govern A Global Economy, Leo E. Strine Jr., Michael Klain

Seattle University Law Review

The Berle XIV: Developing a 21st Century Corporate Governance Model Conference asks whether there is a viable 21st Century Stakeholder Governance model. In our conference keynote article, we argue that to answer that question yes requires restoring—to use Berle’s term—a “public consensus” throughout the global economy in favor of the balanced model of New Deal capitalism, within which corporations could operate in a way good for all their stakeholders and society, that Berle himself supported.

The world now faces problems caused in large part by the enormous international power of corporations and the institutional investors who dominate their governance. These …

Henderson And The Objective Observer Standard: The Future Of Race-Conscious Standards Post-Students For Fair Admissions, Gabriela Dionisio

Seattle University Law Review

On June 29, 2023, the Supreme Court of the United States decided Students for Fair Admissions v. President & Fellows of Harvard College, which struck down race-conscious admissions policies. Within just a year after its ruling, Students for Fair Admissions has already had a sweeping impact, reaching beyond higher education. Although the Supreme Court did not indicate whether Students for Fair Admissions applies to sectors beyond higher education, law firms, and other employers have already modified their diversity policies and initiatives, erasing race and company diversity considerations. Given those dramatic changes, there is growing fear that Students for Fair Admissions …

Same Crime, Different Time: Sentencing Disparities In The Deep South & A Path Forward Under The Fourteenth Amendment, Hailey M. Donovan

Seattle University Law Review

The United States has the highest incarceration rate of any country in the world. The American obsession with crime and punishment can be tracked over the last half-century, as the nation’s incarceration rate has risen astronomically. Since 1970, the number of incarcerated people in the United States has increased more than sevenfold to over 2.3 million, outpacing both crime and population growth considerably. While the rise itself is undoubtedly bleak, a more troubling truth lies just below the surface. Not all states contribute equally to American mass incarceration. Rather, states have vastly different incarceration rates. Unlike at the federal level, …

Offshore Wind: A Comparative Of The United States And Norway

Fordham Environmental Law Review

No abstract provided.

Assessing The Human Right To Water And Sanitation In International Law And The Conflict In The Nile Basin

Fordham Environmental Law Review

Ethiopia’s construction and operation of the Grand Ethiopian

Renaissance Dam (GERD) on the Blue Nile has intensified the long-

standing water conflict involving Ethiopia, Egypt, and Sudan, and

highlights the urgent need for a new legal framework for the Nile

Basin’s governance. This article traces the history of the international

human right to water and sanitation and previous attempts to govern

water use in the Nile Basin. We argue that outdated colonial-era

treaties, which Egypt and Sudan insist on using as a baseline for

negotiations, are a significant obstacle to resolving the Nile conflict

and managing the region’s water resources …

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 …