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Food and Drug Law

2024

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Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha Oct 2024

Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha

All Faculty Scholarship

Energy drinks first rose to popularity in the 1980s. Red Bull energy drinks were the first of its kind, opening the door to a new consumer and regulatory landscape. Since Red Bull first launched, multiple companies have released countless new energy drink products. Some energy drinks, like Red Bull, contain less than 100 mg of caffeine per 8 oz can. However, other energy drinks contain much higher amounts of caffeine. A 12 oz can of Celsius contains 200 mg of caffeine, and up until recently, Celsius offered a product called Celsius Heat, a 12 oz can containing 300 mg of …


Confronting Cosmetic Carcinogens: A Proposal Regarding The Dangers Of Talcum Powder, Rachael Howell Apr 2024

Confronting Cosmetic Carcinogens: A Proposal Regarding The Dangers Of Talcum Powder, Rachael Howell

Helm's School of Government Conference - American Revival: Citizenship & Virtue

The Federal Government needs to stop the import, export, mining, and distribution of talcum powder in the United States. This is an issue that affects all Americans, especially active-duty military members.

Since 2013, there have been over 38,000 lawsuits against Johnson & Johnson, which allege that their talcum-based baby powder caused cancer. The plaintiffs in the very first talc case in the U.S. have died. All four of the plaintiffs from a 2019 suit have died. Yet, the 2019 case has been reversed and remanded. The FDA has redacted the names of scientist(s) that conduct “safety tests” on talc samples. …


I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha Apr 2024

I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha

All Faculty Scholarship

In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”).1 The MOU proscribes that the FTC regulates truth in advertising relating to foods, drugs, devices and cosmetics while the FDA controls labeling and the misbranding of foods, drugs, devices, and cosmetics shipped in interstate commerce.2 The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century.3

Importantly, the FDA and the …


Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka Apr 2024

Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka

Vanderbilt Law Review

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …


The Wild, Wild West Of Laboratory Developed Tests, John Gilmore Mar 2024

The Wild, Wild West Of Laboratory Developed Tests, John Gilmore

Washington and Lee Law Review Online

Since the 1950’s, scientists have built novel technologies to screen for genetic diseases and other biological irregularities. Recently, researchers have developed a method called “liquid biopsy” (as opposed to a standard tissue biopsy) that uses a liquid sample (e.g., blood) to non‑invasively spot biomarkers indicating different types of cancers in the patient’s body. While the U.S. Food and Drug Administration (FDA) has fully cleared a small number of liquid biopsy tests under its rigorous and expensive review process, most biotech companies have instead followed a less restrictive regulatory path through the Centers for Medicare and Medicaid Services (CMS), which label …


U'Wa Indigenous People Vs. Columbia: Potential Applications Of The Escazu Agreement, Ariana Lippi Mar 2024

U'Wa Indigenous People Vs. Columbia: Potential Applications Of The Escazu Agreement, Ariana Lippi

Sustainable Development Law & Policy

Though the case is ongoing, and results are still to be seen, it in many ways sets a precedent for indigenous communities in Latin America seeking redress for environmental and cultural injustices. With Colombia’s recent ratification of The Escazú Regional Agreement (the Agreement herein) in 2022, this case presents a unique opportunity for implementation of the Agreement and greater accountability within existing domestic legislation.


Natural Resources In The Arctic: The Equal Distribution Of Uneven Resrouces, Ganeswar Matcha, Sudarsanan Sivakumar Mar 2024

Natural Resources In The Arctic: The Equal Distribution Of Uneven Resrouces, Ganeswar Matcha, Sudarsanan Sivakumar

Sustainable Development Law & Policy

This paper analyses the governance machine in place at the Arctic and examines the application of the principles of “common heritage of mankind” at the Arctic. This paper also offers some tentative propositions aimed at protecting Out Bound investment rights and how the World Trade Organization or other countries, like the U.S., can intercede in the Arctic investment sphere and attempt to regulate along with the United Nations Convention for the Law of the Sea.


Incentivizing Sustainability In American Enterprise: Lessons From Finnish Model, Vasa T. Dunham Mar 2024

Incentivizing Sustainability In American Enterprise: Lessons From Finnish Model, Vasa T. Dunham

Sustainable Development Law & Policy

The disparate climate performances of Finland and the United States, two of the wealthiest countries in the world, bring to light the question of how corporate responsibility has been inspired in each jurisdiction. Having established the urgency of the climate crisis and the importance of corporate behavior in optimizing a given country’s approach to protection of the global environment, an examination of each nation’s legal frameworks may shed light on features of the corporate regime that are effective in advancing sustainability goals and those that are not.22 Part I of this paper establishes a comparative framework by providing background on …


Editor's Note, Shade Streeter, Reagan Ferris Mar 2024

Editor's Note, Shade Streeter, Reagan Ferris

Sustainable Development Law & Policy

The Sustainable Development Law & Policy Brief (ISSN 1552-3721) is a student-run initiative at American University Washington College of Law that is published twice each academic year. The Brief embraces an interdisciplinary focus to provide a broad view of current legal, political, and social developments. It was founded to provide a forum for those interested in promoting sustainable economic development, conservation, environmental justice, and biodiversity throughout the world.


Just Don’T Do It: Why Cannabis Regulations Are The Reason Cannabis Businesses Are Failing, Edward Adams Mar 2024

Just Don’T Do It: Why Cannabis Regulations Are The Reason Cannabis Businesses Are Failing, Edward Adams

Nevada Law Journal

No abstract provided.


High Times, Higher Stakes: Mental Health Impacts In New Recreational Marijuana Legal Landscape, Jason T. Lorenzon J.D., Chris Pezalla, Diana Semilia Feb 2024

High Times, Higher Stakes: Mental Health Impacts In New Recreational Marijuana Legal Landscape, Jason T. Lorenzon J.D., Chris Pezalla, Diana Semilia

National Training Aircraft Symposium (NTAS)

This presentation delves into the societal and mental health consequences arising from the increasing trend of legalizing recreational marijuana. Specifically, we will examine the potential normalization of unconventional behavior among aviation college students, who may grapple with substance use challenges due to stress, sleep difficulties, and the demands of college life. Given the rigorous nature of flight training, prioritizing the mental well-being of pilots becomes imperative.

With the recent legalization of recreational marijuana in Ohio, this presentation integrates insights from Diana Semilia's 2022 study on Kent State Flight Students Ages 19-26. The study's objective was to extract practical recommendations applicable …


Seeding A Movement: Indigenous Food Sovereignty, Mariaelena Huambachano Jan 2024

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.”


‘Rounding Up’ Roundup: One Last Hope For Glyphosate Regulation, Gabrielle Argimón-Cartaya Jan 2024

‘Rounding Up’ Roundup: One Last Hope For Glyphosate Regulation, Gabrielle Argimón-Cartaya

University of Miami Law Review

Since 1974, Bayer’s Roundup remains the world’s most popular herbicide and pervades United States farmland and food production. However, in 2015, Roundup landed centerstage in an international and presently unsettled debate over whether its active ingredient, glyphosate, causes cancer. Environmental groups regularly call for the de-registration of glyphosate due to the plethora of ailments, ecological harm, and weed resistance resulting from glyphosate use. Dissenting experts, however, believe that strict bans would devastate agriculture because of global dependence and the lack of any popular alternatives. Faced with mounting litigation, silence from the highest court, and unreliable regulators, Bayer continues to effect …


Cracking Down On Egg Law: Legal Discrepancies Impacting Sales Of Ungraded Eggs In Texas, Parker Benton Jan 2024

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 Jan 2024

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, …


We(Ed) Hold These Truths To Be Self Evident: All Things Cannabis Are Inequitable, Garrett I. Halydier Jan 2024

We(Ed) Hold These Truths To Be Self Evident: All Things Cannabis Are Inequitable, Garrett I. Halydier

University of Massachusetts Law Review

Current approaches to social equity in the cannabis industry continue to fail to promote racial equity while simultaneously exacerbating gender, environmental, and other inequities. To better understand the structural dynamics underlying this phenomenon, I first present a multi-disciplinary recounting of not only the racial inequities, but also the stigma, business, research, energy, sex and gender, hemp, and international inequities of the War on Drugs. This serves as the foundation for a compilation of the structural and theoretical reasons for how current social equity policies, whether targeting the cannabis industry, community reinvestment, social justice, or access equity, will only continue to …


Free For All: Proposing Legislation To Eliminate Food Insecurity In Arkansas Public Schools, A. Mills Bryant Jan 2024

Free For All: Proposing Legislation To Eliminate Food Insecurity In Arkansas Public Schools, A. Mills Bryant

Journal of Food Law & Policy

Schools serve millions of students daily as one of the largest food distribution sites in the United States. However, more than 13.1 million children in the United States, and almost 150,000 in Arkansas, are food insecure. Before the COVID-19 pandemic, most Arkansas schools offered free and reduced lunch to students at or below the poverty line through participation in the National School Lunch Program (“NSLP”). During COVID-19, Congress passed The Families First Coronavirus Response Act (“FFCRA”) and The Coronavirus Aid, Relief, and Economic Security Act (“CARES”) (hereinafter “The Acts”). This legislation effectively eliminated food insecurity in participating American public schools, …


Chewing The Welfare Cud: A Digested Analysis Of A Consumer Versus Producer-Defined Standard Of Welfare Practices In Animals Raised For Human Consumption, Caitlin C. Robb Jan 2024

Chewing The Welfare Cud: A Digested Analysis Of A Consumer Versus Producer-Defined Standard Of Welfare Practices In Animals Raised For Human Consumption, Caitlin C. Robb

Journal of Food Law & Policy

Since the eighteenth century, animal well-being remains a concern for American citizens. Yet, underlying this concern is the thought that while humans should not be cruel to animals, animals are still private property subject to human ownership. Therefore, multi-faceted questions of what constitutes “animal welfare” find a place in modern American debate. One such question becomes: should the producer or the consumer define welfare practice standards of animals raised for human consumption?7 This note provides an answer to this question by first analyzing the robust history of animal welfare in the United States, along with the domestic and international impact …


Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha Jan 2024

Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha

Journal of Food Law & Policy

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be proven safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. We call on Congress to amend DSHEA to …


The Contradictory Nature Of U.S. Laws And Nutrition Programs And Their Effects On Infant Feeding, Lily Patel Jan 2024

The Contradictory Nature Of U.S. Laws And Nutrition Programs And Their Effects On Infant Feeding, Lily Patel

Journal of Food Law & Policy

The contradictory nature of U.S. laws, including the laws concerning infant feeding, though supposedly aligned with policies to promote wellness in Americans, can exacerbate gender and race inequality and work against the National Strategy. The overarching goal of U.S. laws concerning infant feeding is to ensure that infants are fed, nourished, and receive proper nutrition. However, the laws often appear to be directly contradictory to one another in the priorities they are promoting.


Journal Of Food Law & Policy - Fall 2023, Journal Editors Jan 2024

Journal Of Food Law & Policy - Fall 2023, Journal Editors

Journal of Food Law & Policy

No abstract provided.


The Need For Corporate Guardrails In U.S. Industrial Policy, Lenore Palladino Jan 2024

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 …


Table Of Contents, Seattle University Law Review Jan 2024

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents


Public Primacy In Corporate Law, Dorothy S. Lund Jan 2024

Public Primacy In Corporate Law, Dorothy S. Lund

Seattle University Law Review

This Article explores the malleability of agency theory by showing that it could be used to justify a “public primacy” standard for corporate law that would direct fiduciaries to promote the value of the corporation for the benefit of the public. Employing agency theory to describe the relationship between corporate management and the broader public sheds light on aspects of firm behavior, as well as the nature of state contracting with corporations. It also provides a lodestar for a possible future evolution of corporate law and governance: minimize the agency costs created by the divergence of interests between management and …


Shareholder Primacy Versus Shareholder Accountability, William W. Bratton Jan 2024

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 …


Stakeholder Governance As Governance By Stakeholders, Brett Mcdonnell Jan 2024

Stakeholder Governance As Governance By Stakeholders, Brett Mcdonnell

Seattle University Law Review

Much debate within corporate governance today centers on the proper role of corporate stakeholders, such as employees, customers, creditors, suppliers, and local communities. Scholars and reformers advocate for greater attention to stakeholder interests under a variety of banners, including ESG, sustainability, corporate social responsibility, and stakeholder governance. So far, that advocacy focuses almost entirely on arguing for an expanded understanding of corporate purpose. It argues that corporate governance should be for various stakeholders, not shareholders alone.

This Article examines and approves of that broadened understanding of corporate purpose. However, it argues that we should understand stakeholder governance as extending well …


Corporate Law In The Global South: Heterodox Stakeholderism, Mariana Pargendler Jan 2024

Corporate Law In The Global South: Heterodox Stakeholderism, Mariana Pargendler

Seattle University Law Review

How do the corporate laws of Global South jurisdictions differ from their Global North counterparts? Prevailing stereotypes depict the corporate laws of developing countries as either antiquated or plagued by problems of enforcement and misfit despite formal convergence. This Article offers a different view by showing how Global South jurisdictions have pioneered heterodox stakeholder approaches in corporate law, such as the erosion of limited liability for purposes of stakeholder protection in Brazil and India, the adoption of mandatory corporate social responsibility in Indonesia and India, and the large-scale program of Black corporate ownership and empowerment in South Africa, among many …


A Different Approach To Agency Theory And Implications For Esg, Jonathan Bonham, Amoray Riggs-Cragun Jan 2024

A Different Approach To Agency Theory And Implications For Esg, Jonathan Bonham, Amoray Riggs-Cragun

Seattle University Law Review

In conventional agency theory, the agent is modeled as exerting unobservable “effort” that influences the distribution over outcomes the principal cares about. Recent papers instead allow the agent to choose the entire distribution, an assumption that better describes the extensive and flexible control that CEOs have over firm outcomes. Under this assumption, the optimal contract rewards the agent directly for outcomes the principal cares about, rather than for what those outcomes reveal about the agent’s effort. This article briefly summarizes this new agency model and discusses its implications for contracting on ESG activities.


The Limits Of Corporate Governance, Cathy Hwang, Emily Winston Jan 2024

The Limits Of Corporate Governance, Cathy Hwang, Emily Winston

Seattle University Law Review

What is the purpose of the corporation? For decades, the answer was clear: to put shareholders’ interests first. In many cases, this theory of shareholder primacy also became synonymous with the imperative to maximize shareholder wealth. In the world where shareholder primacy was a north star, courts, scholars, and policymakers had relatively little to fight about: most debates were minor skirmishes about exactly how to maximize shareholder wealth.

Part I of this Essay discusses the shortcomings of shareholder primacy and stakeholder governance, arguing that neither of these modes of governance provides an adequate framework for incentivizing corporations to do good. …


Table Of Contents, Seattle University Law Review Jan 2024

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents