Food and Drug Law Commons^™

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 …

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

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

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

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

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

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

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 …

‘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 …

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 …