Food and Drug Law Commons^™

A First Amendment Failure: Surrendering To Science Misinformation For Bioengineered Foods, Casey J. Nelson

University of Colorado Law Review

Government-compelled commercial disclosures are not unfamiliar to consumers. Common labels include nutrition facts and ingredient information. The National Bioengineered Food Disclosure Standard, which took full force at the start of 2022, is of a different nature. The new law requires all manufacturers, all importers, and certain retailers of bioengineered foods to disclose on the food’s packaging that it has been produced with bioengineering technology. Even so, a large swath of the public is ignorant of “bioengineering’s” true meaning and bioengineering technology’s true quality. The politically charged and fact-lacking debate on bioengineered foods renders this standard an impermissible coercion of speech …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

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 …

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 …

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 …

Stakeholder Governance On The Ground (And In The Sky), Stephen Johnson, Frank Partnoy

Seattle University Law Review

Professor Frank Partnoy: This is a marvelous gathering, and it is all due to Chuck O’Kelley and the special gentleness, openness, and creativity that he brings to this symposium. For more than a decade, he has been open to new and creative ways to discuss important issues surrounding business law and Adolf Berle’s legacy. We also are grateful to Dorothy Lund for co-organizing this gathering.

In introducing Stephen Johnson, I am reminded of a previous Berle, where Chuck allowed me some time to present the initial thoughts that led to my book, WAIT: The Art and Science of Delay. Part …

The Structure Of Corporate Law Revolutions, William Savitt

Seattle University Law Review

Since, call it 1970, corporate law has operated under a dominant conception of governance that identifies profit-maximization for stockholder benefit as the purpose of the corporation. Milton Friedman’s essay The Social Responsibility of Business is to Increase Its Profits, published in September of that year, provides a handy, if admittedly imprecise, marker for the coronation of the shareholder-primacy paradigm. In the decades that followed, corporate law scholars pursued an ever-narrowing research agenda with the purpose and effect of confirming the shareholder-primacy paradigm. Corporate jurisprudence followed a similar path, slowly at first and later accelerating, to discover in the precedents and …

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 …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

How To Interpret The Securities Laws?, Zachary J. Gubler

Seattle University Law Review

In discussions of the federal securities laws, the SEC usually gets most of the attention. This makes some sense. After all, it is the agency charged with administrating the securities laws and regulating the industry as a whole. It makes the majority of the laws; it engages in enforcement actions; it reacts to crises; and it, or sometimes even its individual commissioners, intervene publicly in policy debates. Often overlooked in such discussion, however, is the role of the Supreme Court in shaping securities law, and a new book by Adam Pritchard and Robert Thompson demonstrates why this is an oversight. …

After Affirmative Action, Meera E. Deo

Seattle University Law Review

This is a time of crisis in legal education. In truth, we are in the midst of several crises. We are emerging from the COVID pandemic, a period of unprecedented upheaval where law students and law faculty alike struggled through physical challenges, mental health burdens, and decreased academic and professional success. The past few years also have seen a precipitous drop in applications to and enrollment in legal education. Simultaneously, students have been burdened with the skyrocketing costs of attending law school, taking on unmanageable levels of debt. And with the Supreme Court decision in SFFA v. Harvard, we are …

Going Forward: The Role Of Affirmative Action, Race, And Diversity In University Admissions And The Broader Construction Of Society, Steven W. Bender

Seattle University Law Review

The third annual EPOCH symposium, a partnership between the Seattle University Law Review and the Black Law Student Association took place in late summer 2023 at the Seattle University School of Law. It was intended to uplift and amplify Black voices and ideas, and those of allies in the legal community. Prompted by the swell of public outcry surrounding ongoing police violence against the Black community, the EPOCH partnership marked a commitment to antiracism imperatives and effectuating change for the Black community. The published symposium in this volume encompasses some, but not all, the ideas and vision detailed in the …

The Sffa V. Harvard Trojan Horse Admissions Lawsuit, Kimberly West-Faulcon

Seattle University Law Review

Affirmative-action-hostile admissions lawsuits are modern Trojan horses. The SFFA v. Harvard/UNC case—Students for Fair Admissions, Inc. v. President & Fellows of Harvard College and Students for Fair Admissions, Inc. v. University of North Carolina, et. al., decided jointly—is the most effective Trojan horse admissions lawsuit to date. Constructed to have the distractingly appealing exterior façade of a lawsuit seeking greater fairness in college admissions, the SFFA v. Harvard/UNC case is best understood as a deception-driven battle tactic used by forces waging a multi-decade war against the major legislative victories of America’s Civil Rights Movement, specifically Title VI and Title VII …

Feeding The Good Fire: Paths To Facilitate Native-Led Fire Management On Federal Lands, Kevin Burdet

Seattle University Law Review

In 2003, nearly twenty Native American reservations were devastated by wildfires that originated on adjacent federal lands. The San Pasqual Reservation’s entire 1,400 acres were burned along with over a third of its homes, and seventy-five percent of the Rincon Reservation was burned, taking twenty homes with it. These devastating fires, along with others in 2002, brought about the Tribal Forest Protection Act of 2004 (TFPA), which offered hope for Tribes to propose projects on bordering or adjacent federal lands and protect reservation lands in the process. Unfortunately, twenty years later, the TFPA has had a marginal effect in enabling …

The First Amendment To The Constitution, Associational Freedom, And The Future Of The Country: Alabama’S Direct Attack On The Existence Of The Naacp, Helen J. Knowles-Gardner

Seattle University Law Review

Sixty years ago, on Wednesday, April 8, 1964, Professor Harry Kalven, Jr., gave the second of three lectures at The Ohio State University College of Law Forum. These lectures were published two years later in a book entitled The Negro & the 1st Amendment. In the second lecture, Kalven distinguished between direct and indirect threats to the associational freedom of the National Association for the Advancement of Colored People (NAACP). Kalven categorized the 1958 decision in NAACP v. Alabama ex rel. Patterson as an indirect effort to control the NAACP.

With the benefit of material obtained from numerous archival sources, …

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, …

Due Process Shaped By The Present Instead Of The Past: The Needed Reinvigoration Of A Lawrence Vision Of Due Process, Azor Cole

Seattle University Law Review

The recognition of unenumerated rights, rights implied from the text of the constitution, is a political battlefield waged through law with profound implications for all Americans. Generally, there have been two prongs for an inquiry into an unenumerated constitutional right under the Fourteenth Amendment. One is to ask whether the right to be found is objectively deeply rooted in this Nation’s history and tradition. The other is to ask whether the right to be found is fundamental to this Nation’s scheme of ordered liberty. The current Supreme Court has effectively done away with this present-day liberty analysis, saying it is …

Sneakers, The Shoes That Talk The Talk And Walk The Walk: How Jack Daniel’S Properties, Inc. V. Vip Products Left Its Footprint On Trademark Law And The Sneaker Industry, Nitya Tolani

Seattle University Law Review

As the fashion industry—including the sneaker industry housed within it—continues to go through the motions of collectively flocking out, and then collectively flocking again to the newest innovations in the world of wearables, the landscape of laws to protect and promote those innovations expands as well, mainly in the area of intellectual property law. Although copyright, trademark, and patent law can cover innovations in the fashion industry, this Note centers its analysis on trademark law. Trademark law has been through notable change in recent years because of the United States Supreme Court’s 2023 decision in Jack Daniel’s Properties, Inc. v. …

Prejudice Standards In Washington’S Appellate Courts, Andrew B. Van Winkle

Seattle University Law Review

When an appellate court finds an error to have occurred during a proceeding, the error is not yet subject to correction. In order to merit a remedy, the error must have been sufficiently prejudicial to the aggrieved party’s case. Drawing the line between correctable and non-correctable errors is not an easy task, for it often requires guessing at what was in the minds of jurors and trial judges. To cope with this task, courts have devised various rules and tests for deciding whether an error was likely prejudicial or not. These standards often go by names such as “harmless error,” …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

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 …

Rethinking Innovation At Fda, Rachel E. Sachs, Nicholson Price, Patricia J. Zeitler

Articles

In several controversial drug approval decisions in recent years, the Food & Drug Administration (“FDA”) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the Agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the Agency has come to make many innovation-related judgments as part of …

Use Of Artificial Intelligence In Drug Development, Louise C. Druedahl, Nicholson Price, Timo Minssen, Dipl Jur, Ameet Sarpatwari

Articles

Considerable focus has been placed on the health care applications of artificial intelligence (AI). Already, machine learning, a subset of AI that involves “the use of data and algorithms to imitate the way that humans learn” has been used to predict diseases, while AI-powered smartphone apps have been developed to promote mental health and weight loss. Owing in part to such successes, the market for AI in health care has been forecasted to increase more than 1000% between 2022 and 2029, from $13.8 billion to $164.1 billion. One area of substantial promise is drug development, which is poised to benefit …

Speech Regulation And Tobacco Harm Reduction, Jonathan H. Adler, Jacob James Rich

Faculty Publications

Part I of this essay describes what is currently understood about the relative health risks of ENDS [electronic nicotine delivery systems] and other vaping products, particularly as compared to combustible cigarettes.

Part II of this essay describes the current regulatory regime governing tobacco products and how this regime has been applied to ENDS and other vaping products.

Part III of this essay explains how the FDA’s regulatory regime hampers the ability of ENDS manufacturers to inform consumers about the relative risks of their products and the potential use of ENDS as smoking cessation aids.

Part IV explains why this regulation …

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 …