Food and Drug Law Commons^™

A Shifting Focus: How Algal Turf Scrubbers (Ats) In Natural Waterways Can Prevent Toxic Blooms And Could Save The Algae Energy Industry

Fordham Environmental Law Review

Biofuels have generated global interest among oil companies and governments. In particular, algal biofuels are slated to be more promising than traditional biofuel feedstocks, like corn and sugarcane, which are simultaneously cultivated as food products. However, the drawbacks of harvesting algae on a large industrial scale has led to intense criticism. Most critics focus on issues of sustainability, scalability of production, and the legal and ethical concerns of genetically modified crops. New research in cyanobacteria, however, illustrates algae’s potential to produce clean electricity in addition to oil, ethanol, and gasoline. Moreover, using Algal Turf Scrubbers (“ATS”) in natural waterways offers …

Why We Need A Constitutional Right To Healthy Environment In Canada

Fordham Environmental Law Review

The increasing demand for constitutional recognition of the right to a healthy environment (‘RTHE’) has been a matter of public concern and debate in many countries, including Canada.2 This paper asks, will a constitutional RTHE within the Canadian Constitution add any value when statutes already exist to protect the environment (and thereby health)? The present environmental statutes work towards protecting the environment, and by protecting the environment, public health can be protected.3 Together, both of them form a ‘healthy environment’, ie., an environment that fosters a healthy life.4 This paper will argue that there is additional value in recognizing a …

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 …

Regulatory Takings In Climate Change: Geo- Engineering One’S Way Around The Fifth Amendment, Noah Chase

Fordham Environmental Law Review

Picture yourself as the owner of a small business located in the downtown area of a large city; your business consists of a shop and an adjoining parking lot. A new regulation has just been passed which requires any owner of property within the city limits to paint all roofs and parking areas with a new reflective coating, in order to reduce the heat which is absorbed by such structures. The idea of closing your business down for this time, along with other connected issues, scares you, and you begin to wonder if your local government truly has your best …

Arizona V. Navajo Nation And Systemic Failures In The Tribal Water Allocation Scheme, Jennifer Horkovich

Fordham Environmental Law Review

When the United States Supreme Court’s decision in Arizona v. Navajo Nation was published in June 2023, Indian Country was hardly surprised with the Court’s ruling. There, the Court found that the United States had no affirmative duty to affirmatively protect the Navajo Nation’s water rights under the 1868 Treaty.1 The Court was clear: the treaty is insufficient for the Navajo’s current water needs, but the judiciary is unable to step in to find relief.2 This decision is another in a long series of cases on water allocation and the federal reserved water right, where tribes have been unable to …

Environmental Protection, Sustainability And The Prevention Of Satellite Collisions In Outer Space, Yun Zhao

Fordham Environmental Law Review

With space commercialization and privatization continuing apace, more space objects are expected to be launched and put into operation in the future, adding to the already large number of defunct satellites and space debris present in outer space. Hence, serious study should be devoted to possible mechanisms for dealing with potential collisions in outer space for the purpose of realizing environmental protection and space sustainability. In view of the inadequacy of the existing legal regime, this article explores possible such mechanisms (including a preventive mechanism, avoidance mechanism and compensation mechanism) from the perspective of interdependence theory and puts forward a …

Empirically Assessing Medical Device Innovation, George Horvath

Minnesota Journal of Law, Science & Technology

No abstract provided.

Food Price Narratives, Tammi S. Etheridge

Scholarly Articles

The use of antitrust in the context of food is problematic because it so clearly violates the Consumer Welfare Standard as prescribed by the courts. Ultimately, antitrust rhetoric promoting ad nauseam enforcement will not improve consumer welfare. Advancing consumer welfare in the food industry must mean prioritizing lower food prices over some arbitrary threshold of market competition or protecting small farms. Courts can and should begin distinguishing these goals immediately.

Fda Overreach: Is Your Pet’S Health A “Major Question” To You?, Ross C. Reggio

Washington and Lee Law Review

Pharmacy compounding of drugs for companion animals and humans is as old as time. For hundreds of years, pharmacists created these drugs using active pharmaceutical ingredients, otherwise known as bulk drug substances, to address the medical needs of these patients. Congress recognized this longstanding practice when it enacted the Food, Drug, and Cosmetic Act (“FDCA”), with lawmakers then noting that while pharmacists, physicians, and veterinarians were already highly regulated by the states, mass-producing drug manufacturers were not regulated. The FDCA would regulate such manufacturers.

Thereafter, pharmacy compounding from bulk drug substances continued for decades after the FDCA’s enactment and without …

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 …

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, …

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 …

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 …

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 …

Robo-Voting: Does Delegated Proxy Voting Pose A Challenge For Shareholder Democracy?, John Matsusaka, Chong Shu

Seattle University Law Review

Robo-voting is the practice by an investment fund of mechanically voting in corporate elections according to the advice of its proxy advisor— in effect fully delegating its voting decision to its advisor. We examined over 65 million votes cast during the period 2008–2021 by 14,582 mutual funds to describe and quantify the prevalence of robo-voting. Overall, 33% of mutual funds robo-voted in 2021: 22% with ISS, 4% with Glass Lewis, and six percent with the recommendations of the issuer’s management. The fraction of funds that robo-voted increased until around 2013 and then stabilized at the current level. Despite the sizable …

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. …

The Pioneers, Waves, And Random Walks Of Securities Law In The Supreme Court, Elizabeth Pollman

Seattle University Law Review

After the pioneers, waves, and random walks that have animated the history of securities laws in the U.S. Supreme Court, we might now be on the precipice of a new chapter. Pritchard and Thompson’s superb book, A History of Securities Law in the Supreme Court, illuminates with rich archival detail how the Court’s view of the securities laws and the SEC have changed over time and how individuals have influenced this history. The book provides an invaluable resource for understanding nearly a century’s worth of Supreme Court jurisprudence in the area of securities law and much needed context for …

Three Stories: A Comment On Pritchard & Thompson’S A History Of Securities Laws In The Supreme Court, Harwell Wells

Seattle University Law Review

Adam Pritchard and Robert Thompson’s A History of Securities Laws in the Supreme Court should stand for decades as the definitive work on the Federal securities laws’ career in the Supreme Court across the twentieth century.1 Like all good histories, it both tells a story and makes an argument. The story recounts how the Court dealt with the major securities laws, as well the agency charged with enforcing them, the Securities and Exchange Commission (SEC), and the rules it promulgated, from the 1930s into the twenty-first century. But the book does not just string together a series of events, “one …

On The Value Of History: A Review Of A.C. Pritchard & Robert B. Thompson’S A History Of Securities Law In The Supreme Court, Joel Seligman

Seattle University Law Review

A.C. Pritchard and Bob Thompson have written a splendid history of securities law decisions in the Supreme Court. Their book is exemplary because of its detailed use of the long unpublished papers of Supreme Court justices, including those of Harry Blackmun, William O. Douglas, Felix Frankfurter and Lewis F. Powell, primary sources which included correspondence with other Justices and law clerks as well as interviews with law clerks. The use of these primary sources recounted throughout the text and 67 pages of End Notes deepens our understanding of the intentions of the Justices and sharpens our understanding of the conflicts …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Memories Of An Affirmative Action Activist, Margaret E. Montoya

Seattle University Law Review

Some twenty-five years ago, the Society of American Law Teachers (SALT) led a march supporting Affirmative Action in legal education to counter the spate of litigation and other legal prohibitions that exploded during the 1990s, seeking to limit or abolish race-based measures. The march began at the San Francisco Hilton Hotel, where the Association of American Law Schools (AALS) was having its annual meeting, and proceeded to Union Square. We, the organizers of the march, did not expect the march to become an iconic event; one that would be remembered as a harbinger of a new era of activism by …

Defeat Fascism, Transform Democracy: Mapping Academic Resources, Reframing The Fundamentals, And Organizing For Collective Actions, Francisco Valdes

Seattle University Law Review

The information we gathered during 2021–2023 shows that critical faculty and other academic resources are present throughout most of U.S. legal academia. Counting only full-time faculty, our limited research identified 778 contacts in 200 schools equating to nearly four contacts on average per school. But no organized critical “core” had coalesced within legal academia or, more broadly, throughout higher education expressly dedicated to defending and advancing critical knowledge and its production up to now. And yet, as the 2021–2022 formation of the Critical (Legal) Collective (“CLC”) outlined below demonstrates, many academics sense or acknowledge the need for greater cohesion among …

Sffa V. Harvard College: Closing The Doors Of Equality In Education, Ediberto Roman

Seattle University Law Review

The United States Supreme Court’s recent combined decision ending affirmative action in Students for Fair Admissions v. Harvard College and Students for Fair Admissions v. University of North Carolina was hailed in conservative circles as the beginning of “the long road” towards racial equality. Others declared that “the opinion may begin the restoration of our nation’s constitutional colorblind legal covenant.” Another writer pronounced, “Affirmative action perpetuated racial discrimination. Its end is a huge step forward.” A Washington-based opinion page even declared: “[T]he demise of race-based affirmative action should inspire renewed commitment to the ideal of equal opportunity in America.” Despite …

Religious Freedom And Diversity Missions: Insights From Jesuit Law Deans, Anthony E. Varona, Michèle Alexandre, Michael J. Kaufman, Madeleine M. Landrieu

Seattle University Law Review

This Article is a transcript of a panel moderated by Anthony E. Varona, Dean of Seattle University School of Law. During the panel, Jesuit and religious law school deans discussed what law schools with religious missions have to add to the conversation around SFFA and the continuing role of affirmative action in higher education.

The Class Of Injuries Test: A Unifying Proposal To Determining Duty, Proximate Cause, And Superseding Cause In Negligence Claims, Judge Leonard J. Feldman, Julia Doherty

Seattle University Law Review

While there seems to be universal agreement that liability in tort cannot be unlimited, there is widespread disagreement regarding the various tests that courts utilize to limit such liability. We assume here that breach can be proven: the defendant failed to conduct themself in accordance with the salient standard of conduct (for example, failure to exercise reasonable care under all the circumstances). In the ensuing litigation, the court and jury are asked to decide several issues that each limit liability for negligence. Here, we focus on three oft-debated issues: duty, proximate cause, and superseding cause. The tests for each are …

Ai, New Technologies, And Corporate Governance: Three Phenomena, Martin Petrin

Seattle University Law Review

Artificial intelligence (AI) and other new technologies are increasingly influencing the operations, business models, and structures of companies. This Article focuses on three emerging phenomena that impact significant aspects of corporate governance and regulation: (1) perforation and blurring of firm boundaries through the ubiquitous use of externally provided AI services; (2) businesses engaging in strategic access and leveraging of critical resources held by third parties without owning them; and (3) the unusual hybrid role of online platforms between market facilitators and markets themselves. The Article explores how these phenomena challenge traditional views of firms as separate units, with technology leading …