Food and Drug Law Commons^™

Preempting State Prevention: How Fda Regulation Ensures Access To Abortion Medication, Jared Shea

Mitchell Hamline Law Review

No abstract provided.

Gag With Malice, Shaakirrah R. Sanders

Washington and Lee Law Review

This Article brings agriculture privacy and other commercial gagging laws into the ongoing debate on the First Amendment actual malice rule announced in New York Times v. Sullivan. Despite a resurgence in contemporary jurisprudence, Justices Clarence Thomas and Neil Gorsuch have recently questioned the wisdom and viability of Sullivan, which originally applied actual malice to state law defamation claims brought by public officials. The Court later extended the actual malice rule to public figures, to claims for infliction of emotional distress, and—as discussed in this Article—to claims for invasion of privacy and to issues of public importance or concern.

United …

The Disrupted Path To Becoming Easy, Breezy, Beautiful: How Companies Are Deceiving Consumers With Their Animal Testing Products, Wendy Chao

University of San Francisco Law Review

No abstract provided.

Nestlé V. Doe: A Death Knell To Corporate Human Rights Accountability?, Phillip Ayers

Seattle University Law Review

The Supreme Court in Nestlé v. Doe held that foreign plaintiffs who claimed to be victims of overseas tortious conduct by corporate defendants had no jurisdiction to sue in federal courts using the Alien Tort Statute. This Comment looks at the history of the Alien Tort Statute, from its inspiration, long dormancy, and recent reinvigoration beginning in the 1980s. The Comment then explores the background of Nestlé and its issues with child slavery in its cocoa supply chain. From there, the Comment analyzes the Nestlé v. Doe decision, and posits an alternative outcome. Finally, this Comment looks for a new …

Duped By Dope: The Sackler Family’S Attempt To Escape Opioid Liability And The Need To Close The Non-Debtor Release Loophole, Bryson T. Strachan

Law Student Publications

The opioid epidemic continues to rage on in the United States, ravaging its rural populations. One of its main causes? OxyContin. Purdue Pharma (“Purdue”), the maker of OxyContin, aggressively marketed opioids to the American public while racking up a fortune of over $13 billion dollars for its owners,3 the Sackler family. As a result, roughly 3,000 lawsuits were filed against Purdue and members of the Sackler family. Generally, the lawsuits alleged that Purdue and members of the Sackler family knew OxyContin was highly addictive yet aggressively marketed high dosages of the drug and misrepresented the drug as nonaddictive and without …

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

All Faculty Scholarship

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a $40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter.

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 …

Criminality And Inequity Under Canada's Legalization Of Cannabis: A Study Of Vancouver's Downtown Eastside, Stephanie Lake, Margot Young

All Faculty Publications

The origin of this essay reminds us of the importance of interdisciplinary collaboration to the development and assessment of public policy. It also demonstrates the serendipitous beginnings of many interesting inquiries. This collaboration was thus fortuitous: authors Lake and Young met during Lake’s doctoral dissertation defence. Young was on the examining committee. Lake presented a series of epidemiological studies (three of which are summarized below) involving the use of cannabis for therapeutic and harm reduction purposes among marginalized people who use drugs (PWUD) in Vancouver. Young’s lines of questioning involving the legal implications of Lake’s findings spurred the idea to …

Fight For Your Life: A Study Of Fairness In The Ultimate Fighting Championship's Anti-Doping Policy Appeals Process, Brandon Hamroff

Cardozo Journal of Conflict Resolution

No abstract provided.

Pacifying Professional Negligence Disputes - The Prospective Path For Mediation Within The Psilocybin Industry, Miranda Sapoznik

Cardozo Journal of Conflict Resolution

No abstract provided.

Developing American Wine Law – Lessons From European Wine Regulation In The Face Of Climate Change And Growing Demand, Kyle Amendt Shimomura

Emory International Law Review

No abstract provided.

Corporate Governance And Gender Equality: A Study Of Comply-Or-Explain Disclosure Regulation, Aaron A. Dhir, Sarah Kaplan, Maria Arabella Robles

Seattle University Law Review

In 2020, the Nasdaq Stock Market filed a proposal with the U.S. Securities and Exchange Commission seeking permission to adopt a board diversity-related disclosure requirement for its listed companies. In 2021, the SEC approved the proposal, thus entrenching Nasdaq’s position as the most significant stock exchange to date to mandate listing rules that reflect the intention of diversifying corporate boardrooms. Nasdaq’s movement into the diversity space is not the first attempt to address homogeneous boards in the U.S. In 2009, the SEC adopted a rule requiring publicly traded firms to report on whether they consider diversity in identifying director nominees. …

Judicial Ethics And The Eradication Of Racism, Dontay Proctor-Mills

Seattle University Law Review

In 2020, the Washington Supreme Court entrusted the legal community with working to eradicate racism from its legal system. Soon after, Washington’s Commission on Judicial Conduct (hereinafter the Commission) received a complaint about a bus ad for North Seattle College featuring King County Superior Court Judge David Keenan. Along with a photo of Judge Keenan’s face, the ad included the following language: “A Superior Court Judge, David Keenan got into law in part to advocate for marginalized communities. David’s changing the world. He started at North.” The Commission admonished Judge Keenan for violating the Code of Judicial Conduct, in part …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Why Corporate Boards Should Include Lgbtq+ People, Jeremy Mcclane, Darren Rosenblum

Seattle University Law Review

Corporate boardrooms sit at the heart of most of society’s most consequential decisions but fall far short of the diversity of our society. The current movement toward board diversification aims to remedy the underrepresentation of marginalized groups on corporate boards. More recently, some efforts have included LGBTQ+ people, even though the basis for their inclusion on corporate boards remains largely unstated. This Article examines both the normative and instrumental bases for LGBTQ+ inclusion in board diversity initiatives, articulating unspoken assumptions and linking LGBTQ+ people to the broader inclusion effort. In so doing, it begins to surface the unique issues LGBTQ+ …

The Immigration Implications Of Presidential Pot Pardons, Jason A. Cade

Scholarly Works

This Essay examines the immigration implications of President Joe Biden’s Proclamation on October 6, 2022, pardoning most federal and D.C. offenders who committed the offense of simple marijuana possession. A late twentieth century interpretive shift by the Board of Immigration Appeals holds that pardons only prevent deportation for certain criminal history categories, which do not include controlled substance offenses, and thus far lower federal courts have deferred to the agency’s approach.Nevertheless, according to the analysis I offer, President Biden’s cannabis pardons should be deemed fully effective to eliminate all immigration penalties. All of the immigrant pardon cases to reach the …

Opening A Federal Reserve Account, Julie Andersen Hill

Articles

To open bank accounts, new customers provide personal information and make a deposit. Within a few minutes (or perhaps a few days), new customers get access to payment services. For many years, the process financial institutions used to open accounts at FederalReserve Banks was similar. Eligible banks filled out a one-page form and within a week received an account allowing them access to the FederalReserve's payment systems. Recently, however, Federal Reserve Banks have spent years considering account requests from novel banks.

This Article examines the Federal Reserve's process for evaluating requests for accounts. Using interviews, court documents, and other sources, …

Regulating Organic, Sarah J. Morath

American University Law Review

Even highly regulated labels, such as the organic label, have the potential for greenwashing. As recently as January 2023, a grain seller was indicted in federal court for a $43 million scheme that involved the sale of non-organic grain as USDA-certified organic. But today’s organic market is also full of sellers who follow the current federal organic regulations but fail to demonstrate the spirit of the organic movement—forgoing soil, animal welfare, and community for profit. I call this nuanced form of greenwashing quasi-greenwashing. It arises when a business complies with a rule or standard but takes advantage of consumer misunderstanding …

Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore

Faculty Scholarship

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

2023 Update: A Water Rights Manual For Mutual Domestic Water Consumers Associations, Utton Center, Zackeriah Carpenter, Gregory Chakalian, Darcy S. Bushnell

Publications

This is the 2023 update of the Water Rights Manual. The archival version is also available in our digital repository. 

The Utton Center prepared this Water Rights Manual to assist Mutual Domestic Water Consumers Associations (MDWCAs) with the development, protection and management of their water rights.

This manual provides an introduction to and defines Water Rights in New Mexico, as well as to acquire and have recognized Water Rights. This document also covers water management and planning, and provides additional resources.

Retroviral Protease (Rvp) Ddi2 Is A Viable Alternative For Full-Length (Fl) Ddi2, Ethan Chi

Undergraduate Research Symposium Lightning Talks

Proteasome inhibitors are drugs used to treat multiple myeloma. Currently, three are approved by the FDA.

Ministerial Decision On The Trips Agreement (Wto), Ana Santos Rutschman

Faculty Publications

No abstract provided.

Examining Comity And The Exhaustion Doctrine In Tribal Court Civil Jurisdiction: The Cherokee Nation’S Opioid Litigation, Joëlle Klein

Washington Law Review

The opioid epidemic has devastated communities throughout the United States over the last two decades. Native American and Alaska Native tribes faced disproportionate impacts and suffered the long-lasting consequences that opioid addiction causes families and communities. In response, states and municipalities across the United States sued the distributors and pharmacies responsible for illegally diverting opioids. In April of 2017, the Attorney General for the Cherokee Nation, Todd Hembree, initiated a civil suit against opioid pharmaceutical distributors and retailers: CVS, Walgreens, Wal-Mart (pharmacies), and McKesson, Cardinal Health, and AmerisourceBergen (distributors). Although other tribes in the United States also brought claims against …

A Uniform Approach To Farm Animal Welfare Laws: Thought For Our Food Instead Of Food For Our Thought, Channing Burd

Journal of Food Law & Policy

We have all seen the commercials and know “Happy Cows Come from California,” but there is a larger issue hidden inside the phrase. Why should not all farm animals be happy, regardless of which state they were raised in? Why are only the cows in California happy, but not the chickens and the hogs as well? Farm animal welfare in the United States needs regulatory overhaul, and we needed it decades ago. This article will illustrate why regulatory overhaul is needed. First, we will examine how a new system of laws, which are part of a uniform code enacted by …

The Cow Has Left The Barn: Updating Standards Of Identity To Reflect Consumer Understanding Of Plant-Based Foods, Nicholas G. Miller

Journal of Food Law & Policy

Have you ever seen “tofurkey” at the supermarket and thought it was a rare, delicious cousin of the turkey? The animal based food industries, led by milk and meat producers, are claiming that the reasonable consumer might. On the other hand, the plant based food substitutes are appearing on supermarket shelves with increasingly bold names for their products that tap into our familiarity with animal-based foods, using names like “Beyond Meat.” Where do we draw the line on what plant based food can be called? And who should draw that line? This paper examines the debate surrounding the labeling of …

The Cost Of Compassion: Why State Ballot Initiatives Complicate Farm Animal Welfare And Overlook The True Problems In Modern Agriculture, Seth Victor

Journal of Food Law & Policy

Farm animal welfare is a concern for many Americans, both among those who value a higher standard of care for the animals’ own sake, and those concerned with food safety. Industrial agriculture has become the dominant form of animal production to satiate a daunting demand for meat, eggs, and dairy products. Industrial animal-raising facilities, also known as concentrated animal feeding operations (“CAFOs”), prioritize volume and efficiency and are a key factor in keeping consumer prices low. CAFOs are highly specialized and excel at production by minimizing inputs, maximizing confined animals, and externalizing environmental costs. This production method comes at the …

Federal Food Safety Framework: Where Does Seaweed Fit In?, Catherine M. Janasie

Journal of Food Law & Policy

When one mentions seaweed as food, what do you think of? The dried nori used to wrap your sushi roll or perhaps the seaweed salad on the side? In fact, seaweed has many uses, including as both a food source in its own right and as a food additive. While the seaweed market has been dominated by East Asian countries, seaweed is cultivated in about 50 countries, and the U.S. seaweed industry is steadily growing. The global seaweed industry is currently worth about $6 billion annually. Food products for human consumption account for about 85% of this value.

Do States Prefer Alcohol Over Marijuana? A Look At Labeling Regulatory Differences Between The Alcohol And Edibles Industries, Mckinley H. Groves

Journal of Food Law & Policy

In the children’s book "Through the Looking Glass and What Alice Found There", Alice interacts with Humpty Dumpty. During their conversation, Humpty notes that he, alone, can decide the meaning of words. Even Alice, at the young age of seven, casts doubt on this idea. Definitions of words and phrases play an important role in human interactions and even more so when the words and phrases defined are within a statute. In the United States, Congress and state legislatures play the role of Humpty Dumpty by coming up with meanings of important words and phrases found in the laws they …

Following The Framework: Intentional Genomic Alterations In Animals, Sarah Copper

Journal of Food Law & Policy

Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, …

The Helicopter State: Misuse Of Parens Patriae Unconstitutionally Precludes Individual And Class Claims, Gabrielle J. Hanna

Washington Law Review

The doctrine of parens patriae allows state attorneys general to represent state citizens in aggregate litigation suits that are, in many ways, similar to class actions and mass-tort actions. Its origins, however, reflect a more modest scope. Parens patriae began as a doctrine allowing the British king to protect those without the ability to protect themselves, including wards and mentally disabled individuals. The rapid expansion of parens patriae standing in the United States may be partly to blame for the relative absence of limiting requirements or even well-developed case law governing parens patriae suits. On the one hand, class actions …