Food and Drug Law Commons^™

A Market-Based Approach To Effective Slaughterhouse Line Speed Regulation, Kailey Mcneal

Animal Law Review

The nature of animal agriculture in the United States is heavily industrialized and profit-centered. Industrial animal agriculture maximizes profits and production by employing low-wage workers to do significant loads of labor. Slaughterhouses’ implementation of faster line speeds reflects this tactic. As the industry continues to increase line speeds to boost profits, workers, animals, and the environment continue to face augmented risks to their health and safety. Nonetheless, slaughterhouse line speeds at the federal level remain largely un- and under-regulated. The current federal regulatory scheme is unduly influenced by industry interests, prioritizes profit over safety, and lacks effective enforcement mechanisms. Through …

Transitioning To Regenerative Agriculture: One "Net-Zero" Pledge At A Time, Alexia Brunet Marks

Publications

As climate change intensifies, food sector multinational companies (MNCs), like Nestlé; Mars, Inc.; Unilever; PepsiCo; and Danone, face increasing pressure to reach net-zero by 2050, whereby they would reduce and ultimately eliminate carbon dioxide emissions from their supply chains by 2050. Carbon dioxide emissions are a major business liability, decreasing a firm’s value an average of $212,000 for every one thousand metric tons produced. As companies seek to align their pledges with regional, national, and subnational climate goals, they are legally required to comply with a growing number of disclosure rules for foods entering the United States and the European …

The 340b Drug Pricing Program: Administration, Litigation, And Reform, Ryan P. Knox, Ameet Sarpatwari

Oklahoma Law Review

No abstract provided.

A Spoonful Of Sugar Won’T Help This Medicine Go Down: The Inflation Reduction Act’S Failure To Address Pharmaceutical Evergreening, Megan E.A. Davis

Oklahoma Law Review

No abstract provided.

Revisiting Patent Linkage, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Alfred Engelberg’s article of a quarter-century ago, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, raised a provocative question that retains currency today. The special provisions that Hatch-Waxman established, and Engelberg addressed, have come to be known as patent linkage. Following the principle of linkage, the Food and Drug Administration (FDA) cannot approve generic drugs for marketing if they would infringe a patent.

Hatch-Waxman’s complex patent provisions aspire towards multiple salutary purposes, including encouraging the prompt availability of generic drugs, improving public notice of pharmaceutical patents, and accelerating dispute resolution proceedings. Congress also attempted to ameliorate perceived …

The Future Of Ai Regulation In Drug Development: A Comparative Analysis, Gabriela Lenarczyk, Timo Minssen, W. Nicholson Price Ii, Arti Rai

Articles

As artificial intelligence (AI) transforms drug development, regulatory frameworks are evolving to oversee its implementation, particularly at the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This paper makes three contributions to understanding emerging regulatory approaches. First, we offer a comparative analysis of how these agencies have responded to AI-driven advances, incorporating new US executive orders and the European Union (EU)’s AI Act. Second, we propose a novel analytical framework to understand regulatory divergence: the FDA’s flexible, dialog-driven model contrasts with the EMA’s structured, risk-tiered approach, reflecting broader institutional and political-economic differences. While the former encourages …

A "One Health" Approach To Healthy Food, Katya S. Cronin

Brooklyn Law Review

Diet-related diseases are the number one killer of Americans. Nutrition and food healthfulness are increasingly seen as foundational to public health. As a result, the healthy foods industry is booming, the medical community is integrating nutrition into healthcare, and even insurance companies are subsidizing food prescriptions. The federal government invests heavily in nutrition, spending more than $166 billion a year on federal programs that provide healthy food to vulnerable populations. After the Biden Administration announced its agenda to “promote a healthy diet among Americans,” the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”) sprang into …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Corporate Scenarios: Drawing Lessons From History, Madison Condon

Seattle University Law Review

As corporations are increasingly pressed to reveal information about their exposure to climate-related risks, they are often asked to undertake and disclose the outcome of “scenario analysis.” In this exercise, corporations, including financial institutions, examine how their business would fare under different pathways the future may take. One oft-used scenario, for example, is the International Energy Agency’s “Net-Zero by 2050: A Roadmap for the Energy Sector.” This Essay presents a history of the use of scenarios as a corporate planning tool, particularly in the oil industry, arguing that it is key for understanding our present moment and the role of …

Shareholder Expression In A Time Of Heightened Political Tension, Aaron A. Dhir

Seattle University Law Review

In this article, I provide context for my forthcoming research project on shareholder proposals and racial equity audits. Since the murder of George Floyd in May of 2020, progressive shareholder actors have increasingly used the proposal mechanism to advance diversity, equity, inclusion, and justice-related goals. These proposals have frequently gone beyond requesting the usual corporate fare of diversity trainings, intersectionality workshops, affinity groups, etc. Instead, a more ambitious type of proposal asks corporate America to conduct racial equity audits, defined as “an independent, objective and holistic analysis of a company’s policies, practices, products, services and efforts to combat systemic racism …

Corporate Governance Speech, Sarah C. Haan

Seattle University Law Review

The State has always regulated the intra-firm communications that make corporate governance possible, most commonly by mandating disclosures of information by a corporation to its shareholders. Some such laws are labeled “securities regulation,” but securities regulation is a broad category that extends to speech by actors who are outside the corporate enterprise as well. Also, the conventional securities regulation category does not capture all such laws; other examples, including informationforcing mandates, can be found in state corporate law. This Article uses the term “corporate governance speech” to describe the communications among shareholders, directors, and officers through which corporate governance is …

Dark Accounting Matter, Colleen Honigsberg

Seattle University Law Review

Physicists calculate that approximately 85% of the matter in the universe is composed of “dark matter” that “does not absorb, reflect, or emit electromagnetic radiation and is therefore difficult to detect.” The S&P 500 currently trades at a price-to-book value of 4.2, suggesting that book value accounts for less than 20% of the S&P 500’s market value. The remaining 80% appears nowhere in these firms’ balance sheets—it is invisible to contemporary accounting techniques and constitutes “dark accounting matter.”

Some “dark accounting matter” is composed of factors commonly described as components of “ESG.” Human capital, for example, is an intangible asset …

The Employees’ Dilemma: Balancing Internal Reporting, Whistleblowing, And Insider Trading Risks, Geeyoung Min

Seattle University Law Review

The Essay examines how recent developments in insider trading regulations and whistleblower reward programs can lead to unintended and counterproductive results of discouraging employees from using internal reporting channels within corporate compliance programs. While the presence of a robust and well-functioning corporate compliance program is a critical factor both in mitigating the level of public enforcement actions against companies and in protecting corporate managers from liability in private litigation, these programs often provide little incentive for employees to report potential misconduct internally.

Corporate compliance programs are designed to promote the upward information flow within the company, which is essential for …

How The Antidiscrimination Law Of Commercial Transactions Really Works, Helen Norton

Seattle University Law Review

A variety of businesses now cite 303 Creative when seeking First Amendment protection for their refusal to serve certain customers based on those customers’ protected class status. How this litigation will play out remains to be seen. But future courts need not, and should not, repeat the 303 Creative Court’s misunderstanding of how the antidiscrimination law of commercial transactions actually works.

Part I of this Essay explains the Court’s longstanding understanding of the antidiscrimination law of commercial transactions, and then describes the Court’s failure to engage with this precedent in 303 Creative. Part II then identifies the 303 Creative decision’s …

Understanding The Big Three’S Wavering Support Of Environmental And Social Shareholder Proposals, Jeff Schwartz, Jefferson Jensen

Seattle University Law Review

Because of their substantial equity portfolios, BlackRock, Vanguard, and State Street (the Big 3) are central players in corporate governance. It is, therefore, critical to understand how they vote. One puzzle is that their support for shareholder proposals on environmental and social matters appears to waiver. In 2020, for instance, BlackRock supported 11.1% of environmental proposals at S&P 500 firms. In 2021, it seemingly reversed course, supporting 55.2%. It then flipped again, supporting 32.1% in 2022. Such statistics suggest that the Big 3 are constantly changing their views on these topics. This Article seeks to better understand whether this is …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Most-Favored-Nation Drug Pricing—How Courts Could Shape Future Health Regulation, Nicholas Bagley, Craig Garthwaite, Benedic Ippolito

Other Publications

The Trump administration recently issued an Executive Order aimed at delivering most-favored- nation (MFN) drug pricing to the US. The order instructs drug manufacturers to reduce the prices of brand-name drugs to match the lowest price among selected high-income countries. If drug makers do not make significant progress toward this goal, the administration will pursue several strategies to lower prices. Most notably, the Executive Order directs the Secretary of Health and Human Services (HHS) to propose a rule to impose MFN pricing. In all likelihood, the administration will revisit prior efforts to enact MFN pricing through the Center for Medicare …

Birthdate Phaseout, Katharine B. Silbaugh

Faculty Scholarship

This article explores the Nicotine Free Generation (NFG) policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: Prohibition, or a legal age-gate, such as 21 for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco, and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the 21 …

Legal Implications Of Digital Health Apps Informing Food Allergy Labeling For Consumers' Health And Privacy Protection, Kathy Keunghee Kim

Maurer Theses and Dissertations

This dissertation examines food allergy labeling’s use in a digital format. Allergy information is typically found on food packaging and containers to help consumers identify individually concerned allergens. Given the critical role that food allergy labels play in preventing unexpected allergic reactions before selecting or consuming food, it is essential to comprehend the labeling descriptions. However, current regulations and laws regarding allergy labeling often confuse consumers due to the existence of mandatory and voluntary Precautionary Allergy Labeling (PAL) categories and the absence of laws and regulations that require allergy information for restaurant meals. Technology companies have introduced digital health and …

From "Maine Law" To Model Act: Liquor Liability In Maine, William P. Shumaker

Maine Law Review

With the passage of the Maine Liquor Liability Act by the 112th Legislature, the State of Maine has completed a thorough reexamination of its public policy in the area of liability for injuries resulting from the use of alcoholic beverages. For 130 years the state's policy in this area was expressed by the statute commonly known as the dram shop act, the essential provisions of which had remained unchanged for over a century. This statute held sellers and other providers of alcoholic beverages strictly liable to any third party injured as a result of the intoxication of the recipient of …

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

Journal of Food Law & Policy

Energy drinks first rose to popularity in the 1980s after the creation of Red Bull. In addition to high caffeine amounts, energy drinks often contain herbal stimulant additives, vitamin and mineral mixtures, and sugar. There is very little information available on the long-term effects of these stimulant mixtures on the body. Although many consumers purchase energy drinks because of their caffeine content, many are left in the dark when it comes to labeling transparency and are unaware of their true contents. Energy drinks are classified as dietary supplements, meaning they are not directly regulated by the FDA before hitting store …

Forced To Weather The Storm: Reforming The Livestock Indemnity Program To Improve Farm Animal Welfare, Cameron Krier Massey

Journal of Food Law & Policy

Each year, extreme weather events put the lives and wellbeing of millions of farm animals at risk. These events can lead to injury, suffering, acute and chronic stress, decreased productivity, and loss of life. As storms increase in frequency and intensity, efforts should be made to ensure livestock are protected. This paper proposes modifications to the Livestock Indemnity Program (LIP), a federally run disaster assistance program that compensates livestock owners and growers for animal deaths and reduced value caused by eligible conditions, including extreme weather. Surprisingly, the program does not require producers to show proof and use of a disaster …

Udder Confusion: An Almond Milk Case Study To Examine The Complex Interplay Of Consumer Choices, Social Media, And Regulation, Madeline Mcculloch

Journal of Food Law & Policy

The preference for plant-based diet options has steadily increased for the American public. This is all particularly true for alternative milks. By the end of 2020, plant-based milk alternatives (“PBMA”) accounted for approximately fifteen percent of the total milk market and thirty-five percent of the overall plant-based market, making alternative milks, particularly almond, one of the most popular ways for people to dabble in a plant-based diet. Almond milk holds the gold in the U.S. plant-based milk market. It is, first, essential to examine the comprehensive context surrounding almond milks’ status on grocery shelves. This writing will attempt to do …

Legal Chefs’ Appetizing Taglines To Engage Consumers In The Age Of Social Media: The Struggle Against Trademark Genericide, Emily Mcdonald

Journal of Food Law & Policy

Many have heard the phrases “raisin bran,” “escalator,” “nylon,” and “aspirin,” all of which are “old” trademarks that have undergone genericide. Genericide occurs when a trademark has become common from the customer’s perspective concerning specific goods or services rather than associated with the source, which is usually the company that registered the trademark. In short, businesses are no longer able to use the trademark exclusively. Another common trademark phrase that became generic was “Taco Tuesday.” In light of the prolific use of social media today, recent data and statistics show that “food” has become a predominant category and trend on …

Food Identity, Mathilde Cohen

Journal of Food Law & Policy

Food identities are typically ascribed either based on medical or social definitions or chosen by individuals. But they can also be expressive dimensions of other identity traits such as race, ethnicity, religion, national origin, gender, age, body size, disability, and socio-economic status, among others. What role does the law play in supporting or undermining certain food identities? This Article makes two central contributions. First, it highlights that though U.S. law recognizes food identity as an interest to be protected in certain contexts, it does so in an unsystematized way, contributing to systemic deprivation and discrimination in relation to foodways. The …

Time To Stop Trip-Ing: The World Needs A New Geographical Indications Agreement, Evan Glatt

Brooklyn Journal of International Law

When it comes to purchasing food and alcohol, a product’s name carries weight and helps consumers make decisions. When the product’s name includes a place and establishes a certain level of quality and expectation, consumers trust that the product is what it purports to be. This concept, the reputation of a particular food product by name, is known as a geographical indication (GI). GIs cover a wide range of products, from the well-known champagne to lesser known products such as Roquefort cheese. GIs create financial value for local producers, contribute to sustainability initiatives, and raise the quality of goods for …

I Ain't Afraid Of No Ghost…Kitchen! A New Realm Of Consumer Protection After The Inform Consumers Act, Johanna Silva

Brooklyn Journal of Corporate, Financial & Commercial Law

The effects of the COVID-19 pandemic were pervasive, sparing none from its impact. However, the restaurant industry bore an even greater change and a heavier burden than most. At the height of the pandemic, some 110,000 restaurants shut down. QR codes replaced paper menus, street parking transformed into outdoor dining sheds, and Friday night dinners at the “great spot on the corner” became takeout orders from the couch. Reopening was an unpredictable gamble for restaurant owners, fraught with tiered plans and inconsistent regulations on safe and unsafe dining practices. The desperate search for creative solutions to stay in business propelled …

What Is In Your Drink? How Ingredient Lists For Alcoholic Beverages Would Protect Persons With Food Allergies, Benjamin Leraris

DePaul Law Review

No abstract provided.

On The Nature Of Regulating Medication Abortion: A Post-Dobbs Analysis On The Legality Of Emerging Efforts To Ban Federally Approved Mifepristone, Yann Kaufman

MC Law Review

No abstract provided.