Food and Drug Law Commons^™

Voting Matters: Materiality Considerations And The Shareholder Vote, Renee M. Jones

Seattle University Law Review

For the shareholder franchise to have meaning, shareholders must have access to relevant information to inform their voting decisions. The securities laws’ disclosure requirements play an essential role in informing the shareholder vote.

This Essay focuses on the question of the materiality of information in the context of shareholder voting. It addresses the question of whether ESG-related information is material, positioning the materiality inquiry within the context of shareholders’ voting decisions. It explores the definition of materiality with a focus on the “reasonable investor” concept embedded within the definition. The Essay argues that the implicit expectations of many commentators that …

Fraud In Feeding Our Future: An Analysis Of “The Largest Pandemic Relief Fraud Scheme Yet”, Alena Johnston

Criminal Law Practitioner

Since the 1930s, the public school system in the United States has provided a distinct place for students to develop, learn, and grow.  Public schools level the playing field for students in academics, allowing them to receive an education at no direct cost. However, students from economically disadvantaged backgrounds continue to face challenges, and their inability to secure nutritious meals can affect their ability to perform academically. In 1946, President Harry Truman signed the National School Lunch Act, forming the first Child Nutrition Program in the United States to remedy the food security issue.

 The program was implemented as “a …

Through A Glass Darkly: How Securities Disclosures Give A Distorted View Of The Economy, Gerald F. Davis

Seattle University Law Review

Our understanding of the American economy often relies on stylized facts derived from mandatory disclosures by listed corporations. Data vendors like Standard & Poor’s vacuum up 10Ks and proxy statements into databases, and scholars distill these into tentative maps. This may have been adequate for a postwar economy centered on asset-heavy manufacturers, but it is increasingly out of step with an information-based economy. Companies listed on the stock market are fewer in number and less representative than they were, light in tangible assets and people, and heavy on IP. Basic facts such as what industry they are in are increasingly …

Beyond Agency Authority: Regulating Sulfur Hexafluoride Under An Enhanced Title Ii Framework Of The Clean Air Act, Matthew Gawley

Fordham Environmental Law Review

This paper explores the critical need for robust Congressional action to regulate sulfur hexafluoride (SF6), a greenhouse gas with a global warming potential more than 20,000 times greater than carbon dioxide. Recent Supreme Court decisions––in West Virginia v. EPA and Loper Bright Enterprises v. Raimondo––to restrict EPA authority and end the Chevron doctrine have curtailed federal environmental agencies’ regulatory authority, shifting the responsibility for addressing major environmental challenges back to Congress. Despite being addressed under Title I of the Clean Air Act (CAA) through the 2022 Inflation Reduction Act (IRA), current SF6 regulations prove grossly inadequate. The utilities industry––the largest …

Article Iii Standing For Cercla Private Cost Recovery Actions: How The Test's Strained Logic Belies Its Authority, Jonathan M. Palacios

Fordham Environmental Law Review

This Note examines how Article III standing doctrine applies to

private plaintiffs’ cost recovery actions under § 107(a)(4)(B) of the

Comprehensive Environmental Response, Compensation, and

Liability Act. A review of judicial decisions reveals inconsistencies

in the analysis of injury in fact and traceability, and suggests that

current Article III standing doctrine is misaligned with its purported

objectives. In response, this Note proposes a structured framework

for assessing injury in fact and a refined approach to analyzing

traceability that distinguishes between different forms of causal

uncertainty. These doctrinal adjustments should better align case

outcomes with Article III standing doctrine’s constitutional and …

Green Dividends: A Case Study In Green Dividends And The Conditions For Private Ordering Solutions, Anne M. Tucker

Seattle University Law Review

This Essay introduces a novel private ordering solution to facilitate corporate investments in pro-social and environmental initiatives: Green dividends. Green dividends are an optional increase in shareholder dividends that are returned to the company to be reinvested in environmental initiatives or kept by a shareholder.

Green dividends pose an alternative to the current gridlocked debate that corporations can’t, won’t, shouldn’t, and shouldn’t even try to act in pro-social or environmental ways. Turning the common refrains on their head converts each narrative into an element for a successful private ordering solution: authority, accountability, shareholder buy-in, and government- backed enforcement. With Green …

Does Climate Disclosure Work To Reduce Greenhouse Gas Emissions? Emerging Evidence Suggests Cautious Optimism, Cynthia A. Williams

Seattle University Law Review

Significant regulatory resources have been spent developing global, voluntary climate and sustainability disclosure standards, such as the TCFD, TNRD, and ISSB’s Sustainability and Climate Disclosure standards, or domestically required disclosures, such as in the EU and in the U.S. Thus, it is important to evaluate whether this disclosure, particularly voluntary, qualitative disclosure, will have the power to shift the allocation of capital, will have a significant effect on the management of climate risk within firms, and ultimately will reduce climate change risk and biodiversity loss.

In this Article, several interrelated questions will be discussed. First, what does the empirical evidence …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Jbs’S Initial Public Offering: Threats To Environmental And Human Rights, Kayla Thompson

Indiana Journal of Law and Social Equality

This paper centers around the decision to be made regarding JBS, the world’s largest meat company, wanting to list shares on the New York Stock Exchange (NYSE), and the environmental and social impacts that could result from the Security and Exchange Commission’s (SEC) approval. JBS has been at the center of various controversies over the last several years, including sourcing cattle from ranches acquired through illegal deforestation, engaging in greenwashing practices, incorrectly reporting greenhouse gas emissions, and engaging in human rights abuses. Many environmental groups have filed complaints with the SEC concerning JBS’s bid to list on the NYSE. The …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

The Interchangeable-Part Structure Of Food And Drug Law, Adam I. Muchmore

FIU Law Review

This Article demonstrates that nested tiers of interchangeable parts serve as the foundation for the regulatory programs administered by the U.S. Food and Drug Administration. Core interchangeable parts used in FDA-administered programs include product categories, prohibitions on adulteration and misbranding, agency-registration requirements, current good manufacturing practices, product standards, marketing authorization requirements, postmarket requirements, and user fees. In each of these areas, Congress or the FDA has engaged in interchangeable-part lawmaking (IPL). IPL occurs when a government takes a portion of its law in one subject area and uses it as a model for its own law in another subject area. …

The Hunger Games: Food As A Right, Not A Privilege, Camesha F. Little

FIU Law Review

Despite the United Nations' explicit declaration that all humans have a right to food, food insecurity and hunger remain persistent problems in the United States and around the globe. The dystopian landscapes depicted in novels such as The Hunger Games and Parable of the Sower—societies crippled by poverty, oppression, and pervasive starvation—resonate with sobering contemporary realities. This Article examines existing food laws, food rights, and the current protections safeguarding the United States food supply from a humanitarian perspective. Ultimately, this Article argues that the human right to food must expand to encompass a right to healthy or natural food, and …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

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 …

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

Oklahoma Law Review

No abstract provided.

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

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 …

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 …

Why The United States Should Change Its Standards For Food Additives, Sara Smith

Touro Law Review

Processed food products sold in the United States are vastly different than those in Europe, often containing unnecessary and potentially dangerous additives. Recently, food consumer advocacy groups and reporters are bringing attention to these differences, thereby raising awareness of the poor processed food quality in the United States. The United States should take a new and improved method to food safety that mirrors the European Union’s approach. This Note will compare the differences between food additives in the United States and Europe, and further, will propose solutions to increase regulation on food additives in the United States.

Crypto & The Climate: Will Local & National Environmental Regulation Save Or Stifle The Cryptocurrency Boom?

Fordham Environmental Law Review

As cryptocurrencies continue to gain traction among mainstream investors and consumers, regulators and lobbyists are increasingly taking note of the potential environmental impacts of the industry. At its core, the process of mining new currency for virtual wallets is energy intensive, which can place strains on electrical grids and accelerate the impacts of climate change. However, these effects are felt very differently depending on what source of electricity the mining operation utilizes and the methodology behind the specific currency. These variable factors are on the minds of legislators and regulators as public pressure to better understand and regulate the industry …

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 …