Food and Drug Law Commons^™

The End Of Fda Exceptionalism? Dissecting Deference To The Fda In Drug Disputes, Anjali Deshmukh

Cardozo Law Review

On April 7, 2023, a federal judge issued a nationwide stay on the United States Food and Drug Administration (FDA) approval of the abortifacient medication mifepristone. It was instantly a landmark case, decried as the first time in over one-hundred years that a federal court nullified an FDA drug approval. A few hours later, a second federal district court enjoined FDA restrictions on mifepristone. Two federal courts substantively evaluating FDA drug approval data in one day is unprecedented. It begs the question: will courts overturn FDA drug approvals again?

Conventional wisdom says no. Abortion exceptionalism, the trend of legislatures and …

Public Patent Powers, Laura E. Dolbow

Michigan Law Review

Congress has created multiple structures for agencies to control how patents are used, but that institutional design choice has received little academic attention. This Article provides the first comprehensive survey of existing laws that expressly authorize agencies to control patents. I locate 113 express conditions across 68 laws that expressly authorize executive actors to make some form of decision about patents. These powers, which I refer to as “public patent powers,” allow the government to use patented inventions, to obtain patents, to authorize third parties to use patented inventions, and to regulate how patents are used. Agencies have used many …

The False Promise Of Breaking Patents To Lower Drug Prices, Adam Mossoff

St. John's Law Review

The Biden Administration, congressional leaders, and academic commentators have argued that patents cause high drug prices. They have proposed price controls as a solution. They allege that two federal statutes authorize the government to impose price controls on drug patents to lower drug prices: 28 U.S.C. § 1498 and the Bayh-Dole Act.

Neither § 1498 nor the Bayh-Dole Act authorize price controls on patents. Section 1498 is an eminent domain statute that applies only when a patent is used by and for the federal government, such for the military or by the U.S. Postal Service. The Bayh-Dole Act promotes the …

The Big Cost Of Small Farms, Tammi S. Etheridge

Scholarly Articles

Americans love meat. We celebrate our independence with steaks on the grill, we enjoy our favorite pastime with hot dogs, and we give thanks with turkey. Our love of meat is so ingrained in our culture that, historically, small increases in meat prices have driven the populace to riot. Today, meat prices are rising. Simultaneously, the largest meat processors and packagers are seeing record profits. Consumers, in turn, are outraged. Their emotions are being fueled by politicians who blame rising profits on a pandemic of greed and collusion and then argue that rigid antitrust enforcement is the only solution.

This …

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 …

Abundance And Other Food Fixations, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

Although most people in the United States no longer devote the majority of their time to food production, processing, and distribution, food remains a daily fixation. This Article explores three driving food fixations--abundance, thinness, and health--and situates each against an inverse fear--scarcity, fatness, and illness, respectively. Mapping these threats onto U.S. food policy, this Article examines, among other policy arenas, food waste policy, nutrition and health claim labeling law, and food additive regulations. Across food policy, these fixations feed what this Article calls the “politics of abundance.” This politics helps to insulate the food industry from deeper systemic reform aimed …

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 …

Reflections And Gratitude: The Journal Of Food Law & Policy From A Twenty-Year Perspective, Margie Alsbrook

Articles

Twenty years after the Journal of Food Law & Policy published its first issue, I find myself looking back with deep gratitude for the people who helped create it, for the students who sustained it, and for the community that continues to make it thrive. What began as an untested idea has grown into a respected publication and a cornerstone of a still-growing field. This essay is both a reflection on that journey and a heartfelt thank-you to everyone who made it possible.

Don’T Trust The Process: The Viability Of Eighth Amendment Claims For Ultra-Processed Food Overconsumption In Prisons, Markus C. Johnson, Rita L. Rahoi-Gilchrest

Marquette Law Review

With the largest prison population worldwide, American prisons serve more food than anywhere else. To cut costs, American prisons overwhelmingly (or even entirely) serve prisoners ultra-processed foods, which, if overconsumed, have detrimental and long-lasting health effects. Prisoners taking issue with the food being served to them rely on the courts to counteract any inappropriate prison dietary practices, wielding the Eighth Amendment as a constitutional guarantee to be free from cruel and unusual punishment. But courts are failing to protect this constitutional guarantee by relying on precedent that is at odds with modern Eighth Amendment principles. Indeed, when it comes to …

The Right To 'Trip:' Navigating Psilocybin-Assisted Psychotherapy Under The Right To Try Pathway, Caitlyn S. Greenspun

Loyola University Chicago Law Journal

This Comment explores the legal, ethical, and regulatory challenges surrounding the use of psilocybin-assisted psychotherapy for terminally ill patients under the federal Right to Try (RTT) Act. While psychedelics like psilocybin are demonstrating extraordinary therapeutic potential, particularly in easing end-of-life psychological distress, patients remain barred from access due to the Controlled Substances Act (CSA) and the Drug Enforcement Administration's (DEA) narrow interpretation of its authority. Through a comprehensive analysis of legislative history, regulatory frameworks, and administrative law principles, this Comment argues that the DEA's position not only misinterprets the statutory relationship between the RTT Act and the CSA, but also …

Remediating Public Health Crises Through Litigation: Lessons From Oklahoma In The Tobacco And Opioid Epidemic Litigations, Caroline Beckworth

Oklahoma Law Review

No abstract provided.

Psychedelic Medicine Exceptionalism, Mason Marks, I. Glenn Cohen

Scholarly Publications

Research on psychedelic medicines is experiencing a revival. Some clinicians, scientists, and ethicists believe that psychedelics are so different from other treatments that they warrant special consideration in how they are researched, regulated, commercialized, and administered. Others argue that psychedelic medicines show clinical potential, but they should be treated like other medical interventions. In other words, identical standards should apply. This article analyzes whether psychedelic medicines warrant special consideration from a regulatory and ethical perspective.

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 …

High Hopes, Clouded Realities: Minnesota's Cannabis Legalization And The Hidden Health Risks, Allison Crescimanno

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

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

The Alchemy Of Sin: Turning Tobacco Sin Tax Revenue Into Public Health Gold, Audre L. Sylvester

Lewis & Clark Law Review

This Note proposes a reallocation of tobacco excise tax revenue towards health and education programs related to tobacco cessation. Revenue collected from federal excise taxes on tobacco products is currently used to support the daily and long-term operations of the United States while tobacco cessation and education programs remain underfunded and underutilized. This Note examines the history of these “sin taxes,” their modern-day function, and the issues that arise from the current allocation of sin tax revenue to support the argument that revenue from federal sin taxes on tobacco products should be exclusively allocated to a dedicated federal trust fund …

Money Talks: The Disproportionate Influence Of Corporations On U.S. Governance Today, David C. Hayter

Lewis & Clark Law Review

Corruption: “Dishonest or illegal behavior especially by powerful people (such as government officials . . . )”; and “inducement to wrong by improper or unlawful means (such as bribery).”

What does the word “corruption” first bring to mind? For some, maybe a foreign country—where political regimes blatantly use the government as a tool to further personal agendas or gains without due consideration of the citizenry. For others, a fictional movie or TV show depicting politicians and police officers providing protections to mafia members in exchange for cash. No matter what comes to mind, many today think of corruption as manifested …

An Integrated Approach Can Improve China’S Food Additives Security, Qian Li, Jingru Hou, Jennifer S. Stevenson, Cihui Liu

Faculty Articles

In China, the development of food additives remains a critical challenge in food additives security research. We discuss an integrated approach that can improve China’s food additives security, including technical management, standards implementation, and punitive damages regime. Through this integration, we identify that technical management, standards implementation, and punitive damages regime are each complementary to each other. Technical management helps reduce the inherent risks of food additives beforehand. Standards implementation helps prevent and control risks of food additives use halfway. Punitive damages regime helps relieve secondary risks arising from food additives use. Crucially, this integration enhances the suitability of food …

The Grass Is Not Always Greener: How The Legalization Of Recreational Cannabis Across The United States Is At Odds With Incarceration And Continued Punishment, Marc Sendra

Washington and Lee Journal of Civil Rights and Social Justice

Whether you call it Mary Jane, skunky funky, green, ganja, reefer, or just plain-old cannabis, this special green plant doused in purple and orange accents has become a popular topic of discussion within the legal community and American culture. Cannabis has been held in “high” regard for its scientific advances in the medical industry, alongside its recreational usage, enjoyed by laughs and giggles, munchies, and plenty of water, leading to a wave of medical and recreational legalization.

Incentives for legalization come at the onset of promising medical research, economic growth motives, and social justice, reflecting upon a comprehensive approach that …

Flaws In The Preemption Defense To Liability Claims Against Generic Drug Manufacturers, Lars Noah

UF Law Faculty Publications

More than a dozen years have passed since the U.S. Supreme Court decided that federal preemption protects manufacturers of generic (but not brand-name) drugs from most types of products liability claims. This seemingly arbitrary distinction sprang from a peculiarity in the regulations of the U.S. Food and Drug Administration (FDA). That agency soon thereafter proposed to modify its rules in order to eliminate this asymmetry in how the implied preemption defense worked to bar inadequate warning claims, but its effort ultimately failed, while lower courts have confronted some creative efforts to circumvent the special protection enjoyed by generic drug manufacturers. …

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 …

Customary Corruption, Ani B. Satz, Liza Vertinsky

Faculty Articles

For over a hundred years, it has been well-accepted among tort scholars that physicians—as one of the legally recognized professions— determine their own customary practices. Within tort law, and medical malpractice more specifically, customary practice establishes whether physicians breach or uphold the required standard of care toward their patients. The results of our hand-coded examination of decided cases and statutes show a more complex picture. While some states have endeavored to shift the standard away from professional custom, it continues to play a critical, and in many cases a determinative, role in establishing physician liability in most states.

Using illustrative …

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 …