Food and Drug Law Commons^™

Navigating Compliance In A Geopolitical Era: The Case Of Chinese Multinationals In The United States, Ji Li

Seattle University Law Review

This Article examines how Chinese multinational companies (MNCs) approach compliance in the United States amid deepening geo-political rivalry and intensified regulatory scrutiny. Drawing on original survey data, this Article maps variations in compliance structures, staffing, and governance mechanisms across Chinese firms and identifies key determinants such as industry-specific regulatory intensity, listing status, and organizational imprinting from headquarters. The analysis employs a dual institutional framework to explain how compliance systems emerge from the interplay between host-state regulatory demands and home-state institutional legacies, producing hybrid structures that blend local adaptation with headquarters-driven replication. Findings reveal that while certain compliance features—such as committee …

Antibiotics In Animal Agriculture, The Risks To Health, And Differences In The Us And The Eu, Li-Ting Chou

Seattle Journal of Technology, Environmental, & Innovation Law

No abstract provided.

Pills, Powders, And Proprietary Blends: The Ip And Regulatory Battle Over Dietary Supplement Transparency, Anna Marie Saunders

Journal of Intellectual Property Law

Available in the form of pills, powders, gummies, bars, and countless other options, dietary supplements have become a cornerstone of the health and wellness industry and a popular product amongst health-conscious consumers. Fueled by the rise of social media influencers and a surge in health-awareness following the COVID-19 pandemic, the supplement industry has experienced rapid growth, evolving into a multi-billion-dollar market.  While widely embraced, these products often face criticism due to labeling and marketing practices that leave  consumers with an incomplete understanding of exactly they are consuming.  This tension arises from the unique legal intersection governing dietary supplements.  These products …

The Transatlantic Clinical Trial Transparency Gap, Gabriela Lenarczyk

Journal of Intellectual Property Law

Clinical trial data occupy a contested space between private commercial assets and public goods. While the United States Food and Drug Administration (FDA) has historically shielded these data through expansive trade-secret interpretations, the European Union (EU) has adopted a more open disclosure regime. This Article compares the two regimes and traces how the EU’s two-decade journey toward transparency has become a key reference for researchers and advocates of open data-sharing.

Focusing on EU practices—targeted redactions, time-bound access, granular disclosure guidelines—the paper shows that U.S. objections to broader transparency often rest on overstated concerns about competitive harm. A Filspari (sparsentan) case …

Medical Device Dangers: Choosing Ignorance In The Courts And At The Fda, George Horvath

William & Mary Law Review

Medical devices save lives and improve well-being but have caused as many as 83,000 deaths and 1.7 million injuries in a recent decade. Decisions of critical importance—patients’ decisions whether to have a device implanted, doctors’ decisions about which device to use, insurers’ decisions whether to reimburse for those devices—depend on information about risk that is provided by manufacturers. But producing this information is costly. Injured patients, through private lawsuits under state products liability theories, can incentivize device manufacturers to incur these costs and to produce and disclose information about device risk. Unfortunately, courts are making it increasingly unlikely that this …

Drug Scheduling As Institutional Design, Matthew B. Lawrence, David E. Pozen

Faculty Scholarship

Controlled Substances Act (CSA), U.S. drug law has simultaneously fueled mass incarceration, inhibited needed access, and enabled an opioid crisis. To make better choices, this Article argues that the CSA’s institutional design must account for three distinctive features of psychoactive drugs: the prohibition problem (drug bans tend to backfire when demand is inelastic), the pharma problem (drug companies have supercharged incentives to manipulate markets and exploit consumers), and the pluralism problem (drug policy involves irreducibly political questions that no expert discipline can answer). On their own, each of these problems calls for reform to the CSA. Taken together, they call …

Tracing The Truth: Strengthening U.S. Food Traceability With Lessons From The Eur. Union, Carolina Gomez

University of Miami Business Law Review

The United States (U.S.) has made significant progress in improving food traceability, with the FDA’s Final Food Traceability Rule set to take effect in 2026. This long-overdue regulation aims to improve outbreak response and better protect public health. However, major gaps in the U.S. traceability system remain, leaving consumers exposed to preventable foodborne illness outbreaks. Legislative challenges, including H.R. Bill 7563 and provisions in the Fiscal Year 2025 Agriculture Appropriations bill, threaten to delay or weaken these necessary reforms. Compounding these challenges, on August 7, 2025, the FDA proposed extending the compliance deadline for the rule by 30 months, to …

Fda Policy Shift On Clinical Efficacy Study Requirements For Monoclonal Antibody Biosimilars, Rileigh Rahrig, Madilyn Paphanchith, Allie Honigford, Daniella Egbujor, Haley Brown, Jenny Magana Figueroa, Connor Dains, Brenna Hissong, Kyle W. Parker

Pharmacy and Wellness Review

Biologic products are widely used in the treatment of various disease states, including rheumatoid arthritis, inflammatory bowel disease, cancers, and genetic diseases. These products are derived from proteins and genes produced by living organisms and are subsequently used to treat specific disease states. Due to the complexity of biological products, the costs of research and production are high. Currently, the United States approval pathway requires extensive testing for biologics to be designated as biosimilars, meaning there are no clinically meaningful differences in safety or purity of their active components. These required tests can be redundant, as biosimilars are developed using …

A New Framework For Drug Pricing Law And Policy, Rachel E. Sachs

Indiana Law Journal

Scholars and policymakers have expressed concern about the impact of high prescription drug costs on patients and healthcare budgets. This Article presents a new theoretical framework for evaluating both the problem to be addressed by drug pricing reforms as well as the efficacy of potential solutions. In seeking to solve “the drug pricing problem,” our legal system has given primacy to competition rather than regulation to drive down drug prices. This Article disaggregates the broader concept of drug competition into four steps, each of which must be addressed and each of which elevates different institutional actors to key roles. In …

The Law’S Failure To Protect Our Drinking Water From Pfas, Emily Levine

Indiana Law Journal

How did per- and polyfluoroalkyl substances (PFAS), the forever chemicals known to harm human health and appear in most Americans’ blood, spread so widely in drinking water? Why didn’t someone with the power and knowledge to stop this crisis step in sooner? Simply imposing limits on PFAS levels in public water systems is the bare minimum to protect American drinking water—a necessary step but only the starting point of a long path toward creating a regulatory framework that can withstand the whims of changing presidential administrations and political influences.

     It is too easy for the EPA Administrator, either out of …

Rebalancing The Milk Market: A Shared-Burden Framework For Dairy And Plant-Based Producers, Isabelle Ulrich

Mitchell Hamline Law Review

This Note examines the structural and regulatory differences between traditional dairy products and the rapidly expanding plant-based milk products in the United States. Through analysis of historical Federal Milk Marketing Order policies, mandatory checkoff programs, and contrasting labeling standards in the United States and European Union, this Note reveals how plant-based milk producers enjoy competitive advantages without sharing the financial or regulatory burden that traditional dairy producers face. This Note argues for a shared-burden policy requiring all entities marketing “milk,” whether dairy or plant-based, to contribute to promotional and regulatory funds. This framework will restore market fairness, preserve consumer choice, …

Hester’S Dubious Roots And Legacy: Open Fields Doctrine Under Scrutiny, Laura K. Donohue

Georgetown Law Faculty Publications and Other Works

For over a century, open fields doctrine has shaped Fourth Amendment law, denying people the right to be secure on their own property. Its application has steadily expanded, with the result that, by some estimates, the Government can now engage in warrantless surveillance of some ninety-six percent of private land and buildings regardless of fences, postings, the distance from public roads or byways, or the use to which the property is put. An originalist approach throws the doctrine into disarray: at the time of the Founding, common law protected the curtilage, which extended to the fields, barns, storehouses, and other …

Legalizing Magic Mushrooms: A Different Set Of Laws For A Different Kind Of Drug, Edward S. Adams

Articles

This Article explores the regulation of the cannabis industry, highlighting its origins, history, and shortcomings. The Article then compares the cannabis and psilocybin industries, arguing against the replication of the cannabis regulatory structure for psilocybin. Instead, this Article will propose tailored regulatory solutions designed to address the unique characteristics of psilocybin and foster a well-regulated, safe, and effective market.

Meat Is Dead, Melissa D. Mortazavi

Faculty Articles

The legal and cultural landscape surrounding meat in the United States is evolving as plant-based alternatives, GMO farm animals, and cell-cultivated meat move from test tube to table. While global demand for meat rises amid environmental, ethical, and resource challenges, cell-cultivated meat emerges as a scientifically viable alternative, offering identical nutritional value without the drawbacks of conventional livestock production. Despite federal regulatory approval from USDA and FDA, multiple states have enacted unusually restrictive laws—including bans— targeting cell-cultivated meat. These are motivated largely by economic protectionism, but also deeper cultural anxieties tied to tradition and identity. This Article argues that food …

Plowing With A Pencil: Policy Approaches For States Squaring Agricultural Interests With Select Public Interests, Mary Eichenberger

Journal of Food Law & Policy

From a fifth-generation wheat farmer on the Kansas plains to a cattle rancher in Montana to a beginning peach producer in Georgia, American agriculture produces, provides, and protects sources of food, fiber, fuel, and shelter. American agriculture, once solely supported by rural family farmers and steeped in an agrarian system, now relies heavily on industrialized operations, creating an arena ripe for the clash of diverse policy perspectives. As farmers produce the food enjoyed at dinner tables across the country, the inevitable impacts of agriculture production on the environment have led to policy and legal arguments surrounding the regulation of agriculture. …

Key Contributions To Agricultural Law Select Works By Agricultural Law Professor, Susan A. Schneider, An Annotated Bibliography, Susan A. Schneider

Journal of Food Law & Policy

The authors provide an annotated list of publications, remarks, books, and book chapters authored by agricultural law scholar and professor, Susan A. Schneider, in honor of her forthcoming retirement.

The growth and evolution of the study of agricultural and food law may be attributed to several legal scholars who, based on a personal connection with agriculture, chose to dedicate their careers to advocating for the family farmer. Professor Susan A. Schneider is one such legal scholar.

Professor Susan A. Schneider, a native of Minnesota, is currently the William H. Enfield Professor of Law and the Director of the LL.M. in …

P-E-S-T-O-G-O: This Third Circuit Ruling Has Got To Go, A Deep Dive Into The Circuit Split Issue Of Fifra Preemption, R. Dylan Smith

Journal of Food Law & Policy

The American public is becoming increasingly concerned about pesticides. From “forever chemicals” to environmental justice concerns, public awareness of pesticide issues is only becoming more prevalent. However, one pesticide has seized public attention in a significant way. Glyphosate, the active ingredient in Monsanto’s “Roundup” and other commercial pesticides has been the subject of heated debate in federal courtrooms across the nation. The rising controversy over glyphosate has even led some jurisdictions to attempt to ban or restrict the use of the product altogether.

While the scientific studies and legal definitions about glyphosate and its cancer link are inconsistent, a reasonable …

An Interview With Former United States Department Of Agriculture General Counsel Janie Simms Hipp And Former Farm Credit Administration General Counsel David Grahn: Reflections On The Past & Future Of The Field Of Agricultural Law, Lauren Wustenberg

Journal of Food Law & Policy

Former United States (“U.S.”) Department of Agriculture (“USDA” or “Department”) General Counsel Janie Simms Hipp and Former Farm Credit Administration (“FCA”) General Counsel David Grahn have worked as public servants in the field of agricultural law for over forty years. They have led careers that are illustrative of the meaningful impact that a career in agriculture can have, the breadth and value of the Department of Agriculture, and the diversity of experiences and opportunities that a career in agricultural law can bring.

Janie and David graciously agreed to sit for the following interview in recognition of the 20th Anniversary Edition …

Municipalities, Let The People Have Their Chickens And Eat Them, Too, Cindy Vong

Journal of Food Law & Policy

In the pre-industrial era, before the advent of long-distance transportation or food preservation, human survival necessitated proximity to where food was grown or husbanded. Cities located near agriculturally productive lands and domesticated livestock animals were commonplace within cities. But by the 1920s, the technological innovations of the Second Industrial Revolution left urban areas free of farm animals and farm-related activities. Local governments exercised their powers to codify the separation of residential and agricultural uses within cities and reinforce the idea that food production was not proper in community neighborhoods. Yet, a century later, local governments use those same powers to …

Why Food In The United States May (Still) Never Be Safe: A Look Back At My Over Thirty Years Thinking About Food And The Law, Denis Stearns

Journal of Food Law & Policy

This article can serve a function as a concluding section—a kind of coda—for issues addressed in greater depth by the author (Denis Stearns) before.

This article also allows Sterns to return to a central question that prompted his thought-journey in the first place: Why does the food in this country continue to be so unsafe, despite all of the laws, all of the enforcement efforts, all of the food safety advocacy, and all of the lawsuits filed to recover damages on behalf of people injured and killed year after year. What follows, then, are additional and updated conclusions that thirty …