Food and Drug Law Commons^™

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 …

Magic Mushrooms As Medicine: What The United States Can Learn From Jamaica’S Unregulated Psilocybin Industry As Fda Approval Nears, Kyle Spohn

University of Miami Inter-American Law Review

In 1970, Congress passed the Controlled Substances Act and swiftly placed psilocybin (the active chemical in “magic mushrooms”) under Schedule I—the strictest level of regulation withheld for substances with “no currently accepted medical use.” While the United States has maintained this rigid framework, Jamaica has taken the opposite approach. Psilocybin was never listed under Jamaica’s Dangerous Drugs Act, and remains unregulated. In recent decades, research has shown that psilocybin, when administered in controlled settings, can effectively treat depression, anxiety, and other psychiatric conditions. In response, the Jamaican government has not only preserved psilocybin’s legality but has encouraged research and industry …

Redressing The Harm Of Accelerated Approval, Laura Karas

Articles

The accelerated approval pathway of the United States Food and Drug Administration (FDA) enables drugs to come to market more quickly than would be possible under a traditional FDA approval pathway. Accelerated approval is based upon the agency's determination that changes in a surrogate or intermediate clinical endpoint are "reasonably likely" to predict a clinical benefit meaningful for patients. In essence, the pathway affords sick patients earlier access to potentially beneficial drugs while trials to confirm clinical benefit continue. Accelerated approval has been likened to a social compromise in which promising drugs enter the market sooner in exchange for a …

If You Can’T Beat Hemp, Join Hemp: A Policy Argument For A Federal Regulatory Framework Encompassing Intoxicating Hemp Derivatives And Marijuana And Why Re-Scheduling Marijuana Isn’T The Answer, Frances Alaina Rodriguez

University of Miami Business Law Review

The Agriculture Improvement Act of 2018 (2018 Farm Bill) legalized industrial hemp and its downstream uses by removing hemp from the definition of marijuana under the Controlled Substances Act (CSA). Its enactment led to the explosion of a multi-billion dollar intoxicating hemp derivatives (IHD) market. This boom, combined with growing state–level marijuana legalization, presents a unique opportunity for comprehensive federal cannabis reform.

This Note argues that the traditional pathways for marijuana legalization—rescheduling through the Controlled Substances Act or state-by-state legislation—are inadequate given the emergence of a federally legal but largely unregulated IHD industry. Instead, this Note proposes a unified federal …

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

University of Miami Law Review

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. …

Are Healthy Foods “White People Food”: A Legal Analysis Of Disparities In Healthy Food Accessibility And Affordability At Grocery Stores And Restaurants In Low-Income Neighborhoods, Sara St. Juste

University of Miami Race & Social Justice Law Review

No abstract provided.

‘Rounding Up’ Roundup: One Last Hope For Glyphosate Regulation, Gabrielle Argimón-Cartaya

University of Miami Law Review

Since 1974, Bayer’s Roundup remains the world’s most popular herbicide and pervades United States farmland and food production. However, in 2015, Roundup landed centerstage in an international and presently unsettled debate over whether its active ingredient, glyphosate, causes cancer. Environmental groups regularly call for the de-registration of glyphosate due to the plethora of ailments, ecological harm, and weed resistance resulting from glyphosate use. Dissenting experts, however, believe that strict bans would devastate agriculture because of global dependence and the lack of any popular alternatives. Faced with mounting litigation, silence from the highest court, and unreliable regulators, Bayer continues to effect …

Seeding A Movement: Indigenous Food Sovereignty, Mariaelena Huambachano

University of Miami Law Review

For many Indigenous peoples, well-being is bound up with and inseparable from the natural world. But since colonialism, Indigenous traditions and access to traditional foods or foodways have been disrupted, imperiling their health and well-being. In this Article, I discuss the role of Indigenous cosmovision/worldview and Indigenous Food Sovereignty in achieving environmental justice. Specifically, in this Article, I discuss that despite, or perhaps because of, efforts to deny Indigenous peoples’ access to healthy and culturally appropriate foods, Indigenous Food Sovereignty took a rise of preciousness in informing natural regenerative food systems, and ultimately, “holistic/collective well-being.”

On The Scales Of Private Law: Nano Contracts, Yonathan A. Arbel

Articles

Contracts are falling in scale. New contracting trends and technologies facilitate the formation of smaller scale contracts that have ephemeral duration, token stakes, and narrow scope. These nano contracts embody ephemeral interactions of minuscule value - interactions that were previously far outside the law and away from explicit markets, governed only by social norms. The rise of nano contracts can unlock new transaction types, create opportunities to build wealth, and reduce dependence on private ownership. Yet nano contracts also carry important risks, and their small scale makes them difficult to effectively regulate. At the limit, nano contracts collapse private law …

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

Hard Truths: Cracking Open The Case Of Whether Hard Seltzer Is Beer, Scott Fraser

University of Miami Law Review

Following the line of cases asking questions such as what is a chicken, and is a burrito a sandwich, comes the next deep legal issue, what is beer? How do we determine this seemingly simple question? Do we simply know it when we see (or taste) it? Does it require a mix of specific ingredients or certain processes? Or, if we should rely on definitions, do we look to the dictionary, history, or statutes? In a dispute in the United States District Court for the Southern District of New York, the court is asked to resolve this question. Courts have …

Legal And Ethical Implications Of U.S. And Canadian Vaccine Contracts: The Impact Of Vaccine Nationalism On The Global Pandemic Response, Ryan S. Tahiri

University of Miami Inter-American Law Review

This note explores the COVID-19 vaccine contracts between the U.S. and Canada and the impact of these types of agreements on the global pandemic response. These “pre-purchases,” many of which were executed before the development of a vaccine, have afforded a select few nations the opportunity to stockpile vaccines, while other nations with fewer resources are unable to secure any doses. An effective method to counter the effects of the pandemic is the creation of a global vaccine network that provides equitable access to vaccine doses for nations in need. COVAX was launched to ensure that lower and middle-income nations …

Pharmaceutical "Pay-For-Delay" Reexamined: A Dwindling Practice Or A Persistent Problem?, Laura Karas, Gerard F. Anderson, Robin Feldman

Articles

The Supreme Court ruled in FTC v. Actavis that a delay in generic entry may be anticompetitive when part of a patent settlement includes a large and otherwise unjustified value transfer to the generic company, termed a reverse payment patent settlement, or "pay-for-delay." Following Actavis, drug companies have limited the size of reverse payments and have fashioned settlement terms that include more discreet categories of compensation to generic companies. In light of the fact that such settlements retain the potential for anticompetitive effects, the apparent size of the reverse payment may no longer be a useful gauge of the …

Addiction-Informed Immigration Reform, Rebecca Sharpless

Articles

Immigration law fails to align with the contemporary understanding of substance addiction as a medical condition. The Immigration and Nationality Act regards noncitizens who suffer from drug or alcohol substance use disorder as immoral and undesirable. Addiction is a ground of exclusion and deportation and can prevent the finding of "good moral character" needed for certain immigration applications. Substance use disorder can lead to criminal behavior that lands noncitizens, including lawful permanent residents, in removal proceedings with no defense. The time has come for immigration law to catch up to today's understanding of addiction. The damage done by failing to …

Pharmaceutical Industry Funding To Patient-Advocacy Organization: A Cross-National Comparison Of Disclosure Codes And Regulation, Laura Karas, Robin Feldman, Bai Ge, So Yeon Kang, Gerard F. Anderson

Articles

Transparency has become one of the primary themes in health care reform efforts in the United States and across the world. In the face of exorbitant drug prices, high levels of patient cost-sharing, and pharmaceutical expenditures that consume a growing proportion of public sector budgets, much attention has been drawn to the pharmaceutical industry. Congressional investigations, academic publications, and news articles have endeavored to reveal the extent of drug and device industry influence on health care actors. In response, several nations, including the United States, have passed legislation mandating disclosure of drug company payments to physicians. In the United States, …

Regulating The Blue Revolution: A Sea Of Change For The United States’ Offshore Aquaculture Industry Or A Missed Opportunity For Increased Sustainability, Elan Lowenstein

University of Miami International and Comparative Law Review

Aquaculture has the potential to be one of the most efficient methods of food production to date. In recent years, the developments in offshore finfish aquaculture have proven to be more environmentally friendly than large-scale terrestrial animal farming, requiring a fraction of resources such as freshwater which are becoming more scarce in the face of global population growth, while also relieving pressures on wild fisheries. The United States is one of the largest global consumers of seafood, importing about ninety-percent of its supply. The current regulatory framework for offshore aquaculture in the United States is effectively non-existent. Federal courts have …

Kratom Crackdown: How The Dea Abused Its Emergency Scheduling Authority Under The Controlled Substances Act, Olivia Castillo

University of Miami Law Review

The Drug Enforcement Administration wields tremendous power at scheduling a new drug or substance on an emergency basis under the Controlled Substances Act. The DEA newly leveled this power at a plant—kratom—with the potential to curb the menacing opioid epidemic in North America. This unprecedented effort has generated considerable controversy. Many individuals remonstrated the agency’s action, especially those facing life-threatening hardships because of the opioid crisis. Members of Congress also took a stand against the DEA’s unrivalled move to schedule kratom, suggesting that the agency had abused the emergency scheduling authority delegated by the legislative branch.

This Comment explores the …

The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid

University of Miami Business Law Review

In recent years, some pharmaceutical companies have started increasing the price of their existing drugs to exorbitant levels. Often, these drugs are medically necessary for patients, who are left to take on the high costs of the medicine. One recent example is Mylan, who raised the price of the EpiPen by four hundred percent, solely for the profit of its own company and to the detriment of consumers who rely on the EpiPen. Similar patterns of drug price increases have occurred in the past and will likely happen again in the future. This Comment will seek to identify the common …

Beyond Zero-Sum Environmentalism, Jessica Owley, Shalanda Baker, Robin Kundis Craig, John Dernbach, Keith Hirokawa, Sarah Krakoff, Melissa Powers, Shannon Roesler,, Jonathan Rosenbloom, J. B. Ruhl, Jim Salzman, Inara Scott, David Takacs

Articles

Environmental law and environmental protection are often portrayed as requiring trade offs: "jobs versus environment," "markets versus regulation," "enforcement versus incentives." In the summer of 2016, members of the Environmental Law Collaborative gathered to consider how environmentalism and environmental regulation can advance beyond this framing to include new constituents and offer new pathways to tackle the many significant challenges ahead. Months later, the initial activities of the Trump Administration highlighted the use of zero-sum rhetoric, with the appointment of government officials and the issuance of executive orders that indeed seem to view environmental issues as in a zero-sum relationship with …

Pitfalls Of The Food Safety Modernization Act: Enhanced Regulation, Minimal Consumer Benefit, And Zero Tolerance Levels For Naturally-Occurring Trace Pathogens, Lindsey Lazopoulos Friedman, Wesley Van Camp

University of Miami Inter-American Law Review

Congress enacted the Food Safety Modernization Act (“FSMA”), to regulate the fresh produce industry in the United States and increase consumer safety when handling and consuming raw produce. But FSMA risks imposing a zero tolerance policy on raw produce, even where a naturally occurring low-level pathogen, such as listeria, is found in negligible amounts. A zero tolerance policy for all naturally-occurring pathogens does not increase consumer safety, and only serves to increase the cost of raw produce for consumers. This article begins with a summary of the modern history of FSMA, including a brief overview of how the law has …

Fsma: The Future Of Food Litigation, Robert Shawn Hogue

University of Miami Inter-American Law Review

No abstract provided.

Food Justice As Interracial Justice: Urban Farmers, Community Organizations And The Role Of Government In Oakland, California, Christopher J. Curran, Marc-Tizoc González

University of Miami Inter-American Law Review

No abstract provided.

The Sentencing Commission Takes On Crack, Again, David Yellen

Articles

We may be entering a new era of drug sentencing policy. For the first time, an effort by the United States Sentencing Commission to reduce the disparity in treatment between crack and powder cocaine offenders by somewhat reducing crack sentences has succeeded. Decisions of the United States Supreme Court, culminating most recently in Kimbrough v. United States and Gall v. United States, have clarified and expanded the flexibility federal judges have in sentencing under the post- United States v. Booker advisory sentencing guidelines. Political leaders have begun to accept the need for relaxation of at least some of the …

Scientific Secrecy And "Spin": The Sad, Sleazy Saga Of The Trials Of Remune, Susan Haack

Articles

No abstract provided.

Reforming Cocaine Sentencing: The New Commission Speaks, David Yellen

Articles

No abstract provided.