Food and Drug Law Commons^™

The Public Square In A Private-Property Obsessed Country: What New York City’S Pops Regulations Get Right And Why Other Cities Should (Mostly) Copy Them, Carson Mcgregor

Seattle University Law Review

When New York City (NYC) was first becoming the metropolitan monolith it is today, it had a problem: the city streets were chock full of skyscrapers, and sunlight, air, and usable open space were at a premium. In response, the City promulgated its first Privately Owned Public Spaces (POPS) regulations, which allowed developers to build skyward in exchange for providing public space on the street level. Unfortunately, in July of 2023, the New York Times (NYT) discovered that New Yorkers received only a fraction of what they were promised. Building owners received billions of dollars’ worth of added floor space, …

Intellectual Property Or Modern Folklore? The Problem With Open Gaming Licenses In Tabletop Gaming, Rosie Midget

Seattle University Law Review

This Note addresses how courts and legislatures should address “Open Gaming Licenses” commonly attached to tabletop roleplaying games (TTRPGs), which game publishers use to promote a false image of accessibility—misleading consumers and building goodwill from the misunderstanding. Part I discusses what TTRPGs are, including the defining features of the hobby and culture surrounding it, as well as the unique interplay between publishers and players. Part II explores the question of which elements in a TTRPG system may be subject to copyright protection. Part III examines these elements in practice using Wizards of the Coast’s Dungeons and Dragons TTRPG as a …

Food Inspections: Searching For Contamination (And Solutions) In A Haystack, Abigail Schneider, Benjamin Kelly, Michael S. Sinha

Journal of Food Law & Policy

Food recalls in the United States often reveal serious mismanagement and structural issues in both government and private industry, yet they have become unremarkable and even expected in our modern world. The procedure employed by the U.S. Food and Drug Administration (“FDA”) to monitor food manufacturing is a valuable process which protects every person who lives in the United States. However, the effects of monitoring as a tool for oversight is limited if there is no efficient response when problems arise. FDA inspects pharmaceutical, cosmetic, and food manufacturing facilities both domestically and abroad. When those inspections reveal the presence of …

A Critical Look At A New Iowa Law Allowing Minors To Serve Alcohol, Tom Hubbard

Journal of Food Law & Policy

In the never-ending tug-of-war of today’s charged political climate, the child labor discussion has been caught right in the crosshairs. While the Biden administration promised to crack down on child labor law violations (with varying degrees of success), more states continue making it easier for children to work. Because of this, the opportunity to exploit a progressively younger workforce will continue to grow. Amidst this backdrop, this article focuses particularly on a new Iowa law that expands child labor across the state. While there are many states seeking to roll back child labor law protections, Iowa’s new law seems to …

Food For Thought: Funding The National School Lunch Program While Simultaneously Providing Tax Incentives To Farmers, Carter Wade

Journal of Food Law & Policy

This note will focus primarily on the National School Lunch Program (“NSLP”) and propose a solution aimed at reducing the costs of implementing it. It begins with a historical background into how the NSLP came to be and the various adaptations and programs that came out of it. This note then covers current programs and organizations that have arisen to support nutritional education and provide healthy meals to school children. It then compares several contribution-based tax incentive programs, which serve as inspiration for the final proposed tax incentive program for farmers in the closing section. Through the years, rising costs …

Negotiating Food Security, Maria Cudowska

Journal of Food Law & Policy

In the United States and worldwide, nutrition and food emerge as both high-profile public policy targets and as fundamental aspects of the right to self-determination. This Article examines how national security impacts food security in the United States. It explores conflicts and synergies between municipal, state, and federal law developments related to the right to food and investigates recent developments in how those commitments have been negotiated. The challenge and nebulous justiciability of the right to food can be in part attributed to existing global and national systems, which include supply chains, welfare programs, and foreign investment in the U.S. …

Ai V. Mqd: Navigating New Regulatory Challenges In The Life Sciences, Hayden W. Smith

William & Mary Law Review

This Note proceeds in four parts. Part I introduces AI as an emerging technology in the life sciences, the FDA’s inherited regulatory regime, and challenges under the MQD [major questions doctrine]. Part II explores how hypervigilant regulation obstructs innovation and exposes agencies to judicial challenges. Part III offers solutions to safely and effectively navigate the major questions landscape within a framework that fosters AI innovation. This Note proposes a solution that conceptually balances growth in the life sciences with the statutory elements required for a safe and effective regulatory scheme.

This abstract has been taken from the author's introduction.

Abortion Travel Restrictions Under The Dormant Commerce Clause After National Pork Producers Council V. Ross, Katherine Bartley

Fordham Law Review

Since Dobbs v. Jackson Women’s Health Organization, twelve states have banned abortion entirely, and seven states have banned abortion earlier in pregnancy than the standard set in Roe v. Wade. As abortion access dwindles, patients increasingly cross state lines to seek reproductive healthcare. In response, antiabortion state officials and lawmakers have made efforts to restrict interstate travel for abortion care.

This Note examines abortion travel restrictions under the “Dormant” Commerce Clause doctrine, which limits state laws that burden interstate commerce. In 2023, the U.S. Supreme Court affirmed but narrowed the judge-made doctrine in National Pork Producers Council v. …

When Prenatal Care Becomes A Crime, Casey Hunter

Fordham Law Review

For decades, pregnant women have increasingly faced criminalization for their actions and conduct during pregnancy, with Alabama emerging as a focal point due to its aggressive use of section 26-15-3.2: Chemical Endangerment of Exposing a Child to an Environment in Which Controlled Substances Are Produced or Distributed. Originally intended to protect children from the dangers of methamphetamine labs, this law has been reinterpreted to prosecute pregnant women who test positive for controlled substances. Central to these prosecutions are positive drug tests obtained from prenatal health records, causing many women to avoid prenatal care for fear of legal consequences.

This Note …

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 …

Cultivating Legal Protection: Replacing Wine Labeling Regulations With Regional Certification Marks, David Corasaniti

Washington and Lee Law Review Online

While wine labeling in the United States is currently governed by a complex regulatory framework administered by the Alcohol and Tobacco Tax and Trade Bureau (“TTB”), intellectual property (“IP”) rights for wine producing regions could serve this core function of protecting consumers better and more efficiently. Regulating wine labeling through IP would more closely mirror the system used by the European Union, which recognizes Geographical Indications, such as Champagne, Rioja, and Bordeaux, as a unique form of IP. By deregulating American wine labeling, and encouraging wine producing regions to assert their IP rights in the form of collectively held certification …

Amgen Enablement And Its Undue Burden On An Overburdened Biomedical Industry, Carter Chippi

Journal of Law and Health

This paper examines the Supreme Court decision in Amgen Inc. v. Sanofi and its profound impact on the patentability of biotechnology inventions, particularly biologic drugs. By virtually eliminating the possibility of claiming genera patents, the decision exacerbates existing challenges within the biologic sector, including high development costs and rigorous regulatory hurdles. The analysis sets forth the enablement requirement’s precedent, emphasizing historical case law and the unforeseen implications of setting a stringent standard for biotechnology patents. This paper further critiques suggested industry compromises, deeming them insufficient to address the ramifications of Amgen, and proposes legislative intervention. Options include granting biologics …

The Incremental Development Of An Extra-Statutory System Of Regulation: A Critique Of Food And Drug Administration Regulation Of Added Poisonous And Deleterious Substances, James David Poliquin

Maine Law Review

Federal regulation of added poisonous and deleterious substances in food by the Food and Drug Administration has become an administrative quagmire. Although responsibility for this situation evades precise assignment, FDA regulatory problems typically arise through the operation of three factors. First, the applicable statutory provisions are highly ambiguous, far exceeding the level of ambiguity traditionally viewed as necessary to administrative flexibility and efficiency. Even resort to the legislative history of these provisions often leaves many questions unanswered. Second, the perpetual amendment of the original Federal Food, Drug, and Cosmetic Act without the simultaneous repeal of all the inapplicable and inconsistent …

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. …

The Public Utility Regulation Of Dollar General, Olivia R. Sokos

West Virginia Law Review

As food insecurity persists across the country, few solutions have been proposed to address the lack of access to healthy food in rural regions. This Note explores whether public utilities regulation is a theoretical avenue for addressing rural food deserts. The contribution of this Note is to encourage the recognition of healthy food as a critical public good through a modern public utility lens and build solutions to inadequate food access in rural regions by considering the qualities unique to rural populations. One solution proposed herein is to apply a modern public utility framework to dollar stores, ensuring reliable and …

Cannabis At Work: Navigating The Intersection Of Employment Law And Legalized Marijuana, Eva Lane

Washington and Lee Journal of Civil Rights and Social Justice

As states increasingly legalize forms of cannabis use, federal regulation remains stagnant. These outdated laws still hold power, undermining state-granted rights. This impact is especially felt in the employment sector. While states pass laws legalizing cannabis use, employers still have a right to a drug free workplace. Many employment agreements prohibit drug use, even if legal under state law. This Note examines recent caselaw to analyze how courts are handling the battle between state and federal government as it relates to cannabis legalization. Ultimately, the argument highlights the risk employees face – engaging in what they believe is legal behavior …

Meat, The Future: The Role Of Regulators In The Lab-Grown Revolution, Joseph B. Davault, Michael S. Sinha

All Faculty Scholarship

The United States is one of the largest consumers of meat globally. The production of meat contributes substantially to climate change due to the levels of greenhouse gasses emitted and the amount of land, water, feed, and other natural resources required to raise animals used for meat. Traditional meat production is another major source for the emergence of zoonotic diseases and antimicrobial-resistant pathogens. Nevertheless, Americans consume more meat now than at any time in the nation’s history.

Advocates for policy change aimed at addressing the risks associated with meat production have typically focused on reducing meat consumption, alternatives to meat, …

Delta-8 Tetrahydrocannabinol Policy And Related Health Impact Among College-Aged Individuals In South Carolina: A Scoping Review, Emily K. Luoma

Senior Theses

After the 2018 Farm Bill passed, loopholes were quickly found that led to the popularization of delta-8 THC, a derivative of delta-9 THC, more commonly known as marijuana. Use of this substance became particularly high in states that criminalized marijuana, such as South Carolina. This scoping review aimed to assess South Carolina’s current delta-8 policies in the context of health-related impacts among college-aged students. Comprehensively analyzing the results of relevant studies, it was determined that there are three commonly observed threats to public health that are direct outcomes of existing policies: 1) a lack of quality control standards; 2) misleading …

No Just Cause: A Decades-Long Strategy Of Deception And Secrecy That Enabled America's Deadly Opioid Crisis, Patrick C. Mcginley, Suzanne Weise

West Virginia Law Review

This Essay examines the national epidemic of prescription opioid addiction and overdose deaths that began in the mid-1990s and continues to the present. Litigating from West Virginia—ground-zero of the opioid crisis—the authors draw from their experiences providing pro bono representation of a West Virginia newspaper and The Washington Post to successfully uncover long-buried facts. If revealed to the public, that hidden information could have stopped the epidemic in its tracks, saving millions of Americans from addiction and hundreds of thousands from cruel overdose deaths. The Essay highlights how political influence and industry capture hindered effective oversight of prescription opioid profiteers. …

A Masque Of Red Death: The Fda's "Individual Risk-Based" Blood Donor Final Guidance Report Is A Poorly Constructed Facade Covering Continued Animus Toward Queer Men, Gerald Dryden

Cardozo Journal of Equal Rights & Social Justice

The note argues that the FDA's blood donation guidelines discriminatorily target queer men, perpetuating stigma and failing to align with contemporary science. These guidelines, while aiming to protect blood recipients, are unconstitutional and not tailored to avoid discrimination, thus requiring revision to reflect current scientific understanding and eliminate bias.