Food and Drug Law Commons^™

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.

Brief Of 11 Narcolepsy Patients, Public Interest Orgnizations, Medical Professionals, And Professors Of Law As Amici Curiae In Support Of Defendants-Appellees, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are patients, organizations, medical professionals, and legal scholars who share a common interest in advancing the law toward better patient health and welfare. New, clinically superior drug products for treating rare diseases and conditions tremendously benefit patients and society, because those products offer choice, competition, and improved patient care. In filing this brief, amici hope to make this Court aware of the broad real-world implications of this case, both for narcolepsy patients and for the public interest generally. Generation Patient is a nonprofit organization that represents young adults with chronic and rare conditions across the United States. Created …

Brief Of 12 Narcolepsy Patients, Public Interest Organizations, Medical Professionals, And Professors Of Law And Medicine As Amici Curiae In Support Of Defendants-Appellees (Amended To Add Further Signatories), Charles Duan

Amicus Briefs & Court Filings

A prior copy of this brief was filed, inadvertently omitting one signatory. This brief has accordingly been amended to correct the error, reflected in the Certificate as to parties and the Appendix.

Brief Of 30 Scholars Of Law, Economics, And Medicine As Amici Curiae In Support Of The Petition, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are scholars of law, economics, and medicine, listed in the Appendix. Their interest is in the proper development of patent law in ways that best promote the interests of innovation access and the public interest.

Let The Sunshine In: Crafting Constitutional Transparency Regulations For Content Moderation, Caitlin Ring Carlson

Seattle University Law Review

In response to public concern about the impact of social media, legislators in some U.S. states have developed laws to regulate the process of content moderation. Many include mandatory transparency and disclosure requirements, some of which courts have already deemed an unconstitutional infringement on social media platforms’ right to free expression. This article explores the parameters for crafting constitutional social media transparency regulations using existing U.S. media policy and insights from recent legal challenges. The resulting analysis identifies content neutral transparency requirements that mandate the disclosure of purely factual, non-controversial information as those most likely to withstand judicial scrutiny. Specifically, …

This Is Not A Game: The Addictive Allure Of Digital Companions, Nizan Geslevich Packin, Karni Chagal-Feferkorn

Seattle University Law Review

Artificial Intelligence (AI) agents have become an inescapable part of modern childhood, reshaping education, leisure activities, entertainment, and social interaction. From AI-powered tutors that adapt to individual learning styles to emotionally responsive chatbots that simulate human companionship, these systems promise unprecedented personalization, cognitive stimulation, and social support. However, these benefits mask significant risks that remain unregulated and inadequately addressed.

Although adults are also susceptible to forming deep emotional bonds with AI companions—often trusting them as if they possessed genuine understanding and empathy—children are particularly vulnerable. Their misplaced trust can more severely distort social development, weaken critical thinking, and foster unhealthy …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Re-Imagining Tomorrow: A Technology, Innovation Law, And Ethics Symposium On Addictive Technology And Children, Margaret Chon

Seattle University Law Review

In this Foreword, Professor Margaret Chon introduces Seattle University's Technology, Innovation Law, and Ethics (TILE) program, the 2024 TILE Symposium, and Dr. Gaia Bernstein’s Unwired: Gaining Control Over Addictive Technologies.

Keynote Address: The Movement To Protect Kids From Addictive Technologies, Gaia Bernstein

Seattle University Law Review

In this keynote address, I describe my personal journey starting with a school outreach program I created in 2017 to address technology overuse among kids. While I initially advocated for self-help methods, I grew to recognize that the tech industry bore responsibility. This realization led me to write Unwired: Gaining Control over Addictive Technologies, which focused on collective action to pressure the tech industry to redesign its addictive products.

I then describe the movement to control addictive technologies and protect kids, which has gained momentum since the end of the pandemic. This movement combines grassroots parent activism with legal-political action. …

Moral Panic Or Public Health Crisis? Lessons From Drugs And Gambling For “Addictive” Design, Matthew B. Lawrence, Haomin (Kevin) Yan

Seattle University Law Review

Alcohol, automobiles, guns, lottery, loot boxes, meat, music, opioid painkillers, processed foods, prop bets, slot machines, television, tobacco, violent video games. Over the last century each of these has been subject to concerns—some might even say “moral panics”—from parents and policymakers about avoidable harms to kids and adults. In some cases we look back with the benefit of hindsight and dismiss those concerns as naïve or moralistic. In others we look back at them as justified or as having come too late to check an expanding industry before it did unfathomable harm while growing so powerful that it became all …

Responding To Digital Addiction, Ned Snow

Seattle University Law Review

In Unwired: Gaining Control over Addictive Technologies, Professor Gaia Bernstein calls our attention to the growing problem of digital addiction. Digital addiction may sound like something out of a science-fiction novel or something that does not raise the same sort of real-life practical concerns as are present in a physical health crisis or an economic decline. But as Bernstein presents the evidence, we learn that the consequences of digital addiction can be just as harmful as a serious disease or a financial depression. Cognitive development disorders, anxiety, emotional depression, social isolation, and other mental health ills can be debilitating—as much …

The Ai Doppelgänger Dilemma: Cloned Voices In The Music Industry, Elizabeth Shields

Seattle University Law Review

With the rise of generative artificial intelligence (AI), there has been an influx of “voice clones”—deep-learning algorithms that create synthetic speech to realistically mimic human voices. Celebrities and, in particular, music artists, have been subjected to the proliferation of AI voice clones on social media platforms like TikTok and streaming platforms such as Spotify. Despite music utilizing AI voice clones having amassed much popularity, this technology can be harmful and highly invasive to musicians whose livelihoods often depend on their distinct voices. While legal scholars have attempted to articulate various rights that could protect a person’s voice, individuals are largely …

State-Powered Acceleration Of Cannabis Economy Growth Engines, Benjamin C. Varadi

Pace Law Review

Small cannabis companies in state-regulated markets have driven extraordinary job creation and economic growth, but now face extinction as consolidation looms. Government intervention can build a future populated with prosperous small business growth engines, while failure to act will magnify economic disparity. This Article proposes state-backed loan guarantees, funded by municipal “cannabonds,” as a novel solution to guide the industry toward a healthier and more diverse economic landscape. This approach offers constitutionally resilient strategies to express explicit preference for local stakeholders and inverts traditional risk metrics to leverage historic institutional lending bias as a force for positive change. In doing …

Hemp And Marijuana: The Necessity Of Lab Testing For Fair Prosecutions, Jessica Aycock

Pace Law Review

This Article examines the evidentiary and ethical challenges prosecutors nationwide face in distinguishing between hemp and marijuana under current federal and state laws. Following the legalization of hemp under the federal 2018 Farm Bill, the legal distinction between hemp and marijuana now hinges on the concentration of delta-9 tetrahydrocannabinol (THC). This distinction requires quantitative lab testing to be established. Without quantitative lab testing, prosecutors cannot accurately determine THC levels, making it challenging, if not impossible, to meet the burden of proof required for marijuana possession convictions. This Article argues that the absence of testing raises evidentiary and ethical concerns that …

Fighting Drugs With Drugs: Medical Mushrooms In Utah’S War On Opioids, Paul Helms

Utah Law Review

In addition to the happy side effect of improving psilocybin’s odds of rescheduling under the proposed new CAMU standard (potentially increasing national psilocybin accessibility for opioid recovery), Senator Escamilla’s S.B. 200 could represent the beginning of a new era for the State of Utah in its battle against opioids. Despite S.B. 200’s failure to pass, the medical application of psilocybin under S.B. 266 (S.B. 200’s spiritual successor) should positively impact several interconnected issues in Utah, including mental illness, addiction, and transiency. However, specific proof of psilocybin’s effectiveness in combatting opioid addiction should be especially persuasive in garnering bipartisan support for …

Washington's Implementation Of Legalized Cannabis: A Model For Other States And The Federal Government, Bruce Turcott, Daniel Shortt

Washington Law Review

This Article examines the process and outcomes of cannabis legalization in Washington State, offering insights for other states and potential federal legalization schemes. It begins with an overview of the campaign that led to the passage of Initiative 502 (I-502), detailing the initiative’s structure, which draws from liquor licensing laws. The Article then explores the establishment of a recreational cannabis market from scratch, focusing on agency structure, federal responses such as the Cole Memorandum, and the state’s regulatory framework aimed at preventing adverse outcomes.

Additionally, this Article highlights Washington’s efforts to promote social equity, emphasizing that I-502 was framed as …

Cannabis In The Clink: An Argument In Favor Of Medical Marijuana For Disabled Inmates, Sophia Dechurch

Journal of Law and Health

In recent decades, medical marijuana programs have become commonplace, and most states in the United States of America are ready to accept marijuana as a natural alternative to treat symptoms of certain conditions such as chronic pain, cancer, mental illness, multiple sclerosis (MS), HIV/AIDS, and substance use disorder; as such, medical marijuana is readily accessible to those who have a qualifying diagnosis – the exception being those who are incarcerated. Although disability, substance abuse, and mental illness are prevalent among those under state supervision, these individuals are effectively prohibited from enjoying the benefits of medical marijuana. This Note will provide …

Race, The Academy, And The Constitution Of The War On Drugs, Jeffrey Bellin, Bennett Capers

Vanderbilt Law School Faculty Publications

The war on drugs is widely viewed as a policy failure. Despite massive government intrusions on personal liberty, drug addiction, overdoses, and drug-related violence have only in- creased since the war was declared in 1971. David Pozen's new book, The Constitution of the War on Drugs, reveals a constitutional failure as well. Pozen chronicles a host of constitutional arguments that American litigants deployed to protect a "right" to use drugs with surprising, if fleeting, suc- cess. Pozen asks what might have been, exploring why the courts backtracked and effectively re- moved the Constitution as a meaningful obstacle to drug prohibitions. …

Brief Of Law Scholars As Amicus Curiae In Support Of Appellees And Affirmance, Charles Duan

Amicus Briefs & Court Filings

Amici are law professors and scholars who focus their scholarship and teaching on intellectual property law, property law, regulatory law, and health law. They write to address the plaintiff, Novartis Pharmaceuticals Corporation (Novartis), contention that the Medicare drug price negotiation program effectuates a taking of personal property in violation of the Fifth Amendment. Amici submit this brief to provide the Court with the historical and legal background necessary to understand two issues: first, the constitutionality of government price negotiations and price regulations; second, the federal government’s use of patents. The amici explain how Courts have historically ruled on these questions, …

Buyer, Beware Of Addiction, Erin E. Meyers, Clayton J. Masterman

Cardozo Law Review

Addictive products kill more than 700,000 people in the United States every year. Despite the large-scale risks that addiction poses, the law requires manufacturers of addictive products to disclose little-to-no information about the risk of addiction—the single most consequential characteristic of a class of products contributing to mass death every year.

While consumers understand that addictive products are, in fact, addictive, they generally do not understand the magnitude of the addiction risks that they face. Metaphorically, consumers understand that they are playing a game of “Russian roulette” when they consume an addictive product—but they play without knowing how many bullets …

The End(S) Of Bankruptcy Exceptionalism: Purdue Pharma And The Problem Of Social Debt, Jonathan C. Lipson, Pamela Foohey

Cardozo Law Review

The Supreme Court’s recent 5-4 decision in the controversial chapter 11 bankruptcy reorganization of opioid-maker Purdue Pharma ends the use of nonconsensual third-party “releases,” which discharge (eliminate) liabilities of nondebtors who may share liability with a corporate debtor. Although the majority opinion is correct that the Bankruptcy Code does not permit this, it failed to recognize the problematic exceptionalism of the lower courts which approved those releases or the “social” qualities of Purdue Pharma’s mass tort liability.

Bankruptcy exceptionalism has been a contested concept since it emerged over fifteen years ago and reflects a willingness to bend the rule of …