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. …

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 …

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 …

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. …

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, …

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.

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 …

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, …