Food and Drug Law Commons^™

Covid-19 Impacts: How A Global Pandemic Amid The Sunsets Of The Ptc And Itc Made The U.S. Wind And Solar Industries More Resilient, Kimberly E. Diamond

Fordham Environmental Law Review

A cataclysmic event is sometimes the necessary catalyst for companies within certain industries to re- examine, radically shift, and replace their standard practices with technologically-advanced alternatives. In the United States, the occurrence of the Coronavirus pandemic (“COVID-19”) during the sunsets of the Production Tax Credit (“PTC”) and the Investment Tax Credit (“ITC”) created a unique confluence of factors that produced a perfect storm tantamount to such a cataclysmic event for companies in the wind and solar industries, particularly developers. Over the years, the domestic utility-scale wind industry has come to rely heavily upon the PTC, while the domestic utility- scale …

Illegal Discharge: Exploring The History Of The Criminal Enforcement Of The U.S. Clean Water Act, Dr. Joshua Ozymy, Dr. Melisssa L. Jarrell

Fordham Environmental Law Review

The criminal prosecution of defendants that violate federal clean water laws has been ongoing for roughly four decades. Yet, we continue to have a poor understanding of how federal prosecutors use the U.S. Clean Water Act (“CWA”) to charge and prosecute criminals and the outcomes of those prosecutions. We use content analysis to analyze 2,588 federal criminal prosecution case summaries, 1983-2019, to gain a better historical understanding of how the CWA has been used as a prosecutorial tool, to bring out the major themes in the prosecutions, and quantify sentencing outcomes. Findings from the 828 CWA prosecutions undertaken during this …

Red Tide: A Blooming Concern For Florida Manatees, Shannon Price Esq.

Fordham Environmental Law Review

Although red tides are a common and natural occurrence around the coast of Florida, within the last few decades they have intensified and become much more deadly. Several identifiable human-caused factors exacerbate the size, concentration, and duration of the harmful algae bloom and disturb the environment’s natural balance. The Florida Gulf Coast provides all the algae’s necessary requirements for survival, the perfect storm to create a resilient super bloom that annihilates its host ecosystem.

This article explains the plight of Florida manatees who, like other marine animals and plants, are being injured or killed by this algae crisis. It also …

The Use Of Regular Militaries For Natural Disasters After A Major Event Where The Military Was Seen As A Failure - The Somalia Effect In The Age Of Black Lives Matters And Covid-19, Donald D.A. Schaefer

Fordham Environmental Law Review

This is written as a continuation of Dr. Schaefer’s recent article entitled, “The Use of the Regular Militaries for Natural Disaster Assistance: Climate Change and the Increasing Need for Changes to the Laws in the United States, China, Japan, the Philippines, and Other Countries.” 2 Perhaps few other areas have affected so many people than the Covid-19 pandemic. Coupled with this has been the struggle over the use of force by the military and police in the age of “black lives matters” and the movements that have been transpired as a result. With the increased global warming likely to continue …

"Eco" Your Own Way: An Argument For State-Specific Climate Change Legislation, Amanda Voeller

Fordham Environmental Law Review

The consequences of climate change seriously and immediately threaten the American way of life, but proposed federal legislation like the Green New Deal is overly broad, unrealistic, and inefficient. The most effective way for the United States to combat climate change is not with a one-size-fits-all plan like the Green New Deal, but with federal legislation that incentivizes states and cities to enact and enforce individualized, local climate legislation. Different states and cities have different climates, available energy sources, and transportation needs, so the federal government should use financial incentives to encourage states and cities to pass tailor-made bills and …

The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards

Journal of the National Association of Administrative Law Judiciary

The 21st Century Cures Act is designed to expedite the FDA’s approval of pharmaceutical and medical device applications in order to increase patient access to innovative therapies. However, many experts claim that the Act’s Title III provisions promote evidentiary “‘shortcuts’” that eviscerate the safety and efficacy standards of the FDA approval process. For new drugs, Title III permits surrogate endpoints and real-world evidence in lieu of more rigorous scientific data. For new medical devices, Title III requires the FDA to exempt certain Class I and II devices from any kind of safety or efficacy evaluation. Moreover, Title III forces the …

Revolving Doors - We Got It Backwards, Hadar Yoana Jabotinsky Dr.

University of Cincinnati Law Review

The revolving door phenomenon, in which senior public officials transfer from the public service to the private sector after finishing their term as public officials, and vice versa, is widespread. This gives rise to concern of regulatory capture, which happens when the regulators respond to the wishes of strong interest groups, such as the regulated industry, instead of protecting the interests of the general public. The solution is usually found in conflict-of-interest rules which set cooling-off periods for individuals moving from the public to the private sector. This paper proposes that although revolving doors do incur some costs, they also …

Brewing Green Beer: Building A Regulatory Scheme Robust To Changes In Brewing Technologies, Daniel Pashang Withers

Texas A&M Law Review

New beer brewing technologies provide brewers with options to produce beer in more eco-friendly, less resource-intensive ways; however, as brewers adopt these technologies, they may find themselves straddling between the regulatory schemes of the Alcohol and Tobacco Tax and Trade Bureau (“TTB”) and the Food and Drug Administration (“FDA”). The two agencies have divided control over beers based on their ingredients, which places some beers under the TTB’s purview as “malted beverages” and others under the FDA’s purview. These distinctions have implications for the regulatory hurdles that brewers must overcome to market their products. Additional regulations that eco-friendly, green beers …

Food And Drug Regulation: A Statutory Approach, Adam I. Muchmore

Books

This is the first chapter of a new casebook on food and drug regulation. This book presents food and drug regulation as a statutory subject. It is organized around the structure of the Federal Food, Drug, and Cosmetic Act, and emphasizes guided reading of statutes, regulations, and federal register documents. Cases are presented primarily when they involve major issues of statutory interpretation, are historically significant, or are in one of the areas where case law plays a major role.

The book is designed to work with a Statutory and Regulatory Supplement provided as a PDF. The statutes and regulations in …

Food And Drug Regulation: Statutory And Regulatory Supplement, Adam I. Muchmore

Books

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than comprehensive.

Supply And Demand: Navigating Emergency Regulatory Developments In The Fight Against Opioid Use Disorder, Eva Bogdewic

Upper Level Writing Requirement Research Papers

No abstract provided.

The Spirit Is Willing: A Proposal For American Single Malt Whiskey, Raymond Cleaveland

Seattle University Law Review

Over the past twenty-five years, small, independent American distilleries have carved out a new niche in the United States liquor market: craft single malt whiskey. Inspired by the success of single malt Scotch and other single malts, American craft distillers are now fighting for their own shelf behind the bar and in the liquor store aisle. In 2018, a cadre of these distillers petitioned the U.S. Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau to formally recognize a new category of whiskey in the Code of Federal Regulations: American Single Malt Whiskey. For purposes of consumer protection, the Treasury …

No Ifs, Ands, Or Juuls About It: Why Influencers Must Be Held Accountable, Krystina Dorta

Catholic University Journal of Law and Technology

This article analyzes how the FTC’s Endorsement Guide regulating the advertising of e-cigarette products should be applied to social media influencers. The struggle to regulate e-cigarettes by the FDA and the FTC has led to different advertising methods, which either comply with or neglect the FTC’s Endorsement Guide. This article evaluates the federal government’s reaction to the e-cigarette health crisis, followed by a review of the FTC’s previous actions addressing Endorsement Guide violations, along with the consequences on other companies’ marketing strategies. Finally, this article reviews influencer liability standards for Endorsement Guide violations and develops recommendations to improve those standards.

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

The Fda’S Power Over Non-Therapeutic Uses Of Drugs And Devices, Patricia J. Zettler

Washington and Lee Law Review

Although we often—and rightly—think of the U.S. Food and Drug Administration (FDA) as regulating important therapies for patients, the agency also can regulate non-therapeutic uses of drugs and devices. The Federal Food, Drug, and Cosmetic Act defines drugs and devices as including not only products intended to address disease but also those intended to affect the structure or function of the body, such as cognitive enhancements, wrinkle removers, and recreational drugs. Indeed, if these broad definitions were read literally, many everyday consumer products—such as winter jackets intended to keep wearers’ warm—may be drugs or devices. Accordingly, Congress, courts, and the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Tobacco Reborn: The Rise Of E-Cigarettes And Regulatory Approaches, Daniel G. Aaron

Lewis & Clark Law Review

This Article examines e-cigarettes, FDA-regulated products which heat nicotine-containing fluid into an aerosol to be breathed into the lungs. Recent data show that e-cigarettes are used by about one-fifth of U.S. high school students. Given that we have, in the Surgeon General’s words, reached an epidemic of youth e-cigarette use, it is worth asking how a product within FDA jurisdiction became a serious threat to 3.6 million youth.

This Article reviews the law surrounding e-cigarettes and the history of FDA’s attempts to regulate them. Administrative law doctrines instruct us that increased presidential control will rein in misbehaving agencies by allowing …

Regaining Control Over The Climate Change Narrative: How To Stop Right-Wing Populism From Eroding Rule Of Law In The Climate Struggle In India, Binit Agrawal

Fordham Environmental Law Review

No abstract provided.

Innovative Regulatory And Financial Parameters For Advancing Carbon Capture And Storage Technologies, Zen Makuch, Slavina Georgieva & Behdeen Oraee-Mirzamani

Fordham Environmental Law Review

No abstract provided.

Textiles As A Source Of Microfiber Pollution And Potential Solutions, Lea M. Elston

Fordham Environmental Law Review

No abstract provided.

Lessons From Renewable Energy Diffusion For Carbon Dioxide Removal Development, Anthony E. Chavez

Fordham Environmental Law Review

No abstract provided.

Dispute Settlement Under The African Continental Free Trade Area Agreement: A Preliminary Assessment, Olabisi D. Akinkugbe

Articles, Book Chapters, & Popular Press

The African Continental Free Trade Area Agreement (AfCFTA) will add a new dispute settlement system to the plethora of judicial mechanisms designed to resolve trade disputes in Africa. Against the discontent of Member States and limited impact the existing highly legalized trade dispute settlement mechanisms have had on regional economic integration in Africa, this paper undertakes a preliminary assessment of the AfCFTA Dispute Settlement Mechanism (DSM). In particular, the paper situates the AfCFTA-DSM in the overall discontent and unsupportive practices of African States with highly legalized dispute settlement systems and similar WTO-Styled DSMs among other shortcomings. Notwithstanding the transplantation of …

Enough Is As Good As A Feast, Noah C. Chauvin

Seattle University Law Review

Ipse Dixit, the podcast on legal scholarship, provides a valuable service to the legal community and particularly to the legal academy. The podcast’s hosts skillfully interview guests about their legal and law-related scholarship, helping those guests communicate their ideas clearly and concisely. In this review essay, I argue that Ipse Dixit has made a major contribution to legal scholarship by demonstrating in its interview episodes that law review articles are neither the only nor the best way of communicating scholarly ideas. This contribution should be considered “scholarship,” because one of the primary goals of scholarship is to communicate new ideas.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

The Incredible Edible: Protecting Businesses And Consumers In A Society Of Legalized Cannabis, Brandon M. Thompson

Nevada Law Journal Forum

This Article briefly discusses the history and origin of marijuana, or more precisely the cannabis plant, before branching into an examination of its chemical properties, forms, and uses. Including a concise survey of the various effects—including adverse side effects—of cannabis use. Additionally, it provides an introduction to products liability as it relates to drugs, in general, and then more specifically to the production and distribution of edibles. It will discuss some of the dangers that edibles pose to children. The focus will be primarily on issues with the marketing and presentation of edibles that have led to unintended cannabis consumption …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Dickinson Law Review (2017-Present)

No abstract provided.

Mhpaea & Marble Cake: Parity & The Forgotten Frame Of Federalism, Taleed El-Sabawi

Dickinson Law Review (2017-Present)

No abstract provided.

State Regulatory Responses To The Prescription Opioid Crisis: Too Much To Bear?, Lars Noah

Dickinson Law Review (2017-Present)

In order to prevent further overuse of prescription opioids, states have adopted a variety of strategies. This article summarizes the growing use of prescription drug monitoring programs, crackdowns on “pill mills,” prohibitions on the use of particularly hazardous opioids, limitations on the duration and dosage of prescribed opioids, excise taxes, physician education and patient disclosure requirements, public awareness campaigns, and drug take-back programs. Although occasionally challenged on constitutional grounds, including claims of federal preemption under the Supremacy Clause, discrimination against out-of-state businesses under the dormant Commerce Clause doctrine, and interference with rights of commercial free speech, this article evaluates the …

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Safe Consumption Sites And The Perverse Dynamics Of Federalism In The Aftermath Of The War On Drugs, Deborah Ahrens

Dickinson Law Review (2017-Present)

In this Article, I explore the complicated regulatory and federalism issues posed by creating safe consumption sites for drug users—an effort which would regulate drugs through use of a public health paradigm. This Article details the difficulties that localities pursuing such sites and other non-criminal-law responses have faced as a result of both federal and state interference. It contrasts those difficulties with the carte blanche local and state officials typically receive from federal regulators when creatively adopting new punitive policies to combat drugs. In so doing, this Article identifies systemic asymmetries of federalism that threaten drug policy reform. While traditional …