Food and Drug Law Commons^™

Where's The Meat? A Constitutional Analysis Of Arkansas's Law Prohibiting The Use Of "Meat" Terms On Plant-And Cell-Based Products, Christy Wyatt

University of Cincinnati Law Review

No abstract provided.

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 Prison Litigation Reform Act And The Physical Injury Requirement In The Context Of Transgender Inmates, Hunter Kravitz

Cardozo International & Comparative Law Review

The note examines the impact of the Prison Litigation Reform Act (PLRA) on transgender inmates, focusing on its physical injury requirement, which disproportionately bars access to justice for those with mental or emotional injuries. It highlights the ethical and constitutional concerns arising from the PLRA's application, particularly its unequal treatment of transgender inmates, and advocates for reforms to ensure equitable access to justice.

We Need A Cole Memorandum For Magic Mushrooms, Robert A. Mikos

Vanderbilt Law School Faculty Publications

In fall 2020, as the nation elected Joe Biden to be our Forty-Sixth President, Oregon voters also passed a noteworthy new drug law reform. Known as Measure 109, Oregon’s path-breaking law legalizes the use of psilocybin, a hallucinogenic substance found in magic mushrooms. Measure 109 is designed to unlock the therapeutic potential of psilocybin, which advocates tout as an effective and safe treatment for depression and other psychological conditions.

Given the burgeoning interest in psychedelics, many people are excited to see how Oregon’s psilocybin experiment pans out. But at this point, it remains unclear whether the experiment will even get …

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 …

The War On Drugs: Moral Panic And Excessive Sentences, Michael Vitiello

Cleveland State Law Review

The United States’ War on Drugs has not been pretty. Moral panic has repeatedly driven policy when states and the federal government have regulated drugs. Responding to that panic, legislators have authorized severe sentences for drug offenses.

By design, Article III gives federal judges independence, in part, to protect fundamental rights against mob rule. Unfortunately, the Supreme Court has often failed to protect fundamental rights in times of moral panic. For example, it eroded Fourth Amendment protections during the War on Drugs. Similarly, it failed to protect drug offenders from excessive prison sentences during the War on Drugs. This Article …

The Opioid Crisis Or Climate Change: Which Is More Likely To Succeed Under The Tobacco Litigation Model?, Elizabeth W. De Leon

Texas A&M Law Review

Societal problems can occasionally have legal solutions, and several tools exist to implement change, including litigation and regulation. However, what elements make a societal problem more suitable for litigation or regulation? This Article examines four different societal issues (tobacco use, obesity, opioid addiction, and climate change) to determine whether litigation or regulation is the more appropriate route for success. The tobacco litigation serves as a successful example, while the fast food litigation serves as an unsuccessful example. Six signs of success are derived from the tobacco litigation: a large settlement agreement, evidence of corporate wrongdoing, change in public opinion, the …

Protection Of Pharmaceutical Products And The Second Medical Indications In Comparative Legislation And International Conventions, Kameran Hossen Al-Salihi

UAEU Law Journal

During the past decades, many changes have occurred in the legal system of patents, protection of pharmaceutical products and methods of manufacturing pharmaceutical products. The World Trade Organization (WTO) and the European Patent Convention (EPC), in 1977, has extended the protection of pharmaceutical products and the method of their manufacturing. The TRIPS Agreement which came into force in 1995, committed its Members to provide protection to all their pharmaceutical products regardless of the field of technology. Thus, pharmaceutical products and methods of manufacturing are now covered by this International Protection Act as well as by their National Legislations. However, this …

A Review Of Grey Literature Cited By Food Loss Law And Policy Scholarship, Angela Hackstadt

University Libraries Faculty Scholarship

In the United States, state and federal programs, rules, and legislation attempt to address the social, economic, and environmental impacts of food waste. Research on the efficacy of these interventions rely on a variety of grey literature resources. Grey literature is valuable to policy research but may be overlooked because it is not published commercially and is often deemed unauthoritative. This review focuses on the use of grey literature in food waste law and policy scholarship to identify the most used sources and to determine what, if any, archiving strategies authors use. Recommendations for librarians and researchers are discussed.

Professional Medical Judgment And Pharmaceutical Marketing: Drawing Legal And Ethical Lines Around Conflict Of Interest, Steven R. Salbu

William & Mary Business Law Review

Pharmaceutical manufacturers develop relationships with healthcare providers for several purposes, including the marketing and sale of their products. Professional associations give guidance to physicians and companies for managing these relationships ethically. Some practices permitted by these associations entail conflicts of interest. This Article explores two of these practices: (i) company funding of external educational seminars, conferences, and continuing medical education; and (ii) company-hosted speaker programs. The conflict of interest concerns raised by the former practice are manageable, and the practice should continue to be permitted subject to appropriate safeguards; however, the conflict of interest concerns raised by the latter practice …

Coronavirus "Cures" And The Courts, Chad G. Marzen, Michael Conklin

William & Mary Business Law Review

The coronavirus pandemic has drastically affected nearly every aspect of American life. Unfortunately, it has also created an opportunity for those willing to exploit vulnerable citizens by selling fake “cures.” This Article analyzes a lawsuit against televangelist Jim Bakker for doing just that. This Article also calls for increased protection for individuals when a global health pandemic and national emergency have been declared. This Article advocates a novel proposal—the enacting of a federal statute making it a felony for an individual to knowingly sell a fraudulent cure for any disease that has been designated a pandemic by the World Health …

Contractual Responsibility Of The Drug Manufacturer In The Federal Legal System, Sayed Hatem Saif El-Din

UAEU Law Journal

Very bad results and dangerous consequences might be the outcome of a simple mistake in the process of medicine production or manufacturing. This danger aggravates and the problem increasingly complicates in the case that these damages and dangers do not appear but after a period of time that might extend to generations, and that such symptoms were not expected upon production.

In the event that there is no legislation in the UAE law to regulate the responsibility of the producer for his dangerous products, the general rules in the contractual responsibility shall be studied, there appropriateness and sufficiency to provide …

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 …

Pricing Drugs Fairly, Govind Persad

William & Mary Law Review

Dissatisfaction with drug prices has prompted a flurry of recent legislation and academic research. But while pharmaceutical policy often regards fair pricing as a goal, the concept of fairness itself frequently goes undefined. Legal scholarship—even work ostensibly focused on fairness—has not defined and defended an account of fair pricing. Recent legislative proposals in the House and Senate have similarly avoided a determinate position on fairness. This Article explains and defends an account of what makes a price for a drug fair (identifying fair price with social value), argues for implementing fair pricing through a price ceiling grounded in social value, …

Foods-Related Fraud Crimes In Accordance With Uae Federal Law No. 19 Of 2016 On Combating Commercial Fraud, Dr. Ezzat Mohamed El Omary

UAEU Law Journal

Adulteration of food is one of the vital issues that countries concerned about; that is due to their negative impact recently on consumers’ health. Especially, with the liberalization of markets and the globalization. This alongside with the development of fraud methods increased risks to consumers. Thus, The UAE legislator considered this by issuing the Anti-fraud Federal Law No. 19 of 2016, which considered any commitments against human or animal food as a punishable crime. Criminalization in this regard requires that the criminal needs to be a consumer pre to the commit of the crime; such commitments are specified in the …

Mobile Methadone Clinics: A Necessary Step In Fighting The Opioid Epidemic, Laurel E. Via

University of Richmond Law Review

Part I of this Article will discuss the rise in opioid use disorder, the need for effective treatment, and the utility of methadone maintenance treatment options, as well as the history of the ban on mobile clinics. Part II will discuss the NPRM issued by the DEA on February 26, 2020, and explain the likely impact of the rule. Part III will provide an overview of the NPRM in its current form, explain its likely impact as written and show that mobile clinics are effective treatment options, and then argue that while a great start, the NPRM should be amended …

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 …

Cle Working Paper No. 3/2021--A Roof Over Our Stomachs: The Right To Housing In Canada And Its Implications For The Right To Food, Tasha Stansbury

Centre for Law and the Environment

In 2019, the Canadian government passed the National Housing Strategy Act, legislating for the first time a human right to housing in Canada. This was largely the result of pressure from housing advocates to align Canada’s legislation with the right to housing embedded in international human rights instruments. Despite similar efforts, food rights advocates have not had the same success in having the right to food recognized in Canadian law. This paper considers the question of whether, and how, food rights advocates can use the process of achieving a legislated right to housing as a model in pursuing the legislation …

Hitting The Trip Wire: When Does A Company Become A "Marijuana Business"?, Lauren A. Newell

Law Faculty Scholarship

Like the alcohol industry was during Prohibition, the marijuana industry is a profitable one. And, as bootlegging was then, selling marijuana in the United States is currently illegal. Despite the number of states that have legalized or decriminalized the sale of marijuana for medical or recreational use under state law, marijuana sales remain illegal as a matter of federal law under the federal Controlled Substances Act of 1970 (“CSA”). Individuals and entities that violate the CSA face substantial criminal and civil liability, including prison time and fines, alongside a host of additional negative consequences arising from business, tax, bankruptcy, and …

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.

Pediatric Off-Label Use Of Covid-19 Vaccines: Ethical And Legal Considerations, Elizabeth Lanphier, Shannon Fyfe

Scholarly Articles

After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical permissibility of and considerations for pediatric off-label Covid-19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of the blanket prohibition against off-label pediatric Covid-19 vaccination in the VPA, as it blocks clinicians from providing the care they may determine to be clinically and ethically appropriate for their patient. At the same time, our analysis acknowledges that Covid-19 creates population-level ethical considerations that are at times in tension with individual health interests.

A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll

Faculty Publications

Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …

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.

Off-Label Use In The Twenty-First Century: Most Myths And Misconceptions Mitigated, 54 Uic J. Marshall L. Rev. 1 (2021), James Beck

UIC Law Review

No abstract provided.

The Tobacco Control Act’S Pmta And Mrtp Provisions Mean To Protect The Usa From Any New Tobacco Products That Will Not Reduce Health Harms—But Fda Isn’T Cooperating, Eric N. Lindblom

Journal of Health Care Law and Policy

No abstract provided.