Food and Drug Law Commons^™

Reckitt-Benckiser And Buprenorphine: Opioid Addiction Treatment, Drug Monopolies, And Consumer Implications, Peri G. Heyen

Theses/Capstones/Creative Projects

The opioid crisis in the United States is a deadly epidemic that demands fair and accessible treatment for those affected. The introduction of buprenorphine for opioid addiction disorder in 2002 allowed for the first treatment of the disorder beyond the time intensive and stigmatized practices of methadone clinics, which proved to be revolutionary. Reckitt-Benckiser (“Reckitt”) and former subsidiary Indivior were able to gain a legal monopoly of buprenorphine through their orphan drug exclusivity designation on Suboxone tablets that was approved by the FDA. Once orphan drug exclusivity was near expiration and generic competition began to prepare to enter the market, …

Red 40 Riot: An Interdisciplinary Perspective On The Fight For Food Additive Regulation, Margaret Q. Gray

Honors Theses

This paper explores the chemical, business, and governmental influences that impact the perception and future of Red 40. This inquiry was inspired by the increasing trends towards health-conscious consumer preferences and the 2025 Red 3 ban. This thesis examines foundational research, modern sources, and public-facing articles to create a comprehensive understanding of both sides of the argument in support of and against regulation. The paper concludes that a three-pronged approach would be ideal to target each key perspective included: chemistry, business, government. The approaches include confirming chemical research method validity, encouraging governmental regulation, and corporate accountability and enforcement. The paper …

The Next Drug Epidemic Is Legal: The Nation's Kratom Problem Is More Complicated—And More Harmful—Than It Seems, Elizabeth Walsh

Capstones

This two-part health and science investigative piece reports how kratom and its offshoots have quietly fueled a lucrative and legal addiction epidemic for the last decade. While kratom’s derivative alkaloid 7-hyrdoxymitragynine made headlines this year and as the DEA is poised to ban the strong derivative, “natural” kratom and other kratom-derived products will remain. This piece tracks the history of the 'gas‑station opioid' crisis in the U.S. over ten years: what was thought to be an innocuous southeast Asian supplement has become multi-billion dollar industry built on gray‑area laws, marketed falsehoods, and regulatory loophooles.

Part 1: The ‘Gas Station Opioid’ …

The Ethics Of Advertising Unhealthy Food To Children: A Study On Potential Advertising Policy Restrictions And Their Effects On Children Of Disadvantaged Minority Groups, Riley M. O'Neal

Honors Theses

According to the Centers for Diseases Control and Prevention, one in five children in America have obesity. Black and Hispanic children experience obesity at higher rates than children of other racial groups. With obesity rates increasing, what should be done to stop this increase? One partial solution is to restrict the advertisements of foods high in sugar fat, and/or refined grains directed towards children. Advertisements may be restricted in their mode (i.e., the media through which they are viewed) or their content (i.e., the substance of the advertisement or product packaging). While these restrictions on advertising may help lower overall …

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 …

Legal Implications Of Digital Health Apps Informing Food Allergy Labeling For Consumers' Health And Privacy Protection, Kathy Keunghee Kim

Maurer Theses and Dissertations

This dissertation examines food allergy labeling’s use in a digital format. Allergy information is typically found on food packaging and containers to help consumers identify individually concerned allergens. Given the critical role that food allergy labels play in preventing unexpected allergic reactions before selecting or consuming food, it is essential to comprehend the labeling descriptions. However, current regulations and laws regarding allergy labeling often confuse consumers due to the existence of mandatory and voluntary Precautionary Allergy Labeling (PAL) categories and the absence of laws and regulations that require allergy information for restaurant meals. Technology companies have introduced digital health and …

Whither The Regulator: Food And Drug Law, The Natural Health Product Regulations And The Erosion Of Safety, Efficacy And Quality, Michael Taylor

PhD Dissertations

The following thesis considers whether the regime established by the Natural Health Product Regulations (NHPR) is a suboptimal framework. It explores the effects that the creation and implementation of the NHPR have had on the safety, efficacy, and quality (SEQ) standard used in Canadian food and drug law. The original regulations, largely brought in to support the licensing of traditional medicines, herbs, vitamins, and other naturally occurring substances, have with time come to be dominated by non-traditional products making poorly demonstrated health claims. Over time, the Natural Health Products Directorate (NHPD) came to focus on access and speed of approval …

Identifying Youth Appeals In Alcohol Alternative Social Media Content Through Framing, Melina Oneal

West Chester University Master’s Theses

Proposed regulations for alcohol advertising prevent beverage companies from targeting people under the legal drinking age. However, similar regulations for alcohol alternative beverages are less explored, which could allow alcohol alternative products to create awareness for alcoholic beverages among youth. Alcohol alternatives beverages, including no-alcohol and low-alcohol products, are increasing in popularity and can function as compliments to alcoholic products to decrease the total alcohol volume consumed or as substitutes for alcoholic products. Framing theory can be operationalized through the Content Appealing to Youth Index, an index of content elements found in research literature to be appealing to youth, to …

Representations Of Drug-Related Harms In Sentencing: Towards Evidence-Informed, Non-Stigmatizing Approaches, Niki Kiepek

LLM Theses

This thesis explores how the concept of harm is constituted in case law pertaining to the importation, production, possession, and trafficking of drugs in Canada. A specific focus of analysis is whether judges accurately use empirical research to inform decisions. Drugs are understood as a social construct – encompassing psychoactive substances that are both legal and illegal – and as variably regulated in Canadian law. I use critical discourse analysis to examine how harm is represented in case law (n=129), identify which sources influence legal discourses (e.g., past cases, expert testimony, empirical research), and analyze outcomes arising from how harm …

Altering United States Drug Policy And Shifting The Focus Of Drug Use From Conviction Toward Drug Addiction Treatment, Natalie Marra

Honors Projects

While these substances were not always controlled by law, drug use has been as issue throughout time going back thousands of years and continues to be a concern in the twenty-first century. Possession, distribution, and manufacturing of controlled substances outside of what is considered legal can lead to fines and or jail time and can also increases the severity of other crimes committed either due to or under the influence of drugs. As of Saturday June 10th, 2023, 44.5% of Federal inmates are incarcerated for drug offenses, including possession, distribution, and manufacturing1. Drug offenses make up the largest percentage of …

The 1994 Federal Crime Bill: An Evaluation Of The Past, Present, And Future Of Its Impact On The Criminal Justice System, Jade R. Philpot

Honors College Theses

The 1994 Violent Crime Control and Law Enforcement Act was signed into law in response to the crack cocaine and crime epidemic of the 1980s. In this thesis I address the major elements of this bill, the racial, financial, and ethical conflicts that arose thereafter, and the reforms that should be implemented today to correct said conflicts.

Marijuana-Related Crime In Oregon Following Legalization Of Recreational Use, Ana Alicia Soto

Dissertations and Theses

In this decade we are seeing the legalization of recreational marijuana occurring across the nation, with new legislation being passed every year. This necessitates research into what works within the regulatory framework of states where MJ has been legalized. This study sets out to look at Oregon's implementation of recreational marijuana and its impact on marijuana-related offenses. Using NIBRS, we examine marijuana-related offenses across 13 counties with crime data from 41 agencies in Oregon from pre-legalization to post-legalization (2010 to 2019). This study uses elements of legalization, licenses, and production to analyze the association between these aspects and offenses that …

Out Of Sight, Out Of Mind: Analyzing Inhumane Practices In Mississippi’S Correctional Institutions Due To Overcrowding, Understaffing, And Diminished Funding, Ariel A. Williams

Honors Theses

The purpose of this research is to examine the political, social, and economic factors which have led to inhumane conditions in Mississippi’s correctional facilities. Several methods were employed, including a comparison of the historical and current methods of funding, staffing, and rehabilitating prisoners based on literature reviews. State-sponsored reports from various departments and the legislature were analyzed to provide insight into budgetary restrictions and political will to allocate funds. Statistical surveys and data were reviewed to determine how overcrowding and understaffing negatively affect administrative capacity and prisoners’ mental and physical well-being. Ultimately, it may be concluded that Mississippi has high …

The Impact Of Wine Nutrition And Ingredient Labeling On Consumers’ Attitudes And Purchase Intentions, Kara Tate

Honors Theses

Current TTB regulations do not require that US wine producers display nutrition and ingredient labeling on their wine labels. However, recent attempts at passing legislation to mandate that such information be provided on labels in the EU suggests that US policy makers will soon follow suit. Research on how this addition would impact consumers has been scarce and has been primarily conducted in Europe, but what is available suggests that consumers are unaware of the nutritional values in a glass of wine and many do not look at the back label when selecting a bottle to purchase. We conducted a …

The Effects Of Police Officer Ideology On Opinions Of Marijuana Legalization, Decriminalization, And Medical Marijuana, Erin Alpandinar

Honors Capstones

No abstract provided.

Neither “Post-War” Nor Post-Pregnancy Paranoia: How America’S War On Drugs Continues To Perpetuate Disparate Incarceration Outcomes For Pregnant, Substance-Involved Offenders, Becca S. Zimmerman

Pitzer Senior Theses

This thesis investigates the unique interactions between pregnancy, substance involvement, and race as they relate to the War on Drugs and the hyper-incarceration of women. Using ordinary least square regression analyses and data from the Bureau of Justice Statistics’ 2016 Survey of Prison Inmates, I examine if (and how) pregnancy status, drug use, race, and their interactions influence two length of incarceration outcomes: sentence length and amount of time spent in jail between arrest and imprisonment. The results collectively indicate that pregnancy decreases length of incarceration outcomes for those offenders who are not substance-involved but not evenhandedly -- benefitting white …

Biosimilars: The Quest For A Rational Regulatory And Intellectual Property Approach In Canada, Elizabeth S. Dipchand

LLM Theses

Biologics and biosimilars represent the promise for more effective treatments of many diseases. International treaty obligations influenced heavily by the biopharmaceutical industry and advanced through the international trade agenda may lead to an imbalance between incentivizing innovation and the public interest. Canada’s implementation of its obligations into national patent and regulatory laws encourages aggressive biologic patent protection strategies that, coupled with linked regulatory assessments, may establish compounding layers of exclusion that disproportionately disincentivizes both the biologics innovation and biosimilar development. This comparative analysis addresses the progression of international obligations and the way in which they have been implemented into Canada’s …

Food In Prison: An Eighth Amendment Violation Or Permissible Punishment?, Natasha M. Clark

Honors Thesis

This piece analyzes aspects such as; Eighth Amendment provisions, penology, case law, privatization and monopoly, and food law, that play into the constitutionality of privatized prisons using food as punishment. Prisoners have protection from excessive bail and fines and from cruel and unusual punishment, as per the 8^th Amendment; however, deprivations such as restricted diets and harm caused by them is only a valid violation if the prisoner can prove deliberate indifference. Privatization of the prison industry has led to reduced quality, choice, and diversity in areas such as food, which comes at a detrimental cost to prisoners. Serving …

An Exploration Of Zero Waste Policies And Recommendations For Missoula, Sarah Blyth Lundquist

Graduate Student Theses, Dissertations, & Professional Papers

“Zero Waste” is a concept and community goal that has arisen to challenge the current consumerist economic system and offer solutions for a number of environmental issues. In adopting this goal, individuals and communities pledge to reduce and divert at least 90% of their waste in a certain number of years. These goals can be reached by employing policies, programs, and other intervention tactics which establish Zero Waste infrastructure, ensure equitable and widespread access to Zero Waste services, and provide educational outreach and resources to the community. Missoula adopted a Zero Waste goal in 2016 and created a Zero Waste …

Effect Of Poor Sanitation Procedures On Cross-Contamination Of Animal Species In Ground Meat Products, Sunjung Chung

Food Science (MS) Theses

While the presence of ≥1% of an undeclared species in ground meat generally used as an indicator of intentional mislabeling as opposed to cross-contamination, the actual percent of undeclared species resulting from cross-contamination has not been experimentally determined. The objective of this study was to quantify the effect of sanitation procedures on the crosscontamination of animal species in ground meat products, using undeclared pork in ground beef. Pork (13.6 kg) was processed using a commercial grinder, then one of three sanitation treatments was completed (“no cleaning”, “partial cleaning”, or “complete cleaning”). Next, beef (13.6 kg) was ground using the same …

Food Fight: A Case Study Of The Community Food Security Coalition’S Campaign For A Fair Farm Bill, Marni Salmon

Capstone Collection

The farm bill is an all-encompassing piece of legislation that is reauthorized approximately every five years and establishes federal policy for everything from farm subsidies and crop insurance to energy, conservation, food stamps and school lunches. The current law expires at the end of September 2012. Reauthorization of the farm bill represents the single largest opportunity to reform the policies that shape food systems in the United States. The Community Food Security Coalition (CFSC) is campaigning to improve access to healthy food by increasing links with family farmers and to strengthen local and regional food systems. This case study traces …

Intellectual Property, Traditional Knowledge, And Biodiversity In The Global Economy: The Potential Of Geographical Indications For Protecting Traditional Knowledge-Based Agricultural Products, Teshager W. Dagne

PhD Dissertations

The relationship between international regimes regulating intellectual property, traditional knowledge and biodiversity has received much attention in recent times. Of the many complex and controversial issues in contemporary international legal discourse on this matter, the protection of traditional knowledge (TK) stands out as a significant challenge. Choices abound in the search for modalities to regulate rights to use and control TK systems and their underlying biodiversity. In recent times, the protection of geographical indications (GIs) has emerged as an option for protecting TK. Despite the considerable enthusiasm over it, there is appreciable research dearth on how far and in what …

Drinking Motives Of College Students At A Hbcu In Oklahoma, Yasmeen Shumate

McCabe Thesis Collection

The use of alcohol can be found throughout colleges across the nation (O'Malley and Johnston, 2002). Whether the college is a 2 year institution or a 4 year institution, private of public, there have been multiple studies conducted over alcohol use in various settings. College students consistently report higher levels of alcohol use than their non-college counterparts (O'Malley and Johnston, 2002). In addition, specific demographic characteristics, such as gender, ethnicity, and age, have been studied in relation to college drinking. It's been proven that college men are found to drink more than college females (Humara and Sherman, 2004). Non- White …

The Analyses Of State And Federal Medical Marijuana Laws And How They Apply To Employment, Lizaveta Sergeev

UNLV Theses, Dissertations, Professional Papers, and Capstones

The purpose of this study is to analyze and discuss the current discrepancies in the legal system as it applies to medical marijuana in the employment sector. The laws regarding the legalization of medical marijuana are relatively new and have many constraints when applied to employment. On the federal level, medical marijuana remains illegal. Many states have passed some form of legislation legalizing medical marijuana. Unfortunately, only two states have laws that protect users from being discriminated in employment. This leaves employers and employees uncertain about what actions to take when dealing with medical marijuana in the employment sector.

What Is The Impact Of Liquor Licensing Laws On Portland’S Entertainment Venues? A Case Study, Will Etheridge

Muskie School Capstones and Dissertations

In January 2009, Port City Music Hall in Portland, Maine was preparing to open its doors to the public for the first time. With a capacity for nearly six hundred attendees, Port City Music Hall was designed to attract national touring acts to Portland too big for the bar scene, but not suited for the Merrill Auditorium or Cumberland Civic Center. With the State Theatre still shuttered at the time, this new venue hoped to fill an important niche in the city’s creative economy, bringing a diverse array of performers that would not otherwise be able to find a viable …

An Evaluation Of Lead In Imported Candies Within Clark County, Nevada, Usa, Lee Reuben Ibarra

UNLV Theses, Dissertations, Professional Papers, and Capstones

Imported candies from Latin America pose a danger to children because of the potential for those candies to contain harmful levels of lead. This study sought to identify characteristics of imported candies that typically display higher concentrations of lead. This study also explored the Integrated Exposure Uptake Biokinetic model developed by the EPA. Using lead exposure data specific to Clark County, Nevada, the IEUBK model was used to estimate the amounts of candy a child would have to consume in order to raise his blood lead level to over 10µg/dL (the federal allowable limit).

The results showed that candies with …

A Bitter Pill To Swallow: Canadian Drug Regulation, Michael Duncan Taylor

LLM Theses

This thesis assesses the current status of Canadian prescription drug regulation and the policy drivers that guide this process. This analysis is accomplished by first providing a general survey of the steps, law, and institutional players involved in the full life-cycle of a drug. Next the evolution of current clinical trials and the gaps that the present legal regime creates in the scientific standards employed in clinical research is reviewed. This is followed by a discussion of how commercialization (innovation) and speed of approval (market access) are slowly becoming the dominant policy drivers for the Canadian regime. Finally a discussion …

The Effect Of The Food Allergen Labeling And Consumer Protection Act (Falcpa) On The Accidental Food Allergen Ingestion Rate In Adults With Self-Reported Food Allergies, Susan Liebert

Master's Theses and Doctoral Dissertations

Background: The Food Allergen Labeling and Consumer Protection Act (FALCPA) recently required bolded allergens or “contains” statements on food product labels. Very few U.S. studies have looked at the accidental food allergen ingestion rate in adults. Since the emotional and medical costs of allergic reactions can be high, it is important to determine if the FALCPA is helping to reduce the accidental food allergen ingestion rate in adults with self-reported food allergies.

Background: The Food Allergen Labeling and Consumer Protection Act (FALCPA) recently required bolded allergens or “contains” statements on food product labels. Very few U.S. studies have looked at …

Reefer Madness: How Voters Responded To Medicinal Marijuana Initiatives In The 1998 State Elections, Ryan E. Wood

Masters Theses

In recent years, a growing number of states have witnessed the passage of state initiatives that have authorized the medicinal use of marijuana. The medicinal marijuana movement has circumvented elected state legislatures by relying on an increasingly popular form of direct democracy - the direct initiative. This paper briefly examines the history and continuing legacy of illicit drugs and the initiative process in the context of the movement for medicinal marijuana. However, the primary focus of this study is to uncover the voter characteristics that influenced attitudes toward medicinal marijuana in the 1998 state elections. This paper uses Voter News …

Food And Drug Law Summer Internship Program: Issues In Food And Drug Law, Melinda Michelle Moss

All Graduate Theses and Dissertations, Spring 1920 to Summer 2023

In recent years, the main food regulatory agency, the Food and Drug Administration, has faced a number of diverse and complicated issues. The impact of these issues has resonated throughout the entire food community. The coarse of action that regulators decide to take in coming years will change how the nation relates to food. Regulators and industry leaders must deal with the increased amount of responsibility they hold, the changing face of food products, contention between industry and consumers, and administrative shortcomings. Both the Food and Drug Administration and industry leaders are working to maintain the high level of food …