Digital Commons Network^™

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, …

Bridging The False Certification Gap: Why “Resulting From” In The 2010 Aks Amendment Requires But-For Causation, Alexandra Wildman

Fordham Law Review

Before 2010, violators of the Anti-Kickback Statute (AKS) could avoid False Claims Act (FCA) liability if claims for items or services borne of their kickback scheme were submitted to federal healthcare programs by a third party. In 2010, as part of the Affordable Care Act (ACA), Congress attempted to close this loophole in the FCA by amending the AKS. Under the amendment’s terms, claims submitted to federal healthcare programs for items or services “resulting from” an AKS scheme are false for the purposes of establishing FCA liability, regardless of who submitted the claims.

Although the amendment widened the FCA liability …

The Challenges Of Investigating Derived Psychoactive Cannabis Product Brand Quality: Using A Popular Brand As An Example, Cassidy R. Loparco, Zachary L. Prater, Doug Henry

Health Behavior Research

With widely divergent state and federal regulations and a history of suspect brands and illicit markets, derived psychoactive cannabis products (DPCPs) face contested discourse as to their content, quality, and safety. We conducted exploratory research on public-health related factors related to brand quality including assessing potential counterfeit products, website and social media presence, third party laboratory testing, distribution practices, and consumer experiences on social media. Findings indicate the difficulty consumers face in finding information related to DPCP brands, and the questionable quality of popularly branded products. We recommend regulation and oversight to ensure product safety.

The Dark Side Of The Balloon: Restrictions On Foreign Investment In U.S. Farmland, Sarah Everhart

Journal of Food Law & Policy

This Article argues that if legislators truly want to strengthen our food system, they should shift their focus from preventing foreign investment in farmland to supporting domestic investment in farmland. According to the National Young Farmer Survey, finding affordable land to buy is the top challenge for young farmers. This Article begins with examining the history of restricting foreign ownership of U.S. farmland. This Article also explores the current landscape of foreign investment in U.S. farmland and the

Developing An Efficient Regulatory Framework For Safe Street Food In Bangladesh: Lessons From Comparative Analyses With India, Thailand, And New York City, Usa., Abu Noman Mohammad Atahar Ali

Journal of Food Law & Policy

Globally, approximately 2.5 billion individuals consume street food1 daily. Street food is affordable, convenient, and sometimes nutritious, offering diverse and appealing food choices. A World Health Organization (WHO) report in 1996 ascertained that 74% of countriesrecognized the substantial contribution ofstreet foods to their urban food supply The following parts of the article look into street food's impact on public health and its implications for the lives of people in Bangladesh. Subsequently, it will examine previous initiatives and current endeavors to ensure street food safety and hygiene. Following this literature review, the study will conduct a detailed examination of existing laws …

Misinformation In U.S. Food And Agriculture: A Policy Analysis Of Impacts And Recommended Solutions, Jamie Woodside

Journal of Food Law & Policy

This paper aims to review the current state of play of misinformation in the U.S. food and agriculture sectors—delving into the roots of misinformation, its propagation through social media and traditional channels, and its consequences for the agricultural sector and society at large. Additionally, through an examination of existing laws, regulations, and potential legal remedies, this paper aims to shed light on the challenges posed by misinformation and offers recommendations for mitigating its harmful effects.

The Costs Of Convenience: A Case For Regulating Online Food Marketplaces In The Public Interest, Angela Lee

Journal of Food Law & Policy

As digital platforms have become more popular, including those relating to food ordering and delivery, the range of both their positive and negative impacts have become more apparent. In response, governments in various jurisdictions have made efforts at regulating such platforms, as part of their mandate of balancing complex and often competing goals in the public interest. Unfortunately, attempts at governing digital platforms to date have largely proven ineffective at checking the power of the large corporations that are behind their growth and expansion. I argue that a critical assessment of these new forms of online food marketplace further supports …

I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha

Journal of Food Law & Policy

In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”). The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century. The FTC has regulatory authority over fast food advertising while the FDA regulates fast food, which creates a proverbial fork in the road. The fork in the road widens when considering the FDA has an active role in curbing the obesity epidemic through …

Regulatory Takings In Climate Change: Geo- Engineering One’S Way Around The Fifth Amendment, Noah Chase

Fordham Environmental Law Review

Picture yourself as the owner of a small business located in the downtown area of a large city; your business consists of a shop and an adjoining parking lot. A new regulation has just been passed which requires any owner of property within the city limits to paint all roofs and parking areas with a new reflective coating, in order to reduce the heat which is absorbed by such structures. The idea of closing your business down for this time, along with other connected issues, scares you, and you begin to wonder if your local government truly has your best …

Arizona V. Navajo Nation And Systemic Failures In The Tribal Water Allocation Scheme, Jennifer Horkovich

Fordham Environmental Law Review

When the United States Supreme Court’s decision in Arizona v. Navajo Nation was published in June 2023, Indian Country was hardly surprised with the Court’s ruling. There, the Court found that the United States had no affirmative duty to affirmatively protect the Navajo Nation’s water rights under the 1868 Treaty.1 The Court was clear: the treaty is insufficient for the Navajo’s current water needs, but the judiciary is unable to step in to find relief.2 This decision is another in a long series of cases on water allocation and the federal reserved water right, where tribes have been unable to …

A Drug's Life: The Untapped Potential Of Secondary Pharmacology Studies In Drug Development, Christina Scott

The University of New Hampshire Law Review

The United States Food and Drug Administration has evolved over the past century to regulate new medicine and protect the public from harmful or ineffective drugs. Drug development and testing science have advanced rapidly alongside the FDA’s increased regulation, enabling pharmaceutical companies to assess a drug's potential adverse reactions by studying its reactivity with various proteins called "off-target receptors." Off-target proteins are often screened and reported in the Investigational New Drug Application as a percentage indicating the drug's binding strength to each protein, which suggests the strength of a particular adverse drug effect. Adverse drug effects often lead to unfavorable …

Preempting Red State Restrictions On The Use Of Fda-Approved Drugs In Gender-Affirming Care?, Lars Noah

Utah Law Review

Some observers recently have wondered whether actions by the U.S. Food and Drug Administration (“FDA”) could federally preempt increasingly common state restrictions on gender-affirming care, particularly prohibitions on the use of puberty blockers and cross-sex hormones in adolescent patients. In theory, such a legal strategy might sidestep the need to lodge increasingly unsuccessful challenges under the Fourteenth Amendment. The Supremacy Clause offers little assistance, however, in attempting to get around these state laws. Indeed, even if the FDA eventually approved such uses for currently marketed drugs, implied preemption doctrine as currently configured probably would not do the trick, though securing …

Where's The Beef? The Fifth Circuit's Attempt To Clarify Plant-Based Food Labeling Laws In Turtle Island Foods S.P.C. V. Strain, Andrew J. Kash

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Criminalizing Transgender Care, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

Since 2021, twenty-four states, in extraordinarily quick succession, have enacted statutes banning physicians from prescribing puberty blockers and cross-sex hormones to minors for treatment of gender dysphoria. Although the Food and Drug Administration has not approved these drugs for this use, off-label prescribing is a common practice, and leading medical organizations all agree that this off-label use of puberty blockers and sex hormones is an essential component of transgender medical care. These state laws thus represent an extreme, and unprecedented, interference with the provision of standard-of-care medicine. This article, after exploring the ongoing litigation challenging these bans, argues that they …

We(Ed) The People Of Cannabis, In Order To Form A More Equitable Industry: A Theory For Imagining New Social Equity Approaches To Cannabis Regulation, Garrett I. Halydier

University of Massachusetts Law Review

States increasingly implement “social equity” programs as an element of new cannabis regulations; however, these programs routinely fail to achieve their goals and frequently exacerbate the inequities they purport to solve, leaving inequitable industries, high incarceration rates, and broken communities in their wake. This ineffectiveness is due to the industry’s fundamental confusion of the modern, individualized concept of “equity” with the historical, society-level concept of “social equity.” In this paper, I develop a new theory of “cannabis social equity” to integrate these concepts, and I apply that theory, first, to diagnose why current policies fall short and, second, to propose …

Draining Chicago’S Food Swamps: Legal Approaches, Sofia Fernandez

DePaul Journal of Health Care Law

Public health is a collective responsibility of society to improve the health and wellbeing of communities, focusing on preventing disease and promoting health as opposed to providing medical care for those already ill.1 The law consists of rules issued and enforced by government entities “through which populations organize their governments, regulate social and economic interactions, and guide behavior.”2 Public health law exists at the intersection of these two fields, comprising “the legal powers and duties of the state to identify, prevent, and ameliorate risks to the health of populations, as well as the study of legal structures that have a …

Empirically Assessing Medical Device Innovation, George Horvath

Minnesota Journal of Law, Science & Technology

No abstract provided.

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 …

Confronting Cosmetic Carcinogens: A Proposal Regarding The Dangers Of Talcum Powder, Rachael Howell

Helm's School of Government Conference - 2021-2024

The Federal Government needs to stop the import, export, mining, and distribution of talcum powder in the United States. This is an issue that affects all Americans, especially active-duty military members.

Since 2013, there have been over 38,000 lawsuits against Johnson & Johnson, which allege that their talcum-based baby powder caused cancer. The plaintiffs in the very first talc case in the U.S. have died. All four of the plaintiffs from a 2019 suit have died. Yet, the 2019 case has been reversed and remanded. The FDA has redacted the names of scientist(s) that conduct “safety tests” on talc samples. …

Symposium Remarks: Public Litigation Values Versus The Endless Quest For Global Peace, Elizabeth Chamblee Burch

West Virginia Law Review

No abstract provided.

I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha

All Faculty Scholarship

In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”).¹ The MOU proscribes that the FTC regulates truth in advertising relating to foods, drugs, devices and cosmetics while the FDA controls labeling and the misbranding of foods, drugs, devices, and cosmetics shipped in interstate commerce.² The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century.³

Importantly, the FDA and the …

The Wild, Wild West Of Laboratory Developed Tests, John Gilmore

Washington and Lee Law Review Online

Since the 1950’s, scientists have built novel technologies to screen for genetic diseases and other biological irregularities. Recently, researchers have developed a method called “liquid biopsy” (as opposed to a standard tissue biopsy) that uses a liquid sample (e.g., blood) to non‑invasively spot biomarkers indicating different types of cancers in the patient’s body. While the U.S. Food and Drug Administration (FDA) has fully cleared a small number of liquid biopsy tests under its rigorous and expensive review process, most biotech companies have instead followed a less restrictive regulatory path through the Centers for Medicare and Medicaid Services (CMS), which label …

Natural Resources In The Arctic: The Equal Distribution Of Uneven Resrouces, Ganeswar Matcha, Sudarsanan Sivakumar

Sustainable Development Law & Policy

This paper analyses the governance machine in place at the Arctic and examines the application of the principles of “common heritage of mankind” at the Arctic. This paper also offers some tentative propositions aimed at protecting Out Bound investment rights and how the World Trade Organization or other countries, like the U.S., can intercede in the Arctic investment sphere and attempt to regulate along with the United Nations Convention for the Law of the Sea.

Incentivizing Sustainability In American Enterprise: Lessons From Finnish Model, Vasa T. Dunham

Sustainable Development Law & Policy

The disparate climate performances of Finland and the United States, two of the wealthiest countries in the world, bring to light the question of how corporate responsibility has been inspired in each jurisdiction. Having established the urgency of the climate crisis and the importance of corporate behavior in optimizing a given country’s approach to protection of the global environment, an examination of each nation’s legal frameworks may shed light on features of the corporate regime that are effective in advancing sustainability goals and those that are not.22 Part I of this paper establishes a comparative framework by providing background on …

High Times, Higher Stakes: Mental Health Impacts In New Recreational Marijuana Legal Landscape, Jason T. Lorenzon J.D., Chris Pezalla, Diana Semilia

National Training Aircraft Symposium (NTAS)

This presentation delves into the societal and mental health consequences arising from the increasing trend of legalizing recreational marijuana. Specifically, we will examine the potential normalization of unconventional behavior among aviation college students, who may grapple with substance use challenges due to stress, sleep difficulties, and the demands of college life. Given the rigorous nature of flight training, prioritizing the mental well-being of pilots becomes imperative.

With the recent legalization of recreational marijuana in Ohio, this presentation integrates insights from Diana Semilia's 2022 study on Kent State Flight Students Ages 19-26. The study's objective was to extract practical recommendations applicable …

Seeding A Movement: Indigenous Food Sovereignty, Mariaelena Huambachano

University of Miami Law Review

For many Indigenous peoples, well-being is bound up with and inseparable from the natural world. But since colonialism, Indigenous traditions and access to traditional foods or foodways have been disrupted, imperiling their health and well-being. In this Article, I discuss the role of Indigenous cosmovision/worldview and Indigenous Food Sovereignty in achieving environmental justice. Specifically, in this Article, I discuss that despite, or perhaps because of, efforts to deny Indigenous peoples’ access to healthy and culturally appropriate foods, Indigenous Food Sovereignty took a rise of preciousness in informing natural regenerative food systems, and ultimately, “holistic/collective well-being.”

‘Rounding Up’ Roundup: One Last Hope For Glyphosate Regulation, Gabrielle Argimón-Cartaya

University of Miami Law Review

Since 1974, Bayer’s Roundup remains the world’s most popular herbicide and pervades United States farmland and food production. However, in 2015, Roundup landed centerstage in an international and presently unsettled debate over whether its active ingredient, glyphosate, causes cancer. Environmental groups regularly call for the de-registration of glyphosate due to the plethora of ailments, ecological harm, and weed resistance resulting from glyphosate use. Dissenting experts, however, believe that strict bans would devastate agriculture because of global dependence and the lack of any popular alternatives. Faced with mounting litigation, silence from the highest court, and unreliable regulators, Bayer continues to effect …

Legal, Policy, And Environmental Scholars Discuss Global Food Systems At Indiana Law Symposium, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

The Indiana University Maurer School of Law and its Indiana Journal of Global Legal Studies are hosting scholars from around the country Friday and Saturday (Jan. 19-20) for an interdisciplinary discussion on one of the world’s most prevalent problems—food insecurity.

Data from the World Bank estimate more than 780 million people around the world suffered from chronic hunger in 2022. As climate change affects agricultural production and water accessibility, the problem could worsen in coming years.

“A Fragile Framework: How Global Food Systems Intersect with the International Legal Order, the Environment, and the World’s Populations” will bring together legal, policy, …

We(Ed) Hold These Truths To Be Self Evident: All Things Cannabis Are Inequitable, Garrett I. Halydier

University of Massachusetts Law Review

Current approaches to social equity in the cannabis industry continue to fail to promote racial equity while simultaneously exacerbating gender, environmental, and other inequities. To better understand the structural dynamics underlying this phenomenon, I first present a multi-disciplinary recounting of not only the racial inequities, but also the stigma, business, research, energy, sex and gender, hemp, and international inequities of the War on Drugs. This serves as the foundation for a compilation of the structural and theoretical reasons for how current social equity policies, whether targeting the cannabis industry, community reinvestment, social justice, or access equity, will only continue to …

Free For All: Proposing Legislation To Eliminate Food Insecurity In Arkansas Public Schools, A. Mills Bryant

Journal of Food Law & Policy

Schools serve millions of students daily as one of the largest food distribution sites in the United States. However, more than 13.1 million children in the United States, and almost 150,000 in Arkansas, are food insecure. Before the COVID-19 pandemic, most Arkansas schools offered free and reduced lunch to students at or below the poverty line through participation in the National School Lunch Program (“NSLP”). During COVID-19, Congress passed The Families First Coronavirus Response Act (“FFCRA”) and The Coronavirus Aid, Relief, and Economic Security Act (“CARES”) (hereinafter “The Acts”). This legislation effectively eliminated food insecurity in participating American public schools, …