Food and Drug Law Commons^™

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

Scholarly Articles in Law Reviews & 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 …

Consumption Governance: The Role Of Production And Consumption In International Economic Law, Timothy Meyer

BYU Law Review

Over the last decade, international economic conflict has increased dramatically. To name only a few examples, the European Union banned the import of products from deforested land and is poised to impose duties on carbon-intensive imports; the United States banned Chinese imports made with forced labor; and countries the world over threatened to impose digital services taxes on U.S. corporations, leading to a new multilateral agreement on apportioning income tax revenue among countries.

This Article argues that these conflicts represent a shift in norms governing the authority to tax and regulate international commerce. Different fields within international economic law describe …

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.

On The Defensive: Analyzing Insurers' Duty To Defend Pharmaceutical Companies For Contributing To The Opioid Epidemic, Madison Perry

Vanderbilt Law Review

Opioids have had a devastating impact on the United States. They have drained governmental agencies’ resources, decreased property values, and destroyed families and entire communities. A growing number of individuals, local governments, and states have filed lawsuits, aiming to hold pharmaceutical companies accountable for their negligent contributions to the epidemic. Such manufacturers, distributors, and retailers have called upon their insurers, asserting that their commercial general liability policies demand an insurer- backed and bankrolled defense. Courts are divided in their interpretation of the language contained within the at-issue policies. Some consider the claims made by certain states and local governments to …

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 …

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.

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 …

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 perceived threat associated with this investment. The Article also examines the current renewed interest in preventing foreign landholding and what has happened …

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 countries recognized the substantial contribution of street 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 …

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 …

Thai Drug Offenses And Narcotic Charges: Tracing Thailand’S Drug Control And Capital Punishment History, Jonathan Hasson, Carolyn Hoyle

Brooklyn Journal of International Law

The Article examines Thailand's political economy of drugs and use of sanctions, including capital punishment, using a historical approach. It traces Thailand's nation building and emergence as a global hub for illicit drugs against the backdrop of European and US interventions since the colonial era. The Article reveals how Western concepts and discourses were appropriated by Thai elites to advance local agendas while suppressing democratic movements. The Article explores how the drug trade became entangled with government corruption, militarization, and extrajudicial state violence which often targeted ethnic minorities. In light of recent cannabis policy changes, the Article considers the historical …

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. …

Food Price Narratives, Tammi S. Etheridge

Scholarly Articles

The use of antitrust in the context of food is problematic because it so clearly violates the Consumer Welfare Standard as prescribed by the courts. Ultimately, antitrust rhetoric promoting ad nauseam enforcement will not improve consumer welfare. Advancing consumer welfare in the food industry must mean prioritizing lower food prices over some arbitrary threshold of market competition or protecting small farms. Courts can and should begin distinguishing these goals immediately.

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

West Virginia Law Review

No abstract provided.

Nonviolent Drug Offenders Need Treatment--Not Prison: The Solution To Prison Overcrowding In West Virginia, Kendra Amick

West Virginia Law Review

A tenfold increase in prison populations has occurred due to the policies and laws enacted by the War on Drugs campaign in the United States. This increase is the direct result of a rise in the incarceration of nonviolent drug offenders. Rearrest rates for nonviolent drug-related offenders sentenced to prison are 50%. For those offenders permitted to participate in a drug court program, this rate decreases by over half. In West Virginia, the battle against the opioid epidemic has caused it to become one of the fastest-growing prison populations in the nation. With a fast-emerging crisis on the rise, West …

Fda Overreach: Is Your Pet’S Health A “Major Question” To You?, Ross C. Reggio

Washington and Lee Law Review

Pharmacy compounding of drugs for companion animals and humans is as old as time. For hundreds of years, pharmacists created these drugs using active pharmaceutical ingredients, otherwise known as bulk drug substances, to address the medical needs of these patients. Congress recognized this longstanding practice when it enacted the Food, Drug, and Cosmetic Act (“FDCA”), with lawmakers then noting that while pharmacists, physicians, and veterinarians were already highly regulated by the states, mass-producing drug manufacturers were not regulated. The FDCA would regulate such manufacturers.

Thereafter, pharmacy compounding from bulk drug substances continued for decades after the FDCA’s enactment and without …

Illegal Contracts And Agreements: A New Standard For Prostitution And Marijuana Agreements, Doug Rendleman

Washington and Lee Law Review

Agreements exchanging sex for money and those involving marijuana may encounter illegality defenses in court. Granting a legal remedy for breach of an agreement that exchanges seriously illegal consideration would lower the court’s public standing and endanger its legitimacy. On the other hand, the spectacle of a buyer claiming its own illegality to escape paying its seller troubles courts.

Lord Mansfield stated the illegality defense in Holman v. Johnson: “No Court will lend its aid to a man who founds his cause of action upon an immoral or an illegal act.” Yet he rejected the illegality defense in that case …

Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka

Vanderbilt Law Review

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …