Food and Drug Law Commons^™

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 …

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 …

U'Wa Indigenous People Vs. Columbia: Potential Applications Of The Escazu Agreement, Ariana Lippi

Sustainable Development Law & Policy

Though the case is ongoing, and results are still to be seen, it in many ways sets a precedent for indigenous communities in Latin America seeking redress for environmental and cultural injustices. With Colombia’s recent ratification of The Escazú Regional Agreement (the Agreement herein) in 2022, this case presents a unique opportunity for implementation of the Agreement and greater accountability within existing domestic legislation.

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 …

Editor's Note, Shade Streeter, Reagan Ferris

Sustainable Development Law & Policy

The Sustainable Development Law & Policy Brief (ISSN 1552-3721) is a student-run initiative at American University Washington College of Law that is published twice each academic year. The Brief embraces an interdisciplinary focus to provide a broad view of current legal, political, and social developments. It was founded to provide a forum for those interested in promoting sustainable economic development, conservation, environmental justice, and biodiversity throughout the world.

Just Don’T Do It: Why Cannabis Regulations Are The Reason Cannabis Businesses Are Failing, Edward Adams

Nevada Law Journal

No abstract provided.

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 …

U.S. Food & Drug Administration V. Alliance For Hippocratic Medicine: Brief For Food And Drug Law Scholars And Professors As Amici Curiae Supporting Petitioners And Reversal, Rebecca S. Eisenberg

Appellate Briefs

Amici curiae are U.S. food and drug law scholars and professors from academic institutions across the United States. A full list of amici is included as an Appendix to this brief. Amici have expertise in food and drug law, including the drug approval process and regulation of pharmaceuticals under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. Amici submit this brief to address important issues raised by this case concerning the authority of the U.S. Food & Drug Administration (FDA or the Agency) to regulate prescription drugs.

The Federal Food, Drug, and Cosmetic Act …