Food and Drug Law Commons^™

Muddying The Waters: Catfish Inspection Authority Transitions To The Food Safety And Inspection Service, Michelle Johnson-Weider

Journal of Food Law & Policy

The Food and Drug Administration regulates the safety and labeling of almost all food in the United States other than meat, poultry, and egg products, which fall under USDA’s Food Safety and Inspection Service (FSIS). Effective September 1, 2017, FSIS assumed inspection responsibility for catfish after years of Congressional lobbying by the small domestic catfish industry. This article examines how this unlikely legislative victory was won against free trade advocates representing much larger economic interests.

The Role Of Non-Profit Organizations In Shaping Food Law And Corporate Responsibility In The United States, Melissa M. Card

Journal of Food Law & Policy

This article assesses whether the United States should adopt an institutional process similar to Europe’s through giving non-profit organizations a role in shaping food law and corporate responsibility. Part I provides a comparative analysis of genetically engineered product regulations in the US and the EU. Part II explains how the institutional processes of the US and the EU led to the varying regulations. Part III asserts that the United States should change its institutional process through allowing public universities and private colleges to influence food law and corporate responsibility.

The Fda's Guidance On Dietary Supplement Naming And The Emperor's New Clothes, Neal D. Fortin

Journal of Food Law & Policy

In 2016 the FDA revised the agency’s guidance on dietary supplement labeling. This modification permits the term “dietary supplement” be the entire statement of identity for a dietary supplement. This is an error in the interpretation of the plain language of the Food, Drug, and Cosmetic Act, the plain language of 21 C.F.R. § 101.3(g); and does not comport with numerous rules of statutory interpretation. Moreover, this change violates the Administrative Procedures Act and the FDA’s rules on notice and comment. This change is a disguised rescission of 21 C.F.R. § 101.3(g ...

Food Law & Policy: An Essential Part Of Today's Legal Academy, Emily M. Broad Leib, Baylen J. Linnekin

Journal of Food Law & Policy

This Article updates the authors’ seminal 2014 Wisconsin Law Review article, "Food Law & Policy: The Fertile Field’s Origins and First Decade," which was the first scholarly work to detail the fascinating origins and explosive growth of the legal field of Food Law & Policy. Using the same ten criteria the authors developed to measure the growth of Food Law & Policy for the 2014 article, this Article measures and details the field’s impressive growth since that time.

School Of Law Faculty And Professional Staff, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Editoral Board, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Journal Of Food Law & Policy - Volume 13 Fall 2017, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Kratom Crackdown: How The Dea Abused Its Emergency Scheduling Authority Under The Controlled Substances Act, Olivia Castillo

University of Miami Law Review

The Drug Enforcement Administration wields tremendous power at scheduling a new drug or substance on an emergency basis under the Controlled Substances Act. The DEA newly leveled this power at a plant—kratom—with the potential to curb the menacing opioid epidemic in North America. This unprecedented effort has generated considerable controversy. Many individuals remonstrated the agency’s action, especially those facing life-threatening hardships because of the opioid crisis. Members of Congress also took a stand against the DEA’s unrivalled move to schedule kratom, suggesting that the agency had abused the emergency scheduling authority delegated by the legislative branch ...

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more ...

Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa

Ryan B. Stoa

The United States and Canada may be friends and allies, but the two countries' approaches to the regulation of marijuana agriculture have not evolved in tandem. On the contrary, their respective paths toward legalization and regulation of marijuana agriculture are remarkably divergent. In the United States, where marijuana remains a federally prohibited and tightly-controlled substance, legalization and regulation have remained the province of state legislatures and their administrative agencies for decades. In Canada, a succession of court cases paving the way toward medicinal marijuana use has prompted the federal government to develop a national framework committed to "legalize, regulate, and ...

Marijuana Appellations: The Case For Cannabicultural Designations Of Origin, Ryan Stoa

Ryan B. Stoa

An appellation is a certified designation of origin that may also require that certain quality or stylistic standards be met. Appellations are most commonly associated with the wine industry, but they can be applied to any agricultural product for which the geographic origin carries importance. The MMRSA [California Medical Marijuana Regulation and Safety Act] … may have far-ranging effects on the marijuana industry in the United States. [A provision of the act permits the state Bureau of Medical Marijuana Regulation to ‘establish appellations of origin for marijuana grown in California.’] As the most populous state in the Union and the most ...

Quitting Cold Turkey?: Federal Preemption Doctrine And State Bans On Fda-Approved Drugs, Thomas A. Costello

William & Mary Bill of Rights Journal

No abstract provided.

Consumers In Shock: How Federal Government Overregulation Led Mylan To Acquire A Monopoly Over Epinephrine Autoinjectors, Nicole O'Toole

DePaul Business and Commercial Law Journal

The philosophy that federal government intervention increases costs and decreases options and values available to consumers can be analyzed across a plethora of markets. This Note will focus on the epinephrine autoinjector market, specifically looking at Mylan's epinephrine autoinjector known as the EpiPen. Today, the EpiPen is considered the “Kleenex” of epinephrine autoinjectors as it is estimated to control over ninety percent of the market share. From a Darwinist perspective it would appear that because the EpiPen controls most of the market, it must be the most superior product available to consumers. However, as this note will cover, this ...

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on ...

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a ...

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is ...

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory ...

Sin Taxes: Have Governments Gone Too Far In Their Efforts To Monetize Morality?, Franklin Liu

Boston College Law Review

In June 2016, Philadelphia became the largest city in the United States to pass a soda tax, which went into effect on January 1, 2017. Soda taxes, an umbrella term for taxes that are assessed on sugar-sweetened beverages, represent the latest incarnation in a recent wave of non-traditional “sin taxes.” Sin taxes target behaviors that the government considers to be socially undesirable, and traditionally have been levied to curb consumption of alcohol and tobacco products. As state and local governments continue to face burgeoning budget deficits, legislators have increased the amount of existing sin taxes and expanded the sin tax ...

How Commonsense Consumption Acts Are Preventing “Big Food” Litigation, Grace Thompson

Seattle University Law Review

This Note takes a critical look at Commonsense Consumption Acts and how they are detrimental to the possibility of “Big Food” litigation. The tobacco industry was held accountable through the effective use of tort litigation (commonly referred to as “Big Tobacco” litigation), and the food industry could theoretically be held similarly accountable, but CCAs are preventing the possibility of similar reform. Therefore, in order for health reform to be as effective as tobacco reform, CCAs must be repealed in the states where they exist. Part I of this Note discusses why the food industry needs tort reform. Specifically, it argues ...