Food and Drug Law Commons^™

Editoral Board, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Strengthening The National Organic Program With State Organic Programs, Kelly Damewood

Journal of Food Law & Policy

With an increasing amount of organic imports and steady growth in the organic sector, the U.S. Department of Agriculture’s (USDA) National Organic Program (NOP) needs additional enforcement resources to oversee a growing and evolving organic marketplace. California has the most efficient, robust organic enforcement in the U.S. because it has a state-administered organic enforcement program, the California State Organic Program (SOP). Based on the costs and benefits of the SOP, additional state organic programs are a viable means to increasing NOP enforcement resources when they are established in states where additional enforcement adds value to the state’s organic sector, organic …

The Antitrust Duty To Charge Low Prices, Ramsi A. Woodcock

Cardozo Law Review

Over the past forty years, antitrust has come to embrace a goal of consumer welfare maximization that cannot be achieved solely through condemnation of collusive or exclusionary conduct. To address cases in which firms achieve the power to raise prices and harm consumers without engaging in collusive or exclusionary conduct, antitrust should impose a general duty on businesses to charge a price no higher than economic cost. Courts would not need to set prices to enforce this duty, because violations would be punishable only by nominal damages, and shame, rather than by an injunction setting a reasonable price. Although the …

Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan

Georgetown Law Faculty Publications and Other Works

Diets high in fats, sugars, and sodium are contributing to alarming levels of obesity, cardiovascular disease, type 2 diabetes, and certain cancers throughout the United States. Sugary drinks, which include beverages that contain added caloric sweeteners such as flavored milks, fruit drinks, sports drinks, and sodas, are the largest source of added sugar in the American diet and an important causative factor for obesity and other diet-related diseases.

City and county governments have emerged as key innovators to promote healthier diets, adopting menu labeling laws to facilitate informed choices and soda taxes, warnings labels, and a soda portion cap to …

No Farms No Food? A Response To Baylen Linnekin, Joshua Ulan Galperin

Elisabeth Haub School of Law Faculty Publications

You have likely seen the bumper sticker, bold white text on a green background, reading “No Farms No Food.” The sticker is a product of, and in fact a tagline for, the American Farmland Trust. On the one hand, the point is obvious: As American Farmland Trust puts it, “[e]very meal on our plates [c]ontains ingredients grown on a farm. We all need farms to survive.” On the other hand, what seems like a plain statement on its face, “no farms no food,” is not so simple. Farms produce affordable food, they produce vast quantities of food, they produce healthy …

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.

This Comment explores the …

Fighting For Your Life In America: A Study Of "Right To Try" Laws Throughout The Country, Danielle Delgrosso

St. John's Law Review

(Excerpt)

This Note argues that there should be a federal statute granting terminally ill patients access to experimental drugs, but that the Trickett Wendler Act, as written is not the proper vehicle for change. An ideal congressional “Right to Try” statute should be crafted to make experimental drugs realistically obtainable for terminally ill patients while protecting those patients and their quality of life. The Trickett Wendler Act’s weaknesses prevent it from reaching this objective because it is too deferential to already unclear state Right to Try laws. Part I explores the right to try movement generally, explaining what a “right …

Food Localization: Empowering Community Food Systems Through The Farm Bill, Joshua Ulan Galperin, Brian Fink, Alexandra Schluntz

Elisabeth Haub School of Law Faculty Publications

Our intent in this Article is not to delineate foods that are local or not local, nor is it to lionize one agricultural production method over another. Rather, we hope to build on the literature that for many decades has documented how local communities have emerged as influential actors on the American food system through establishing control over local supply chains often alongside national and global supply chains. We begin with Part I, which explores how some food-system scholars have conceptualized these democratic changes occurring. We look to Thomas Lyson’s concept of civic agriculture, which attempts to move corporation-oriented communities …

Marijuana Edibles And “Gummy Bears”, Paul J. Larkin Jr.

Buffalo Law Review

Contemporary American society has decided that, whatever may be the benefits and harms of liberalizing marijuana use by adults, we should continue to outlaw the sale of recreational-use marijuana to children and adolescents. Even the states that permit recreational marijuana use under state law draw the line between adults and minors. Unfortunately, some companies pay only lip service to that line. The ability to develop products that closely resemble cookies, brownies, candies, and other substances that are attractive to children and adolescents — albeit, for different reasons — poses the risk that minors — some accidentally, some intentionally — will …

How Subterranean Regulation Hinders Innovation In Assisted Reproductive Technology, Myrisha S. Lewis

Cardozo Law Review

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This belief I contend, is wrong. In this Article, I examine agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past fifteen years to reveal an overlooked regulatory program. The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (advanced assisted reproductive technologies or AARTs) through regulatory actions that receive little public, media, or scholarly attention. I term this method of regulation "subterranean …

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 & 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 is …

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Faculty Scholarship

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication

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 …

Serving Pets In Poverty: A New Frontier For The Animal Welfare Movement, Amanda Arrington, Michael Markarian

Sustainable Development Law & Policy

No abstract provided.

How Fast Is Too Fast? Osha’S Regulation Of The Meat Industry’S Line Speed And The Price Paid By Humans And Animals, Israel Cook

Sustainable Development Law & Policy

No abstract provided.

The Farts Heard ‘Round The World: Where Cow-Tapping Falls On The International Agenda Of Sustainable Development, Alexandra C. Nolan

Sustainable Development Law & Policy

No abstract provided.

This Is Not The Bee’S Knees: A Critical View Of The Government’S Lack Of Policy To Conserve The Pollinators, Savannah Pugh

Sustainable Development Law & Policy

No abstract provided.

Legislative Efforts To Increase State Management For Imperiled Species Should Be Rejected, Stephanie Kurose

Sustainable Development Law & Policy

No abstract provided.

Anthropogenic Noise And The Endangered Species Act, Carolyn Larcom

Sustainable Development Law & Policy

No abstract provided.

Cruelty To Human And Nonhuman Animals In The Wild-Caught Fishing Industry, Kathy Hessler, Rebecca Jenkins, Kelly Levenda

Sustainable Development Law & Policy

No abstract provided.

The “Fowl” Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith

Sustainable Development Law & Policy

Chickens raised specifically for meat production are the world’s most intensively farmed land animals. Yet, the existing legal frameworks that regulate the production and labeling of poultry products in the United States allow poultry producers to mistreat chickens, falsely distinguish poultry products, and defraud conscious consumers. This article proposes unique opportunities to improve poultry welfare in the United States’ agricultural industry and offers methods to ensure the accurate labeling of poultry products.

Cafos: Plaguing North Carolina Communities Of Color, Christine Ball-Blakely

Sustainable Development Law & Policy

No abstract provided.

About Sdlp

Sustainable Development Law & Policy

No abstract provided.

Editor's Note, Luke Trompeter, Ingrid Lesemann

Sustainable Development Law & Policy

No abstract provided.

Microscopic Allies: Examining And Tackling Legal And Regulatory Barriers To The Development Of Phage Therapy, Jacob Zent

William & Mary Environmental Law and Policy Review

No abstract provided.

Gmos, International Law And Indigenous Peoples, Casandia Bellevue

Pace International Law Review

This Article sprung from a desire to discover why—despite scientific uncertainty and the oft-cited precautionary principle in international law—genetically modified organisms are still allowed to spread via international trade and natural ecological cycles. While exploring this topic, it did not take long to come across the environmental justice impacts of genetically modified crops, and their particularly disparate impact upon indigenous peoples across the globe. Not only are GMOs threatening biodiversity and our planet, but also the very existence and cultural foundations of many indigenous groups.

This Article seeks to answer the following questions: What are the international agreements that can …

Update On Fda Regulation Of Mhealth And Wellness Devices, Barbara Zabawa

Faculty Works

This article provides an update on the evolving regulatory landscape of mobile health (mHealth) and wellness devices, focusing on changes introduced by the Food and Drug Administration (FDA) through its 2017 Draft Guidance. These updates aim to clarify inconsistencies in the definitions and regulatory status of various categories of devices, such as mobile medical apps, general mobile apps, and low-risk wellness devices. The Draft Guidance redefines certain wellness devices, emphasizing that those related to chronic diseases or conditions may now be recognized as medical devices but remain under FDA's enforcement discretion if they pose minimal safety risks. Additionally, the article …

Hb 249 - Controlled Substances And Prescription Drug Monitoring Database, Emily R. Polk, Brandon M. Reed

Georgia State University Law Review

The Act amends Georgia’s controlled-substances statutes to expand medical provider requirements to record prescription drug information in an electronic prescription drug monitoring program database (PDMP). Medical providers are now required to use the PDMP to enter information about their prescription of certain types and quantities of opioids. The purpose of the act is to fight Schedule II opioid abuse throughout the state of Georgia. A medical provider’s failure to report required information is reported to his or her respective state regulatory board for possible reprimand. In addition to mandatory reporting, the Act includes various other provisions related to regulating opioid …

Sb 104 - Carjacking, Fentanyl And "Upskirting", Katherine H. Krouse, Lauren R. Light

Georgia State University Law Review

The Act includes various amendments to Georgia’s criminal code. Three changes are most notable. First, the Act designates the offense of hijacking a motor vehicle as hijacking a motor vehicle in the first degree and creates the offense of hijacking a motor vehicle in the second degree. Second, the Act criminalizes the use of a device to film underneath or through an individual’s clothing. Lastly, the Act adds the drug Fentanyl and its various analogs to the list of controlled substances.