Food and Drug Law Commons^™

Cooperation Or Compromise? Understanding The Farm Billas Omnibus Legislation, Margaret Sova Mccabe

Journal of Food Law & Policy

The Farm Bill (the Bill) is the principal driver of U.S. food law and policy. Its substance spans the food system including commodities, conservation, trade, nutrition, credit, rural development, forestry, and energy. These substantive titles command much scholarly analysis yet there is comparatively little review of the law-making process that yields the Bill. Given increased focus on Congress’s ability to use its legislative powers effectively, this essay questions whether the Bill’s traditional treatment as omnibus legislation leads to beneficial coherence or too much compromise in food system policy. Interestingly, disparate stakeholders prioritize maintaining the Bill as omnibus legislation. Some scholars …

The Snap Sugar-Sweetened Beverage Debate: Restricting Purchases To Improve Health Outcomes Of Low-Income Americans, Nicole E. Negowetti

Journal of Food Law & Policy

The Supplemental Nutrition Assistance Program (SNAP) is a highly effective government program that reduces poverty and improves food security for millions of our country’s most vulnerable families. Amid threats of budget cuts to this critical program in the 2018 Farm Bill, advocates representing various interests have banded together in support of this vital program. However, the issue of restricting the purchase of sugar-sweetened beverages (SSB) with SNAP benefits has divided anti-hunger and public health advocates. While public health and medical officials support the idea of restrictions on junk food, arguing that SNAP should improve health and nutrition, not contribute to …

The End Of The Ramen Diet: Higher Education Students And Snap Benefits, Erika M. Dunyak

Journal of Food Law & Policy

Americans joke that college students have so little money that they subsist on 10 cent packs of ramen. Statistically, college students face much higher rates of food insecurity than the general population and the situation is particularly dire for students of color. Much has been written on this area in recent months and years and many commentators are seeking to denormalize poverty, hunger, and the “freshman 15” on campuses. This article will look to a solution for this hungry and often neglected population. In 2010, the Health, Hunger-Free Kids Act (HHFKA) reauthorized the Federal School Lunch Program. HHFKA contained several …

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

Journal of Food Law & Policy

More diverse and value-driven public engagement has transformed the American food system. This engagement has changed the behavior of industries, consumers, policymakers, and communities. At the heart of this change is the drive among countless individuals and organizations to promote a wider variety of food choices and shape the food system in harmony with their values. Despite the local and sovereign nature of this engagement, federal food and agricultural policies have contributed substantially to this transformation of the American food system. In isolation, many of these policies support discrete programs and individuals. In the aggregate, these policies strengthen different facets …

Improving Generic Drug Approval At The Fda, Kathleen Craddock

Michigan Journal of Environmental & Administrative Law

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …

Reforming Regenerative Medicine Regulation, Sarah Duranske

Georgia State University Law Review

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …

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 …