Food and Drug Law Commons^™

Emergent Regulatory Systems And Their Challenges: The Case Of Combination Medical Products, George Horvath

Washington Law Review

Where regulatory systems overlap, courts and scholars often focus on the undesirable aspects of the overlap—the ways in which systems conflict. One such context involves the regulation of prescription drugs and medical devices by the FDA’s premarket evaluation processes and by state common-law tort and products liability actions. FDA regulation and state common law are often described as separate, conflicting regulatory systems. This Article challenges that description by proposing a model in which FDA premarket evaluation and state common law function as a single regulatory system. This model brings order to the Supreme Court’s seemingly inconsistent medical products preemption cases, …

Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi

Journal of the National Association of Administrative Law Judiciary

This comment explores the types of legislation, approaches to regulating e-cigarettes, and analyzes whether the FDA’s campaign and current regulations are effective. So far, it appears that the United States is ahead of the game with its new, aggressive proposal for regulating e-cigarettes. The FDA is standing against the companies and products that target youthful consumers. Most countries acknowledge the gaps in current scientific research regarding the long-term health risks of vaping, and some are waiting to take a legislative stance until it is clearer which side of the health line e-cigarettes fall. Section II of this comment discusses the …

Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs

Journal of the National Association of Administrative Law Judiciary

The American cosmetics industry is not required by the Food and Drug Administration (FDA) to conduct pre-market safety assessments of cosmetics. The FDA only reviews personal care products when people voluntarily report problems. Further, companies continue to test animals for cosmetics, despite the FDA’s recommendation that manufacturers seek more humane and accurate testing. Although the FDA does not require animal testing for product safety or premarket approval, the United States is one of the largest users of laboratory animals for product testing. There are two pending pieces of legislation, which if passed would be the first acts of cosmetic regulation …

Even Marijuana Needs A Zone: Utah’S H.B. 3001 As The Next Battleground For Zoning Ordinances And State Medical Marijuana Laws, Kyle A. Harvey

Brigham Young University Journal of Public Law

No abstract provided.

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

Has The "M" Word Been Framed? Marijuana, Cannabis And Public Opinion, Robert A. Mikos, Cindy D. Kam

Vanderbilt Law School Faculty Publications

Over the past two decades, a growing cadre of US states has legalized the drug commonly known as “marijuana.” But even as more states legalize the drug, proponents of reform have begun to shun the term “marijuana” in favor of the term “cannabis.” Arguing that the “M” word has been tainted and may thus dampen public support for legalization, policy advocates have championed “cannabis” as an alternative and more neutral name for the drug. Importantly, however, no one has tested whether calling the drug “cannabis” as opposed to “marijuana” actually has any effect on public opinion. Using an original survey …

Marijuana’S Continuing Illegality And Investors’ Securities Fraud Problem: The Doctrines Of Unclean Hands And In Pari Delicto, Casey W. Baker

The Journal of Business, Entrepreneurship & the Law

Marijuana-related businesses have blossomed into an industry with an estimated total market value of $7.2 billion in 2016, with annual growth projected at 17%. Industry surveys report that 62% of marijuana-related businesses have offered equity stakes to investors and approximately one-half of marijuana-related businesses planned to actively seek investment funding in 2017. Along with the investment opportunity comes heightened fraud risk, with regulators cautioning investors against investment due to the lack of accurate and publicly-available information. Also, despite state-level decriminalization, marijuana possession, sale, and distribution continues to be a crime under federal law. The criminal nature of the marijuana industry …

Ensuring Economic Viability And Sustainability Of Coffee Production, Jeffrey D. Sachs, Kaitlin Y. Cordes, James Rising, Perrine Toledano, Nicolas Maennling

Columbia Center on Sustainable Investment Staff Publications

Coffee, the world’s favorite beverage, provides livelihoods for at least 60 million people across dozens of countries. Yet this beloved drink is experiencing a sustainability crisis. A sustained decline in world coffee prices has squeezed coffee producers, and thrown a tremendous number of producers below the global extreme poverty line. This report presents our research into sustainability within the coffee sector, including the results of our analytical and empirical modeling, and provides several recommendations.

When "Things" Go Wrong: Redefining Liability For The Internet Of Medical Things, Bethany A. Corbin

South Carolina Law Review

No abstract provided.

The Future Of Dairy Cooperatives In The Modern Marketplace: Redeveloping The Capper-Volstead Act, Sarah K. Phillips

Dickinson Law Review (2017-Present)

Agriculture plays a fundamental role in the U.S. economy as a multibillion-dollar industry that feeds people all over the world. However, over the past decade, the dairy industry in particular has changed from a reliable sector of the greater agricultural industry into an unsettled, politically-charged, and fractured group. Dairy farmers’ consistently receiving low milk prices has facilitated this divide. Tired of being ignored and underpaid, dairy farmers are demanding change in the current dairy market structure.

Federal Milk Marketing Orders and a variety of statutes regulate the dairy industry, but the 1922 Capper-Volstead Act remains the most notable piece of …

School Of Law Faculty And Professional Staff, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Journal Of Food Law & Policy - Volume 14 Fall 2018, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

The Renewed Concern Over Soil Erosion: The Current Federal Programs And Proposals, Linda A. Malone

Linda A. Malone

Because soil erosion affects the quantity and quality of farmland, it is a matter of great concern for both the government and the farm industry. Whereas in the past concern was over the potential damage to productivity, concern is now being voiced over off-site damage and water pollution. There are numerous federal programs set up to fight soil erosion, but they are all voluntary, thereby making it difficult for the government to target funds. The author reviews the seriousness of the problem, looks at the numerous government programs, and then analyzes the Food Security Act of 1985—the first act to …

A Historical Essay On The Conservation Provisions Of The 1985 Farm Bill: Sodbustin, Swampbusting, And The Conservation Reserve, Linda A. Malone

Linda A. Malone

No abstract provided.

Legislative And Executive Branch Developments Affecting The United States Department Of Agriculture Supplemental Nutrition Assistance Program, Sheila Fleischhacker, Alyssa Moran, Sara N. Bleich

Journal of Food Law & Policy

For more than forty years, the United States Department of Agriculture Supplemental Nutrition Assistance Program (SNAP; formerly Food Stamps) has offered nutrition assistance to nearly forty million eligible individuals and families each month. This article first provides a brief overview of the evolution of the United States’ largest domestic food security and nutrition safety net program. Then, the article reviews Congressional actions taken regarding SNAP during the 2018 Farm Bill deliberations, appropriations for fiscal years 2017 through 2020, and oversight (in)activities. The article focuses on Congressional activities regarding block grants; participant eligibility; benefit adequacy, issuance, and redemption; and strengthening SNAP’s …

Federal Regulation Of Pesticide Residues: A Brief History And Analysis, Kate Z. Graham

Journal of Food Law & Policy

In the United States today, there are over 900 pesticides in use1 and over 400 are approved for use in food production, whether used as part of the growing process or in post-harvest handling. Although the history of pesticide use in food crops goes back centuries, the post-war period has seen an enormous growth in the varieties and amounts of pesticides used in our food system. As our reliance on pesticides has grown, pesticides have become a divisive issue. Pesticide advocates view them as essential to a secure and reliable food supply needed to feed a growing world population. Detractors, …

Blockchain Meets Genomics: Governance Considerations For Promoting Food Safety And Public Health, Walter G. Johnson

Journal of Food Law & Policy

Foodborne illness remains an ongoing public health challenge in both the developing and industrialized worlds. In the United States, almost 50 million reported cases of infectious disease occur every year from a food product, resulting in substantial morbidity and mortality with economic burdens to health care and productivity. Despite recognition as a leader in food safety, the U.S. experiences longstanding and novel issues in food safety. Advances in whole genome sequencing (WGS) promise to bolster food safety regulators’ capabilities to identify pathogens and determine their source. However, inefficiencies in tracing food products through the supply chain remain.

The Clash Of Agricultural Exceptionalism And The First Amendment: A Discussion Of Kansas' Ag-Gag Law, Meredith Kaufman

Journal of Food Law & Policy

Since the Nation’s founding, agricultural production has been treated differently than other industries. This concept, known as “agricultural exceptionalism,” has manifested in many different ways throughout U.S. history. Since the 1990s, one manifestation of agricultural exceptionalism has been the enactment of “Ag-gag laws,” state laws that limit information gathering activities at animal production facilities. Ag-gag laws are frequently criticized by animal welfare advocates and legal scholars for seeking to shield animal production facilities from public scrutiny, a state-sanctioned protection not afforded to other industries.

Consumer Power To Change The Food System? A Critical Reading Of Food Labels As Governance Spaces: The Case Of Acai Berry Superfoods, Christine Parker, Hope Johnson, Janine Curll

Journal of Food Law & Policy

This article argues that the marketing claims on food labels are a governance space worthy of critical examination. We use a case study of superfood açaí berry products to illustrate how marketing claims on food labels encapsulate dominant neoliberal constructions of global food systems. These marketing claims implicitly promise that by making careful choices consumers can resist and redress the ravages of unbridled global capitalism. Food labels suggest that consumers can use market signals to simultaneously govern our own selves and the market to ensure sustainable, fair, and healthy consumption. In response, this article develops, justifies and applies a socio-legal …