Food and Drug Law Commons^™

Patents As Property: Oil States And Its Implications On The Takings Clause, Jordan T. Owens

Cardozo Law Review

No abstract provided.

Tiptoeing Through The Landmines: The Evolution Of States’ Legal Ethics Authority Regarding Representing Cannabis Clients, Karen E. Boxx

Seattle University Law Review

Despite the continued federal classification of cannabis as an illegal drug, states have legalized the possession, use, production, and sale of cannabis. In order to do so, the states have created complex regulatory schemes to control and monitor the cannabis industry and satisfy the federal government concerns, such as use by minors and organized crime involvement. First, this Article presents the ethical dilemma of cannabis lawyering. Second, this Article describes the history, evolution, and current status of the various states’ pronouncements on a lawyer’s ethical duties with respect to the business and use of cannabis that may be legal under …

A Quixotic Quest For Definition: Perceptions Of “Organic” And Implications For The Environment And For Market Participants, Becky L. Jacobs, Chelsea Jacobs

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Say “No” To Discrimination, “Yes” To Accommodation: Why States Should Prohibit Discrimination Of Workers Who Use Cannabis For Medical Purposes, Anne Marie Lofaso, Lakyn D. Cecil

Seattle University Law Review

This Article addresses the question of how the law should treat medical cannabis in the employment context. Using Colorado as a primary example, we argue that states such as Colorado should amend their constitutions and legislate to provide employment protections for employees who are registered medical cannabis cardholders or registered caregivers.

Part I briefly traces the legal regulation of cannabis from an unregulated medicine known as cannabis to a highly regulated illicit substance known as marijuana under the Controlled Substances Act. Our travail through this history reveals, unsurprisingly, an increasing demonization of cannabis throughout the twentieth century. That socio-legal demonization …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Welcome To The World Of Tomorrow: An Exploration Of Cell-Based Meats And How The Fda And Usda May Protect Intellectual Property Rights, Sean A. Grafton

Catholic University Journal of Law and Technology

Lab-grown meats are ready to be sold in United States markets. However, the meat product needs approval from regulators such as the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”). The regulation approval process takes a significant amount of time. This approval period will cut into the lab-grown meat producers’ patent time, rendering a period of the patent ineffective.

This Comment analyzes the effect of, and possible changes to, our current laws on the emerging lab-grown meat market. To look at this problem, this Comment compares FDA and USDA regulations, analyzes the Hatch-Waxman Act, and …

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

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 …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

The New Food Safety, Margot J. Pollans, Emily M. Broad Leib

Elisabeth Haub School of Law Faculty Publications

A safe food supply is essential for a healthy society. Our food system is replete with different types of risk, yet food safety is often narrowly understood as encompassing only foodborne illness and other risks related directly to food ingestion. This Article argues for a more comprehensive definition of food safety, one that includes not just acute, ingestion-related risks, but also whole-diet cumulative ingestion risks, and cradle-to-grave risks of food production and disposal. This broader definition, which we call “Food System Safety,” draws under the header of food safety a variety of historically siloed, and under-regulated, food system issues including …

Antiquated Relics Or Misunderstood Mess, Why South Carolina Liquor Laws Are Ripe For Restructuring, Annie Day Bame

South Carolina Law Review

No abstract provided.

Don't Feel Like Going To The Store, I'Ll Drink To That, How To Govern The Direct Shipment Of Alcohol In South Carolina, Frederick N. Hanna

South Carolina Law Review

No abstract provided.

Defining Fishing, The Slippery Seaweed Slope, Ross V. Acadian Seaplants Ltd., Rebecca P. Totten

Ocean and Coastal Law Journal

In Maine, the intertidal zone has seen many disputes over its use, access, and property rights. Recently, in Ross v. Acadian Seaplants, Ltd., the Maine Supreme Judicial Court, sitting as the Law Court, held that rockweed seaweed in the intertidal zone is owned by the upland landowner and is not part of a public easement under the public trust doctrine. The Court held harvesting rockweed is not fishing. This case will impact private and public rights and also the balance between the State's environmental and economic interests. This Comment addresses the following points: first, the characteristics of rockweed and the …

How Chevron Deference Is Inappropriate In U.S. Fishery Management And Conservation, Charles T. Jordan

Seattle Journal of Environmental Law

Well managed fisheries represent an excellent source of sustainable food making the management of which incredibly important. The management of fisheries in the United States is governed by The Magnuson-Stevens Fishery Conservation and Management Act (MSFCMA). While the Act creates strong goals and mandates to ensure the best management of fisheries as an important natural resource, there are issues of delegation within the act. The MSFCMA ultimately delegates authority to eight regional councils which are made up of unelected and un-appointed members. The membership of these councils is at risk of industry influence with little legal protections. Critical in how …

Pharmaceutical Price Gouging: The Need For Direct Regulation On The Gray Market, Nicole Rende

Journal of Civil Rights and Economic Development

(Excerpt)

This Note proposes federal legislation that will ultimately shut down the Pharmaceuticals gray market. The federal government should directly regulate the gray market and the price gouging mechanisms used. Congress should pass the Fair Accountability and Innovative Research Drug Pricing Act of 2016, currently proposed. This Act will increase price transparency and provide a civil penalty for wrong doers. In addition to the passage of this Act, there needs to be a direct attack on the gray market by creating an act that does not allow companies to participate in these distributions and ultimately form monopolies. This act needs …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers

Barry Law Review

No abstract provided.

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

The Crazy Maze Of Food Labeling And Food Claims Laws, Patrick Meyer

St. John's Law Review

(Excerpt)

This Article critiques the role of the FDA in providing consumers with accurate and relevant food label information, identifies impediments in the pursuit of its mission, and offers solutions to those impediments.

Part I of this Article traces the history of U.S. food labeling and health claims laws. Current food laws and their regulation have developed over time. The first federal legislation was passed in the early 1900s. The food laws of today have certainly been influenced by past food laws, which were largely a reaction to societal events. A brief summary of the historical development of our nation’s …

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

The Gm Food Debate: An Evaluation Of The National Bioengineered Food Disclosure Standard And Recommendations For The United States Based On Food Justice, Courtnee Grego

Seattle University Law Review

This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …

The Gm Food Debate: An Evaluation Of The Nationalbioengineered Food Disclosure Standard Andrecommendations For The United States Based On Foodjustice, Courtnee Grego

Seattle University Law Review

This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …

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 …

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 …

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 …

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 …

Administrative Guidance And Genetically Modified Food, Edward L. Rubin, Joanna K. Sax

Faculty Scholarship

One of the most controversial issues in administrative law, the use of guidance, is exemplified by the regulation of one of the most controversial areas in modern society: genetically modified (GM) food. The appropriate use of guidance versus notice and comment rulemaking is a much-debated issue in administrative law. While agency officials generally assert that they are using guidance to express an agency’s thoughts about how to comply with a specific statutory provision or agency rule, the practical consequence is that the regulated party will hesitate to disobey, even if it believes that the guidance goes beyond the requirements of …

The “Deeming Rule”: The Fda’S Destruction Of The Vaping Industry, Lauren H. Greenberg

Brooklyn Law Review

The FDA has recently passed sweeping regulations, which classifies and then regulates electronic cigarettes as “tobacco products” in the same manner as traditional cigarettes. Though the agency reasons that unknowing adults and children may easily turn to e-cigarettes without fully understanding the potential health effects, there is a lack of conclusive evidence in this field to justify such a comprehensive regulatory scheme. Through the far-reaching “Deeming Rule,” e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market. The channels by which the FDA proposes manufacturers and retailers gain permission from …