Law Commons^™

United States Food Law Update: Labeling Contoversies, Biotechnology Litigation, And The Safety Of Imporeted Food, A. Bryan Endres

Journal of Food Law & Policy

This update summarizes significant changes and developments in food law throughout the first half of 2007. Out of necessity, not every change is included; rather, this update is limited to significant changes in national law. This series of updates provides a starting point for scholars, practitioners, food scientists, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates also builds an important historical context for the overall development of the discipline.

Beetles For Breakfast: What The Fda Should Be Telling You, Kaycee L. Wolf

Journal of Food Law & Policy

Imagine sitting down to breakfast and eating strawberry yogurt with a glass of grapefruit juice. You think you are eating a healthy meal, but along with vitamins, calcium, and nutrients, you are getting a side of crushed beetles. Cochineal extract and carmine, two color additives derived from the cochineal beetle, color many foods such as strawberry yogurt. When people consume products with color additives, most do not realize that they could be ingesting insects, which can also be potentially dangerous, not to mention possibly unappetizing or upsetting. Imagine that one minute you are sitting down to eat a healthy cup …

Uncapping The Bottle: A Look Inside The History, Industry, And Regulation Of Bottled Water In The United States, Joyce S. Ahn

Journal of Food Law & Policy

"Agu chupa! Agu chupa!" As we drove through the lush rolling hills of northwestern Rwanda, a crowd of young children appeared from the tea fields and repeatedly shouted these words to us. The taxi driver explained that the children wanted our "water bottes." Aware that visitors often drink bottled water, the children run alongside taxis with the hopes of obtaining the plastic bottles. Although Rwandan children typically carry their drinking water in tightly-woven baskets, the modern plastic bottles have become popular and prized possessions.

Reputation And Authority: The Fda And The Fight Over U.S. Prescription Drug Importation, Thomas J. Bollyky, Aaron S. Kesselheim

Vanderbilt Law Review

There is popular and bipartisan support for legalizing the importation of lower-cost medicines from Canada to help reduce the high prescription drug costs that Americans pay. Despite the wide interest in this policy, attempts over the last sixteen years to create a formal system for large-scale prescription drug importation in the United States have failed. The Trump Administration recently issued a final rule to enable the legal importation of prescription drugs from Canada, but the rule has important design flaws and seems destined to suffer a similar fate as previous efforts.

In this Article, we argue that prescription drug importation …

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Going Hemp Wild: Understanding The Challenges And Opportunities For Fda Regulation Of Cbd In Food Products, Hannah Catt

Journal of Food Law & Policy

After the passage of the 2018 Farm Bill, champions of hemp began to tout opportunities for farmers and businesses involved with the crop. The industry has rallied around one of hemp’s major byproducts, cannabidiol, or CBD. However, the demand for CBD has left the Food and Drug Administration (“FDA”) playing catch-up. This article explains what CBD is, how it is derived, current FDA-approved uses, and a current path forward for the FDA in creating guidance for industry and consumers.

Fighting America’S Best-Selling Product: An Analysis Of And Solution To The Opioid Crisis, Ashley Duckworth

Washington and Lee Journal of Civil Rights and Social Justice

Deaths from drug overdoses have doubled over the last ten years and are now the leading cause of accidental death in the United States. Although some overdoses may have involved more than one drug, prescription and/or illicit opioids were involved in many of these drug overdose fatalities. The Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC), and Congress have enacted a string of regulations, statutes, and programs since the early 1990s, but nothing has seriously improved the opioid epidemic as it stands. If anything, the use of opioids has persisted. Many people want pharmaceutical companies to …

Why The Dea & Not The Fda? Revisiting The Regulation Of Potentially Addictive Substances, Taleed El-Sabawi

Faculty Publications

In addressing the opioid overdose crisis, Congress has explicitly questioned its historic reliance on a criminal justice approach to problem drug use and has instead adopted a more health-oriented approach. Despite Congress' rhetoric, the DEA, a criminal justice agency, continues to retain the power to make key decisions on the classification of potentially-addictive substances, thereby affecting their manufacture, distribution, and overall availability. While the DEA is statutorily required to defer to the Food and Drug Administration (“FDA”), a public health agency, at junctions of the decision-making process, the current “split enforcement” scheme laid out in the statutes has not actualized …

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 …

Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise

Faculty Publications & Other Works

In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug …

Fda Publicity And Enforcement In The Covid-19 Era, Jordan Paradise, Elise Fester

Faculty Publications & Other Works

No abstract provided.

Deadly Delay: The Fda's Role In America's Covid-Testing Debacle, Barbara J. Evans, Ellen Wright Clayton

UF Law Faculty Publications

In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) published a series of 2020 guidance documents on how to seek Emergency Use Authorizations (EUAs) for new SARS-CoV-2 tests. These guidance documents suggest EUAs are needed for laboratory-developed tests (LDTs), a type of test created and used in-house by high-complexity clinical laboratories that already are regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These CLIA-regulated laboratories traditionally have provided a rapid response to emerging epidemics. Many laboratories viewed the FDA’s 2020 guidance documents as having a practical binding effect even though the FDA lacked clear …