Food and Drug Law Commons^™

Mending Invisible Wounds: The Efficacy And Legality Of Mdma-Assisted Psychotherapy In United States' Veterans Suffering With Post-Traumatic Stress Disorder, Jonathan Perry

Journal of Law and Health

Though Veteran Affairs has provided crucial life sustaining—and often lifesaving—treatments to returning soldiers, the substantial and ever-increasing rates of veteran suicides, drug addictions, and criminal behavior indicate a need for broader options in treatment. One of the most profound discoveries uncovered through MDMA-assisted psychotherapy research is MDMA’s facilitation of the alleviation of addictive behavior in subjects, and, as a result, an alleviation of addictions in general. Addiction is one of the key symptoms of post-traumatic stress disorder (PTSD) and drug abuse plays a large role in the other afflictions suffered by veterans, namely criminal activity and a high rate of …

Pitfalls Of The Food Safety Modernization Act: Enhanced Regulation, Minimal Consumer Benefit, And Zero Tolerance Levels For Naturally-Occurring Trace Pathogens, Lindsey Lazopoulos Friedman, Wesley Van Camp

University of Miami Inter-American Law Review

Congress enacted the Food Safety Modernization Act (“FSMA”), to regulate the fresh produce industry in the United States and increase consumer safety when handling and consuming raw produce. But FSMA risks imposing a zero tolerance policy on raw produce, even where a naturally occurring low-level pathogen, such as listeria, is found in negligible amounts. A zero tolerance policy for all naturally-occurring pathogens does not increase consumer safety, and only serves to increase the cost of raw produce for consumers. This article begins with a summary of the modern history of FSMA, including a brief overview of how the law has …

Fsma: The Future Of Food Litigation, Robert Shawn Hogue

University of Miami Inter-American Law Review

No abstract provided.

Local And State Governments Are Taking The Stage When It Is Fda's Curtain Call - Are Local And State Governments' Safety Warnings Preempted By Federal Law?, Melissa M. Card

Journal of Food Law & Policy

Eliminated from fad diets, sworn off by celebrities, and frantically reformulated out of processed foods, added sugars have been deemed the new nutritional scoundrel. Recent studies from the American Heart Association, the World Health Organization, and the American Cancer Association demonstrate that the consumption of added sugar leads to increased risks of obesity, diabetes, heart disease, and gout. While all foods containing added sugar are deemed unhealthy, Sugary-Sweetened Beverages ("SSBs") are said to be especially toxic by the American health community, by virtue of these beverages' being excessively high in added sugar content, low in satiety, and incomplete in compensation …

Moving Towards Harmonization Of The Food Safety Standards: Role Of The Tpp And Ttip Agreements, Ksenia A. Petrovets

Journal of Food Law & Policy

We are now less dependent on locally available food resources that we have ever been. The continuing industrialization of food production, the advancement in technologies and the rapid development of supply chains granted us the luxury of immediate access to a variety of products originating from local supermarkets all over the world. This, along with the greater level of food production industrialization, inevitably comes the rise of related food safety risks. Because of the enlargement of producing operations, an emerging safety threat in one place may result in a foodborne illness outbreak thousands of miles away from its place of …

Will Consumers Be In The "Dark" About Labels On Genetically Engineered And Modified Foods?, Hilary Nat

Journal of Food Law & Policy

In the 1900s, the United States began to sell genetically engineered foods. One of the first genetically engineered foods sold in the United States and approved by the Food and Drug Administration (FDA) was the Flavr Savr tomato. The tomato's genetic structure was modified to prevent softening which allowed it to ripen after being picked. In the United States, statistics demonstrate that 92% of com, 94% of soybeans, and 94% of cotton sold is genetically engineered. In addition, it is estimated that 75% of the processed foods sold in supermarkets around the United States contain ingredients that are products of …

Energy Drink Regulations: Why The Time For More Fda Authority Is Not Ripe And How States Can Protect Children Without Unjustly Infringing On Adult Autonomy, Larry D. Treat

Journal of Food Law & Policy

In December of 2011, Anais Fournier ("Anais"), a fourteen-year-old from Maryland, was at the mall with her friends when she drank a twenty-four ounce Monster energy drink. Within twenty-four hours, Anais consumed a second twenty-four ounce energy drink. Together, the two Monster energy drinks Anais consumed contained around 480 milligrams ("mg") of caffeine. A few hours after the second drink, Anais went into cardiac arrest and later died from cardiac arrhythmia. An autopsy found that caffeine toxicity caused Anais's arrhythmia and impeded her heart's ability to pump blood. As it turns out, Anais suffered from a preexisting heart condition called …

2016 China Food Law Update, Michael T. Roberts, Ching-Fu Lin

Journal of Food Law & Policy

This update of China food law builds on a unique feature for the Journal of Food Law & Policy that has been provided since the Journal's inception - separate food law updates for both the United States and European Union. "Recognizing the globalness of the modem food system, these updates have served an invaluable role in keeping scholars and practitioners abreast of the world's leading food regulatory systems." China's emergence as a developed, modem food regulatory system with the potential of being a leading food regulatory system makes sense given its position as a world economic powerhouse. China's role in …

The New York Pharmaceutical Cost Transparency Act: How A Narrow View Of The Prescription Drug Pricing Puzzle Renders A Well-Intentioned Bill Irrational, John G. Curran

Brooklyn Law Review

Pricing prescription pharmaceuticals is a complex process that entails the consideration of a multitude of factors, not the least of which is the research and development expenditure exhausted by drug makers to gain FDA approval. While public sentiment has increasingly turned against the pharmaceutical industry due to its perceived greed as manifested in the high cost of its drugs, the intricacies of pricing such unique products is rarely discussed. A recently proposed New York state bill, the Pharmaceutical Cost Transparency Act (the NYPCTA), continues this unfortunate trend, by requiring companies to disclose the R&D costs of newly approved drugs in …

Potholes: Dui Law In The Budding Marijuana Industry, Zack G. Goldberg

Brooklyn Law Review

The rapid legalization of marijuana across the United States has produced a number of novel legal issues. One of the most confounding issues is that presented by the marijuana-impaired driver. In jurisdictions that have legalized the use of marijuana, how high is too high to get behind the wheel? This note assesses the various marijuana DUI laws that states have implemented to combat marijuana-impaired driving. Many of these statutes have followed in the footsteps of the BAC-based standard used to combat drunk driving—using THC measurements to quantify a driver’s level of marijuana-based impairment. Unfortunately, unlike alcohol, the scientific properties of …

A Trademark Holder's Hangover: Reconciling The Lanham Act With The Alcohol And Tobacco Tax And Trade Bureau's System Of Designating American Viticultural Areas, Julia Lynn Titolo

Georgia Journal of Law & Technology

No abstract provided.

Why Coca-Cola's Fictional Lawsuit Against Coke Zero For Taste Infringement Is A Losing Battle, Jessica Nicole Cox

Georgia Journal of Law & Technology

No abstract provided.

Traversing The Triangulum: The Intersection Of Tobacco, Legalised Marijuana And Electronic Vaporisers In Denver, Colorado, Emily Anne Mcdonald, Lucy Popova, Pamela M. Ling

Publications and Research

Objective: To explore the intersection of tobacco, legalised marijuana and electronic vaporiser use among young adults in the ‘natural laboratory’ of Colorado, the first state with legalised retail marijuana.

Methods: We conducted semistructured interviews with 32 young adults (18–26 years old) in Denver, Colorado, in 2015 to understand the beliefs and practices related to the use of tobacco, marijuana and vaporisers.

Results: We found ambiguity about whether the phrase ‘to smoke’ refers to the use of tobacco or marijuana products. Smoking marijuana blunts (emptied cigarillo or tobacco wrap filled with marijuana) was common, but few interpreted this as tobacco use. …

Price Controls Through The Back Door: The Parallel Importation Of Pharmaceuticals, A. Bryan Baer

Georgia Journal of Law & Technology

No abstract provided.

Rethinking Body Property, Kara W. Swanson

Florida State University Law Review

Body products, including blood, gametes, and kidneys, are a routine part of contemporary medicine. They are also controversial. There is a strong preference for donated gifts, based on an intuition that gifts are pure, altruistic, and healthy, and that purchased products (commodities) are tainted, exploitative, and dangerous. Law and policy reflect this dichotomy, preventing market exchanges either by declaring body products non-property or banning sales by the supplying body. Yet with growing scarcity leading to injustice in the allocation and harvesting of body products, calls to allow sales have been increasing, motivating proposals to increase supplies by compensating bone marrow …

What’S Wrong With Sentencing Equality?, Richard A. Bierschbach, Stephanos Bibas

Articles

Equality in criminal sentencing often translates into equalizing outcomes and stamping out variations, whether race-based, geographic, or random. This approach conflates the concept of equality with one contestable conception focused on outputs and numbers, not inputs and processes. Racial equality is crucial, but a concern with eliminating racism has hypertrophied well beyond race. Equalizing outcomes seems appealing as a neutral way to dodge contentious substantive policy debates about the purposes of punishment. But it actually privileges deterrence and incapacitation over rehabilitation, subjective elements of retribution, and procedural justice, and it provides little normative guidance for punishment. It also has unintended …

Medical Cannabis: Miracle Or Myth?, Blair Henry, Arnav Agarwal, Edward Chow, Hatim A. Omar, Joav Merrick

Pediatrics Faculty Publications

No abstract provided.

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.

Newsroom: Horwitz On Marijuana Legalization 7/15/2016, John S. Kiernan, Roger Williams University School Of Law

Life of the Law School (1993- )

No abstract provided.

The Death Penalty Experiment: State-Sanctioned Laboratories Of Death, Steffi Yellin

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete

Catholic University Law Review

The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …

International Fisheries Regulation, John P. Rivers

Georgia Journal of International & Comparative Law

No abstract provided.

Decline Of Dosage Regimen Patents In Light Of Emerging Next-Generation Dna Sequencing Technology And Possible Strategic Responses, Na An

Minnesota Journal of Law, Science & Technology

No abstract provided.

3d-Printed Food, Jasper L. Tran

Minnesota Journal of Law, Science & Technology

No abstract provided.

The Negative Effects Of Cumulative Abortion Regulations: Why The 5th Circuit Was Wrong In Upholding Regulations On Medication Abortions (Planned Parenthood Of Greater Texas Surgical Health Services V. Abbott), Benjamin A. Hooper

University of Cincinnati Law Review

No abstract provided.

Getting A Handle On Growler Laws, Adam Star

Seattle University Law Review

This Note will begin with a brief general history of growlers in the United States and the benefits they provide to consumers, retailers, and small craft brewers. Part II will provide an overview of national alcohol distribution regulation and how the present growler law exists within this larger framework. To complete the necessary background information, Part III will provide context to the competitive landscape by way of an examination of the craft beer industry’s explosive growth. The substantive portion of the Note will follow in Part IV, beginning with an outline of the various key types of growler restrictions such …

It’S Time For The Fda To Define ‘Natural’, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

The authors discusses the FDA 's recent call for comments on a definition of the term natural as it applies to food.

Animal Legal Defense Fund V. Otter: Industrial Food Production Simply Is Not A Private Matter, Lucy L. Holifield

Journal of Food Law & Policy

About half of the states have either passed or attempted to pass laws aimed at stifling criticism and exposure of factory farms throughout the country. This unwanted exposure is often the result of undercover reporters gaining access to the interior of meat-producing entities by seeking and obtaining employment. Their reports often expose filthy and dangerous conditions, substantial animal abuse, and the incorporation of unfit animal products into the public's food supply.

School Of Law Faculty And Professional Staff, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Implementation Of The Public Distribution System: An Empirical Analysis Of The Right To Food In An Urban Slum, Dipika Jain, Brian Tronic

Journal of Food Law & Policy

Malnutrition is one of the biggest problems facing India today. Thus, the functioning of the Public Distribution System (PDS) - which provides subsidized food to hundreds of millions of people is critically important. However, while numerous studies have evaluated the performance of the PDS in rural areas, there is a notable lack of research in urban slums, a rapidly growing population. Through interviews with PDS beneficiaries and other stakeholders, the present study examines the PDS in one slum in Delhi and finds numerous problems, including low quality grain, corruption, and the lack of an effective complaint mechanism. Although several states …