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 …

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 …

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 …

Fsma: The Future Of Food Litigation, Robert Shawn Hogue

University of Miami Inter-American Law Review

No abstract provided.

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 …

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

Journal of Intellectual Property Law

No abstract provided.

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

Journal of Intellectual Property Law

No abstract provided.

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

Journal of Intellectual Property Law

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 …

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.

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 …

The Insufficiency Of The Law Surrounding Food Allergies, Aimee Nienstadt

Pace Law Review

This paper proceeds in five parts. First, I will give an overview of food allergies. The second section will discuss legal protections at the federal level, including the ADA and other specific federal laws that are aimed at food allergies. The third section will discuss legal protections at the state level, including state laws directed at school districts and state laws directed at restaurants. The fourth section will discuss actions by the private/non-profit sector. The final section of my paper will discuss further necessary legislative changes for people with food allergies.

Recent Developments And Future Prospects Of The Common Market, Michael Waelbroeck

Georgia Journal of International & Comparative Law

No abstract provided.

When Tuna Still Isn’T Always Tuna: Federal Food Safety Regulatory Regime Continues To Inadequately Address Seafood Fraud, Stephen Wagner

Ocean and Coastal Law Journal

In 2012 alone, Americans consumed approximately 4.5 billion pounds of seafood, over 90% of which was imported. Simply put, Americans eat a lot of seafood, with upwards of 500 different species available to satiate the demand. Consequently, imported and domestic seafood in the United States is a thriving 80.2 billion dollar market, with certain highly desired species of fish fetching steep prices.

One fundamental assumption of the consumer-driven market is that the label on the seafood correctly identifies the species of seafood, thereby, among other things, justifying the market price. It is increasingly clear, however, that this assumption is often …

Food Patents: The Unintended Consequences, Jay Dratler Jr.

Akron Intellectual Property Journal

This short paper explores the unintended consequences of this strong economic incentive. The underlying assumptions of patent law and its economic incentive are that innovation is good, and newer is better. But is that always so? Science and history suggest maybe not, for some very fundamental reasons. And there are reasons to believe that the risks of unintended consequences of innovation in food may be more hazardous than those in other fields of innovation.

Give And Take-Back: Pharmaceutical Manufacturers Required To Dispose Of Drugs At Local Level, Allie Craver

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

The Legal Status Of Cannabidiol Oil And The Need For Congressional Action, Shelly B. Deadder J.D.

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Post Amarin: Drug Promotion Superhighway Or Speed Trap, Beth E. Wolfe

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Despite What You've Been Sold - Unwrapping The Falsities Surounding Food Labels, Camille Currey

West Virginia Law Review

No abstract provided.

Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier

Akron Intellectual Property Journal

Pharmaceutical product hopping is a relatively new phenomenon in which a brand-name pharmaceutical company tactically reformulates a drug and patents the reformulation in an attempt to avoid competition by a generic competitor. When viewed in the context of the HatchWaxman framework, product hopping can effectively eliminate generic competitors from the market, thereby implicating § 2 of the Sherman Act. In addressing antitrust liability, this Note advocates a per se legal approach to product hopping so long as the hop is supported by a valid patent. Although some have argued that deference to the United States Patent and Trademark Office and …

Underbanked: Cooperative Banking As A Potential Solution To The Marijuana-Banking Problem, Patrick A. Tighe

Michigan Law Review

Numerous states have recently legalized recreational marijuana, which has created a burgeoning marijuana industry needing and demanding access to a variety of banking and financial services. Due, however, to the interplay between the federal criminalization of marijuana and federal anti-money laundering laws, U.S. financial institutions cannot handle legally the proceeds from marijuana activity. As a result, most financial institutions are unwilling to flout federal anti-money laundering laws, and so too few marijuana-related businesses can access banking services. This Note argues that the most viable policy option for resolving this “underbanking” problem is a financial cooperative approach such as a cannabis-only …

Immortal Invasive Initiatives? The Need For A Genetic "Right To Be Forgotten", Thomas Hale-Kupiec

Minnesota Journal of Law, Science & Technology

No abstract provided.

The Technical Barriers To Trade Agreement: A Reconciliation Of Divergent Values In The Global Trading System, Samantha Gaul

Chicago-Kent Law Review

In the context of multilateral trading, there is a historical tension between economically oriented, laissez-faire, pro-trade concerns as they are juxtaposed with social, environmental, and health concerns. These conflicting values are inextricable from one another in a world that encourages, and quite frankly mandates, a high level of economic interdependency. But what if institutional actors could reconcile these conflicting values—at least toward the more efficient and practical goals of alleviating (rather than eliminating) the underlying tension? This Note argues that Article 2.2 of the World Trade Organization’s Technical Barriers to Trade Agreement operates to reconcile these fundamental tensions to some …

Comment: Maryland State Bank: The Responsible Solution For Fostering The Growth Of Maryland's Medical Cannabis Program, David Bronfein

University of Baltimore Law Forum

In 2013, Maryland passed its initial medical cannabis law.1 Although seemingly a success in the medical cannabis reform movement, the law only allowed for “academic medical centers” to participate in the program.2 In essence, an academic medical center could dispense medical cannabis to patients who met the criteria for participation in their research program.3 The success of this type of program structure was a concern for medical cannabis advocates,4 and the concerns were validated when no academic medical centers decided to participate.5 As a result of this lackluster program, the General Assembly responded by passing a bill6 during the 2014 …

Perpetual Twilight: How The Usda's Change To The Sunset Process Violates The Organic Foods Production Act Of 1990, Valentina Lumaj

Brooklyn Law Review

In 1990, Congress enacted the Organic Foods Production Act of 1990 (OFPA) in response to consumer and industry demands for uniform standards in organic production. The drafters recognized that the basic tenet of the legislation was that organic foods would be produced without the use of synthetic materials, but they left room for minimal exceptions in the National List of Allowed and Prohibited Substances (the National List). The National List enumerates the exemptions for synthetic substances, as well as prohibitions of natural substances, such as arsenic, in organic production. In September 2013, the USDA amended the Sunset Process, which is …