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Articles 61 - 90 of 97
Full-Text Articles in Food and Drug Law
Protecting Trade Secrets Under International Investment Law: What Secrets Investors Should Not Tell States, 15 J. Marshall Rev. Intell. Prop. L. 228 (2016), Daria Kim
UIC Review of Intellectual Property Law
The article addresses specifics of trade secret protection under international investment law. As a particular example, it analyzes protection of pharmaceutical regulatory data against the background of the growing public policy campaign for broader access to clinical trial data and the recent unprecedented practice of the European Medicines Agency of disclosing clinical dossiers submitted for drug marketing approval. Given the significant role of foreign direct investment in the global pharmaceutical industry and substantial, exponentially increasing costs incurred by drug originator companies in conducting clinical trials, the prospect of investor-state dispute over data disclosure does not appear purely hypothetical. The question …
Lessons From Washington And Colorado: The Potential Financial Gains Of Recreational Marijuana To Canada, Nachshon Goltz, Ekaterina Bogdanov
Lessons From Washington And Colorado: The Potential Financial Gains Of Recreational Marijuana To Canada, Nachshon Goltz, Ekaterina Bogdanov
Osgoode Legal Studies Research Paper Series
While Colorado and Washington are among the jurisdictions spearheading the global trend towards legalization of recreational Cannabis (marijuana), Canada lags behind in the regulatory process - but not in Cannabis consumption. An empirical study conducted in downtown Toronto, as well as studies done by Statistics Canada, reveal that Cannabis use is widespread among Canadians, which indicates that the current regulatory regime is not effective as a deterrent.
This paper details the results of the above-mentioned empirical study, reviews the regulatory framework of recreational Cannabis use in Colorado, Washington and Canada, and uses taxation data from Colorado to estimate the potential …
The Role Of States In Shaping The Legal Debate On Medical Marijuana, Florence Shu-Acquaye
The Role Of States In Shaping The Legal Debate On Medical Marijuana, Florence Shu-Acquaye
Faculty Scholarship
The ongoing debate in the United States about the legality and use of medical marijuana (also known as medicinal cannabis) is intriguing.
The Food And Drug Administration Versus The Federal Trade Commission: Reconciling Their Interests In Regulating Homeopathic Products, 49 J. Marshall L. Rev. 1193 (2016), Jordannah Bangi
UIC Law Review
This Comment suggests that the FDA should require homeopathic products to carry a disclaimer label similar to those used on prescription drugs or certain food or food products.
Gras-Fed Americans: Sick Of Lax Regulation Of Food Additives, Martha Dragich
Gras-Fed Americans: Sick Of Lax Regulation Of Food Additives, Martha Dragich
Faculty Publications
Americans are “GRAS-fed” because of a “loophole” in the strict regime Congress provided for the regulation of food additives. Additives - and food products containing them - are exempt from this strict regime if they are accorded GRAS (Generally Recognized as Safe) status. The guidelines Congress provided for achieving that status by scientific evidence of safety are no longer observed. Most additives are determined by the producer alone to be GRAS. At the same time, Americans’ consumption of highly processed foods continues to rise, giving rise to long-term health problems that are increasingly tied to diet. The average American’s diet …
Towards A Human Right To Food: Implications For Urban Growing In Baltimore City, Maryland, Becky L. Witt
Towards A Human Right To Food: Implications For Urban Growing In Baltimore City, Maryland, Becky L. Witt
Fordham Urban Law Journal
No abstract provided.
The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi
The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi
Faculty Publications
The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the harm or the risk …
Public Policy Arguments For Enacting Kentucky's Cannabis Freedom Act, Amanda Goff Connors
Public Policy Arguments For Enacting Kentucky's Cannabis Freedom Act, Amanda Goff Connors
Kentucky Journal of Equine, Agriculture, & Natural Resources Law
No abstract provided.
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post
Faculty Publications
In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …
The Art Of Food Placement: Will The U.S. Follow Germany's Lead In Copyrighting Artistic Food Placement?, 15 J. Marshall Rev. Intell. Prop. L. 565 (2016), Julianna Walo
UIC Review of Intellectual Property Law
Recently, German courts created groundbreaking precedent allowing copyright protection for the artistic placement of food on a plate. The rulings allow chefs to prohibit people from taking pictures of the copyrighted food placement. While Germany’s moral-based legal system allows for such copyright protections, this comment compares the U.S. legal system to that of Germany and examines if and how such copyright protection could extend to food placement in the U.S.
Foreword: The Food Law Era, Nathan Cortez
Foreword: The Food Law Era, Nathan Cortez
SMU Science and Technology Law Review
No abstract provided.
State Legalization Of Marijuana As A “Diagonal Federalism” Problem, Brannon P. Denning
State Legalization Of Marijuana As A “Diagonal Federalism” Problem, Brannon P. Denning
FIU Law Review
No abstract provided.
Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson
Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson
Indiana Law Journal
This Note investigates the origins of Inwood that led to the slim opinion with wide influence. It argues that the very vagueness for which scholars and practitioners have decried Inwood is the case's greatest virtue: Inwood provides a flexible standard that has allowed the common law to evolve and address new business models. Part I discusses the origins of contributory infringement in intellectual property. Part II investigates the Inwood case and the climate of trademark law at the time Inwood was litigated. It also dissects the majority opinion and Justice White's concurrance. Part III examines the Inwood standard's evolution at …
Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd
Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd
Faculty Articles
This Article examines a relatively new business strategy in the pharmaceutical market -- "product hopping" or "product replacement" -- in which brand pharmaceutical companies shift their marketing efforts from a drug nearing the end of its patent period to a new, substitute drug with a longer patent life. In July 2015, the Second Circuit issued an opinion in the first appellate case addressing pharmaceutical product replacement, New York ex rel. Schneiderman v. Actavis PLC. This Article explains that product replacement is the predictable business response to the incentives created by patent law and state substitution laws, and withdrawing an …
A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise
A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise
Faculty Publications & Other Works
No abstract provided.
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
Scholarly Works
In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.
Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi
Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi
Faculty Articles
No abstract provided.
A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks
A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks
Publications
Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries learn …
The Right To Regulate (Cooperatively), Alexia Brunet Marks
The Right To Regulate (Cooperatively), Alexia Brunet Marks
Publications
The growing number of new technologies in food production— such as nanotechnology, genetic modification, animal cloning, and irradiation—are garnering different regulatory responses around the world. Based on their threshold for tolerating risk, countries are asserting their national right to regulate at home using labeling, quarantine, and outright bans on foods. But domestic regulation has its limits in a free trade environment. Countries that are not mindful of treaty obligations could face legal liability, as seen in the recent litigation between Uruguay and Philip Morris International. In short, traditional models of international regulatory cooperation (IRC) are failing to provide countries with …
The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan, Jr.
The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan, Jr.
Faculty Articles and Papers
No abstract provided.
Introducing Marijuana Law Into The Legal Writing Curriculum, Howard Bromberg, Mark K. Osbeck
Introducing Marijuana Law Into The Legal Writing Curriculum, Howard Bromberg, Mark K. Osbeck
Articles
Interest in marijuana law continues to grow, due in large part to the complicated and rapidly evolving landscape of marijuana laws in the United States. Nearly every day, newspapers report on new or proposed legislation and the legal controversies that have arisen with regard to this evolving landscape. There are now several marijuana-law blogs on the Internet, Congress is considering sweeping legislation that would essentially grant significant deference to the individual states, and public opinion continues to move in favor of increased legalization. For the last two years, Newsweek magazine has published special editions devoted exclusively to marijuana law and …
We Built It And They Did Not Come: Using Governance Theory In The Fight For Food Justice In Low-Income Communities Of Color, Deborah N. Archer, Tamara Belinfanti
We Built It And They Did Not Come: Using Governance Theory In The Fight For Food Justice In Low-Income Communities Of Color, Deborah N. Archer, Tamara Belinfanti
Articles & Chapters
Food deserts and food insecurity have received considerable attention from various stakeholders, such as state and local governments, community organizations, and private sector institutions. These stakeholders have sought to overcome food insecurity by turning food deserts into oases by providing “access” to fresh, healthy food. However, many of their solutions—building supermarkets and sponsoring farmers markets—have missed the mark. Residents of food deserts did not flock to grocery stores to purchase fruits andvegetables. As a result, many stakeholders blame the residents of food deserts for their own predicament, lamenting, to paraphrase Field of Dreams, “we built it but they did not …
Persistent Threats To Commercial Speech, Jonathan H. Adler
Persistent Threats To Commercial Speech, Jonathan H. Adler
Faculty Publications
The current Supreme Court is very protective of speech, including commercial speech. Threats to commercial speech persist nonetheless. This article briefly examines two: the use of commercial speech restrictions as a form of rent-seeking, and compelled commercial speech. Regulation of commercial speech is sometimes used to protect established corporate interests from competitors who are less able to bear the costs of regulation, with consequences that extend beyond the economic marketplace. In the case of commercial speech, courts have also been unduly deferential to claims of a consumer “right to know” as a basis for mandated labeling and disclosure. Greater and …
Classwide Arbitration: A Method Of Resolving The "Natural" Food Label Litigations, Angelina Dalia
Classwide Arbitration: A Method Of Resolving The "Natural" Food Label Litigations, Angelina Dalia
Cardozo Journal of Conflict Resolution
This Note discusses how classwide arbitration in food labeling disputes can better serve as a resolution method for both parties. Part I will review the current legal landscape surrounding food labeling litigations and the limitations of the FDA's regulatory and enforcement power. It will analyze how the lack of regulation has led to the recent surge in food labeling class actions. Part II will introduce the general benefits and downfalls of mandatory arbitration in comparison to litigation as a means of legal remedy. Furthermore, it will describe the recent trend of incorporating mandatory arbitration clauses and class action waivers in …
Breaking The Silence: The Veterinarian’S Duty To Report, Martine Lachance
Breaking The Silence: The Veterinarian’S Duty To Report, Martine Lachance
Animal Sentience
Animals, like children and disabled elders, are not only the subjects of abuse, but they are unable to report and protect themselves from it. Veterinarians, like human physicians, are often the ones to become aware of the abuse and the only ones in a position to report it when their human clients are unwilling to do so. This creates a conflict between professional confidentiality to the client and the duty to protect the victim and facilitate prosecution when the law has been broken. I accordingly recommend that veterinarian associations make reporting of abuse mandatory.
Panel 1: False Advertising, Ashima Dayal, Jeffrey Greenbaum, Jen Lavie, Rebecca Tushnet, Brett Frischmann
Panel 1: False Advertising, Ashima Dayal, Jeffrey Greenbaum, Jen Lavie, Rebecca Tushnet, Brett Frischmann
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Mystery Date: Advocating For A Harmonized System Of Expiration Date Labeling Of Food, Akshat Tiwari
Mystery Date: Advocating For A Harmonized System Of Expiration Date Labeling Of Food, Akshat Tiwari
Vanderbilt Journal of Transnational Law
Americans throw out roughly 25 percent of the food they bring home. Negative perceptions associated with expiration dates are a leading cause for this waste. However, a complex patchwork of state-run regulatory regimes and varying terminology makes it difficult for consumers to determine whether a food product is unsafe to eat or simply past a peak quality level arbitrarily set by manufacturers. Regulatory trends in Europe, the United Kingdom, Canada, Australia, and New Zealand suggest a move towards binding expiration date labeling through guidelines for establishing a "best before" or "use-by" date. This Note examines laws currently in place in …
Introductions, Tatsuya Adachi
Introductions, Tatsuya Adachi
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Aids Activists, Fda Regulation, And The Amendment Of America's Drug Constitution, Lewis Grossman
Aids Activists, Fda Regulation, And The Amendment Of America's Drug Constitution, Lewis Grossman
Scholarly Articles in Law Reviews & Journals
This Article explores how AIDS activists, desperate for access to potentially life-saving pharmaceuticals, permanently transformed America’s “drug constitution.” Their advocacy altered the FDA’s interpretation and application of the federal Food, Drug, and Cosmetic Act (FDCA) so as to expedite the availability of new, unproven drugs for critical illnesses, thus enhancing individual patients’ autonomy to make therapeutic choices without government interference. The FDCA is more than simple set of instructions to a federal agency — it is a source of vitally important and deeply entrenched institutional and normative frameworks. Like major civil rights, antitrust, and environmental statutes, the FDCA should be …
Enforcement Discretion Under Attack: Implications For Fda, Lewis Grossman
Enforcement Discretion Under Attack: Implications For Fda, Lewis Grossman
Scholarly Articles in Law Reviews & Journals
Author's Note: On June 23, as this article was going to press, the Supreme Court deadlocked 4-4 in U.S. v. Texas, thus affirming a preliminary injunction against implementation of the Obama Administration’s deferred-action program for millions of undocumented immigrants. Because the Court’s terse per curiam decision established no precedent, the questions that the case raised regarding the permissible scope of administrative enforcement discretion remain unresolved on the national level. The Supreme Court will likely consider them again—after a decision on a permanent injunction in the same case, in a similar immigration dispute, or perhaps in another field of administrative law. …