Open Access. Powered by Scholars. Published by Universities.®

Food and Drug Law Commons™

Open Access. Powered by Scholars. Published by Universities.®

2,834 Full-Text Articles 2,756 Authors 2,470,758 Downloads 153 Institutions

All Articles in Food and Drug Law

Faceted Search

2,834 full-text articles. Page 75 of 102.

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 2016 UIC School of 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 2016 Osgoode Hall Law School of York University

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 2016 Nova Southeastern University - Shepard Broad Law Center

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 2016 UIC School of Law

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.


Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi 2016 Brooklyn Law School

Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi

Brooklyn Law Review

The law recognizes a right to legal redress for exposure to food that is tainted in the sense of being toxic or poisonous, but what about exposure to food products individuals find socially, morally, or religiously repugnant? Jews eating “kosher” hot dogs containing standard non-kosher meats. Vegetarians fed beef. Muslims ingesting vitamins containing pork. Aren’t these food products also “tainted”? Despite the fact that the American legal system has long recognized the need to protect individual dignitary rights, the law provides little meaningful redress in these situations or other instances of offensive food taint. So why has food autonomy, an …


The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan Jr. 2016 Brooklyn Law School

The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan Jr.

Brooklyn Law Review

Foodborne illnesses sicken millions and kill thousands of Americans every year, leading many to conclude that our dysfunctional government food safety system, which still relies heavily on physical inspections of food and facilities, is incapable of protecting us. As a result, many now look to the private market for solutions to our food safety crisis. One private market approach, food safety liability insurance, is gaining popularity. This article examines the benefits and drawbacks to food safety liability insurance and raises doubts about its ability to improve food safety. The market for safe food is plagued by overwhelming information problems that …


Perpetual Twilight: How The Usda's Change To The Sunset Process Violates The Organic Foods Production Act Of 1990, Valentina Lumaj 2016 Brooklyn Law School

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 …


The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi 2016 University of Missouri School of Law

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 …


Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher 2016 University of Nevada, Las Vegas -- William S. Boyd School of Law

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.


Persistent Threats To Commercial Speech, Jonathan H. Adler 2016 William & Mary Law School

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 …


Public Policy Arguments For Enacting Kentucky's Cannabis Freedom Act, Amanda Goff Connors 2016 University of Kentucky

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 2016 University of Missouri School of Law

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 2016 UIC School of Law

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.


Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson 2016 Maurer School of Law: Indiana University

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 …


Towards A Human Right To Food: Implications For Urban Growing In Baltimore City, Maryland, Becky L. Witt 2016 Fordham Law School

Towards A Human Right To Food: Implications For Urban Growing In Baltimore City, Maryland, Becky L. Witt

Fordham Urban Law Journal

No abstract provided.


Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd 2016 Emory University School of Law

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 …


Introducing Marijuana Law Into The Legal Writing Curriculum, Howard Bromberg, Mark K. Osbeck 2016 University of Michigan Law School

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 …


The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan, Jr. 2016 University of Connecticut School of Law

The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan, Jr.

Faculty Articles and Papers

No abstract provided.


A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise 2016 Loyola University Chicago, School of Law

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.


Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi 2016 University of Oklahoma College of Law

Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi

Faculty Articles

No abstract provided.


Digital Commons powered by bepress