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

Food and Drug Law Commons™

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

2016

Discipline
Institution
Keyword
Publication
Publication Type

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 Jan 2016

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 …

Go to article

Lessons From Washington And Colorado: The Potential Financial Gains Of Recreational Marijuana To Canada, Nachshon Goltz, Ekaterina Bogdanov Jan 2016

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 …

Go to article

The Role Of States In Shaping The Legal Debate On Medical Marijuana, Florence Shu-Acquaye Jan 2016

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.

Go to article

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 Jan 2016

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.

Go to article

Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi Jan 2016

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 …

Go to article

The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan Jr. Jan 2016

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 …

Go to article

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

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 …

Go to article

The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi Jan 2016

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 …

Go to article

Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher Jan 2016

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.

Go to article

Persistent Threats To Commercial Speech, Jonathan H. Adler Jan 2016

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 …

Go to article

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

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

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Go to article

The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post Jan 2016

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 …

Go to article

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 Jan 2016

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.

Go to article

Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson Jan 2016

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 …

Go to article

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

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

Fordham Urban Law Journal

No abstract provided.

Go to article

Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd Jan 2016

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 …

Go to article

Introducing Marijuana Law Into The Legal Writing Curriculum, Howard Bromberg, Mark K. Osbeck Jan 2016

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 …

Go to article

The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan, Jr. Jan 2016

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

Faculty Articles and Papers

No abstract provided.

Go to article

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise Jan 2016

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Go to article

Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi Jan 2016

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

Faculty Articles

No abstract provided.

Go to article

Foreword: The Food Law Era, Nathan Cortez Jan 2016

Foreword: The Food Law Era, Nathan Cortez

SMU Science and Technology Law Review

No abstract provided.

Go to article

The Right To Regulate (Cooperatively), Alexia Brunet Marks Jan 2016

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 …

Go to article

Classwide Arbitration: A Method Of Resolving The "Natural" Food Label Litigations, Angelina Dalia Jan 2016

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 …

Go to article

Gras-Fed Americans: Sick Of Lax Regulation Of Food Additives, Martha Dragich Jan 2016

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 …

Go to article

Panel 1: False Advertising, Ashima Dayal, Jeffrey Greenbaum, Jen Lavie, Rebecca Tushnet, Brett Frischmann Jan 2016

Panel 1: False Advertising, Ashima Dayal, Jeffrey Greenbaum, Jen Lavie, Rebecca Tushnet, Brett Frischmann

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Go to article

Mystery Date: Advocating For A Harmonized System Of Expiration Date Labeling Of Food, Akshat Tiwari Jan 2016

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 …

Go to article

Baptists, Bootleggers & Electronic Cigarettes, Jonathan H. Adler, Roger E. Meiners, Andrew P. Morriss, Bruce Yandle Jan 2016

Baptists, Bootleggers & Electronic Cigarettes, Jonathan H. Adler, Roger E. Meiners, Andrew P. Morriss, Bruce Yandle

Faculty Publications

Electronic cigarettes pose a competitive threat to the makers of cigarettes and other tobacco products, as well as to nicotine replacement therapies such as nicotine gum and patches. A common response to such a threat is support for government regulation to suppress competition. Predictably, cigarette manufacturers and other threatened producers, as well as the governments that earn revenue from tobacco taxes, are supporting greater regulation of electronic cigarettes that would replicate the cartel-supporting rules of the Master Settlement Agreement. These efforts are aided by anti-smoking organizations that would like to prevent the growth of demand for electronic cigarettes. This episode …

Go to article

Compelled Commercial Speech And The Consumer "Right To Know", Jonathan H. Adler Jan 2016

Compelled Commercial Speech And The Consumer "Right To Know", Jonathan H. Adler

Faculty Publications

Compelled commercial speech, including mandatory labeling and the disclosure of factually true information, should not be seen as a separate category of speech under the First Amendment. Rather, compelled commercial speech should be understood as a type of commercial speech and be subject to the same level of protection as commercial speech generally. Accordingly, commercial speech compulsions, such as mandatory disclosures and labeling requirements, must be supported by a substantial government interest under the Central Hudson framework. The assertion of a consumer “right to know” does not constitute such an interest and cannot, by itself, justify compelled commercial speech within …

Go to article

Fda's Troubling Failures To Use Its Authority To Regulate Genetically Modified Foods, Leslie Francis, Robin Kundis Craig, Erika George Jan 2016

Fda's Troubling Failures To Use Its Authority To Regulate Genetically Modified Foods, Leslie Francis, Robin Kundis Craig, Erika George

Faculty Scholarship

This Article concerns the particular regulatory responsibilities only of FDA. It sets to one side the possible regulatory authority of agencies such as the Environmental Protection Agency ("EPA") or the U.S. Department of Agriculture ("USDA"). This approach risks replicating the regulatory fracture introduced during the Reagan Administration and criticized by some scholars,15 but there is a great deal to say about current FDA practices. Out of similar considerations of space and focus, this Article also sets to one side many other important issues that surround GM foods: intellectual property rights; rights to free speech or commercial speech; fair trade …

Go to article

Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens Jan 2016

Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens

Reports & Public Policy Documents

In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “F&D Act”]. Known as “Vanessa’s Law,” these amendments were intended to enhance the regulation of pharmaceutical drugs and thereby protect Canadians from harm by giving the regulator, Health Canada, new powers to, inter alia, recall drugs, require active post-market surveillance, and improve the transparency of information around pharmaceutical drugs. Vanessa’s Law explicitly recognized that “new measures are required to further protect Canadians from the risks related to drugs and medical devices.” (emphasis added) (Bill C-17, An Act to Amend the …

Go to article

First Prev Next Last