Food and Drug Law Commons^™

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.

Memory And Punishment, O. Carter Snead

O. Carter Snead

This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish are inextricably intertwined with how a crime is remembered - by the offender, by the sentencing authority, and ...

Effectively Regulating E-Cigarettes And Their Advertising—And The First Amendment, Eric N. Lindblom

Eric Lindblom

If tobacco smoking did not exist in the United States, there would be no reason, from a public health perspective, to allow addictive, nicotine-containing e-cigarettes to be marketed and sold. Because e-cigarette use, by itself, is neither beneficial nor benign to users and nonusers, the only public health justification for allowing e-cigarettes in the existing U.S. market would be if doing so would not sustain or increase existing smoking levels but would help smokers quit completely or provide addicted smokers a less harmful way to obtain the nicotine they crave. Yet e-cigarettes are now pervasive in the U.S ...

Geographical Indications, Food Safety, And Sustainability: Challenges And Synergies, David A. Wirth

Boston College Law School Faculty Papers

This paper examines the legal and policy relationships amongst international standards for GIs, food safety requirements, and voluntary claims related to a food’s attributes. The paper addresses those relationships within the context of international trade agreements protecting GIs, such as the 1994 TRIPS Agreement, the EU-Canada Comprehensive Economic and Trade Agreement (CETA), and the chapter on intellectual property and geographical indications in the Transatlantic Trade and Investment Partnership (TTIP) currently under negotiation. Trade agreements also discipline food safety measures and non-GI indications of quality or safety such as “organic” and “GMO-free.” Accordingly, the paper also considers the extent to ...

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 Current Scientific And Legal Status Of Alternative Methods To The Ld50 Test For Botulinum Neurotoxin Potency Testing, Sarah Adler, Gerd Bicker, Hans Bigalke, Christopher Bishop, Jörg Blümel, Dirk Dressler, Joan Fitzgerald, Frank Gessler, Heide Heuschen, Birgit Kegel, Andreas Luch, Catherine Milne, Andrew Pickett, Heidemarie Ratsch, Irmela Ruhdel, Dorothea Sesardic, Martin Stephens, Gerhard Stiens, Peter D. Thornton, René Thürmer, Martin Vey, Horst Spielmann, Barbara Grune, Manfred Liebsch

Martin Stephens, Ph.D.

No abstract provided.

The Administrative State And The Common Law: Regulatory Substitutes Or Complements?, Catherine M. Sharkey

New York University Public Law and Legal Theory Working Papers

The modern administrative state looms larger than ever, and grows at an ever-accelerating pace. Not everyone is pleased with these developments. Four such individuals — Chief Justice Roberts, Justices Thomas, Alito, and the late Justice Scalia — have expressed their displeasure, indeed their alarm, with consistency, clarity, and vigor. They warn that the rise of administrative agencies, and the attendant ascendance of doctrines of mandatory judicial deference to agency interpretations of federal law, signals no less than the end of our government’s separation-of-powers structure, and our right to live our lives without fear of bureaucratic encroachment at every turn. Their opinions ...

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 ...

International Fisheries Regulation, John P. Rivers

Georgia Journal of International & Comparative Law

No abstract provided.

3d-Printed Food, Jasper L. Tran

Minnesota Journal of Law, Science & Technology

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.

Human Papillomavirus Vaccine Legislation: Are We Oversexualizing Our Youth?, Darryn Cathryn Beckstrom

University of St. Thomas Journal of Law and Public Policy

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 ...

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

Pace 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.

States Vs. Fda, Catherine M. Sharkey

New York University Law and Economics Working Papers

In the United States, food and drug safety is regulated in two ways: a stringent ex ante, national regime led by the Food and Drug Administration (“FDA”) and a robust ex post system of state-law enforcement. This federalist structure, operating on dual regulatory levels, sets the stage for synergy and for conflict.

Two recent high-profile preemption lawsuits showcase a novel dimension of the dual regulatory structure: the role of states as competing and/or complementary actors vis-à-vis the FDA in regulating food and drug safety. In Zogenix, Inc. v. Patrick, a federal district court enjoined the Massachusetts government from enacting ...

States Vs. Fda, Catherine M. Sharkey

New York University Public Law and Legal Theory Working Papers

In the United States, food and drug safety is regulated in two ways: a stringent ex ante, national regime led by the Food and Drug Administration (“FDA”) and a robust ex post system of state-law enforcement. This federalist structure, operating on dual regulatory levels, sets the stage for synergy and for conflict.

Two recent high-profile preemption lawsuits showcase a novel dimension of the dual regulatory structure: the role of states as competing and/or complementary actors vis-à-vis the FDA in regulating food and drug safety. In Zogenix, Inc. v. Patrick, a federal district court enjoined the Massachusetts government from enacting ...

Reflexiones Con Respecto A La Política De La Dea , Y, De Antinarcóticos En América Latina®, Daniel Fernando Gomez Tamayo

Daniel Fernando Gómez Tamayo.

The Patented Medicines (Notice Of Compliance) Regulations: An Examination Of The Decision Making Patterns In These Cases At The Supreme Court Of Canada, Jason D. Newman

Electronic Thesis and Dissertation Repository

Abstract

Generic drug approval cases involving Canada’s Patented Medicines (Notice of Compliance) Regulations are adjudicated at the Federal Court through the judicial review process. The European Union alleges that this abbreviated process is unfair to litigants who hold patents on medicines, since it does not encompass all of the features of a trial, nor is it an actual suit for patent infringement. In addition, the process has unequal appeal rights for the patent holder and the patent challenger, where the generic challenger can appeal a decision at Federal Court, but the patent holder cannot.

When examining the pattern of ...

An Unsealed Package: The Ninth Circuit Creates A Circuit Split When Interpreting Fda Regulations On Food Label Nutrient Content Claims In Reid V. Johnson & Johnson, Danielle M. Haikal

Boston College Law Review

On March 13, 2015, in Reid v. Johnson & Johnson, the U.S. Court of Appeals for the Ninth Circuit held that the statement “No Trans Fat” on the label of Benecol, a food that contains between 0 and 0.5 grams of trans fat, was not a permitted nutrient content claim. The court held that such a statement made on the label was false or misleading and was therefore not authorized by Food and Drug Administration (“FDA”) regulations. The court came to this conclusion despite the Third Circuit reaching the opposite conclusion in 2013, in Young v. Johnson & Johnson, regarding ...