Food and Drug Law Commons^™

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi

Journal of the National Association of Administrative Law Judiciary

This comment explores the types of legislation, approaches to regulating e-cigarettes, and analyzes whether the FDA’s campaign and current regulations are effective. So far, it appears that the United States is ahead of the game with its new, aggressive proposal for regulating e-cigarettes. The FDA is standing against the companies and products that target youthful consumers. Most countries acknowledge the gaps in current scientific research regarding the long-term health risks of vaping, and some are waiting to take a legislative stance until it is clearer which side of the health line e-cigarettes fall. Section II of this comment discusses the …

Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs

Journal of the National Association of Administrative Law Judiciary

The American cosmetics industry is not required by the Food and Drug Administration (FDA) to conduct pre-market safety assessments of cosmetics. The FDA only reviews personal care products when people voluntarily report problems. Further, companies continue to test animals for cosmetics, despite the FDA’s recommendation that manufacturers seek more humane and accurate testing. Although the FDA does not require animal testing for product safety or premarket approval, the United States is one of the largest users of laboratory animals for product testing. There are two pending pieces of legislation, which if passed would be the first acts of cosmetic regulation …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Pass The Revenue: How Section 280e Is Harming The Medical Marijuana Industry, Liam Mckillop

Cardozo International & Comparative Law Review

The note argues that Section 280E of the Internal Revenue Code unfairly penalizes medical marijuana businesses by disallowing ordinary business expense deductions, despite their legality under state laws. It proposes that Congress should amend Section 280E to create an exception for medical marijuana companies, allowing them to deduct business expenses, thereby promoting industry growth and aligning tax policy with current societal and scientific understanding of marijuana's medical benefits.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

"Hash"Ing Out Inequality In The Legal Recreational Cannabis Industry, Maya Rahwanji

Northwestern Journal of International Law & Business

No abstract provided.

Greater Uniformity And Centralization: The Regulatory Development Of Chinese Food And Product Safety Under The Wto, Nga Kit (Christy) Tang

Washington International Law Journal

The WTO Agreements emphasize free trade, which links with diversity, deregulation, and decentralization. China, on the other hand, emphasizes uniformity and centralization, especially regarding the political control and the one-party system of “democratic dictatorship.” China’s joining the WTO, therefore, may be considered as a development that changes the regulatory structure to become more diverse, deregulated, and decentralized. This paper, however, finds the opposite. Under the WTO law, China is encouraged to move towards greater uniformity and centralization with its decentralized and non-uniform settings under the market policy. Moreover, the WTO’s uniform and centralized encouragements can be integrated into the rule-by-man …

Encouraging Food Safety Standard Negotiations In The One-Belt-One-Road Initiative, Yi Seul Kim

Cardozo International & Comparative Law Review

Participation and attendance in food safety negotiations such as Codex meetings are of critical importance. Common problems have existed throughout history in the area of food safety standards and their formulation regulations. First, there is a lack of interest by the public. Second, the public becomes interested only after a food safety crisis. Consequences are two-fold: with lack of public interest, governments often do not allocate enough budget and resources. Then, when the government turns to face the problem with a sudden spike in public interest, it is often too late. The situation becomes more of a crisis management, rather …

A Case For United States Overhaul Of Its Current Biotechnology Regulation Scheme Through The Implementation Of Biotechnology-Specific Legislation To Clarify Existing Uncertainties Seen In The Collective Framework, Jordan Emmert

Cardozo International & Comparative Law Review

The U.S. biotechnology regulatory framework, established by the 1986 Coordinated Framework and its 1992 Update, is outdated and insufficient to address modern biotechnology products, particularly genetically modified organisms (GMOs). While efforts such as the Obama Administration’s 2015 Memorandum and the 2016 Update aimed to modernize the system, they failed to resolve jurisdictional ambiguities and regulatory gaps, leading to inconsistent agency enforcement and public distrust. The note argues that updating the statutory framework is essential to align U.S. regulations with international norms, ensure public safety, and maintain global competitiveness.

Regulating China's Ecommerce: Harmonizations Of Laws, Pinghui Xiao

Journal of Food Law & Policy

Internet commercialization began in China in 1995. Since then, China has seen a digitalization movement, which has become a joint undertaking between industry and government in the age of ubiquitous Internet in China. China’s Premier Li Keqiang announced ‘Internet Plus’ as the national strategy in his Government Work Report presented during the Two Sessions of the year of 2015. Following Premier Li’s vision for the ‘Internet Plus’ Strategy, China is now determined “to integrate mobile Internet, cloud computing, big data, and the Internet of Things with modern manufacturing, to encourage the healthy development of e-commerce, industrial networks, and Internet banking, …

How Subterranean Regulation Hinders Innovation In Assisted Reproductive Technology, Myrisha S. Lewis

Cardozo Law Review

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This belief I contend, is wrong. In this Article, I examine agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past fifteen years to reveal an overlooked regulatory program. The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (advanced assisted reproductive technologies or AARTs) through regulatory actions that receive little public, media, or scholarly attention. I term this method of regulation "subterranean …

The Penal Construction Of Drug-Related Offenses In The Context Of "Asian Values" - The Rise Of Puntitive Anti-Drug Campaigns In Asia, Michelle Miao

Cardozo International & Comparative Law Review

This article examines the penal construction of drug-related offenses as "the most serious offenses" in the context of "Asian values ". It explains that there are at least three ways in which the serious nature of drug-related criminality is constructed - populism, moral culpability and security - all of which are deeply embedded in the political culture and practices in Asian countries which adopt a punitive approach to drug-related offenses. The article explores social and political discourses in support of state reliance on harsh penal sanctions to tackle complex drug-related problems. It shows that these discourses are frequently exploited and …

A Legal Approach To Combating Terrorist Organization Funding Through The Counterfeit Market, Amanda Kusnierz

Cardozo International & Comparative Law Review

The note argues that counterfeiting has become a critical funding mechanism for terrorist organizations, particularly radical Islamic jihadist groups, due to its profitability and relative anonymity. Current legal frameworks, such as the Anti-Counterfeiting Trade Agreement (ACTA) and material support laws like section 2339B of the USA PATRIOT Act, are insufficient to address this threat effectively. The analysis highlights the need for stricter penalties, increased consumer awareness, and international cooperation to disrupt the financial networks supporting terrorism through counterfeiting.

Public Conservation Policies On Private Land: A Case Study Of The Brazilian Forest Code And Implications For The Agro-Industry Sector, Rayane Aguiar, Jody M. Endres, Caroline Taylor, Samuel Evans

Pace Environmental Law Review

The objectives of this paper are to discuss (1) a brief history of the Brazilian Forest Code (FC); (2) key aspects of the 2012 FC revisions; (3) the status of implementation, including institutional and field-level challenges, as well as economic incentives to ease compliance; and (4) the importance of the FC for the Brazilian agro-industrial sector.

Appellations And Adaptations: Geographical Indication, Viticulture, And Climate Change, Raz Barnea

Washington International Law Journal

Fine wine as we know it is a relatively modern innovation. But French wine culture presents a mythology of a stable and venerable tradition dating back centuries. Central to this mythology is the concept of terroir: the notion that the place—both the land and the people—defines the product. In the early Twentieth Century, France adopted laws giving local producers of wine exclusive rights to name the wine for the region of its origin. These regions, called appellations, have come to stand for the type and quality of wine produced within them—Champagne and Bordeaux are two well-known examples. The appellation regime …

Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Anon

Washington Journal of Law, Technology & Arts

A transcript of the symposium's proceedings.

Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Robin Jacob

Washington Journal of Law, Technology & Arts

The Future of Innovation in Medicine Conference (“Conference”) proceedings contained in this Symposium Issue are about the problem of incentivizing research into new uses for established medicines. Putting the problem into the wider context of financing pharma research generally gives an important perspective.

The Patent And Non-Patent Incentives For Research And Development Of New Uses Of Known Pharmaceuticals In Japan, Toshiko Takenaka

Washington Journal of Law, Technology & Arts

Japan is one of most innovative drug manufacturer-friendly countries because it revised its patent and drug regulation systems for providing patent and non-patent incentives for new use and treatment R&D based on its pro-patent and pro-medical science policies. This article provides an overview of the pharmaceutical industry and examines patent and non-patent incentives for drug R&D in focusing on incentives for developing new uses of and treatments for known drugs from a comparative law perspective. After discussing the difficulties in establishing infringement and in obtaining injunctions against generic drug manufacturers who infringe new use product patents, the article reviews measure …

Infringement Of Swiss-Type Second Medical Use Patent Claims In Germany—Recent Developments In Case Law, Matthias Zigann

Washington Journal of Law, Technology & Arts

Following recent regional court decisions on the infringement of second medical use patent claims, the German concept of manifest arrangement—previously believed to provide a safe harbor for generic pharmaceutical companies as long as they skinny-labeled their products—may be subject to a new interpretation. The German decisions are part of a Europe wide series of decisions on the same or similar subject matter and prove to be patent owner friendly.

Innovation In Known Drugs—The European Angle, Galit Gonen

Washington Journal of Law, Technology & Arts

Research into new uses for known drugs should be encouraged because the “repurposing” of known drug molecules can be a highly effective route of innovation for pharmaceutical companies. Investment in the development of these products should be rewarded. However, incentives that are designed to reward innovation must be in line with the size and value of the innovation in order to maintain a sustainable balance between incentivizing research and developing and encouraging a competitive market. In the context of encouraging innovation of new uses for known drugs, factors that facilitate access to drug development and innovation should also be considered …

Conference Of Soviet And American Jurists On The Law Of The Sea And The Protection Of The Marine Environment, Milton Katz, Richard R. Baxter, O. V. Bogdanov, William E. Butler, Thomas M. Franck, Richard Frank, P. P. Gureev, John L. Hargrove, L. A. Ivanaschenko, Y. Kasmin, V. A. Kiselev, B. M. Klimenko, H. G. Knight, O. S. Kolbasov, A. L. Kolodkin, V. M. Koretsky, F. N. Kovalev, V. N. Kudrjavtsev, B. A. Kuvshinnikov, M. I. Lazarev, A. L. Makovsky, Charles W. Maynes, P. A. Moiseev, John N. Moore, A. P. Movchan, T. M. Starzhina, Robert E. Stein, Grigory I. Tunkin, E. T. Usenko, A. F. Vysotsky, A. K. Zhudro

Georgia Journal of International & Comparative Law

Included in the papers for the Conference of Soviet and American Jurists on the Law of the Sea and the Protection of the Marine Environment:

Introduction by Milton Katz and Richard R. Baxter, p. 1

Freedom of Scientific Research in the World Ocean by A.F. Vysotsky, p. 7

The International Law of Scientific Research in the Oceans by Richard R. Baxter, p. 27

Responsibility and Liability for Harm to the Marine Environment by Robert E. Stein, p. 41

Liability for Marine Environment Pollution Damage in Contemporary International Sea Law by A. L. Makovsky, p. 59

Protection of the Marine Environment …

Shooting Stars And Dancing Fish: A Walk To The World We Want, Tony Oposa

Environmental Law Program Publications @ Haub Law

From the foreword by Durwood Zaelke, President, Institute for Governance & Sustainable Development, Washington, DC.

“Since the beginning of time, human knowledge and culture have been passed down through stories. Short stories, songs, prayers, poems, even paintings can stick in your mind forever. These have always been the most powerful ways we learn and remember.

Tony is not only one of the world’s greatest lawyers, he is also one of the world’s greatest storytellers.

This book, in which he generously shares his experiences, his scars, and most importantly his humanity, is Tony’s gift to generations to come.

But he does …

Regulating Milk: Women And Cows In France, Mathilde Cohen

Faculty Articles and Papers

Animal milk, most commonly cow’s milk, is one of the most heavily regulated commodities in both France and the United States. With the increasing popularity of breastfeeding and the possibility of pumping, freezing, and storing breast milk, a cottage industry has emerged for people wishing to buy, sell, or donate milk produced by humans. Yet the legal landscape for human milk remains inchoate, prompting public health officials and medical professionals to call for tighter regulation. Animal and human milk are typically viewed as two distinct substances with little in common beyond a name. In contrast, this Article highlights the analogies …

What Is The Purpose Of The Orphan Drug Act?, Matthew Herder

Articles, Book Chapters, & Popular Press

The Orphan Drug Act (ODA) [1], first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed. Three decades later, a growing proportion of industry research and development (R&D) [2] and regulatory drug approvals [3] target diseases affecting fewer than 200,000 persons in the United States, the prevalence-based threshold of rare disease under the ODA.

In a new article published in PLOS Medicine, Aaron Kesselheim and colleagues document an embedded trend: within the …

International Fisheries Regulation, John P. Rivers

Georgia Journal of International & Comparative Law

No abstract provided.

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

Georgia Journal of International & Comparative Law

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 …

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 …