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2019

Food and Drug Law

Institution
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Full-Text Articles in Law

Addiction-Informed Immigration Reform, Rebecca Sharpless Dec 2019

Addiction-Informed Immigration Reform, Rebecca Sharpless

Articles

Immigration law fails to align with the contemporary understanding of substance addiction as a medical condition. The Immigration and Nationality Act regards noncitizens who suffer from drug or alcohol substance use disorder as immoral and undesirable. Addiction is a ground of exclusion and deportation and can prevent the finding of "good moral character" needed for certain immigration applications. Substance use disorder can lead to criminal behavior that lands noncitizens, including lawful permanent residents, in removal proceedings with no defense. The time has come for immigration law to catch up to today's understanding of addiction. The damage done by failing to …


Has The "M" Word Been Framed? Marijuana, Cannabis And Public Opinion, Robert A. Mikos, Cindy D. Kam Oct 2019

Has The "M" Word Been Framed? Marijuana, Cannabis And Public Opinion, Robert A. Mikos, Cindy D. Kam

Vanderbilt Law School Faculty Publications

Over the past two decades, a growing cadre of US states has legalized the drug commonly known as “marijuana.” But even as more states legalize the drug, proponents of reform have begun to shun the term “marijuana” in favor of the term “cannabis.” Arguing that the “M” word has been tainted and may thus dampen public support for legalization, policy advocates have championed “cannabis” as an alternative and more neutral name for the drug. Importantly, however, no one has tested whether calling the drug “cannabis” as opposed to “marijuana” actually has any effect on public opinion. Using an original survey …


Ensuring Economic Viability And Sustainability Of Coffee Production, Jeffrey D. Sachs, Kaitlin Y. Cordes, James Rising, Perrine Toledano, Nicolas Maennling Oct 2019

Ensuring Economic Viability And Sustainability Of Coffee Production, Jeffrey D. Sachs, Kaitlin Y. Cordes, James Rising, Perrine Toledano, Nicolas Maennling

Columbia Center on Sustainable Investment Staff Publications

Coffee, the world’s favorite beverage, provides livelihoods for at least 60 million people across dozens of countries. Yet this beloved drink is experiencing a sustainability crisis. A sustained decline in world coffee prices has squeezed coffee producers, and thrown a tremendous number of producers below the global extreme poverty line. This report presents our research into sustainability within the coffee sector, including the results of our analytical and empirical modeling, and provides several recommendations.


Response To 'Reverse Al Capone-Ism' And The Tax Treatment Of Marijuana Businesses, Douglas A. Kahn, Howard J. Bromberg Aug 2019

Response To 'Reverse Al Capone-Ism' And The Tax Treatment Of Marijuana Businesses, Douglas A. Kahn, Howard J. Bromberg

Other Publications

Mr. Silverberg’s comment stresses that the proponents of the legalization of marijuana have not been able to convince Congress to legalize it, and so it is appropriate for Congress to penalize trafficking in that drug. Apparently, he sees our contention that the penalty adopted in I.R.C. § 280E is irrational and contravenes established punitive jurisprudence as a backdoor attempt to accomplish indirectly, by weakening the penalties on the marijuana businesses, what has not been able to be accomplished by those seeking its federal legalization. That was not the motive for our proposal and is not a fair reading of our …


Response To Dude, Where's My Deduction?, Douglas A. Kahn, Howard J. Bromberg Aug 2019

Response To Dude, Where's My Deduction?, Douglas A. Kahn, Howard J. Bromberg

Other Publications

Mr. Pullin’s thesis is that marijuana should be excluded from § 280E when it is operated legally under state law. However, his preferred solution is that the federal government remove marijuana from Schedules I and II of the Controlled Substances Act of 1970 (CSA), thereby legalizing it for federal law purposes. Either action would exclude the marijuana business from § 280E.


The New Food Safety, Margot J. Pollans, Emily M. Broad Leib Aug 2019

The New Food Safety, Margot J. Pollans, Emily M. Broad Leib

Elisabeth Haub School of Law Faculty Publications

A safe food supply is essential for a healthy society. Our food system is replete with different types of risk, yet food safety is often narrowly understood as encompassing only foodborne illness and other risks related directly to food ingestion. This Article argues for a more comprehensive definition of food safety, one that includes not just acute, ingestion-related risks, but also whole-diet cumulative ingestion risks, and cradle-to-grave risks of food production and disposal. This broader definition, which we call “Food System Safety,” draws under the header of food safety a variety of historically siloed, and under-regulated, food system issues including …


Driving While High, Page D. Dobbs, Michael Smith, David T. Rolfe Aug 2019

Driving While High, Page D. Dobbs, Michael Smith, David T. Rolfe

All Faculty Scholarship for the College of Education and Professional Studies

As of May 2019, ten U.S. states and Washington DC have legalized non-medical/recreational use of cannabis. With increased access to legal marijuana across the country, some have raised concerns regarding unintended implications of these policies, such as the risk of motor vehicle crashes, which is the leading cause of mortality and injury among youth and young adults. Driving under the influence of marijuana is particularly concerning among young adults and college students, due to the increased level of substance use reported during the transition from high school to post-high school environments, such as college.


You Don’T Need Lungs To Suffer: Fish Suffering In The Age Of Climate Change With A Call For Regulatory Reform, David N. Cassuto, Amy O'Brien Aug 2019

You Don’T Need Lungs To Suffer: Fish Suffering In The Age Of Climate Change With A Call For Regulatory Reform, David N. Cassuto, Amy O'Brien

Elisabeth Haub School of Law Faculty Publications

Fish are sentient — they feel pain and suffer. Yet, while we see increasing interest in protecting birds and mammals in industries such as farming and research (albeit few laws), no such attention has been paid to the suffering of fish in the fishing industry. Consideration of fish welfare including reducing needless suffering should be a component of fisheries management. This article focuses on fisheries management practices, the effects of anthropogenic climate change on fisheries management practices, and the moral implications of fish sentience on the development and amendment of global fishing practices. Part I examines domestic and international fisheries, …


Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg Jun 2019

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Articles

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …


Access Before Evidence And The Price Of The Fda's New Drug Authorities, Erika Lietzan May 2019

Access Before Evidence And The Price Of The Fda's New Drug Authorities, Erika Lietzan

Faculty Publications

Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA's standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States "gold standard" for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …


Hemp Fiber, Howard J. Bromberg, Ming Y. Zheng May 2019

Hemp Fiber, Howard J. Bromberg, Ming Y. Zheng

Book Chapters

Hemp, Cannabis sativa, is indigenous to temperate regions in Asia. All major industrialized countries but the United States cultivate hemp for its fibers and oil-rich seeds. The former Soviet Union was the world's leading producer until the 1980s. As of 2018, China was the largest producer, with other significant industries in Ukraine, Russia, China, Canada, Austria, Australia, Great Britain, Hungary, Romania, Poland, France, Italy, and Spain.

Cannabis was initially spread around the world because of its fiber, not its intoxicant chemicals or its nutritious oil seeds. It is one of the oldest sources of textile fiber, whose use for cloth …


Animal Agriculture Liability For Climatic Nuisance: A Path Forward For Climate Change Litigation?, Daniel E. Walters May 2019

Animal Agriculture Liability For Climatic Nuisance: A Path Forward For Climate Change Litigation?, Daniel E. Walters

Faculty Scholarship

Despite possessing statutory authority to regulate at least some contributing causes of climate change, environmental regulators in the United States have recently found themselves tied up in political gridlock. In response, advocates are turning from the regulatory track to a common law liability track, bringing public nuisance suits against fossil fuel producers and electric utilities. However, most of these public nuisance suits have met a common fate: they have been held to be displaced by the comprehensive regulatory framework for controlling greenhouse gas emissions contained in the Clean Air Act. As long as there is even the possibility of regulatory …


“Big” Food, Tobacco, And Alcohol: Reducing Industry Influence On Noncommunicable Disease Prevention Laws And Policies, Belinda Reeve, Lawrence O. Gostin May 2019

“Big” Food, Tobacco, And Alcohol: Reducing Industry Influence On Noncommunicable Disease Prevention Laws And Policies, Belinda Reeve, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The food, tobacco and alcohol industries have penetrated markets in low- and middle-income countries (LMICs), with a significant impact on these countries’ burden of noncommunicable diseases (NCDs). Tangcharoensathien and colleagues describe the aggressive marketing of unhealthy food, alcohol and tobacco in LMICs, as well as key tactics used by these industries to resist laws and policies designed to reduce behavioural risk factors for NCDs. This commentary expands on the recommendations made by Tangcharoensathien and colleagues for preventing or managing conflicts of interest and reducing undue industry influence on NCD prevention policies and laws, focusing on the needs of LMICs. A …


Legal Implications Of "Organic" Seafood Labeling Based On Foreign Standards, Read Porter, Kathryn Kulaga Apr 2019

Legal Implications Of "Organic" Seafood Labeling Based On Foreign Standards, Read Porter, Kathryn Kulaga

Sea Grant Law Fellow Publications

No abstract provided.


Time For A Fresh Look At Strict Liability For Pharmaceuticals, Mary J. Davis Apr 2019

Time For A Fresh Look At Strict Liability For Pharmaceuticals, Mary J. Davis

Law Faculty Scholarly Articles

Part I provides a brief and basic explanation of pharmaceutical liability treatment. Part II explains the impact of federal preemption doctrine, which has dramatically limited the operation of tort law in pharmaceutical liability cases. Part III explains the parallel trends in the marketing and use of pharmaceuticals that increase the incidence of adverse drug events, affect prescribing practices, and fail to enhance informed practitioner and consumer choice in use of pharmaceuticals. Part IV provides support for the application of strict liability given the convergence of these trends. This Part also provides a theoretical justification for strict liability in tort for …


The Current State Of Opioid Litigation, Richard C. Ausness Apr 2019

The Current State Of Opioid Litigation, Richard C. Ausness

Law Faculty Scholarly Articles

Opioid litigation began around the turn of the century and mostly involved unsuccessful lawsuits by addicts against the manufacturers of prescription opioids. The landscape began to change several years ago when a number of state and local governments filed lawsuits against opioid drug manufacturers, seeking damages and other relief for the social and economic consequences of widespread opioid addiction in their territory. Since then, hundreds of government entities (hereinafter referred to as "government plaintiffs") have sued the manufacturers, distributors, prescribers, retail sellers, corporate officers and physician promoters of opioid products (hereinafter referred to as "defendants"). When I began working on …


Local Perceptions Of Cannabis And Cannabis Laws In Morocco: Unpacking Past Laws, Moroccans' Perceptions, And Exploring Organizational Efforts, Shadae Tingman Apr 2019

Local Perceptions Of Cannabis And Cannabis Laws In Morocco: Unpacking Past Laws, Moroccans' Perceptions, And Exploring Organizational Efforts, Shadae Tingman

Independent Study Project (ISP) Collection

In Morocco, cannabis production and consumption are illegal, both medicinally and recreationally. The cultivation of the plant is among the top five in the world. This research will explore many aspects of cannabis in Morocco. There is much literature that exists surrounding the agricultural, economic, and political implications of cannabis, but this research will focus on social perceptions of cannabis and cannabis laws of local Moroccans. This research will explore past government attempts to legalize marijuana and why they did not pass. It will also explore the work of local youth organizations (that focus on cannabis) to understand what they …


Food Waste Legislation Scholarship: A Mapping Study, Angela Hackstadt Mar 2019

Food Waste Legislation Scholarship: A Mapping Study, Angela Hackstadt

University Libraries Faculty Scholarship

The purpose of this study is to examine research activity on food waste legislation published in law journals to identify top sources and experts cited by recent scholarship. Searches for "food loss" and "food waste" were conducted in three legal research databases for law journal articles published between January 2013 and January 2018. The core list of selected articles consists of 13 law journal articles. The citations from each of the core articles were collected to form a database, which was analyzed to determine what kinds of resources legal scholars rely on when conducting research in food waste legislation. Government …


Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman Mar 2019

Cannabis For Medical Use: Fda And Dea Regulation In The Hall Of Mirrors, Rebecca S. Eisenberg, Deborah B. Leiderman

Articles

A majority of Americans now live in states that purport to authorize medical use of cannabis, although federal law continues to prohibit both recreational and medical use. The current legal regime for cannabis is unstable and may be more effective at deterring research than it is at deterring medical use. Lack of data on medical cannabis products poses public health risks as well as policy and legal challenges. Modified regulatory approaches for other kinds of products provide alternative models for encouraging safety and effectiveness research and providing better information about cannabis products already in clinical use.


Comparative Analysis Of State Regulation Of Direct-To-Market Sales Of Finfish, Marine Affairs Institute, Roger Williams University School Of Law, James Philopena Jr. Feb 2019

Comparative Analysis Of State Regulation Of Direct-To-Market Sales Of Finfish, Marine Affairs Institute, Roger Williams University School Of Law, James Philopena Jr.

Sea Grant Law Fellow Publications

No abstract provided.


The Surprising Reach Of Fda Regulation Of Cannabis, Even After Descheduling, Erika Lietzan, Sean M. O'Connor Feb 2019

The Surprising Reach Of Fda Regulation Of Cannabis, Even After Descheduling, Erika Lietzan, Sean M. O'Connor

Faculty Publications

As more states legalize cannabis, the push to "deschedule" it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis - cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA's focus on precise analytical characterization and on individual active and inactive ingredients may be …


The Role Of Pressure Groups And Problem Definition In Crafting Legislative Solutions To The Opioid Crisis, Taleed El-Sabawi Jan 2019

The Role Of Pressure Groups And Problem Definition In Crafting Legislative Solutions To The Opioid Crisis, Taleed El-Sabawi

Faculty Publications

Organized interest groups and federal administrative agencies have historically been influential in defining problem drug use during nationwide crisis. As such, the manner in which these pressure groups defined the problem may have influenced or, at least, provided support for legislators’ decisions to shy away from a criminal justice approach and towards acceptance of a more “health-oriented” — one that did not comprehensively address demand factors or demonstrate a commitment to reforming U.S. drug policy to meet international standards of best practice. In an effort to provide a snapshot of what such involvement may look like, this article explores the …


Interactions, Iteration And Early Institutionalization: Competing Lessons Of Globalgap’S Legitimation, Donal Casey Jan 2019

Interactions, Iteration And Early Institutionalization: Competing Lessons Of Globalgap’S Legitimation, Donal Casey

Transnational Business Governance Interactions Working Papers

Since its inception, GLOBALGAP has transformed from an informal grouping of retailers into a highly elaborate regulatory organisation. This chapter critically examines GLOBALGAP’s development. I argue that, through an iterative process of legitimation, actual and anticipated interactions with state, market and civil society actors led GLOBALGAP to develop structures, practices and processes that sought to enhance representation and participation of structurally weaker parties such as smallholders, whilst also addressing concerns relating to the exclusionary effect of its standards. I tease out how, as non-state regulatory organisations emerge and develop, they respond to actual and anticipated governance interactions in order to …


Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle Jan 2019

Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle

Articles in Law Reviews & Other Academic Journals

Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …


Life, Liberty, [And The Pursuit Of Happiness]: Medical Marijuana Regulation In Historical Context, Lewis Grossman Jan 2019

Life, Liberty, [And The Pursuit Of Happiness]: Medical Marijuana Regulation In Historical Context, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

The struggle for access to medical marijuana differs from most other battles for therapeutic freedom in American history because marijuana also has a popular, though controversial, nontherapeutic use—delivery of a recreational high. After considering struggles over the medical use of alcohol during prohibition as a precedent, this chapter relates the history of medical marijuana use and regulation in the United States. The bulk of the chapter focuses on the medical marijuana movement from the 1970s to present. This campaign has been one of the prime examples of a successful extrajudicial social movement for freedom of therapeutic choice. With the exception …


Rohrabacher-Blumenauer Amendment, Case Law And The Department Of Justice: Who Prevails In The Medical Marijuana Legalization Debate?, Florence Shu-Acquaye Jan 2019

Rohrabacher-Blumenauer Amendment, Case Law And The Department Of Justice: Who Prevails In The Medical Marijuana Legalization Debate?, Florence Shu-Acquaye

Faculty Scholarship

No abstract provided.


Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker Jan 2019

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.


Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder Jan 2019

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

  • The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
  • Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
  • Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …


The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan Jan 2019

The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan

Articles

As more states legalize cannabis, the push to “deschedule” it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis—cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA’s focus on precise analytical characterization and on individual active and inactive ingredients may be fundamentally inconsistent …


The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite Jan 2019

The Orphan Drug Act At 35: Observations And An Outlook For The Twenty-First Century, Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite

Articles

On the thirty-fifth anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new orphan drugs appears to be greater today than it was in 1983. All else equal, this should reduce the threshold for research and development (R&D) investment in an economically viable product. Further, the small size of patient populations for orphan drugs, together with the increasing prevalence of biologics among orphan drugs, have created a set …