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Food and Drug Law

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2018

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Articles 31 - 41 of 41

Full-Text Articles in Entire DC Network

Defining The Opioid Epidemic: Congress, Pressure Groups, And Problem Definition, Taleed El-Sabawi Jan 2018

Defining The Opioid Epidemic: Congress, Pressure Groups, And Problem Definition, Taleed El-Sabawi

Faculty Publications

The passage of the Comprehensive Addiction and Recovery Act of 2016 evidences a shift in federal legislative support from criminal justice oriented legislative alternatives to more health oriented legislative alternatives to addressing the ongoing Opioid Epidemic. Such a shift was preceded by a redefinition of problem drug use in the policy discourse from an issue of deviancy to a health issue. However, the redefinition of problem drug use as a health issue, has been dominated by policy narratives and causal stories that do not define problem drug use in a manner that aligns with a multi-modal public health oriented legislative …


Localism, Labels And Animal Welfare, Samuel R. Wiseman Jan 2018

Localism, Labels And Animal Welfare, Samuel R. Wiseman

Scholarly Publications

The law does relatively little to improve the welfare of animals raised for food. In the short term, at least, market-based solutions appear to have more promise as a means of promoting farm animal welfare, as consumers increasingly seek out local and humanelyraised meat and eggs. To aid consumers in identifying these products, certification systems of varying degrees of rigor exist, but even these are of little use to consumers in the restaurant context, which accounts for a large percentage of meat consumption. Patrons see only finished meals, making fraud difficult to detect, and a recent newspaper investigation suggests that …


Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim Jan 2018

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …


Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen Jan 2018

Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen

Articles

In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article were …


Crafting Next Generation Eco-Label Policy, Jason J. Czarnezki, Katrina F. Kuh Jan 2018

Crafting Next Generation Eco-Label Policy, Jason J. Czarnezki, Katrina F. Kuh

Elisabeth Haub School of Law Faculty Publications

Eco-labels present a promising policy tool in the effort to achieve sustainable consumption. Many questions remain, however, about the extent to which eco-labels can contribute to sustainability efforts and how to maximize their effectiveness. This Article deploys research from evolutionary psychology, behavioral law and economics, and norm theory to offer specific insights for the design and implementation of eco-labels to enhance their influence on sustainable consumer choice. Notably, this research suggests possibilities for eco-labels to shape or expand consumer preferences for green goods, and thereby enhance eco-label influence on consumer behavior by extending it beyond eco-minded consumers. We suggest that …


Guns N' Ganja: How Federalism Criminalizes The Lawful Use Of Marijuana, Ira P. Robbins Jan 2018

Guns N' Ganja: How Federalism Criminalizes The Lawful Use Of Marijuana, Ira P. Robbins

Articles in Law Reviews & Other Academic Journals

Federalism is a vital tenet of our Republic. Although federal law is the supreme law of the land, our Constitution recognizes the integral role that state law plays in the national scheme. Like any pharmaceutical drug that withstands rounds of clinical testing, state law functions as a laboratory in which Congress can evaluate and potentially adopt novel policies on a nation-wide basis. Most of the time, federal and state law exist harmoniously, complementing one another; other times, however, the two systems clash, striking a dissonant chord.

In the United States, state marijuana laws are currently on a crash course with …


“High” Standards: How The Tide Of Marijuana Legalization Sweeping The Country Ignores The Hidden Risks Of Edibles, Steve Calandrillo, Katelyn Fulton Jan 2018

“High” Standards: How The Tide Of Marijuana Legalization Sweeping The Country Ignores The Hidden Risks Of Edibles, Steve Calandrillo, Katelyn Fulton

Articles

As a tide of marijuana legalization sweeps across the United States, there is a surprising lack of scrutiny as to whether the benefits of recreational marijuana outweigh the risks. Notably, marijuana edibles present special risks to the population that are not present in smoked marijuana. States that have legalized recreational marijuana are seeing an increase in edible-related calls to poison control centers and visits to emergency rooms. These negative reactions are especially prevalent in vulnerable populations such as children, persons with underlying preexisting conditions, and out-of-state marijuana novices. Unfortunately, research on edible marijuana is scant and state regulatory regimes are …


The United States, Mexico, And The War On Drugs In The Trump Administration, James M. Cooper Jan 2018

The United States, Mexico, And The War On Drugs In The Trump Administration, James M. Cooper

Faculty Scholarship

This Article examines the war on drugs as persecuted by the United States and how it has been exported to Mexico. It also explores the increased efforts in the drugs war that the Trump administration, through the U.S. Department of Justice, is pursuing at a domestic level. Part I of this Article provides an outline of the dynamics in the quickly evolving and highly tense relationship between the United States and Mexico. Part II of this Article details the historical background of the U.S.-Mexico border region and demonstrates that the border has long been a contested site. Part III provides …


Beyond Corporate Form: A Response To Dan Depasquale, Surbhi Sarang, And Natalie Bump Vena’S Forging Food Justice Through Cooperatives In New York City, Jonathan Brown Jan 2018

Beyond Corporate Form: A Response To Dan Depasquale, Surbhi Sarang, And Natalie Bump Vena’S Forging Food Justice Through Cooperatives In New York City, Jonathan Brown

Elisabeth Haub School of Law Faculty Publications

In their article, Forging Food Justice Through Cooperatives in New York City, Dan DePasquale, Surbhi Sarang, and Natalie Bump Vena (the “Authors”) argue that consumer-owned and worker-owned cooperatives hold promise as a means for advancing policy objectives associated with “food justice,” namely building community wealth and power and providing more affordable access to healthy food in low-income and minority communities. Looking to examples of legislation and policies in other jurisdictions, they advocate for a wide range of policies to promote the viability of cooperatives in New York City, including reforms to cooperative corporation laws and strategies for better allocating funding …


Food Federalism: States, Local Governments, And The Fight For Food Sovereignty, Sarah B. Schindler Jan 2018

Food Federalism: States, Local Governments, And The Fight For Food Sovereignty, Sarah B. Schindler

Faculty Publications

Recently, a number of states have sought to withdraw or restrain local power. In this Article, which is part of the “Re-Thinking State Relevance” symposium hosted by the Ohio State Law Journal, I write about a state taking the opposite approach, and attempting to affirmatively endow its local governments with additional powers. The state is Maine, and the context is control over local food production and sales. This Article begins by addressing the emergence of the sustainable local foods movement broadly, and reasons for the growth of this movement. It then focuses more pointedly on the food sovereignty movement, considering …


Administrative Guidance And Genetically Modified Food, Edward L. Rubin, Joanna K. Sax Jan 2018

Administrative Guidance And Genetically Modified Food, Edward L. Rubin, Joanna K. Sax

Faculty Scholarship

One of the most controversial issues in administrative law, the use of guidance, is exemplified by the regulation of one of the most controversial areas in modern society: genetically modified (GM) food. The appropriate use of guidance versus notice and comment rulemaking is a much-debated issue in administrative law. While agency officials generally assert that they are using guidance to express an agency’s thoughts about how to comply with a specific statutory provision or agency rule, the practical consequence is that the regulated party will hesitate to disobey, even if it believes that the guidance goes beyond the requirements of …