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Food and Drug Law

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Full-Text Articles in Law

Meat, The Future: The Role Of Regulators In The Lab-Grown Revolution, Joseph B. Davault, Michael S. Sinha Apr 2025

Meat, The Future: The Role Of Regulators In The Lab-Grown Revolution, Joseph B. Davault, Michael S. Sinha

All Faculty Scholarship

The United States is one of the largest consumers of meat globally. The production of meat contributes substantially to climate change due to the levels of greenhouse gasses emitted and the amount of land, water, feed, and other natural resources required to raise animals used for meat. Traditional meat production is another major source for the emergence of zoonotic diseases and antimicrobial-resistant pathogens. Nevertheless, Americans consume more meat now than at any time in the nation’s history.

Advocates for policy change aimed at addressing the risks associated with meat production have typically focused on reducing meat consumption, alternatives to meat, …


Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha Oct 2024

Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha

All Faculty Scholarship

Energy drinks first rose to popularity in the 1980s. Red Bull energy drinks were the first of its kind, opening the door to a new consumer and regulatory landscape. Since Red Bull first launched, multiple companies have released countless new energy drink products. Some energy drinks, like Red Bull, contain less than 100 mg of caffeine per 8 oz can. However, other energy drinks contain much higher amounts of caffeine. A 12 oz can of Celsius contains 200 mg of caffeine, and up until recently, Celsius offered a product called Celsius Heat, a 12 oz can containing 300 mg of …


I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha Apr 2024

I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha

All Faculty Scholarship

In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”).1 The MOU proscribes that the FTC regulates truth in advertising relating to foods, drugs, devices and cosmetics while the FDA controls labeling and the misbranding of foods, drugs, devices, and cosmetics shipped in interstate commerce.2 The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century.3

Importantly, the FDA and the …


Legal, Policy, And Environmental Scholars Discuss Global Food Systems At Indiana Law Symposium, James Owsley Boyd Jan 2024

Legal, Policy, And Environmental Scholars Discuss Global Food Systems At Indiana Law Symposium, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

The Indiana University Maurer School of Law and its Indiana Journal of Global Legal Studies are hosting scholars from around the country Friday and Saturday (Jan. 19-20) for an interdisciplinary discussion on one of the world’s most prevalent problems—food insecurity.

Data from the World Bank estimate more than 780 million people around the world suffered from chronic hunger in 2022. As climate change affects agricultural production and water accessibility, the problem could worsen in coming years.

“A Fragile Framework: How Global Food Systems Intersect with the International Legal Order, the Environment, and the World’s Populations” will bring together legal, policy, …


Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran Jan 2024

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …


Legal Pressure To Attend Substance Abuse Treatment, Angelicia Courteau Jan 2024

Legal Pressure To Attend Substance Abuse Treatment, Angelicia Courteau

AUCTUS: The Journal of Undergraduate Research and Creative Scholarship

This paper was written to bring awareness of how the legal system does not take into consideration those who suffer from substance use disorder, as well as ACEs. Brian Luke Burijon’s battle with addiction while incarcerated was used as an example of how the legal system’s one-size-fits-all approach is flawed. Mr. Burijon opted for a treatment he did not feel was ideal for him because the alternative was to remain incarcerated for a long period. Mr. Burijon was unable to tolerate the treatment at the facility and left early, which resulted in his overdose death.


When John Locke Meets Lao Tzu: The Relationship Between Intellectual Property, Biodiversity And Indigenous Knowledge And The Implications For Food Security, Paolo Davide Farah, Marek Prityi Jan 2024

When John Locke Meets Lao Tzu: The Relationship Between Intellectual Property, Biodiversity And Indigenous Knowledge And The Implications For Food Security, Paolo Davide Farah, Marek Prityi

Articles

This article aims to examine the relationship between the concepts of intellectual property, biodiversity, and indigenous knowledge from the perspective of food security and farmers’ rights. Even though these concepts are interdependent and interrelated, they are in a state of conflict due to their inherently enshrined differences. Intellectual property is based on the need of protecting individual property rights in the context of creations of their minds. On the other hand, the concepts of biodiversity, indigenous knowledge and farmers’ rights accentuate the aspects of equity and community. This article aims to analyse and critically assess the respective legal framework and …


Aducanumab, Accelerated Approvals & The Agency: Why The Fda Needs Structural Reform, Matthew Herder Jan 2024

Aducanumab, Accelerated Approvals & The Agency: Why The Fda Needs Structural Reform, Matthew Herder

Articles, Book Chapters, & Popular Press

The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing upon a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.


Law School News: Rake To Plate: Rwu Law Students Dive Into The Clamming Industry 10-4-2023, Grace Boland Oct 2023

Law School News: Rake To Plate: Rwu Law Students Dive Into The Clamming Industry 10-4-2023, Grace Boland

Life of the Law School (1993- )

No abstract provided.


Twenty Years After Krieger V Law Society Of Alberta: Law Society Discipline Of Crown Prosecutors And Government Lawyers, Andrew Flavelle Martin Oct 2023

Twenty Years After Krieger V Law Society Of Alberta: Law Society Discipline Of Crown Prosecutors And Government Lawyers, Andrew Flavelle Martin

Articles, Book Chapters, & Popular Press

Krieger v. Law Society of Alberta held that provincial and territorial law societies have disciplinary jurisdiction over Crown prosecutors for conduct outside of prosecutorial discretion. The reasoning in Krieger would also apply to government lawyers. The apparent consensus is that law societies rarely exercise that jurisdiction. But in those rare instances, what conduct do Canadian law societies discipline Crown prosecutors and government lawyers for? In this article, I canvass reported disciplinary decisions to demonstrate that, while law societies sometimes discipline Crown prosecutors for violations unique to those lawyers, they often do so for violations applicable to all lawyers — particularly …


Why U.S. States Need Their Own Cannabis Industry Banks, Christoph Henkel, Randall K. Johnson Oct 2023

Why U.S. States Need Their Own Cannabis Industry Banks, Christoph Henkel, Randall K. Johnson

Faculty Works

The legal cannabis trade is the fastest growing industry in the United States. In 2019, about 48.2 million Americans used the drug at least once. As such, it is easy to see why the legal cannabis trade may generate annual revenues exceeding $30 billion in Fiscal Year 2022 alone.

One inconvenient truth, however, is that the parties to any cannabis trade may face a range of difficulties due to conflicts between federal and state laws. These difficulties include the fact that many financial institutions are reluctant to handle cannabis proceeds. One reason is that a lack of alignment in terms …


Vaccine Development, The China Dilemma, And International Regulatory Challenges, Peter K. Yu Oct 2023

Vaccine Development, The China Dilemma, And International Regulatory Challenges, Peter K. Yu

Faculty Scholarship

This article examines the role played by China in the development of international regulatory standards at the intersection of intellectual prop- erty, international trade, and public health. It begins by briefly discussing the role China has played in the global health arena during the COVID-19 pandemic. The article then highlights the difficulty in determining how best to engage with the country in the development of new international regula- tory standards. It shows that the preferred method of engagement will likely depend on one’s perspective on China’s potential contributions and hin- drances: a perspective that focuses on global competition—in the economic, …


Escape From The Hangman's Noose? Singapore's Discretionary Death Penalty For Drug Traffickers, Wing Cheong Chan Sep 2023

Escape From The Hangman's Noose? Singapore's Discretionary Death Penalty For Drug Traffickers, Wing Cheong Chan

Research Collection Yong Pung How School Of Law

After nearly fifty years of the mandatory death penalty for drug offences, Singapore amended its law in 2012 to give judges a choice in certain situations to impose a sentence of death or life imprisonment instead. However, this change should not be misunderstood as an alteration in Singapore’s zero-tolerance approach towards illegal drugs. Escaping the mandatory death penalty regime under the new law requires fulfilment of strict conditions. This article reviews the exceptional circumstances that are required before judges are given the discretion to impose the death penalty or not and the application of the new law by the Singapore …


The Origins Of Covid-19 — Why It Matters (And Why It Doesn’T), Lawrence O. Gostin, Gigi K. Gronvall Jun 2023

The Origins Of Covid-19 — Why It Matters (And Why It Doesn’T), Lawrence O. Gostin, Gigi K. Gronvall

Georgetown Law Faculty Publications and Other Works

When Health emergencies arise, scientists seek to discover the cause — such as how a pathogen emerged and spread — because this knowledge can enhance our understanding of risks and strategies for prevention, preparedness, and mitigation. Yet well into the fourth year of the Covid-19 pandemic, intense political and scientific debates about its origins continue. The two major hypotheses are a natural zoonotic spillover, most likely occurring at the Huanan Seafood Wholesale Market, and a laboratory leak from the Wuhan Institute of Virology (WIV). It is worth examining the efforts to discover the origins of SARS-CoV-2, the political obstacles, and …


Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel Sachs, Nicholson Price May 2023

Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel Sachs, Nicholson Price

Law & Economics Working Papers

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (IRA) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …


Development Of A Cannabinoid Testing Method Using Blood Collection Cards And Lc-Ms/Ms, Lindsey K. Reynolds, Matt J. Vergne May 2023

Development Of A Cannabinoid Testing Method Using Blood Collection Cards And Lc-Ms/Ms, Lindsey K. Reynolds, Matt J. Vergne

Student Works

Cannabis is one of the most widely used drugs in the world. Marijuana is a type of cannabis with high amount of Δ9-tetrahydrocannabinol (Δ9-THC) which is psychoactive and intoxicating. Δ9-THC affects alertness and concentration, reducing driving skills when one is intoxicated. Law enforcement of driving under the influence of drugs (DUID) is difficult for police because there is no rapid way to test for Δ9- THC intoxication at the scene of an accident or police stop. Currently, police have to take suspects to a facility to acquire blood samples for testing and the average time before testing is more than …


Fishing And Fisheries Under International Water Law: A Dialogue Between Professor Gabriel Eckstein And Professor Paul Stanton Kibel, Gabriel Eckstein, Paul Stanton Kibel May 2023

Fishing And Fisheries Under International Water Law: A Dialogue Between Professor Gabriel Eckstein And Professor Paul Stanton Kibel, Gabriel Eckstein, Paul Stanton Kibel

Faculty Scholarship

On April 10 and 11, 2023, the Center on Urban Environmental Law (CUEL) at Golden Gate University School of Law hosted a two-day webinar on International Law Aspects of Fisheries and Hydropower in Europe. To open the webinar, Professor Gabriel Eckstein (of Texas A&M University School of Law) and Professor Paul Stanton Kibel (of Golden Gate University School of Law) participated in a keynote dialogue titled Fishing and Fisheries under International Water Law. What follows is a transcription of this dialogue between Professor Eckstein and Professor Kibel.


The Recipe For Success: How Local Massachusetts And Rhode Island Restaurants Navigated And Survived Covid Restrictions, Han Lambert Apr 2023

The Recipe For Success: How Local Massachusetts And Rhode Island Restaurants Navigated And Survived Covid Restrictions, Han Lambert

Honors Projects in History and Social Sciences

The COVID-19 pandemic and the government restrictions adopted during the pandemic have had a detrimental impact on the continued survival and growth of many industries, including the restaurant industry. This study identifies critical regulations relating to COVID-19, implemented in Rhode Island and Massachusetts, as well as on a federal level, which directly impacted the restaurant industry. It is essential that certain economic and social factors are isolated as a means of establishing trends. In the case of this study, a mixed methods approach was used. The number of restaurants open, the amount of restaurant revenue, and the level of consumer …


Adolescent Use And Co-Use Of Tobacco And Cannabis In California: The Roles Of Local Policy And Density Of Tobacco, Vape, And Cannabis Retailers Around Schools, Georgiana Bostean, Anton M. Palma, Alison A. Padon, Erik Linstead, Joni Ricks-Oddie, Jason A. Douglas, Jennifer B. Unger Apr 2023

Adolescent Use And Co-Use Of Tobacco And Cannabis In California: The Roles Of Local Policy And Density Of Tobacco, Vape, And Cannabis Retailers Around Schools, Georgiana Bostean, Anton M. Palma, Alison A. Padon, Erik Linstead, Joni Ricks-Oddie, Jason A. Douglas, Jennifer B. Unger

Sociology Faculty Articles and Research

Adolescent tobacco use (particularly vaping) and co-use of cannabis and tobacco have increased, leading some jurisdictions to implement policies intended to reduce youth access to these products; however, their impacts remain unclear. We examine associations between local policy, density of tobacco, vape, and cannabis retailers around schools, and adolescent use and co-use of tobacco/vape and cannabis.

We combined 2018 statewide California (US) data on: (a) jurisdiction-level policies related to tobacco and cannabis retail environments, (b) jurisdiction-level sociodemographic composition, (c) retailer locations (tobacco, vape, and cannabis shops), and (d) survey data on 534,176 middle and high school students (California Healthy Kids …


Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman Jan 2023

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …


Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore Jan 2023

Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore

Journal Articles

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than


Duped By Dope: The Sackler Family’S Attempt To Escape Opioid Liability And The Need To Close The Non-Debtor Release Loophole, Bryson T. Strachan Jan 2023

Duped By Dope: The Sackler Family’S Attempt To Escape Opioid Liability And The Need To Close The Non-Debtor Release Loophole, Bryson T. Strachan

Law Student Publications

The opioid epidemic continues to rage on in the United States, ravaging its rural populations. One of its main causes? OxyContin. Purdue Pharma (“Purdue”), the maker of OxyContin, aggressively marketed opioids to the American public while racking up a fortune of over $13 billion dollars for its owners,3 the Sackler family. As a result, roughly 3,000 lawsuits were filed against Purdue and members of the Sackler family. Generally, the lawsuits alleged that Purdue and members of the Sackler family knew OxyContin was highly addictive yet aggressively marketed high dosages of the drug and misrepresented the drug as nonaddictive and without …


Speech Regulation And Tobacco Harm Reduction, Jonathan Adler, Jacob James Rich Jan 2023

Speech Regulation And Tobacco Harm Reduction, Jonathan Adler, Jacob James Rich

Faculty Publications

Regulation of commercial speech is a major component of federal regulation of tobacco products. Since adoption of federal tobacco legislation, the Food and Drug Administration has asserted regulatory authority over ENDS and other vaping products as “tobacco products,” subjecting them to the same regulatory regime as traditional tobacco products even though such projects appear to pose less of a threat to public health. Such regulation, and the restriction on truthful speech in particular, may be having negative consequences for public health. Barring producers from informing consumers about the relative risks of vaping products and their potential to reduce smoking eliminates …


Burning Questions: Changing Legal Narratives On Cannabis In Indian Country, Robin M. Rotman, Sam J. Carter Jan 2023

Burning Questions: Changing Legal Narratives On Cannabis In Indian Country, Robin M. Rotman, Sam J. Carter

Faculty Publications

In the not-so-distant past, thoughts of Cannabis legalization in the United States were radical. In the present day, the narratives around Cannabis are changing. The term “present day” affixes this Article to early 2023, a snapshot in time. To understand the current legal narratives surrounding Cannabis, and what they might become in the future, it is important to examine the history of Cannabis law and policy in United States. This Article begins by discussing Cannabis regulation in the United States, from the rise of federal regulation to the gradual deregulation by states with tacit federal consent. The Article then examines …


Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri Jan 2023

Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri

Faculty Publications

For years pharmaceutical policymaking discussions have been revolving around allegations of supposed “evergreening” by pharmaceutical companies, and policymakers have considered a range of significant policy reforms — including to antitrust law and drug regulatory law — to address this purported problem. This paper evaluates empirical data offered to substantiate “evergreening” and explains that these data — though mostly accurate — do not support proposed policy changes.

The “evergreening” claim is that by securing additional patents and FDA-related exclusivities after approval of their new drugs, brand drug companies enjoy a period of exclusivity in the market that is longer than the …


Opening A Federal Reserve Account, Julie Andersen Hill Jan 2023

Opening A Federal Reserve Account, Julie Andersen Hill

Articles

To open bank accounts, new customers provide personal information and make a deposit. Within a few minutes (or perhaps a few days), new customers get access to payment services. For many years, the process financial institutions used to open accounts at FederalReserve Banks was similar. Eligible banks filled out a one-page form and within a week received an account allowing them access to the FederalReserve's payment systems. Recently, however, Federal Reserve Banks have spent years considering account requests from novel banks.

This Article examines the Federal Reserve's process for evaluating requests for accounts. Using interviews, court documents, and other sources, …


Abortion Pills, David S. Cohen, Greer Donley, Rachel Rebouché Jan 2023

Abortion Pills, David S. Cohen, Greer Donley, Rachel Rebouché

Articles

Abortion is now illegal in roughly a third of the country, but abortion pills are more widely available than ever before. Though antiabortion advocates and legislators are attacking pills with all manner of strategies, clinics, websites, and informal networks are openly facilitating the distribution of abortion pills, legally and illegally, across the United States. This Article is the first to explain this defining aspect of the post-Roe environment and the novel issues it raises at the level of state law, federal policy, and on-the-ground advocacy.

This Article first details antiabortion strategies to stop pills by any means necessary. These tactics …


Disciplining Doctors: A Call For Caution When Responding To Physicians' Counter-Consensus Speech In The Time Of Covid-19, Timothy Macdonnell Jan 2023

Disciplining Doctors: A Call For Caution When Responding To Physicians' Counter-Consensus Speech In The Time Of Covid-19, Timothy Macdonnell

Scholarly Articles

The COVID-19 pandemic affected nearly every aspect of life in the United States, including most notably, work-life, home-life, and community-life. During the pandemic, the government took extraordinary steps to try and reduce the spread of the disease by closing businesses, mandating the wearing of masks, and requiring vaccines. Government officials repeatedly justified their actions by stating that they were "following the science." However not all members of the scientific/medical community agreed with these actions. Some of these counter-consensus opinions were labeled mis/dis/mal/information.

As the COVID-19 pandemic dragged on, calls to punish doctors for COVID-19 misinformation increased. Some doctors who claimed …


Not So Juris-Prudent: The Misguided Movement To Abandon Chevron Deference Through The Lens Of Mifepristone And The Attacks On Fda Autonomy, Ella Seltzer Jan 2023

Not So Juris-Prudent: The Misguided Movement To Abandon Chevron Deference Through The Lens Of Mifepristone And The Attacks On Fda Autonomy, Ella Seltzer

Upper Level Writing Requirement Research Papers

No abstract provided.


The Promise Of Telehealth For Abortion, Greer Donley, Rachel Rebouché Jan 2023

The Promise Of Telehealth For Abortion, Greer Donley, Rachel Rebouché

Book Chapters

The COVID-19 pandemic catalyzed a transformation of abortion care. For most of the last half century, abortion was provided in clinics outside of the traditional healthcare setting. Though a medication regimen was approved in 2000 that would terminate a pregnancy without a surgical procedure, the Food & Drug Administration required, among other things, that the drug be dispensed in person. This requirement dramatically limited the medication’s promise to revolutionize abortion because it subjected medication abortion to the same physical barriers of procedural care.

Over the course of the COVID-19 pandemic, however, that changed. The pandemic’s early days exposed how the …