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Food And Drug Regulation: Statutory And Regulatory Supplement (2022 ), Adam I. Muchmore

Books

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 comprehensive.

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore

Journal Articles

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.

The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …

Interlocking Directorates Among The S&P 500: Social Networks, Gender Diversity, And Corporate Governance, Eric P. Magistad

School of Business Student Theses and Dissertations

This multi-article investigation examines corporate board composition and the implications for regulatory penalties. Director diversity on key board committees and board interlocks influence board behaviors as they relate to regulatory risk. Directors bring experience and inter-industry ties to a board position and subsequently transfer and receive specific knowledge, practices, and contacts with other directors (Hillman & Haynes, 2010). Despite this exchange, firms may suffer regulatory oversight penalties because different directors perceive and respond to risk differently (Douglas & Wildavsky, 1983; Flynn et al., 1994). Leveraging the tenets of the cultural theory of risk perception (Douglas & Wildavsky, 1983) and of …

The Multi-Level Marketing Pandemic, Christopher G. Bradley, Hannah E. Oates

Law Faculty Scholarly Articles

Among the societal effects of the COVID-19 pandemic has been a sharp rise in the activities of multi-level marketing companies (MLMs). MLMs are business enterprises in which participants seek not only to sell products to friends, family, and social media contacts, but also to recruit them as MLM participants, with the promise of "building their own business from home."

False promises often pervade MLM sales pitches. Evidence shows that few participants see even a dollar of profit from their MLM work; the vast majority of recruits quickly abandon their MLM dreams and lose their investments. Yet the pitch has become …

Responding To Mass, Computer-Generated, And Malattributed Comments, Steven J. Balla, Reeve Bull, Bridget C.E. Dooling, Emily Hammond, Michael A. Livermore, Michael Herz, Beth Simone Noveck

Faculty Articles

A number of technological and political forces have transformed the once staid and insider dominated notice-and-comment process into a forum for large scale, sometimes messy, participation in regulatory decisionmaking. It is not unheard of for agencies to receive millions of comments on rulemakings; often these comments are received as part of organized mass comment campaigns. In some rulemakings, questions have been raised about whether public comments were submitted under false names, or were automatically generated by computer “bot” programs. In this Article, we examine whether and to what extent such submissions are problematic and make recommendations for how rulemaking agencies …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

All Faculty Scholarship

New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

Urgensi Prinsip Non-Diskriminasi Dalam Regulasi Untuk Pengarus-Utamaan Kesetaraan Gender, Anisatul Hamidah

Jurnal Hukum & Pembangunan

Discrimination against women seems to have become part of the human history and development because it has happened since years ago until now.Therefore,the issue of discrimination against women is still interesting and becomes an important topic to discuss both at the global level and in Indonesia. Efforts to minimize the existence of discrimination against women have actually been carried outby establishing global consensus listed in various legal instruments such as the Universal Declaration of Human Rights (UDHR) and the Convention on the Elimination of All Forms of Discrimination against Women (CEDAW). These instruments explicitly state the obligation of countries to …

A Bittersweet Deal For Consumers: The Unnatural Application Of Preemption To High Fructose Corn Syrup Labeling Claims, Josh Ashley

Journal of Food Law & Policy

The recent rise of consumer consciousness regarding the health qualities of foods and beverages has become something akin to common knowledge. Reflecting this rise, studies reveal that labels regarding the health qualities of a food are more likely to increase sales. And among the health labels consumers prefer, labels describing the product as natural top the list. One website reports that according to a recent study, 31.3-percent of respondents thought that "100% natural" was the best description to read on a label, compared with only 14.2-percent who thought that "100% organic" was the best description. "All natural ingredients" was the …

Cheaters Shouldn't Prosper And Consumers Shouldn't Suffer: The Need For Government Enforcement Against Economic Adulteration Of 100% Pomegranate Juice And Other Imported Food Products, Michael T. Roberts

Journal of Food Law & Policy

In the modern global food system - marked by the trade flow of a variety of food products and ingredients from multiple locations in the world - economically motivated adulteration has emerged as a growing menace that threatens the health and wellbeing of consumers, the economic livelihoods of honest purveyors of food in the global marketplace, and the integrity and viability of national food regulatory systems. Economic adulteration is a form of cheating that includes the padding, diluting, and substituting of food product. Although this cheating is rooted in past food systems, the new paradigm for economic adulteration - a …

The Tragedy Of The Horse, American Icon, Tim Opitz

Journal of Food Law & Policy

Whether a prohibition on slaughter improves the welfare of the American horse population is the focus of this article. At the time it was written, winter of 2010-2011, a confluence of Federal and State legislative action had ended domestic slaughter. These actions are detailed in the body of this article. Since 2007, the legal status of horse slaughter remained static. Just as Sir Isaac Newton's first law of motion explained, an object at rest tends to stay at rest. Legislative inertia is the perspective from which this article was originally written. However, Newton's first law also stated that the object …

Penerapan Perlindungan Kesehatan Dan Keselamatan Kerja Terhadap Buruh Anak Yang Bekerja Di Perkebunan Tembakau Garut, Jawa Barat, Monalisa Silitonga

"Dharmasisya” Jurnal Program Magister Hukum FHUI

The research is aimed to analyze the application of occupational health and safety protection to child laborers and analyze the obstacles that may occur in the application of occupational health and safety protection to child laborers in Tobacco Plantation in Garut, West Java. This research is an empirical legal research, which is conducted by looking at the law in a real sense in the scope of society, which is primary data and legislation as secondary legal material. So the approach taken is a case approach and a statute approach. Based on an analysis of Indonesian laws and regulations governing the …

Jasa Layanan Transportasi Daring (Gojek Dan Grab) Dalam Perspektif Asean On Framework Agreement On Services (Afas), Luthfi Hanifa Ryani

"Dharmasisya” Jurnal Program Magister Hukum FHUI

Online transportation has become a major necessity in an era that bases needs on the internet. The ease of using the application, finding vendors, drivers to calculating profits per day is the reason why slowly all the people in the world choose to use online transportation rather than non-online transportation. Indonesia is one of the countries that has a high dependency on Gojek and Grab online transportation. However, this new business must also be followed by fair rules so that there is openness with all users of online transportation, the Government as a regulator and entrepreneurs as vendors and partners.

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of the developments in Canadian food law and policy in 2011. This update considers the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm.

Reviving Negotiated Rulemaking For An Accessible Internet, Julie Moroney

Michigan Law Review

Web accessibility requires designing and developing websites so that people with disabilities can use them without barriers. While the internet has become central to daily life, websites have overwhelmingly remained inaccessible to the millions of users who have disabilities. Congress enacted the Americans with Disabilities Act (ADA) to combat discrimination against people with disabilities. Passed in 1990, it lacks any specific mention of the internet Courts are split as to whether the ADA applies to websites, and if so, what actions businesses must take to comply with the law. Further complicating matters, the Department of Justice (DOJ) initiated the rulemaking …

Regtech And Predictive Lawmaking: Closing The Reglag Between Prospective Regulated Activity And Regulation, John W. Bagby, Nizan G. Packin

Michigan Business & Entrepreneurial Law Review

Regulation chronically suffers significant delay starting at the detectable initiation of a “regulable activity” and culminating at effective regulatory response. Regulator reaction is impeded by various obstacles: (i) confusion in optimal level, form and choice of regulatory agency, (ii) political resistance to creating new regulatory agencies, (iii) lack of statutory authorization to address particular novel problems, (iv) jurisdictional competition among regulators, (v) Congressional disinclination to regulate given political conditions, and (vi) a lack of expertise, both substantive and procedural, to deploy successful counter-measures. Delay is rooted in several stubborn institutions, including libertarian ideals permeating both the U.S. legal system and …

The Rule Of Five Guys, Lisa Heinzerling

Michigan Law Review

A Review of The Rule of Five: Making Climate History at the Supreme Court. by Richard J. Lazarus.

Compensation, Commodification, And Disablement: How Law Has Dehumanized Laboring Bodies And Excluded Nonlaboring Humans, Karen M. Tani

Michigan Law Review

A Review of Injury Impoverished: Workplace Accidents, Capitalism, and Law in the Progressive Era. by Nate Holdren.

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill

Journal of Food Law & Policy

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law on October 25, 1994. At the signing, President Clinton endorsed the "intense efforts" of manufacturers and legislators to change the "treatment of dietary supplements under regulation and law." Further, the bill was signed with the hope that it would benefit consumers by permitting more access to dietary supplements and more choices for consumer directed healthcare. In support, politicians on both sides of the aisle claimed the DSHEA as a victory for consumer freedom, populist protection, and preventative medicine.

Greenwashing The Organic Label: Abusive Green Marketing In An Increasingly Eco-Friendly Marketplace, Greg Northen

Journal of Food Law & Policy

The green wave of environmental advertising among organic food producers, distributors, and retailers begun during the 1990s has become an all-out green tsunami. The organic food market is the fastest growing segment of the American food industry. Consumers are increasingly becoming aware of the impact their purchases have on several environmental issues. As a result, those consumers are becoming more aware of their spending power and are willingly altering their buying practices to purchase from companies that emphasize environmental responsibility. In fact, some retailers' inventory is already being scanned for alternative green products by their customers' iPhones because, guess what, …

The History And Future Of Genetically Modified Crops: Frankenfoods, Superweeds, And The Developing World, Brooke Glass-O'Shea

Journal of Food Law & Policy

In a 1992 letter to the New York Times, a man named Paul Lewis referred to genetically modified (GM) crops as "Frankenfood," and wryly suggested it might be "time to gather the villagers, light some torches and head to the castle." Little did Lewis know that his neologism would become the rallying cry for activists around the world protesting the dangers of genetic engineering. The environmental activist group Greenpeace made great use of the "Frankenfood" epithet in their anti-GM campaigns of the 1990s, though they have since backed away from the word and the hardline stance it represents. But genetically …

A Healthy Diet Of Preemption: The Power Of The Fda And The Battle Over Restricting High Fructose Corn Syrup From Food And Beverages Labeled 'Natural', Adam C. Schlosser

Journal of Food Law & Policy

America is unhealthy. America faces an obesity epidemic. The food consumed by Americans is making them fat. Americans, bombarded every single day by negative headlines like these, are becoming more and more health conscious. This newfound commitment to health is reflected in the food and beverages Americans purchase.

Food And Drug Regulation: A Statutory Approach, Adam I. Muchmore

Books

This is the first chapter of a new casebook on food and drug regulation. This book presents food and drug regulation as a statutory subject. It is organized around the structure of the Federal Food, Drug, and Cosmetic Act, and emphasizes guided reading of statutes, regulations, and federal register documents. Cases are presented primarily when they involve major issues of statutory interpretation, are historically significant, or are in one of the areas where case law plays a major role.

The book is designed to work with a Statutory and Regulatory Supplement provided as a PDF. The statutes and regulations in …

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

Books

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 comprehensive.

Administrative Law In The Automated State, Cary Coglianese

All Faculty Scholarship

In the future, administrative agencies will rely increasingly on digital automation powered by machine learning algorithms. Can U.S. administrative law accommodate such a future? Not only might a highly automated state readily meet longstanding administrative law principles, but the responsible use of machine learning algorithms might perform even better than the status quo in terms of fulfilling administrative law’s core values of expert decision-making and democratic accountability. Algorithmic governance clearly promises more accurate, data-driven decisions. Moreover, due to their mathematical properties, algorithms might well prove to be more faithful agents of democratic institutions. Yet even if an automated state were …

Introduction, Daniel A. Crane, Samuel Gregg

Other Publications

The regulation of economic life, whether through law or politics, has been a fixture of daily life from time immemorial. Formal regulation occurs through a variety of formal devices, the efficacy of which is argued about by legal scholars, economists, policymakers, legislators, and governments. Even expressions like “to regulate” or “to deregulate” carry a range of political and even moral connotations, depending on who is using the phrase and how they are deploying it.

La Privatización, La Desregulación Y El Interés Público: Un Análisis Comparado, Alfred C. Aman

Articles by Maurer Faculty

This Spanish-language paper analyzes the structural elements of Administrative Law in the United States of America, such as deregulation and privatization, which define the particular relationship between State and Society in that country. The analysis focuses on the limits to privatization in some sectors (prisons, water, health care) using a comparative approach with Spain. From a critical position with the marketization and hegemony of economics, alternatives are proposed for a reform of the Administrative Law that allows a more democratic and inclusive functioning of the governmental institutions.

How The Administrative State Got To This Challenging Place, Peter L. Strauss

Faculty Scholarship

Written for a dispersed agrarian population using hand tools in a local economy, our Constitution now controls an American government orders of magnitude larger that has had to respond to profound changes in transportation, communication, technology, economy, and scientific understanding. How did our government get to this place? The agencies Congress has created to meet these changes now face profound new challenges: transition from the paper to the digital age; the increasing centralization in an opaque, political presidency of decisions that Congress has assigned to diverse, relatively expert and transparent bodies; the thickening, as well, of the political layer within …

Symmetry And (Network) Neutrality, Tejas N. Narechania

Michigan Law Review Online

In this short Essay, I take the opportunity to highlight one further potential asymmetry that may yet emerge from the Supreme Court’s application of Chevron’s many doctrines. Drawing on then-Judge Kavanaugh’s disdissental from the D.C. Circuit’s decision affirming network neutrality rules, I suggest that there is at least one vote on the Supreme Court—and perhaps more—for an asymmetric approach to the major questions doctrine. Moreover, I demonstrate how asymmetry in this context is deeply irrational. As applied to network neutrality, the asymmetry has at least one of two effects. One, it might simply favor one large industry over another, …

Implementing Nepa In The Age Of Climate Change, Jayni Foley Hein, Natalie Jacewicz

Michigan Journal of Environmental & Administrative Law

The national government has a crucial role to play in combating climate change, yet federal projects continue to constitute a major source of United States greenhouse gas emissions. Under the National Environmental Policy Act, agencies must consider the environmental impacts of major federal actions before they can move forward. But agencies frequently downplay or ignore the climate change impacts of their projects in NEPA analyses, citing a slew of technical difficulties and uncertainties. This Article analyzes a suite of the most common analytical failures on the part of agencies with respect to climate change: failure to account for a project’s …

What A Difference A State Makes: California’S Authority To Regulate Motor Vehicle Emissions Under The Clean Air Act And The Future Of State Autonomy, Chiara Pappalardo

Michigan Journal of Environmental & Administrative Law

Air pollutants from motor vehicles constitute one of the leading sources of local and global air degradation with serious consequences for human health and the overall stability of Earth’s climate. Under the Clean Air Act (“CAA”), for over fifty years, the state of California has served as a national “laboratory” for the testing of technological solutions and regulatory approaches to improve air quality. On September 19, 2019, the Trump Administration revoked California’s authority to set more stringent pollution emission standards. The revocation of California’s authority frustrates ambitious initiatives undertaken in California and in other states to reduce local air pollution …