Food and Drug Law Commons^™

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

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

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 …

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.

Local Rule Through The Lens Of Food Sovereignty, Anna Nuler

Senior Projects Spring 2022

Senior Project submitted to The Division of Social Studies of Bard College.

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.

Narratives Of Quality In European Food Governance And Beyond, Lorenzo Bairati

FIU Law Review

No abstract provided.

Meat Wars: The Unsettled Intersection Of Federal And State Food Labeling Regulations For Plant-Based Meat Alternatives, Shareefah Taylor

University of Massachusetts Law Review

Due to technological advances and the rise in popularity of plant-based meat alternatives (i.e., Beyond Meat, the Impossible Burger, etc.), nearly thirty states have proposed or enacted legislation to limit which foods can be labeled with terms that have traditionally been used to describe products derived from animal carcasses (i.e., meat, burger, sausage, etc.). Fueled in many places by the cattle industry, the states’ legislation proposes stricter guidelines than the federal counterparts in an attempt to specifically prohibit plant-based, cell-based (lab-grown meat), and even insect-based products from being labeled in meat-associated terms. To date, lawsuits have been filed by opponents …

Food In Prison: An Eighth Amendment Violation Or Permissible Punishment?, Natasha M. Clark

Honors Thesis

This piece analyzes aspects such as; Eighth Amendment provisions, penology, case law, privatization and monopoly, and food law, that play into the constitutionality of privatized prisons using food as punishment. Prisoners have protection from excessive bail and fines and from cruel and unusual punishment, as per the 8^th Amendment; however, deprivations such as restricted diets and harm caused by them is only a valid violation if the prisoner can prove deliberate indifference. Privatization of the prison industry has led to reduced quality, choice, and diversity in areas such as food, which comes at a detrimental cost to prisoners. Serving …

When Food Is A Weapon: Parental Liability For Food Allergy Bullying, D'Andra Millsap Shu

Marquette Law Review

Food allergies in children are rising at an alarming pace. Increasingly, these children face an added threat: bullies targeting them because of their allergies. This bullying can take a life-threatening turn when the bully exposes the victim to the allergen. This Article is the first major legal analysis of food allergy bullying. It explores the legal system’s failure to adequately address the problem of food allergy bullying and makes the case for focusing on the potential tort liability of the bully’s parents. Parents who become aware of their child’s bullying behavior and fail to take adequate steps to stop it …

Advancing The Aquaculture Industry Through The Federal Crop Insurance Program, Matthew H. Bowen

Ocean and Coastal Law Journal

In recent times, the aquaculture industry has experienced dramatic growth. The growth of the industry is a direct result of an increase in demand for seafood, and a decrease in supply from wild fisheries. The industry, however, is also experiencing growing pains. Aquaculture species, compared to their wild counterparts, are at a higher risk of catastrophic loss from a variety of different perils. These perils make investment in the aquaculture industry significantly risky. The federal crop insurance program could be a tool that mitigates these risks, but the program was designed around terrestrial agriculture, and while aquaculture may be covered …

Life Cycle Costing And Food Systems: Concepts, Trends, And Challenges Of Impact Valuation, Katherine Fiedler, Steven Lord, Jason J. Czarnezki

Michigan Journal of Environmental & Administrative Law

Our global food systems create pervasive environmental, social, and health impacts. Impact valuation is an emerging concept that aims to quantify all environmental, social, and health costs of food systems in an attempt to make the true cost of food more transparent. It also is designed to facilitate the transformation of global food systems. The concept of impact valuation is emerging at the same time as, and partly as a response to, calls for the development of legal mechanisms to address environmental, social, and health concerns. Information has long been understood both as a necessary precursor for regulation and as …

The Gm Food Debate: An Evaluation Of The National Bioengineered Food Disclosure Standard And Recommendations For The United States Based On Food Justice, Courtnee Grego

Seattle University Law Review

This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …

The Gm Food Debate: An Evaluation Of The Nationalbioengineered Food Disclosure Standard Andrecommendations For The United States Based On Foodjustice, Courtnee Grego

Seattle University Law Review

This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …

Law Library Blog (June 2018): Legal Beagle's Blog Archive, Roger Williams University School Of Law

Law Library Newsletters/Blog

No abstract provided.

No Farms No Food? A Response To Baylen Linnekin, Joshua Ulan Galperin

Elisabeth Haub School of Law Faculty Publications

You have likely seen the bumper sticker, bold white text on a green background, reading “No Farms No Food.” The sticker is a product of, and in fact a tagline for, the American Farmland Trust. On the one hand, the point is obvious: As American Farmland Trust puts it, “[e]very meal on our plates [c]ontains ingredients grown on a farm. We all need farms to survive.” On the other hand, what seems like a plain statement on its face, “no farms no food,” is not so simple. Farms produce affordable food, they produce vast quantities of food, they produce healthy …

Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan

Georgetown Law Faculty Publications and Other Works

Diets high in fats, sugars, and sodium are contributing to alarming levels of obesity, cardiovascular disease, type 2 diabetes, and certain cancers throughout the United States. Sugary drinks, which include beverages that contain added caloric sweeteners such as flavored milks, fruit drinks, sports drinks, and sodas, are the largest source of added sugar in the American diet and an important causative factor for obesity and other diet-related diseases.

City and county governments have emerged as key innovators to promote healthier diets, adopting menu labeling laws to facilitate informed choices and soda taxes, warnings labels, and a soda portion cap to …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …

How Commonsense Consumption Acts Are Preventing “Big Food” Litigation, Grace Thompson

Seattle University Law Review

This Note takes a critical look at Commonsense Consumption Acts and how they are detrimental to the possibility of “Big Food” litigation. The tobacco industry was held accountable through the effective use of tort litigation (commonly referred to as “Big Tobacco” litigation), and the food industry could theoretically be held similarly accountable, but CCAs are preventing the possibility of similar reform. Therefore, in order for health reform to be as effective as tobacco reform, CCAs must be repealed in the states where they exist. Part I of this Note discusses why the food industry needs tort reform. Specifically, it argues …

Rethinking The Dormant Commerce Clause?: Climate Change And Food Security, Michael Barsa

Northwestern Journal of Law & Social Policy

No abstract provided.

Serving Up Allergy Labeling: Mitigating Food Allergen Risks In Restaurants, Marie C. Boyd

Faculty Publications

Allergens in restaurant food cause many allergic reactions and deaths. Yet no federal, state, or local law adequately protects people from these harms. Although federal law requires the labeling of “major food allergens” in packaged food, there are no allergen labeling requirements for restaurant-type food. In addition, existing food safety requirements for restaurants are inadequate to prevent allergen cross contact.

The existing legal scholarship on food allergens in restaurants is limited. Much of the legal scholarship on labeling in restaurants focuses on menu labeling — the provision of calorie and other nutrition information to combat obesity. The requirements of Section …

A Window Of Opportunity For Gmo Regulation: Achieving Food Integrity Through Cap-And-Trade Models From Climate Policy For Gmo Regulation, Gabriela Steier

Pace Environmental Law Review

GMOs are the links of our centralized food system, largely dependent on international trade. GMOs are inherently unsustainable because they reduce biodiversity, harm the environment, and empower positive feedback loops between monocultures, industrial agriculture, and biodiversity depletion, thereby jeopardizing food safety, security, and sovereignty. Conglomerates of multi-national companies, in short BigAg, shape multi-lateral food trade and flood international markets with their small array and enormous volumes of crops, while controlling large aspects of agriculture and food production world-wide. Zooming in on the trans-Atlantic dispute about GE crops, this paper uses comparative law to explore how a cap-and-trade model borrowed from …

Selling The Footlong Short: How Consumers Inch Toward Satisfaction In Costly Food Class Action Litigation, Erica A. Burgos

Seventh Circuit Review

Food and beverage class action litigation has increased tremendously over the last five years. While many have ridiculed these lawsuits as ploys to extort money from wealthy food producers, plaintiff consumers maintain that the surge of food litigation suits evidence their growing desire for transparency. Many food-based class actions allege companies are purposefully deceiving consumers with misleading marketing campaigns. Defendants argue that a reasonable consumer should know better than to take their advertising at face value. Even still, defendants are often eager to resolve conflicts without admitting liability and, in turn, rush to settle the matter. Courts are then faced …

From " Food Miles" To "Moneyball": How We Should Be Thinking About Food And Climate, Bret C. Birdsong

Maine Law Review

Since Michael Pollan polarized the push to eat local food in his bestseller, The Omnivore’s Dilemma, the concept of “food miles” has been something of a rallying cry and an organizing principle in the marketing of the local food movement. Among locavores and their sympathizers, the term seems to encapsulate all that is wrong with the food system. Fresh grapes from Chile make their way to supermarkets from Maine to Minnesota, and even California. Major food conglomerates process commodity ingredients like corn, soy, and wheat into packaged food that travels across the country and across oceans before landing on a …

The Recent Enactment Of National Mandatory Gmo Labeling Law: Superior To A Voluntary Labeling Scheme But Unlikely To End The Labeling Controversy, Nan Feng

Seattle University Law Review

Part I of this Note provides background information about the major controversies related to GM foods, including the debate about whether such foods should be labeled, and the history of GMO labeling laws in the United States. Part II compares S. 764 with H.R. 1599 and explains why a national mandatory labeling approach is superior to the voluntary labeling approach advocated by the House. Part III discusses the potential drawbacks and effect of S. 764 and finally concludes that the rulemaking process that will follow may create controversies and litigation.

Eating Is Not Political Action, Joshua Ulan Galperin, Graham Downey, D. Lee Miller

Elisabeth Haub School of Law Faculty Publications

Food and environment are cultural stalwarts. Picture the red barn and solitary farmer toiling over fruited plains; or purple mountains majesty reflected in pristine waters. Agriculture and environment are core, distinct, American mythologies that we know are more intertwined than our stories reveal.

To create policy at the interface of such centrally important and overlapping American ideals, there are two options. Passive governance fosters markets in which participants make individual choices that aggregate into inadvertent collective action. In contrast, assertive governance allows the public, mediated through elected officials, to enact intentional, goal oriented policy.

American mythologies of food and environment …

Eating For The Environment: The Potential Of Dietary Guidelines To Achieve Better Human And Environmental Health Outcomes, Margaret Sova Mccabe

Law Faculty Scholarship

Agriculture and food production contribute significantly to greenhouse gas emissions and environmental pollution. Shifting human dietary patterns has the potential to reduce such environmental harms while also promoting human health. Government policy, in the form of the United States Dietary Guidelines (USDG), recommends what Americans should eat and could play an important role in shifting the food system to one that is more sustainable. However, the USDG are an overlooked aspect of U.S. food policy. While many countries have moved to synthesize environmental goals with dietary guidance, the United States has taken the opposite approach. In 2015, despite recommendations from …

Farming And Eating, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

This essay argues that the “us versus them” rhetoric that dominates food and agriculture policy today drives a wedge between farmers and food consumers. Together, farmers and food consumers could form a powerful coalition to challenge the true obstacle to sustainable and equitable food production: concentration of market and political power elsewhere along the food chain.

The Gmo/Ge Debate, Joanna K. Sax

Faculty Scholarship

The scientific community and the public sphere are having different debates about the application of genetic engineering to improve our food supply. Many that are deeply steeped in the science view genetically engineered food as a more precise way to accomplish what we have been doing for centuries, which is genetically modifying our food supply. Some members of the public view genetically engineered food with skepticism especially as it relates to health, safety and the environment. A disconnect between the scientific consensus and public perception is not a new phenomenon. This Article attempts to bridge this gap by explaining what …