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 …

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 …

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.

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

Preempting State Prevention: How Fda Regulation Ensures Access To Abortion Medication, Jared Shea

Mitchell Hamline Law Review

No abstract provided.

The Disrupted Path To Becoming Easy, Breezy, Beautiful: How Companies Are Deceiving Consumers With Their Animal Testing Products, Wendy Chao

University of San Francisco Law Review

No abstract provided.

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

Scholarly Articles in Law Reviews & 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

Faculty Scholarship

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

Off-Label Speech, David A. Simon

Emory Law Journal

This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The more evidence that an off-label use is safe and effective, the less restrictive the regulation should be. The less evidence that an off-label use is safe and effective, the more restrictive the regulation should be. Although intuitive, this is not exactly how current regulation of off-label information works. If the FDA approves a drug, the manufacturer can advertise to doctors and patients for the approved indication. Drug manufacturers cannot, however, promote or …

The Cow Has Left The Barn: Updating Standards Of Identity To Reflect Consumer Understanding Of Plant-Based Foods, Nicholas G. Miller

Journal of Food Law & Policy

Have you ever seen “tofurkey” at the supermarket and thought it was a rare, delicious cousin of the turkey? The animal based food industries, led by milk and meat producers, are claiming that the reasonable consumer might. On the other hand, the plant based food substitutes are appearing on supermarket shelves with increasingly bold names for their products that tap into our familiarity with animal-based foods, using names like “Beyond Meat.” Where do we draw the line on what plant based food can be called? And who should draw that line? This paper examines the debate surrounding the labeling of …

Following The Framework: Intentional Genomic Alterations In Animals, Sarah Copper

Journal of Food Law & Policy

Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, …

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.

A Hot Topic: Is The Fda’S Approach To Sunscreen Regulation Failing Consumers?, Haley Westman

Seattle University Law Review

This Note suggests a better balance between allowing sunscreen innovation and protecting the public from unsafe products. Part I of this Note will review the factual background of the public’s attention to sunscreen, explain the current sunscreen issues in the news, and highlight the different actors involved in the growing discourse surrounding sunscreen. Part I will also show that the actors involved in the sunscreen industry—scientific researchers, social media influencers, and the public at large—have considerable influence on consumers’ trust in sunscreen, their buying habits, and the FDA’s approach to sunscreen regulation. Part II of this Note will outline the …

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

Faculty Scholarship

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 …

Fda As Food System Stewards, Margot J. Pollans, Matthew F. Watson

Elisabeth Haub School of Law Faculty Publications

The Food and Drug Administration (“FDA”) is one of the primary regulators of the U.S. food system, yet it all but ignores the food system's vast environmental footprint. Although the agency is not technically an environmental agency, it could and should view redressing the food system's significant environmental footprint as part of its health and safety mission. In this Article, we review FDA's history of National Environmental Policy Act (“NEPA”) compliance. This history affirms our hypothesis that FDA does not view its own work as environmental. The review, along with assessment of some of FDA's core food programs, reveals that …

Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina

Scholarship@WashULaw

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers.

Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications …

Agents Of Bioshield: The Fda, Emergency Use Authorizations, And Public Trust, Kirstiana Perryman

Georgia Law Review

The SARS-CoV-2 pandemic spurred the U.S. Food & Drug Administration (FDA) to utilize the Emergency Use Authorization (EUA) procedure more than ever before. The pandemic pushed the relatively obscure procedure into public consciousness, making it a frequent topic of discussion and debate. The EUA procedure permits the FDA Commissioner to authorize the introduction of drugs, devices, or biological products into interstate commerce for use in an actual or potential emergency. To issue an authorization, the FDA Commissioner must determine that it is “reasonable to believe,” based on the “totality of the evidence,” that the product “may be effective.” This standard …

The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards

Journal of the National Association of Administrative Law Judiciary

The 21st Century Cures Act is designed to expedite the FDA’s approval of pharmaceutical and medical device applications in order to increase patient access to innovative therapies. However, many experts claim that the Act’s Title III provisions promote evidentiary “‘shortcuts’” that eviscerate the safety and efficacy standards of the FDA approval process. For new drugs, Title III permits surrogate endpoints and real-world evidence in lieu of more rigorous scientific data. For new medical devices, Title III requires the FDA to exempt certain Class I and II devices from any kind of safety or efficacy evaluation. Moreover, Title III forces the …

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.

Supply And Demand: Navigating Emergency Regulatory Developments In The Fight Against Opioid Use Disorder, Eva Bogdewic

Upper Level Writing Requirement Research Papers

No abstract provided.

Ignoring Drug Trademarks, Erika Lietzan

Faculty Publications

If you walk into a pharmacy with a prescription for Merck’s ZOCOR, which contains simvastatin, the pharmacist will probably give you a product containing simvastatin made by another company. The pharmacist will dispense a “generic” simvastatin product. State generic substitution laws, passed in the 1970s to help the government save money by switching patients to cheaper generic drugs, either permit or require this substitution. But drug brand names -- such as ZOCOR -- are trademarks. Like other trademarks, they distinguish goods in the market from others, and they signal the source of the goods. These state laws essentially treat the …

Putting Paper To Pen: Generation Juul's Case For Harm Reduction, Liz Emanuel

Indiana Law Journal

Part I of this Note soberly explores and delineates the perceived and real threats of vaping for America’s youth, concluding with an analysis of the socioeconomic and developmental health effects of nicotine addiction. Part II delves into the federal government’s response to e-cigarettes as well as the powers and limitations of federal regulation under the Food and Drug Administration’s (FDA) “Deeming Rule” and the potential effectiveness of an increase in the national tobacco purchase age or a federal ban on flavored vaping products. Part III discusses the realistic benefits of taking a harm reduction approach to youth vaping in the …

Insulin Federalism, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Pandemic Politics, Public Health, And The Fda, Jordan Paradise, Becky Bavlsik

Faculty Publications & Other Works

No abstract provided.

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Please Consult Your Lawyer Before Taking Sorrell: How The Fda Should Approach Social Media For Prescription Drug Advertising, Steven Valentino

Upper Level Writing Requirement Research Papers

No abstract provided.

Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina

Scholarship@WashULaw

State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on …

No Ifs, Ands, Or Juuls About It: Why Influencers Must Be Held Accountable, Krystina Dorta

Catholic University Journal of Law and Technology

This article analyzes how the FTC’s Endorsement Guide regulating the advertising of e-cigarette products should be applied to social media influencers. The struggle to regulate e-cigarettes by the FDA and the FTC has led to different advertising methods, which either comply with or neglect the FTC’s Endorsement Guide. This article evaluates the federal government’s reaction to the e-cigarette health crisis, followed by a review of the FTC’s previous actions addressing Endorsement Guide violations, along with the consequences on other companies’ marketing strategies. Finally, this article reviews influencer liability standards for Endorsement Guide violations and develops recommendations to improve those standards.

The Future Of The Agricultural Industry – Is Blockchain A New Beginning?, Ryan Bisel

Seattle University Law Review

As we advance into a digital era, we begin to depend on technological innovations to rapidly help develop and update processes and methods within different industries. Blockchain technology—popularized by cryptocurrency—is slowly making its debut in the agricultural supply chain. Implementing a blockchain requirement for suppliers would be beneficial because it would allow agricultural suppliers and distributors to track their products in a more efficient manner. However, there are four potential legal issues that are foreseeable: (1) preemption, (2) overlapping regulatory authority, (3) applying current legal rules to new technology, and (4) contracting. This Note will specifically focus on issues of …