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Articles 1 - 30 of 42
Full-Text Articles in Food and Drug Law
Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales
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
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
The Tin Man Needs A Heart: A Proposed Framework For The Regulation Of Bioprinted Organs, Linda Foit
The Tin Man Needs A Heart: A Proposed Framework For The Regulation Of Bioprinted Organs, Linda Foit
Fordham Law Review
Each day, seventeen people die in the United States while waiting for an organ transplant. At least part of this need could be met by bioprinting, a technology that allows the on-demand production of custom-sized organs from a patient’s own cells. The field of bioprinting is progressing rapidly: the first bioprinted organs have already entered the clinic. Yet, developers of bioprinted organs face significant uncertainty as to how their potentially lifesaving products will be regulated—and by which government agency. Such regulatory uncertainty has the potential to decrease investment and stifle innovation in this promising technological field. This Note examines how …
Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore
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
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.
The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein
The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein
Brooklyn Law Review
In recent years, concern over the environmental, animal welfare, and human costs of animal agriculture has spurred an increased demand for nonanimal sourced protein. This has led to significant innovation in food technology. As part of this trend, food scientists have developed a process for in-vitro cultivation of meat cells to produce protein that is biologically and nutritionally identical to meat from traditionally raised and slaughtered animal sources, but that involves neither animal agriculture nor animal slaughter. This lab-grown “clean meat” represents a new era in food technology and is already having an effect on the existing meat industry. In …
The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards
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
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
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.
Meat Wars: The Unsettled Intersection Of Federal And State Food Labeling Regulations For Plant-Based Meat Alternatives, Shareefah Taylor
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 …
Ethical Cannabis Lawyering In California, Francis J. Mootz Iii
Ethical Cannabis Lawyering In California, Francis J. Mootz Iii
St. Mary's Journal on Legal Malpractice & Ethics
Cannabis has a long history in the United States. Originally, doctors and pharmacists used cannabis for a variety of purposes. After the Mexican Revolution led to widespread migration from Mexico to the United States, many Americans responded by associating this influx of foreigners with the use of cannabis, and thereby racializing and stigmatizing the drug. After the collapse of prohibition, the federal government repurposed its enormous enforcement bureaucracy to address the perceived problem of cannabis, despite the opposition of the American Medical Association to this new prohibition. Ultimately, both the states and the federal government classified cannabis as a dangerous …
Newsroom: Logan Quoted In Bloomberg News On Opiod Litigation 08-16-2017, Jef Feeley, Jared S. Hopkins
Newsroom: Logan Quoted In Bloomberg News On Opiod Litigation 08-16-2017, Jef Feeley, Jared S. Hopkins
Life of the Law School (1993- )
No abstract provided.
Virginia Executioner To Wear A Cloak: Diversion From The Real Controversy, Paul G. Gill
Virginia Executioner To Wear A Cloak: Diversion From The Real Controversy, Paul G. Gill
University of Richmond Law Review
No abstract provided.
The Impact Of Marijuana Legalization On Youth & The Need For State Legislation On Marijuana-Specific Instruction In K–12 Schools, Amanda Harmon Cooley
The Impact Of Marijuana Legalization On Youth & The Need For State Legislation On Marijuana-Specific Instruction In K–12 Schools, Amanda Harmon Cooley
Pepperdine Law Review
State legalization of marijuana is a divisive and polarizing issue that has resulted in fragmentation between governments and citizens. Contrary to federal law, voters in many states have approved ballot initiatives legalizing the sale of marijuana to adults for their recreational use. This Article argues that any state that legalizes marijuana has a concomitant duty to amend its K–12 public school instructional statutes to provide for substantial marijuana education. No state has yet enacted such legislation even though current alternative educational methods fail to provide sufficient safeguards. Accordingly, this Article proposes new statutory remedies that could bridge the gap between …
Potholes: Dui Law In The Budding Marijuana Industry, Zack G. Goldberg
Potholes: Dui Law In The Budding Marijuana Industry, Zack G. Goldberg
Brooklyn Law Review
The rapid legalization of marijuana across the United States has produced a number of novel legal issues. One of the most confounding issues is that presented by the marijuana-impaired driver. In jurisdictions that have legalized the use of marijuana, how high is too high to get behind the wheel? This note assesses the various marijuana DUI laws that states have implemented to combat marijuana-impaired driving. Many of these statutes have followed in the footsteps of the BAC-based standard used to combat drunk driving—using THC measurements to quantify a driver’s level of marijuana-based impairment. Unfortunately, unlike alcohol, the scientific properties of …
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete
Catholic University Law Review
The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …
Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters
Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters
Indiana Law Journal
Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.
This Article analyzes two examples of FDA inertia and compares …
Genetically Engineered Plant Pesticides: Recent Developments In The Epa's Regulation Of Biotechnology, Mary Jane Angelo
Genetically Engineered Plant Pesticides: Recent Developments In The Epa's Regulation Of Biotechnology, Mary Jane Angelo
Mary Jane Angelo
This paper examines the EPA's new policy regulating plant pesticides and presents the legal, scientific and policy issues surrounding the regulation of genetically engineered plants. Part I introduces the concepts covered in this paper. Part II.A. discusses products that have originated from biotechnology. Part II.B. describes the EPA's legal authority for regulating plant pesticides and other biotechnology products. Part II.C. presents the history of federal regulation of biological pesticides and biotechnology products. Part III examines the controversy surrounding the use of genetically engineered plants, including the potential risks and benefits of genetically engineered plants and the public's perception of these …
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Seattle University Law Review
Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino
University of Richmond Law Review
No abstract provided.
"Natural" Food Labeling: False Advertising And The First Amendment
"Natural" Food Labeling: False Advertising And The First Amendment
Marquette Elder's Advisor
No abstract provided.
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio
Law Student Publications
This comment argues that the FDA should regulate ecigarettes, but in doing so, it should take a minimalist approach to regulation. Instead of continuing its attempts to regulate tobacco products under the drug and device provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), an incredibly stringent statute, the FDA should focus its efforts under the Tobacco Control Act ("TCA"), which is tailored specifically to regulate tobacco products. While the FDA has extensive regulatory options under the TCA, much of this authority should not be applied to ecigarettes. Part II will provide background information on ecigarettes generally as well …
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson
University of Richmond Law Review
No abstract provided.
Fda And The Rise Of The Empowered Consumer, Lewis Grossman
Fda And The Rise Of The Empowered Consumer, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
This Article traces the still-evolving view of consumers of FDA-regulated products as capable, rational, and rights-bearing decision makers. It also examines the corresponding diminution of FDA’s role as a paternalistic gatekeeper collaborating with medical and scientific experts to prevent products and manufacturer-provided information from reaching the public. Compared with their 1960s counterparts, today’s consumers of food and drugs have far greater freedom to make unmediated choices among a wider variety of products, guided by a relative deluge of labeling and advertising information. Moreover, food and drug regulation, once the exclusive domain of bureaucrats and experts, has become a focus of …
California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor
California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor
Pepperdine Law Review
The California Supreme Court, in the novel and unprecedented case of Sindell v. Abbott Laboratories, eliminated the plaintiffs burden of identification of a negligent party, and thus the causation requirement, in a multiple party tort action. In the course of this decision, the court adopted the "market share" theory of liability which dictated in Sindell that nonidentifiable defendant-manufacturers of the generic drug DES would be liable for the damages in proportion to their share of business in the market. The author thoroughly examines various theories of recovery, such as "alternative liability," "concert of action" and "enterprise liability," which the court …
Implications Of The Supreme Court's Decision In Pliva, Inc. V. Mensing: Why Generic And Brand-Name Pharmaceuticals Must Be Treated Equally Under The Federal Food, Drug, And Cosmetic Act
Marquette Elder's Advisor
No abstract provided.
Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff
Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff
Pepperdine Law Review
No abstract provided.
The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety, Matthew Standeven
The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety, Matthew Standeven
Journal of Health Care Law and Policy
No abstract provided.
Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez
Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez
Faculty Journal Articles and Book Chapters
This Article considers whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.
I examine the tests and factors courts claim they use when making this threshold distinction, then identify the various …
The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness
The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness
Law Faculty Scholarly Articles
On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. In …