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Food and Drug Law Commons

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Full-Text Articles in Food and Drug Law

Deterrence Defeats Doping: How Arbitration Can Resolve Major League Baseball's Performance-Enhancing Drug Problem, Brice Barnes Jun 2023

Deterrence Defeats Doping: How Arbitration Can Resolve Major League Baseball's Performance-Enhancing Drug Problem, Brice Barnes

Pepperdine Dispute Resolution Law Journal

This article analyzes MLB’s PED policy and proposes amending the policy by arbitrating the agreement to create one that further deters players from using PEDs. The remainder of this article is divided into five parts: Part II discusses the significance of the PED issue and why resolution is necessary; Part III discusses the history of PED use in baseball and the efforts by the League to address it; Part IV proposes the solution of arbitration and explains how the process might work; Part V addresses potential objections to that solution; and finally, Part VI concludes.


The Intemperate Regulation Of Alcohol, Bradley R. Greenman May 2023

The Intemperate Regulation Of Alcohol, Bradley R. Greenman

The Journal of Business, Entrepreneurship & the Law

This comment will not argue the legitimacy of the policy aims of the Twenty-First Amendment, rather, it will argue the current regulatory and legal apparatuses which govern the alcohol industry are no longer moored to the original moral and philosophical values the Temperance Movement, or those morals and values which carried over into the Twenty-First Amendment. To aid in understanding the current state of alcohol regulation, Section II will outline the history of liquor regulation in the United States from the Founding to the present. Second, Section II will examine the history of legislation and regulation of alcohol that led …


Legalization Without Disruption: Why Congress Should Let States Restrict Interstate Commerce In Marijuana, Scott Bloomberg, Robert A. Mikos Jun 2022

Legalization Without Disruption: Why Congress Should Let States Restrict Interstate Commerce In Marijuana, Scott Bloomberg, Robert A. Mikos

Pepperdine Law Review

Over the past twenty-five years, states have developed elaborate regulatory systems to govern lawful marijuana markets. In designing these systems, states have assumed that the Dormant Commerce Clause (“DCC”) does not apply; Congress, after all, has banned all commerce in marijuana. However, the states’ reprieve from the doctrine may soon come to an end. Congress is on the verge of legalizing marijuana federally, and once it does, it will unleash the DCC, with dire consequences for the states and the markets they now regulate. This Article serves as a wake-up call. It provides the most extensive analysis to date of …


The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards Mar 2021

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 …


Resolving Disputes Before They Decant: An Alternative Dispute Resolution System For Growers And Wine Producers, Savannah Billingham-Hemminger Jul 2020

Resolving Disputes Before They Decant: An Alternative Dispute Resolution System For Growers And Wine Producers, Savannah Billingham-Hemminger

Pepperdine Dispute Resolution Law Journal

No abstract provided.


The California Cannabis Industry: The Complexities Since Recreational Legalization, Talia Lux May 2020

The California Cannabis Industry: The Complexities Since Recreational Legalization, Talia Lux

The Journal of Business, Entrepreneurship & the Law

This comment will first provide a look into the history and legality of cannabis in the United States, followed by a look into California’s cannabis industry. There will be a discussion on both medical and recreational legality in California and the provisions surrounding both types of legality. Next, the complexities of the cannabis industries will be discussed in terms of opening and operating a cannabis business, the different cannabis business types and the requirements for starting them, and state and local limitations. Immediately following, there will be a federal illegality discussion and how federal illegality conflicts with California law in …


Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi Nov 2019

Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi

Journal of the National Association of Administrative Law Judiciary

This comment explores the types of legislation, approaches to regulating e-cigarettes, and analyzes whether the FDA’s campaign and current regulations are effective. So far, it appears that the United States is ahead of the game with its new, aggressive proposal for regulating e-cigarettes. The FDA is standing against the companies and products that target youthful consumers. Most countries acknowledge the gaps in current scientific research regarding the long-term health risks of vaping, and some are waiting to take a legislative stance until it is clearer which side of the health line e-cigarettes fall. Section II of this comment discusses the …


Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs Nov 2019

Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs

Journal of the National Association of Administrative Law Judiciary

The American cosmetics industry is not required by the Food and Drug Administration (FDA) to conduct pre-market safety assessments of cosmetics. The FDA only reviews personal care products when people voluntarily report problems. Further, companies continue to test animals for cosmetics, despite the FDA’s recommendation that manufacturers seek more humane and accurate testing. Although the FDA does not require animal testing for product safety or premarket approval, the United States is one of the largest users of laboratory animals for product testing. There are two pending pieces of legislation, which if passed would be the first acts of cosmetic regulation …


Marijuana’S Continuing Illegality And Investors’ Securities Fraud Problem: The Doctrines Of Unclean Hands And In Pari Delicto, Casey W. Baker Oct 2019

Marijuana’S Continuing Illegality And Investors’ Securities Fraud Problem: The Doctrines Of Unclean Hands And In Pari Delicto, Casey W. Baker

The Journal of Business, Entrepreneurship & the Law

Marijuana-related businesses have blossomed into an industry with an estimated total market value of $7.2 billion in 2016, with annual growth projected at 17%. Industry surveys report that 62% of marijuana-related businesses have offered equity stakes to investors and approximately one-half of marijuana-related businesses planned to actively seek investment funding in 2017. Along with the investment opportunity comes heightened fraud risk, with regulators cautioning investors against investment due to the lack of accurate and publicly-available information. Also, despite state-level decriminalization, marijuana possession, sale, and distribution continues to be a crime under federal law. The criminal nature of the marijuana industry …


Pacta Sunt Servanda State Legalization Of Marijuana And Subnational Violations Of International Treaties: A Historical Perspective, Brian M. Blumenfeld Jan 2019

Pacta Sunt Servanda State Legalization Of Marijuana And Subnational Violations Of International Treaties: A Historical Perspective, Brian M. Blumenfeld

Pepperdine Law Review

In November 2012, voters in the states of Colorado and Washington passed ballot initiatives to legalize recreational marijuana industries. Since then, eight additional states and the District of Columbia have followed suit, and many more have seen legalization debates in their legislative halls and among their electorates. Over twenty bills recently introduced in Congress have sought to break federal marijuana laws away from prohibition. Although the national debate is indeed a vibrant one, it has neglected to address how legalization may be jeopardizing the compliance status of the United States under international drug treaties, and what the consequences may be …


The Impact Of Marijuana Legalization On Youth & The Need For State Legislation On Marijuana-Specific Instruction In K–12 Schools, Amanda Harmon Cooley Jan 2017

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 …


Hidden Risks Of Taking Generic Drugs Over Brand Name: The Impact Of Drug Labeling Regulations On Injured Consumers And The Pharmaceutical Industry , Samantha Koopman Jun 2014

Hidden Risks Of Taking Generic Drugs Over Brand Name: The Impact Of Drug Labeling Regulations On Injured Consumers And The Pharmaceutical Industry , Samantha Koopman

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


Christopher V. Smithkline Beecham Corporation: A Tough Pill To Swallow For Pharmaceutical Sales Representatives?, Hsuan Li May 2014

Christopher V. Smithkline Beecham Corporation: A Tough Pill To Swallow For Pharmaceutical Sales Representatives?, Hsuan Li

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


Brand Name Or Generic? A Case Note On Caraco Pharmaceutical Laboratories V. Novo Nordisck , Michael Vincent Ruocco Nov 2013

Brand Name Or Generic? A Case Note On Caraco Pharmaceutical Laboratories V. Novo Nordisck , Michael Vincent Ruocco

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


Drug Induced Insanity And Unconsciousness - A Clarification Of California Law, Jerome Bleiweis May 2013

Drug Induced Insanity And Unconsciousness - A Clarification Of California Law, Jerome Bleiweis

Pepperdine Law Review

No abstract provided.


A Prescription Warning, Carlton Lee Harpst May 2013

A Prescription Warning, Carlton Lee Harpst

Pepperdine Law Review

No abstract provided.


Drugs And Alcohol In The Workplace , Venable, Baetjer & Howard, Esqs. Apr 2013

Drugs And Alcohol In The Workplace , Venable, Baetjer & Howard, Esqs.

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


Book Reviews, David J. Agatstein Apr 2013

Book Reviews, David J. Agatstein

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


Environmental Regulation And The Doctrine Of Scientific Uncertainty: A Case Study Of The Epa's Cancellation Of 2, 4, 5-T, Wendy Wagner Apr 2013

Environmental Regulation And The Doctrine Of Scientific Uncertainty: A Case Study Of The Epa's Cancellation Of 2, 4, 5-T, Wendy Wagner

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


Utica Packing Co. V. Block, 781 F.2d 71 (6th Cir. 1986), David J. Agatstein Apr 2013

Utica Packing Co. V. Block, 781 F.2d 71 (6th Cir. 1986), David J. Agatstein

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


Jurisdiction Of The Food And Drug Administration To Regulate Tobacco Products Under The Food, Drug, And Cosmetic Act: Food And Drug Administration V. Brown & Williamson Tobacco Corporation Et Al., Alison J. Lezak Apr 2013

Jurisdiction Of The Food And Drug Administration To Regulate Tobacco Products Under The Food, Drug, And Cosmetic Act: Food And Drug Administration V. Brown & Williamson Tobacco Corporation Et Al., Alison J. Lezak

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen Mar 2013

California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor Feb 2013

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 …


Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler Feb 2013

Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler

Pepperdine Dispute Resolution Law Journal

The article presents information on the Vaccine Injury Compensation Program. It discusses the U.S. Federal circuit case Hazlehurst v. Sec'y of Health & Human Servs., in which lawsuit against the defendant was filed by the plaintiff who sought claims against the liability of product to recover damages for alleged injuries which his son had received from vaccines. It also provides information on the structural moral hazard of the program which devolves it into a litigious adjudicatory process.


Mandatory Drug Testing Of College Athletes: Are Athletes Being Denied Their Constitutional Rights? , Allison Rose Jan 2013

Mandatory Drug Testing Of College Athletes: Are Athletes Being Denied Their Constitutional Rights? , Allison Rose

Pepperdine Law Review

No abstract provided.


Reconciling American Marijuana Policy In A Federal System, Catherine Morton Jan 2013

Reconciling American Marijuana Policy In A Federal System, Catherine Morton

Global Tides

The recent successful ballot initiatives in Colorado and Washington to legalize recreational marijuana despite restrictive federal law continue to demonstrate the disconnect between national and state marijuana policy. In order to understand how many of these national policies were enacted, an investigation will be presented of the discriminatory history of marijuana legislation, indicating the inconsistent nature of past regulation. Thus following will be an examination of relevant Supreme Court cases depicting the Supreme Court’s ultimate hesitation to prevent the states from circumventing federal marijuana law. Finally, a discussion will be held on the ramifications of inconsistent state and national policies, …


Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff Nov 2012

Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff

Pepperdine Law Review

No abstract provided.


Vaccines And The Law, Michael Sanzo Ph.D. Nov 2012

Vaccines And The Law, Michael Sanzo Ph.D.

Pepperdine Law Review

The last twenty years have seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence under the National Childhood Vaccine Injury Act compensation program for injuries that might have been the result of vaccinations. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of causal certainty that would be required …


The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano Oct 2012

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.


The Gray Zone In The Power Of Local Municipalities: Where Zoning Authority Clashes With State Law, Skye L. Daley Oct 2012

The Gray Zone In The Power Of Local Municipalities: Where Zoning Authority Clashes With State Law, Skye L. Daley

The Journal of Business, Entrepreneurship & the Law

This article will explore the oft-overlooked area of police powers granted to local municipalities by the California Constitution through the lens of marijuana dispensaries. These dispensaries, and the obstacles they face, provide the perfect vantage point from which to survey the current status of zoning power in California. This article will consider the extent and limits of what is known as the “police powers” of local municipalities: the power of cities, towns and counties to regulate, restrict, and proscribe the way in which land can be utilized within its borders. If local municipalities are the creation of the state--indeed, an …