Food and Drug Law Commons^™

Increasing Access To Emergency Contraceptive Pills Through State Law Enabled Dependent Pharmacist Prescribers, Heather M. Field

Faculty Scholarship

No abstract provided.

Essay: The Risks Of Going Non-Gmo, Drew L. Kershen

Oklahoma Law Review

No abstract provided.

Essay: The Risks Of Going Non-Gmo, Drew L. Kershen

Faculty Articles

No abstract provided.

Risk-Based Monitoring: A Model And Application To Fda’S Imported Food Monitoring Program, Sheila A. Martin, Nancy Dean Beaulieu, Richard Williams

Institute of Metropolitan Studies Publications

Regulatory agencies intervene in risky situations by outlawing practices that impose risks on society or by proscribing practices that reduce risk. Because public resources for enforcing regulation are limited, public policy has recently emphasized maximizing the benefit from enforcement by considering the risk reduction achievable from each intervention. This emphasis requires a shift of resources to monitoring situations in which regulatory violations are most likely, their welfare effects are most serious, and their detection is probable and relatively inexpensive. This article is a risk-based monitoring model applied to the Food and Drug Administration's (FDA) import monitoring program. Although some components …

Pesticide Residue Regulation: Analysis Of Food Quality Protection Act Implementation, Linda-Jo Schierow

RISK: Health, Safety & Environment (1990-2002)

Dr. Schierow discusses the effects of a recent statute on food safety.

Views From The Drugs Summit, Mark Findlay

Research Collection Yong Pung How School Of Law

The jury is still out on whether the Drugs Summit was a political set piece. The Opposition participants regularly accused the Government of just that. Without doubt, however, it was the reaction of the Opposition which was orchestrated and pre-conceived.

Does A Genetically Modified Rose Still Smell As Sweet: Labeling Of Genetically Modified Organisms Under The Biosafety Protocol, Lisa A. Tracy

Buffalo Environmental Law Journal

No abstract provided.

Looking Back: Cyclamate, Allan Mazur, Kevin Jacobson

RISK: Health, Safety & Environment (1990-2002)

The second in a series re-evaluating hazards identified in the 1950s and 60s.

Legislative Developments In The Regulation Of Insurance Coverage: Will These New Regulations Benefit Women With Breast Cancer? , Julia Anastasio

American University Journal of Gender, Social Policy & the Law

No abstract provided.

Deleting The Bolar Amendment To The Hatch-Waxman Act: Harmonizing Pharmaceutical Patent Protection In A Global Village, 32 J. Marshall L. Rev. 751 (1999), Ned Milenkovich

UIC Law Review

No abstract provided.

Licensed To Steal: Has Sovereign Immunity Gone Too Far, 32 J. Marshall L. Rev. 779 (1999), Sulaiman M. Qazi

UIC Law Review

No abstract provided.

It's A Wonderful Genome: The Written-Description Requirement Protects The Human Genome From Overly-Broad Patents, 32 J. Marshall L. Rev. 805 (1999), Emanuel Vacchiano

UIC Law Review

No abstract provided.

Food For Sport Or Faustian Bargain: Regulating Performance Enhancing Dietary Supplements, Jennifer Kay Braman

Cleveland State Law Review

The defining line between legal and illegal substance-between dietary supplement and drug is horribly skewed. Accordingly, Part I of this Note will investigate the complexities that exist with regard to the classification and regulation of dietary supplements, looking at the history leading to the passage of the governing Dietary Health and Supplement Act of 1994. Part II will focus on supplements that consumers may use for performance enhancement purposes, and the regulation of sports products. Part III will look at the regulatory debate over dietary supplements, the andro product example and the interrelationship between drugs and sport. Part IV will …

Current Legal Intervention Regarding Experimental Treatments Must Be Changed: An Analysis Of High Doses Of Chemotherapy With Autologous Bone Marrow Transplantation For Breast Cancer Patients, Emily Smayda

Journal of Law and Health

The specific analysis of HDC-ABMT will help the reader to realize that the medical procedures being dealt with by litigation are not necessarily wildly innovative. Insurance companies are hiding behind the guise of words such as "experimental" to avoid paying for treatments that are both feasible and needed. Further, HDC-ABMT being used for breast cancer patients, suggests a possible discriminatory aspect that cannot be reached with current legal intervention. This Note suggests ways of dealing with insurance coverage denial on a more direct level. Instead of being bogged down by contract language and ERISA preemption, proposals for national standards and …

Misconceptions And Misleading Information Prevail - Less Regulation Does Not Mean Less Danger To Consumers: Dangerous Herbal Weight Loss Products, Jennifer Sardina

Journal of Law and Health

This Note will examine the dangers associated with current dietary supplement regulation under the DSHEA and the problem of ill-informed consumers. As reflected in the title of this Note, misconceptions about dietary supplement regulation are abundant; consequently, section II of this Note will further discuss and offer illustrations in support of this position. Part III gives an overview of current regulation under the Dietary Supplement Health and Education Act of 1994. Also a brief discussion of the legislation that preceded the DSHEA is offered in section VI. Part V of this Note analyzes and defines the dietary ingredients that are …

Thalidomide And The Titanic: Reconstructing The Technology Tragedies Of The Twentieth Century, George J. Annas

Faculty Scholarship

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the …

Judicial Review Of Fda Preemption Determinations, Amanda Frost

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Regulation Of Dietary Supplements: Five Years Of Dshea, Laura A. Webb

Law Faculty Publications

On October 25, 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA),2 passed unanimously by both houses of Congress. This law radically changed the regulatory landscape for the sale and labeling of dietary supplements, restricting the Food and Drug Administration's (FDA's) authority in certain ways, and encouraging the sale of dietary supplements, including vitamins, minerals, herbs, botanicals, and amino acids.

This article examines DSHEA and discusses current FDA attempts to regulate dietary supplements. Part II provides a brief background and discusses FDA's concerns and attitude toward dietary supplements before the passage of DSHEA. Part III …

Professional Athletes-Held To A Higher Standard And Above The Law: A Comment On High-Profile Criminal Defendants And The Need For States To Establish High-Profile Courts, Laurie Nicole Robinson

Indiana Law Journal

No abstract provided.

Extraditing Mexican Nationals In The Fight Against International Narcotics Crimes, Joshua S. Spector

University of Michigan Journal of Law Reform

In recent years, Mexican narcotics trafficking has become a major threat to the security of the Americas. Mexican narco-traffickers have used their wealth and violence to corrupt political and judicial systems and avoid effective prosecution or penalty in Mexican courts. Historically, Mexico has refused to extradite its nationals in reliance on Mexican law prohibiting the extradition of nationals in all but "exceptional" cases. This Note argues that Mexico should take a step toward controlling the cross-border narcotics trade and recognize international drug trafficking as an "exceptional" crime. Upon recognizing narcotics crimes as "exceptional," Mexico should then begin extraditing Mexican narco-traffickers …

Food Stamp Trafficking: Why Small Groceries Need Judicial Protection From The Department Of Agriculture (And From Their Own Employees), Elliot Regenstein

Michigan Law Review

A neon sign in the window of 7-Van Drugs reads "Food Stamps," but the contradictory truth is posted inside on a handwritten sign taped to a thick pane of bulletproof plastic. 7-Van Drugs sits at the intersection of Seven Mile Road and Van Dyke in northern Detroit, where it has "serv[ ed] the community since 1948 at the same corner." Inside 7-Van is an array of staple foods and basic household cleaning items, and there is a small pharmacy in the back. Customers must use a turnstile to pass their purchases through the bulletproof plastic to the cashier. There are …

Identifying The Enemy In The War On Drugs: A Critique Of The Developing Rule Permitting Visual Identification Of Indescript White Powder In Narcotics Prosecutions , Michael D. Blanchard, Gabriel J. Chin

American University Law Review

No abstract provided.

Proposition 215: De Facto Legalization Of Pot And The Shortcomings Of Direct Democracy, Michael Vitiello

University of Michigan Journal of Law Reform

In 1996, California voters passed Proposition 215, officially titled The Compassionate Use Act of 1996, and popularly known as the "medical marijuana" initiative. This initiative allows qualifying people and their caregivers immunity from criminal prosecution when the state attempts to charge them with possession or cultivation of marijuana. Professor Vitiello uses the medical marijuana initiative as a case study illustrating flaws in California's ballot initiative process He examines the history of the initiative process in California, misleading aspects of the campaign for Proposition 215, and ambiguities in the proposition's language. Concluding that the initiative process as it now stands fosters …

Teen Smoking Behavior And The Regulatory Environment, Joni Hersch

Vanderbilt Law School Faculty Publications

Professor Hersch argues that most state regulations aimed at fighting teen smoking have had little or no effect. She provides evidence that despite widespread age restrictions on purchasing tobacco, most teens do not consider it difficult for minors to purchase tobacco products within their community. She also presents evidence demonstrating a strong correlation between smoking rates and perceptions about the addictive nature of smoking. These findings suggest that facilitating greater awareness of the addictive power of cigarettes could be effective in curbing teen smoking. She explores the potential for parental restrictions on limiting teen smoking, but provides indications that parents …

Public Schools And Urinalysis: Assessing The Validity Of Indiana Public Schools' Student Drug Testing Policies After Vernonia, Nancy J. Flatt-Moore

Brigham Young University Education and Law Journal

No abstract provided.

Dollywood Is Not Just A Theme Park In Tennessee Anymore: Unwarranted Prohibitory Human Cloning Legislation And Policy Guidelines For A Regulatory Approach To Cloning, 31 J. Marshall L. Rev. 1385 (1998), Paul Tully

UIC Law Review

No abstract provided.

Overdue Process: Why Denial Of Physician-Prescribed Marijuana To Terminally Ill Patients Violates The United States Constitution, Matthew Segal

Seattle University Law Review

This Comment will begin with a brief history of the medical use of marijuana in western culture and the United States. It will then examine the existing federal statutory scheme governing the use of marijuana and conclude with a look at current beliefs about the medical value of marijuana. Section III will analyze previous attempts to collaterally attack the scheduling of marijuana through the courts and show why those efforts have generally failed. Section IV will perform a substantive due process analysis of William Cohen's case and submit that Mr. Cohen has a fundamental right to consult with his physician …

Terry, Race, And Judicial Integrity: The Court And Suppression During The War On Drugs, Jack B. Weinstein, Mae Quinn

Journal Articles

No abstract provided.

Transcript Of The Florida Tobacco Litigation Symposium - Fact, Law, Policy And Significance, Jeffrey W. Stempel, Jean R. Sternlight

Scholarly Works

On November 17, 1997, Professors Jeffrey W. Stempel and Jean R. Sternlight joined a group of colleagues specializing in litigation at the Florida State University College of Law Review's Symposium on the tobacco litigation settlement reached between the State of Florida and five leading tobacco manufacturers that same year. The professors appeared on a panel to discuss the the relationship among the legal system, public health concerns, and tobacco. This is a transcript of those preceedings.

A Critique Of The Proposed National Tobacco Resolution And A Suggested Alternative, Jon D. Hanson, Kyle D. Logue

Articles

The first criticism is that the proposed resolution would not require manufacturers and, in tum, consumers to pay anything approaching the true total costs of cigarettes, costs that we estimate to be at least $7 per pack, a number that is considerably higher than other estimates that have been reported in the media. Our estimate includes some, but not all, of the costs borne ultimately by smokers themselves, by smokers' insurers, and by individuals injured by second-hand smoke. It includes only future costs and excludes many of those. So, for example, the figure includes neither the health-care costs that have …