Food and Drug Law Commons^™

Smoking Out A Compromise: Splitting The Difference Through A Public Policy Approach To Resolving The Graphic Cigarette Warning Label Circuit Split, Amelia B. Larsen

Cleveland State Law Review

The imposition of graphic warning labels is necessary; the tobacco market exploits the lower class by capitalizing on their under-education regarding the negative health consequences of smoking. This injustice can be corrected by providing the most direct and clear communication imaginable to consumers to ensure they are completely informed of the peril they are placing themselves in when they choose to smoke—the graphic warning labels provide this kind of communication. This Note discusses why the FDA’s warning labels meet First Amendment constitutional scrutiny and serve a substantial governmental interest regarding the country’s public health, socioeconomic equality, and economy. Part II …

Greenwashing And Self-Declared Seafood Ecolabels, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

The credibility and veracity of an environmental claim depends on a high degree of transparency, clarity, and trust. Businesses that utilize ecolabels to market the environmental performance of their seafood products often turn to third-party certifications to minimize the potential for greenwashing and provide a level of verification and independence. Others rely on a riskier approach by developing their own self-declared or first-party ecolabels. Seafood retailers and suppliers considering the creation and use of an ecolabel, certification, or seal to be used in the marketing of seafood products should ensure compliance with applicable Food and Drug Administration and United States …

Sugary Drinks, Happy Meals, Social Norms, And The Law, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

What role should government play in discouraging harmful overconsumption? What modes of government intervention best strike the balance between effectiveness and political acceptability? It is well established that government has a legitimate interest in protecting the health and safety of the people, even from their own choices and actions. Furthermore, there is no fundamental right to sell or purchase particular services or products in particular configurations. The appropriate question, then, is not what government may do to prevent non- communicable diseases that are associated with individual behavior choices, but rather what government should do. This comment on David Friedman's Public …

Water Governance Challenges In New Mexico's Middle Rio Grande Valley: A Resilience Assessment, Melina Harm Benson, Dagmar Llewellyn, Ryan Morrison, Mark Stone

Publications

No abstract provided.

Jump In Before It's Too Late: Protecting And Increasing Streamflows In New Mexico, Sharon Wirth

Publications

Freshwater ecosystems need adequate streamflow to supply clean water for humans and maintain healthy habitat for wildlife. Over-appropriation, overuse, climate change, and drought plague New Mexico's rivers, taxing many rivers beyond sustainability. Despite the myriad of problems caused by little or no water in our rivers, policies and procedures to protect and increase streamflows in New Mexico are limited. While most Western states have made demonstrable progress in alleviating various legal and technical barriers to protecting and increasing streamflows, New Mexico has made only limited, recent progress towards solutions for our drying rivers. This article takes a critical look at …

Developing The Law Of The River: The Integration Of Law And Policy Into Hydrologic And Socio-Economic Modeling Efforts In The Willamette River Basin, Adell Louise Amos

Publications

A legal and policy infrastructure -- referred to as a "law of the river" -- exists for every river basin in the U.S. an can be as important as natural processes in terms of managing the future of the resource. Because of the way that water law and policy have evolved in the U.S., this infrastructure involves a matrix of state and federal law that governs the choices that policymakers, end users, and agencies make. This "law of the river" provides the context in which decisions are made and not made. It also draws the boundaries within which decision makers …

Fraud In The Market, Samuel R. Wiseman

Scholarly Publications

No abstract provided.

The Hang-Up With Hamburg: How Center For Food Safety V. Hamburg Will Alter The Food Industry, Joella Roland

Journal of Business & Technology Law

No abstract provided.

Hatch-Waxman’S Safe-Harbor Provision For Pharmaceutical Development: A Free Ride For Patent Infringers?, 13 J. Marshall Rev. Intell. Prop. L. 445 (2014), Kate Y. Jung

UIC Review of Intellectual Property Law

The Safe-Harbor provision of the Hatch-Waxman Act allows generic drug manufacturers to use a patented invention during pre-market testing of generic drugs. However, the U.S. Court of Appeals for the Federal Circuit’s recent interpretation of the Safe-Harbor provision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. created controversy when it extended the Safe-Harbor exemption to post-FDA approval. This extension was done in an unprecedented manner and would “allow almost all activity by pharmaceutical companies to constitute ‘submission’ and therefore justify a free license to trespass.” The U.S. Supreme Court has yet to settle this matter, and courts are now faced …

Food Choice: Should The Government Be At The Head Of The Table?, Emily Semands

Oklahoma Law Review

No abstract provided.

Excluding Patentability Of Therapeutic Methods, Including Methods Using Pharmaceuticals, For The Treatment Of Humans Under Trade Related Aspects Of Intellectual Property Rights Article 27(3)(A), Michael Henry Davis

Law Faculty Articles and Essays

The Agreement on Trade Related Aspects of Intellectual Property Rights ("TRIPS"), the General Agreement on Tariffs and Trade ("GATT"), and the World Trade Organization ("WTO") debacle has radically altered the traditional ability of nations to adopt whatever patent regime seems appropriate to them. Instead, TRIPS requires all member nations, even those which never thought it appropriate to grant such state monopolies, to afford patent protection to areas which had never been granted before-most dramatically in the area of health related innovations and, most expensively, pharmaceuticals. Until TRIPS, most -- or at least a number approaching half -- countries simply did …

Targeted Drug Donations: A Necessary Evil In Need Of A Global Harness And A Possible Cure For Trips Shortcomings, Gabriella Tzeneva

Indiana Journal of Global Legal Studies

This Note explores the economic and social factors that drive multinational pharmaceutical companies to donate drugs to developing countries and evaluates the effectiveness of such donations in combating medicine shortages. The Note poses that such donations provide necessary economic incentives to drug companies and help curb high medical prices in developed nations while being an essential tool for ameliorating intellectual property requirements imposed by TRIPS. The Note proposes two solutions to further incorporate donations in access to medicine relief efforts and advocates increased international cooperation in the practice.

Implementing The Food Safety Modernization Act: An Examination Of The Inequitable Impact Of The Proposed Preventive Controls And Produce Safety Rules, Ben Metzger

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Private Parties And The Ffdca: How Creative Litigants Have Circumvented Section 310 And Undermined The Nlea’S Express Preemption Amendments, Joe Dages

Catholic University Law Review

No abstract provided.

When Truth Cannot Be Presumed: The Regulation Of Drug Promotion Under An Expanding First Amendment, Christopher Robertson

Faculty Scholarship

The Food, Drug, and Cosmetic Act (FDCA) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off-label” uses, and often do so. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches.

This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark court of appeals decision holding that the First Amendment precludes …

23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely

Other Publications

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.

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 …

The Highs Of Tomorrow: Why New Laws And Policies Are Needed To Meet The Unique Challenges Of Synthetic Drugs , Joseph A. Cohen

Journal of Law and Health

This article reviews the federal government’s attempts to control the influx of synthetic drugs, particularly synthetic cannabinoids and cathinones, into the U.S. recreational drug market since 2008. It offers three recommendations targeted at Congress, the DEA, and the Department of State on ways to prevent and control synthetic drug use in America: (1) Congress should grant the DEA a new “immediate scheduling” authority; (2) the DEA should improve information sharing with states; and (3) the Department of State and the DEA should prioritize the development of a global early warning system.

Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson

Law Student Publications

This article explores whether a graphic warning is possible or preferable in the government's fight against tobacco. Part II outlines a brief history of tobacco regulation in the United States. Part III turns to the Family Smoking Prevention and Tobacco Control Act (FSPTCA) and the FDA's initial rulemaking process. Part IV outlines the doctrine of commercial free speech, and Part V discusses why the Rule faced insurmountable challenges under this jurisprudence. Part VI explores how the FDA may overcome these hurdles in its future rulemaking, while Part VII discusses alternative methods through which the government can pursue its anti-tobacco agenda …

The International War Against Doping: Limiting The Collateral Damage From Strict Liability, Thomas W. Cox

Vanderbilt Journal of Transnational Law

The World Anti-Doping Agency (WADA) and the World Anti-Doping Code are largely considered the model for an effective and well-coordinated antidoping regime. This model has allowed numerous sports and various countries to secure the same rules for domestic and international athletes. Within this regime, strict liability for prohibited substances stands as the "cornerstone." Strict liability has allowed antidoping officials to prosecute doping violations through an effective testing regime. However, this principle occasionally implicates innocent athletes with no intention of performance enhancement. This Note proposes that WADA modify its criteria for including substances on the Prohibited List and suspend strict liability …