Food and Drug Law Commons^™

Sprung From Night Into The Sun: An Examination Of Colorado's Marijuana Regulatory Framework Since Legalization, Robert T. Hoban, Raushanah A. Patterson

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The Lanham Act's Wonderful Complement To The Fdca: Pom Wonderful V.Coca-Cola Enhances Protection Against Misleading Labeling Through Integrated Regulation, Jennifer Thurswell Radis

Loyola University Chicago Law Journal

POM Wonderful sued Coca-Cola under the Lanham Act claiming that it suffered losses due to the misleading label on Coca-Cola’s Minute Maid brand’s Pomegranate Blueberry juice blend. Reversing the Ninth Circuit’s decision in June 2014, the Supreme Court found that POM’s claim was not precluded even though the label was regulated by the FDCA. In fact, the Court acknowledged the complementary nature of private enforcement with FDA regulation, as it did in Wyeth v. Levine in 2009. This Article submits that POM exemplifies the Court’s willingness to strengthen the Lanham Act’s protections against misleading labeling, as it did the same …

From Silicon Valley To The Kitchen Table: Innovative Online Agriculture & Food Start-Ups And The Law, Matthew A. Forcum

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

A Practitioner's Guide To Defending "Natural" Food Labeling Litigation, Lauren E. Handel

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Mad Cow Disease: Is There An App For That?, Sara Gonzalez-Rothi Kronenthal

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The Aged Distilled Spirits Competitiveness Act: Increasing Kentucky's Economic Output While Leveling The Playing Field For Kentucky Distilleries, Drake Staples

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Taking "The War On Drugs" To The Fields: The Importance Of Agriculture In Reforming International Law On The Illegal Drug Market, Terra Rivera

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Independent Drug Testing To Ensure Drug Safety And Efficacy, Marc A. Rodwin

Journal of Health Care Law and Policy

This Article explores a proposal that would preclude biased drug testing by removing all drug sponsor influence on the design and conduct of clinical trials for new drug applications (“NDAs”), a reform that would address the root of institutional corruption. Recently advocated by leading scholars, the idea has a long history, yet was neglected for over half a century due to pharmaceutical industry opposition.

Cool Story: Country Of Origin Labeling And The First Amendment, Rebecca Tushnet

Georgetown Law Faculty Publications and Other Works

Country of origin labeling (COOL) requirements have long been part of government regulation of commerce. While one might ordinarily think of mandatory COOL as part of trade policy--or even as a means of encouraging individual citizens to engage in country-specific buying that would be disallowed as protectionism if carried out by their governments -- the most robust legal challenges to mandatory COOL now come from the First Amendment, not from free trade principles. This reliance on free speech claims offers a stark example of the charismatic force of the First Amendment. Objections having little to do with free speech at …

Why Healthy Behavior Is The Hard Choice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Our society is structured to encourage unhealthy diets and physically inactive lifestyles, which are key risk factors for chronic diseases including diabetes, heart diseases, and cancers. We are bombarded with advertisements for hyperprocessed foods laden with saturated fat, salt, sugar, and refined carbohydrates, “low-fat” foods often contain high amounts of sugar and salt, and parks and recreation spaces are often inaccessible or unsafe.

Four simple ideas - taxes on unhealthy products, product reformulation, improving the informational environment, and increasing healthy food accessibility - could make healthy behaviors the “default” choice for most consumers. First, taxes on unhealthy products, such as …

The Codex Alimentarius Commission, Corporate Influence, And International Trade: A Perspective On Fda's Global Role, Sam F. Halabi

Faculty Publications

Section 305 of the FDA Food Safety Modernization Act specifically calls for FDA to develop recommendations on whether and how to harmonize requirements under the Codex Alimentarius Commission (“Codex”), an international organization charged with developing food standards, guidelines, codes of practice and “other recommendations to ensure fair practices in food trade and protect[ion of] the health of consumers.” FDA’s International Food Safety Capacity-Building Plan is largely supportive and deferential to Codex, concluding that “the use of Codex standards helps assure a safe global food supply.” To be sure, Codex’s stated mission and policies should create and facilitate adoption of universal …

The Implementation Of The Food Safety Modernization Act And The Strength Of The Sustainable Agriculture Movement, Samuel R. Wiseman

Scholarly Publications

In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug …

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

Faculty Publications By Year

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …

Tort As Democracy: Lessons From The Food Wars, Melissa Mortazavi

Faculty Articles

This Article develops alternative emerging theories regarding the function of tort in American civil society. Often, scholars and policymakers evaluate the tort system in terms of compensation, loss allocation, and risk management. This focus overlooks an important modern function of tort; in the context of the modern administrative state, tort is a vital player in the democratic deliberative process. Tort suits bring forth new ideas, force fact-finding, and increase communication amongst public and private institutional actors to develop sound and legitimate law and policy. Perhaps nowhere is this more obvious today than with the current boom of food litigation. Lawsuits …

The Not So "Sweet Surprise": Lawsuits Blaming Big Sugar For Obesity-Related Health Conditions Face An Uphill Battle, Catherine Srithong Wicker

Journal of Law and Health

Because obesity and its associated health problems have been largely attributed to poor self-control, laziness, and various other personal failings, society has been unwilling to assign blame to food manufacturers for their role in contributing to this problem. But, as consumers are becoming more aware of the significantly harmful effect that poor diets can have on a person’s heath, the scales may be tipping in favor of bringing “Big Food” to court. Food manufacturers, however, are not exactly vulnerable. Armed with precedent disputing the causal link between consumption of fast food and adverse health effects, judicially-created barriers to admitting epidemiologic …

Food Policy And Cognitive Bias, Paul F. Campos

Publications

No abstract provided.

Ending Drunk Driving With A Flash Of Light, Andrew Sullivan

Law Student Publications

Among the methods used to combat drunk driving is mandating a person convicted of driving under the influence/driving while intoxicated install an ignition interlock device (“IID”) in his/her vehicle as a condition of restoring his/her driving privileges.This comment argues that the National Highway Traffic Safety Administration (“NHTSA”) has the authority to issue such a regulation; it need only be presented with a workable opportunity to do so. The present state of IID technology is a poor candidate to make this hypothetical regulation workable, but advances in Near Infrared (“near-IR”) Spectroscopy will provide the technology necessary to make a discussion of …

Rethinking The Childhood-Adult Divide: Meeting The Mental Health Needs Of Emerging Adults, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

Part I of this article describes ADHD and explores the extent of ADHD medication abuse, especially among young adults. Part II discusses the characteristics of emerging adults, who may be more likely than their older counterparts to make unwise decisions about medications and other life choices.34 While we protect minors by requiring parental consent for their medical treatments, emerging adults are effectively able to obtain any drug on the market if they convince the doctor that they have the requisite diagnosis. Part III explores HIPAA, the medical malpractice standard of care and the challenges associated with a society that is …

Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition, Neil M. Issar

Vanderbilt Journal of Entertainment & Technology Law

A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA's express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit …

"Pay-For-Delay" Settlements Post-Actavis: Why Mediation Can Tackle The "Unreasonable" Antitrust Settlements, Sheena Ching

Cardozo Journal of Conflict Resolution

This Note discusses the benefits that mediation can have on the reverse payment settlement and antitrust debate, and how it can satisfy the "rule of reason" requirement post-Actavis. Accordingly, Section II discusses the legislative history and policy of the Hatch-Waxman Act. It elaborates on the pioneer drug development process and how the combination of legislation and the inherent nature of drug development resulted in "pay-for-delay" settlements. Section III discusses majority and dissenting opinions in the landmark Supreme Court case FTC v. Actavis as well as the circuit split decisions that led up to the Court's ultimate ruling and …