Food and Drug Law Commons^™

A Meticulous Food Safety Plan Today Avoids Handcuffs Tomorrow, Kim Bousquet

Journal of Food Law & Policy

In August 2010, thousands of people across the United States were poisoned by eating eggs unknowingly tainted with Salmonella enteritidis bacteria. Following a lengthy investigation, the owners of the facility where the outbreak began were sentenced to three months in prison. This is not a one-off case; poor food safety practices are responsible for several outbreaks and often end in incarceration. Filthy hen houses, diseased fruit storage, and negligent food processing may be the last thing we want to imagine, but these practices have much to teach today's food producers. This article first examines how poor food production practices can …

Defining Fishing, The Slippery Seaweed Slope, Ross V. Acadian Seaplants Ltd., Rebecca P. Totten

Ocean and Coastal Law Journal

In Maine, the intertidal zone has seen many disputes over its use, access, and property rights. Recently, in Ross v. Acadian Seaplants, Ltd., the Maine Supreme Judicial Court, sitting as the Law Court, held that rockweed seaweed in the intertidal zone is owned by the upland landowner and is not part of a public easement under the public trust doctrine. The Court held harvesting rockweed is not fishing. This case will impact private and public rights and also the balance between the State's environmental and economic interests. This Comment addresses the following points: first, the characteristics of rockweed and the …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Articles

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Effect Of Poor Sanitation Procedures On Cross-Contamination Of Animal Species In Ground Meat Products, Sunjung Chung

Food Science (MS) Theses

While the presence of ≥1% of an undeclared species in ground meat generally used as an indicator of intentional mislabeling as opposed to cross-contamination, the actual percent of undeclared species resulting from cross-contamination has not been experimentally determined. The objective of this study was to quantify the effect of sanitation procedures on the crosscontamination of animal species in ground meat products, using undeclared pork in ground beef. Pork (13.6 kg) was processed using a commercial grinder, then one of three sanitation treatments was completed (“no cleaning”, “partial cleaning”, or “complete cleaning”). Next, beef (13.6 kg) was ground using the same …

That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn

Concordia Law Review

By their very nature, patents are exclusionary. A patent grants the right to exclude others from making use of an invention or process. But patents are also tools to promote innovation. However, when an invalid patent is granted, the patent becomes an exclusionary tool that also chills innovation. Invalid cannabis patents may be chilling innovation in the cannabis market, but they may not be the only thing. While the Controlled Substances Act continues to prohibit cannabis at a federal level, researchers and medical professionals will be unsure of the legality of their actions. This naturally leads to another chilling effect …

Regulating The Blue Revolution: A Sea Of Change For The United States’ Offshore Aquaculture Industry Or A Missed Opportunity For Increased Sustainability, Elan Lowenstein

University of Miami International and Comparative Law Review

Aquaculture has the potential to be one of the most efficient methods of food production to date. In recent years, the developments in offshore finfish aquaculture have proven to be more environmentally friendly than large-scale terrestrial animal farming, requiring a fraction of resources such as freshwater which are becoming more scarce in the face of global population growth, while also relieving pressures on wild fisheries. The United States is one of the largest global consumers of seafood, importing about ninety-percent of its supply. The current regulatory framework for offshore aquaculture in the United States is effectively non-existent. Federal courts have …

Lactose’S Intolerance: The Role Of Manufacturers’ Rights And Commercial Free Speech In Big Dairy’S Fight To Restrict Use Of The Term “Milk”, Kathleen Justis

Brooklyn Law Review

This note examines the relationship between restrictions on commercial speech and manufacturers’ First Amendment right to describe their products to consumers, with a focus on the DAIRY PRIDE Act. It argues that broad, content-based restrictions of commercial speech, like that proposed in the DAIRY PRIDE Act, likely impose unconstitutional limitations on manufacturers’ First Amendment right to freedom of speech. This note recommends that both Congress and the FDA should refrain from passing a statute or promulgating a regulation like the DAIRY PRIDE Act. Rather, it proposes that adding rules to control the proportions and location of disclaimers on product labels …

The Authorization Continuum: Investigating The Meaning Of "Authorization" Through The Lens Of The Controlled Substances Act, Breanna C. Philips

Vanderbilt Law Review

Federal prohibitions are ubiquitous in society. These prohibitions may be absolute, providing no exceptions, or they may be qualified, providing exemptions that allow specified parties to avoid a law's reach. The power to exempt parties from a prohibition is not limited to the federal government; it may be delegated to states or smaller polities as well. This is the structure that Congress employed when enacting the Mail Order Drug Paraphernalia Control Act: the Act bans, among other things, the sale and distribution of drug paraphernalia but provides an exemption for "any person authorized by local, State, or Federal law."

While …

Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert

Brooklyn Law Review

Milk is one of the most ubiquitous and heavily regulated substances on the planet—and perhaps one of the most contested. It is tied closely to notions of purity, health, and femininity, and is seen as so central to human civilization that our own galaxy—the Milky Way—is named after it. But despite its wholesome reputation, milk has long had a sinister side, being bound up with the exploitation of the (human and nonhuman) bodies it comes from and being a symbol of and tool for white dominance and superiority. The word itself, in verb form, means “to exploit.” It is also …

Solving The Opioid Epidemic In Ohio, Lacy Leduc

Journal of Law and Health

On May 31, 2017, Ohio Attorney General Mike DeWine took a step in fighting Ohio's opioid epidemic, bringing the first of many lawsuits against five top pharmaceutical companies. However, under Federal and State law, there is an exception called the Learned Intermediary Doctrine, which can absolve drug manufacturers of liability from any misconduct that might be found and transfer that liability to a treating physician. This exception is the way many drug manufacturers were able to avoid being held responsible in the past. This Note proposes that with the current pending lawsuit in the State of Ohio, an exception to …

Access Before Evidence And The Price Of The Fda's New Drug Authorities, Erika Lietzan

Faculty Publications

Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA's standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States "gold standard" for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …

Animal Agriculture Liability For Climatic Nuisance: A Path Forward For Climate Change Litigation?, Daniel E. Walters

Faculty Scholarship

Despite possessing statutory authority to regulate at least some contributing causes of climate change, environmental regulators in the United States have recently found themselves tied up in political gridlock. In response, advocates are turning from the regulatory track to a common law liability track, bringing public nuisance suits against fossil fuel producers and electric utilities. However, most of these public nuisance suits have met a common fate: they have been held to be displaced by the comprehensive regulatory framework for controlling greenhouse gas emissions contained in the Clean Air Act. As long as there is even the possibility of regulatory …

Hemp Fiber, Howard J. Bromberg, Ming Y. Zheng

Book Chapters

Hemp, Cannabis sativa, is indigenous to temperate regions in Asia. All major industrialized countries but the United States cultivate hemp for its fibers and oil-rich seeds. The former Soviet Union was the world's leading producer until the 1980s. As of 2018, China was the largest producer, with other significant industries in Ukraine, Russia, China, Canada, Austria, Australia, Great Britain, Hungary, Romania, Poland, France, Italy, and Spain.

Cannabis was initially spread around the world because of its fiber, not its intoxicant chemicals or its nutritious oil seeds. It is one of the oldest sources of textile fiber, whose use for cloth …

“Big” Food, Tobacco, And Alcohol: Reducing Industry Influence On Noncommunicable Disease Prevention Laws And Policies, Belinda Reeve, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The food, tobacco and alcohol industries have penetrated markets in low- and middle-income countries (LMICs), with a significant impact on these countries’ burden of noncommunicable diseases (NCDs). Tangcharoensathien and colleagues describe the aggressive marketing of unhealthy food, alcohol and tobacco in LMICs, as well as key tactics used by these industries to resist laws and policies designed to reduce behavioural risk factors for NCDs. This commentary expands on the recommendations made by Tangcharoensathien and colleagues for preventing or managing conflicts of interest and reducing undue industry influence on NCD prevention policies and laws, focusing on the needs of LMICs. A …

Something To Wine About: What Proposed Revisions To Wine Labeling Requirements Mean For Growers, Producers, And Consumers, Deborah Soh

Brooklyn Journal of Corporate, Financial & Commercial Law

Title 27 of the Code of Federal Regulations governs the standards for the information that is printed on wine bottle labels, including the appellation of origin. Currently, however, wines are exempt from these regulations if they will not be introduced in interstate commerce. There is a proposed amendment to the Code that would bring all wines, regardless of whether they are sold interstate or solely intrastate, under the federal standards for wine labeling. Between the current system, which permits exempt wines to sidestep the regulations, and the proposal, which would exact strict standards of compliance uniformly, lies a middle-ground approach …

How Chevron Deference Is Inappropriate In U.S. Fishery Management And Conservation, Charles T. Jordan

Seattle Journal of Environmental Law

Well managed fisheries represent an excellent source of sustainable food making the management of which incredibly important. The management of fisheries in the United States is governed by The Magnuson-Stevens Fishery Conservation and Management Act (MSFCMA). While the Act creates strong goals and mandates to ensure the best management of fisheries as an important natural resource, there are issues of delegation within the act. The MSFCMA ultimately delegates authority to eight regional councils which are made up of unelected and un-appointed members. The membership of these councils is at risk of industry influence with little legal protections. Critical in how …

Makeup Call: How Cosmetic Product Use Affects Women Absent Federal Regulation, Gabrielle Eriquez

William & Mary Journal of Race, Gender, and Social Justice

No abstract provided.

The Current State Of Opioid Litigation, Richard C. Ausness

Law Faculty Scholarly Articles

Opioid litigation began around the turn of the century and mostly involved unsuccessful lawsuits by addicts against the manufacturers of prescription opioids. The landscape began to change several years ago when a number of state and local governments filed lawsuits against opioid drug manufacturers, seeking damages and other relief for the social and economic consequences of widespread opioid addiction in their territory. Since then, hundreds of government entities (hereinafter referred to as "government plaintiffs") have sued the manufacturers, distributors, prescribers, retail sellers, corporate officers and physician promoters of opioid products (hereinafter referred to as "defendants"). When I began working on …

Legal Implications Of "Organic" Seafood Labeling Based On Foreign Standards, Read Porter, Kathryn Kulaga

Sea Grant Law Fellow Publications

No abstract provided.

Opioid Policing, Barbara Fedders

Indiana Law Journal

This Article identifies and explores a new, local law enforcement approach to alleged drug offenders. Initially limited to a few police departments, but now expanding rapidly across the country, this innovation takes one of two primary forms. The first is a diversion program through which officers refer alleged offenders to community-based social services rather than initiate criminal proceedings. The second form offers legal amnesty as well as priority access to drug detoxification programs to users who voluntarily relinquish illicit drugs. Because the upsurge in addiction to —and death from—opioids has spurred this innovation, I refer to it as “opioid policing.” …