Food and Drug Law Commons^™

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 …

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 …

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. …

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 …

Consumer Power To Change The Food System? A Critical Reading Of Food Labels As Governance Spaces: The Case Of Acai Berry Superfoods, Christine Parker, Hope Johnson, Janine Curll

Journal of Food Law & Policy

This article argues that the marketing claims on food labels are a governance space worthy of critical examination. We use a case study of superfood açaí berry products to illustrate how marketing claims on food labels encapsulate dominant neoliberal constructions of global food systems. These marketing claims implicitly promise that by making careful choices consumers can resist and redress the ravages of unbridled global capitalism. Food labels suggest that consumers can use market signals to simultaneously govern our own selves and the market to ensure sustainable, fair, and healthy consumption. In response, this article develops, justifies and applies a socio-legal …

The Clash Of Agricultural Exceptionalism And The First Amendment: A Discussion Of Kansas' Ag-Gag Law, Meredith Kaufman

Journal of Food Law & Policy

Since the Nation’s founding, agricultural production has been treated differently than other industries. This concept, known as “agricultural exceptionalism,” has manifested in many different ways throughout U.S. history. Since the 1990s, one manifestation of agricultural exceptionalism has been the enactment of “Ag-gag laws,” state laws that limit information gathering activities at animal production facilities. Ag-gag laws are frequently criticized by animal welfare advocates and legal scholars for seeking to shield animal production facilities from public scrutiny, a state-sanctioned protection not afforded to other industries.

Blockchain Meets Genomics: Governance Considerations For Promoting Food Safety And Public Health, Walter G. Johnson

Journal of Food Law & Policy

Foodborne illness remains an ongoing public health challenge in both the developing and industrialized worlds. In the United States, almost 50 million reported cases of infectious disease occur every year from a food product, resulting in substantial morbidity and mortality with economic burdens to health care and productivity. Despite recognition as a leader in food safety, the U.S. experiences longstanding and novel issues in food safety. Advances in whole genome sequencing (WGS) promise to bolster food safety regulators’ capabilities to identify pathogens and determine their source. However, inefficiencies in tracing food products through the supply chain remain.

Federal Regulation Of Pesticide Residues: A Brief History And Analysis, Kate Z. Graham

Journal of Food Law & Policy

In the United States today, there are over 900 pesticides in use1 and over 400 are approved for use in food production, whether used as part of the growing process or in post-harvest handling. Although the history of pesticide use in food crops goes back centuries, the post-war period has seen an enormous growth in the varieties and amounts of pesticides used in our food system. As our reliance on pesticides has grown, pesticides have become a divisive issue. Pesticide advocates view them as essential to a secure and reliable food supply needed to feed a growing world population. Detractors, …

Legislative And Executive Branch Developments Affecting The United States Department Of Agriculture Supplemental Nutrition Assistance Program, Sheila Fleischhacker, Alyssa Moran, Sara N. Bleich

Journal of Food Law & Policy

For more than forty years, the United States Department of Agriculture Supplemental Nutrition Assistance Program (SNAP; formerly Food Stamps) has offered nutrition assistance to nearly forty million eligible individuals and families each month. This article first provides a brief overview of the evolution of the United States’ largest domestic food security and nutrition safety net program. Then, the article reviews Congressional actions taken regarding SNAP during the 2018 Farm Bill deliberations, appropriations for fiscal years 2017 through 2020, and oversight (in)activities. The article focuses on Congressional activities regarding block grants; participant eligibility; benefit adequacy, issuance, and redemption; and strengthening SNAP’s …

“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 …

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 …

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 …

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 …

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.