Food and Drug Law Commons^™

Following The Framework: Intentional Genomic Alterations In Animals, Sarah Copper

Journal of Food Law & Policy

Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, …

The Cow Has Left The Barn: Updating Standards Of Identity To Reflect Consumer Understanding Of Plant-Based Foods, Nicholas G. Miller

Journal of Food Law & Policy

Have you ever seen “tofurkey” at the supermarket and thought it was a rare, delicious cousin of the turkey? The animal based food industries, led by milk and meat producers, are claiming that the reasonable consumer might. On the other hand, the plant based food substitutes are appearing on supermarket shelves with increasingly bold names for their products that tap into our familiarity with animal-based foods, using names like “Beyond Meat.” Where do we draw the line on what plant based food can be called? And who should draw that line? This paper examines the debate surrounding the labeling of …

Fda As Food System Stewards, Margot J. Pollans, Matthew F. Watson

Elisabeth Haub School of Law Faculty Publications

The Food and Drug Administration (“FDA”) is one of the primary regulators of the U.S. food system, yet it all but ignores the food system's vast environmental footprint. Although the agency is not technically an environmental agency, it could and should view redressing the food system's significant environmental footprint as part of its health and safety mission. In this Article, we review FDA's history of National Environmental Policy Act (“NEPA”) compliance. This history affirms our hypothesis that FDA does not view its own work as environmental. The review, along with assessment of some of FDA's core food programs, reveals that …

United States Food Law Update, Michael Tingey Roberts, Margie Alsbrook

Journal of Food Law & Policy

This update summarizes some of the significant changes and developments in food law over the first half of 2006. Not every change in food law is included; instead, this update provides a starting point for scholars, practitioners, food industry members, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates, which appear in each issue of the Journal of Food Law & Policy, also provides historical context for the development of significant food law issues over time. New developments in state law, while certainly important and deserving in …

United States Food Law Update, A. Bryan Endres

Journal of Food Law & Policy

Michael T. Roberts and Margie Alsbrook noted in the Journal's inaugural Food Law Update that "[t]he one constancy about food law in the United States is change, especially in a rapidly-developing food industry." This observation holds true today and also augurs a change in authorship of this section of the Journal. I hope to follow my colleagues' lead and provide timely and cogent updates of the federal (and occasionally state) statutes, regulations, and judicial decisions impacting food law and policy. It is both an honor and a duty, as food and its legal implications remain in many respects "the world's …

The Future Of The Agricultural Industry – Is Blockchain A New Beginning?, Ryan Bisel

Seattle University Law Review

As we advance into a digital era, we begin to depend on technological innovations to rapidly help develop and update processes and methods within different industries. Blockchain technology—popularized by cryptocurrency—is slowly making its debut in the agricultural supply chain. Implementing a blockchain requirement for suppliers would be beneficial because it would allow agricultural suppliers and distributors to track their products in a more efficient manner. However, there are four potential legal issues that are foreseeable: (1) preemption, (2) overlapping regulatory authority, (3) applying current legal rules to new technology, and (4) contracting. This Note will specifically focus on issues of …

Going Hemp Wild: Understanding The Challenges And Opportunities For Fda Regulation Of Cbd In Food Products, Hannah Catt

Journal of Food Law & Policy

After the passage of the 2018 Farm Bill, champions of hemp began to tout opportunities for farmers and businesses involved with the crop. The industry has rallied around one of hemp’s major byproducts, cannabidiol, or CBD. However, the demand for CBD has left the Food and Drug Administration (“FDA”) playing catch-up. This article explains what CBD is, how it is derived, current FDA-approved uses, and a current path forward for the FDA in creating guidance for industry and consumers.

Welcome To The World Of Tomorrow: An Exploration Of Cell-Based Meats And How The Fda And Usda May Protect Intellectual Property Rights, Sean A. Grafton

Catholic University Journal of Law and Technology

Lab-grown meats are ready to be sold in United States markets. However, the meat product needs approval from regulators such as the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”). The regulation approval process takes a significant amount of time. This approval period will cut into the lab-grown meat producers’ patent time, rendering a period of the patent ineffective.

This Comment analyzes the effect of, and possible changes to, our current laws on the emerging lab-grown meat market. To look at this problem, this Comment compares FDA and USDA regulations, analyzes the Hatch-Waxman Act, and …

The New Food Safety, Margot J. Pollans, Emily M. Broad Leib

Elisabeth Haub School of Law Faculty Publications

A safe food supply is essential for a healthy society. Our food system is replete with different types of risk, yet food safety is often narrowly understood as encompassing only foodborne illness and other risks related directly to food ingestion. This Article argues for a more comprehensive definition of food safety, one that includes not just acute, ingestion-related risks, but also whole-diet cumulative ingestion risks, and cradle-to-grave risks of food production and disposal. This broader definition, which we call “Food System Safety,” draws under the header of food safety a variety of historically siloed, and under-regulated, food system issues including …

A National "Natural" Standard For Food Labeling, Nicole E. Negowetti

Maine Law Review

What do Juicy Juice fruit punch, SunChips, Nature Valley granola bars, and Skinny Girl Margaritas have in common? These products are all branded with the term “natural.” From canned vegetables to cereals to soft drinks, the term “natural” has become one of the most common claims on food, drugs, dietary supplements, and personal care products. The word “natural on the label or in advertising brings to mind nature, and things that are pure, clean, healthy, free of artificial additives, and therefore safe, harmless, and beneficial to overall health. In 2011, “all-natural” was the second-most-used claim on the new American food …

Agricultural And Food Law—Food Labeling And Biotechnology—The Food Fight Over Labeling Genetically Engineered Foods And A Natural Solution To Protect Agricultural Biotechnology In The Natural State, Katie W. Branscum

University of Arkansas at Little Rock Law Review

No abstract provided.

A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks

Publications

Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries learn …

Pay No Attention To That Man Behind The Curtain: Concealment, Revelation, And The Question Of Food Safety, Denis W. Stearns

Seattle University Law Review

Despite knowledge that commerce in food is a profit-driven enterprise, the public has consistently put great faith in the wholesomeness and safety of the food being purchased. To some extent, such faith is necessary, even if not always justified. In making the decision to put a bite of food in one’s own mouth, or the mouth of a friend or family member, a form of faith or trust must accompany the act of eating. For who would knowingly eat food suspected to be unsafe? But that is precisely what millions of people do every year, with a great many of …

Scale Economies, Scale Externalities: Hog Farming And The Changing American Agricultural Industry, Shi-Ling Hsu

Scholarly Publications

American agriculture is inexorably concentrating into the hands of a small number of large conglomerates. Expanding farms pursuing scale economies would normally have to abide by a system of environmental and other laws that would, in theory, require farms to account for negative externalities. If those laws were observed and enforced, they would help strike a balance between the greater profitability and the larger externalities of scaling up. But these laws are not widely observed nor rigorously enforced, which upsets this balance and gives large-scale farms a cost advantage while insulating them from corresponding responsibilities.

Perhaps nowhere in agriculture is …

A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor

David R. Kocan Professor

The U.S. Congress frequently passes laws facially unrelated to trade that significantly impact U.S. trade relations. These impacts are often harmful, significant, and long-lasting. Despite this fact, these bills rarely receive adequate consideration of how they will impact trade. Without this consideration, Congress cannot properly conduct a cost-benefit analysis necessary to pass effective laws. To remedy this problem, the U.S. Trade Representative should evaluate U.S. domestic law to determine whether it is consistent with international trade obligations. Moreover, the U.S. Congress committee structure should be amended so that laws that might impact trade are considered within that light. In the …

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

Jonathan R. K. Stroud

No abstract provided.

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.

Superweeds And Suspect Seeds: Does The Genetically-Engineered Crop Deregulation Process Put American Agriculture At Risk, Margaret Sova Mccabe

Law Faculty Scholarship

The federal government’s regulatory approach to genetically engineered (GE) crops, known as “The Framework”, is now twenty-five years old. Despite two and half decades of a consistent regulatory regime, GE crop and food regulation remains controversial. This article suggests that regulatory science and its tenets of independence, transparency, and public science should guide reforms of The Framework so that it is an efficient and reliable regulatory system. The article has four parts: 1) it provides a brief overview of the history of GE crop regulation; 2)it describes the key attributes of The Framework and related regulatory documents, with particular focus …

Cloned Meat, Voluntary Food Labeling, And Organic Oreos, Donna M. Byrne

Faculty Scholarship

In December 2006, the Food and Drug Administration (FDA) announced that it had reviewed all the available evidence and was poised to approve meat and milk from cloned animals and their progeny. Such products, said the FDA, are virtually identical to meat or milk from a non-clone. Further, the FDA announced it would almost certainly not require food from clones to be labeled as such. Part I of this article identifies three functions that labels perform, outlines the types of information usually required, and introduces the rule that voluntary label information cannot be misleading. Part II focuses on process information …

Preparing For The Unknown: The Threat Of Agroterrorism, Matthew Padilla

Sustainable Development Law & Policy

No abstract provided.