Food and Drug Law Commons^™

The Gmo/Ge Debate, Joanna K. Sax

Faculty Scholarship

The scientific community and the public sphere are having different debates about the application of genetic engineering to improve our food supply. Many that are deeply steeped in the science view genetically engineered food as a more precise way to accomplish what we have been doing for centuries, which is genetically modifying our food supply. Some members of the public view genetically engineered food with skepticism especially as it relates to health, safety and the environment. A disconnect between the scientific consensus and public perception is not a new phenomenon. This Article attempts to bridge this gap by explaining what …

It’S Time For The Fda To Define ‘Natural’, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

The authors discusses the FDA 's recent call for comments on a definition of the term natural as it applies to food.

Gras-Fed Americans: Sick Of Lax Regulation Of Food Additives, Martha Dragich

Faculty Publications

Americans are “GRAS-fed” because of a “loophole” in the strict regime Congress provided for the regulation of food additives. Additives - and food products containing them - are exempt from this strict regime if they are accorded GRAS (Generally Recognized as Safe) status. The guidelines Congress provided for achieving that status by scientific evidence of safety are no longer observed. Most additives are determined by the producer alone to be GRAS. At the same time, Americans’ consumption of highly processed foods continues to rise, giving rise to long-term health problems that are increasingly tied to diet. The average American’s diet …

We Built It And They Did Not Come: Using Governance Theory In The Fight For Food Justice In Low-Income Communities Of Color, Deborah N. Archer, Tamara Belinfanti

Articles & Chapters

Food deserts and food insecurity have received considerable attention from various stakeholders, such as state and local governments, community organizations, and private sector institutions. These stakeholders have sought to overcome food insecurity by turning food deserts into oases by providing “access” to fresh, healthy food. However, many of their solutions—building supermarkets and sponsoring farmers markets—have missed the mark. Residents of food deserts did not flock to grocery stores to purchase fruits andvegetables. As a result, many stakeholders blame the residents of food deserts for their own predicament, lamenting, to paraphrase Field of Dreams, “we built it but they did not …

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …

Keeping Up With New Legal Titles, Franklin L. Runge

Law Faculty Scholarly Articles

In this book review, Franklin L. Runge discusses In Food We Trust: The Politics of Purity in American Food Regulation by Courtney I. P. Thomas.

Food Policy And Cognitive Bias, Paul F. Campos

Publications

No abstract provided.

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

Food Deprivation: A Basis For Refugee Status?, James C. Hathaway

Articles

It is commonplace to speak of those in flight from famine, or otherwise migrating in search of food, as “refugees.” Over the past decade alone, millions of persons have abandoned their homes in countries such as North Korea, Sudan, Ethiopia, Congo, and Somalia, hoping that by moving they could find the nourishment needed to survive. In a colloquial sense, these people are refugees: they are on the move not by choice, but rather because their own desperation compels them to pursue a survival strategy away from the desperation confronting their home communities.

The question addressed here is whether persons in …

Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino

University of Richmond Law Review

No abstract provided.

"Natural" Food Labeling: False Advertising And The First Amendment

Marquette Elder's Advisor

No abstract provided.

Food Miles: Environmental Protection Or Veiled Protectionism?, Meredith Kolsky Lewis, Andrew D. Mitchell

Michigan Journal of International Law

Eat local. Such a small phrase yet such a loaded proposition. Buying food from nearby sources has become a popular objective. This aim is associated with helping farmers in one’s country or region; observing the seasonality of one’s location; eating fresher foods; striving for food security; and protecting the environment. One of the unmistakable messages of the “locavore” movement is that importing food—particularly food that comes from far away—causes environmental harm. The theory is that transporting food long distances results in the release of high levels of greenhouse gases (GHGs) into the atmosphere and is thus a dangerous contributor to …

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

Oklahoma Law Review

No abstract provided.

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

University of Richmond Law Review

No abstract provided.

Food Court, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This article, focusing on produce and grain, discusses the environmental and climate change impacts of food production, processing, packaging, and distribution, which ultimately contribute to both economic and social costs. The article addresses environmental energy costs in the food supply. Figure 1 shows, for example, the significant amount of energy used in various aspects of food production, transportation, and processing.

Much of this article's focus will be on commodity crops. Along with wheat and rice, corn and soybeans constitute the world's most popular planted and consumed crops. The United States is the leading producer of corn, growing nearly 40 percent …

Fda And The Rise Of The Empowered Consumer, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

This Article traces the still-evolving view of consumers of FDA-regulated products as capable, rational, and rights-bearing decision makers. It also examines the corresponding diminution of FDA’s role as a paternalistic gatekeeper collaborating with medical and scientific experts to prevent products and manufacturer-provided information from reaching the public. Compared with their 1960s counterparts, today’s consumers of food and drugs have far greater freedom to make unmediated choices among a wider variety of products, guided by a relative deluge of labeling and advertising information. Moreover, food and drug regulation, once the exclusive domain of bureaucrats and experts, has become a focus of …

Taxing Food And Beverage Products: A Public Health Perspective And A New Strategy For Prevention, Jennifer L. Pomeranz

University of Michigan Journal of Law Reform

The power to tax and spend is considered a primary government power, and the use thereof is associated with great public health achievements. The greatest public health challenge at present stems from the increase in obesity and chronic diseases due to poor nutrition. Several taxation strategies have emerged in the health and economic literature to raise revenue, deter consumption, and address food prices and obesity directly. These proposals include taxing obese individuals, taxing problematic food products, and instituting a tax based on certain food components. This article weighs each proposal's value and disadvantages and concludes by proposing a new tax …

Implications Of The Supreme Court's Decision In Pliva, Inc. V. Mensing: Why Generic And Brand-Name Pharmaceuticals Must Be Treated Equally Under The Federal Food, Drug, And Cosmetic Act

Marquette Elder's Advisor

No abstract provided.

Do You Know What's On Your Plate?: The Importance Of Regulating The Processes Of Food Production, Martha Dragich

Faculty Publications

This article argues that the current regulatory approach-focusing on the supposed equivalence of new foods to traditional ones-is unduly narrow, particularly given the characteristics of the modem food system. To achieve the broad objectives of the FDCA in the context of the industrialized, highly processed, and global food supply of the twenty-first century requires adopting a broader understanding of consumer protection needs with respect to food. The FDCA itself is written in very broad terms and provides much of the authority needed today. The FDA's enforcement capacity, however, already is severely strained.52 Moreover, the scientific basis for some process- oriented …

International Law In A Time Of Scarcity: An Introduction, Harlan G. Cohen

Faculty Scholarship

Stories of scarcity litter the morning newspapers. Around the world, resources — food, water, fuel sources, clean air — seem stretched to, or even beyond, capacity. Consequences have already been serious, including suffering and unrest. Competition for resources seems likely only to increase. Does international law have the tools to manage or even solve this growing global problem? It was with this question in mind that the editors of the Georgia Journal of International and Comparative Law convened their 2012 symposium: “International Law in a Time of Scarcity.”

This short essay serves as introduction to that symposium and the related …

From “Food Miles” To “Moneyball”: How We Should Be Thinking About Food And Climate, Bret C. Birdsong

Scholarly Works

Since Michael Pollan popularized the push to eat local food in his bestseller, The Omnivore’s Dilemma, the concept of “food miles” has been something of a rallying cry and an organizing principle in the marketing of the local food movement. Among locavores and their sympathizers, the term seems to encapsulate all that is wrong with the food system. Fresh grapes from Chile make their way to supermarkets from Maine to Minnesota, and even California. Major food conglomerates process commodity ingredients like corn, soy, and wheat into packaged food that travels across the country and across oceans before landing on …

Food Choice And Fundamental Rights: A Piece Of Cake Or Pie In The Sky?, Kammi L. Rencher

Nevada Law Journal

No abstract provided.

Revisiting The Original Tea Party: The History Of Regulating Food Consumption In America, Alison Peck

Law Faculty Scholarship

In response to concerns over rising obesity rates, state and federal policymakers have introduced laws that seek to internalize the public health costs of consuming unhealthy foods. These laws range from taxes on sugared beverages to mandatory nutritional information disclosures and beyond. Vocal opponents to such laws, including many Tea Party members, characterize such laws as government overreaching into the private sphere. That opposition often evokes Revolutionary images and ideology, with references to the Boston Tea Party, the Founding Fathers, and the framing of the Constitution. This article challenges the symbolism used by these opponents by examining the pre-Revolutionary non-importation …

Between Starvation And Globalization: Realizing The Right To Food In India, Lauren Birchfield, Jessica Corsi

Michigan Journal of International Law

This Article evaluates People's Union for Civil Liberties v. Union of India & Others (PUCL) through multiple lenses, examining: (1) the necessary factors that contributed to the success of the Public Interest Litigation (PIL) and its enforcement and (2) both the implications and limitations of PUCL as it relates to India's larger economic policy framework. We argue that the development and success of the PUCL litigation have depended in part on provisions of the Indian Constitution amenable to the incorporation and promotion of economic and social rights as well as on a unique relationship between civil society and judicial institutions. …

Reclaiming The Right To Food As A Normative Response To The Global Food Crisis, Smita Narula

Elisabeth Haub School of Law Faculty Publications

In 2009, the number of hungry in the world crossed the one billion mark, a dubious milestone that has been attributed in large part to consecutive food and economic crises. Over ninety-eight percent of these individuals live in the developing world. Ironically, a great majority are involved in food production as small-scale independent food producers or agricultural laborers. These facts and figures signal a definitive blow to efforts to reduce global hunger and lift the world's poorest from abject and dehumanizing poverty. They also bring to light the deep imbalance of power in a fundamentally flawed food system. Responses to …

Private Regulation And Foreign Conduct, Adam I. Muchmore

Faculty Scholarship

Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens of …

Eatin' Good? Not In This Neighborhood: A Legal Analysis Of Disparities In Food Availability And Quality At Chain Supermarkets In Poverty-Stricken Areas, Nareissa Smith

Michigan Journal of Race and Law

Many Americans-especially the poor-face severe hurdles in their attempts to secure the most basic of human needs-food. One reason for this struggle is the tendency of chain supermarkets to provide a limited selection of goods and a lower quality of goods to patrons in less affluent neighborhoods. Healthier items such as soy milks, fresh fish, and lean meats are not present in these stores, and the produce that is present is typically well past the peak of freshness. Yet, if the same patron were to go to another supermarket owned by the same chain--but located in a wealthier neighborhood-she would …

Got Controversy - Milk Does, Margaret Sova Mccabe

Law Faculty Scholarship

This article analyzes ongoing controversy over how to best label rBST-free milk. Recombinant bovine somatotropin is a genetically engineered drug administered by some farmers to their dairy herds to increase milk production. FDA first approved its use in 1994, despite great controversy. The FDA also issued labeling guidelines that allowed voluntary disclosure of rBST-free milk, so long as it carried the disclaimer that no difference could be detected between milk produced with rBST and rBST-free. The controversy continues today as consumers express a preference for rBST-free milk and many rBST-free producers label their milk this way. "Conventional" milk (with rBST) …

The Environmental Effects Of Cruelty To Agricultural Animals, Kyle H. Landis-Marinello

Michigan Law Review First Impressions

Laws criminalizing animal abuse should apply to the agricultural industry. When we exempt the agricultural industry from these laws, factory farms increase production to unnaturally high levels. This increased production causes devastating environmental effects, such as climate change, water shortages, and the loss of topsoil. In light of these effects, the law needs to do much more to regulate the agricultural industry, and the first step should be to criminalize cruelty to agricultural animals. This would force the industry to slow down production to more natural levels that are much less harmful to the environment.

"It's The Right Thing To Do": Why The Animal Agriculture Industry Should Not Oppose Science-Based Regulations Protecting The Welfare Of Animals Raised For Food, Angela J. Geiman

Michigan Law Review First Impressions

Since the beginning of history, people have used farm animals to assist with their work and to provide a source of food. These agricultural pursuits were not questioned; rather, they were a widely-accepted way of life. In fact, many people still say that the very purpose of livestock on this Earth is to provide these resources for mankind. As for the proper way to treat our livestock, we commonly hear farmers and livestock producers make comments like, “If we take care of the animals, they will take care of us,” and, “We treat our animals well because that’s just good …