Food and Drug Law Commons^™

Beetles For Breakfast: What The Fda Should Be Telling You, Kaycee L. Wolf

Journal of Food Law & Policy

Imagine sitting down to breakfast and eating strawberry yogurt with a glass of grapefruit juice. You think you are eating a healthy meal, but along with vitamins, calcium, and nutrients, you are getting a side of crushed beetles. Cochineal extract and carmine, two color additives derived from the cochineal beetle, color many foods such as strawberry yogurt. When people consume products with color additives, most do not realize that they could be ingesting insects, which can also be potentially dangerous, not to mention possibly unappetizing or upsetting. Imagine that one minute you are sitting down to eat a healthy cup …

The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew

University of Michigan Journal of Law Reform

This Article takes a law and economics approach to exploring some of the costs that arise when governments rely on private enforcement to accomplish the goals of public law. The analysis focuses on qui tam enforcement under the Civil False Claims Act, because a remarkable body of empirical data demonstrates the expansive role private qui tam relators are playing in enforcing Medicare and Medicaid fraud and abuse laws. The Article further focuses on the application of these laws to the pharmaceutical industry. This focus is enlightening because the Government, as well as private enforcers, have recently targeted this industry so …

Uncapping The Bottle: A Look Inside The History, Industry, And Regulation Of Bottled Water In The United States, Joyce S. Ahn

Journal of Food Law & Policy

"Agu chupa! Agu chupa!" As we drove through the lush rolling hills of northwestern Rwanda, a crowd of young children appeared from the tea fields and repeatedly shouted these words to us. The taxi driver explained that the children wanted our "water bottes." Aware that visitors often drink bottled water, the children run alongside taxis with the hopes of obtaining the plastic bottles. Although Rwandan children typically carry their drinking water in tightly-woven baskets, the modern plastic bottles have become popular and prized possessions.

United States Food Law Update: Labeling Controversies, Biotechnology Litigation, And The Safety Of Imported Food, A. Bryan Endres

Journal of Food Law & Policy

This update summarizes significant changes and developments in food law throughout the first half of 2007. Out of necessity, not every change is included; rather, this update is limited to significant changes in national law. This series of updates provides a starting point for scholars, practitioners, food scientists, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates also builds an important historical context for the overall development of the discipline.

"Show-Me" No Rice Pharming: An Overview Of The Introduction Of And Opposition To Genetically Engineered Pharmaceutical Crops In The United States, Jillian S. Hishaw

Journal of Food Law & Policy

Farmers in California and Missouri have one thing in common- opposition to the production of genetically modified (GM) "pharma" crops.' A pharmaceutical crop, or "pharma" crop, is a plant that has been genetically altered so that it produces proteins which are used as drugs. Pharmaceutical companies can then harvest the crop and isolate the proteins, which may be used to make human or veterinary drugs. Farmers' fears include a variety of health and environmental hazards; in particular, they fear contamination of their regular crops and the associated market loss. These concerns surfaced in both states where Ventria Bioscience announced plans …

Journal Of Food Law & Policy - Fall 2007, Journal Editors

Journal of Food Law & Policy

No abstract provided.

The Battle Of The Bulge: Evaluating Law As A Weapon Against Obesity, Margaret Sova Mccabe

Journal of Food Law & Policy

"Silly rabbit, Trix are for kids." Since the 1970s, kids have gotten to know the silly rabbit created to promote sugary, fruit-flavored cereal in television ads. Today, "i'm lovin' it" is the McDonald's slogan, but to millions of children the more recognizable symbol is Ronald McDonald. Ronald McDonald is so recognizable that one study pegged recognition of Ronald among American children at 96% and another at 80% by children in nine other countries. Given the "obesity crisis," many question whether these ads should be permitted, with some questioning whether such products are even safe for children's consumption. The Trix Rabbit …

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Local Agriculture Perspectives In The Middle Rio Grande Valley, Cecilia Rosacker-Mccord

Publications

No abstract provided.

The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck

O'Neill Institute Papers

This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise …

A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck

O'Neill Institute Papers

This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. …

A Basin-Wide Approach To Water Management In The Middle Rio Grande Valley, Rolf Schmidt-Petersen

Publications

No abstract provided.

That’S A Fine Chablis You’Re Not Drinking: The Proper Place For Geographical Indications In Trademark Law, Justin Hughes, Lynne Beresford, Annette Kur, Kenneth Plevan, Susan Scafidi

Articles

No abstract provided.

Model Interstate Water Compact, Ken Knox

Publications

No abstract provided.

Intellectual Property Rights And The Public Sector: Why Compulsory Licensing Of Protected Technologies Critical For Food Security Might Just Work In China, Gregory C. Ellis

Washington International Law Journal

The majority of people in the developed world have the luxury of never having to address food shortages and malnutrition. In developing countries, however, ensuring food security presents greater challenges. Agricultural biotechnology has the potential to alleviate many of the food crises occurring in developing countries. Unlike private sector corporations, public sector entities are creating genetically modified (“GM”) crops to ensure food security. However, the intellectual property rights (“IPRs”) to the many technologies required to create a single GM crop are often fragmented across the private and public sectors. Fragmentation of IPRs creates a “patent thicket” that increases the challenges …

Advisory Committee Recommendations - The Utton Center Model Interstate Water Compact, State Bar Center, State Bar Of New Mexico

Publications

No abstract provided.

Proposition 36: Ignoring Amenability And Avoiding Accountability, Mehgan Porter

Brigham Young University Journal of Public Law

No abstract provided.

Regulatory Marketing Approval For Pharmaceuticals As A Non-Tariff Barrier To Trade: Analysis Under The Wto's Agreement On Technical Barriers To Trade, Mary Hess Eliason

San Diego International Law Journal

At a fundamental level, pharmaceuticals serve two roles: both as a cure for disease and as a product. As a cure for disease, a drug's value cannot be quantified because it saves lives. As a product, profit analysis shapes every step of a drug's progression to market. In least developed nations the barriers to drug access are not solely economic. National regulatory systems for market approval are being used to prevent external pharmaceutical manufacturers from participating in a national market. This article will address how the regulatory framework of pharmaceutical registration may serve as a barrier to trade in drugs, …

Journal Of Food Law & Policy - Spring 2007, Journal Editors

Journal of Food Law & Policy

No abstract provided.

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 …

Safe But Not Wholesome: The Troubling State Of Trans Fat Regulation, Ross Williams

Journal of Food Law & Policy

On March 7, 2007, the New York Times reported that Starbucks, the retail coffee chain which sells millions of baked goods every day from its over 8,700 U.S. stores, had asked its suppliers to eliminate all trans fats from their products by the end of the year. The big story for New York readers, though, was not that Starbucks was requiring the elimination of trans fats from its baked goods. In fact, New York City had just passed an ordinance strictly limiting the use of artificial trans fats, the type present in partially hydrogenated vegetable oil (PHVO), by virtually all …

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

On December 23, 2006, the European Commission published Commission Directive 2006/142/EC "amending Annex IlIa of Directive 2000/13/EC of the European Parliament and of the Council listing the ingredients which must under all circumstances appear on the labelling of foodstuffs" in regard to Directive 2000/13/EC of the European Parliament and of the Council of March 20, 2000, "on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs."' "Annex IIla of Directive 2000/13/EC lists the ingredients which must under all circumstances appear on the labeling of foodstuffs ... " and the new Directive …

Harvey V. Veneman And The National Organic Program: Can Organic Be Synthetic?, Jennifer C. Fiser

Journal of Food Law & Policy

The market for organic products has increased dramatically in the United States and across the world in recent years.' Since 1997, sales of organic foods have grown from 15% to 21% per year, and while organic foods accounted for only 2.5% of total food sales in the United States in 2005, those sales amounted to $13.8 billion.

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Defying Nature: The Ethical Implications Of Genetically Modified Plants, Debra M. Strauss

Journal of Food Law & Policy

Genetic engineering is changing the semantics, the meaning of life itself. We're trying to usurp the plant's choice. To force alien words into the plant's poem, but we [have] a problem. We barely know the root language. Genetic grammar's a mystery.... We've learned a lot about the letters-maybe our ability to read and spell words now sits halfway between accident and design - but our syntax is still haphazard. Scrambled. It's a semiotic nightmare.

Criminal Responsibility And The Disappearing Person, Stephen J. Morse

Cardozo Law Review

No abstract provided.

One Stop, No Stop, Two Stop, Terry Stop: Reasonable Suspicion And Pseudoephedrine Purchases By Suspected Methamphetamine Manufacturers, Andrew C. Goetz

Michigan Law Review

This Note attempts to inject some clarity into courts' reasonable suspicion calculus for cold medicine purchases. It argues that the key factor in analyzing such purchases is whether the purchaser or purchasers appear to be circumventing pseudoephedrine purchasing restrictions in order to obtain inordinately large quantities of pseudoephedrine. Part I provides a general background on the domestic manufacture of methamphetamine in small, clandestine laboratories. Part II then examines the interplay between outward innocence and reasonable suspicion under the Supreme Court's Fourth Amendment jurisprudence. Finally, Part III establishes a framework for identifying purchasing strategies that methamphetamine manufacturers commonly use to circumvent …

The Negative Effect Of Pharmaceutical Patents On South African Industry, Chenxi Jiao

Cardozo Public Law, Policy & Ethics Journal

The note argues that the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has disproportionately favored developed economies, stifling the growth of local pharmaceutical industries in developing countries like South Africa. While TRIPS aimed to balance societal benefits with short-term costs, its strict patent protections have hindered the development of generic drug manufacturing and technology transfer in these regions. The analysis highlights that strong intellectual property rights alone do not drive foreign investment or industrial growth, as market size, infrastructure, and economic stability play more critical roles. The note advocates for a reformed approach to intellectual …

Cold Comfort Pharmacy: Pharmacist Tort Liability For Conscientious Refusals To Dispense Emergency Contraception, Kristen Marttila Gast

ExpressO

The past several years have seen an increasing number of pharmacists refuse to dispense emergency contraception, an effective, post-coital form of contraception, on the grounds that the drug violates their personal beliefs. This Article addresses the impact of those pharmacist refusals under existing principles of tort law. The Article draws on existing pharmacy case law, state-specific refusal clauses, and ethics statements promulgated by professional pharmacy associations to investigate whether pharmacists have a legal duty to dispense emergency contraception, notwithstanding religious or ethical objections. Concluding that in most states, such a legal duty does exist, the Article develops a “wrongful conception” …

Hemp ... Why Not?, Jared B. Kahn

ExpressO

Hemp ... Why Not?

By: Jared Kahn

(Abstract)

Industrial hemp has been utilized as a commodity crop for centuries in the United States, and for millennia throughout the world. Today, the crop is cultivated for industrial uses in thirty countries, but not the United States. United States citizens may import hemp, eat hemp, wear hemp, and do whatever they please with a manufactured hemp product, but nobody grows the valuable crop in the U.S. Several states have legalized industrial hemp cultivation, however, the federal Drug Enforcement Agency (DEA) interprets the Controlled Substances Act (CSA) to prohibit the growing of hemp …