Food and Drug Law Commons^™

Archival: A Water Rights Manual For Mutual Domestic Water Consumers Associations, Utton Center, University Of New Mexico - School Of Law, Zackeriah Carpenter, Gregory Chakalian, Darcy S. Bushnell

Publications

The Utton Center prepared this Water Rights Manual to assist Mutual Domestic Water Consumers Associations (MDWCAs) with the development, protection and management of their water rights.

This manual provides an introduction to and defines Water Rights in New Mexico, as well as to acquire and have recognized Water Rights. This document also covers water management and planning, and provides additional resources.

The U.S. Department Of Agriculture As A Public Health Agency, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Introduction: The "war on obesity" is now well into its second decade.' What began as an effort to encourage medical doctors to screen and treat patients whose weight put them at risk for health problems has transformed into a much broader public health campaign to address the root causes of obesity. A growing number of state, territorial and local health departments are currently exploring new ways to promote healthy eating and physical activity. At the federal level, the U.S. Centers for Disease Control and Prevention (CDC) has made "nutrition, physical activity and obesity" a top priority.

The Crisis Of Over-Medicating Children In Foster Care: Legal Reform Recommendations For New York, Jessica Setless

Cardozo Journal of Equal Rights & Social Justice

No abstract provided.

Front-Of-Package Nutrition Claims: Trustworthy Facts Or Deceptive Marketing? Closing The Loopholes In Labeling, Kathryn E. Hayes

Cardozo Journal of Equal Rights & Social Justice

The note argues that front-of-package (FOP) labeling on children's food products is insufficient and often misleading, failing to meet basic nutritional standards. It advocates for the adoption of uniform, science-based labeling standards developed by an objective body like the Institute of Medicine (IOM) to help parents make healthier choices. The analysis highlights the limitations of self-regulation by manufacturers and the need for stronger governmental oversight to address deceptive practices and improve public health outcomes.

Regulating Prescription Drugs For Patient Safety: Does Bill C-17 Go Far Enough?, Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, Barbara Mintzes

Articles, Book Chapters, & Popular Press

Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962. However, most of the drug’s distribution was in the form of free samples to medical professionals, which the directorate had no legal authority to control. Therefore, to avoid similar situations in the future and to stop sales of thalidomide, on Dec. 4, 1962, the Parliament of Canada amended the Food and Drugs …

When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder

Articles, Book Chapters, & Popular Press

Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …

Undue Process At The Fda, Lisa Heinzerling

Georgetown Law Faculty Publications and Other Works

For over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the FDA …

Taxing The Platypygous, James J. White

Articles

This Article maintains that obesity in the United States is an enormous public health issue that causes the health care costs of the obese Americans greatly to exceed those of citizens of normal weight. Recognizing that that much of that cost will be born by publicly financed programs and that the taxes supporting those programs will constitute an externality that the fat impose on the thin, the Article proposes a tax on high calorie food-but only when that food is purchased by the obese. The Article addresses many of the administrative, moral and other objections to a tax aimed at …

Preemption Under The Controlled Substances Act, Robert A. Mikos

Vanderbilt Law School Faculty Publications

States are conducting increasingly bold experiments with their marijuana laws, but questions linger over their authority to deviate from the federal Controlled Substances Act. The CSA bans marijuana outright, and commentators have assumed that Congress sought to preempt all state laws that might somehow conflict with the CSA. Under the preemption rule now in vogue, state marijuana reforms are preempted if they either require someone to violate the CSA or, more controversially, if they pose an obstacle to Congress’s objective of eradicating marijuana. Seeking to avoid such conflicts, government officials have scuttled a number of important state marijuana reforms. This …

Check Please: Using Legal Liability To Inform Food Safety Regulation, Alexia Brunet Marks

Publications

Food safety is a hotly debated issue. While food nourishes, sustains, and enriches our lives, it can also kill us. At any given meal, our menu comes from a dozen different sources. Without proper incentives to encourage food safety, microbial pathogens can, and do enter the food source--so much so that according to the Centers for Disease Control and Prevention (CDC), each year roughly one in six Americans (or forty-eight million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. What is the optimal way to prevent unsafe foods from entering the marketplace?

Safety in the food …

The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law's Doctrine Of Equivalents With The Fda's Bioequivalence Requirement, Janet Freilich

Faculty Scholarship

Contrary to popular perception, generic drugs often enter the market before the patents covering their brand name counterparts have expired by making slight changes to the drug to avoid the brand name patent. These generics face a paradox: the U.S. Food and Drug Administration (FDA) requires that the generic "not show a significant difference" from the reference product, while patent law requires that the generic have "substantial differences" as compared to the reference product. The generic must be bioequivalent, but not legally equivalent, to the brand name drug. This paradox occurs frequently in the courts but has never been discussed …

Pay-To-Play: The Impact Of Group Purchasing Organizations On Drug Shortages, Christian Deroo

American University Business Law Review

No abstract provided.

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

Review, Risk, Legality And Damages, Paul Craig

Articles by Maurer Faculty

No abstract provided.

Selected Bibliography On Adjudications And New Mexico Water Management, Carol Romero-Wirth, Susan Kelly, Ernesto Longa

Publications

No abstract provided.

The Special Supplemental Nutrition Program For Women, Infants, And Children (Wic) And The Supplemental Nutrition Assistance Program (Snap): Comparing Policies And Suggesting Changes, Regina T. Cucurullo

Journal of Food Law & Policy

National concerns, such as obesity, should be addressed through national efforts. Considering the national reach of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) and the Supplemental Nutrition Assistance Program (SNAP) and their ability to influence the diets of a significant amount of the nation's population, changes to these programs should be made to encourage healthy nutrition.

Food And Agricultural Security Strategy And Its Implementation Under Public Health Security And Bioterrorism Preparedness And Response Act Of 2002, Vivek V. Nemane

Journal of Food Law & Policy

The U.S. agricultural system can be described as concentrated, specialized and industrialized. A typical food chain generally involves agricultural production, storage, processing and distribution. In the U.S. agricultural and food system, most production, distribution and processing is done in a consolidated and centralized manner.

Food Sovereignty In The United States: Supporting Local And Regional Food Systems, Allison Condra

Journal of Food Law & Policy

Today, perhaps more than ever, an increasing portion of U.S. society is paying attention to and asking questions about our food and agricultural system. We are recognizing the immense consequences of the agricultural "efficiencies" we valued and wrote into our policies in the seventies-for example, growing corn "fence row to fence row" and the ease of microwaved meals and prepackaged foods. 3 The increasingly global nature of our food system and its consequences are becoming more apparent. Food safety concerns-prompted by a growing number of foodborne illness outbreaks and the government's response in the 2009 Food Safety Modernization Act-loom large …

The Real Toy Story: The San Francisco Board Of Supervisors Healthy Food Incentives Ordinance, Cortney Price

Journal of Food Law & Policy

Obesity among children in the United States has tripled over the last thirty years. Incidentally, the world's largest fast food restaurant, McDonald's, first introduced its children's Happy Meal thirty-two years ago. Shortly thereafter, the first Disney inspired toy found its way into Happy Meals and the hearts of the "billions and billions served." Although the iconic Happy Meal and accompanying toy have become "a staple of Americana akin to baseball and apple pie," the continued existence of the practice is being threatened in light of the powerful influence toys have on children's food choices, thus contributing to the current obesity …

Cash, Crops, Chemicals, And Cosmetics: A Mid-Green Eco-Labeling Approach, Michael T. Olexa, R. Benjamin Lingle, Kimberly Stewart, Damian C. Adams

Journal of Food Law & Policy

The United States Department of Agriculture (USDA) uses grade standards to uniformly characterize the quality and condition of agricultural commodities. The standards are promulgated by the USDA's Agricultural Marketing Services (AMS) division in consultation with farming industry groups. Emphasizing produce attributes such as surface defects, shape, cleanliness, color, maturity, and decay, grade standards improve the marketability of agricultural commodities by establishing a common industry language for use in contracts. Use of such a language enables wholesale buyers to know the quality of commodities without first having to inspect them, thus facilitating trade by lowering transaction costs.