Food and Drug Law Commons^™

Eating For The Environment: The Potential Of Dietary Guidelines To Achieve Better Human And Environmental Health Outcomes, Margaret Sova Mccabe

Law Faculty Scholarship

Agriculture and food production contribute significantly to greenhouse gas emissions and environmental pollution. Shifting human dietary patterns has the potential to reduce such environmental harms while also promoting human health. Government policy, in the form of the United States Dietary Guidelines (USDG), recommends what Americans should eat and could play an important role in shifting the food system to one that is more sustainable. However, the USDG are an overlooked aspect of U.S. food policy. While many countries have moved to synthesize environmental goals with dietary guidance, the United States has taken the opposite approach. In 2015, despite recommendations from …

Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann

Law Faculty Scholarship

There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely, while pharmaceutical drugs must undergo years of costly pre-market testing, most supplements, like foods, can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (FDA) remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as supplements tend to be most perceived for their apparent medicinal qualities. This philosophy of waiting for a …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

The New England Food System In 2060: Envisioning Tomorrow's Policy Through Today's Assessments, Margaret Sova Mccabe, Joanne Burke

Law Faculty Scholarship

This Essay analyzes how the New England states' planning processes are envisioning revitalized local, state, and regional food systems. This Essay has five parts. First, it begins with examining compelling reasons for promoting more sustainable food systems based on national and global trends, and identifies strategies for promoting regional food systems approaches with a brief introduction to the major influences on the national and New England food system. Second, it describes the states' planning efforts and their enabling legislation or source of authority.

The Essay then introduces the New England Food Vision 2060 (the Vision) an emerging discussion of food …

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 …

Foodshed Foundations: Law's Role In Shaping Our Food System's Future, Margaret Sova Mccabe

Law Faculty Scholarship

[. . .] This symposium Article analyzes how we can rethink the architecture of law based on a foodshed model to provide a greater role for local, state, and regional government in the American food system. In turn, greater roles for different levels of government may help America achieve greater efficiencies in domestic food safety, nutrition and related public health issues, sustainability, and international trade.

Americans need a greater voice in the food system. The foodshed model is a powerful vehicle that allows us to conceptualize change, allowing greater citizen participation and a more nuanced approach to food policy. The …

Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova Mccabe

Law Faculty Scholarship

In 2009, gluten-free foods were not only "hot" in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term "gluten-free." The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers.

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

The University of New Hampshire Law Review

[Excerpt] “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. I remember telling one of my colleagues, a patent law professor, who should be as comfortable with technology as anyone, about this development, and his response was, “Yuck. I’m not eating it!” To which of course I replied, “Humph. You won’t know the difference.” Meat or milk from a clone or its descendant is virtually identical to meat or milk from a non-clone, said the FDA, as …

Revisiting The Regulation Debate: The Effect Of Food Marketing On Childhood Obesity, Nicole E. Hunter

The University of New Hampshire Law Review

[Excerpt] “Despite the widespread concern regarding childhood obesity, there is broad divergence of opinion regarding responsibility for the crisis. Whether the government, food industry, or parents are accountable has become the focus of much debate. Public health groups have attempted various strategies to confront childhood obesity, such as litigation, legislation, and government regulation. While many researchers and advocates agree that government should play an affirmative role with respect to childhood obesity, they are very much divided over what that role should be. For example, although none of these acts has become law, eighty-six bills have been proposed regarding obesity since …

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) …

Loco Labels And Marketing Madness: Improving How Consumers Interpret Information In The American Food Economy, Margaret Sova Mccabe

Law Faculty Scholarship

America's current food labeling scheme, as illustrated by the example of salt, is flawed when examined from the consumer and public health perspective. While the Food, Drug, and Cosmetic Act has sound scientific standards, those standards as currently applied to labels do not efficiently signal health information to consumers. Without better information on labels, consumers will continue to make poor choices at the grocery store. However, there are promising new ways to label. Both the United Kingdom and the domestic supermarket chain Hannaford’s have implemented simple health labeling on food packaging or grocery shelves to improve the amount and location …

Public Perceptions Of Food Safety: Assessing The Risks Posed By Genetic Modification, Irradiation, Pesticides, Microbiological Contamination And High Fat/High Calorie Foods, Michael D. Mehta

The University of New Hampshire Law Review

[Excerpt] "In general, people in the developed world have access to a safe and varied supply of food. Instead of systemic hunger, many developed countries have problems with obesity and other kinds of eating disorders among their citizenry. It is within this context that some find public concerns about the safety of food both paradoxical and misplaced. Nevertheless, understanding how people perceive the risk associated with food is an important exercise in demonstrating accountability and in setting priorities for regulation. With the advent of technologies for producing genetically modified foods, and the development of fat blockers like Olestra, the public …

Bse: Risk, Uncertainty, And Policy Change, Enda Cummins, Pat Grace, Kevin Mcdonnell, Shane Ward

RISK: Health, Safety & Environment (1990-2002)

The authors discuss how, in our "risk society," a range of potential risks and uncertainties are associated with new technologies and new diseases, such as BSE. These risks bring with them worries about human health, while the ability to assess and manage new health scares is an essential skill for government and related industries.

Pesticide Residue Regulation: Analysis Of Food Quality Protection Act Implementation, Linda-Jo Schierow

RISK: Health, Safety & Environment (1990-2002)

Dr. Schierow discusses the effects of a recent statute on food safety.

Looking Back: Cyclamate, Allan Mazur, Kevin Jacobson

RISK: Health, Safety & Environment (1990-2002)

The second in a series re-evaluating hazards identified in the 1950s and 60s.

Daubert's Significance, Thomas G. Field Jr., Colleen M. Keegan

RISK: Health, Safety & Environment (1990-2002)

The authors review and note the limited reach of Daubert v. Merrell Dow Pharmaceuticals. They also address its implications for concerned non-lawyers.

Risk And Value Judgments: A Case Study Of The Poison Prevention Packaging Act, William E. Hilton

RISK: Health, Safety & Environment (1990-2002)

Mr. Hilton attempts to show why important choices presented in current proposals to amend child-resistant packaging regulations are fundamentally normative. He then argues that these choices should not be obscured by the technical issues.