Law Commons^™

Hitting The Trip Wire: When Does A Company Become A "Marijuana Business"?, Lauren A. Newell

Law Faculty Scholarship

Like the alcohol industry was during Prohibition, the marijuana industry is a profitable one. And, as bootlegging was then, selling marijuana in the United States is currently illegal. Despite the number of states that have legalized or decriminalized the sale of marijuana for medical or recreational use under state law, marijuana sales remain illegal as a matter of federal law under the federal Controlled Substances Act of 1970 (“CSA”). Individuals and entities that violate the CSA face substantial criminal and civil liability, including prison time and fines, alongside a host of additional negative consequences arising from business, tax, bankruptcy, and …

Engaging Health Insurers In The War On Prescription Painkillers, Valarie K. Blake

Law Faculty Scholarship

No abstract provided.

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 …

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 …

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.

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 …