Food and Drug Law Commons^™

Intersectionality Matters In Food And Drug Law, Colleen Campbell

University of Colorado Law Review

Feminist scholars critique food and drug law as a site of gender bias and regulatory neglect. The historical exclusion of women from clinical trials by the FDA prioritized male bodies as the object of clinical research and therapies. Likewise, the FDA’s prior restriction on access to contraceptive birth control illustrates how patriarchal and paternalistic attitudes within the Agency can harm women’s reproductive health. However, there is little analysis of how race and gender intersect in this domain. This Article uses the regulation of skin-lightening cosmetics products to illustrate why and how intersectionality matters in food and drug law. While the …

A First Amendment Failure: Surrendering To Science Misinformation For Bioengineered Foods, Casey J. Nelson

University of Colorado Law Review

Government-compelled commercial disclosures are not unfamiliar to consumers. Common labels include nutrition facts and ingredient information. The National Bioengineered Food Disclosure Standard, which took full force at the start of 2022, is of a different nature. The new law requires all manufacturers, all importers, and certain retailers of bioengineered foods to disclose on the food’s packaging that it has been produced with bioengineering technology. Even so, a large swath of the public is ignorant of “bioengineering’s” true meaning and bioengineering technology’s true quality. The politically charged and fact-lacking debate on bioengineered foods renders this standard an impermissible coercion of speech …

Taming America's Sugar Rush: A Traffic-Light Label Approach, Alexia Brunet Marks

Publications

Excess added sugar negatively impacts health and can lead to a litany of problems, such as diet-related chronic diseases, e.g., diabetes, cancer, heart disease, and obesity, costing Americans millions in rising medical bills each year. Even more, new studies reveal that individuals with these underlying chronic diseases are at a higher risk of complications from COVID-19 and other viruses compared to those who are deemed healthy. And yet added sugars are difficult to avoid because unlike naturally occurring sugars found in fruits, vegetables, and milk, these sweeteners are added during food processing and preparation.

The problem is that while consumers …

(Carbon) Farming Our Way Out Of Climate Change, Alexia Brunet Marks

Publications

Numerous climate-related emergencies highlight the challenges and urgency posed by climate change: the 2018 Intergovernmental Panel on Climate Change (IPCC) Report, the Global Climate Action Summit in California and international student walkouts, to name a few. While the IPCC Report sent an urgent cry to reduce total emissions and to achieve specific results—45% reduction by 2030 and net-zero emissions by 2050—reductions need to be combined with capturing and storing atmospheric carbon dioxide. Scientific studies have shown that an annual increase of 0.4% of carbon stored in soils would make it possible to stop the present increase in atmospheric CO2.

This …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks

Publications

Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries learn …

The Right To Regulate (Cooperatively), Alexia Brunet Marks

Publications

The growing number of new technologies in food production— such as nanotechnology, genetic modification, animal cloning, and irradiation—are garnering different regulatory responses around the world. Based on their threshold for tolerating risk, countries are asserting their national right to regulate at home using labeling, quarantine, and outright bans on foods. But domestic regulation has its limits in a free trade environment. Countries that are not mindful of treaty obligations could face legal liability, as seen in the recent litigation between Uruguay and Philip Morris International. In short, traditional models of international regulatory cooperation (IRC) are failing to provide countries with …

The Risks We Are Willing To Eat: Food Imports And Safety, Alexia Brunet Marks

Publications

Recent efforts to regulate the safety of U.S. food imports have not kept up with the complexity of global trade and the risks that accompany globalization. Congress drafted the Food Safety Modernization Act of 2011 ("FSMA") in response to heightened food safety risks, surging imports, and an outdated food import safety system. While the FSMA provides the Food and Drug Administration ("FDA") additional authority to regulate food facilities, establish standards for safe produce, recall contaminated foods, and oversee imported foods, vulnerabilities still exist.

This article exposes problems with the old system of food import rules and significant challenges facing the …

Food Policy And Cognitive Bias, Paul F. Campos

Publications

No abstract provided.

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 …

Crises, Congress, And Cognitive Biases: A Critical Examination Of Food And Drug Legislation In The United States, Sharon B. Jacobs

Publications

No abstract provided.

Common Ground: The Case For Collaboration Between Anti-Poverty Advocates And Public Interest Intellectual Property Advocates, Deborah J. Cantrell

Publications

This article examines the previously unappreciated common ground between scholars and advocates who work to eliminate poverty, and scholars and advocates who work on intellectual property issues in the public interest. The article first illustrates how scholars and advocates working on poverty and on public interest intellectual property have relied on rights talk to frame their social movements. Under the conventional narrative, the framing has accentuated differences between the movements. As the Article explains, the two movements share core principles and should recognize shared interests and goals. By developing a new model of how to view public interest movements, the …