A Regulatory Cookbook for Emerging Foods: U.S. Oversight of Cell-Cultured Meat

Abstract

The United States regulatory framework is continuously confronted with the emergence of new high-potential high-risk technologies and the ensuing task of adapting outdated laws to unanticipated policy challenges. One of the latest instances of this is the development of cell-cultured meat, a technology that cultivates meat from animal stem cells without slaughter, creating opportunities to advance animal welfare, environmental protection, and public health.

Although the U.S. is leading commercial development of cultured meat, the U.S. government is lagging in developing a path to market for this emerging technology. This thesis sets out to advise an effective and efficient regulatory path forward. Specifically, this thesis explores the following research questions: (1) Should decision-makers actively support, restrict, or remain neutral on this technology’s development? (2) What are the implications of a joint FDA/USDA jurisdiction approach on the technology’s development? (3) How can regulators strike the optimal risk-benefit balance in managing food and environmental safety hazards for this technology? (4) How should this novel food be labeled?

In answering these questions, this thesis is guided by the principle of public beneficence, that is, maximizing public benefit and minimizing public harm. Based on analysis of the relevant laws, case studies, academic literature, and interviews, this thesis finds that cultured meat technologies have high potential to improve public welfare and that decision-makers should support the emerging technology. Additionally, this thesis finds that the existing regulatory regime is suited to oversee the risks and benefits of cultured meat production while also identifying potential areas for improvement.

To reduce regulatory inefficiencies while ensuring effective government oversight, this thesis recommends that USDA and FDA form an interagency working group to facilitate coordination. Together these agencies should draft a guidance document to clarify (1) appropriate regulatory pathways for premarket approval that include consultation and notification, and (2) neutral and informative names and descriptions that would constitute proper statements of identity of cultured meat and seafood products. Moving forward, the agencies should be given stronger authority to require consultation, notification, and special labeling for specific emerging foods. With these tools, decision-makers are equipped to act as stewards of a new wave of technologies with transformative potential to shape a better food future.