Faculty Scholarship

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This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is currently regulating these products by focusing on the degree of hazard and the serious problems that arise from this misguided focus. In Part III, the history of the FDCA [Food, Drug, and Cosmetic Act] is summarized in order to explain how, and why, the FDCA came to titer the degree and kind of regulation it uses to protect consumers from harm from third parties to the level and type of vulnerability of targeted consumers. Next, this Article builds on this history to describe how the Act has historically dealt specifically with regulating novel ingredients with unknown health risks in order to deal with consumer vulnerabilities. This history is then used to illuminate the reasons why a switch from a focus on hazard to a focus on novelty is supported by precedent and better fits the policies and goals of the FDCA while, at the same time, achieving the proper balance between protecting public health and encouraging innovation. This Article shows how a simple provision that is already a part of the FDCA can be relied upon to require ingredient listing based on novelty so that additional legislation is not required. In Part IV, this Article illustrates how this focus will operate to achieve the balance between safety and innovation with other innovative, novel technologies used as ingredients in consumer products such as cloned animals, genetically modified plants and animals used for food, as well as with lab-grown meat. Finally, in Part V, this Article describes why the use of cost-benefit analysis by the Office of Management and Budget to evaluate the change suggested by this Article is inappropriate when dealing with novel ingredients in the context of individual risk. [excerpt]