Faculty Scholarship

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This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on to illustrate how the FDA’s dated position on bioequivalence, coupled with preexisting regulations, lead to a lack of a labeling requirement which bars a consumer from engaging in self-protection. Compounding this situation is the tort system’s inadequate response if a consumer is injured from this unavoidable exposure. This Article spells out how the insensitivity of the tort system to injuries from innovative technologies means that an injury from a nanotech product will be borne by the consumer and not the manufacturers who are profiting from product sales. This disconnect violates basic principles of distributive justice. Finally, this Article proposes alternative methods of regulating nanotech products that better protect public health while encouraging technical innovation. These proposals are based on lessons learned from past introductions of new chemicals and innovative technologies, such as asbestos, PCBs, DES, Thalidomide, medical X-rays, and Benzene which all had serious, long-term public health consequences. [excerpt]