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Use of Nanoscale Materials in Commercial Sunscreen Products
Volume 9, Issue 1

Michael F. Cole, Lynn L. Bergeson, and Carla N. Hutton

The decision that the U.S. Food and Drug Administration (FDA) will make on the citizen petition filed by the International Center for Technology Assessment to require FDA to amend its requirements for products containing nanomaterials will be a watershed event in the history of the regulation of products utilizing nanoscale materials. In this article, we will discuss the rise to prominence of nanoscale titanium dioxide and zinc oxide as ingredients of sunscreen formulations, and the reasons for the increase in use. We will review the concerns raised by public interest groups and others regarding potential public health and environmental risks attributed to the unique characteristics of the materials, and the actions taken to design and conduct studies to determine whether the nanoscale materials are suitable for use in sunscreens. We will then move to consider how FDA might utilize the data being developed to respond to the aforementioned petition, reviewing FDA’s possible options. The article will conclude with a recommendation as to how FDA might accommodate the competing considerations involved.

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