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January 11, 2012

Lynn L. Bergeson, “FDA’s Regulation of Nanotechnology: Will the New Draft Guidance Help Industry?,” Nanotechnology Law & Business, Volume 8, Issue 3.

Bergeson & Campbell, P.C.

The U.S. Food and Drug Administration’s (FDA) approach to nanotechnology is the subject of intense interest for at least three reasons. First, many promising and visible applications of nano-technology include cosmetics, sunscreens, pharmaceuticals, dietary supplements, and medical devices. These products are subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA). Second, FDA faces unique challenges in regulating products of nanotechnology be-cause of the product-based regulatory structure created under the FFDCA. The rapid increase in nanotechnology applications in FDA-regulated products raises questions regarding the adequacy of the FDA’s product-based approach given the differing statutory authorities FDA has over these product categories. Third, for regulatory purposes under the Act, FDA classifies medical products as drugs, devices, biologics, or combination products. A product’s mode of action determines which FDA Center has primary jurisdiction over the product. As nanotechnology matures, the distinctions between and among these classifications will blur, further stressing FDA’s ability effectively to oversee products of nanotechnology subject to its jurisdiction.