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September 12, 2008

FDA Nanotechnology Meeting

Lynn L. Bergeson

The United States Food and Drug Administration (FDA) held its publicized Public Meeting on Nanotechnology on Monday, September 8, 2008, near its main offices in Rockville, Maryland. The meeting consisted of a plenary session led by Dr. Norris Alderson, Co-Chair of the FDA Nanotechnology Task Force, followed by separate breakout sessions for prescription and over-the-counter (OTC) drugs, cosmetics, medical devices, food and color additives (including food contact substances), and dietary supplements.  In general, the meeting yielded no new information pertinent to FDA’s nanotechnology plans or policies.

At the beginning of the meeting, Dr. Alderson and the other FDA plenary session speakers made it clear that FDA was not there to present its views on nanotechnology, or describe its activities. Rather, FDA hoped that the speakers and participants from industry, academia, and the public would provide input on the factors it should consider in providing guidance on the information and data that might be needed to demonstrate the safety and effectiveness of regulated products containing nanoscale materials. The FDA speakers also solicited information about the circumstances under which the regulatory status of a product might change if nanoscale materials were utilized in place of the macro-sized materials evaluated by FDA when the product was first cleared for marketing. In the Federal Register notice announcing the meeting, FDA posed questions, the answers to which would help to start providing the information it needed to provide guidance. For the most part, the speakers attempted to provide information on the requested subjects, although the information exchange was hampered by concerns regarding the protection of the confidentiality of commercial information. Dr. Rick Canady, FDA Senior Health Scientist, stated that FDA was hoping to have industry establish food master files, in which confidential information could be protected. FDA would become the consolidator of knowledge and the stronger knowledge base would produce better science.