Nanotechnology and the FDA: Size Matters!

The Food & Drug Administration (FDA) issued in July 2007 its Nanotechnology Task Force Report. This report acknowledged that nanoscale materials potentially could be used in most product types regulated by the agency and that those materials present challenges complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale.

Anticipating the potential for rapid commercialization in the field, the FDA report recommended consideration of agency guidance that would clarify what information industry needs to provide FDA about nanoproducts, and also when the use of nanoscale materials may change the regulatory status of products. On September 8th, FDA is holding a public meeting to gather comments and data to assist the agency in the development of that guidance.

The meeting agenda will include product-specific presentations and discussion on:

1) medical devices; .) prescription drugs, including over-the-counter (OTC) drugs like sunscreens; 3) food and color additives, including food contact substances; 4) dietary supplements; and 5) cosmetics.

Several leading experts and authors of reports on nanotechnology oversight published by the Project will submit and present testimony before this landmark public meeting addressing key policy issues concerning FDA’s current and future regulation of nanoscale materials.

Speakers:

• Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies (presentation: cosmetics)

• William B. Schultz, former FDA official and attorney, Zuckerman Spaeder, LLP (presentation: dietary supplements)

• Michael R. Taylor, former FDA official and Research Professor of Health Policy at the School of Public Health, George Washington University (presentation: food and food packaging)